Biontech SE (BNTX) 2026 Q2 法說會逐字稿

Thank you, operator. Good morning and good afternoon. Thank you for joining BioNTech second-quarter 2026 earnings call. As a reminder, the slides we will be using during this call and the corresponding press release can be found in the Investor section of our website.

謝謝，接線員。各位早安、午安。感謝各位參加 BioNTech 2026 年第二季財報電話會議。提醒各位，本次會議將使用的簡報投影片及相應新聞稿，可於我們網站的投資人專區查閱。

On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the US Securities and Exchange Commission, 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. On slide three, you can see the agenda for today's call.

下一張投影片將顯示我們的前瞻性陳述免責聲明。關於這些陳述及其他風險的更多資訊，已載於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與不確定性影響，且僅截至本次電話會議日期有效。我們不承擔更新或修訂任何此類陳述的義務。在第三張投影片中，您可以看到今天會議的議程。

I am joined by the following members of BioNTech's management team: Ugur Sahin, Chief Executive Officer and Co-Founder; Özlem Türeci, Chief Medical Officer and Co-Founder; and Ramon Zapata, Chief Financial Officer. Also available for the Q&A portion of the call is Anne Marie Hannekamp, Chief Commercial Officer. Related to yesterday's Chief Executive Officer announcement, we will also be joined today by Helmut Jeggle, Chairman of BioNTech Supervisory Board.

與我一同出席的 BioNTech 管理團隊成員包括：共同創辦人兼執行長 Ugur Sahin；共同創辦人兼首席醫療長 Özlem Türeci；以及首席財務長 Ramon Zapata。此外，在問答環節亦有首席商務長 Anne Marie Hannekamp 出席。與昨日的執行長公告相關，我們今天也將由 BioNTech 監事會主席 Helmut Jeggle 一同參與。

With this, I will hand the call over to Helmut.

接下來，我將把電話會議交給 Helmut。

Thank you, Doug, and good morning, everyone. Before we begin with a business update from the management board, I would like to provide further color on the appointment of BioNTech's next chief executive officer. As announced yesterday, Guido Oelkers will take office as CEO as of February 1st at the latest. From the outset, the Supervisory Board's CEO search was guided by three clear priorities: proven strategic leadership, the ability to scale a global biopharmaceutical business, and a strong track record of building and growing innovation-driven, science-based organizations. Guido is an excellent fit on all three dimensions. Most recently, as CEO of Sobi, he more than quadrupled the company's revenues over nine years by strengthening its global capabilities and maximizing the value of its late-stage pipeline.

謝謝你，Doug，各位早安。在管理董事會進行業務更新之前，我想就 BioNTech 下一任執行長的任命提供更多說明。如昨日所宣布，Guido Oelkers 將最遲於 2 月 1 日就任執行長。自一開始，監事會的執行長遴選即以三項明確優先事項為指引：經驗證的策略領導力、擴大全球生物製藥業務的能力，以及建立並成長以創新驅動、以科學為本之組織的卓越紀錄。Guido 在這三個面向都非常契合。最近，他擔任 Sobi 執行長期間，透過強化全球能力並最大化其後期研發管線價值，在九年間使公司營收成長超過四倍。

He brings deep expertise in launching and commercializing innovative products with a focus on the US market, as well as extensive leadership experience across Europe and Asia Pacific. The Supervisory Board believes that Guido is the right leader for BioNTech's next phase. His expertise in scaling innovative organizations in a focused and capital-efficient manner, combined with his deep knowledge of the markets most relevant to BioNTech, will position the company well to deliver on its key objectives, evolve into a multi-product biopharmaceutical company, and continue its remarkable success story.

他在以美國市場為重點的創新產品上市與商業化方面具備深厚專業，並在歐洲與亞太地區擁有豐富的領導經驗。監事會相信，Guido 是帶領 BioNTech 邁入下一階段的合適領導者。他在以聚焦且資本效率高的方式擴大創新組織方面的專長，加上對 BioNTech 最相關市場的深刻理解，將使公司具備良好條件以達成關鍵目標、演進為多產品的生物製藥公司，並延續其卓越的成功故事。

With that, I would like to hand over to Ugur and will be available for questions during the Q&A at the end of the call.

接下來，我想把時間交給 Ugur；在會議最後的問答環節，我也會在場回答問題。

Thank you, Helmut, and a warm welcome to everyone joining us today. I believe it is important to note that this transition reflects the natural evolution of BioNTech from a pioneering research organization into a global biopharmaceutical company with multiple commercial products. The next phase of this evolution requires the corresponding leadership skills, and I am confident we have found it in Guido. During our exchanges, I have come to know Guido as a leader who combines a deep understanding of the pharmaceutical industry and strategic acumen with genuine respect for the culture and people of our organization. He understands what we have built, and importantly, he understands what it will take to scale it. To ensure continuity and a seamless transition, I will remain actively engaged in supporting the preparations for Guido's onboarding. As for BioNTech's next phase, our mission remains constant: to translate science into survival.

謝謝你，Helmut，也熱烈歡迎今天加入我們的各位。我認為重要的是指出，這次交接反映了 BioNTech 從開創性的研究型組織，自然演進為擁有多項商業化產品的全球生物製藥公司。這一演進的下一階段需要相應的領導能力，我有信心我們已在 Guido 身上找到。在交流過程中，我認識到 Guido 是一位領導者，能將對製藥產業的深刻理解與策略敏銳度，結合對我們組織文化與人才的真誠尊重。他理解我們所建立的一切，更重要的是，他理解要如何將其規模化。為確保延續性與順暢交接，我將持續積極投入，支持 Guido 到任前的各項準備。至於 BioNTech 的下一階段，我們的使命始終不變：將科學轉化為生存。

To achieve this, BioNTech has successfully built a diversified toolkit of modalities, including next generation immunomodulators, ADCs, and mRNA cancer immunotherapies. Our multi-product portfolio has progressed further, and a growing share of it's now in late-stage clinical development and pivotal trials. The second quarter was a period of significant progress for BioNTech towards this. First, we are accelerating the late-stage development of our oncology assets. We shared encouraging global data in first-line NSCLC from the Phase 2 portion of our Phase 2-3 trial at ASCO from our potential next generation IO backbone, pumitamig. Second, our combination therapy strategy is gaining momentum. We have expanded our novel combination programs and presented data from ongoing combination trials with our ADCs, with more to come soon. Third, we continue our shift from platform-centric to a tumor-centric clinical development approach around cancers with greatest unmet medical need.

為了達成此目標，BioNTech 已成功建立多元化的技術工具組合（modalities），包括次世代免疫調節劑、ADC，以及 mRNA 癌症免疫療法。我們的多產品組合已進一步推進，且其中愈來愈高的比例已進入後期臨床開發與關鍵性試驗。第二季對 BioNTech 而言，是朝此方向取得重大進展的一段期間。第一，我們正加速腫瘤資產的後期開發。我們在 ASCO 上分享了來自第 2-3 期試驗之第 2 期部分的令人鼓舞的全球數據，顯示我們潛在的次世代 IO 基礎療法 pumitamig 在第一線 NSCLC 的表現。第二，我們的合併療法策略正加速推進。我們已擴大創新的合併療法計畫，並公布了與我們 ADC 相關的進行中合併試驗數據，後續很快還會有更多更新。第三，我們持續從以平台為中心，轉向以腫瘤為中心的臨床開發策略，聚焦於未被滿足醫療需求最高的癌症。

Notably, in our GU tumor area, we dosed the first patient in our Phase 3 trial, evaluating our B7-H3 ADC, elfetabart drozuntecan, formerly known as BNT324, in metastatic castration-resistant prostate cancer. BioNTech is well-positioned for the next phase. With a growing pipeline of potentially registrational trials, strong partnerships, and financial strength, we are on track to become a diversified multi-product company by 2030. We are targeting more than 17 late-stage and pivotal trial readouts through 2030 and beyond, spanning multiple tumor types and different lines of treatment. Our progress to date sets us up for an impactful second half of 2026. We enter the remainder of this year with momentum and diligent execution as we continue to progress towards our long-term vision. With this, I will hand over to Özlem for an update on our oncology execution.

值得一提的是，在我們的泌尿生殖（GU）腫瘤領域，我們已在第 3 期試驗中完成首位受試者給藥，該試驗評估我們的 B7-H3 ADC——elfetabart drozuntecan（先前稱為 BNT324）——用於轉移性去勢抗性前列腺癌。BioNTech 已為下一階段做好充分準備。憑藉日益擴大的、具潛在註冊性（registrational）的試驗管線、強大的合作夥伴關係與穩健的財務實力，我們正按計畫在 2030 年前成為多元化的多產品公司。我們目標是在 2030 年及之後取得超過 17 項後期與關鍵性試驗讀出，涵蓋多種腫瘤類型與不同治療線別。迄今的進展使我們有望在 2026 年下半年帶來具影響力的成果。我們以動能與嚴謹執行力進入今年剩餘時間，持續朝長期願景推進。接下來，我將把時間交給 Özlem，請她更新我們在腫瘤領域的執行進展。

Thank you, Ugur. I'm glad to be speaking with everyone today. Our ambition is to address the full continuum of cancer, utilizing the approaches that Ugur outlined. We have defined a tumor-focused strategy to address significant unmet medical need where our novel combinations can extend survival outcomes for patients and maximize the potential of our pipeline. As such, we are advancing multiple assets from our multimodal oncology pipeline into late-stage development. During the first half of 2026, we made progress across our pipeline, and I'll cover some of these updates today.

