Biontech SE (BNTX) 2025 Q3 法說會逐字稿

Welcome to Biontech's Third Quarter 2025 Earnings Call. I will now hand the call over to Doug Maffei, Vice President, Strategy and Investor Relations. Please go ahead.

歡迎參加BioNTech 2025年第三季財報電話會議。現在我將把電話交給策略與投資者關係副總裁道格·馬菲。請繼續。

Thank you, operator. Good morning and good afternoon, everybody, and thank you for joining BioNTech's Third Quarter 2025 Earnings Call. As a reminder, the slides we'll use during the call and the corresponding press release can be found in the Investors section of our website.

謝謝接線生。各位早安/下午好，感謝各位參加 BioNTech 2025 年第三季財報電話會議。提醒各位，我們將在電話會議中使用的幻燈片和相應的新聞稿可以在我們網站的「投資者」部分找到。

On the next slide, you will see our forward-looking statement disclaimer. Additional information about these statements and other risks are described in our filings with the U.S. 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.

下一頁將展示我們的前瞻性聲明免責聲明。有關這些聲明和其他風險的更多信息，請參閱我們向美國證券交易委員會（SEC）提交的文件。本次電話會議中的前瞻性陳述存在重大風險和不確定性，僅代表截至本次電話會議當天的觀點。我們不承擔更新或修改這些聲明的義務。

On Slide 3, you can find the agenda for today's call. I'm joined by the following members of BioNTech's management team: Ugur Sahin, Chief Executive Officer and Co-Founder; Ozlem Tureci, Chief Medical Officer and Co-Founder; and Ramon Zapata, Chief Financial Officer. With this, I'll hand the call over to Ugur.

在第 3 張投影片上，您可以找到今天電話會議的議程。與我一同出席的還有 BioNTech 管理團隊的以下成員：執行長兼聯合創始人 Ugur Sahin；首席醫療官兼聯合創始人 Ozlem Tureci；以及首席財務官 Ramon Zapata。接下來，我將把電話交給烏古爾。

Thank you, Doug, and warm welcome to you all as you join us today. As BioNTech has grown, our vision has remained constant, namely translating science into survival. We are building a global immunotherapy powerhouse, a fully integrated biopharmaceutical company with the science, scale, capabilities and the aim to deliver multiple approved therapies and reach patients in need.

謝謝道格，也熱烈歡迎各位今天加入我們。隨著 BioNTech 的發展，我們的願景始終如一，那就是將科學轉化為生存。我們正在打造一家全球免疫療法巨頭，一家擁有科學實力、規模、能力和目標的完全一體化的生物製藥公司，致力於提供多種已獲批准的療法，造福有需要的患者。

Cancer remains a systems problem, heterogeneous across patients and variable within individual tumors. We believe the future lies in rationally designed combinations, pairing potent and precise mechanism of action that create biological synergies. To this aim, we have purpose built a diversified clinical pipeline spanning mRNA immunotherapies, next-generation immunomodulators, ADCs and other targeted agents that enable development of potent, personalized precision medicines and novel-novel combinations across solid tumors.

癌症仍然是一個系統性問題，在不同患者之間表現各異，即使在同一個腫瘤內部也存在差異。我們相信未來在於合理設計的組合，將強效且精確的作用機制結合起來，產生生物協同作用。為此，我們專門建立了多元化的臨床研發管線，涵蓋 mRNA 免疫療法、下一代免疫調節劑、抗體藥物偶聯物 (ADC) 和其他標靶藥物，從而能夠開發針對實體瘤的強效、個人化精準藥物和新型組合療法。

Our goal is to address the full continuum of cancer from resected high-risk tumors in the adjuvant setting to advanced and metastatic disease to treatment-resistant and refractory cancer. Our strategy concentrates capital on 2 priority pan-tumor programs that are designed to anchor various combinations.

我們的目標是解決癌症的整個發展過程，從輔助治療中切除的高風險腫瘤到晚期和轉移性疾病，再到抗藥性和難治性癌症。我們的策略是將資金集中投入 2 個優先泛腫瘤計畫中，旨在為各種聯合療法奠定基礎。

One is Pumitamig, formerly BNT327, a PD-L1 VEGF-A bispecific that unites checkpoint inhibition with vascular normalization in 1 molecule. We believe Pumitamig is particularly suited as a next-generation IO backbone to combine with chemo ADC and other immunomodulators. The other is mRNA cancer immunotherapy that is designed to activate and educate the immune system with precision.

其中一種是 Pumitamig，以前稱為 BNT327，是一種 PD-L1 VEGF-A 雙特異性抗體，它將檢查點抑制與血管正常化結合在一個分子中。我們認為 Pumitamig 特別適合作為下一代 IO 骨架，與化療 ADC 和其他免疫調節劑合併使用。另一種是mRNA癌症免疫療法，旨在精準地活化和訓練免疫系統。

Our mRNA cancer immunotherapies have advanced in randomized late-stage trials with focus on the adjuvant setting. Both approaches have disruptive potential and align with our vision. We believe these programs could establish new standards of care and improve survival outcomes. Together, these programs provide breadth, optionality and scalable registrational path across solid tumors. We are investing deliberately scaling clinical development, building manufacturing that ranges from personalized to large-scale production and preparing for commercialization in key markets to reach patients in need.

我們的 mRNA 癌症免疫療法在隨機後期試驗中取得了進展，重點是輔助治療。這兩種方法都具有顛覆性潛力，並且與我們的願景相符。我們相信這些項目可以建立新的護理標準，並改善患者的生存結果。這些項目共同為實體腫瘤提供了廣泛性、選擇性和可擴展的註冊途徑。我們正在有意識地增加投資，擴大臨床開發規模，建立從個人化生產到大規模生產的製造體系，並為在關鍵市場實現商業化做好準備，以幫助有需要的患者。

Now turning to how our achievements in the quarter relate to our vision and strategy. We see Pumitamig as a potential standard of care across diverse tumor types, spanning settings already treated with checkpoint inhibitors and those where checkpoint inhibitors have not demonstrated benefit. With our partner, BMS, we are executing a broad registrational program. This quarter, we made significant progress in advancing Pumitamig, taking concrete steps towards our registrational plan.

現在來談談本季我們所取得的成就與我們的願景和策略有何關聯。我們認為普米他米有望成為多種腫瘤類型的標準治療方案，涵蓋已接受檢查點抑制劑治療的腫瘤以及檢查點抑制劑尚未顯示出療效的腫瘤。我們正與合作夥伴 BMS 一起執行一項廣泛的註冊計劃。本季度，我們在推動 Pumitamig 專案方面取得了重大進展，朝著註冊計劃邁出了具體步伐。

In Q3, we progressed enrollment in 2 global registrational trials in lung cancer and remain on track to initiate the TNBC Phase III this year. This keeps us aligned with our target of first potential launches before the end of the decade. Across the portfolio, more than a dozen signal-seeking studies progressed. Either with chemo backbones to expand into additional indications or at novel-novel combinations with BioNTech proprietory assets.

第三季度，我們在兩項全球肺癌註冊試驗中推進了病患招募工作，並有望在今年啟動 TNBC III 期試驗。這使我們能夠實現十年內首次潛在產品發布的目標。在整個投資組合中，有十幾項訊號尋找研究取得了進展。要麼以化療為基礎，拓展到其他適應症，要麼與 BioNTech 的專有資產進行全新的組合。

Importantly, we advanced clinical mono agent profiling of potential combination partners, helping to derisk dose, schedule and safety assumptions for future registrational design. These steps, including Phase III recruitment momentum, initiation of new combination cohorts and deeper combination partner characterization are all about informing the next wave of our registrational trials planned with BMS from now onwards.

重要的是，我們推進了潛在聯合用藥夥伴的臨床單藥分析，有助於降低未來註冊設計中劑量、給藥方案和安全性假設的風險。這些步驟，包括 III 期招募進展、啟動新的聯合隊列以及更深入地了解聯合合作夥伴的特徵，都是為了指導我們與 BMS 計劃從現在開始開展的下一階段註冊試驗。

Turning to our mRNA cancer immunotherapy platform. In October, we presented Phase II trial updates for BNT111, our fixed candidate in anti-PD-1 resistant refractory melanoma and for Autogene cevumeran, our fully personalized mRNA cancer immunotherapy in first-line treatment of metastatic melanoma. Our data reinforces our view that adjuvant settings, where tumor burden is low and immune control is most effective represents, where mRNA immunotherapy can deliver the most significant benefit to patients.

轉向我們的mRNA癌症免疫療法平台。10 月，我們公佈了 BNT111（一種用於治療抗 PD-1 抗藥性難治性黑色素瘤的固定候選藥物）和 Autogene cevumeran（一種用於一線治療轉移性黑色素瘤的完全個人化 mRNA 癌症免疫療法）的 II 期試驗最新進展。我們的數據強化了我們的觀點，在腫瘤負荷低、免疫控制最有效的輔助治療環境中，mRNA 免疫療法可以為患者帶來最大的益處。

Ozlem will share details on how this readout sharpening our development focus. This quarter, we hosted our second AI Day. It underscores that we are not only pioneers in new pharmaceutical technologies, but a fully integrated AI-tech bio company with AI tools that enable discovery and development of innovative medicines. We showcased AI-based approaches designed to convert complex dimensions of data diversity into personalized therapy development.

