Trop-2 x 4-1BB

寒冬未尽，融资难、现金流短缺依旧是大部分Biotech所面临的头号问题。 强者从来不抱怨环境，总有人逆势而上，如今一家头部Biotech已经向盈亏平衡冲刺成功，在寒冬实现了自我造血。 8月23日，基石药业发布2024年中报业绩：上半年公司实现收入2.542亿元人民币（其中包括1.183亿药品销售收入、1.226亿元的授权费和1330万元的舒格利单抗特许权使用费收入），并实现期内净利润近1600万元人民币（按照国际财务报告准则计量）。值得注意的是，这是公司首度实现盈利的半年报。 基石药业的2024H1盈利除了通过运营的降本增效外，更得益于商业模式调整优先聚焦于高价值项目。 具体表现形式是：一是公司通过人员的精简、将资源聚焦至更具潜力和商业化价值的项目等方式快速实现降本增效；二是公司立足长远利益考量，围绕临床后期、已商业化项目与大药企持续达成商业化、全球化的合作，包括普拉替尼、阿伐替尼、舒格利单抗，公司在获得不菲的首付款的同时在未来有望获得源源不断的里程碑付款，进一步夯实了公司的现金管道。而这样国内、出海两手都要抓的高效战略，恰恰给基石药业带来了强大的发展韧性，成功实现业绩冲过盈亏平衡线。 首次盈利对于基石药业来说只是一个小的里程碑，其更大的想象力，在于公司手握下一代新型ADC、多抗管线矩阵，具备丰富的商业化及全球化潜力，其真正的价值有望在不远的将来被市场再次验证。 1 潜力刚开始释放 收入、成本端高效优化 基石药业无疑走在一条正确的道路上，去争取一个更光明的未来。 在寒冬之下，相比其他Biotech，基石药业做对了三件事情，其一是公司布局丰富（小分子、单抗、ADC，主流疗法其均有布局）并且大部分的商业化和授权预期基本都在一一兑现，包括PD-L1单抗舒格利单抗出海、普拉替尼国内商业化授权、阿伐替尼国内商业化授权；其二是公司果断调整不同分子的优先级，不惧止损；其三是公司为了提升效率变革果决，费用端获得了极大的优化，这些都是一般Biotech不具备的生存能力。 “数字不会骗人。”微观回归到财务数据看，基石药业能够从2023H1净亏损2.09亿人民币，一跃成2024H1完全扭亏并实现近1600万元人民币的盈利，其中最大的奥秘来自于收入端和成本端的高效优化。 首先是在收入端。药品销售收入方面，普拉替尼和阿伐替尼皆具有较大市场潜力且处于快速成长期。根据西南证券的测算，普拉替尼的销售额将于2028年达到它的峰值：15.2亿元，而阿伐替尼的峰值数字为4亿元，目前正处于放量的初期阶段，在之后的三年里才是同比增长最为快速的时期。 另外值得注意的是，阿伐替尼转移至境内生产的药品（又称地产化）上市注册申请已经获得中国国家药品监督管理局的批准，普拉替尼的该项申请目前也正在审评中。可以预见到成功地产化后，这两款精准治疗药物的成本将显著降低，长期盈利能力也将大大提升。 图片来源：西南证券研究所 图片来源：西南证券研究所 当然，基石药业针对国内市场销售，通过与更加专业的国内药企合作，建立更高效的商业化运作。2024年，普拉替尼整合进了艾力斯的高度协同肺癌业务部，同样也是专业的药给专业的公司去推进商业化的逻辑。 艾力斯的肺癌商业化团队非常成熟，目前靠着伏美替尼核心产品撑起了整个公司的营收，净利润从2023年H1的2.08亿到了2024年H1的6.56亿，也是处在商业化加速放量期的公司。搭上艾力斯的放量“高铁”，也有助于普拉替尼的商业化进程加速与营运效率的提高。 不止艾力斯，今年7月，恒瑞与基石药业就阿伐替尼的商业化达成合作，后续由恒瑞的独家商业化团队来推广阿伐替尼，并且销售额仍然算入未来基石药业的财报，恒瑞则向基石收取一定的服务费用。 其次，在今年上半年，舒格利单抗海外重磅授权给基石药业也带来人民币1.226亿元的授权费，尤为关键的这只是舒格利单抗走向全球市场并带给基石药业丰厚汇报的开端。如此可见，坚韧生存并实现盈利的基石药业，在一次又一次的合作中，将商业化的道路走宽。凭借自身的产品拿下了一个又一个商业化成熟药企合作的机会。 其次，在成本端，基石药业做出的降本增效同样值得细细品味。 根据其上半年的业绩说明，其研发开支从去年同期的1.87亿元减少至今年的6620万元，相比降到了去年的三分之一左右，但这不意味着研发强度的下降，其最主要的原因是之前License费用在里程碑扣款中的大幅度下降。 基石药业研发费用开支的高峰期是2019-2021年，研发费用均在10亿以上，当时其几款小分子药物正处于关键性临床阶段，一方面几项III期临床需要支付大额临床费用，另一方面还有Blueprint Medicines处需要支付研发的里程碑付款。 研发费用下降到如今的量级，显然大大减轻了公司的负担，一方面源自于前期小分子和PD-L1产品商业化的有序推进与里程碑费用负担的逐步出清；另一方面，其下一代有想象力的项目都还处在相对早期阶段，例如其管线2.0中的重磅ADC药物CS5001目前正处于临床I期阶段，三抗CS2009则预计今年底进入临床阶段。 基石药业成本端的高效优化更体现在销售费用和行政费用，销售费用和行政费用2024H1分别为6276.9万、4667.2万人民币，同比2023H1分别收窄52.25%、47.67%，这反映出公司通过精简人员架构和减少不必要开支等手段，实现了公司的高效运营，进一步加强了公司的盈利能力。 由此可以明显看出，基石药业正在渐入佳境。一边是已商业化产品梯队进入收获期销售额不断爬坡，以及出海产品在海外商业谈判不断取得实质性进展；一边是公司的费用端进行了高效优化精简，截止2024H1基石药业仍有8.14亿元人民币的现金储备，其现金管道的多元化流入，反映了至少长期都不会面临生存压力。 首次盈利的信号加上健康的财务状况，让基石药业成为了创新药寒冬中一道熹微的晨光。 2 管线价值最大化 首个成功出海的国产PD-L1 在国内创新药支付体系并未完善的环境下，Biotech必须拥有将自身的管线潜力挖掘到极限的能力，这不仅考量公司能否找到靠谱并且有实力的授权方，还考量公司能否获得除首付款之外的长远收入、是否具备长线思维。基石药业用自身切实的实际行动向市场进行了展现，最为经典的案例便是PD-L1舒格利单抗的国内授权以及出海，使得其管线价值最大化。 首先，舒格利单抗的靶点是PD-L1，该类药物目前在国内是一个商业化相对成熟的药物，就国内而言，截止2023年底，已经上市了六个PD-L1单抗创新药。出于此逻辑，目前该药的最大需求是如何找到拥有强大商业化团队的合作伙伴，让其在国内和国外在同质化竞争中靠销售渠道取得优势。 出于此，基石早在2020年便在国内有所布局。2020年9月底，辉瑞认购了基石9.9%的股份，并获得了在中国大陆的商业化权利。也就是说，该药在中国大陆的商业化是由MNC负责的。 当时辉瑞对该药的数据非常看好，较小的毒性加上较好的疗效以及四大一小的肿瘤适应症，让它在竞争也许能展现出差异化优势。基于此，基石获得的里程碑付款总计最高可达到2.8亿美元，换算成人民币接近20亿元。 图片来源：基石药业官网 而海外的逻辑上，首先，PD-L1靶点的药物在欧洲市场相对并不算内卷。舒格利单抗2024年7月在欧盟获批具有里程碑式的意义，正因为这是欧盟批准的第一个联合化疗用于一线治疗鳞状和非鳞状非小细胞肺癌的PD-L1单抗，也是首个出海的国产PD-L1，这片蓝海正等着基石去扬帆远航。 此外，在中东欧这样的非英语国家，中国本土的biotech要进行销售渗透难度并不算小，交给欧洲本土药企不失为明智之举。 而今年五月基石药业与Ewopharma达成在瑞士以及中东欧国家（CEE）商业化权利授权交易，便是处于此种考量。这笔交易中公司将最高获得5130万美元的首付款以及后续注册和销售里程碑付款。 Ewopharma是一家瑞士公司，这家公司本身是一家专注于发掘有潜力单品并主导其在瑞士及中东欧地区的分销的药企，销售渠道和模式都非常成熟。与其合作成功的药企案例包括德国药企Dr.Falk Pharma以及BioGaia，二者都是其长期的合作伙伴。 Dr.Falk Pharma在写在Ewopharma官网的推荐信中对Ewopharma评价非常之高，从Salofalk 和Ursofalk在中东欧地区的分销开始，与其合作了二十多年，称其在医院端有着非常成熟的销售渠道。 中东欧之外，财报透露，舒格利单抗在西欧、拉丁美洲、中东、东南亚等地区的商业合作谈判也已取得实质性进展，预计不久将达成协议。而在欧盟作为一线治疗NSCLC适应症上屈指可数的PD-L1疗法，也一定程度上降低了商业化的难度。吃到这片仅次于美国市场的红利，不仅仅将获得相当一部分的营收增长，还将为之后出海扎下坚实的基础。 舒格利单抗BD交易对于全球各个大市场的覆盖，充分证明了基石药业对于自家管线潜力出色的“挖掘”能力。并且，基石药业对舒格利单抗在海外的期待远不止一个适应症，基石药业正在计划向欧洲药品管理局（EMA）递交舒格利单抗其他适应症，如III期NSCLC、一线胃癌、一线食管鳞癌和复发难治性结外NK/T细胞淋巴瘤的MAA。舒格利单抗针对一线IV期NSCLC的新药上市许可申请（MAA）目前正在英国药品和医疗保健用品管理局（MHRA）审评中。 3 下一代管线 差异化的ADC和多抗 基石药业未来真正的上限，源自于它下一代的管线，未来公司新型潜力分子临床数据的催化大概率将给予投资者非常可观的回报。 目前管线2.0中跑得最快的是CS5001——一款靶向ROR1的ADC。虽然该靶点在从目前全球研发格局来看仍处于早期阶段，但默沙东和勃林格殷格翰两家MNC都对其青睐有加。 根据ROR1靶点的综述《Unlocking the Potential: Advancements and Future Horizons in ROR1-Targeted Cancer Therapies》：该靶点在在多种癌症中表现出高表达，包括慢性淋巴细胞白血病（CLL）、乳腺癌、卵巢癌、肺腺癌、胰腺癌、结直肠癌和黑色素瘤等。 图片来源：《Unlocking the Potential: Advancements and Future Horizons in ROR1-Targeted Cancer Therapies》 靶点越来越丰富的进程将给更多数量癌症患者治疗的希望。最简单的例子：trop2靶点的出现改写了乳腺癌的治疗格局，让三阴性乳腺癌的疗法不只有免疫疗法和化疗。 而ROR1靶点对于ADC药物而言，如前文所述，MNC们已经开始抢先布局，全球共三款药物进入临床开发阶段。默沙东和勃林格殷格翰的进度比基石略快一筹，默沙东的MK-2104最快的适应症已经推进至临床III期。勃林格殷格翰的NBE-002也一度处于临床II期，但目前已经终止。 从现在的视角去看，当时BI收购NBE，为了获得NBE-002，更重要的是为了得到它的蒽环类毒素平台来研发ADC的payload，其开发出的PNU-159682的毒性比化疗类药物柔比多星要强100倍。 图片来源：药智头条 MK-2104作为ADC而言，其linker是经典的mc-vc-PAB偶联方式，蛋白质酶水解，而payload也是MMAE，该linker是目前上市的ADC中最经典的偶联方式之一。 而相比之下，CS5001的linker则比较具有差异化。其引进的是韩国biotech名为LigaChem（LCB）的管线，用得是对方的ADC平台ConjuAll。其采用的linker为β-葡萄糖醛酸，糖类的连接子相比多肽类亲水性好，聚集体产生较少，而劣势则为在临床试验中最大耐受剂量（MTD）较多肽连接子更低。 不过CS5001用LCB差异化的技术——pPBD而解决了这一点。原理来说，其设计在PBD毒素上有遮蔽部分，正常组织中没有毒性。当ADC被肿瘤细胞内吞后，遮蔽组分被酶切掉，毒素才会恢复毒性继而杀死肿瘤细胞。 这个原理之后在I期临床试验中得到了验证。根据基石半年报业绩披露，在CS5001的Ia期剂量爬坡中，7μg/kg-156μg/kg的9个剂量组中均未观察到剂量限制性毒性（DLT），也没达到MTD。这也正说明了payload的毒素遮蔽技术使得该药的剂量安全窗口被大大拓宽。 而更重要的疗效和适应症拓展上，也在Ia期试验中得以体现。 血液瘤方面有霍奇金淋巴瘤和弥漫大B细胞淋巴瘤的受试者。霍奇金淋巴瘤方面，第5-9剂量水平的9名可评估患者中一位达到了CR以及4位达到了PR，ORR达到了55.6%。弥漫大B细胞淋巴瘤方面，7-9剂量水平的6名可评估患者中1位CR及2位PR，ORR达到了50%。 实体瘤方面，非小细胞肺癌（NSCLC），胰腺癌，三阴性乳腺癌(TNBC)及卵巢癌均观察到了不错的反应。其中NSCLC出现了一例PR，胰腺癌出现了一例PR，而TNBC和卵巢癌则各有一例SD。 有意思的是，CS5001是目前三款已经进入临床的ROR1 ADC中唯一一款在血液瘤和实体瘤中均观察到不错疗效的产品。 因此，CS5001很有机会实现后发制人，因为它的路已经比竞品走的更宽更广。该靶点目前来看可能具有比TROP2和nectin-4更加广阔的想象空间，因为它既覆盖了血液瘤也覆盖了实体瘤，这在ADC靶点中非常非常难得，而基石又已经在Ia期中验证了二者的治疗有效性，未来的天花板不可估量。 此外，后续管线基石也已经在提早布局。其三抗CS2009便是非常值得期待的后备力量。目前三抗而言，大部分药企布局的方向是一个肿瘤抗原靶点，一个CD3激活T细胞，再加一个4-1BB类型的共刺激因子。基石药业走了另一条路，其靶点是PD-(L)1，VEGFa以及CTLA-4，类似于目前康方走的结合PD-1以及VEGF的双抗路线。 另一款PD-1/VEGF双抗AK112在患者基线非常糟糕的情况下获得了较好的HR值，并且得到了药监局的加速批准上市。而CTLA4也是经典的免疫检查点抑制靶点之一，细胞表面的CTLA-4主要通过抑制共刺激信号来抑制CD8＋T细胞，将PD-1和VEGF的基础上再加上一条CTLA-4通路的抑制剂，等于在共刺激途径上更进一步削弱了对T细胞的抑制，CS2009未来的临床数据值得期待。 这种复合几个免疫抑制靶点做成三抗的方式目前确实还处于较为早期的阶段，双抗目前的案例不错，也许能给三抗的临床开发更多的印证和走下去的信心。根据基石官网的信息，CS2009未来将会主要用于NSCLC和肝细胞癌上，二者皆为市场非常巨大的癌种，未来留给CS2009的是一片巨大的值得去迭代的市场。 CS2009将会在今年或者明年递交IND申请。也许可以从其之后的临床试验中，看到三抗在免疫抑制途径的方向上走出一条出彩的路，也许基石药业的三抗未来是迭代双抗的最有力管线。 基石管线2.0的庞大布局，远远不止CS5001和CS2009，针对多种高发肿瘤适应症并采用内部机器学习生物信息学算法识别的新型肿瘤相关抗原的ADC——CS5006，和SSTR2 ADC——CS5005也都是同类首创ADC，预计明年递交新药临床试验申请（IND）。 