Pembrolizumab

近日，康方生物（9926.HK）全球首创的三特异性抗体新药AK150（ILT2/ILT4/CSF1R三抗）获得国家药品监督管理局药品审评中心临床试验默示许可批准，开展用于治疗晚期恶性实体瘤的临床试验。 AK150是全球唯一在研的ILT2/ILT4/CSF1R三抗，也是康方生物首个进入临床阶段的三抗新药。AK150是康方生物基于领先的AI制药研发技术平台和Tetrabody多抗技术平台而开发的全球首创新药，是公司在多特异性抗体技术领域强劲实力的又一次见证。 ILT2、ILT4 和CSF1R在多种实体瘤中具有较高的表达水平，尤其在免疫抑制微环境显著的肿瘤类型中表现突出，包括非小细胞肺癌、肝细胞癌、胰腺癌以及部分难治性乳腺癌等。尽管当前全球范围内针对巨噬细胞的单靶点或双靶点药物（如靶向ILT2、ILT4或CSF1R）已展现出一定潜力，但这些药物仍难以进一步打破肿瘤微环境的免疫抑制网络，亟需能够实现多维度免疫重塑的多靶点协同创新疗法，提高抗肿瘤疗效，尤其是进一步破解传统免疫治疗对“冷肿瘤”不敏感的临床难题。 AK150（ILT2/ILT4/CSF1R 三抗） AK150 可协同靶向 CSF1R、ILT2和ILT4靶点，这三个靶点在肿瘤免疫微环境中各自发挥重要的免疫调节作用，共同构建复杂的免疫抑制网络，而三靶点协同阻断作用可以实现在不同层面解除免疫抑制，通过双向调节髓系细胞和淋巴细胞的功能，激活CD8+ T细胞及自然杀伤（NK）细胞，增强抗肿瘤免疫效应。 从分子机制角度，协同靶向CSF1R、ILT2和ILT4可多角度解除免疫抑制，既减少了免疫抑制性髓系细胞的数量（通过CSF1R），又解除了剩余髓系细胞的“刹车”功能（通过ILT2/ILT4），实现了从“源头”到“终端”的全通路抑制，最终突破巨噬细胞介导的免疫抑制，并提高 T/B/NK等免疫细胞协同抗肿瘤活性， 达到“ 解除免疫抑制+清除抑制性细胞+激活抗肿瘤免疫” 的三维调控。 AK150可同时靶向ILT2、ILT4、CSF1R三个靶点，实现协同抗肿瘤，具有同时调节先天免疫和获得性免疫系统的作用，既对热肿瘤具有高效治疗潜力，还可以将冷肿瘤向热肿瘤转换，有望从根本上改善并提高肿瘤对免疫治疗的有效性。 说明：本文作为康方生物的新闻发布，用于披露公司最新进展，并非产品推广广告，不构成康方生物的信息披露或投资建议。 关于 AK150（ILT2/ILT4/CSF1R 三抗） AK150是康方生物自主研发的人源化抗CSF1R、ILT2和ILT4三特异性抗体药物，一方面，它可以结合CSF1R阻断CSF1R与CSF1/IL-34的相互作用，从而阻断CSF1R介导的免疫抑制信号，清除或抑制M2样TAMs，从而发挥抗肿瘤作用；另一方面，还通过结合ILT2/ILT4阻断ILT2/ILT4与HLA-A/B/C/E/G的相互作用，阻断ILT2/ILT4可解除ILT2、ILT4介导的免疫抑制信号，激活和恢复NK细胞、CD8+T细胞的活性与功能，从而恢复先天和适应性免疫反应；同时靶向这三个靶点，既减少了免疫抑制性髓系细胞的数量，又解除了剩余髓系细胞的“刹车”功能，实现了从“源头”到“终端”的全通路抑制。临床前动物模型提示AK150各剂量组均具有肿瘤抑制作用，且呈现出一定的量效关系。 关于康方生物 康方生物（9926.HK）是一家集研究、开发、生产及商业化全球首创或同类最佳创新生物新药于一体的领先企业。自2012年成立以来，公司始终以患者为中心，以临床价值为导向，打造了独有的端对端康方全方位新药研究开发平台，建立了以Tetrabody多特异性抗体开发、抗体偶联Dual-Shield ADC、T细胞衔接器Dual-Lock TCE、Tissue-Smart siRNA、细胞治疗及Flex-Nano mRNA等技术为核心的研发创新体系，国际化标准的GMP生产体系和运作模式先进的商业化体系，成为了在全球范围内具有竞争力的生物医药创新公司。 公司已开发了50个以上用于治疗肿瘤、自身免疫、炎症、代谢疾病等重大疾病的创新候选药物，27个候选药已进入临床（包括15个双抗/多抗/双抗ADC），7个新药已在商业化销售，2个新药4个适应症的上市申请处于审评审批阶段。 康方生物是全球迄今唯一拥有2个肿瘤免疫双抗新药的制药公司： 2022年6月，公司全球首创的PD-1/CTLA-4双抗卡度尼利获批上市，是全球首个获批的肿瘤免疫治疗双抗新药，也是中国第一个双特异性抗体新药。目前卡度尼利一线治疗胃癌、一线治疗宫颈癌和治疗复发/转移性宫颈癌的适应症已获批，11个注册性/III期临床正在开展。 2024年5月，公司全球首创的PD-1/VEGF双抗新药依沃西获批上市，用于EGFR-TKI治疗进展的局部晚期或转移性nsq-NSCLC，成为全球首个获批的“肿瘤免疫+抗血管生成”机制双抗新药。同期，依沃西在与全球“药王”帕博利珠单抗的随机、双盲、对照一线治疗PD-L1阳性NSCLC的“头对头”III期临床研究中获得显著阳性结果，依沃西可降低患者疾病进展/死亡风险达49%，依沃西成为全球首个在头对头III期临床研究中证明疗效显著优于“药王”帕博利珠单抗的药物。基于该研究结果，依沃西该项适应症于2025年4月获批上市，成为一线肺癌治疗新的标准治疗方案，为患者提供全新更优的“去化疗”选择。目前依沃西有15项注册性/III期临床已开展/启动，包括5项国际多中心注册性III期临床研究。 2024年12月，卡度尼利和依沃西均通过医保谈判被纳入国家新版医保目录。2025年12月，除派安普利新获批的一线肝细胞癌适应症，康方生物5个自主商业化自研新药的其余全部获批适应症均已纳入国家医保目录。 此外，基于公司在肿瘤免疫双抗领域取得的全球领先优势，公司正全力推进IO2.0+ADC2.0全球战略，构建“跨代”式国际竞争优势。目前，公司自主研发的首个双抗ADC药物Trop2/Nectin4 ADC（AK146D1）、新一代Her3 ADC（AK138D1） 已经获得中国NMPA和美国FDA批准，正在中国和澳洲等开展临床研究。后续一系列自研新一代ADC/双抗ADC/双毒素ADC也将相继进入临床开发阶段。这将助力公司产品组合在全球范围内建立“跨代”式的竞争战略优势。 国际市场开发是康方生物核心发展战略，继2015年开中国先河将自主研发的CTLA-4单抗权益许可给默沙东公司之后，2022年12月，公司再次创造中国纪录，以50亿美金+2位数百分比销售提成的方案，将依沃西部分海外权益许可给美国Summit公司，该合作创下了彼时中国新药对外许可的最高交易金额纪录。此外，派安普利单抗治疗鼻咽癌的两项适应症于2025年4月获得美国食品药品监督管理局（FDA）批准上市。 公司非肿瘤板块也已全面进入商业化发展阶段：伊努西单抗（PCSK9）治疗高胆固醇血症两项适应症获批销售；依若奇单抗（IL-12/IL-23）治疗中重度斑块状银屑病成人患者适应症获批上市销售；此外，古莫奇单抗（IL-17）和曼多奇单抗（IL-4R）多项III期临床研究成功，正处于上市审评阶段。公司非肿瘤领域的产品协同效应和战略组合力进一步提升。 康方生物期望通过高效及突破性的研发创新，开发国际首创及同类药物最佳疗法的新药，为全球患者提供更优疾病解决方案，成为全球领先的生物制药企业。 往期推荐 产品动态 康方5个新药所有适应症全部谈判成功，纳入国家医保：2个首创双抗新增一线适应症及3个新药首次进医保 临床 进展 HARMONi-A OS最终分析显示：依沃西达到OS临床终点，取得具有临床意义和统计学显著的OS获益 产品动态 依沃西联合化疗1L治疗sq-NSCLC的上市申请获NMPA受理 数据发布 HARMONi研究发布：PFS HR=0.52，OS HR=0.79  依沃西2L+ EGFRm NSCLC国际多中心III期 产品动态 卡度尼利获批第三项适应症：一线宫颈癌全人群 产品动态 依沃西一线治疗NSCLC获批上市（全球首个对比帕博利珠单抗获显著阳性结果的III期研究） 产品动态 派安普利2个适应症美国重磅上市！获FDA批准用于晚期鼻咽癌治疗 临床 进展 康方首个双抗ADC（Trop2/Nectin4 ADC）临床入组，“IO+ADC”2.0 迭代战略加速推进 临床 进展 康方非肿瘤领域首个双抗IL-4Rα/ST2（AK139）IND获受理，剑指呼吸系统及皮肤疾病领域 临床 进展 头对头度伐利尤单抗方案，依沃西方案一线治疗胆道肿瘤III期临床完成首例患者入组 临床 进展 全球首个CD47单抗实体瘤III期临床首例入组：依沃西联合莱法利一线治疗HNSCC（对比帕博利珠单抗） 数据发布 IGCS 2024 LBA & 《柳叶刀》主刊，卡度尼利1L宫颈癌III期研究PFS和OS双阳性结果重磅发布 产品动态 卡度尼利第二个适应症获批：一线胃癌全人群 数据发布 全球首个对比帕博利珠单抗取得显著阳性结果的随机对照大III期研究——依沃西HARMONi-2重磅研究成果在WCLC发表 临床 进展 卡度尼利联合方案治疗uHCC的III期临床研究完成首例患者入组 临床 进展 针对PD-1/L1治疗进展晚期胃癌，卡度尼利+普络西（VEGFR-2）联合疗法Ⅲ期临床完成首例入组 数据发布 ASCO Oral & JAMA主刊丨Ⅲ期HARMONi-A研究重磅公布，依沃西疗法有望改变EGFR-TKI进展肺癌全球治疗标准 临床 进展 国际多中心注册性III期研究HARMONi-3中国启动：依沃西单抗联合化疗对比帕博利珠单抗联合化疗1L治疗sq-NSCLC 产品动态 高达50亿美金！康方生物与Summit就PD-1/VEGF双抗依沃西达成合作和许可协议 产品动态 全球首个肿瘤免疫治疗双抗——开坦尼®（PD-1/CTLA-4双抗，卡度尼利）获批上市

BioNTech on track for a catalyst-rich year with six late-stage data readouts expected across immunomodulators, antibody-drug conjugates and mRNA cancer immunotherapies Increased focus on PD-L1 1 /VEGF-A bispecific immunomodulator pumitamig with e ight global Phase 3 clinical trials planned to be ongoing for year-end in collaboration with Bristol Myers Squibb Full year 2025 revenues of €2.9 billion 2 , net loss of €1.1 billion (adjusted 3 net loss of €0.1 billion) and diluted loss per share of €4.70 ($5.31 4 ) (adjusted 3 diluted loss per share of €0.48 ($0.55 4 )) Strong financial position continues to de-risk execution with cash, cash equivalents and security investments of €17.2 billion 5 Expect 2026 total revenues of €2.0 billion to €2.3 billion, adjusted 3 R&D expenses between €2.2-2.5 billion and adjusted 3 SG&A expenses 7 between €700-800 million BioNTech co-founders Ugur Sahin and Özlem Türeci to establish an independent company  with a focus on next-generation mRNA innovations; management transition by end of 2026 Conference call and webcast scheduled for March 10, 2026, at 8:00 a.m. EDT (1:00 p.m. CET) MAINZ, Germany, March 10, 2026 