Ozlem 將詳細介紹這項結果如何幫助我們更專注於研發工作。本季度，我們舉辦了第二次人工智慧日活動。這凸顯了我們不僅是新藥技術領域的先驅，而且是一家完全整合的人工智慧技術生物公司，擁有人工智慧工具，能夠發現和開發創新藥物。我們展示了基於人工智慧的方法，旨在將複雜的數據多樣性維度轉化為個人化的治療方案開發。

We demonstrated 2 distinct strengths of our AI capabilities, addressing inter-patient heterogeneity and intra-tumor variability and driving precision and potency in our treatment approaches. With regard to our COVID-19 vaccine franchise, which is partnered with Pfizer, we successfully launched our variant adapted vaccine for the current season following regulatory approval.

我們展現了人工智慧能力的兩大優勢，即解決患者間異質性和腫瘤內變異性，並提高治療方法的精確度和有效性。關於我們與輝瑞公司合作的 COVID-19 疫苗項目，在獲得監管部門批准後，我們已成功推出針對本季病毒變異的疫苗。

With these launches in major markets and with a strong balance sheet, over EUR 16 billion in total cash, equivalents and securities, we have the resources and the flexibility to fund the oncology transition, while maintaining a disciplined P&L. Simply put, we are transforming scientific advances into late-stage programs in our priority oncology program across indications. In parallel, we are building the capabilities and the financial strength to translate positive data rapidly into market opportunities and most importantly, into patient benefit.

憑藉在主要市場的這些產品上市以及強勁的資產負債表（超過 160 億歐元的現金、等價物和證券），我們擁有足夠的資源和靈活性來為腫瘤轉型提供資金，同時保持穩健的損益表。簡而言之，我們正在將科學進步轉化為我們優先腫瘤學計畫中各個適應症的後期計畫。同時，我們正在建立能力和財務實力，以便將積極的數據迅速轉化為市場機會，而最重要的是，轉化為患者的利益。

With that, I will hand over to Ozlem to discuss our clinical execution and near-term data readouts.

接下來，我將把發言權交給奧茲萊姆，讓他來討論我們的臨床執行情況和近期數據解讀。

Thank you, Ugur. I'm glad to be speaking with everyone today. I'll start with a top line status of the programs that are heading our pipeline before moving to specifics. Firstly, with our PD-L1 VEGF-A bispecific antibody Pumitamig, we are executing a broad registrational program in partnership with Bristol-Myers Squibb.

謝謝你，烏古爾。很高興今天能和大家交流。我先概述一下我們正在推進的專案的整體情況，然後再深入到具體細節。首先，我們正在與百時美施貴寶公司合作，進行一項廣泛的註冊計劃，推廣我們的 PD-L1 VEGF-A 雙特異性抗體 Pumitamig。

Second, for our mRNA cancer immunotherapies, we have recently provided 2 Phase II updates that support and inform our current development strategy. And third, for Trastuzumab-Pamirtecan or TPAM, our HER2-targeted ADC known previously as BNT323 that we developed with our partner, Duality, we continue to progress towards first BLA submission now planned for 2026, subject to regulatory feedback.

其次，對於我們的 mRNA 癌症免疫療法，我們最近提供了 2 個 II 期最新進展，這些進展支持並指導了我們目前的研發策略。第三，對於曲妥珠單抗-帕米替康（Trastuzumab-Pamirtecan，簡稱TPAM），即我們與合作夥伴Duality共同開發的靶向HER2的抗體藥物偶聯物（ADC），此前被稱為BNT323，我們正繼續推進其首次生物製品許可申請（BLA）的提交工作，目前計劃提交於2026年反饋部門的反饋。

We are evaluating TPAM as a monotherapy into a randomized Phase III trials, 1 in metastatic endometrial cancer and 1 in breast cancer. For both studies, we expect data in 2026. We have also initiated a signal-seeking trial evaluating the novel combination of TPAM with Pumitamig. For Pumitamig, let me recap the clinical development framework, our refined 3 wave plan that we are pursuing with our partner, BMS. Wave 1 aims to establish Pumitamig in 3 foundational first-line indications, small cell lung cancer, non-small cell lung cancer and triple-negative breast cancer through global registrational Phase III trials.

我們正在對 TPAM 作為單藥療法進行隨機 III 期試驗，其中一項針對轉移性子宮內膜癌，另一項針對乳癌。這兩項研究的數據預計將於 2026 年公佈。我們也啟動了一項訊號探索試驗，評估 TPAM 與 Pumitamig 的新組合。對於 Pumitamig，讓我回顧一下臨床開發框架，以及我們與合作夥伴 BMS 正在推進的改進後的 3 階段計劃。Wave 1 旨在透過全球註冊性 III 期試驗，確立 Pumitamig 在 3 個基礎一線適應症中的療效：小細胞肺癌、非小細胞肺癌和三陰性乳癌。

Wave 2 and 3 aim to expand the opportunity of Pumetamic by amplifying its differentiation, and we do this in 2 dimensions: first, through signal-seeking studies in combination with standard of care across tumors that inform our indication strategy and prioritization; and second, through novel-novel combinations, notably with our ADCs that enhance efficacy. We have delivered tangible progress on all these 3 waves in Q3.

第二波和第三波旨在透過增強 Pumetamic 的差異化來擴大其應用機會，我們從兩個方面著手：首先，透過與標準療法相結合的訊號探索研究，為我們的適應症策略和優先順序提供資訊；其次，透過新型組合，特別是與我們的 ADC 組合，增強療效。第三季度，我們在所有這三個方面都取得了實際進展。

Regarding Wave 1, in small cell lung cancer, the global Phase III is recruiting and the Phase III dose is locked based on the dose optimization data set with a safety profile consistent with known PD-L1 VEGF chemo experience. In non-small cell lung cancer, the Phase II part of the seamless Phase II/III trial achieved full enrollment and the Phase III portion is recruiting.

關於 Wave 1，在小細胞肺癌領域，全球 III 期試驗正在招募受試者，並且 III 期劑量已根據劑量優化數據集鎖定，其安全性與已知的 PD-L1 VEGF 化療經驗一致。在非小細胞肺癌領域，無縫銜接的 II/III 期試驗的 II 期部分已完成全部入組，III 期部分正在招募中。

In TNBC, we remain on track to initiate the global Phase III this year, targeting the PD-L1 low segment, where unmet need is highest. This slide shows additional studies. These are supportive studies for dose finding, setting refinement and regional programs that contribute to the body of evidence supporting our 3 foundational global Phase IIIs.

在 TNBC 領域，我們仍按計劃於今年啟動全球 III 期臨床試驗，目標是 PD-L1 低表達群體，該群體的未滿足需求最高。此投影片展示了其他研究。這些研究為劑量探索、設定改進和區域計畫提供了支持，為我們的 3 項基礎性全球 III 期試驗提供了證據。

Wave 2 serves as our expansion engine. We now have more than a dozen chemo-based signal-seeking studies across tumor types and lines of therapy. In Q3, we opened new cohorts and continue to mature data sets that will feed into our pivotal planning. This helps to ensure that the next registrational wave is evidence-led and prioritized by benefit risk profiles, patient population size, well-informed study design and commercial opportunity alongside other key factors in our decision matrix.

第二波浪潮是我們擴張的引擎。目前，我們針對不同腫瘤類型和治療方案進行了十幾項基於化療的訊號尋找研究。第三季度，我們開設了新的隊列，並繼續完善數據集，這些數據集將用於我們的關鍵規劃。這有助於確保下一波註冊浪潮以證據為導向，並根據獲益風險概況、患者人群規模、充分知情的研究設計和商業機會以及我們決策矩陣中的其他關鍵因素進行優先排序。

Spearheading this next round of pivotal trials, we are initiating 2 trials in partnership with BMS with registrational intent for Pumitamig in combination with chemotherapy in first-line microsatellite stable colorectal cancer and first-line gastric cancer. Wave 3 elevates the potential of Pumitamig through novel-novel combinations to maximize its clinical impact, reinforce class differentiation and set up a multiyear pathway to sustain the value and the longevity of the drug into the new decade.

為了引領下一輪關鍵性試驗，我們與 BMS 合作啟動了 2 項試驗，旨在註冊 Pumitamig 與化療聯合用於一線微衛星穩定型結直腸癌和一線胃癌的療效。Wave 3 透過全新的組合提升了 Pumitamig 的潛力，以最大限度地發揮其臨床影響，強化類別差異化，並建立多年路徑，以在新的十年中維持該藥物的價值和持久性。

Here, several combo cohorts of Pumitamig with our ADCs or other novel compounds are already enrolling and have gained momentum in Q3. Initial data over the next year will inform decision-making for our first pivotal combinational regimen. In parallel, we are continuing mono-agent profiling of potential combination partners to set clear baseline for dose safety and sequence.

目前，Pumitamig 與我們的 ADC 或其他新型化合物的幾個組合隊列已經開始招募患者，並在第三季度取得了進展。接下來一年的初步數據將為我們第一個關鍵性聯合治療方案的決策提供基礎。同時，我們正在繼續對潛在的聯合用藥夥伴進行單藥分析，以明確劑量安全性和用藥順序的基線。

Taken together, Q3 was a quarter of strong clinical execution that strengthened our registrational core, widened our expansion engine and advanced the novel-novel combination rationale that we believe will further distinguish and elevate Pumitamig over time. Let me now highlight 2 Q3 focal points. First, our first-line small-cell lung cancer registrational program and why the recent updates are catalytic. And second, our advances in mono agent profiling for refining our combination strategy.