此外，靶向2种经临床验证的实体瘤靶点的潜在同类最优双特异性ADC——CS5007及其相应的双特异性抗体CS2011，也正在向IND阶段推进。 管线2.0有望为基石药业输送更多潜在同类首创或同类最优的候选药物。源源不断的创新管线，意味着更多的全球商业合作机会和潜在的授权收入。 结语：寒冬之中，总有不抱怨环境的强者。基石药业通过销售的放量、核心管线的授权和成本的削减已经冲线盈亏平衡，而未来的管线布局更加体现了其出色的战略眼光。在CS5001等下一代管线横空出世，其市值也将水涨船高；寒冬中活下来的强者，将在下一个周期，迎来一飞冲天的时刻。 关于同写意  同写意论坛是中国新药研发行业权威的多元化交流平台，二十年来共举办会议论坛百余期。“同写意新药英才俱乐部”基于同写意论坛而成立，早已成为众多新药英才的精神家园和中国新药思想的重要发源地之一。同写意在北京、苏州、深圳、成都设立多个管理中心负责同写意活动的运营。 尊享多重企业/机构会员特权  ● 分享庞大新药生态圈资源库； 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Research丨宣泰医药丨先声药业丨海金格丨普瑞盛医药丨Informa丨科特勒丨谋思医药丨HLT丨莱佛士丨辉瑞丨科林利康丨冠科生物丨科文斯丨卫信康丨龙沙（Lonza）丨美迪西丨阳光诺和丨润东医药丨勃林格殷格翰（中国）丨艾苏莱生物丨领晟医疗丨驯鹿医疗丨燃石医学丨中肽生化丨鸿运华宁丨泰格医药丨易迪希丨希麦迪丨百奥赛图丨迪纳利丨青云瑞晶丨鼎丰生科资本丨中源协和丨维亚生物丨青松医药丨中科谱研丨长风药业丨艾欣达伟丨鼎康生物丨中晟全肽丨海步医药丨勤浩医药丨奥萨医药丨太美医疗科技丨生特瑞丨东富龙丨Cytiva丨优辰实验室丨苏桥生物丨君达合创丨澎立生物丨南京澳健丨南京科默丨东阳光丨亚盛医药丨杰克森实验室丨上海科州丨三优生物丨三迭纪丨泰诺麦博丨Cell Signaling Technology丨PPC佳生丨澳斯康丨先为达丨智享生物丨锐得麦丨宜明昂科丨明济生物丨英百瑞丨六合宁远丨天津天诚丨百拓生物丨星药科技丨亓上生物丨真实生物丨引光医药丨方达医药丨高博医疗集团丨赞荣医药丨国投创新丨药明生物丨康哲药业丨高特佳投资丨普瑞基准丨臻格生物丨微谱医药丨和玉资本 | 倚锋资本

Announced positive data from multiple mRNA cancer vaccine clinical trials, including topline results from the ongoing Phase 2 evaluating FixVac candidate BNT111Launched updated variant-adapted COVID-19 vaccine in the European Union (“EU”), received approval in the United Kingdom and initiated rolling supplemental Biologics Licensing Application (“sBLA”) with the United States Food and Drug Administration (“U.S. FDA”)Reiterates guidance for total revenues in the range of €2.5-3.1 billionReports second quarter 2024 revenues of €128.7 million, net loss of €807.8 million and loss per share of €3.36 ($3.621)Invested €525.6 million or approximately 90% of the Company’s total R&D spend in Q2 in non-COVID-19 related activities, mainly oncology and mRNA; investments are in line with the reiterated full-year R&D expense guidanceEnded the second quarter of 2024 with €18.5 billion in cash, cash equivalents and security investments Conference call and webcast scheduled for August 5, 2024, at 8:00 a.m. EDT (2:00 p.m. CEST) MAINZ, Germany, August 5, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today reported financial results for the three and six months ended June 30, 2024, and provided an update on its corporate progress. “The year to date has been marked by significant data updates across our oncology portfolio. These readouts reinforce the potential of our platform technologies including our individualized and off-the-shelf mRNA vaccine platforms, iNeST and FixVac. We have also advanced our strategy by initiating clinical trials evaluating novel combinations of synergistic drug candidates. Notably, we dosed the first patient in a trial evaluating the combination of the TROP2 antibody-drug conjugate BNT325/DB-1305 and the PD-L1-VEGF-A bispecific BNT327/PM8002, aiming to harness the potent anti-tumor activity of antibody drug conjugates along with the sustained benefit of immunomodulators,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “In addition, we have started commercializing variant-adapted COVID-19 vaccines for the upcoming season, while accelerating our clinical development efforts to realize the full potential of our technologies. We are making progress towards our goal of becoming a company with marketed medicines for cancer and infectious diseases.” Financial Review for Second Quarter and First Half of 2024 in millions €, except per share data Second Quarter 2024 Second Quarter 2023 First Half 2024 First Half 2023Revenues 128.7 167.7 316.3 1,444.7Net Profit / (Loss) (807.8) (190.4) (1,122.9) 311.8(Loss) / Diluted Earnings per Share (3.36) (0.79) (4.67) 1.28 Revenues reported were €128.7 million for the three months ended June 30, 2024, compared to €167.7 million for the comparative prior year period. For the six months ended June 30, 2024, revenues were €316.3 million, compared to €1,444.7 million for the comparative prior year period. The year-over-year change was mainly due to lower revenues from the sales of the Company’s COVID-19 vaccines worldwide resulting from the continued shift in demand from a pandemic to a seasonal endemic COVID-19 vaccine market. Cost of sales were €59.8 million for the three months ended June 30, 2024, compared to €162.9 million for the comparative prior year period. For the six months ended June 30, 2024, cost of sales were €118.9 million, compared to €258.9 million for the comparative prior year period. The change was mainly due to COVID-19 vaccine production in line with demand. Research and development (“R&D”) expenses were €584.6 million for the three months ended June 30, 2024, compared to €373.4 million for the comparative prior year period. For the six months ended June 30, 2024, R&D expenses were €1,092.1 million, compared to €707.4 million for the comparative prior year period. R&D expenses were mainly influenced by progressing clinical studies for the Company’s late-stage oncology pipeline candidates. Further contributions to the increase came from wages, benefits and social security expenses resulting from an increase in headcount. Sales, general and administrative (“SG&A”) expenses2, in total, amounted to €183.8 million for the three months ended June 30, 2024, compared to €137.9 million for the comparative prior year period. For the six months ended June 30, 2024, SG&A expenses were €316.4 million, compared to €261.9 million for the comparative prior year period. SG&A expenses were primarily driven by increased expenses for IT environment and wages, benefits, and social security expenses resulting from an increase in headcount. Other operating result amounted to €266.7 million negative operating result during the three months ended June 30, 2024, compared to €56.8 million negative operating result for the comparative prior year period. For the six months ended June 30, 2023, other operating result amounted to €262.3 million negative operating result compared with €125.4 million negative operating result for the prior year period. This change was primarily due to the recording of a provision related to a contractual dispute. Income taxes were accrued with an amount of €2.0 million of tax expenses for the three months ended June 30, 2024, compared to €221.8 million of realized tax income for the comparative