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today reported financial results for the three months and full year ended December 31, 2025 and provided an update on its corporate progress. “2025 was a year of strong execution and pipeline momentum, marked by substantial progress in delivering on our strategy. We advanced our oncology pipeline by moving multiple programs into late-stage development and initiated trials assessing novel-novel combination approaches with the aim of delivering differentiated therapeutic pro ” said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech . “With our unique pipeline and strong financial position, we remain committed to leveraging our pioneering position in the immuno-oncology space with next-generation agents designed to elevate outcomes for patients with cancer. 2026 is poised to be a pivotal year with multiple readouts expected across our portfolio, representing a significant step toward our objective of becoming a multi-product company by 2030.” Financial Review for Fourth Quarter and Full Year 2025 3 in millions €, except per share data Full Year 2025 Full Year 2024 IFRS Results Adjusted Results 3 IFRS Results Adjusted Results 3 Revenues 2,869.9 2,869.9 2,751.1 2,751.1 Net profit / (loss) (1,136.1) (117.1) (665.3) 121.7 Diluted earnings / (loss) per share (4.70) (0.48) (2.77) 0.50 in millions €, except per share data Fourth Quarter 2025 Fourth Quarter 2024 IFRS Results Adjusted Results 3 IFRS Results Adjusted Results 3 Revenues 907.4 907.4 1,190.0 1,190.0 Net profit / (loss) (305.0) (79.5) 259.5 432.4 Diluted earnings / (loss) per share (1.25) (0.33) 1.08 1.79 Revenues for the three months ended December 31, 2025 were €907.4 million, compared to €1,190.0 million for the comparative prior year period. For the year ended December 31, 2025, revenues were €2,869.9 million, compared to €2,751.1 million for the comparative prior year period. The quarterly year-on-year decrease was primarily driven by lower sales of the Company’s COVID-19 vaccines due to reduced market demand. The full year revenue increase was primarily driven by revenues related to BioNTech’s collaboration with Bristol Myers Squibb Company (“BMS”) that were recognized in the third quarter of 2025. Research and development (“R&D”) expenses were €505.4 million for the three months ended December 31, 2025, compared to €611.8 million for the comparative prior year period. For the year ended December 31, 2025, R&D expenses were €2,104.9 million, compared to €2,254.2 million for the comparative prior year period. Both quarterly and full year year-on-year decreases were mainly driven by cost savings resulting from active portfolio management and positive effects resulting from our pumitamig cost sharing with BMS, partly offset by the acceleration of late-stage trials for immuno-oncology (“IO”) and antibody-drug conjugate (“ADC”) development programs. Adjusted R&D expenses were €505.4 million for the three months ended December 31, 2025, compared to €530.3 million for the comparative prior year period. For the year ended December 31, 2025, adjusted R&D expenses were €2,019.5 million, compared to €2,172.7 million for the comparative prior year period. For 2025 and 2024, the Company’s adjusted R&D expenses exclude impairments. Sales, general and administrative (“SG&A”) expenses 7 were €217.9 million for the three months ended December 31, 2025, compared to €132.1 million for the comparative prior year period. For the year ended December 31, 2025, SG&A expenses were €624.4 million, compared to €599.0 million for the comparative prior year period. Both quarterly and full year year-on-year increases were mainly driven by our ongoing commercial build-up, partly offset by lower costs for external services. Other operating result was negative €173.6 million during the three months ended December 31, 2025, compared to negative €54.0 million for the comparative prior year period. For the year ended December 31, 2025, other operating result was negative €903.7 million compared to negative €670.9 million for the prior year period. Both quarterly and full year year-on-year decreases were primarily driven by expenses from settlements of contractual disputes, expenses in connection with our pipeline prioritization and foreign exchange differences. Adjusted other operating result was €21.4 million during the three months ended December 31, 2025, compared to negative €1.6 million for the comparative prior year period. For the year ended December 31, 2025, other operating result was negative €0.6 million compared to negative €13.5 million for the prior year period. For fiscal years 2025 and 2024, our quarterly and full year adjusted other operating results exclude expenses in connection with the settlements of legal proceedings. In addition, our quarterly and full year adjusted other operating results during fiscal year 2025 exclude employee-related costs in connection with our pipeline prioritization and a bargain purchase. Net loss was €305.0 million for the three months ended December 31, 2025, compared to a net income of €259.5 million for the comparative prior year period. For the year ended December 31, 2025, net loss was €1,136.1 million, compared to a net loss of €665.3 million for the comparative prior year