總的來說，第三季我們在臨床執行方面取得了強勁的進展，鞏固了我們的註冊核心，拓寬了我們的擴張引擎，並推進了我們認為將進一步凸顯和提升 Pumitamig 優勢的新型組合療法。現在讓我重點介紹第三季的兩個重點。首先，介紹我們的一線小細胞肺癌登記計劃，以及為何最近的更新具有催化作用。其次，我們在單藥分析方面取得了進展，以改善我們的組合策略。

Small cell lung cancer remains a challenging immunologically cold disease in which responses to immune checkpoint therapy tend to be short-lived, resulting in modest gains over chemotherapy alone and low long-term survival. Over the last 18 months, we have built a cohesive evidence base across multiple Phase II studies in first- and second-line small cell lung cancer initially in China and now globally, showing encouraging activity and a manageable safety profile.

小細胞肺癌仍然是一種具有挑戰性的免疫冷疾病，對免疫檢查點療法的反應往往是短暫的，與單獨化療相比，療效提升有限，長期存活率較低。在過去的 18 個月裡，我們透過多項 II 期研究，在最初於中國開展的一線和二線小細胞肺癌治療中，建立了一個連貫的證據基礎，現在已擴展到全球範圍，結果顯示該藥物具有令人鼓舞的療效和可控的安全性。

This quarter, at WCLC, we reported the first global data from our Phase II dose optimization study in untreated extensive-stage small cell lung cancer, evaluating 2 dose levels of Pumitamig plus chemotherapy. All patients irrespective of dose had disease control at 20 mg per kg we observed a confirmed objective response rate of 85% and a median progression-free survival of 6.3 months. 30 mg per kg yielded a confirmed objective response rate of 66% and a median PFS of 7 months.

本季度，在 WCLC 上，我們公佈了針對未經治療的廣泛期小細胞肺癌的 II 期劑量優化研究的首個全球數據，該研究評估了普米他米加化療的 2 個劑量水平。無論劑量如何，所有患者的疾病均受到控制。在 20 mg/kg 的劑量下，我們觀察到確認的客觀緩解率為 85%，中位無惡化存活期為 6.3 個月。 30 mg/kg 的劑量下，確認的客觀緩解率為 66%，中位無惡化存活期為 7 個月。

Median overall survival data were not yet mature. Safety remained consistent and manageable with low discontinuation and no new signals beyond those typically seen with chemo and PD-L1 VEGF agents. 2 points are worth emphasizing. First, dose clarity, which is a critical derisking step for any registrational program. The global dose optimization readout allowed us to lock the Phase III regimen at 20 mg per kg every 3 weeks.

中位總存活期數據尚未成熟。安全性保持穩定且可控，停藥率低，除化療和PD-L1 VEGF藥物通常出現的不良反應外，未發現其他新的不良反應。有兩點值得強調。首先是劑量明確，這是任何註冊項目降低風險的關鍵步驟。全球劑量優化結果使我們能夠將 III 期治療方案鎖定為每 3 週每公斤 20 毫克。

Second, consistent performance across regions. Earlier China data sets in first-line extensive stage small cell lung cancer showed robust activity and manageable safety. The global Q3 data are consistent with those findings, which further strengthens our confidence in Pumitamig's benefit across patient populations and practice patterns.

第二，各地區表現一致。先前中國一線治療廣泛期小細胞肺癌的數據表明，該藥物具有良好的療效和可控的安全性。全球第三季數據與這些發現一致，這進一步增強了我們對普米他明在不同患者群體和治療模式下的益處的信心。

Together, these results support our ongoing global Phase III ROSETTA LUNG-01 trial, which compares Pumitamig plus chemotherapy against atezolizumab plus chemotherapy in untreated small cell lung cancer. In parallel, in China, we continue with second-line randomized Phase III trial of Pumetamic plus chemo versus chemo alone. This quarter, we expanded our Pumetamic small cell lung cancer program to include novel-novel testing, and we launched signal-seeking studies of Pumetamic plus our B7H3 ADC, BNT324 in both first- and second-line small cell lung cancer.

這些結果共同支持我們正在進行的全球 III 期 ROSETTA LUNG-01 試驗，該試驗比較了普米他米加化療與阿特珠單抗加化療在未經治療的小細胞肺癌中的療效。同時，在中國，我們繼續進行普美他米聯合化療與單純化療的二線隨機 III 期試驗。本季度，我們擴大了 Pumetamic 小細胞肺癌項目，納入了新型測試，並啟動了 Pumetamic 聯合我們的 B7H3 ADC BNT324 在一線和二線小細胞肺癌中的信號探索研究。

As Phase III readouts and Phase I/II ADC combination data sets mature, we will be increasingly well positioned to select and advance additional regimens designed to establish long-standing presence in small cell lung cancer. This brings me to our strategy for advancing combinations of Pumetamic with other novel agents, one of our key differentiation approaches. The cornerstone is establishing mono agent evidence of activity, durability and safety before we decide to pair with Pumetamic.

隨著 III 期臨床試驗結果和 I/II 期 ADC 聯合用藥數據日益成熟，我們將越來越有能力選擇和推進更多旨在長期治療小細胞肺癌的治療方案。這讓我想到我們推進普美他明與其他新型藥物合併使用的策略，這是我們的關鍵差異化方法之一。在決定是否與普美他米合併使用之前，關鍵在於建立單一藥物的活性、持久性和安全性證據。

For our B7H3 ADC, BNT324, our mono agent database has expanded significantly over the last 12 months. B7-H3's broad expression profile aligns well with Pumitamig's expand tumor opportunity. In small cell lung cancer, BNT324 as monotherapy achieved an objective response rate of 56% with deep tumor shrinkage across the waterfall, an unusually strong single-agent signal in this setting.

對於我們的 B7H3 ADC 藥物 BNT324，我們的單藥資料庫在過去 12 個月中顯著擴大。B7-H3 的廣泛表現譜與 Pumitamig 擴大腫瘤治療機會的潛力非常契合。在小細胞肺癌中，BNT324 作為單藥療法實現了 56% 的客觀緩解率，並實現了瀑布圖上腫瘤的深度縮小，這在此類情況下是一個異常強烈的單藥療效信號。

In non-small cell lung cancer, activity was observed in both squamous and non-squamous disease, including an EGFR mutant subset with an objective response rate of 21%. In heavily pretreated metastatic castration-resistant prostate cancer, we observed meaningful tumor shrinkage with BNT324 and a durable radiographic progression-free survival with a manageable safety profile.

在非小細胞肺癌中，鱗狀細胞癌和非鱗狀細胞癌均觀察到了活性，包括 EGFR 突變亞群，客觀緩解率為 21%。在接受過大量預處理的轉移性去勢抵抗性前列腺癌中，我們觀察到 BNT324 能顯著縮小腫瘤，並能帶來持久的影像學無進展生存期，且安全性良好。

Recently at ESMO, we reported data for our TROP2 ADC, BNT325 in second-line plus TNBC with an objective response rate around 35%, disease control rate of roughly 81% and median progression-free survival of about 5.5 months. Also in Q3 for our HER2 ADC T-PAM, we saw a substantial expansion of the monotherapy data base by the DYNASTY-Breast02 Phase III trial, our partner DualityBio conducts in China that met its primary endpoint of PFS improvement versus trastuzumab emtansine in pretreated patients with HER2-positive un-resectable or metastatic breast cancer. T-PAM is another promising combination partner with the potential to expand Pumitamig's therapeutic reach into the HER2-expressing tumor spectrum.

最近在 ESMO 會議上，我們報告了我們的 TROP2 ADC BNT325 在二線及以上 TNBC 治療中的數據，客觀緩解率約為 35%，疾病控制率約為 81%，中位無進展生存期約為 5.5 個月。第三季度，我們的 HER2 ADC T-PAM 單藥治療資料庫也得到了大幅擴展，這得益於我們的合作夥伴 DualityBio 在中國進行的 DYNASTY-Breast02 III 期試驗。該試驗達到了主要終點，即在接受過治療的 HER2 陽性不可切除或轉移性乳癌患者中，與曲妥珠單抗 emtansine 相比，PFS 得到改善。T-PAM 是另一個有前途的組合夥伴，有可能將 Pumitamig 的治療範圍擴展到表達 HER2 的腫瘤譜。

Taken together, these data provide a clear monotherapy baseline and help us set the bar for add-on benefit from Pumitamig plus ADC combinations. Across these programs, the mechanistic rationale is consistent. VEGF-A blockade can normalize vasculature to improve ADC delivery, while PD-L1 inhibition can convert ADC-mediated cytotoxicity and antigen release into a broader durable immune response, aiming for deeper debulking plus immune control.

綜合來看，這些數據提供了明確的單藥治療基線，並幫助我們設定普米他米加抗體藥物偶聯物合併用藥的額外獲益標準。在這些項目中，機制原理是一致的。VEGF-A 阻斷可使血管正常化，從而改善 ADC 遞送；而 PD-L1 抑制可將 ADC 介導的細胞毒性和抗原釋放轉化為更廣泛、更持久的免疫反應，旨在實現更深層的減瘤和免疫控制。

These represent complementary mechanisms that single agents cannot engage simultaneously. So operationally, we made 2 key advances in Q3, continued mono-agent profiling to refine dose and sequence and codification of our add-on benefit threshold and expansion of Pumitamig plus ADC cohorts across prioritized settings. Of note, our go/no-go decision-making process is driven by a holistic evaluation that goes beyond efficacy signals and safety profiles. We strategically assess market opportunity, unmet needs, competitive dynamics and weigh other key factors to ensure every decision aligns with our mission to deliver transformative benefit for patients.