prior year period. For the six months ended June 30, 2024, income taxes were realized with an amount of €14.7 million of tax income for the six months ended June 30, 2024, compared to €16.3 million of realized tax income for the comparative prior year period. The effective income tax rate for the six months ended June 30, 2024, was approximately 1.3%. Net loss was €807.8 million for the three months ended June 30, 2024, compared to €190.4 million loss for the comparative prior year period. For the six months ended June 30, 2024, loss was €1,122.9 million for the six months ended June 30, 2024, compared to a profit of €311.8 million for the comparative prior year period. Cash and cash equivalents plus security investments as of June 30, 2024, reached €18,485.1 million, comprising €10,376.7 million cash and cash equivalents, €6,916.7 million current security investments and €1,191.7 million non-current security investments. This position increased during the second quarter of 2024 largely attributable to a cash payment received from BioNTech’s collaboration partner Pfizer Inc. (“Pfizer”). Loss per share was €3.36 for the three months ended June 30, 2024, compared to €0.79 for the comparative prior year period. For the six months ended June 30, 2024, loss per share was €4.67, compared to diluted earnings per share of €1.28 for the comparative prior year period. Shares outstanding as of June 30, 2024 were 237,766,235, excluding 10,785,965 shares held in treasury. “Our second quarter revenues correspond to the current demand of a seasonal endemic COVID-19 vaccine market,” said Jens Holstein, CFO of BioNTech. “Supported by our strong financial position, we will continue to focus on our long-term growth strategy throughout the remainder of the year. This includes our clinical pipeline for individualized therapies, the build-out of our manufacturing capacities and capabilities to support additional late-stage trials as well as our commercialization activities. These investments build the foundation for the next stage of growth and the transformation of BioNTech into a multi-product company.” 2024 Financial Year Guidance3 Reiterated The Company reiterates its prior outlook for the financial year: Total revenues for the 2024 financial year €2.5 billion - €3.1 billion BioNTech expects revenues for the full 2024 financial year to be in the range of €2.5 to €3.1 billion. The range reflects certain assumptions and expectations, including, but not limited to: the timing and granting of regulatory approvals and recommendations; COVID-19 vaccine uptake and price levels; inventory write-downs by BioNTech’s collaboration partner Pfizer that would negatively influence BioNTech’s revenues; seasonal variations in SARS-CoV-2 circulation and vaccination uptake, which are expected to lead to demand peaks in the autumn and winter compared to other seasons; and revenues from a pandemic preparedness contract with the German government as well as revenues from the BioNTech Group service businesses, namely InstaDeep Ltd., JPT Peptide Technologies GmbH, and in Idar-Oberstein at BioNTech Innovative Manufacturing Services GmbH. Generally, the Company continues to remain largely dependent on revenues generated in its collaboration partner’s territories in 2024. Planned 2024 Financial Year Expenses and Capex: R&D expenses4 €2.4 billion - €2.6 billion SG&A expenses €700 million - €800 million Capital expenditures for operating activities €400 million - €500 million The full interim unaudited condensed consolidated financial statements can be found in BioNTech’s Report on Form 6-K for the period ended June 30, 2024, filed today with the United States Securities and Exchange Commission (“SEC”) and available at https://www.sec.gov/. Endnotes 1 Calculated applying the average foreign exchange rate for the six months ended June 30, 2024, as published by the German Central Bank (Deutsche Bundesbank). 2 “SG&A expenses’’ includes sales and marketing expenses as well as general and administrative expenses. 3 Guidance excludes external risks that are not yet known and/or quantifiable. It does not include potential payments resulting from the outcomes of ongoing and/or future legal disputes or related activity, such as judgements or settlements, which may have a material effect on the Company’s results of operations and/or cash flows. BioNTech continues to expect to report a loss for the 2024 financial year and expects to recognize the vast majority of its full year revenues mostly in the fourth quarter. 4 Numbers include effects identified from additional collaborations or potential M&A transactions to the extent disclosed and are subject to update due to future developments. Operational Review of the Second Quarter 2024, Key Post Period-End Events and Outlook Variant-adapted Monovalent COVID-19 Vaccines (COMIRNATY®) In April 2024, the World Health Organization (“WHO”), the European Medicines Agency (“EMA”) and, subsequently, other health authorities, provided guidance highlighting that updated vaccines targeting Omicron JN.1 or JN.1 sublineages may contribute to maintaining protection against COVID-19 during the upcoming fall and winter seasons. On June 27, 2024, BioNTech and Pfizer announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA recommended marketing authorization for the companies’ Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY® JN.