period. Adjusted net loss was €79.5 million for the three months ended December 31, 2025, compared to an adjusted net profit of €432.4 million for the comparative prior year period. For the year ended December 31, 2025, adjusted net loss was €117.1 million, compared to an adjusted net profit of €121.7 million for the comparative prior year period. Diluted loss per share was €1.25 for the three months ended December 31, 2025, compared to diluted earnings per share of €1.08 for the comparative prior year period. For the year ended December 31, 2025, diluted loss per share was €4.70, compared to diluted loss per share of €2.77 for the comparative prior year period. Adjusted diluted loss per share was €0.33 for the three months ended December 31, 2025, compared to adjusted diluted earnings per share of €1.79 for the comparative prior year period. For the year ended December 31, 2025, adjusted diluted loss per share was €0.48, compared to adjusted diluted earnings per share of €0.50 for the comparative prior year period. Cash, cash equivalents and security investments as of December 31, 2025 were €17,235.6 million, comprising €7,675.4 million in cash and cash equivalents, €7,158.5 million in current security investments disclosed as financial assets and €2,401.7 million in non-current security investments disclosed as financial assets. Shares outstanding as of December 31, 2025 were 251,325,340, excluding 7,702,147 shares held in treasury. “Our strong financial position fuels and de-risks our R&D activities as we prepare for multiple product launches in the coming years. Our financial discipline, active portfolio management and targeted investments will continue to drive innovation and create long-term value for BioNTech’s stakeholders,” said Ramón Zapata, Chief Financial Officer at BioNTech . 2026 Financial Year Guidance 6 : Revenues for the 2026 financial year €2,000 – €2,300 m In 2026, BioNTech anticipates lower COVID-19 vaccine revenues compared to 2025, driven by declines in both the European and United States markets. The United States continues to be a competitive and dynamic market, where as a result, lower revenues are expected. In Europe, we expect lower revenues as we defend our market share and begin managing the transition of multi-year contracts. In Germany, specifically, BioNTech recognizes direct sales of its COVID-19 vaccines as revenue. Hence, the anticipated declines in the Company’s sales of COVID-19 vaccines in the country will have a direct impact on its topline, whereas revenues outside of Germany only affect the Company’s topline as part of the 50% gross profit split with our partner Pfizer Inc. (“Pfizer”). Per the outlined partnership terms, revenues from the collaboration with BMS in 2026 are expected to be broadly in line with 2025. Revenues from the pandemic preparedness contract with the German government and service businesses are expected to remain stable. Planned 2026 Financial Year Adjusted Expenses 6 : Adjusted R&D expenses €2,200 – €2,500 m Adjusted SG&A expenses €700 – €800 m BioNTech will continue to focus investments on R&D and scaling the business for late-stage development and commercial readiness in oncology, while remaining cost-disciplined. Strategic capital allocation will continue to foster innovation and be a key driver of the Company’s trajectory. As part of BioNTech’s strategy, the Company may continue to evaluate appropriate corporate development opportunities with the aim of driving sustainable long-term growth and creating future value. The full audited consolidated financial statements as of and for the year ended December 31, 2025, can be found in BioNTech’s Annual Report on Form 20-F filed today with the U.S. Securities and Exchange Commission (“SEC”) and available at . Endnotes 1 An overview of abbreviations is compiled in a directory at the end of this press release. 2 All numbers in this press release have been rounded. 3 In addition to BioNTech’s results determined in accordance with International Financial Reporting Standards (“IFRS”), or IFRS Accounting Standards, or IFRS results, BioNTech reports certain adjusted, non-IFRS measures used internally as a supplemental measure of our business performance (each referred to with the prefix “Adjusted” or, as a whole, “Adjusted Results”). The calculation of these measures and the adjusted results as a whole is based on the concepts of the applicable IFRS Accounting Standards, but includes certain adjustments. Reconciliation of the adjusted results to BioNTech’s measures based on IFRS Accounting Standards and more information can be found at the end of this press release and in BioNTech’s Report on Form 20-F for the year ended December 31, 2025 filed on March 10, 2026, which is available at . While non-IFRS measures may offer additional insights, BioNTech’s non-IFRS measures are not, and should not be viewed as, a substitute for their most directly comparable IFRS Accounting Standards measures, and should always be considered alongside our financial statements prepared in accordance with IFRS Accounting Standards. 4 Calculated applying the average foreign exchange rate for the year ended December 31, 2025, as published by the German Central Bank (Deutsche Bundesbank). 