謝謝你，Ugur。很高興今天能與各位交流。我們的抱負是運用 Ugur 所概述的方法，涵蓋癌症的完整連續照護。我們已制定以腫瘤為核心的策略，聚焦於重大未被滿足的醫療需求領域，在這些領域中，我們的新型合併療法可延長患者存活結果，並最大化我們研發管線的潛力。因此，我們正推進多項來自多模式腫瘤研發管線的資產進入後期開發。在 2026 年上半年，我們在整體研發管線上取得進展，今天我將分享其中部分更新。

I'll begin with lung cancer, which is one of the cancers of highest unmet medical need in the tumor area where we have the broadest and most diverse coverage. We are aiming to tackle unmet medical needs at every stage of the lung cancer patient journey. Our lung cancer strategy covers various disease stages, settings, and enlists various modalities.

我將從肺癌開始，這是未被滿足醫療需求最高的癌症之一，也是我們在腫瘤領域中覆蓋最廣、最多元的領域。我們的目標是在肺癌患者旅程的每一個階段都能解決未被滿足的醫療需求。我們的肺癌策略涵蓋不同疾病期別與治療情境，並採用多種治療模式。

Next-generation immunomodulators, ADCs, and mRNA cancer immunotherapy. For certain settings, we have multiple opportunities with the aim to change the standard of care and move forward with our combination strategy. At the core of this tumor-based oncology strategy is pumitamig, our investigational bispecific immunomodulator targeting PD-L1 and VEGF-A, now in development with our partner BMS. In lung cancer, we are now running four registrational programs for pumitamig. ROSETTA-Lung 01 in first-line extensive stage small cell lung cancer, ROSETTA-Lung 02 in first-line non-small cell lung cancer, where global Phase 2 data were presented at ASCO. ROSETTA-Lung 202, our pivotal trial in first-line PD-L1 high non-small cell lung cancer is now enrolling. ROSETTA-Lung 201, our pivotal trial in unresectable Stage 3 non-small cell lung cancer is also underway. We are generating novel combination data to inform the first wave of combination trials with registrational intent. Zooming in on pumitamig.

新一代免疫調節劑、ADC 與 mRNA 癌症免疫療法。在特定治療情境中，我們擁有多項機會，目標是改變照護標準，並推進我們的聯合治療策略。此一以腫瘤為核心的腫瘤學策略之核心，是 pumitamig——我們的研究性雙特異性免疫調節劑，靶向 PD-L1 與 VEGF-A，目前與合作夥伴 BMS 共同開發中。在肺癌方面，我們目前正在進行四項 pumitamig 的註冊性計畫。ROSETTA-Lung 01 用於一線廣泛期小細胞肺癌；ROSETTA-Lung 02 用於一線非小細胞肺癌，其全球第 2 期數據已於 ASCO 發表。ROSETTA-Lung 202——我們在一線 PD-L1 高表達非小細胞肺癌的關鍵性試驗——目前正在招募中。ROSETTA-Lung 201——我們在不可切除第 3 期非小細胞肺癌的關鍵性試驗——也正在進行中。我們正在產生新的聯合治療數據，以指引第一波具註冊意圖的聯合試驗。聚焦 pumitamig。

Here we again have pioneered by delivering the first global Phase 2 data for a PD-L1 VEGF bispecific in first-line non-small cell lung cancer. At ASCO in June, we presented Phase 2 data from ROSETTA-Lung 02, our global randomized Phase 2/3 trial evaluating pumitamig in combination with chemotherapy in patients with previously untreated advanced non-small cell lung cancer. In 40 evaluable patients with both squamous and non-squamous histology, pumitamig plus chemotherapy demonstrated robust clinical activity with unconfirmed and confirmed overall response rates for combined doses of 72.5% and 62.5% respectively. Two features of this data deserve particular emphasis. First, the encouraging activity observed across PD-L1 expression levels is noteworthy. Second, the particularly strong response rate in PD-L1 low disease across histologies. This includes patients with PD-L1 TPS less than 1%, who represented approximately 58% of patients in this cohort, a subgroup typically with poor response to anti-PD-1, PD-L1 treatment.

在此我們再次率先提供 PD-L1/VEGF 雙特異性藥物於一線非小細胞肺癌的首份全球第 2 期數據。在 6 月的 ASCO，我們發表了 ROSETTA-Lung 02 的第 2 期數據；該試驗為全球隨機分派的第 2/3 期試驗，評估 pumitamig 聯合化療用於既往未治療之晚期非小細胞肺癌患者。在 40 名可評估患者（包含鱗狀與非鱗狀組織學）中，pumitamig 加化療展現強勁臨床活性；合併劑量的未確認與已確認總反應率分別為 72.5% 與 62.5%。此數據有兩項特徵值得特別強調。第一，跨 PD-L1 表達水準所觀察到的令人鼓舞之活性值得關注。第二，在不同組織學中，PD-L1 低表達疾病的反應率特別強。其中包含 PD-L1 TPS 低於 1% 的患者，約占本隊列的 58%；此亞群通常對抗 PD-1/PD-L1 治療反應不佳。

In that population, the confirmed objective response rate was 47.6%. In patients with TPS between 1% and 49%, it was 77.8%, and all six patients with TPS 50% or above responded. The safety profile was manageable in both histologies with no new safety signals. These data support the ongoing global Phase 3 program for pumitamig in lung cancer. The robust clinical responses across PD-L1 strata align with our expectations. It speaks to the potential of pumitamig to confer benefit in the all-comer patient population, including the PD-L1 low expression levels where unmet medical need is high. The ROSETTA-Lung 02 trial is currently recruiting in its Phase 3 portion, and we look forward to presenting additional Phase 2 data from this trial as the data mature.

在該族群中，已確認的客觀反應率為 47.6%。在 TPS 介於 1% 至 49% 的患者中為 77.8%，而 TPS 50% 或以上的 6 名患者皆有反應。兩種組織學的安全性概況均可管理，且未出現新的安全性訊號。這些數據支持 pumitamig 在肺癌的全球第 3 期計畫持續推進。跨 PD-L1 分層所見之強勁臨床反應與我們的預期一致。這顯示 pumitamig 可能使所有入組（all-comer）患者族群受益，包括 PD-L1 低表達、未滿足醫療需求高的族群。ROSETTA-Lung 02 試驗目前正在其第 3 期部分招募中，我們期待隨著數據成熟，發表該試驗更多第 2 期數據。

The central question in the PD-1, PD-L1, VEGF class has been whether the clinical activity observed in trials conducted in China would be consistent with the data in global populations. We have been able to address that question with our own asset across three key tumor types in Phase 2 trials. Firstly, in first-line small cell lung cancer. The China Phase 1/2 demonstrated a disease control rate of 94% and a confirmed overall response rate of 82%. With the global Phase 2 trial, we showed a disease control rate of 100% and a confirmed objective response rate of 76%. There is the first-line non-small cell lung cancer indication. We observed in the China monotherapy Phase 1/2, a confirmed objective response rate of approximately 47% in PD-L1 positive patients.

在 PD-1、PD-L1、VEGF 這一類別中，核心問題一直是：在中國試驗中觀察到的臨床活性，是否能與全球族群的數據一致。我們已在第 2 期試驗中，透過我們自有資產於三個關鍵腫瘤類型回答了此問題。首先是一線小細胞肺癌。中國第 1/2 期顯示疾病控制率為 94%，且已確認總反應率為 82%。在全球第 2 期試驗中，我們顯示疾病控制率為 100%，且已確認客觀反應率為 76%。其次是一線非小細胞肺癌適應症。在中國單藥第 1/2 期中，我們在 PD-L1 陽性患者觀察到已確認客觀反應率約為 47%。

In the global Phase 2 of pumitamig plus chemotherapy, which includes a PD-L1 unselected population, we saw a confirmed objective response rate of approximately 63%. In TNBC, the disease control rate was 92% in both the trials conducted in China and globally. In the China Phase 1/2, in first-line TNBC, we reported a confirmed objective response rate of approximately 74%, and in the global Phase 2 cohort, which included a heterogeneous population of first- and second-line patients, we reported a confirmed objective response rate of approximately 62%, as expected given the treatment line population. Across these three tumor types of high unmet need, we are observing a meaningful consistency between the data generated in China and globally. While cross-trial comparisons must be interpreted with caution, we are encouraged by this cross-regional consistency. This gives us increased confidence in the global potential of pumitamig.