這些是互補的機制，單一主體無法同時參與其中。因此，在營運方面，我們在第三季度取得了 2 個關鍵進展，繼續進行單藥分析以改進劑量和順序，並對我們的附加獲益閾值進行編碼，以及在優先設定中擴大 Pumitamig 加 ADC 隊列。值得注意的是，我們的「繼續/不繼續」決策過程是由一個整體評估驅動的，這個評估超越了療效訊號和安全性概況。我們從策略上評估市場機會、未滿足的需求、競爭動態，並權衡其他關鍵因素，以確保每個決策都符合我們為患者帶來變革性利益的使命。

Moving now to our second oncology cornerstone, mRNA cancer immunotherapy. iNeST is individually manufactured per patient to target personal neoantigens. The biology and our clinical experience point to greatest relevance in earlier disease settings, where lower tumor burden allow the immune system to consolidate control. Our ongoing randomized Phase II trials are designed to test that premise in a rigorous way.

接下來我們來談談腫瘤治療的第二個基石—mRNA癌症免疫療法。 iNeST是根據每位患者的個別情況量身定制生產的，旨在靶向特定的腫瘤新抗原。生物學和我們的臨床經驗表明，在疾病早期階段，腫瘤負荷較低，免疫系統能夠鞏固控制，因此這種方法最為相關。我們正在進行的隨機 II 期試驗旨在以嚴格的方式檢驗此前提。

Off-the-shelf FixVac that includes BNT111 for melanoma, BNT113 for HPV16 positive head and neck cancer and BNT116 for non-small cell lung cancer targets shared antigens and is intended to pair with checkpoint inhibitors and increasingly our next-gen backbones. We continue to advance execution and evidence generation across multiple tumor settings, while keeping optionality around where and how FixVac is best positioned longer term.

現成的 FixVac 疫苗包括用於治療黑色素瘤的 BNT111、用於治療 HPV16 陽性頭頸癌的 BNT113 和用於治療非小細胞肺癌的 BNT116，它們靶向共同抗原，旨在與檢查點抑製劑以及我們越來越多的下一代骨架藥物配合使用。我們將繼續推進在多種腫瘤環境下的執行和證據生成，同時保留選擇權，以確定 FixVac 在長期發展中的最佳定位方式和地點。

This quarter at WCLC, we presented results for BNT116 plus cemiplimab as consolidation treatment in unresectable Stage III non-small cell lung cancer. We also presented data at ESMO from 2 randomized Phase II trials in melanoma, 1 with BNT111 FixVac and the other for Autogene cevumeran iNeST. I will briefly walk you through the melanoma readouts and their implications. Starting with BNT111 FixVac in the high medical need population of patients who had relapsed or not responded to PD-1 treatment.

本季在 WCLC 上，我們展示了 BNT116 合併 cemiplimab 作為不可切除的 III 期非小細胞肺癌鞏固治療的結果。我們也向 ESMO 展示了 2 項黑色素瘤隨機 II 期試驗的數據，一項試驗使用 BNT111 FixVac，另一項試驗使用 Autogene cevumeran iNeST。我將簡要地向您介紹黑色素瘤的各項檢測結果及其意義。首先在對 PD-1 治療有復發或無反應的高醫療需求患者族群中使用 BNT111 FixVac。

The Phase II study evaluated BNT111 plus cemiplimab against a historical control objective response rate of 10% reported for anti-PD-1 treatment in this setting. The study included 2 calibrator monotherapy cohorts to characterize the safety of each agent and its activity on objective response rate. The objective of this design was signal characterization, not cross-arm efficacy claims. In the monotherapy cohorts on progression addition of the second agent was permitted.

II 期研究評估了 BNT111 聯合 cemiplimab 與歷史對照客觀緩解率 10% 的療效，該對照研究報告稱，在此情況下，抗 PD-1 治療的客觀緩解率為 10%。研究包括 2 個校準單藥治療隊列，以描述每種藥物的安全性及其對客觀緩解率的影響。此設計的目的是訊號特徵分析，而不是跨組療效聲明。在單藥治療組中，病情進展時允許添加第二種藥物。

More than half of the patients in each arm opted for this addition, after a median duration of [ IVA ] monotherapy treatment of around 4 months. The study met its prespecified primary endpoint by rejecting the null hypothesis of an ORR of 10% with statistical significance. The ORR of the combination was 18%, including deep and durable responses. Notably, 2/3 of the responses were complete responses, supporting the depth of activity.

在接受 [ IVA ] 單藥治療的中位數持續時間約為 4 個月後，各組中超過一半的患者選擇添加此藥物。該研究達到了預先設定的主要終點，以統計意義拒絕了 ORR 為 10% 的零假設。此聯合療法的客觀緩解率為 18%，包括深度和持久緩解。值得注意的是，三分之二的回復是完整的回复，這反映了活動的深度。

Follow-up showed a positive impact on long-term survival. 37% of patients were still alive after 24 months, 21% were free of tumor progression. Safety was manageable, driven largely by expected mostly grade 1, 2 cytokine-related events consistent with the mRNA platform. BNT111 monotherapy also demonstrated objective responses and a consistent safety profile. Taken together, these results support that BNT111 is active in this difficult post-IO setting and provide us useful footing to guide setting selection and optimal combinations going forward.

追蹤結果顯示，該療法對長期存活率有正面影響。 24個月後，37%的患者仍存活，21%的患者未出現腫瘤惡化。安全性可控制，主要表現為預期的 1 級、2 級細胞激素相關事件，這與 mRNA 平台一致。BNT111 單藥治療也顯示出客觀療效和一致的安全性。綜上所述，這些結果表明 BNT111 在這種困難的 IO 後環境中具有活性，並為我們提供了有用的基礎，以指導未來的設置選擇和最佳組合。

Turning to iNeST. The data presented at ESMO come from our randomized Phase II trial evaluating Autogene cevumeran in combination with pembrolizumab versus pembrolizumab alone in first-line metastatic advanced melanoma. As previously disclosed, the trial did not meet the primary endpoint of a statistically significant improvement in progression-free survival. That said, we observed a numerical trend favoring the combination and overall survival.

轉向 iNeST。在 ESMO 上發表的數據來自我們隨機 II 期試驗，該試驗評估了 Autogene cevumeran 聯合 pembrolizumab 與單獨使用 pembrolizumab 治療一線轉移性晚期黑色素瘤的療效。如先前所揭露的那樣，該試驗並未達到無惡化存活期有統計學意義的顯著改善這一主要終點。儘管如此，我們觀察到一種有利於聯合治療和整體存活率的數值趨勢。

In the combination arm, 12 months overall survival was 88% and 24 months overall survival was 74% compared to 71% and 63% in the pembrolizumab arm, respectively. Of note, crossover was allowed and patients randomized to pembrolizumab received the combination at progression. For the overall survival analysis, those patients remain in their originally assigned arm, which can dilute the observed treatment effect over time.

合併治療組的 12 個月總存活率為 88%，24 個月總存活率為 74%，而帕博利珠單抗組的相應數據分別為 71% 和 63%。值得注意的是，允許交叉治療，隨機分配至帕博利珠單抗組的患者在疾病進展時接受聯合治療。對於整體存活分析而言，這些患者仍留在他們最初分配的組別中，這可能會隨著時間的推移而稀釋觀察到的治療效果。

We observed robust neoantigen-specific T-cell responses in the majority of evaluable patients with multi-epitope breadth and persistence of T-cell clones well beyond induction, indicating that the mRNA therapy is mediating the intended biological activity that we want to achieve. The translational readouts give us 3 actionable insights. First, T cell response breadth correlates with activity. Within the combination arm, patients who mounted a broader neoantigen-specific T-cell response experienced longer progression-free survival, supporting our ongoing efforts to maximize antigen breadth and to target early and low tumor burden disease with still proficient immune cell priming capacity.

我們觀察到，在大多數可評估的患者中，存在強大的新抗原特異性 T 細胞反應，具有多表位廣度和 T 細胞克隆在誘導後仍能持續存在，這表明 mRNA 療法正在介導我們想要實現的預期生物活性。翻譯結果為我們提供了 3 個可操作的見解。首先，T細胞反應廣度與活性有關。在聯合治療組中，產生更廣泛的新抗原特異性 T 細胞反應的患者經歷了更長的無進展生存期，這支持了我們正在進行的最大限度地擴大抗原範圍​​，並針對早期和低腫瘤負荷疾病，同時保持有效的免疫細胞啟動能力的努力。

Second, immune cell PD-L1 matters. We saw a trend of improved overall survival for the combination in tumors, where immune cell PD-L1 was high, while tumor cell PD-L1 did not discriminate overall survival in this data set, supporting that low tumor cell PD-L1 should not exclude tumor types from vaccine PD-1 strategies.

其次，免疫細胞PD-L1很重要。我們發現，在免疫細胞 PD-L1 表達高的腫瘤中，聯合治療可改善總體生存率；而腫瘤細胞 PD-L1 表達在該數據集中並不能區分總體生存率，這表明低腫瘤細胞 PD-L1 表達不應將腫瘤類型排除在 PD-1 疫苗策略之外。

Third, signal in IO-insensitive biology. There was a trend of improved overall survival with the combination in tumor mutational burden low patients. Precisely the population that typically gains less from IO. This is consistent with the concept that the vaccine can supply immunogenic targets, when endogenous mutation load is limited and further encourages development in settings such as pancreatic cancer and MSS colorectal cancer with low tumor mutational burden and unresponsiveness to IO.