5 As of December 31, 2025. 6 Excludes risks that are not yet known and/or quantifiable and related activities. It includes effects identified from licensing arrangements, collaborations and Merger & Acquisitions (“M&A”) transactions to the extent disclosed. The guidance is based on non-IFRS measures and excludes certain effects compared to measures based on IFRS Accounting Standards. More information can be found in BioNTech’s Report on Form 20-F for the year ended December 31, 2025 filed on March 10, 2026, which is available at . 7 Sales, general and administrative expenses (“SG&A”) include sales and marketing expenses as well as general and administrative expenses. Adjusted SG&A expenses include adjusted sales and marketing expenses as well as adjusted general and administrative expenses. Operational Review for the Fourth Quarter and Full Year 2025, Key Post Period-End Events and Outlook on 2026 Corporate Update for the Fourth Quarter 2025 and Post Period Events On March 10, 2026, BioNTech announced plans for an independent company to be established and led by BioNTech co-founders Prof. Ugur Sahin, M.D., and Prof. Özlem Türeci, M.D. The new company with distinct resources, operations and funding options will advance next-generation mRNA innovations. BioNTech plans to contribute related rights and mRNA technologies to the new company to enable and support the prioritized development of next-generation mRNA innovations with disruptive potential. With both companies focusing on their respective strategic priorities, BioNTech expects to maximize value for patients and shareholders alike. Ugur Sahin and Özlem Türeci will transition into the management of their new company by the end of 2026 after their current service agreements end. BioNTech’s Supervisory Board has initiated an executive search to identify successors for the positions to ensure a smooth transition and seamless execution of BioNTech’s strategy. On March 1, Kylie Jimenez joined BioNTech’s Management Board as Chief People Officer (“CPO”). The appointment is in line with BioNTech’s strategy to become a multi-product biopharmaceutical company by 2030 and underscores the importance of its global, highly skilled workforce in achieving this objective. Kylie will focus on attracting, developing and retaining talent, while strengthening an inclusive culture. Select Oncology Pipeline Updates Next-Generation Immunomodulators and Combinations Pumitamig (BNT327/BMS986545) is a bispecific immunomodulator candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization that is being developed in collaboration with BMS. A global Phase 3 clinical trial in patients with first-line triple-negative breast cancer (“TNBC”) (ROSETTA Breast-01; NCT07173751 ) is enrolling. A global Phase 2/3 clinical trial to evaluate pumitamig in first-line microsatellite stable colorectal cancer (“CRC”) (ROSETTA CRC-203; NCT07221357 ) is enrolling. A global Phase 2/3 clinical trial to evaluate pumitamig in first-line gastric cancer (ROSETTA Gastric-204; NCT07221149 ) is enrolling. A global Phase 2/3 clinical trial (ROSETTA Lung-02; NCT06712316 ) is ongoing to evaluate pumitamig in combination with chemotherapy compared to pembrolizumab and chemotherapy in patients with first-line non-small cell lung cancer (“NSCLC”). The Phase 2 part of the seamless Phase 2/3 trial achieved full enrollment and the Phase 3 portion is currently recruiting. Data from the Phase 2 part of the trial are expected in 2026. Additional pivotal Phase 2/3 and Phase 3 trials are planned to start in 2026, in unresectable stage III NSCLC (ROSETTA Lung-201, NCT07361497 ), first-line PD-L1 ≥ 50% NSCLC (ROSETTA Lung-202, NCT07361510 ) and first-line head and neck squamous cell carcinoma (“HNSCC”) (ROSETTA HNSCC-205). Pumitamig is also being evaluated in additional solid tumor indications, including first-line hepatocellular carcinoma (“HCC”), second-line glioblastoma (“GBM”), first-line pancreatic ductal adenocarcinoma (“PDAC”) and first-line renal cell carcinoma (“RCC”) in various Phase 1/2 and Phase 2 trials, both as monotherapy and in combination with standard of care. In 2025, BioNTech initiated several signal-seeking clinical trials to evaluate pumitamig with the Company’s proprietary assets. These trials will inform the dose selection for pumitamig and explore anti-tumor activity in multiple tumors for later-stage development. Gotistobart (BNT316/ONC-392) is a tumor microenvironment-selective regulatory T cell depletion candidate that targets CTLA-4 and is being developed in collaboration with OncoC4, Inc. (“OncoC4”). A global Phase 3 clinical trial (PRESERVE-003; NCT05671510 ) is ongoing to evaluate the efficacy and safety of gotistobart as monotherapy in patients with metastatic squamous NSCLC (“sqNSCLC”) that progressed under previous platinum-based chemotherapy and PD-(L)1-inhibitor treatment. In December 2025, data from the non-pivotal dose-confirmation stage, the first of two stages of the global Phase 3 clinical trial, were presented at the International Association for the Study of Lung Cancer (“IASLC”) American Society of Clinical Oncology (“ASCO“) 2025 North America Conference on Lung Cancer (“NACLC”). Gotistobart demonstrated a clinically meaningful overall survival benefit compared to