在 pumitamig 聯合化療的全球第 2 期（包含未依 PD-L1 篩選之族群）中，我們看到已確認客觀反應率約為 63%。在 TNBC 中，中國與全球試驗的疾病控制率皆為 92%。在中國第 1/2 期的一線 TNBC 中，我們報告已確認客觀反應率約為 74%；而在全球第 2 期隊列（包含一線與二線患者的異質族群）中，我們報告已確認客觀反應率約為 62%，此與治療線別族群差異所致的預期一致。在這三種未滿足醫療需求高的腫瘤類型中，我們觀察到中國與全球所產生數據具有具意義的一致性。雖然跨試驗比較必須謹慎解讀，但我們對此跨區域一致性深受鼓舞。這使我們對 pumitamig 的全球潛力更具信心。

We are advancing multiple pivotal Phase 3 programs to confirm these signals. As covered here on our tumor map slide, we are deploying multiple modalities to tackle lung cancer. gotistobart is a critical component of that map. As a reminder, gotistobart is our selective TREG-depleting antibody targeting CTLA-4, developed in collaboration with our partner, OncoC4. We are advancing gotistobart through the pivotal Stage 2 of PRESERVE-003, our global Phase 3 in patients with metastatic squamous, non-small cell lung cancer who progressed following platinum-based chemotherapy and PD-L1 inhibitor treatment. This is a setting with very few effective options and poor prognosis. Gotistobart's differentiated mechanism of selectively depleting regulatory T-cells in the tumor microenvironment is designed to re-engage the immune system even after prior checkpoint inhibitor exposure. Earlier this year at ELCC, we presented updated data from the non-pivotal Stage 1 of PRESERVE-003, our global Phase 3 trial.

我們正在推進多項關鍵性第 3 期計畫以確認這些訊號。如同我們的腫瘤版圖投影片所示，我們正部署多種治療模式以應對肺癌。gotistobart 是該版圖中的關鍵組成。提醒一下，gotistobart 是我們選擇性耗竭 TREG 的抗體，靶向 CTLA-4，並與合作夥伴 OncoC4 共同開發。我們正推進 gotistobart 進入 PRESERVE-003 的關鍵性第 2 階段；該試驗為全球第 3 期，納入轉移性鱗狀非小細胞肺癌患者，且其在接受含鉑化療與 PD-L1 抑制劑治療後仍出現疾病進展。此治療情境有效選項極少，且預後不佳。gotistobart 具差異化機制：選擇性耗竭腫瘤微環境中的調節性 T 細胞，旨在即使在既往接受檢查點抑制劑後，仍可重新啟動免疫系統。今年稍早於 ELCC，我們發表了 PRESERVE-003（全球第 3 期試驗）非關鍵性第 1 階段的更新數據。

The data are very encouraging. The 12-month PFS rate of 25% for gotistobart versus zero for docetaxel is a signal of durable disease control. gotistobart reduced the risk of death in this IO pre-treated patient population by 54% compared to docetaxel, with a hazard ratio of 0.46. The median OS in the gotistobart arm has not yet been reached, compared to approximately 10 months with docetaxel. At 12 months, 63% of patients treated with gotistobart were alive, versus 30% in the docetaxel arm. The safety profile was consistent with the previously established profile for gotistobart, with no new signals of concern. We expect to present longer follow-up data at the World Conference on Lung Cancer next month. Based on current event accrual projections, we expect to conduct the first interim analysis from the pivotal stage of the trial towards the end of this year.

這些數據非常令人鼓舞。gotistobart 的 12 個月 PFS 率為 25%，而 docetaxel 為 0%，顯示具持久的疾病控制訊號。與 docetaxel 相比，gotistobart 在此已接受 IO 治療的患者族群中將死亡風險降低 54%，風險比（hazard ratio）為 0.46。gotistobart 組的中位 OS 尚未達到，而 docetaxel 約為 10 個月。在 12 個月時，接受 gotistobart 治療的患者有 63% 仍存活，而 docetaxel 組為 30%。安全性概況與先前已建立的 gotistobart 概況一致，未出現新的疑慮訊號。我們預期將於下個月的世界肺癌大會發表更長期追蹤數據。根據目前事件累積（event accrual）預測，我們預期將於今年年底前後，對試驗關鍵性階段進行首次期中分析。

At ASCO this year, we presented overall survival data from the Phase 2 study evaluating gotistobart in combination with pembrolizumab in ovarian cancer patients who had received prior platinum-based chemotherapy. The data showed a compelling and differentiated signal with a median overall survival of 18.9 months. Together, these data reinforce the potential of gotistobart to provide an extended overall survival benefit and serve as a potential chemo-free treatment option for lung patients. I will now turn to LFD, or BNT324, our B7-H3-targeted ADC developed in collaboration with DualityBio. B7-H3 is overexpressed across multiple tumor types, including prostate cancer, non-small cell lung cancer, small cell lung cancer, and others. The target biology, combined with the pharmacology of a Topo 1 inhibitor, ADC with drug to antibody ratio of six, positions LFD as a potentially versatile oncology asset across a wide range of solid tumors.

在今年的 ASCO，我們發表了第 2 期研究的總體存活期（overall survival）數據，該研究評估 gotistobart 與 pembrolizumab 聯合用於既往接受過含鉑化療的卵巢癌患者。數據顯示出具吸引力且具差異化的訊號，中位總體存活期為 18.9 個月。綜合而言，這些數據強化了 gotistobart 可能帶來延長總體存活期獲益的潛力，並可作為肺癌患者一種潛在的無化療治療選項。接下來我將談到 LFD（或 BNT324），這是我們與 DualityBio 合作開發、以 B7-H3 為標的的 ADC。B7-H3 在多種腫瘤類型中呈現過度表達，包括前列腺癌、非小細胞肺癌、小細胞肺癌等。該標的的生物學特性，加上以 Topo 1 抑制劑為載荷、藥物抗體比（DAR）為 6 的 ADC 藥理特性，使 LFD 有望成為可跨廣泛實體腫瘤的多用途腫瘤資產。

More than 1,000 patients have now been treated with LFD across more than 10 tumor types, including 400 patients treated with LFD in combination with pumitamig. The growing body of clinical evidence demonstrates anti-tumor activity across multiple indications with a favorable safety profile. This quarter, we dosed our first patient in the Phase 3 clinical trial for LFD, evaluating it against docetaxel in patients with taxane-naive metastatic castration-resistant prostate cancer. Prostate cancer is our first Phase 3 indication for LFD, and it represents one of the strongest B7-H3 expression profiles of any tumor type. The trial targets the patient population with substantial unmet need following progression on second-generation androgen receptor pathway inhibitors. In parallel, LFD is being evaluated in combination with pumitamig across multiple Phase 1/2 programs. These results will help inform the optimal clinical design for upcoming registrational combination trials.

目前已有超過 1,000 名患者在超過 10 種腫瘤類型中接受 LFD 治療，其中包括 400 名患者接受 LFD 與 pumitamig 的聯合治療。日益累積的臨床證據顯示，LFD 在多個適應症中具有抗腫瘤活性，且安全性概況良好。本季度，我們在 LFD 的第 3 期臨床試驗中完成首位患者給藥，該試驗在未接受過紫杉烷（taxane-naive）的轉移性去勢抗性前列腺癌患者中，將其與 docetaxel 進行比較評估。前列腺癌是 LFD 的首個第 3 期適應症，且其 B7-H3 表達譜系為各腫瘤類型中最強之一。該試驗鎖定在第二代雄激素受體途徑抑制劑治療後出現疾病進展、且仍有重大未滿足醫療需求的患者族群。同時，LFD 亦正於多個第 1/2 期計畫中評估與 pumitamig 的聯合治療。這些結果將有助於為即將到來的註冊性（registrational）聯合試驗提供最佳臨床設計的依據。

We expect to present some of these data at a medical conference later this year. Moving now to our portfolio of innovative mRNA cancer immunotherapies, which aim to activate and educate the immune system with precision. Our individualized neoantigen-specific immunotherapy, autogene cevumeran, developed in collaboration with Genentech, is advancing into ongoing randomized Phase 2 trials. In adjuvant ctDNA Stage 2 high risk or Stage 3 colorectal cancer, we have a Phase 2 trial evaluating autogene cevumeran monotherapy against the standard of watchful waiting. Enrollment is now complete, and in June, an interim analysis based on the centrally assessed primary endpoint of disease-free survival was reviewed by the independent Data Safety Monitoring Board with the recommendation to continue the trial without modification. The study will continue as planned per protocol, and we will remain masked to the data until the final analysis.

我們預期將於今年稍晚在醫學會議上發表其中部分數據。接著談到我們創新 mRNA 癌症免疫治療產品組合，其目標是以精準方式活化並教育免疫系統。我們的個人化新抗原特異性免疫治療 autogene cevumeran（與 Genentech 合作開發）正推進至進行中的隨機分派第 2 期試驗。在輔助治療（adjuvant）ctDNA 第 2 期高風險或第 3 期大腸直腸癌中，我們有一項第 2 期試驗評估 autogene cevumeran 單藥治療，並與標準的密切觀察（watchful waiting）進行比較。目前已完成收案；6 月時，獨立資料安全監測委員會（Data Safety Monitoring Board）審閱了基於中央評估之主要終點「無病存活期（disease-free survival）」的期中分析，並建議試驗不需修改、持續進行。本研究將依方案按計畫持續進行，且在最終分析前我們將維持對數據的盲態（masked）。

The data readout from the final analysis of this trial is event-driven and expected in 2027. In adjuvant pancreatic cancer, recruitment for the Phase 2 IMcode-003 trial is well underway. Data from a Phase 1 investigator-initiated trial, including a six-year update presented at AACR this year, continue to demonstrate durable immune responses against the encoded neoantigens for up to six years, evidence that supports our therapeutic rationale in the adjuvant and minimal residual disease setting. On our FixVac platform, BNT113, our off-the-shelf HPV16-targeting immunotherapy, is advancing in the AHEAD-MERIT Phase 2/3 trial in combination with pembrolizumab as a first-line treatment for patients with PD-L1-positive, HPV16-positive head neck squamous cell cancer. A Phase 3 interim analysis is expected for PFS this year.