第三，在對 IO 不敏感的生物學中發出訊號。腫瘤突變負荷低的患者採用合併治療後，整體存活率有提高的趨勢。恰恰是這部分人群通常從產業組織中獲益較少。這與疫苗可以提供免疫原性標靶的概念一致，當內源性突變負荷有限時，這進一步促進了在胰腺癌和 MSS 結直腸癌等腫瘤突變負荷低且對免疫療法無反應的疾病中的開發。

Altogether, these mechanistic insights support our ongoing randomized Phase II trials, both the specific indications we have chosen, which is colorectal, pancreatic and bladder cancer as well as our focus on the adjuvant setting, where tumor burden and heterogeneity is lowest and T-cell proficiency is still high. Now looking ahead, what comes next? We will continue to generate and present new clinical data across our oncology pipeline, data that directly steer late-stage decisions.

總而言之，這些機制的見解支持我們正在進行的隨機 II 期試驗，包括我們選擇的特定適應症（即結直腸癌、胰腺癌和膀胱癌）以及我們對輔助治療的關注，在輔助治療中，腫瘤負荷和異質性最低，T 細胞能力仍然很高。展望未來，接下來會發生什麼事？我們將繼續產生並展示我們腫瘤產品線中的新臨床數據，這些數據將直接指導後期決策。

For Pumitamig, we will share early data from our TNBC program in December, including from our dose optimization cohorts, which are central to defining the Phase III regimen. From our ADC platform, we expect additional monotherapy updates from BNT324 in cervical cancer and platinum-resistant ovarian cancer, from BNT325 in TNBC and from BNT326 in HER2-null and low hormone receptor positive breast cancer.

對於 Pumitamig，我們將在 12 月分享我們 TNBC 計畫的早期數據，包括來自我們的劑量優化隊列的數據，這些數據對於確定 III 期治療方案至關重要。我們期待從我們的 ADC 平台獲得以下單藥療法更新：BNT324 用於治療子宮頸癌和鉑耐藥卵巢癌，BNT325 用於治療三陰性乳腺癌，以及 BNT326 用於治療 HER2 陰性和激素受體低陽性乳腺癌。

These studies explore indications defined dose and sequence guardrails and set the add-on benefit bar for Pumitamig's novel-novel combinations. For the randomized Phase II trial evaluating Autogene Cevumeran monotherapy treatment versus watchful waiting in adjuvant ctDNA-positive Stage II high-risk or Stage III colorectal cancer, we expect an interim update in early 2026.

這些研究探討了適應症，明確了劑量和順序的指導原則，並為普米他米格的新型組合設定了附加獲益標準。對於評估 Autogene Cevumeran 單藥治療與觀察等待治療輔助 ctDNA 陽性 II 期高風險或 III 期結直腸癌的隨機 II 期試驗，我們預計將在 2026 年初獲得中期更新。

The efficacy evaluation of the primary endpoint of disease-free survival is projected for the end of 2026, when the data set will have reached the intended maturity. Then later this year, we plan to present data together with our partner, Onco C4 from the nonregistrational first part of the ongoing global Phase III trial evaluating our anti-CTLA-4 antibody, Gotisrobart versus chemotherapy as a second-line treatment for squamous non-small cell lung cancer.

預計在 2026 年底，當資料集達到預期成熟度時，將對無疾病存活期這一主要終點進行療效評估。今年晚些時候，我們計劃與合作夥伴 Onco C4 一起公佈正在進行的全球 III 期試驗的非註冊第一部分的數據，該試驗旨在評估我們的抗 CTLA-4 抗體 Gotisrobart 與化療作為鱗狀非小細胞肺癌二線治療的療效。

Overall, these upcoming data points advance the same theme. Evidence-led prioritization by establishing dose finding and mono ADC baselines to further refine Pumitamig registrational path and leverage randomized setting-specific readouts to position our mRNA immune therapies where they are most likely to succeed.

整體而言，這些即將公佈的數據點都印證了同一主題。透過建立劑量探索和單藥 ADC 基線，以證據為導向進行優先排序，進一步完善 Pumitamig 的註冊路徑，並利用隨機的特定環境讀數，將我們的 mRNA 免疫療法定位在最有可能成功的地方。

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

接下來，我將把匯報工作交給我們的財務長拉蒙·薩帕塔，由他來報告財務最新情況。

Thank you, Ozlem, and a warm welcome to everyone who has joined today's call. I will begin by reviewing our financial results for the 3 months ended September 30, 2025. Note that all figures are in euros unless otherwise specified.

謝謝奧茲萊姆，也熱烈歡迎今天參加電話會議的各位。我將首先回顧截至 2025 年 9 月 30 日的三個月的財務表現。請注意，除非另有說明，所有數字均以歐元為單位。

The total revenues reported for the period were EUR 1.519 billion, an increase from the same quarter in 2024, which was EUR 1.245 billion. This increase was mainly driven by the recognition of USD 700 million as part of the BMS collaboration in the third quarter of 2025. For context, in total, we expect to receive USD 3.5 billion in upfront and noncontingent cash payments from BMS between 2025 and 2028. We expect to recognize this as revenue in increments annually over the development phase of Pumitamig. For the third quarter 2025, we reflected USD 700 million in our revenues.

該期間報告的總收入為 15.19 億歐元，比 2024 年同期的 12.45 億歐元有所增長。這一增長主要是由於在 2025 年第三季確認了與 BMS 合作的 7 億美元收入。作為參考，我們預計在 2025 年至 2028 年間，將從 BMS 收到總計 35 億美元的預付款和非或有現金付款。我們預計將在 Pumitamig 的開發階段每年分期確認這部分收入。2025年第三季度，我們的營收為7億美元。

Moving to cost of sales. This amounted to approximately EUR 148 million for the third quarter of 2025 compared to approximately EUR 179 million for the same period last year, driven by lower inventory write-downs. Research and development expenses were approximately EUR 565 million for the third quarter of 2025, compared to approximately EUR 550 million for the same period last year.

轉入銷售成本。2025 年第三季度，該金額約為 1.48 億歐元，而去年同期約為 1.79 億歐元，主要原因是庫存減損減少。2025 年第三季的研發費用約為 5.65 億歐元，而去年同期約為 5.5 億歐元。

R&D expenses were mainly driven by the initiation of late-stage trials for our immunomodulators and ADC programs and partly offset by cost savings resulting from active portfolio management towards our priority programs. SG&A expenses amounted to approximately EUR 148 million in the third quarter of 2025 compared to EUR 150 million for the same period last year. The decrease was mainly driven by lower external costs, partially compensated by our ongoing commercial build-out.

研發費用主要由免疫調節劑和抗體藥物偶聯物 (ADC) 計畫的後期試驗啟動所驅動，部分被積極進行優先項目組合管理所帶來的成本節約所抵消。2025 年第三季銷售、一般及行政費用約為 1.48 億歐元，去年同期為 1.5 億歐元。下降的主要原因是外部成本降低，但部分被我們正在進行的商業建設所抵消。

Our other operating results amounted to approximately negative EUR 705 million in the third quarter of 2025 compared to approximately negative EUR 355 million for the same period last year. Our other operating results for the third quarter of 2025 was primarily influenced by the settlement of a contractual dispute. For the third quarter of 2025, we reported a net loss of EUR 29 million compared to a net income of EUR 198 million for the comparative prior-year period. This was mainly driven by the effect of settlement disputes.

2025 年第三季度，我們的其他經營業績約為虧損 7.05 億歐元，而去年同期約為虧損 3.55 億歐元。我們 2025 年第三季的其他經營業績主要受到合約糾紛解決的影響。2025 年第三季度，我們報告淨虧損 2,900 萬歐元，而去年同期淨利為 1.98 億歐元。這主要是由和解糾紛的影響所造成的。

Our basic and diluted loss per share for the third quarter of 2025 was EUR 0.12 compared to basic earnings per share of EUR 0.82 and diluted earnings per share of EUR 0.81 for the comparative prior-year period. At the end of the third quarter of 2025, our cash, cash equivalents and security investments totaled EUR 16.7 billion, including the USD 1.5 billion upfront payment received from BMS. Our strong financial position empowers continued investments in our late-stage priority programs and preparations for commercialization of our diversified oncology portfolio.

2025 年第三季度，我們的基本每股虧損和稀釋每股虧損均為 0.12 歐元，而去年同期基本每股收益為 0.82 歐元，稀釋每股收益為 0.81 歐元。截至 2025 年第三季末，我們的現金、現金等價物和證券投資總額為 167 億歐元，其中包括從 BMS 收到的 15 億美元預付款。我們雄厚的財務實力使我們能夠繼續投資於後期重點項目，並為多元化腫瘤產品組合的商業化做好準備。

Turning to the next slide. We are updating the company's financial guidance for the 2025 financial year. Our previously issued revenue guidance range for 2025 was $1.7 billion to $2.2 billion. And today, we are increasing it to $2.6 billion to $2.8 billion. This is mainly driven by the recognition of USD 700 million from our BMS collaboration. Further guidance considerations, such as those related to our COVID-19 vaccine business, including inventory write-downs from COVID-19 vaccine sales in Pfizer's territories as well as expected revenues from the pandemic preparedness contract with the German government and revenues from our service businesses remain unchanged.

翻到下一張投影片。我們正在更新公司 2025 財年的財務預期。我們先前發布的 2025 年營收預期範圍為 17 億美元至 22 億美元。今天，我們將這一數字增加到 26 億至 28 億美元。這主要是因為我們從與 BMS 的合作中獲得了 7 億美元的收入。其他指導性考慮因素，例如與我們的 COVID-19 疫苗業務相關的因素，包括輝瑞地區 COVID-19 疫苗銷售的庫存減值，以及與德國政府簽訂的疫情防範合約的預期收入和我們服務業務的收入，均保持不變。

Turning to expenses. We are lowering our prior 2025 financial year R&D expense guidance by EUR 600 million to a new range of EUR 2 billion to EUR 2.2 billion. This updated guidance reflects our active portfolio management that has enabled significant R&D efficiencies. As part of that, we follow a rigorous go/no-go decision-making across all development stages as part of the prioritization efforts. This allows us to focus on the programs in our portfolio, which we believe represents the largest opportunities.