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. On July 3, 2024, the European Commission (“EC”) adopted a decision following the CHMP’s recommendation. Shortly following the EC decision, the updated vaccine was made available to ship to EU member states.On June 6, 2024, the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) issued guidance recommending the manufacturing of a JN.1-adapted monovalent COVID-19 vaccine for the 2024/2025 fall and winter seasons. On June 13, 2024, the U.S. FDA announced the KP.2 strain as the preferred JN.1-lineage for COVID-19 vaccines (2024-2025 Formula). In June 2024, BioNTech and Pfizer submitted regulatory applications to the U.S. FDA for the companies’ Omicron JN.1-adapted monovalent vaccine, and initiated a rolling sBLA for an Omicron KP.2-adapted monovalent vaccine. The companies plan to prepare shipments in the United States of KP.2-adapted monovalent COVID-19 vaccines for fast delivery following potential regulatory approval, currently expected in September 2024.On July 24, 2024, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) approved the companies’ Omicron JN.1-adapted vaccine. COVID-19 – Influenza Combination Vaccine Program BNT162b2 + BNT161 is an mRNA-based combination vaccine program against COVID-19 and influenza being developed in collaboration with Pfizer. Top-line data from the Phase 1/2 trial (NCT05596734) demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains and that the safety profile of the candidates was consistent with the profile of the companies’ COVID-19 vaccine. A Phase 3 clinical trial (NCT06178991) is fully enrolled and data are expected later this year. Select Oncology Pipeline Highlights Cancer Vaccine Programs BNT111 is based on BioNTech’s FixVac platform, and is a wholly owned, systemically administered, off-the-shelf uridine mRNA-lipoplex based cancer vaccine candidate encoding shared melanoma associated antigens. A randomized Phase 2 clinical trial (NCT04526899) being conducted in collaboration with Regeneron Pharmaceuticals Inc. (“Regeneron”) is ongoing to evaluate BNT111 in combination with cemiplimab, BNT111 alone, or cemiplimab alone in anti-PD-1-/anti-PD-L1 refractory/relapsed, unresectable stage III or IV melanoma.In July 2024, BioNTech announced that the study met its primary efficacy outcome measure, demonstrating a statistically significant improvement in overall response rate (“ORR”) in patients treated with BNT111 in combination with the anti-PD-1 checkpoint inhibitor, cemiplimab, as compared to a historical control in this indication and treatment setting. The ORR in the cemiplimab monotherapy arm was in line with the historical control of anti-PD-L1 or anti-CTLA-4 treatments in this patient group. The treatment was well tolerated and the safety profile of BNT111 in combination with cemiplimab in this trial was consistent with previous clinical trials assessing BNT111 in combination with anti-PD-L1-containing treatments. The Phase 2 trial will continue as planned to further assess the secondary endpoints which were not mature at the time of the primary analysis.BioNTech plans to present data from this trial at an upcoming medical conference. BNT113 is a cancer vaccine candidate based on FixVac’s platform encoding for shared antigens associated with Human Papilloma Virus (“HPV16+”) head and neck cancer. A global, randomized Phase 2 clinical trial (NCT04534205) evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment in patients with unresectable recurrent or metastatic HPV16+ head and neck squamous cell carcinoma expressing PD-L1 is ongoing. Data updates are expected to be presented at the 2024 Congress of the European Society of Medical Oncology (“ESMO”) taking place from September 13-17, 2024 in Barcelona, Spain. Abstract Title: Exploratory efficacy and translational results from the safety run in of AHEAD-MERIT, a phase II trial of first line pembrolizumab plus the fixed-antigen cancer vaccine BNT113 in advanced HPV16+ HNSCC Poster Date: September 14, 2024Presentation Number: 877PAuthor: C. N. F. Saba Abstract Title: HARE-40: A phase I/II trial of therapeutic HPV vaccine (BNT113) in patients with HPV16 driven carcinomaMini-oral Date & Time: September 16, 2024, 11:15 - 11:20 a.m. CESTPresentation Number: 999MMOAuthor: C. Ottensmeier Autogene cevumeran (BNT122) is a uridine mRNA-lipoplex based cancer vaccine candidate for individualized neoantigen-specific immunotherapy (“iNeST”) being developed in collaboration with Genentech, Inc. (“Genentech”), a member of the Roche Group (“Roche”). Autogene cevumeran is being evaluated in ongoing Phase 2 trials in adjuvant resected pancreatic ductal adenocarcinoma (“PDAC”) (NCT05968326), first-line melanoma (NCT03815058) and adjuvant colorectal cancer (“CRC”) (NCT04486378). A Phase 2 clinical trial in an additional indication is planned.In June 2024, epidemiologic data were presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting, including data on post-operative circulating tumor DNA (“ctDNA”) prevalence and prognostic value in disease-free survival, from an observational study (NCT04813627) in patients with resected high-risk stage II/III CRC. These epidemiological and prognostic data are supportive of the ongoing interventional Phase 2 clinical trial (NCT04486378).Also in June 2024, at the 2024 European Society for Medical Oncology Gastrointestinal Cancers (“ESMO-GI”) Congress, immunogenicity data were presented from the biomarker cohort of the ongoing Phase 2 (NCT04486378) that enrolled patients irrespective of post-surgical ctDNA status. The data indicate that autogene cevumeran is highly immunogenic and induces de novo polyepitopic, ex vivo detectable T-cell responses in all evaluable patients with resected​ stage II (high risk) or III CRC after completion of adjuvant chemotherapy.​ Among patients included in the immunogenicity analysis, all (12/12) were disease-free at data cut off.Preliminary data from the ongoing Phase 2 clinical trial (NCT04486378) in stage II (high risk) and III ctDNA+ adjuvant CRC is expected in late 2025 or 2026. Next-Generation Immune Checkpoint Immunomodulator Programs BNT327/PM8002 is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization and is being developed in collaboration with Biotheus Inc. (“Biotheus”). BNT327/PM8002 is currently being evaluated in multiple Phase 2 and Phase 3 clinical trials in China to assess the efficacy and safety of the candidate as monotherapy or in combination with chemotherapy in various indications.In June 2024, at the 2024 ASCO Annual Meeting, monotherapy data were presented from an ongoing Phase 1/2 clinical trial (NCT05918445) for cohorts of patients with advanced cervical cancer (“CC”), platinum-resistant recurrent ovarian cancer (“PROC”), and advanced non-small cell lung cancer (“NSCLC”). Data on 48 patients with advanced CC showed an ORR of 42.2% (52.4% in patients with PD-L1-positive tumors), a disease control rate (“DCR”) of 93.3%, and a median progression-free survival (“mPFS”) of 8.3 months. Data