本試驗最終分析的數據讀出為事件驅動（event-driven），預計於 2027 年取得。在輔助治療胰臟癌方面，第 2 期 IMcode-003 試驗的招募進展順利。來自一項第 1 期研究者發起試驗（investigator-initiated trial）的數據（包括今年於 AACR 發表的 6 年更新）持續顯示，針對所編碼新抗原的免疫反應可持續長達 6 年；此證據支持我們在輔助治療與微小殘存病灶（minimal residual disease）情境下的治療理據。在我們的 FixVac 平台上，BNT113（現成型、針對 HPV16 的免疫治療）正於 AHEAD-MERIT 第 2/3 期試驗中推進，並與 pembrolizumab 聯合，作為 PD-L1 陽性、HPV16 陽性頭頸部鱗狀細胞癌患者的一線治療。今年預期將進行以 PFS 為主的第 3 期期中分析。

For BNT116, our mRNA immunotherapy targeting multiple non-small cell lung cancer-associated antigens, we expect to present data at WCLC 2026 from Cohort 6 in combination with cemiplimab and chemotherapy. These programs reflect our conviction that mRNA cancer immunotherapy, particularly in combination with checkpoint inhibition, can deliver meaningful benefit in defined patient populations.

針對 BNT116（我們的 mRNA 免疫治療，靶向多種與非小細胞肺癌相關的抗原），我們預期將於 WCLC 2026 發表第 6 隊列（Cohort 6）與 cemiplimab 及化療聯合治療的數據。這些計畫反映了我們的堅定信念：mRNA 癌症免疫治療，特別是與免疫檢查點抑制聯用時，能在特定患者族群中帶來具意義的臨床獲益。

In closing, today's review underscores the significant progress across our portfolio. We have reached multiple key milestones and continue to execute on plan in 2026 and beyond. Within our late-stage programs, we anticipate three further readouts this year. Gotistobart in squamous non-small cell lung cancer, our FixVac immunotherapy BNT113 in head and neck cancer, and T-PAM in breast cancer. For gotistobart, we expect a first interim analysis in late 2026 based on the projected event accrual rates. This initial review by the independent Data Monitoring Committee is intended as an early checkpoint before the next pre-planned interim analysis.

最後，今天的回顧凸顯了我們產品組合的重大進展。我們已達成多項關鍵里程碑，並將在 2026 年及其後持續按計畫執行。在我們的後期（late-stage）計畫中，我們預期今年還會有三項進一步的數據讀出。分別為：鱗狀非小細胞肺癌中的 gotistobart、頭頸癌中的 FixVac 免疫治療 BNT113，以及乳癌中的 T-PAM。就 gotistobart 而言，基於預估的事件累積速率，我們預期於 2026 年底進行首次期中分析。此由獨立資料監測委員會（Data Monitoring Committee）進行的初步審查，旨在作為下一次預先規劃之期中分析前的早期檢核點。

For BNT113, based on current event accrual projections, we expect a Phase 3 interim analysis for progression-free survival later this year. Overall survival, which is the trial's other core primary endpoint, is not expected to be mature at this interim. T-PAM is currently being advanced in two pivotal clinical trials, one in second-line endometrial cancer and one in HER2-low hormone receptor-positive metastatic breast cancer. The candidate has generated encouraging data to date in both indications. With the primary analysis in breast cancer expected in the fourth quarter of 2026, we will determine the optimal regulatory pathway based on aggregated data across both indications. With this data-driven approach, we aim to pursue a value optimization strategy for T-PAM in an evolving treatment landscape while prioritizing opportunities where we can deliver significant benefit for patients.

就 BNT113 而言，根據目前的事件累積預估，我們預期今年稍晚將進行以無惡化存活期（progression-free survival）為主的第 3 期期中分析。總體存活期（overall survival）為本試驗另一個核心主要終點，但在此次期中分析時預期尚未成熟。T-PAM 目前正於兩項關鍵性（pivotal）臨床試驗中推進，一項為二線子宮內膜癌，另一項為 HER2 低表達、荷爾蒙受體陽性之轉移性乳癌。迄今該候選藥物在兩個適應症中均產生令人鼓舞的數據。由於乳癌的主要分析預計於 2026 年第四季進行，我們將基於兩個適應症的彙總數據來決定最佳的法規（regulatory）路徑。透過此以數據為導向的方法，我們旨在於不斷演變的治療環境中，為 T-PAM 採取價值最佳化策略，同時優先聚焦於我們能為患者帶來顯著獲益的機會。

Following our mid-year review of upcoming late-stage milestones, we have updated the expected timing for the Phase 3 pumitamig trial in triple-negative breast cancer in China and for the Phase 2 gotistobart trial in second-line castration-resistant prostate cancer, both of which are now expected in 2027. With regards to our earlier-stage novel/novel readouts, we have already published data on some of those combinations and expect more soon. I want to highlight one data set that is strategically significant for our ambitions in lung, the upcoming readout for the Phase 1/2 trial evaluating pumitamig in combination with BNT324, our B7-H3 ADC, across advanced non-small cell lung cancer and small cell lung cancer. This will be the first clinical data for a PD-L1 VEGF-A bispecific antibody in combination with an antibody drug conjugate in lung cancer.

在年中回顧即將到來的後期里程碑後，我們更新了中國三陰性乳癌中第 3 期 pumitamig 試驗，以及二線去勢抗性前列腺癌中第 2 期 gotistobart 試驗的預期時程；兩者目前皆預計於 2027 年讀出。至於我們較早期的新藥/新藥（novel/novel）讀出，我們已發表其中部分聯合治療的數據，並預期很快會有更多結果。我想特別強調一組對我們在肺癌領域企圖具有策略性重要性的數據：即將讀出的第 1/2 期試驗，該試驗評估 pumitamig 與 BNT324（我們的 B7-H3 ADC）聯合治療，涵蓋晚期非小細胞肺癌與小細胞肺癌。這將是 PD-L1/VEGF-A 雙特異性抗體與抗體藥物複合體在肺癌中聯合使用的首批臨床數據。

The combination brings together two mechanistically distinct and potentially synergistic approaches, the immune reactivation enabled by pumitamig with the targeted cytotoxic payload of BNT324. We execute these earlier combination studies to provide the signal seeking evidence we need to inform and potentially de-risk our next steps. This data generation will guide the entry of our novel/novel combination strategy into the pivotal stage and it is the foundation of the next chapter towards BioNTech's growing leadership in oncology.

此聯合療法結合了兩種機制上不同且可能具協同效應的方法：pumitamig 所促成的免疫再活化，以及 BNT324 的標靶細胞毒性載荷。我們執行這些較早期的聯合研究，是為了取得我們所需的訊號探索（signal seeking）證據，以用於指引並可能降低後續步驟的風險。這些數據的產出將引導我們的新藥/新藥聯合策略進入關鍵性階段，並成為 BioNTech 在腫瘤領域持續擴大領導地位之下一篇章的基礎。

With that, I will now turn the presentation over to our CFO, Ramon Zapata, for the financial update.

接下來，我將把簡報交給我們的財務長 Ramon Zapata，由他進行財務更新。

Thank you, Özlem, and a warm welcome to everyone joining us. I will cover three topics today. Firstly, our second quarter and first half 2026 financials. Secondly, our full year 2026 financial guidance. Lastly, the execution of our share purchase program announced in May this year as part of our capital allocation strategy. Note that all figures will be in EUR unless otherwise stated. Starting with the second quarter financial performance. Revenues for the second quarter of 2026 were EUR106 million, compared to EUR261 million in the prior year quarter. This decline mainly reflects lower demand for our COVID-19 vaccine in the US. In addition, the prior year quarter was positively impacted by a one-time revenue effect. This related to a compensation payment from Pfizer opting out from our shingles vaccine development program. Moving to R&D.

謝謝你，Özlem，也熱烈歡迎所有與會者。我今天將涵蓋三個主題。第一，我們 2026 年第二季及上半年財務表現。第二，我們 2026 年全年財務指引。最後，作為我們資本配置策略一部分、於今年 5 月宣布之股份回購計畫的執行情況。請注意，除非另有說明，所有數字皆以歐元（EUR）表示。先從第二季財務表現開始。2026 年第二季營收為 1.06 億歐元，相較於去年同期的 2.61 億歐元。此下滑主要反映我們在美國的 COVID-19 疫苗需求降低。此外，去年同期的營收亦受到一次性收入因素的正面影響。這與輝瑞（Pfizer）選擇退出我們帶狀疱疹疫苗開發計畫所支付的補償款有關。接著談研發（R&D）。

Adjusted R&D expenses decreased to EUR477 million from EUR509 million in the prior year quarter. This change mainly reflects the execution of our disciplined prioritization across the portfolio. Lower spending on unfocused programs, together with favorable cost-sharing effects from our collaboration partners, supported an efficient cost structure. At the same time, we continue to invest in our prioritized immuno-oncology and ADC programs, including pumitamig and gotistobart.