接下來談談費用。我們將先前對 2025 財年研發支出的預期下調 6 億歐元，新的預期範圍為 20 億歐元至 22 億歐元。此次更新後的指導方針反映了我們積極的投資組合管理，從而顯著提高了研發效率。為此，我們在所有開發階段都遵循嚴格的「通過/不通過」決策流程，作為優先排序工作的一部分。這使我們能夠專注於我們投資組合中的項目，我們認為這些項目代表著最大的機會。

Consistent with our commitment to disciplined and sustainable growth, we are also improving our full-year guidance for SG&A and capital expenditure for operating activities. We are reducing our full year SG&A expense guidance by $100 million to a range of $550 million to $650 million as a result of ongoing cost optimization initiatives. We are also reducing our full-year guidance for capital expenditures for operating activities to a range of $200 million to $250 million to better reflect our targeted investment in manufacturing.

秉承我們對穩健永續成長的承諾，我們也提高了全年銷售、管理及行政費用和營運活動資本支出的預期。由於持續推進成本優化措施，我們將全年銷售、管理及行政費用預期下調 1 億美元，至 5.5 億美元至 6.5 億美元之間。我們同時將全年營運活動資本支出預期下調至 2 億至 2.5 億美元，以更能反映我們對製造業的定向投資。

Aligned with our disclosures earlier in the year, we expect to report a loss for the 2025 financial year as we continue to invest in our transition to become a fully integrated commercial oncology company. As Ugur outlined, we continue to focus on executing our strategy around 2 pan-tumor product opportunities, Pumitamig and our mRNA cancer immunotherapies. We currently have multiple ongoing Phase II and III trials across these programs, reflecting our strategy to bring novel combinations to patients. We expect to generate additional meaningful data for these programs in the months ahead.

與今年稍早披露的資訊一致，我們預計 2025 財年將出現虧損，因為我們將繼續投資轉型，成為一家完全一體化的商業腫瘤公司。正如 Ugur 所概述的那樣，我們將繼續專注於執行我們圍繞 2 個泛腫瘤產品機會的策略，即 Pumitamig 和我們的 mRNA 癌症免疫療法。目前，我們在這些計畫中進行了多項 II 期和 III 期試驗，這反映了我們為患者帶來創新組合療法的策略。我們預計在未來幾個月內，這些項目將產生更多有意義的數據。

As we advance, we will continue to maintain rigorous financial discipline and remain focused on achieving long-term sustainable growth. Before concluding, I would like to invite you to watch our annual Innovation Series R&D Day event on November 11. During the R&D Day, we plan to provide a deeper dive into our oncology strategy, including plans for Pumitamig and our mRNA immunotherapy candidate.

隨著我們繼續前進，我們將繼續保持嚴格的財務紀律，並繼續專注於實現長期永續成長。最後，我想邀請您觀看我們於11月11日舉行的年度創新系列研發日。在研發日期間，我們計劃深入探討我們的腫瘤學策略，包括 Pumitamig 和我們的 mRNA 免疫療法候選藥物的計劃。

Thank you for your ongoing support and interest as we continue to create value for cancer patients, society and shareholders. With that, we would like to open the floor for questions.

感謝您一直以來的支持和關注，我們將繼續為癌症患者、社會和股東創造價值。接下來，我們歡迎各位提問。

[Operator Instructions] We will now take our first question. From the line of Tazeen Ahmad, Bank of America Securities.

【操作員說明】現在我們來回答第一個問題。來自美國銀行證券的塔津·艾哈邁德 (Tazeen Ahmad) 的記錄。

I wanted to get a sense about how you're thinking about the market opportunity for MSS CRC and first-line gastric cancer. Can you just talk about how your product can be particularly differentiated from what's currently used?

我想了解一下您是如何看待 MSS CRC 和第一線胃癌的市場機會的。您能否談談您的產品與目前使用的產品有哪些顯著差異？

Tazeen, thank you for the question. We lost your audio there a little bit. Could you just -- sorry, could you just repeat that question? I just want to make sure we get it correct.

塔津，謝謝你的提問。剛才你的音頻有點斷斷續續的。您能—不好意思，您能再說一次嗎？我只是想確保我們做對了。

I wanted to ask a question about the market opportunity for MSS CRC and for first-line gastric. I wanted to get a sense of how you think about the opportunity relative to the competition?

我想問一個關於 MSS CRC 和一線胃癌治療的市場機會的問題。我想了解您如何看待這個機會相對於競爭對手的情況？

Thank you, Tazeen. We got it this time. So that was a question about how we think about the CRC first-line opportunity in gastric and how it compares to the competitive field. So Ozlem, would you like to take that question?

謝謝你，塔津。這次我們成功了。所以這個問題是關於我們如何看待 CRC 在胃癌一線治療的機會，以及它與競爭領域的比較。那麼，奧茲萊姆，你願意回答這個問題嗎？

Yes, I can take that question. Both indications as CRC and gastric first-line are still high medical need indications. And we think that the combination of VEGF-A and PD-L1 blocking from a biology point of view, has a rationale for development and has the potential of improving the clinical benefit for these patient populations.

是的，我可以回答這個問題。CRC 和胃癌第一線治療仍屬於高度醫療需求適應症。我們認為，從生物學角度來看，VEGF-A 和 PD-L1 阻斷的結合具有開發合理性，並有可能改善這些患者群體的臨床效益。

We will now take the next question from the line of Terence Flynn, Morgan Stanley.

接下來，我們將回答來自摩根士丹利的 Terence Flynn 的下一個問題。

I had 1 question and then 1 just clarification. So for BNT323, was just wondering, if you can share any more color on the delay in the BLA filing in terms of the gating factor here? And then on the new R&D guidance, just want to clarify that, that reflects the assumption of some of the BNT327 expenses by Bristol-Myers and that, that was the driver of the change here, if there's other prioritizations that fed into this?

我有一個問題，然後還有一個需要澄清的地方。所以關於BNT323，我想問一下，您能否就BLA申請延遲的審批流程方面提供更多細節？關於新的研發指導，我想澄清一下，這是否反映了百時美施貴寶承擔的部分 BNT327 費用，以及這是否是此次調整的驅動因素，還有其他優先事項促成了此次調整嗎？

Yes. Okay. Thank you, Terence. So, 2 clarifications in there. So maybe if we do the R&D guidance first, and I'll direct that one to Ramon. And then Ozlem, I'll direct the BNT323 BLA progress question to you after that.

是的。好的。謝謝你，特倫斯。所以，這裡有兩點需要澄清。所以也許我們可以先制定研發指導，然後我會把這個指導意見轉交給拉蒙。然後，Ozlem，之後我會把 BNT323 BLA 的進度問題轉交給你。

Thank you for the question, Terence. I would say that the lower guidance on R&D is not about reducing spending on BNT327. We are updating this guidance to reflect the lower R&D expenses for the year. The reduction is mainly driven by the phasing of certain programs and a deliberate focus on our key strategic priorities, meaning BNT327 as you rightly mentioned.

謝謝你的提問，特倫斯。我認為降低研發指導並不是為了減少對 BNT327 的投入。我們正在更新此指南，以反映本年度研發費用的降低。削減主要得益於某些專案的分階段實施以及對我們關鍵策略重點的刻意關注，正如您所提到的，即BNT327。

We demonstrate disciplined portfolio management, but I would say it's too early to say whether this represents a structural shift. Depending on the pace of our late-stage programs, including the expanded efforts on Pumitamig, R&D spending will remain at similar levels or increase again next year. I think what really matters is that we continue to allocate resources with focus and flexibility to maximize long-term value and support our key strategic priorities and programs.

我們展現了嚴謹的投資組合管理，但我認為現在斷言這是否代表著結構性轉變還為時過早。根據我們後期專案的進展情況，包括擴大對 Pumitamig 的投入，明年的研發支出將維持在類似水準或再次增加。我認為真正重要的是，我們要繼續有針對性、靈活地分配資源，以最大限度地提高長期價值，並支持我們的關鍵策略重點和計劃。

And Ozlem, would you now like to take BNT323?

奧茲萊姆，你現在想選修 BNT323 嗎？

I can take the second question, Terence. The reason why we -- originally, we guided towards end of '25 for BNT323 BLA submission. This moves now into '26 because we have continued discussions and conversations with the FDA to further understand additional data needs and are generating this information. The plan is still to submit in '26. And in '26, we will also get for this program data from our ongoing breast cancer study.

特倫斯，我可以回答第二個問題。原因是我們最初將 BNT323 BLA 提交時間定在 2025 年底。現在這項工作將推進到 2026 年，因為我們一直在與 FDA 進行討論和對話，以進一步了解其他數據需求，並且正在產生這些資訊。該計劃仍將於 2026 年提交。2026 年，我們也將從正在進行的乳癌研究中取得該節目的數據。

We will now take the next question from the line of Daina Graybosch, Leerink Partners.

接下來，我們將回答來自 Leerink Partners 的 Daina Graybosch 的下一個問題。

Thank you for the question. I have a question on the overall strategy with Pumitamig of Establish and Elevate as 2 steps. And why you're taking that approach versus in some indications doing them simultaneously let's say, in multi-arm Phase III studies with ADC combos and Pumitamig on top of traditional standard-of-care chemo to leapfrog, particularly where you have some early data with the ADC in an indication and the competition is fierce.