on 39 patients with PROC showed an ORR of 20.6%, a DCR of 67.7%, and a mPFS of 5.5 months. Treatment related adverse events (“TRAEs”) occurred in 95.4% of patients (83/87) with ≥ Grade 3 TRAEs in 36.8% (32/87) and 14.9% (13/87) of patients discontinued BNT327/PM8002 treatment due to TRAEs. Median follow-up time in patients with CC and PROC was 13.8 months and 14.8 months, respectively. Data on 61 patients with non-squamous NSCLC were also presented. Data on 17 evaluable patients with untreated NSCLC wild-type and PD-L1-positive showed an ORR of 47.1%, a DCR of 100% and a mPFS of 13.6 months at a median follow-up of 11.3 months. Data on 36 evaluable patients with epidermal growth factor receptor (“EGFR”)-mutant NSCLC after progression on prior EGFR-tyrosine kinase inhibitor treatment showed an ORR of 19.4%, a DCR of 69.4% and a mPFS of 5.5 months at a median follow-up of 12.6 months. Data from 8 evaluable patients with EGFR/anaplastic lymphoma kinase (“ALK”) wild-type NSCLC that progressed after anti-PD-1/L1 therapy and platinum-based chemotherapy showed an ORR of 12.5%, a DCR of 62.5%, and a mPFS of 5.8 months at a median follow-up of 5.8 months. TRAEs occurred in 85.2% of patients (52/61) with ≥Grade 3 TRAEs in 19.7% (12/61), serious adverse events were observed in 24.6% (15/61) of patients, 8.2% (5/61) of patients discontinued BNT327/PM8002 treatment due to TRAEs. In June 2024, the first patient was dosed in the Phase 1/2 clinical trial (NCT05438329) evaluating the combination of BNT327/PM8002 with BNT325/DB-1305, an antibody-drug conjugate (“ADC”) candidate targeting TROP-2. Additional trials with novel BNT327 and other ADC combinations are planned to begin this year.Two Phase 2 dose optimization studies are expected to start soon. A Phase 2 clinical trial (NCT06449222) to evaluate the safety, efficacy, and pharmacokinetics of BNT327/PM8002 at two dose levels in combination with chemotherapy in the first- and second-line treatment of patients with locally advanced/metastatic triple negative breast cancer (“TNBC”).A Phase 2 clinical trial (NCT06449209) to evaluate BNT327/PM8002 in combination with chemotherapy in patients with untreated extended-stage small-cell lung cancer (“ES-SCLC”) or small-cell lung cancer (“SCLC”) progressed on first- or second-line treatment.Data from these studies are expected as early as 2025. At the 2024 ESMO Congress the following datasets will be presented: Abstract Title: A Phase II Safety and Efficacy Study of PM8002/BNT-327 in Combination with Chemotherapy in Patients with EGFR-mutated NSCLCMini-oral Presentation Date & Time: September 14, 2024, 10:25 - 10:30 a.m. CESTPresentation Number: 1255MOAuthor: Y-L. Wu Abstract Title: A Phase Ib/II Study to Assess the Safety and Efficacy of PM8002/BNT327 in Combination with Nab-Paclitaxel for First Line Treatment of Locally Advanced or Metastatic Triple-Negative Breast CancerMini-oral Presentation Date & Time: September 16, 2024, 08:35 - 08:40 a.m. CESTPresentation Number: 348MOAuthor: J. Wu Abstract Title: A Phase Ib/IIa Trial to Evaluate the Safety and Efficacy of PM8002/ BNT327, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients with advanced renal cell carcinomaPoster Date: September 15, 2024Presentation Number: 1692PAuthor: X. Sheng BNT311/GEN1046 (acasunlimab) is a potential first-in-class bispecific antibody candidate combining PD-L1 checkpoint inhibition with 4-1BB costimulatory activation that is being developed for the treatment of solid tumors. A Phase 2, multi-center, randomized, open-label clinical trial (NCT05117242) of BNT311/GEN1046 (acasunlimab) as monotherapy and in combination with pembrolizumab is ongoing in patients with relapsed/refractory metastatic NSCLC and a tumor PD-L1 expression of tumor proportion score, or TPS, of ≥1% after treatment with standard of care therapy with an immune checkpoint inhibitor. The primary endpoint is ORR according to Response Evaluation Criteria in Solid Tumors, or RECIST v1.1. Secondary endpoints include duration of response (“DOR”), time to response (“TTR”), progression-free survival (“PFS”), overall survival “OS” and safety.Data from the ongoing Phase 2 trial (NCT05117242) evaluating BNT311/GEN1046 (acasunlimab) in combination with pembrolizumab in pretreated NSCLC patients were presented at the 2024 ASCO Annual Meeting. The results showed a 12-month OS rate of 69%, a median OS (“mOS”) of 17.5 months, and a 30% ORR (confirmed ORR 17%) at the time of data cut-off in patients treated with the combination of BNT311/GEN1046 (acasunlimab) and pembrolizumab every 6 weeks. Anti-tumor activity was observed in patients with tumor proportion score (“TPS”) of 1–49% and ≥50%, in patients with <6 months and ≥6 months of previous immune checkpoint inhibitor (“CPI”) treatment, and in patients with squamous and non-squamous histology. Adverse events were consistent with the safety profiles of the individual drugs and TRAEs were primarily Grade 1 and 2.Updated data from this ongoing trial is expected to be presented at the 2024 World Conference on Lung Cancer (“WCLC”) taking place from September 7-10, 2024 in San Diego, California, U.S. Abstract Title: Dosing Regimen for Acasunlimab (DuoBody-PD-L1x4-1BB) In Combination with Pembrolizumab Poster Presentation Date & Time: September 9, 2024, 18:30-20:00 PDT Presentation Number: 845Author: G. Bajaj Abstract Title: Acasunlimab Alone or in Combination with Pembrolizumab for Previously Treated Metastatic Non-Small Cell Lung CancerMini-oral Presentation Date & Time: September 10, 2024, 15:07 - 15:12 PDTPresentation Number: 1309Author: L. Paz-Ares While the emerging clinical profile of BNT311/GEN1046 (acasunlimab) is encouraging, for reasons relating to portfolio strategy, BioNTech opted not to participate in the further development of the program, including a planned Phase 3 trial. BioNTech and Genmab A/S (“Genmab”) will continue their collaboration under the existing agreements which was expanded in 2022. ADC Programs BNT323/DB-1303 is an ADC candidate targeting Human Epidermal Growth Factor 2 (“HER2”) that is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”). BNT323/DB-1303 is being evaluated in a Phase 1/2 clinical trial (NCT05150691) in patients