standard of care chemotherapy and a manageable safety pro patients with squamous NSCLC whose disease had progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy. Based on current event accrual projections, interim data from the pivotal stage of the two-stage Phase 3 clinical trial are expected in 2026. In January 2026, gotistobart received Orphan Drug Designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of squamous NSCLC. In 2022, gotistobart received Fast Track Designation from the FDA for the treatment of patients with metastatic NSCLC whose disease progressed on prior anti-PD-(L)1 therapy. Antibody-Drug Conjugates Trastuzumab pamirtecan (BNT323/DB-1303) is an ADC candidate targeting HER2 that is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”). A Phase 1/2 clinical trial ( NCT05150691 ) is ongoing to evaluate trastuzumab pamirtecan in patients with advanced HER2-expressing tumors. A potentially registrational cohort with HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) patients with recurrent endometrial cancer is ongoing. Data are expected to be shared at a medical conference in 2026. BioNTech and DualityBio plan to biologics license application (“BLA”) in 2026, subject to regulatory feedback from the FDA. A global Phase 3 clinical trial (DYNASTY-Breast02, NCT06018337 ) to evaluate trastuzumab pamirtecan in patients with HR-positive, HER2-low metastatic breast cancer is ongoing. Based on current event accrual projections, data are expected in 2026. BNT324 /DB-1311 is an ADC candidate targeting B7H3 that is being developed in collaboration with DualityBio. In February 2026, updated data from a Phase 1/2 clinical trial ( NCT05914116 ) were presented at the ASCO Genitourinary Cancers Symposium. BNT324/DB-1311 demonstrated durable efficacy in heavily pretreated metastatic castration-resistant prostate cancer (“mCRPC”) patients with no new safety signals reported. A Phase 3 clinical trial ( NCT07365995 ) to evaluate BNT324/DB-1311 compared to docetaxel in patients with mCRPC is expected to initiate in 2026. mRNA Cancer Immunotherapies BNT113 is an mRNA cancer immunotherapy candidate and based on BioNTech’s fully owned, off-the-shelf FixVac platform, encoding the two oncoproteins E6 and E7 that are frequently found in human papillomavirus type 16 positive (“HPV16+”) solid tumors. In December 2025, the FDA granted Fast Track designation to BNT113 for the treatment of patients with PD-L1+, HPV16+ HNSCC. Based on current event accrual projections, data are expected in 2026 from the first interim analysis of the Phase 3 part of the ongoing Phase 2/3 clinical trial (AHEAD-MERIT; NCT04534205 ) evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment for patients with unresectable recurrent or metastatic, PD-L1+, HPV16+ HNSCC. Autogene cevumeran (BNT122/RO7198457) is an mRNA cancer immunotherapy candidate for individualized neoantigen-specific immunotherapy (“iNeST”) that is being developed in collaboration with Genentech, Inc. (“Genentech”), a member of the Roche Group (“Roche”). An update from the ongoing Phase 2 clinical trial in Stage II (high-risk)/Stage III circulating tumor DNA positive (“ctDNA+”) adjuvant colorectal cancer (“CRC”) is expected in early 2026. Data read-out from the final analysis of this trial has been updated from 2026 to 2027, given that events have accrued more slowly than projected. BioNTech and Roche, the sponsor of the trial, have decided to discontinue the Phase 2 clinical trial (IMcode004; NCT06534983 ) evaluating autogene cevumeran as an adjuvant treatment in combination with nivolumab compared to nivolumab alone in patients with high-risk muscle-invasive urothelial carcinoma due to the rapidly emerging treatment landscape and shifting standard of care. The companies will focus on advancing autogene cevumeran in the currently ongoing randomized Phase 2 clinical trials in adjuvant pancreatic ductal adenocarcinoma (“PDAC”) and adjuvant CRC. Expected 2026 Milestones Program Modality Trial Readout Phase Indication Late-Stage Trial Readouts Trastuzumab pamirtecan 3 ADC Single-arm Phase 2 2L+ HER2-expressing endometrial cancer Phase 3 interim analysis Chemo naïve HR+ HER2-low breast cancer Gotistobart 2 Immunomodulator Phase 3 interim analysis 2L+ sqNSCLC Phase 2 2L+ mCRPC BNT113 mRNA cancer immunotherapy Phase 3 interim analysis 1L HPV16+ PD-L1+ HNSCC Pumitamig 1 Immunomodulator Phase 3 in China interim analysis 1L TNBC Early-Stage Pumitamig & ADC Trial Readouts Pumitamig 1 Immunomodulator Phase 2 1L NSCLC Phase 2 1L extensive-stage small-cell lung cancer (“ES-SCLC”) Phase 2 in China 1L HCC Phase 2 in China 1L microsatellite stable colorectal cancer (“MSS-CRC”) Pumitamig 1 + Trastuzumab pamirtecan (HER2-ADC) 3 Immunomodulator + ADC Phase 1/2 Breast cancer Pumitamig 1 + BNT324/DB-1311 (B7H3-ADC) 3 Phase 1/2 Advanced solid tumors Phase 2 NSCLC/SCLC Pumitamig 1 + BNT325/DB-1305 (TROP2-ADC) 3 Phase 2 TNBC Pumitamig 1 + BNT326/YL202 (HER3-ADC) 4 Phase 1/2 NSCLC BNT324/DB-1311 (B7H3-ADC) 3 ADC Phase 1/2 2L+ mCRPC Phase 3 Trial Initiations Pumitamig 1 Immunomodulator Phase 3 1L MSS-CRC Phase 3 1L HER2- PD-L1+ gastric cancer Phase 3 1L HNSCC Phase 3 NSCLC stage 3 unresectable Phase 3 1L NSCLC PD-L1 high BNT324 /DB-1311 (B7H3-ADC) 3 ADC Phase 3 