謝謝你的提問。我有一個關於 Pumitamig 的整體策略的問題，該策略將建立和提升分為兩個步驟。為什麼你要採取這種方法，而不是在某些情況下同時進行，例如在多臂 III 期研究中，將 ADC 組合和普米他米（Pumitamig）添加到傳統的標準治療化療中以實現跨越式發展，尤其是在你已經有一些關於 ADC 的早期數據並且競爭非常激烈的情況下。

Thank you, Daina, for that question. So that's a question about our strategy for Pumitamig and the various stages, the various steps to our strategy with Establish and Elevate. So I'll direct that question to Ozlem.

謝謝你，黛娜，提出這個問題。所以這是一個關於我們 Pumitamig 策略以及我們透過建立和提升策略的各個階段、各個步驟的問題。所以我會把這個問題轉給奧茲萊姆。

You are actually right. We have this 3-wave strategy, Establish, Expand, Elevate. And even though we call it 3 waves these are activities, which are going on in parallel. We have a certain focus on the chemo combination or combinations with standard-of-care because these studies can be simply started much faster, and we have a focus on speed to be really first to market in certain indications. However, there is data generation in combination studies ongoing in these indications with our ADCs, for example, and will come very soon also following this established waves.

你說的沒錯。我們採用三階段策略：建立、擴張、提升。雖然我們稱之為 3 次浪潮，但這些活動是並行的。我們特別關注化療聯合療法或與標準療法的聯合療法，因為這些研究可以更快地啟動，而我們注重速度，以便在某些適應症領域中真正成為第一個上市的。然而，例如，在這些適應症中，我們正在進行聯合研究以產生數據，這些數據很快就會隨著這波既定浪潮而出現。

We will now take the next question from the line of Asad Haider, Goldman Sachs.

接下來，我們將回答來自高盛的阿薩德·海德爾提出的問題。

This is Nick Jennings on for Asad and the Goldman team. Given that the BNT327 Phase III trial in triple-negative breast cancer is initiating this year, could you provide any insight as to what we can expect to see in the Phase II details coming up at SABCS. And is there any new information we can expect that provides additional confidence in the Phase III success?

這裡是尼克詹寧斯，代表阿薩德和高盛團隊為您報道。鑑於 BNT327 在三陰性乳癌中的 III 期試驗將於今年啟動，您能否就即將在 SABCS 上公佈的 II 期試驗細節提供一些見解？是否有任何新的資訊可以讓我們更加確信第三期臨床試驗會成功？

Thank you, Nick, for that question. It's a good one. So just to recap that from Pumitamig the Phase III triple-negative breast cancer, which is initiating and Ozlem, the specific question is whether we can provide any additional details on the Phase II results that we'll be presenting SABCS.

謝謝你，尼克，提出這個問題。這是個好主意。所以，簡單回顧一下，Pumitamig 針對 III 期三陰性乳癌的治療進展，以及 Ozlem 的治療進展，具體問題是，我們能否提供一些關於我們將在 SABCS 上公佈的 II 期結果的更多細節。

So, we will present some more efficacy data, safety data and also dose data.

因此，我們將提供更多療效數據、安全性數據以及劑量數據。

We will now take the next question from the line of Akash Tewari, Jefferies.

接下來，我們將回答來自傑富瑞的阿卡什·特瓦里提出的問題。

This is Manoj for Akash. Just 1 question. So, we recently saw HARMONi-3 trial in first line and the CLC making some changes to look at primary PFS and OS statistical analysis separately for squamous and non-squamous populations. So considering these changes, do you still think ROSETTA-02 trial in BNT327 plus chemo is sufficiently powered for PFS and OS endpoints in the Phase III portion. Will there be any trial change, any trial-design changes based on these new information?

這是Manoj給Akash的問候。只有一個問題。因此，我們最近看到 HARMONi-3 試驗作為一線治療方案，CLC 做出了一些改變，分別針對鱗狀細胞癌和非鱗狀細胞癌人群進行主要 PFS 和 OS 統計分析。考慮到這些變化，您是否仍認為 ROSETTA-02 試驗中 BNT327 加化療的統計效力足以達到 III 期 PFS 和 OS 終點？基於這些新訊息，試驗方案或試驗設計是否會有任何改變？

So, it's a little hard to hear some of the details on that, but I heard you talking about HARMONi-3 and whether that may have any read-through or effect on the way that we're conducting our trials for Pumitamig. So I'll direct that question to Ozlem.

所以，有些細節很難聽清，但我聽到你談到了 HARMONi-3，以及它是否會對我們進行 Pumitamig 試驗的方式產生任何影響。所以我會把這個問題轉給奧茲勒姆。

Yes, we are constantly with upcoming new data, reevaluating our statistical analysis plans for ongoing trials, and we'll also look into this specific trial.

是的，我們會不斷關注即將出現的新數據，重新評估正在進行的試驗的統計分析方案，我們也會研究這項特定的試驗。

We will now take the next question from the line of Yaron Werber, TD Cowen.

接下來，我們將回答來自 TD Cowen 的 Yaron Werber 的下一個問題。

Great. And I had a quick follow-up for Ozlem on BNT323. Just that the need to generate more data to support filing, can you be -- maybe a little bit more explicit? Do you need to generate -- it sounds like you're going to have more data, as you noted, in breast cancer next year. And so is the thought to then file for breast cancer next year. And what was the feedback for endometrial cancer? And do you still plan to file for that? Or maybe just give us better clarity.

偉大的。我很快向 Ozlem 詢問了 BNT323 的相關情況。只是需要產生更多數據來支持申報，您能否－或許可以更明確一些？你需要產生數據嗎？ ——正如你所提到的，明年你將在乳癌方面獲得更多數據。所以，有人會考慮明年申請乳癌診斷。那麼，子宮內膜癌的回饋如何？你還打算提交申請嗎？或許只是希望你能把話說得更清楚。

Yes, maybe I was misleading for the endometrial cancer discussions with FDA, have nothing to do with the ongoing breast cancer study. It's not about generating new data. It's about follow-up data and further analysis. So that pushes the time line a bit into '26, but does not change our submission strategy and our plans for BNT323 overall.

是的，我可能誤導了大家，關於子宮內膜癌與 FDA 的討論與正在進行的乳癌研究無關。關鍵不在於產生新數據。這關乎後續數據和進一步分析。因此，時間軸會稍微推遲到 2026 年，但這並不會改變我們的提交策略和我們對 BNT323 的整體計劃。

Okay. And that's for breast cancer. And then what about endometrial cancer? What's the plan there?

好的。這是針對乳癌的。那麼子宮內膜癌呢？那裡的計劃是什麼？

No, no, no. Endometrial cancer is our first submission. This is what we said all along. Originally, it was planned for '25. We -- this is pushed out to '26 because, as I said, we are in discussions with -- it's in pre-BLA discussions with the FDA and providing further data breast cancer, the breast cancer study, Phase III study is ongoing, will readout later in 2026.

不，不，不。子宮內膜癌是我們提交的第一個主題。我們一直都是這麼說的。原計劃於 2025 年實施。我們——之所以推遲到 2026 年，是因為正如我所說，我們正在與 FDA 進行 BLA 前的討論，並提供更多關於乳腺癌的數據，乳腺癌研究，III 期研究正在進行中，將於 2026 年晚些時候公佈結果。

We will now take the next question from the line of Mohit Bansal, Wells Fargo.

接下來，我們將回答來自富國銀行的 Mohit Bansal 的下一個問題。

So again, a question on VEGF PD-1. One key comment we get from KOLs or experts is that with these bispecifics, it does look like that they are better VEGF inhibitors, but it doesn't look like that the PD-1 is -- the component is better.

所以，再次提出一個關於 VEGF PD-1 的問題。我們從 KOL 或專家那裡得到的一個關鍵評論是，這些雙特異性抗體看起來確實是更好的 VEGF 抑制劑，但 PD-1 抑制劑似乎不是——只是其成分更好。

So I mean, how do you think about that? And in the context of these -- this bispecific showing an OS benefit in lung cancer trials, how important it is for PD-1 to be better at this point, given that -- we are seeing good PFS benefit, but OS is kind of on border line. So, I would like to get your thoughts on that.

所以，你對此有什麼看法？在這些背景下——這種雙特異性抗體在肺癌試驗中顯示出總生存期獲益，鑑於 PD-1 在目前階段表現更佳是多麼重要——我們看到了良好的無進展生存期獲益，但總生存期卻處於臨界狀態。所以，我想聽聽你的看法。

Thank you, Mohit. So, a question generally around how much confidence we or others have in the bispecific class. And you mentioned that VEGF binding is maybe better, but PD-1, you're saying maybe not as good in bispecifics. And specifically, that OS benefit in lung. So direct that question to -- Ozlem?

謝謝你，莫希特。所以，這個問題大致上是關於我們或其他人對雙特異性抗體類有多大的信心。你提到 VEGF 結合可能更好，但 PD-1，你的意思是說雙特異性抗體可能不太好。具體而言，OS 在肺部有益。所以，這個問題應該要問奧茲勒姆嗎？

I can start and Ozlem can take the second part. Is it okay, Ozlem.

我可以先開始，奧茲萊姆可以做第二部分。奧茲勒姆，這樣可以嗎？

Yes, sure, please. Go ahead.