調整後研發費用由去年同期的 5.09 億歐元降至 4.77 億歐元。此變動主要反映我們在整體產品組合中執行嚴謹的優先順序管理。對非聚焦專案的支出降低，加上與合作夥伴之間有利的成本分攤效果，支持了更有效率的成本結構。同時，我們仍持續投資於優先的免疫腫瘤與 ADC 專案，包括 pumitamig 與 gotistobart。

Moving to SG&A. SG&A expenses on an adjusted and IFRS basis were EUR198 million, compared to EUR137 million in the prior year's quarter. This increase was mainly driven by a global initiative on scaling our processes and ERP infrastructure to strengthen efficient operational execution and our ongoing pre-launch activities for late-stage products. Our cost base in 2026 also reflects the inclusion of CureVac operations post-merger.

接著談銷售、一般及行政費用（SG&A）。以調整後及 IFRS 基礎計算，SG&A 費用為 1.98 億歐元，去年同期為 1.37 億歐元。此增加主要由一項全球性計畫所帶動，該計畫旨在擴展我們的流程與 ERP 基礎設施，以強化高效率的營運執行，以及我們針對後期產品持續進行的上市前活動。我們 2026 年的成本基礎亦反映併購後納入 CureVac 的營運。

At the same time, we continue to realize meaningful savings through pipeline prioritization measures and enhanced cost discipline across the organization. When comparing IFRS and adjusted results overall, the key adjustments are as follows. Within R&D expenses, the difference is driven by impairment charges related to intangible assets outside our focused programs. Within other operating results, the difference relates to actions we are taking following our manufacturing footprint consolidation, the decision we announced in May. The costs are mainly employee-related expenses and impairment charges. These charges reflect our progression from announcing that decision to actively executing it. While these costs weigh on our near-term results, they are a deliberate investment in reshaping our future cost base. We are positioning the company for enhanced operational efficiency and expect sustainable savings going forward.

同時，我們也透過研發管線優先順序措施，以及全公司更嚴謹的成本紀律，持續實現具意義的節省。整體比較 IFRS 與調整後結果時，主要調整項如下。在研發費用中，差異主要來自與我們聚焦專案之外之無形資產相關的減損費用。在其他營運結果中，差異與我們在製造據點整併後所採取的行動有關，該決策已於 5 月宣布。相關成本主要為員工相關費用與減損費用。這些費用反映我們已從宣布該決策，推進至積極執行階段。雖然這些成本會對短期業績造成壓力，但它們是我們為重塑未來成本基礎所做的刻意投資。我們正讓公司具備更高的營運效率，並預期未來可帶來可持續的節省。

Importantly, we are acting from a position of strength, allowing us to make these adaptations proactively since we maintain a strong financial position of EUR16.6 billion in cash equivalents, and security investments at the end of the second quarter, compared to EUR16 billion as of June 30th, 2025. This empowers sustained investments across our pipeline, our preparations for commercialization, and in our long-term goal to become a global multi-product biopharmaceutical company. Before we go into our full-year guidance, let's first turn from the quarter review to our year-to-date financials, comparing the performance of the first half of 2026 with the prior year period. The drivers are mostly in line with the factors I have described for the quarter. In the first half of 2026, revenues were EUR224 million.

重要的是，我們是在強勢的基礎上採取行動，使我們能夠主動進行這些調整；因為截至第二季末，我們仍維持強勁的財務狀況，現金等價物與有價證券投資合計為 166 億歐元，相較於 2025 年 6 月 30 日的 160 億歐元。這使我們得以在研發管線、商業化準備，以及成為全球多產品生物製藥公司的長期目標上，持續投入。在進入全年指引之前，我們先從季度回顧轉向年初至今的財務表現，將 2026 年上半年與去年同期比較。其驅動因素大多與我在季度部分所描述者一致。2026 年上半年營收為 2.24 億歐元。

While we expect the seasonal phasing of the COVID-19 vaccine business throughout the year, as mentioned, this decline mainly reflects lower demand in the US. Secondly, lower adjusted R&D expenses of EUR1,004 million in comparison to the prior year period reflect our focused R&D investments approach in our prioritized programs and positive cost-sharing effects with our collaboration partners. Thirdly, higher adjusted SG&A expenses of EUR349 million reflect the ongoing pre-launch activities and commercial buildup for our first oncology launches, as well as costs newly incorporated in 2026, like our ERP infrastructure initiative that I already mentioned.

如前所述，雖然我們預期 COVID-19 疫苗業務在全年會呈現季節性分布，但這一下滑主要反映美國需求降低。第二，調整後研發費用為 10.04 億歐元，較去年同期下降，反映我們在優先專案上採取聚焦的研發投資方式，以及與合作夥伴之間正面的成本分攤效果。第三，調整後 SG&A 費用上升至 3.49 億歐元，反映我們針對首批腫瘤產品上市持續進行的上市前活動與商業化建置，以及 2026 年新納入的成本，例如我先前提到的 ERP 基礎設施計畫。

As we look to the second half of the year, we are taking a disciplined view on our full-year outlook. We anticipate changes in some of the factors driving our business and are revising our previously disclosed full-year 2026 financial guidance. We now expect revenues in the range of EUR1.6 billion-EUR1.9 billion. Adjusted R&D expenses in the range of EUR2 billion-EUR2.3 billion, and adjusted SG&A expenses remaining unchanged in the range of EUR700 million-EUR800 million. I will now detail the factors driving our revised revenue guidance. While COVID-19 has been endemic for some time, we continue to monitor the evolving vaccine market and expect softer-than-anticipated global COVID-19 vaccine demand.

展望下半年，我們以嚴謹的角度看待全年展望。我們預期推動業務的部分因素將出現變化，因此修訂先前揭露的 2026 年全年財務指引。我們目前預期營收介於 16 億至 19 億歐元。調整後研發費用介於 20 億至 23 億歐元，而調整後 SG&A 費用維持不變，仍為 7 億至 8 億歐元。接下來我將說明推動我們修訂後營收指引的因素。雖然 COVID-19 已成為地方性流行病一段時間，我們仍持續監測疫苗市場的演變，並預期全球 COVID-19 疫苗需求將低於先前預期。

In addition, the European Medicines Agency recommendation issued in May allows the use of the previous year's vaccine formula as an alternative to the newly recommended XFG variant-adapted vaccines. This year, for the first time, Germany will utilize previously manufactured on-stock vaccine doses for the upcoming vaccination season. As a result, we expect significantly reduced sales in Germany this week. Also, the timing of milestone related revenues resulting from an out-licensed R&D program, which are no longer expected in 2026. In terms of revenue phasing through the rest of the year, we continue to expect the majority of our 2026 revenues to be realized in the second half of the year, specifically in the third quarter when we expect to recognize the EUR613 million BMS collaboration payment.

此外，歐洲藥品管理局（EMA）於 5 月發布的建議，允許使用前一年度的疫苗配方，作為新近建議之 XFG 變異株適配疫苗的替代方案。今年德國將首次在即將到來的接種季使用先前已製造並在庫存中的疫苗劑量。因此，我們預期本週在德國的銷售將大幅降低。另外，來自一項對外授權研發專案之里程碑相關收入的認列時點也有所變動，該等收入目前預期不會在 2026 年發生。就今年剩餘期間的營收分布而言，我們仍預期 2026 年大部分營收將在下半年實現，尤其是在第三季，屆時我們預期將認列 6.13 億歐元的 BMS 合作款項。

Moving to operating expenses, we have revised our adjusted R&D expenses to the range of EUR2 billion-EUR2.3 billion. This reflects our focus on optimizing our R&D resources and continued cost discipline as we prioritize the development of our late-stage clinical pipeline. We expect these cost savings based on prioritization and optimization to continue into future years. Our assumption for adjusted SG&A expenses remain unchanged in the range of EUR700 million-EUR800 million as we continue to gradually build out our commercial capabilities. Despite these changes, our strong balance sheet and disciplined cost management position us well to continue investing strategically.

接著談營運費用，我們已將調整後研發費用修訂至 20 億至 23 億歐元的區間。這反映我們專注於最佳化研發資源，並在優先推進後期臨床研發管線的同時，持續維持成本紀律。我們預期基於優先順序與最佳化所帶來的成本節省，將延續至未來年度。我們對調整後 SG&A 費用的假設維持不變，仍為 7 億至 8 億歐元，因我們將持續逐步建置商業化能力。儘管有這些變動，我們強健的資產負債表與嚴謹的成本管理，使我們仍具備良好條件持續進行策略性投資。

Turning to my final slide, I'm giving you an update on the execution of our capital allocation framework, which we presented during our first quarter earnings call. Our approach remains clear and disciplined, centered on three priorities. First, focus R&D investments. Second, disciplined capital deployment. As well as third, optimized operational efficiency and sustainable value creation. We are executing against these priorities with consistency and intent. As shown on the slide, with respect to the second pillar, we started the execution on our up to $1 billion share repurchase program and repurchased an amount of $152 million so far. This execution reflects our conviction in the intrinsic value of BioNTech, while importantly, we retain full optionality to advance our pipeline, execute on partnerships, and pursue corporate development opportunities.

