BioNTech (BNTX) Q1 2025 Earnings Call May 05, 2025 08:00 AM ET Company Participants Michael Horowicz - Director - IRUgur Sahin - Co-Founder, CEO & Chair of the Management BoardÖzlem Türeci - Co-Founder, Chief Medical Officer & Member of Management BoardJens Holstein - CFORyan Richardson - Chief Strategy OfficerAkash Tewari - Managing DirectorCory Kasimov - Senior Managing DirectorMohit Bansal - Managing DirectorKarina Rabayeva - VP - Biotech Equity ResearchHarry Gillis - Vice President - Pharmaceuticals Equ ...

Financial Data and Key Metrics Changes - In Q1 2025, total revenues were approximately €183 million, a slight decrease from €188 million in Q1 2024, reflecting expected seasonality in the COVID-19 vaccine market [26] - Research and development expenses increased to €526 million from €508 million in the prior year, driven by late-stage clinical studies [26] - The net loss for Q1 2025 was €416 million, compared to a net loss of €350 million in the same period last year, with a basic and diluted loss per share of €1.73 versus €1.31 [27][28] Business Line Data and Key Metrics Changes - The oncology segment is advancing with multiple clinical trials, including BNT327, which is being developed for various cancer types, including triple-negative breast cancer and small cell lung cancer [14][15] - The COVID-19 vaccine franchise remains a significant revenue driver, with preparations for a variant-adapted vaccine for the upcoming season [8] Market Data and Key Metrics Changes - The addressable market for the second-line endometrial cancer treatment is estimated at around 10,000 patients in the US and Europe, indicating a sizable opportunity [41] - The company anticipates stable vaccination rates and market shares for its COVID-19 vaccine, with revenue guidance for 2025 expected to be between €1.7 billion and €2.2 billion [30][31] Company Strategy and Development Direction - The company aims to become a fully integrated biopharmaceutical company with a focus on oncology, particularly through the development of BNT327 and mRNA cancer immunotherapies [28][36] - There is a strong emphasis on combination therapies to improve treatment outcomes across various cancer types, with ongoing investments in clinical development and commercialization capabilities [12][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of their oncology pipeline to establish new standards of care and improve patient outcomes [12][25] - The company is closely monitoring regulatory changes and public sentiment regarding COVID-19 vaccines, which could impact future revenues [31][56] Other Important Information - The company announced a new Chief Financial Officer, Ramon Sapater, who will take over in July 2025, as current CFO Jens Holstein prepares for retirement [10][34] - The company is diversifying its manufacturing supply base for BNT323, currently reliant on a China-based CDMO, to mitigate risks associated with tariffs [41][44] Q&A Session Summary Question: What is the addressable population for endometrial cancer? - The estimated second-line market in endometrial cancer is about 10,000 patients in the US and Europe [41] Question: How do you see the NSCLC market evolving in five years? - Both bispecifics and ADCs will play a role in the NSCLC market, with the expectation that clinical benefit thresholds will evolve over time [50][72] Question: What impact do you anticipate from the CDC's upcoming vote on COVID boosters? - The company expects the market is already oriented towards a risk-based vaccination approach, with a base scenario of around 20% vaccination rates continuing [55] Question: Can you elaborate on the Phase II and Phase III trial timelines for BNT327? - The Phase II portion of the Rosetta trial will be completed later this year, with data to inform the Phase III portion [87] Question: How do you plan to manage toxicity observed in initial data for BNT327? - The stomatitis rate in combination with TROP-two ADC was comparable to that observed with BNT325 alone, indicating no additional additive toxicity [94]

Exhibit 99.1 Our principal executive offices are located at An der Goldgrube 12, D-55131 Mainz, Germany. Our telephone number is +49 6131- 9084-0. Our website address is www.biontech.com. The information contained on, or that can be accessed through, our website is not part of this document. Our agent for service solely for the purpose of notices and communications from the Securities and Exchange Commission in the United States is c/o BioNTech US Inc., 40 Erie Street, Suite 110, Cambridge, Massachusetts 02 ...

BioNTech仍预计全财年营收17亿-22亿欧元，市场预估20.4亿欧元。 BioNTech仍预计今年的资本支出2.5亿欧元-3.5亿欧元。 BioNTech一季度营收1.828亿欧元，市场预估1.871亿欧元。 一季度每股亏损1.73欧元，市场预估每股亏损2.2欧元。 ...

Core Viewpoint - BioNTech SE expects its research and development expenditure for the current fiscal year to be between €2.6 billion and €2.8 billion, aligning closely with market expectations of €2.7 billion [1] Summary by Category - **Company Financials** - The projected R&D spending for BioNTech SE is set between €2.6 billion and €2.8 billion for the fiscal year [1]

BioNTech SE(BNTX.O)一季度营收为1.828亿欧元，一季度EPS为-1.73欧元。 ...