1L mCRPC BLA Submission Trastuzumab pamirtecan (HER2-ADC) 3 ADC - 2L+ HER2-expressing endometrial cancer Partnered with: 1. BMS; 2. OncoC4; 3. DualityBio; 4. MediLink Therapeutics (Suzhou) Co., Ltd. (“MediLink"). Upcoming Investor and Analyst Events BioNTech First Quarter 2026 Financial Results and Corporate Update: May 5, 2026 BioNTech Annual General Meeting: May 15, 2026 Conference Call and Webcast Information BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, March 10, 2026, at 8:00 a.m. EDT (1:00 p.m. CET) to report its financial results and provide a corporate update for the fourth quarter and full year 2025. To access the live conference call via telephone, please register via this link . Once registered, dial-in numbers and a PIN number will be provided. The slide presentation and audio of the webcast will be available via this link . Participants may also access the slides and the webcast of the conference call via the “Events & Presentations” page of the Investor section of the Company’s website at A replay of the webcast will be made available shortly after the closing of the call and archived on the Company’s website for 30 days following the call. About BioNTech Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, Pfizer and Regeneron. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: expected changes to BioNTech’s leadership and the transition of responsibilities at the Management Board, including identification and recruitment of successors; the terms of the preliminary discussions between BioNTech and the co-founders regarding the potential contribution of certain BioNTech assets to an independent company; BioNTech’s expected revenues and net profit/(loss) related to sales of BioNTech’s COVID-19 vaccine in territories controlled by BioNTech’s collaboration partners, particularly for those figures that are derived from preliminary estimates provided by BioNTech’s partners; the rate and degree of market acceptance of BioNTech’s COVID-19 vaccine and, if approved, BioNTech’s investigational medicines; expectations regarding anticipated changes in COVID-19 vaccine demand; the initiation, timing, progress, results, and cost of BioNTech’s research and development programs, including BioNTech’s current and future preclinical studies and clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of studies or clinical trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations; BioNTech’s expectations regarding potential future commercialization in oncology, including goals regarding timing and indications; the targeted timing and number of additional potentially registrational clinical trials, and the registrational potential of any clinical trial BioNTech may initiate; discussions with regulatory agencies; BioNTech’s expectations with respect to intellectual property; the impact of BioNTech’s collaboration and licensing agreements, including BioNTech’s partnership with Bristol Myers Squibb; BioNTech’s expectations with respect to developments in law, public policy, and international trade; BioNTech’s estimates of revenues, research and development expenses, selling, general and administrative expenses and capital expenditures for operating activities; BioNTech’s expectations for upcoming scientific and investor presentations; and BioNTech’s expectations of net profit/(loss). In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events, and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, projected data release timelines, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; BioNTech’s pricing and coverage negotiations with governmental authorities, private health insurers and other third-party payors; the future commercial demand and medical need for initial or annual booster doses of a COVID-19 vaccine; the impact of tariffs and escalations in trade policy; competition from other COVID-19 vaccines or related to BioNTech’s other product candidates; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; the ability of BioNTech’s COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Annual Report on Form 20-F for the period ended December 31, 2025 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at . These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. CONTACTS Investor Relations Douglas Maffei, PhD Investors@biontech.de Media Relations Jasmina Alatovic Media@biontech.de Abbreviation Overview 1L First line 2L Second line adj. Adjuvant B7H3 B7 homologue B3 (MSS-)CRC (Microsatellite stable-) colorectal cancer ctDNA Circulating tumor DNA CTLA-4 Cytotoxic T-lymphocyte-associated protein ES-SCLC Extensive-stage small cell lung cancer GBM Glioblastoma HCC Hepatocellular carcinoma HER2 (or HER3) Human epidermal growth factor receptor 2 (or 3) HNSCC Head and neck squamous cell carcinoma HPV16 Human papilloma virus 16 HR Hormone receptor IHC3+, 2+, 1+ Immunohistochemistry score 1+ (or 2+ or 3+) ISH-positive In-situ hybridization positive mCRPC Metastatic castration resistant prostate cancer RCC Renal cell carcinoma (sq) NSCLC (Squamous) non-small cell lung cancer PDAC Pancreatic ductal adenocarcinoma PD-(L)1 Programmed cell death protein (death-ligand) 1 TNBC Triple-negative breast cancer TROP2 Trophoblast cell-surface antigen 2 VEGF-A Vascular endothelial