最後一張投影片，我將更新我們資本配置框架的執行情況，該框架已在第一季法說會中對外說明。我們的方法仍然清晰且嚴謹，聚焦於三項優先事項。第一，聚焦研發投資。第二，嚴謹的資本運用。第三，最佳化營運效率與可持續的價值創造。我們正以一致性與明確目標來落實這些優先事項。如投影片所示，就第二支柱而言，我們已開始執行最高達 10 億美元的庫藏股回購計畫，迄今已回購 1.52 億美元。此一執行反映我們對 BioNTech 內在價值的信心；同時也重要的是，我們仍保有充分的彈性，以推進研發管線、推動合作夥伴關係，並把握企業發展機會。

Taken together, our strong financial position on these three pillars of our capital allocation strategy continue to serve as a clearly defined long-term objective to become a global multi-product company, addressing the high unmet medical needs of cancer patients worldwide. On a final note, regarding the announcement of Ugur and Özlem's new company and potential contributions by BioNTech, the discussions are ongoing, and as with all potential deals, BioNTech's guiding principle in the negotiations is to maximize value for patients and our shareholders. With that, I will hand back to the operator to open the call for questions. Thank you.

綜合而言，我們在資本配置策略這三大支柱上的強勁財務狀況，持續作為一項清晰界定的長期目標，支持我們成為一家全球多產品公司，以滿足全球癌症患者高度未被滿足的醫療需求。最後補充一點，關於Ugur與Özlem新公司的公告，以及BioNTech可能的貢獻，目前討論仍在進行中；如同所有潛在交易，BioNTech在談判中的指導原則是為患者與股東最大化價值。接下來我把時間交還給接線員，開放提問。謝謝。

(Operator Instructions) Cory Kasimov, Evercore ISI.

(接線員指示) Cory Kasimov，Evercore ISI。

Hey, good morning, everyone. Thank you for taking my question. I wanted to ask on BNT324, the B7-H3 ADC candidate, and what data that you've seen that prompted the decision to choose metastatic CRPC as the first indication for Phase 3 development, and kind of what gives you the confidence that you have a competitive ADC construct here? Thank you very much.

嗨，大家早安。謝謝讓我提問。我想請教BNT324，也就是B7-H3 ADC候選藥物：你們看到了哪些數據，促使你們決定選擇轉移性CRPC作為第三期開發的第一個適應症？以及是什麼讓你們有信心，認為你們在這裡擁有具競爭力的ADC構型？非常感謝。

Thank you, Cory. Özlem, will you please care to answer the question from Cory?

謝謝你，Cory。Özlem，請你回答Cory的問題好嗎？

Hi, Cory. What is very encouraging for our B7H3 is the combination of durable disease control, plus the so far excellent safety profile that we are seeing for this B7H3. To remind you, various ADCs come either with challenges related to hematosuppression, stomatitis, or ILDs. With our B7H3 ADC, we see a very tolerable safety profile, allowing us not only to get temporary disease control with this compound but enable long-term application. We have a range of patients who have been dosed now for more than a year, without significant ILD events observed so far

嗨，Cory。對我們的B7H3而言，非常令人鼓舞的是：我們看到持久的疾病控制，再加上迄今為止非常優異的安全性概況。提醒一下，各種ADC往往會面臨與骨髓抑制、口腔炎或間質性肺病（ILD）相關的挑戰。而在我們的B7H3 ADC上，我們看到非常可耐受的安全性概況，這不僅讓我們能以此化合物達到暫時性的疾病控制，也使長期用藥成為可能。目前已有一批患者用藥超過一年，迄今未觀察到顯著的ILD事件

If I may add to that, Cory, we have presented this data at ASCO 25 and ASCO GU 26, also follow-up data from our heavily pretreated population which we have tested in a Phase 1/2 study, which is still ongoing.

如果我可以補充一下，Cory，我們已在ASCO 25與ASCO GU 26上發表這些數據，也包含我們在一項仍在進行中的第1/2期研究中、針對重度既往治療族群的追蹤數據。

Great. Thank you very much.

很好。非常感謝。

Tazeen Ahmad, Bank of America.

Tazeen Ahmad，美國銀行。

Hi, good morning. Thanks for taking my question. Can you just give us a sense about the data updates that are expected for the remainder of the year? Can you just remind us how your updated guidance for what data to expect has changed since earlier in the year? Specifically, are we still expecting pumitamig Phase 3 data for triple-negative breast cancer this year? Should there be any expectation that this data would be presented in a press release versus just released at a medical meeting? Thanks.

嗨，早安。謝謝讓我提問。你們能否說明一下，今年剩餘時間預期會有哪些數據更新？也請提醒我們，相較於年初，你們對於預期數據的最新指引有哪些變化？具體來說，我們今年是否仍預期會看到pumitamig在三陰性乳癌的第3期數據？這些數據是否可能以新聞稿形式發布，而不是僅在醫學會議上公布？謝謝。

With regard to changed milestones and specifically also the China interim analysis testing for first-line TNBC, we are continuously monitoring events, and the data readouts are event-driven. In our China TNBC study, we observed that the events take longer, so the readout is pushed out to 2027, which in principle is also actually a good sign for us. Another study which will come a bit later with regard to its readout is our pumitamig study in first-line CRCC in China, which is a Phase 2 study. Here we have decided to look in more chemo combinations than originally planned, so they are added on top of this. Another readout, which is now projected for 2027, is the gotistobart Phase 2 in second-line positive prostate cancer. The reason is that we want to see more maturity.

關於里程碑的變動，特別是中國一線TNBC的期中分析，我們會持續監測事件進展，而數據讀出是以事件驅動。在我們的中國TNBC研究中，我們觀察到事件累積所需時間更長，因此讀出時間延後至2027年；原則上這其實也對我們是個好訊號。另一項讀出時間也會稍晚的研究，是我們在中國一線CRCC的pumitamig研究，這是一項第2期研究。在此我們決定評估比原先規劃更多的化療合併方案，因此新增了這些組合。另一個目前預計在2027年的讀出，是gotistobart在二線陽性前列腺癌的第2期研究。原因是我們希望看到更成熟的數據。

Major milestones and readouts this year are the gotistobart interim analysis for part two, meaning the pivotal part of our non-small cell lung cancer study in squamous non-small cell lung cancer, second-line in combination with docetaxel. We are excited about that. Pardon?

今年的主要里程碑與讀出包括：gotistobart在第二部分的期中分析，也就是我們非小細胞肺癌研究中的關鍵性部分，針對鱗狀非小細胞肺癌二線、與docetaxel合併。我們對此感到興奮。抱歉？

Control.

對照。

Yes, as a control. We are excited about that. The BNT113 trial, where we expect the Phase 3 interim analysis for progression-free survival later this year, and the T-PAM study in HER2-low hormone receptor-positive metastatic breast cancer.

是的，作為對照。我們對此感到興奮。另外還有BNT113試驗，我們預期今年稍晚會有無惡化存活期（PFS）的第3期期中分析，以及在HER2-low、荷爾蒙受體陽性轉移性乳癌中的T-PAM研究。

David Dai, UBS.

David Dai，瑞銀（UBS）。

Great. Thank you, sir, for taking my questions. Just on pumitamig plus chemo in front-line non-small cell lung cancer, we've seen some encouraging Phase 2 data so far, especially showing translation from China to global. I'm just curious, what additional preclinical evidence or, let's say, efficacy, safety, or biomarker features give you confidence that pumitamig can be differentiated versus PD-1 versus other VEGF/PD-1 approaches?

很好。先生，謝謝讓我提問。關於pumitamig加化療用於一線非小細胞肺癌，我們迄今看到一些令人鼓舞的第2期數據，特別是顯示從中國到全球的可轉譯性。我想請教的是：有哪些額外的臨床前證據，或例如療效、安全性或生物標誌物特徵，讓你們有信心pumitamig相較於PD-1或其他VEGF/PD-1策略能夠做出差異化？

Maybe I take the question. With regard to the bispecific class, they have one thing in common, that they both, due to the bispecific activity, enable either improved binding to PD-1 or to PD-L1. We have one feature which we believe is differentiating with our molecule binding to PD-L1 in the tumor microenvironment. This gives us, in principle, the opportunity to have a double tumor microenvironment-directed compound. Whether this translates at the end of the day to a differentiated efficacy, we have to see. There are, of course, no head-to-head trials here. We believe that the true differentiation will come with the overall portfolio in which we combine pumitamig not only with chemotherapy but with a differentiated set of ADCs and other compounds.

也許我來回答這個問題。就雙特異性這一類而言，它們有一個共同點：由於雙特異性活性，能夠提升對PD-1或PD-L1的結合。我們認為自身分子的一個差異化特徵，是其在腫瘤微環境中與PD-L1結合。原則上，這讓我們有機會打造一個雙重、以腫瘤微環境為導向的化合物。至於這是否最終能轉化為差異化的療效，我們還需要觀察。當然，這裡並沒有頭對頭試驗。我們相信真正的差異化將來自整體產品組合：我們不僅將pumitamig與化療合併，也會與一組具差異化的ADC及其他化合物合併。

Daina Graybosch, Leerink Partners.

Daina Graybosch，Leerink Partners。

Hi, thank you for the question. I wonder if you could help us understand your TPAM comments more. Give us the details. Is there a specific outcome or threshold in the HER2-low breast cancer you're looking to exceed, and how various outcomes from that study could impact your strategy forward with regulators and potentially launching TPAM?