with advanced/unresectable, recurrent or metastatic HER2-expressing solid tumors. A potentially registrational cohort with HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) patients with advanced/recurrent endometrial carcinoma has completed enrollment. Data from this cohort are expected in 2025.A confirmatory Phase 3 trial (NCT06340568) in patients with advanced endometrial cancer is planned to start in 2024.A pivotal Phase 3 trial (NCT06018337) evaluating BNT323/DB-1303 in patients with Hormone Receptor-positive (“HR+”) and HER2-low metastatic breast cancer (“BC”) that have progressed on hormone therapy and/or cyclin-dependent kinase 4/6 (“CDK4/6”) inhibition is ongoing.Topline data from the ongoing Phase 3 trial in HR+ and HER2-low metastatic BC that have progressed on hormone therapy and/or CDK4/6 inhibition are expected as early as 2025. BNT324/DB-1311 is an ADC candidate targeting B7H3 that is being developed in collaboration with DualityBio. A first-in-human, open-label Phase 1/2a clinical trial (NCT05914116) evaluating BNT324/DB-1311 in patients with advanced solid tumors is ongoing.In June 2024, BioNTech and DualityBio announced that BNT324/DB-1311 was granted Fast Track designation by the U.S. FDA for the treatment of patients with advanced/unresectable or metastatic castration-resistant prostate cancer who have progressed on or after standard systemic regimens.In July 2024, the U.S. FDA granted Orphan Drug designation to BNT324/DB-1311 for the treatment of patients with advanced or metastatic esophageal squamous cell carcinoma. BNT326/YL202 is an ADC candidate targeting HER3 that is being developed in collaboration with MediLink Therapeutics (Suzhou) Co., Ltd. (“MediLink”). A multicenter, international, open-label, first-in-human Phase 1 clinical trial (NCT05653752), sponsored by MediLink, evaluating BNT326/YL202 as a later-line treatment in patients with locally advanced or metastatic EGFR-mutated NSCLC or HR+ and HER2-negative BC is on partial clinical hold by the U.S. FDA, as announced on June 17, 2024. BioNTech and MediLink are working to address the U.S. FDA’s requirements and resolve the partial clinical hold.Preliminary data from this study were presented at the 2024 ASCO Annual Meeting. BNT326/YL202 demonstrated encouraging activity in heavily pretreated locally advanced/metastatic NSCLC and BC with an ORR of 42.3% (22 out of 52 evaluable patients) and a DCR of 94.2% (49/52), with responses seen from the first dose level at 0.5 mg/kg. The safety profile of BNT326/YL202 was consistent with its mechanism of action and dose-dependent. The most common TRAEs were due to hematologic toxicity and gastrointestinal disorders. 7.3% (4/55) of patients discontinued treatment due to TRAEs, and there were 3 treatment-related Grade 5 events (deaths) at higher doses. Further clinical development is expected to focus on dose levels below 4.0 mg/kg, where the safety profile was manageable and encouraging clinical activity was observed. Cell Therapy Programs BNT211 consists of two investigational medicinal products: a CAR-T cell product candidate targeting Claudin-6 (“CLDN6”)-positive solid tumors in combination with a CAR-T cell-amplifying RNA vaccine (“CARVac”) encoding CLDN6. A first-in-human, open-label, multi-center Phase 1 dose escalation and dose expansion basket trial (NCT04503278) evaluating CLDN6 CAR-T cells as monotherapy or in combination with CLDN6 CARVac in patients with CLDN6-positive relapsed or refractory solid tumors, including ovarian cancers and testicular germ cell tumors, is ongoing.A data update is expected to be presented at the 2024 ESMO Congress. Abstract Title: Updated results from BNT211-01 (NCT04503278), an ongoing, first-in-human, Phase 1 study evaluating safety and efficacy of CLDN6 CAR T cells and a CLDN6-encoding mRNA vaccine in patients with relapsed/refractory CLDN6+ solid tumorsMini-oral Presentation Date & Time: September 15, 2024, 15:45 - 15:55 CESTPresentation Number: 611OAuthor: J. B. Haanen A pivotal Phase 2 trial in patients with testicular germ cell tumors is expected to start in 2025 based on encouraging data in this patient group observed in the Phase 1 trial.BioNTech presented an analysis of real-world evidence investigating overall survival and treatment patterns of patients with testicular germ cell tumors receiving palliative chemotherapy at the 2024 ASCO Annual Meeting. This analysis will inform the design of the Company’s planned pivotal clinical trial to evaluate BNT211 in patients with germ cell tumors. Corporate Update for the Second Quarter 2024 and Key Post Period-End Events In May 2024, BioNTech expanded its strategic partnership with the Coalition for Epidemic Preparedness Innovations (“CEPI”) to contribute to building a sustainable and resilient end-to-end African vaccine ecosystem. CEPI is committing up to US $145 million to support BioNTech in broadening the scope of the manufacturing facility in Kigali, Rwanda. These capabilities will contribute to BioNTech and CEPI’s efforts to better prepare for potential future epidemic and pandemic threats in Africa.On July 1, 2024, Annemarie Hanekamp joined the Company’s Management Board as Chief Commercial Officer and James Ryan, Ph.D., Chief Legal Officer, also assumed the role of Chief Business Officer. Upcoming Investor and Analyst Events Innovation Series (AI Day): October 1, 2024Third Quarter 2024 Financial Results and Corporate Update: November 4, 2024Innovation Series: November 14, 2024 Conference Call and Webcast Information BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, August 5, 2024, at 8:00 a.m. EDT (2:00 p.m. CEST) to report its financial results and provide a corporate update for the second quarter of 2024. 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 Investors' section of the Company’s website at www.BioNTech.com. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call. About BioNTechBiopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are 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 Biotheus, DualityBio, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron. For more information, please visit www.BioNTech.com. Forward-Looking StatementsThis 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: BioNTech’s expected revenues related to sales of BioNTech’s COVID-19 vaccine, referred to as COMIRNATY where approved for use under full or conditional marketing authorization, 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, including changes to the ordering environment and expected regulatory recommendations to adapt vaccines to address new variants or sublineages; 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 timing of initiation, enrollment, and completion of studies or 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 trials, and the registrational potential of any 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; the development, nature and feasibility of sustainable vaccine production and supply solutions; BioNTech’s estimates of revenues, research and development expenses, selling, general and administrative expenses and capital expenditures for operating activities; 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, 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 regarding its COVID-19 vaccine with governmental authorities, private health insurers and other third-party payors; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; competition from other COVID-19 vaccines or related to BioNTech’s other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; 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 and its counterparties’ ability to manage and source necessary energy resources; 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; the impact of COVID-19 on BioNTech’s development programs, supply chain, collaborators and financial performance; 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 BioNTech’s COVID-19 vaccine and, if approved, its product candidates; BioNTech’s ability to manage its development and expansion; regulatory developments in the United States and other countries; 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 Report on Form 6-K for the period ended June 30, 2024 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. 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 RelationsVictoria Meissner, M.D.+1 617 528 8293Investors@biontech.de Media Relations Jasmina Alatovic +49 (0)6131 9084 1513 Media@biontech.de Interim Consolidated Statements of Profit or Loss Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 (in millions €, except per share data) (unaudited) (unaudited) (unaudited) (unaudited) Revenues 128.7 167.7 316.3 1,444.7 Cost of sales (59.8) (162.9) (118.9) (258.9) Research and development expenses (584.6) (373.4) (1,092.1) (707.4) Sales and marketing expenses (12.9) (18.1) (28.5) (30.3) General and administrative expenses (1) (170.9) (119.8) (287.9) (231.6) Other operating expenses (1) (290.8) (77.1) (314.7) (202.8) Other operating income 24.1 20.3 52.4 77.4 Operating income / (loss) (966.2) (563.3) (1,473.4) 91.1 Finance income 167.7 152.4 345.3 208.9 Finance expenses (7.3) (1.3) (9.5) (4.5) Profit / (Loss) before tax (805.8) (412.2) (1,137.6) 295.5 Income taxes (2.0) 221.8 14.7 16.3 Profit / (Loss) for the period (807.8) (190.4) (1,122.9) 311.8 Earnings / (Loss) per share Basic earnings / (loss) for the period per share (3.36) (0.79) (4.67) 1.29 Diluted earnings / (loss) for the period per share (3.36) (0.79) (4.67) 1.28 (1) Adjustments to prior-year figures due to change in functional allocation of general and administrative expenses and other operating expenses. Interim Consolidated Statements of Financial Position June 30, December 31, (in millions €) 2024 2023 Assets (unaudited) Non-current assets Goodwill 372.4 362.5 Other intangible assets 862.3 804.1 Property, plant and equipment 868.6 757.2 Right-of-use assets 256.4 214.4 Other financial assets 1,386.1 1,176.1 Other non-financial assets 108.2 83.4 Deferred tax assets 102.3 81.3 Total non-current assets 3,956.3 3,479.0 Current assets Inventories 340.1 357.7 Trade and other receivables 75.8 2,155.7 Contract assets 3.9 4.9 Other financial assets 6,919.0 4,885.3 Other non-financial assets 359.3 280.9 Income tax assets 206.8 179.1 Cash and cash equivalents 10,376.7 11,663.7 Total current assets 18,281.6 19,527.3 Total assets 22,237.9 23,006.3 Equity and liabilities Equity Share capital 248.6 248.6 Capital reserve 1,232.3 1,229.4 Treasury shares (10.8) (10.8) Retained earnings 18,640.4 19,763.3 Other reserves (1,038.2) (984.6) Total equity 19,072.3 20,245.9 Non-current liabilities Lease liabilities, loans and borrowings 219.3 191.0 Other financial liabilities 42.1 38.8 Provisions 9.0 8.8 Contract liabilities 353.6 398.5 Other non-financial liabilities 77.9 13.1 Deferred tax liabilities 37.8 39.7 Total non-current liabilities 739.7 689.9 Current liabilities Lease liabilities, loans and borrowings 35.3 28.1 Trade payables and other payables 881.5 354.0 Other financial liabilities 146.0 415.2 Income tax liabilities 365.2 525.5 Provisions 363.9 269.3 Contract liabilities 474.3 353.3 Other non-financial liabilities 159.7 125.1 Total current liabilities 2,425.9 2,070.5 Total liabilities 3,165.6 2,760.4 Total equity and liabilities 22,237.9 23,006.3 Interim Consolidated Statements of Cash Flows Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 (in millions €) (unaudited) (unaudited) (unaudited) (unaudited) Operating activities Profit / (Loss) for the period (807.8) (190.4) (1,122.9) 311.8 Income taxes 2.0 (221.8) (14.7) (16.3) Profit / (Loss) before tax (805.8) (412.2) (1,137.6) 295.5 Adjustments to reconcile profit before tax to net cash flows: Depreciation and amortization of property, plant, equipment, intangible assets and right-of-use assets 49.9 31.9 88.2 63.3 Share-based payment expenses 20.2 13.1 36.5 21.7 Net foreign exchange differences (13.2) (397.0) (41.9) (343.9) (Gain) / Loss on disposal of property, plant and equipment (0.2) 0.1 (0.2) 0.3 Finance income excluding foreign exchange differences (167.7) (126.6) (342.6) (208.9) Finance expense excluding foreign exchange differences 4.8 1.3 9.5 2.5 Government grants (3.1) — (12.2) (3.0) Unrealized loss on derivative instruments at fair value through profit or loss(1) 5.0 124.0 6.7 200.2 Working capital adjustments: Decrease in trade and other receivables, contract assets and other assets(1) 