growth factor A Consolidated Statements of Profit or Loss (IFRS Results) Three months ended December 31, Years ended December 31, 2025 2024 2025 2024 (in millions €, except per share data) (unaudited) (unaudited) Revenues 907.4 1,190.0 2,869.9 2,751.1 Cost of sales (333.3) (243.5) (641.8) (541.3) Research and development expenses (505.4) (611.8) (2,104.9) (2,254.2) Sales and marketing expenses (49.3) (21.3) (110.0) (67.9) General and administrative expenses (168.6) (110.8) (514.4) (531.1) Other operating expenses (208.0) (91.6) (1,088.3) (811.5) Other operating income 34.4 37.6 184.6 140.6 Operating profit / (loss) (322.8) 148.6 (1,404.9) (1,314.3) Finance income 99.6 165.2 423.9 664.0 Finance expenses (4.2) (12.6) (69.8) (27.4) Profit / (Loss) before tax (227.4) 301.2 (1,050.8) (677.7) Income taxes (77.6) (41.7) (85.3) 12.4 Net profit / (loss) (305.0) 259.5 (1,136.1) (665.3) Earnings / (Loss) per share Basic earnings / (loss) per share (1.25) 1.08 (4.70) (2.77) Diluted earnings / (loss) per share (1.25) 1.08 (4.70) (2.77) Condensed Consolidated Statements of Profit or Loss (Adjusted Results) Adjusted Results (non-IFRS measures) 1 Three months ended December 31, Years ended December 31, 2025 2024 2025 2024 (in millions €, except per share data) (unaudited) (unaudited) Adjusted cost of sales (302.8) (204.5) (611.3) (493.2) Adjusted research and development expenses (505.4) (530.3) (2,019.5) (2,172.7) Adjusted other operating expenses (13.0) (39.2) (170.2) (154.1) Adjusted other operating income 34.4 37.6 169.6 140.6 Adjusted operating profit / (loss) (97.3) 321.5 (385.9) (527.3) Adjusted profit / (loss) before tax (1.9) 474.1 (31.8) 109.3 Adjusted net profit / (loss) 2 (79.5) 432.4 (117.1) 121.7 Adjusted earnings / (loss) per share Adjusted basic earnings / (loss) per share (0.33) 1.80 (0.48) 0.51 Adjusted diluted earnings / (loss) per share (0.33) 1.79 (0.48) 0.50 1 Certain adjusted results presented in this table are identical to our results under IFRS Accounting Standards. Reconciliation of all other adjusted results to our IFRS results can be found at the end of this press release and in BioNTech’s Report on Form 20-F for the year ended December 31, 2025, filed on March 10, 2026, which is available at 2 Tax effects are not considered as part of our non-IFRS adjustments Consolidated Statements of Financial Position December 31, December 31, (in millions €) 2025 2024 Assets Non-current assets Goodwill 367.9 380.6 Other intangible assets 1,606.0 790.4 Property, plant and equipment 1,080.9 935.3 Right-of-use assets 210.2 248.1 Contract assets 2.0 9.8 Other financial assets 2,554.2 1,254.0 Other non-financial assets 7.3 26.3 Deferred tax assets 13.5 81.7 Total non-current assets 5,842.0 3,726.2 Current assets Inventories 110.7 283.3 Trade and other receivables 924.2 1,463.9 Contract assets 8.1 10.0 Other financial assets 7,201.8 7,021.7 Other non-financial assets 173.8 212.7 Income tax assets 52.6 50.0 Cash and cash equivalents 7,675.4 9,761.9 Total current assets 16,146.6 18,803.5 Total assets 21,988.6 22,529.7 Equity and liabilities Equity Share capital 259.0 248.6 Capital reserve 2,473.3 1,398.6 Treasury shares (7.7) (8.6) Retained earnings 17,961.9 19,098.0 Other reserves (1,462.3) (1,325.5) Total equity 19,224.2 19,411.1 Non-current liabilities Lease liabilities, loans and borrowings 215.2 214.7 Other financial liabilities 94.9 46.9 Provisions 35.5 20.9 Contract liabilities 88.0 183.0 Other non-financial liabilities 104.2 87.5 Deferred tax liabilities 84.3 42.4 Total non-current liabilities 622.1 595.4 Current liabilities Lease liabilities, loans and borrowings 52.2 39.5 Trade payables and other payables 534.9 426.7 Other financial liabilities 351.7 1,443.4 Income tax liabilities 65.6 4.5 Provisions 145.3 144.8 Contract liabilities 754.9 294.9 Other non-financial liabilities 237.7 169.4 Total current liabilities 2,142.3 2,523.2 Total liabilities 2,764.4 3,118.6 Total equity and liabilities 21,988.6 22,529.7 Consolidated Statements of Cash Flows Three months ended December 31, Years ended December 31, 2025 2024 2025 2024 (in millions €) (unaudited) (unaudited) Operating activities Net profit / (loss) (305.0) 259.5 (1,136.1) (665.3) Income taxes 77.6 41.7 85.3 (12.4) Profit / (Loss) before tax (227.4) 301.2 (1,050.8) (677.7) Adjustments to reconcile loss before tax to net cash flows: Depreciation, amortization and impairment of property, plant, equipment, intangible assets and right-of-use assets 164.8 165.4 382.8 298.0 Share-based payment expenses 24.1 23.5 106.2 100.9 Net foreign exchange differences (43.0) (32.1) (6.6) (109.5) (Gain) / Loss on disposal of property, plant and equipment (0.8) (0.1) (2.5) (0.3) Finance income excluding foreign exchange differences (99.1) (149.7) (423.9) (648.5) Finance expense excluding foreign exchange differences 4.3 12.6 21.4 27.4 Government grants (19.5) (4.7) (63.0) (31.5) Other non-cash (income) / loss 600.4 — 585.4 — Unrealized (gain) / loss on derivative instruments at fair value through profit or loss 2.5 3.9 (10.4) 4.6 Working capital adjustments: (Increase) / Decrease in trade and other receivables, contract assets and other assets 81.0 (879.9) 1,083.7 387.7 Decrease in inventories 116.2 19.9 177.9 74.5 (Decrease) / Increase