好的，當然可以。前進。

Yes. Let's start with our confidence. Our confidence is increasing into this drug class. And the confidence is not based on better VEGF better PD-L1s, but what the antibody really does as a bispecific molecule and we are seeing now that this is getting more and more clinical data that this is not only called on PFS, but also have an impact in OS. And maybe, Ozlem, if you would like to add mechanistic understanding how that could also be helpful.

是的。讓我們先從自信說起。我們對這類藥物的信心正在增強。這種信心並非基於更好的 VEGF 或更好的 PD-L1，而是基於抗體作為雙特異性分子的實際作用。我們現在看到越來越多的臨床數據表明，這不僅對 PFS 有影響，而且對 OS 也有影響。奧茲萊姆，或許你還可以補充一些關於機制理解的內容，看看這又會如何有所幫助。

Yes. Mechanistically, in principle, our preclinical data, and that was also part of develop of -- preclinical development and selection process for this antibody shows that blocking of PD-1, PD-L1 pathway, as well as the VEGF-A blocking in the respective preclinical settings is robust and it's not inferior to what you would see with the individual antibodies. Having said that, we also think that the fact that we have a PD-L1, not a PD-1 arm here as an additional elements to the mode of action, namely targeting of this molecule into the tumor micro environment.

是的。從機制上講，原則上，我們的臨床前數據（這也是該抗體的臨床前開發和選擇過程的一部分）表明，在相應的臨床前環境中，PD-1、PD-L1 通路的阻斷以及 VEGF-A 的阻斷是穩健的，並且不遜於使用單一抗體所觀察到的效果。話雖如此，我們也認為，我們在這裡使用的是 PD-L1 而不是 PD-1，這是作用機制的附加要素，也就是把這種分子靶向腫瘤微環境。

And this, again, is a very good condition to amplify both on the PD-1, PD-L1 side, but also on the VEGF receptor signaling side all the effects on economical and non-economical effects of these 2 targets. So this is the preclinical piece and mode of action piece, but the clinical data has to -- to tell the truth from the data we have across tumor indications. This is not yet Phase III data. We are very confident that the activity has PFS effect in certain important indications and also duration of progression-free survival starts to look good.

而且，這又是一個非常好的條件，可以增強 PD-1、PD-L1 以及 VEGF 受體訊號傳導方面的所有效應，從而增強這兩個目標的經濟和非經濟效應。所以這是臨床前研究和作用機制研究，但臨床數據必須——才能從我們掌握的腫瘤適應症數據中得出真相。這還不是第三期臨床試驗數據。我們非常有信心，該活性成分在某些重要適應症中具有 PFS 效應，且無惡化存活期也開始呈現良好趨勢。

We will now take the next question from the line of [indiscernible], BMO.

現在我們將回答來自[聽不清楚]的下一個問題，BMO。

This is actually Malcolm Hoffman for Evan from BMO. Thinking about the guidance range for this quarter, could you quantify how much of this reflects the relatively stronger quarter for COVID versus just general updates for the BMS collaboration and U.K. government agreements. I know you mentioned most of this was tied to the collaboration, but I was curious, if there were any minor changes on the COVID front would be helpful to think about the relative contributions there. I appreciate it.

這其實是馬爾科姆·霍夫曼代表BMO的艾文。考慮到本季的業績指引範圍，您能否量化一下，其中有多少反映了新冠疫情在本季度相對強勁的影響，又有多少僅僅是百時美施貴寶合作和英國政府協議的總體進展？我知道您提到大部分內容都與合作有關，但我很好奇，如果新冠疫情方面有任何細微的變化，是否有助於思考這方面的相對貢獻。謝謝。

Thank you, Malcolm. So let us talk a little bit about the revenues. And I will refer to your COVID-19 question, but I also think it would be helpful for the audience to understand that bit of the BMS revenue. So on COVID-19. So for COVID-19, we continue to see a stable position with a strong market share and stable pricing. U.S. vaccination rates are roughly 20%, which is in line with what we had anticipated. We have always assumed lower volumes versus last year. So overall, the business is performing within our expectations for the year. While the broader market remains uncertain, we continue to lean on our strengths like strong brand recognition, reliable supply and rapid variant adaptation, and we do expect to close the year in line with our outlook.

謝謝你，馬爾科姆。那我們來談談收入狀況吧。關於您提出的 COVID-19 問題，我也會提及，但我認為讓聽眾了解 BMS 的這部分收入也會有所幫助。所以，關於新冠肺炎。因此，就新冠肺炎而言，我們繼續看到其市場地位穩定，市場份額強勁，價格穩定。美國的疫苗接種率約為20%，這與我們先前的預期相符。我們一直都預期銷量會比去年下降。整體而言，公司今年的業績符合我們的預期。儘管整體市場仍不明朗，但我們將繼續依靠自身優勢，例如強大的品牌知名度、可靠的供應和快速的產品變體適應能力，我們預計今年的業績將與我們的預期相符。

Now if we talk about the BMS revenues, the updated revenue guidance mainly reflects the collaboration with BMS, as you rightly point out. And under this agreement, we will receive a total of USD 3.5 billion in upfront and on continuing cash payments between 2025 and 2028. While the timing of cash inflows and revenue recognition deferred revenues will be recognized in broadly equal amounts over the next 3 years, with the remaining balance recognized together with a final payment in 2028. This will provide a clear and predictable contribution over the next several years.

現在，如果我們談到 BMS 的收入，正如您所指出的，更新後的收入預期主要反映了與 BMS 的合作。根據這項協議，我們將在 2025 年至 2028 年期間收到總計 35 億美元的預付款和持續現金支付。雖然現金流入和收入確認的時間有所不同，但遞延收入將在未來 3 年內以大致相等的金額確認，剩餘餘額將在 2028 年與最終付款一起確認。這將為未來幾年帶來清晰且可預測的貢獻。

We will now take the next question from the line of Joshua Chazaro, Evercore ISI.

接下來，我們將回答來自 Evercore ISI 的 Joshua Chazaro 的下一個問題。

This is Josh on for Cory Kasimov. On your and your partner's decision to push Pumitamig into gastric cancer, did you see compelling clinical data, not sure if this is presented or not? Or is this push into this new indication based off your understanding of the mechanism of action?

這裡是喬什，替科里·卡西莫夫為您報道。關於您和您的伴侶決定將普米他米用於治療胃癌，您是否看到了令人信服的臨床數據？我不確定這方面是否有人提出過。或者，您之所以推動該新適應症的出現，是基於您對作用機制的理解？

Thanks, Josh, for that question. So, it was a question about Pumitamig and our announced decision to move into gastric cancer, what was that based on? Have we seen any data that we can speak to that support that decision. So Ugur, would you like to take that question?

謝謝你的提問，喬希。所以，問題是關於普米他米（Pumitamig）以及我們宣布進軍胃癌領域的決定，這個決定是基於什麼？我們是否有任何數據可以佐證這項決定？那麼，烏古爾，你願意回答這個問題嗎？

Yes. We have emerging data for Pumitamig in gastric cancer and as an indication, which -- for which checkpoint blockade is approved. It's an indication that we have seen responses in combination with chemotherapy and an indication where we see based on the data that we've got in other GI indications. A clear room for improving over standard of care.

是的。我們有關於普米他米治療胃癌的初步數據，並且作為一項適應症，該適應症是檢查點阻斷療法批准的適應症。這表明我們已經看到與化療聯合使用時取得了療效，根據我們在其他胃腸道適應症中獲得的數據，也表明了療效。護理水準還有很大的提升空間。

And also, the mechanistic rationale that anti-angiogenic and PD-1 targeting approaches are validated approaches in gastric.

此外，抗血管新生和 PD-1 標靶療法在胃癌治療中也得到了驗證。

We will now take the final question from the line of Jay Olson, Oppenheimer.

現在我們來回答來自 Jay Olson 和 Oppenheimer 的最後一個問題。

We're curious about your collaboration with Bristol-Myers Squibb. And can you talk about the governance structure, and which party makes the decisions for new trials and who leads the new clinical trials when you initiate them?

我們對您與百時美施貴寶的合作很感興趣。您能否談談治理結構，以及由哪一方決定是否進行新的試驗，以及在啟動新的臨床試驗時由誰領導？

Yes. Okay. Thank you, Jay. Thanks for that question. It's an interesting one about how our collaboration with BMS works mechanically. I can't say that word. So Ozlem, I'll pass that over to you, who makes decisions for [Auriga], who makes decisions on clinical development.

是的。好的。謝謝你，傑伊。謝謝你的提問。這是一個很有趣的例子，它講述了我們與 BMS 在機制上的合作方式。我不能說那個字。所以，奧茲萊姆，我把這個決定交給你，你是[Auriga]的決策者，是臨床開發的決策者。

But it's a classical approach with multiple collaborative arms. We have a JSC in which we discussed all the indications so far or indicate all decisions that are made are based from interest of both partners, but both partners have the opportunity to do combination trials with their products. Yes, regardless whether the other partner is interested to join directly or not. So we have a lot of flexibility in this collaboration aiming really to do all kind of studies and to exploit the pipeline of the other partner as exhausted as possible.

但這是一種包含多個協作部門的經典方法。我們有一個股份公司，我們在其中討論了迄今為止的所有適應症，或者說所有做出的決定都是基於雙方合作夥伴的利益，但雙方合作夥伴都有機會用他們的產品進行聯合試驗。是的，無論另一方合夥人是否有意直接加入。因此，我們在此次合作中擁有很大的彈性，旨在進行各種研究，並盡可能充分利用另一位合作夥伴的研發資源。

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

謝謝。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。