1,599.6 4,137.0 2,097.8 5,030.8 Decrease / (Increase) in inventories 5.3 (24.8) 17.6 (9.3) (Decrease) / Increase in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions 760.8 592.7 472.8 (268.9) Interest received and realized gains from cash and cash equivalents 80.8 42.5 280.2 96.1 Interest paid and realized losses from cash and cash equivalents (1.6) (1.3) (5.3) (2.5) Income tax received / (paid), net(1) 66.4 437.3 (192.4) (407.6) Share-based payments (6.8) (31.3) (9.2) (757.0) Government grants received 32.8 — 42.0 — Net cash flows from operating activities 1,627.2 4,386.7 1,309.9 3,709.3 Investing activities Purchase of property, plant and equipment (88.6) (67.2) (147.1) (112.4) Proceeds from sale of property, plant and equipment 0.2 — 0.2 — Purchase of intangible assets and right-of-use assets (52.7) (242.1) (131.1) (251.7) Investment in other financial assets (2,448.2) (1,982.5) (7,343.3) (2,663.1) Proceeds from maturity of other financial assets 2,347.9 — 5,075.5 — Net cash flows used in investing activities (241.4) (2,291.8) (2,545.8) (3,027.2) Financing activities Repayment of loans and borrowings (2.3) — (2.3) — Payments related to lease liabilities (20.6) (9.4) (28.4) (18.7) Share repurchase program — (154.0) — (436.0) Net cash flows used in financing activities (22.9) (163.4) (30.7) (454.7) Net increase / (decrease) in cash and cash equivalents 1,362.9 1,931.5 (1,266.6) 227.4 Change in cash and cash equivalents resulting from exchange rate differences (3.3) 91.2 3.5 64.1 Change in cash and cash equivalents resulting from other valuation effects 40.5 — (23.9) — Cash and cash equivalents at the beginning of the period 8,976.6 12,143.9 11,663.7 13,875.1 Cash and cash equivalents as of June 30 10,376.7 14,166.6 10,376.7 14,166.6 (1) Adjustments to prior-year figures relate to reclassifications within the cash flows from operating activities.

本次以“突破瓶颈 打造健康产业新引擎”为主题，设一场主论坛和八场主题论坛，从前沿创新突破、临床应用拓展、工艺技术优化、商业化开发等多个全新视角推动CGT技术开发与应用，成就健康产业未来。 青黄不接的年纪，难免遇到人生的瓶颈，也许跳脱出产业界，转型做一级市场投资，去更广阔地看看这个行业，看看这片天地，历练一下人生，也不失为一种选择。恰逢朋友推荐了一个机会，我选择转型做投资，更因为没有哪个时刻比当下更适合投资中国创新药。 我有我的理解，也有对中国创新药的期待。而我以我的理解来看，未来生物创新药可能朝向这几个赛道发展。 1 ADC 经历了国内这几年的ADC的发展，国内的biotech的局势分布已经接近明朗，DXD微改的企业，如恒瑞，百利天恒等，豪森也基本贯彻了这条道路，目前已经有了不错的对外BD，百利天恒也取得了不错的进展。其它如exatecan的应用，如普方，百奥泰，信达，普方如今已经被成功收购，信达在CLDN18.2 ADC展现了初步优异的数据。百奥泰爬坡剂量稍低，但目前响应率初步数据，也还算不错。 一级市场中的biotech，除了普方有回报之外，其它公司可以说各有各的困境。 当下的follow式 ADC，已经来到了末尾，如果一味布局跟随微改式的ADC，可能会面临尴尬的局面，因为已经有临床试验证明在经喜树碱治疗后，后续相应机制的ADC效果会削弱。 我们从目前的数据来看，ADC除了在DS8201在HER2阳性乳腺癌等适应症有较为亮眼的数据外，其它适应症以及其它ADC，惊艳度一般，甚至出现PFS获益，OS并不获益的情况。而通常PFS在5-8个月之间。 惊艳度不够，价格高昂，英国国家卫生与临床优化研究所(NICE)与阿斯利康/第一三共为未能就其HER2-ADC药物Enhertu的价格协商达成一致，NICE最终拒绝推荐其在英国用于治疗her2低表达乳腺癌患者。在国内可能也会面临这种局面。 所以，未来降价，联用PD1抑制剂走一线是其必经选择。当然新兴靶点及适应症还有一些机会。 也开始有新的尝试，吉利德在ESMO上公布了双ADC I期联用临床试验初步数据，即Sacituzumab govitecan（SG）与enfortumab vedotin（EV）联用作为二线治疗转移性尿路上皮癌（mUC）的方案，客观缓解率高达71%，具有良好的耐受性，进一步证明不同靶点不同机制的毒素双ADC联用开发，或许也是未来可以选择的一种开发路径。在一定程度上，也增强了双毒素单ADC开发的可能性。 默沙东在clinical trials网站上，登记了一项靶向TROP-2 ADC药物（MK-2870/SKB264）+Nectin-4 ADC药物(Enfortumab Vedotin)+PD-1抗体Pembrolizumab，在晚期尿路上皮癌瘤患者中启动1/2期临床MK-3475-04C/KEYMAKER-U04，编号为NCT06483334，预计将于2024年8月启动，计划入组人数为98例。这都为不同机制ADC联用或者双payloadADC的开发，提供一定的理论基础。 如果双payload ADC能够成功挑战DS8201，那将为ADC开启下一个里程碑，所有的靶点又可以摆到台面，重新被开发，这在未来具有巨大的价值和潜力。也是ADC新的起点。 在我开发ADC的经历中，是发现过不同机制的ADC有协同作用，但要考虑活性的匹配，及未来临床毒性和安全性的问题。linker的改造也可能会在这其中起到很大的作用，解决本身疏水性payload载荷过多导致ADC理化成药性问题。 旧有的跟随式ADC，除了新靶点，新适应症的突破外，如果一味模仿，未来必定尴尬。国内几乎每家都在做，这在未来将是巨大的隐患。所以，探索新的联用方式，以及下一代ADC，可能未来取得突破的关键。 同时，双表位ADC，在我的研发经历中，并没有发现更优的特质。近日，zymeworks也选择终止旗下双表位HER2 ADC，ZW49（zanidatamab zovodotin）的临床开发。对于双抗ADC，也无需过多赞誉和期待，它需要一定的应用背景。如果患者不适合，它可能所获得效果更差。 一定找到合适的定位，才能发挥双抗ADC的优势。 2 白介素的改造 信达的IBI363 (PD-1/IL-2α-bias)，着实亮眼，数据目前呈现也比较扎实，如果成功，将会引领下一代重磅药物的浪潮。而信达IBI363的成功不一定代表其它细胞因子改造的成功。其设计与其它公司的设计采取了相反的策略。但其理论对IBI363改造提供一定理论依据，在肿瘤细胞内有一群肿瘤特异性T细胞（tumor-specific T cells，TSTs）表达CD8，PD1，CD25，α-biased IL-2突变体可以更有效地激活肿瘤特异性T细胞。TSTs高表达CD25，从而可以更好地接收到α-biased IL-2的信号。 同时在外周，"not-α"IL-2能够显著扩增外周T细胞，而α-biased IL-2突变体则更偏向于扩增外周Treg细胞，从而减少IL-2带来的毒性作用。使得α-biased IL-2具有更优的抗肿瘤活性，且安全性更高。这使得IBI363爬坡很高，能够满足PD1抑制剂起效剂量。 3 CD3/41BB多抗 第一代CAR-T，因缺少共刺激信号，如41BB，CD28等，效果极差，后来加上共刺激信号，才成就了如今的CAR-T。这也为CD3，41BB双抗和多抗，提供一定的理论基础。CD28，目前临床数据来看，有很多风险存在，41BB具有更多的可能。 如今对于CD3双抗和41BB双抗的设计均为依赖TAA的T细胞激活，以实现对肿瘤细胞的精准杀伤。所以CD3双抗，并不跟41BB冲突，且存在联用优势。 Englumafusp alfa是罗氏一种双特异性抗体样融合蛋白，可同时靶向B细胞上的CD19，以及T细胞等免疫细胞上的4-1BB，从而引发强烈的共刺激信号，增强和延长细胞活性，增强抗肿瘤活性。Englumafusp alfa在T细胞受体信号存在且严格依赖CD19交联的情况下，通过4-1BB激动作用对T细胞提供强烈的共刺激，与CD20/CD3 T细胞衔接双特异性抗体联用，可以进一步增强后者的抗肿瘤活性。 罗氏正在开展1期临床试验中评估englumafusp alfa与CD20×CD3双特异性抗体格菲妥单抗（glofitamab）联用，治疗复发/难治性非霍奇金淋巴瘤（r/r NHL）患者。 初步研究数据表明，该联合疗法在侵袭性r/r NHL（r/r aNHL）患者中显示出良好的抗肿瘤活性，最佳客观缓解率（BoR）为67.0%，完全缓解（CR）率为57.0%；二线治疗r/r侵袭性NHL患者的BOR为77.0%，CR率为77.0%。此外，联合治疗具有与格菲妥单抗单药相当的安全性和细胞因子释放综合征（CRS）情况。 这将是未来新一代T cell engager改造的机会。 4 自免 长效皮下多抗注射将成为下一代自免抗体药物的主流。2024年3月5日，Apogee Therapeutics公布长效IL-13抗体APG777的一期临床数据，半衰期长达75天，非灵长类研究数据表明：APG777和Lebrikizumab相比，可以更长久抑制pSTAT6水平。 2024年6月13日，明济生物制药（北京）有限公司和艾伯维（纽约证券交易所股票代码：ABBV）共同宣布一项开发FG-M701的许可协议。FG-M701是一种用于治疗炎症性肠病的下一代TL1A抗体，FG-M701通过独特的工程化改造，旨在为炎症性肠病治疗提供更高的疗效并减少给药频率，目前正处于临床前开发阶段。 根据协议条款，艾伯维将获得FG-M701在全球进行开发、生产和商业化的独家许可权。明济生物将获得1.5亿美元的首付款和近期里程碑付款，并有资格获得后续高达15.6亿美元的临床开发、监管注册和商业化里程碑付款，以及高达净销售额低两位数比例的分级特许权使用费。 目前在自免适应症中不同靶点如TNFa，IL23，TLIA等也展现出协同作用，所以未来多抗皮下长半衰期药物，可能会成为设计的主流，同时拥有着巨大的商业前景。 5 小分子及联用ADC 2024年，Revolution pharmaceuticals公布旗下RAS(ON)多选择抑制剂RMC-6236早期临床数据，在KRAS G12X亚型患者中位PFS达8.1个月，任意类型RAS突变达7.6个月，而benchmark仅为2.0-3.5个月。对于KRAS G12X亚型患者，2线治疗RMC-6236中位PFS达8.1个月，3线治疗中位PFS达4.2个月，benchmark相应基线下mPFS仅为2.0-3.5个月和1.9个月。对于KRAS G12X亚型患者，中位OS，RMC-6236未达到，benchmark为6.1-6.9个月。RMC-6236耐受性良好，安全性可控。 目前胰腺癌主要以化疗为主，PFS仅有3个月左右。RMC-6236无疑展现了巨大的市场潜力。 2024年4月5日，阿斯利康在Clinicaltrials.gov网站上注册了三期临床试验TROPION-Lung14，奥希替尼联合或不联合Trop2 ADC新药Dato-DXd一线治疗EGFR突变阳性非小细胞肺癌。 与此同时，阿斯利康也在开展奥希替尼与EGFRxcMET ADC（AZD9592）联用临床，为未来小分子靶向治疗+ADC提供了一定的思路。 未来RAS(ON)多选择抑制剂也或成为未来一线联用ADC重要基石药物。 同时，CD3/CLDN18.2双抗也在胰腺癌中展现了初步的疗效，或许也是RAS(ON)多选择抑制剂联用的一种可能。 RNA药物如今也迎来收获期，2024年8月1日，Alnylam发布二季度财报，二季度产品收入4.1亿美元，同比增长34%，合作收入2.27亿美元，盈利1.38亿美元，今年一季度基本盈亏平衡（盈利200万美元）。国内biotech已在奋起直追。 不可否认，国内biotech面临着种种困难，但庆幸的是当下的生物药研发基本面是非常好的，我们仍然可以找寻机会。出海，将是国内biotech未来的首要目标。 如今转型做投资，我将尽我所能，如果说当下的环境需要带着脚镣跳舞，我尽我所能跳好这支舞。 都说如今不是投资的最佳时期，而我却认为，没有哪个时刻比当下更适合投资中国创新药。 如果我有幸加入到中国生物制药的历程进程中，并参与或主导某一个伟大的企业的创立，那将是我毕生的荣幸。 同写意媒体矩阵，欢迎关注↓↓↓