in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions (424.6) 167.7 (723.8) 758.4 Interest received and realized gains from cash and cash equivalents 61.8 121.6 337.0 474.9 Interest paid and realized losses from cash and cash equivalents (2.8) (6.6) (11.0) (13.5) Income tax received / (paid), net 40.5 (198.4) 3.8 (389.2) Share-based payments (6.0) (10.9) (25.3) (154.5) Government grants received 37.1 3.3 75.1 106.0 Net cash flows from operating activities 309.5 (463.3) 456.0 207.7 Investing activities Purchase of property, plant and equipment (63.2) (66.6) (175.1) (286.5) Proceeds from sale of property, plant and equipment 0.6 0.7 4.5 1.2 Purchase of intangible assets 1.1 (24.5) (573.9) (165.8) Acquisition of subsidiaries and businesses, net of cash acquired 264.8 — 186.3 — Investment in other financial assets (4,375.8) (2,068.8) (11,422.5) (12,370.3) Proceeds from maturity of other financial assets 1,446.9 2,765.9 9,512.2 10,740.2 Net cash flows used in investing activities (2,725.6) 606.7 (2,468.5) (2,081.2) Financing activities Proceeds from loans and borrowings 6.7 — 6.7 — Repayment of loans and borrowings (8.6) — (18.0) (2.3) Payments related to lease liabilities (10.4) (7.3) (39.6) (43.6) Transaction costs related to issuance of share capital (2.0) — (2.0) — Net cash flows used in financing activities (14.3) (7.3) (52.9) (45.9) Net decrease in cash and cash equivalents (2,430.4) 136.1 (2,065.4) (1,919.4) Change in cash and cash equivalents resulting from exchange rate differences 1.4 13.6 (27.0) 14.8 Change in cash and cash equivalents resulting from other valuation effects 11.5 (12.4) 5.9 2.8 Cash and cash equivalents at the beginning of the period 10,092.9 9,624.6 9,761.9 11,663.7 Cash and cash equivalents as of December 31 7,675.4 9,761.9 7,675.4 9,761.9 Non-IFRS Reconciliation Non-IFRS Reconciliation for the year ended December 31, 2025 non-IFRS adjustments (in millions €, except per share data) IFRS Results Expenses and income from legal proceedings Impairment and reversal Employee-related expenses from restructuring Income from bargain purchase and income and expenses from divestiture related items Adjusted Results Cost of sales (641.8) — 30.5 — — (611.3) Research and development expenses (2,104.9) — 85.4 — — (2,019.5) Other operating expenses (1,088.3) 789.5 71.6 57.0 — (170.2) Other operating income 184.6 — — — (15.0) 169.6 Operating loss (1,404.9) 789.5 187.5 57.0 (15.0) (385.9) Loss before tax (1,050.8) 789.5 187.5 57.0 (15.0) (31.8) Net loss 1 (1,136.1) 789.5 187.5 57.0 (15.0) (117.1) Loss per share Basic loss per share (4.70) (0.48) Diluted loss per share (4.70) (0.48) 1 Tax effects are not considered as part of our non-IFRS adjustments. Non-IFRS Reconciliation for the three months ended December 31, 2025 non-IFRS adjustments (in millions €, except per share data) IFRS Results Expenses and income from legal proceedings Impairment and reversal Employee-related expenses from restructuring Income from bargain purchase and income and expenses from divestiture related items Adjusted Results (unaudited) Cost of sales (333.3) — 30.5 — — (302.8) Other operating expenses (208.0) 111.4 71.6 12.0 — (13.0) Operating loss (322.8) 111.4 102.1 12.0 — (97.3) Loss before tax (227.4) 111.4 102.1 12.0 — (1.9) Net loss 1 (305.0) 111.4 102.1 12.0 — (79.5) Loss per share Basic loss per share (1.25) (0.33) Diluted loss per share (1.25) (0.33) 1 Tax effects are not considered as part of our non-IFRS adjustments. Non-IFRS Reconciliation for the year ended December 31, 2024 non-IFRS adjustments (in millions €, except per share data) IFRS Results Expenses and income from legal proceedings Impairment and reversal Employee-related expenses from restructuring Income from bargain purchase and income and expenses from divestiture related items Adjusted Results Cost of sales (541.3) — 48.1 — — (493.2) Research and development expenses (2,254.2) — 81.5 — — (2,172.7) Other operating expenses (811.5) 657.4 — — — (154.1) Operating loss (1,314.3) 657.4 129.6 — — (527.3) Profit / (Loss) before tax (677.7) 657.4 129.6 — — 109.3 Net profit / (loss) 1 (665.3) 657.4 129.6 — — 121.7 Earnings / (Loss) per share Basic earnings / (loss) per share (2.77) 0.51 Diluted earnings / (loss) per share (2.77) 0.50 1 Tax effects are not considered as part of our non-IFRS adjustments. Non-IFRS Reconciliation for the three months ended December 31, 2024 non-IFRS adjustments (in millions €, except per share data) IFRS Results Expenses and income from legal proceedings Impairment and reversal Employee-related expenses from restructuring Income from bargain purchase and income and expenses from divestiture related items Adjusted Results (unaudited) Cost of sales (243.5) — 39.0 — — (204.5) Research and development expenses (611.8) — 81.5 — — (530.3) Other operating expenses (91.6) 52.4 — — — (39.2) Operating profit 148.6 52.4 120.5 — — 321.5 Profit before tax 301.2 52.4 120.5 — — 474.1 Net profit 1 259.5 52.4 120.5 — — 432.4 Earnings per share Basic earnings per share 1.08 1.80 Diluted earnings per share 1.08 1.79 1 Tax effects are not considered as part of our non-IFRS adjustments. For the three months ended and the year ended December 31, 2023, our adjusted results were identical to our results under IFRS Accounting Standards.