嗨，謝謝讓我提問。我想請你們協助我們更理解你們對TPAM的評論。請提供細節。在HER2-low乳癌中，你們是否有特定想要超越的結果或門檻？以及該研究的不同結果，可能如何影響你們後續與監管機構的策略，以及可能推動TPAM上市？

Our TPAM program, as you know, is broader. We are developing TPAM in endometrial cancer, second line, and in breast cancer with our Phase 3 trial in hormone receptor-positive HER2-low. We have, what is also important to note, ongoing signal-seeking studies of TPAM with pumitamig in a different breast cancer patient segment, which is an important part of the strategy. Ultimately, our ADCs are part of our portfolio because of their potential to further elevate pumitamig and allow us to leapfrog. With regard to our breast cancer study, the benchmarks are, if you compare with published benchmarks, median PFS in the range of 9 to 13 months, and an 18-month median OS of around 85%, according to other studies in this indication and approved treatments.

如你所知，我們的TPAM計畫更為廣泛。我們正在子宮內膜癌二線開發TPAM，也在乳癌中進行第3期試驗，針對荷爾蒙受體陽性、HER2-low族群。同樣重要的是，我們也正在進行TPAM與pumitamig的訊號探索研究，涵蓋不同的乳癌患者分群，這是策略中的重要一環。最終，我們的ADC之所以納入產品組合，是因為其有潛力進一步提升pumitamig的表現，讓我們能夠實現跨越式進展。就乳癌研究而言，若與已發表的基準相比，中位PFS約在9到13個月區間，而18個月的中位OS約為85%，這是根據此適應症其他研究與已核准治療所示。

Geoff Meacham, Citigroup.

Geoff Meacham，花旗集團。

Hey, everyone. Thanks for the question. Just had a bigger picture one on capital deployment. You guys have a substantial cash position, you're also streamlining the pipeline with the cost savings initiative. On the latter, I guess, can you talk a little bit about what your sort of North Star is in this? Is it deprioritizing overlapping indications? Are you eliminating some earlier stuff based on competitive landscape? I just want to get a sense for the strategy there. Thank you.

嗨，各位。謝謝這個問題。我想從資本部署的更宏觀角度問一題。你們有相當可觀的現金部位，同時也透過成本節省計畫來精簡研發管線。就後者而言，我想請你們談談你們在這方面的「北極星」目標是什麼？是降低重疊適應症的優先順序嗎？還是基於競爭態勢而淘汰一些較早期的項目？我只是想了解一下那裡的策略。謝謝。

Hi, thank you for the question. I think because of the cash position that we have and the strength of our balance sheet, we are able to take on the number of pivotal and Phase 3 trials that we are running now with pumitamig. The strategy with our partners is to add on these efforts as much as possible to really widen the net of all the indications where we can use pumitamig and the novel combinations. I would say that our capital allocation priorities remain unchanged. We continue to fully fund our priority pipeline and the commercial capabilities needed to support these upcoming launches. Second, we maintain the flexibility to pursue attractive external opportunities that have the potential to strengthen our portfolio or our capabilities. Third, we continue to return capital to shareholders through the authorized share buyback program that we announced last quarter.

嗨，謝謝你的提問。我認為，憑藉我們目前的現金部位以及資產負債表的強勁，我們有能力承擔目前正在以 pumitamig 進行的多項關鍵性與第3期試驗。我們與合作夥伴的策略，是盡可能在這些努力上加碼，真正擴大我們能夠使用 pumitamig 以及新型合併療法的所有適應症範圍。我會說，我們的資本配置優先順序維持不變。我們將持續全額資助我們的優先研發管線，以及支援即將到來上市所需的商業化能力。第二，我們保有彈性以追求具吸引力的外部機會，這些機會有潛力強化我們的產品組合或能力。第三，我們持續透過上季宣布並已獲授權的庫藏股回購計畫，向股東返還資本。

On your comment on portfolio optimization, we continuously review our pipeline to ensure that the resources are focused on the areas with the greatest strategic and value creation potential. That means continuing to invest behind our core programs while reviewing or stopping investments in non-core assets where we feel it's appropriate.

關於你提到的產品組合最佳化，我們會持續檢視研發管線，以確保資源聚焦在具有最大策略性與價值創造潛力的領域。這意味著持續加大對核心計畫的投資，同時在我們認為適當時，檢討或停止對非核心資產的投資。

Maybe I can add here another aspect. This year is the year of combination trials where we evaluate pumitamig in combination with our larger ADC portfolio. The results of the studies, of course, will provide further prioritization of the best combinations, thereby reducing maybe the investment in some of the ADCs in certain indications. The overlap at the moment is by purpose, yeah, to identify the winners. In 2027, we expect that we will have identified the winners and engage into several Phase 3 clinical trials, including assets from our partner, BMS.

我也許可以在這裡補充另一個面向。今年是合併試驗之年，我們會評估 pumitamig 與我們更大型的 ADC 產品組合的合併使用。這些研究結果當然會進一步協助我們優先排序最佳合併方案，從而可能降低在某些適應症上對部分 ADC 的投資。目前的重疊是刻意為之，對，目的是找出勝出者。我們預期到 2027 年將已辨識出勝出者，並投入多項第3期臨床試驗，其中也包括來自我們合作夥伴 BMS 的資產。

Great. Thank you.

很好。謝謝。

Akash Tewari, Jefferies.

Akash Tewari，Jefferies。

Hey, thanks so much. You have three interim Phase 2 readouts expected in the second half of this year. You have your HER2, your CTLA-4, and your Head and Neck cancer vaccine. Can you talk about your confidence on a positive interim analysis for each of these programs? Is there a particular program where maybe the team's internal view is particularly bullish? Thanks so much.

嗨，非常感謝。你們預期今年下半年會有三項第2期的期中讀出。分別是 HER2、CTLA-4，以及你們的頭頸癌疫苗。能否談談你們對這三個計畫各自取得正面期中分析結果的信心？是否有某個計畫在團隊內部的看法特別偏多、特別看好？非常感謝。

It's a difficult question. We have to see the data. Yeah. We are positive. We have, of course, positive expectations for each of the trials. If the data for gotistobart that we have seen in the first part of the Phase 3 clinical trial is recapitulated, this would become a game-changing result in this indication. Everyone knows that docetaxel remained unbeaten for decades now, and this would be the first time that if the data are recapitulated, we would have a significant benefit with a mono compound as compared to the standard of care.

這是一個很難的問題。我們必須看數據。是的。我們是正向的。當然，我們對每一項試驗都有正面的期待。如果我們在 gotistobart 第3期臨床試驗前半段所看到的數據能夠重現，那將會是這個適應症的顛覆性結果。大家都知道 docetaxel 幾十年來一直未被超越；若數據得以重現，這將是首次以單一藥物相較於標準治療展現顯著效益。

Terence Flynn, Morgan Stanley.

Terence Flynn，摩根士丹利。

Hi. Thanks for taking the question. Appreciate the update on your iNeST CRC data coming next year, but was wondering if you could help us think about potential read-through from the Moderna/Merck I.N.T. adjuvant melanoma Phase 3 data that we might get this year. What would you be looking for in that data to give you confidence in your own iNeST program? Thank you.

嗨。謝謝讓我提問。感謝你們更新明年將公布的 iNeST CRC 數據，但我想請你們協助我們思考：今年可能會取得 Moderna/Merck I.N.T. 輔助治療黑色素瘤第3期數據，這些數據是否可能對你們的 iNeST 計畫有任何可參照的啟示（read-through）？你們會在那份數據中尋找什麼訊號，來增強你們對自家 iNeST 計畫的信心？謝謝。

In terms of biology and indication, we don't see any read-through opportunities. Melanoma versus colorectal cancer, these are very different biologies and indications and responsiveness to immunotherapy and, in particular, antigen-specific T-cell antigens. We remain committed to the way we are conducting together with our partner, Genentech our program focusing on adjuvant settings, focusing also on cancers where checkpoint inhibition immunotherapy has a lower probability of success and does not serve the medical need. You know new antigen vaccines are not created equal. It's difficult to read from one platform to the other.

就生物學與適應症而言，我們看不到任何可參照的啟示（read-through）機會。黑色素瘤與大腸直腸癌在生物學、適應症特性、對免疫治療的反應性，尤其是對抗原特異性 T 細胞抗原的反應性方面，都非常不同。我們仍致力於與合作夥伴 Genentech 共同推進我們的計畫：聚焦於輔助治療（adjuvant）情境，也聚焦於檢查點抑制免疫治療成功機率較低、且未能滿足醫療需求的癌種。你知道，新抗原疫苗並非都一樣。很難從一個平台推論到另一個平台。

Jessica Fye, JPMorgan.

Jessica Fye，摩根大通。

Great. Good morning, guys. Thanks for taking my question. Ramon, I was hoping you'd help us out with the EUR400 million reduction to guide to the midpoint. Can you just quantify how much of the change was driven by the milestone pushout versus the German decision to use existing inventory and how much is just softer COVID-19 demand? What specifically was the partner milestone that was pushed out? Thank you.