Core Insights - BioNTech reported a net loss of €415.8 million for Q1 2025, compared to a net loss of €315.1 million in Q1 2024, indicating a significant increase in losses year-over-year [3][7][10] - Revenues for Q1 2025 were €182.8 million, a decrease from €187.6 million in the same period last year, primarily driven by COVID-19 vaccine collaboration [3][10] - The company maintains a strong financial position with €15.9 billion in cash, cash equivalents, and security investments as of March 31, 2025 [8][9] Financial Review - Revenues for Q1 2025: €182.8 million, down from €187.6 million in Q1 2024 [3] - Net loss for Q1 2025: €415.8 million, compared to €315.1 million in Q1 2024 [7] - Basic and diluted loss per share: €1.73 for Q1 2025, up from €1.31 in Q1 2024 [9] - Cost of sales increased to €83.8 million in Q1 2025 from €59.1 million in Q1 2024 [4] - R&D expenses rose to €525.6 million in Q1 2025 from €507.5 million in Q1 2024, driven by late-stage clinical studies [5] - SG&A expenses decreased to €120.6 million in Q1 2025 from €132.6 million in Q1 2024 [6] Corporate Strategy and Outlook - BioNTech is focusing on advancing its oncology pipeline, particularly the bispecific antibody candidate BNT327 and mRNA cancer immunotherapies [8][17] - The company confirmed its financial guidance for 2025, expecting revenues between €1,700 million and €2,200 million, with a similar revenue phasing to 2024 [10][11] - Planned R&D expenses for 2025 are estimated between €2,600 million and €2,800 million, with SG&A expenses projected at €650 million to €750 million [11] Clinical Development Updates - BioNTech presented multiple clinical updates for its oncology pipeline, including promising data for BNT327 in combination with antibody-drug conjugates [8][19] - Preliminary data from ongoing trials indicate anti-tumor activity and manageable safety profiles for BNT327 in various cancer indications [18][19] - The company is preparing for the 2025/2026 season variant-adapted COVID-19 vaccine [8][26] Management Changes - Ramón Zapata-Gomez has been appointed as the new CFO effective July 1, 2025, succeeding Jens Holstein [26]

Core Insights - BioNTech SE has appointed Ramón Zapata-Gomez as Chief Financial Officer (CFO) effective July 1, 2025, succeeding Jens Holstein who will retire on June 30, 2025 [1][2][3] Company Leadership Transition - Ramón Zapata will focus on aligning BioNTech's financial direction with its strategy to become a multi-product company in oncology, optimizing financial infrastructure and performance in key markets [2][3] - Jens Holstein expressed gratitude for his tenure and highlighted BioNTech's growth into a leading global biotechnology company [3] Ramón Zapata's Background - Ramón Zapata brings over 25 years of experience in the pharmaceutical and consumer goods industries, having held leadership roles at Novartis AG, Sandoz AG, and Mondelēz International [3][4] - He has a strong track record in finance functions, overseeing M&A transactions, and driving digital finance transformations [3] BioNTech Overview - BioNTech is a global next-generation immunotherapy company focused on developing novel therapies for cancer and other serious diseases, with a diverse portfolio of oncology product candidates [5][6] - The company is leveraging its expertise in mRNA development and manufacturing capabilities to research and develop multiple mRNA vaccine candidates for infectious diseases alongside its oncology pipeline [5]

Core Viewpoint - The vaccine sector is experiencing a decline in stock prices following reports of a significant policy change by the FDA, which will require all new vaccines to undergo placebo-controlled clinical trials before approval [1][2]. Group 1: Market Reaction - Major vaccine companies such as GSK, Sanofi, Merck, AstraZeneca, Pfizer, BioNTech, Moderna, and Novavax have seen stock declines ranging from over 1% to more than 3.7% [1]. - Specifically, Moderna's stock dropped over 3.7%, while BioNTech fell more than 2.5% [1]. Group 2: Regulatory Changes - The FDA plans to implement a new policy requiring all new vaccines to include a placebo group in clinical trials, marking a significant shift in the vaccine approval process [1]. - This policy mandates that new vaccines must undergo safety testing with a control group receiving an inactive substance, such as saline, for comparison [1]. Group 3: Scope of the New Policy - There is uncertainty regarding the definition of "new vaccines," but it is reported that the policy is unlikely to apply to flu vaccines, which have a long-established safety record [2]. - The HHS has not clarified whether vaccines that have already completed safety studies will be subject to re-evaluation under this new policy, focusing mainly on COVID-19 vaccines in their response [2].

Core Viewpoint - The biotech sector, particularly companies involved in monoclonal antibody cancer therapies, experienced significant stock price volatility due to competitive developments, particularly the FDA approval of Akeso's cancer drug [1][2]. Group 1: Company Developments - Summit Therapeutics saw its shares drop by 36.1% following the news of Akeso's FDA approval, despite having positive phase 3 trial data for ivonescimab [1][5]. - BioNTech's shares fell by 15.4%, likely influenced by the competitive landscape as Akeso's drug received approval while BioNTech's drugs remain in late-stage trials [1][7]. - Akeso's penpulimab-kcqx received FDA approval for treating nasopharyngeal carcinoma, and ivonescimab was approved in China for PD-L1-positive non-small cell lung cancer [3][4]. Group 2: Competitive Landscape - Akeso's approval of its cancer drugs has created a competitive challenge for Summit, especially since Akeso holds rights to ivonescimab in China [4][5]. - The approval of Akeso's drugs may allow it to explore additional cancer treatments, potentially impacting Summit's market position [6]. - The rapid developments in the bispecific antibody space highlight the intense competition and uncertainty in the biotech industry, affecting investor sentiment towards companies like Summit and BioNTech [8].