很好。各位早安。謝謝讓我提問。Ramon，我希望你能協助我們理解指引中位數下調 4 億歐元的原因。你能否量化一下，這個變動有多少是由里程碑款延後所驅動、又有多少是因德國決定使用既有庫存所致，以及有多少只是 COVID-19 需求轉弱？具體而言，被延後的是哪一項合作夥伴里程碑款？謝謝。

Thank you for the question. Most of the adjustment of the guidance is a reflection of the weaker COVID-19 vaccination rates and the current regulatory and public health environment. It is really incorporating the latest input from our partners and the teams that are operating in our key markets. I would like to remind you that the COVID revenue is back-end weighted into the late Q3 and Q4. This will only reflect until then. Also that we're expecting approximately EUR613 million revenues from the BMS collaboration that is also giving us a good uplift for the second half of the year. Based on the information currently available, we believe that this revised range is appropriate.

謝謝你的提問。本次指引調整的大部分，反映的是較弱的 COVID-19 疫苗接種率，以及目前的監管與公共衛生環境。這確實納入了我們合作夥伴以及在主要市場運作的團隊所提供的最新資訊。我想提醒你，COVID 收入在時間分布上偏向後段，主要落在第3季後期與第4季。因此在那之前只會部分反映。另外，我們預期來自與 BMS 合作的收入約為 6.13 億歐元，這也會在今年下半年為我們帶來不錯的上行支撐。基於目前可得資訊，我們認為這個修訂後的區間是適當的。

In relation to the comment of license milestone that we were expecting, yeah, we were expecting that as well at the second half of the year, it's not the key driver of the revenue adjustment. It's mainly lower demand across every market. Specifically for Germany, it impacts us a little bit different because Germany is a direct market versus the other countries that are Pfizer-managed markets. We get the impact on our revenues a little bit more acute than versus the other markets. I would say if you would think about percentage, 80% is COVID-related completely, the rest is the loss of the out-licensed milestones that we would expect.

關於我們原先預期的授權里程碑款（license milestone），是的，我們也原本預期會在下半年入帳，但它並非收入調整的主要驅動因素。主要是各個市場的需求都較低。就德國而言，對我們的影響略有不同，因為德國是我們直營市場，而其他國家則由輝瑞管理。因此相較於其他市場，對我們收入的影響會更為直接、也更為明顯。若以比例來看，我會說 80% 完全與 COVID 相關，其餘則是我們原先預期的對外授權里程碑款未入帳所致。

Thank you.

謝謝。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Great, thank you. I wanted to ask about ROSETTA-Lung 02. Clinicaltrials.gov is showing data in 2029, but you changed the endpoint now to PFS and not OS. Is there any chance that we can get this data potentially earlier? Any sense when you might finish enrollment? Thank you.

很好，謝謝。我想問一下 ROSETTA-Lung 02。Clinicaltrials.gov 顯示資料在 2029 年，但你們現在把終點改成 PFS 而不是 OS。我們有沒有可能更早拿到這些資料？你們大概何時可能完成收案？謝謝。

We can't at the moment, not speculate on when to expect the data. As compared to waiting for OS, it will be obviously earlier that PFS reads out, but we don't have any guidance for the final readout yet.

我們目前無法推測何時會有資料。相較於等待 OS，PFS 的讀出時間顯然會更早，但我們目前對最終讀出時間仍沒有任何指引。

Maybe can you just remind us when you changed the endpoint, did the interim analysis change in any way? Anything you can share would be great. Thank you.

也許你們可以提醒我們一下，你們是在什麼時候更改終點的？中期分析是否有任何改變？任何你們能分享的資訊都很棒。謝謝。

With the change endpoint and the interim analysis for PFS, they become now an opportunity to file if it's positive. We can't still, so as said, it is expected to read out earlier than the interim OS, okay? We can't at the moment say when we are going to expect, because this is again an event-driven trial, and it's the first time in this indication that we evaluate this large population.

隨著終點的變更，以及針對 PFS 的中期分析，若結果為正面，現在就成為一個申報的機會。我們仍然無法（如先前所說）提供時間點；但可以確定的是，它預期會比 OS 的中期分析更早讀出，好嗎？我們目前無法說預計何時會有結果，因為這同樣是一項事件驅動的試驗，而且這是我們首次在此適應症中評估如此龐大的人群。

Evan Seigerman, BMO Capital Markets.

Evan Seigerman，BMO Capital Markets。

Hi, this is Haven on for Evan. Thanks for taking our question. Just one from us. As you think about the broader opportunity for pumitamig, can you discuss how the asset might be differentiated in MSS, CRC given the historically limited efficacy of checkpoint inhibitors in the indication and immune cold phenotype of tumors? Also, what gives you confidence that Pumi's mechanism could overcome these past challenges? Thank you.

嗨，我是代 Evan 提問的 Haven。謝謝讓我們提問。我們只有一個問題。在你們思考 pumitamig 更廣泛的機會時，能否談談在 MSS、CRC 中，考量到該適應症中檢查點抑制劑歷來療效有限，以及腫瘤呈免疫冷表型，這個資產可能如何實現差異化？另外，什麼讓你們有信心 Pumi 的機制能克服過去這些挑戰？謝謝。

To provide, because we do not yet have data in CRC, the strongest evidence that pumitamig or the bispecific class is differentiated comes from the observations of objective response rate, but also durable disease control in patient populations who are PD-L1 negative. For example, in TNBC, we have documented data showing more or less the same rates of objective response in the patient, in PD-L1 positive, PD-L1 low positive, and PD-L1 high positive patient populations. CRC is an indication in which checkpoint blockade was not successful. We have now this combination, and we have to see from our interim analysis, which is coming in 2027. We are going to test, or we are testing at the moment, different chemotherapy combinations, whether this translates to better data as compared to traditional benchmarks, the chemotherapy alone.

我先說明一下，因為我們在 CRC 尚未有資料；目前最有力的證據顯示 pumitamig 或雙特異性抗體這一類別具差異化，來自於在 PD-L1 陰性患者族群中觀察到的客觀反應率，以及持久的疾病控制。例如在 TNBC，我們已有紀錄資料顯示，在 PD-L1 陽性、PD-L1 低陽性與 PD-L1 高陽性患者族群中，客觀反應率大致相近。CRC 是一個檢查點阻斷治療未能成功的適應症。我們現在有這個組合療法，並需要從將於 2027 年出爐的中期分析來觀察結果。我們將會（或目前正在）測試不同的化療組合，看看相較於傳統基準（單用化療）是否能轉化為更好的數據。

The broader pumitamig opportunity again is based on the one side, improving response rate and durable disease control and OS in indications where checkpoint blockade PD-1 is approved. Opening up indications in which PD-1 treatments are not approved. As a third component, combining pumitamig as a potential next standard of care with a new generation of ADCs that allow disease control even in advanced disease with a good safety profile.

pumitamig 更廣泛的機會同樣基於：一方面，在已核准 PD-1 檢查點阻斷治療的適應症中，提高反應率、延長疾病控制並改善 OS。另一方面，開拓目前尚未核准 PD-1 治療的適應症。第三個面向是，將 pumitamig 與新一代 ADC 結合，作為潛在的下一個標準治療，即使在晚期疾病中也能在良好安全性下達到疾病控制。

Mohit Bansal, Wells Fargo.

Mohit Bansal，Wells Fargo。

Great, thank you very much for taking my question. I have a question regarding squamous versus non-squamous. There will be a lot of data coming this year from competitors as well. The first trial that is reading out is for squamous cell lung cancer for VEGF/PD-1. My question is, how much read-through there could be for the non-squamous program if squamous were to be successful, and what specifically you would be looking at the competitor data to gain confidence in your own programs or think about the future trials. Thank you.

很好，非常感謝讓我提問。我有一個關於鱗狀與非鱗狀的問題。今年競爭對手也會有很多數據出爐。第一個讀出的試驗是針對鱗狀細胞肺癌的 VEGF/PD-1。我的問題是，如果鱗狀的結果成功，對非鱗狀項目會有多少可參照（read-through）的意義？以及你們會特別從競品數據中觀察哪些點，以增強對自家項目的信心或思考未來試驗設計？謝謝。

With regard to the read-through, in principle, these histologies are like different diseases, right? We would be very cautious to read from data in squamous to non-squamous, or vice versa. We really need to produce the clinical data for both histologies. And in our ROSETTA-Lung 02 trial, for example, we have therefore also separated both histologies in sub-trials.

關於可參照性（read-through），原則上這些組織學類型就像是不同的疾病，對吧？我們會非常謹慎，不會把鱗狀的數據推論到非鱗狀，或反過來。我們確實需要針對兩種組織學都產出臨床數據。因此在我們的 ROSETTA-Lung 02 試驗中，例如，我們也將兩種組織學分開成子試驗。

On the other side, our own data, but also the data coming from ivonescimab indicate that in both indications, PFS is improved. We have seen now in the recent update that the improved PFS appears also to translate into OS signals in other indications. We are cautiously optimistic that we will see in both indications PFS benefit and OS benefit.

另一方面，我們自己的數據，以及 ivonescimab 的數據都顯示，在兩個適應症中 PFS 都有所改善。我們在近期更新中也看到，PFS 的改善似乎也在其他適應症中轉化為 OS 的訊號。我們審慎樂觀地認為，在兩個適應症中都會看到 PFS 受益與 OS 受益。

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

謝謝。這是我們最後一個問題。今天的電話會議到此結束。感謝各位參與。您現在可以斷線。