BioNTech SE Q1 FY2025 earnings call

• Oncology updates: Presented new clinical data for pan-tumor priority programs like BNT327 and mRNA cancer immunotherapies. BNT327 had Phase 2 data in small-cell lung cancer and Phase 1 data in combination with ADC BNT325. mRNA immunotherapies like BNT116 showed synergistic potential with checkpoint inhibition. First BLA submission for BNT323 in oncology. - Acquisition: Closed Biotheus acquisition, gaining global control over BNT327. - Management Board: Announced new CFO Ramón Zapata to join July 2025, current CFO Jens Holstein to retire end of June. - Clinical details: Özlem Türeci discussed BNT327's development in triple-negative breast cancer, small cell and non-small cell lung cancer, including Phase 2 data in small cell lung cancer and Phase 1 data in non-small cell lung cancer. - Financials: Jens Holstein provided Q1 2025 financial results and 2025 guidance, noting revenue range, R&D, SG&A, and CapEx expectations. - Strategic priorities: Ryan Richardson highlighted focus on executing BNT327 and mRNA cancer immunotherapies programs, building oncology commercial capabilities, and maintaining COVID-19 vaccine leadership.

In the first quarter of 2025, BioNTech reported total revenues of approximately €183 million, down from €188 million in Q1 2024. Research and development expenses were €526 million, an increase from €508 million in the prior-year period. SG&A expenses were €121 million, down from €133 million. The net loss was €416 million compared to a net loss of €315 million in the prior-year period. Cash position ended the quarter at €15.9 billion.

• Revenue expected to be in the range of €1.7 billion to €2.2 billion for 2025. - R&D expense expected to be in the range of €2.6 billion to €2.8 billion. - SG&A expense expected to be in the range of €650 million to €750 million. - Capital expenditure expected to be in the range of €250 million to €350 million. - Revenue guidance assumes stable vaccination rates, pricing, and market share; phasing similar to 2024. - Potential impacts from tariffs, public health policy, and vaccine sentiment monitored. - Estimated inventory write-downs and other charges related to COVID-19 vaccine sales in Pfizer territory. - Revenues from service businesses and German Pandemic Preparedness agreement to contribute.

• Potential negative impact on COVID-19 vaccine revenues and expenses from changes in law, government policy, tariffs, and public sentiment. - Uncertainty around the impact of tariffs on the pharmaceutical industry and its implications for clinical trials and research work.

Q: As you prepare for your first launch for endometrial cancer, can you talk to us about how big you think that particular addressable population is? And then, related to that, can you remind us where manufacturing of 327 is expected to take place? And if you expect any impacts from those tariffs?

A: Ryan Richardson stated the second line market in endometrial cancer is about 10,000 patients in the US and Europe. Manufacturing of BNT323 is currently supplied from China, with plans to diversify supply nodes. No significant financial impact from current tariffs anticipated but monitoring policies.

Q: CDC's ACIP is going to have a vote in June on the recommendation of COVID boosters. And my interpretation of their pre-meeting was there is a likelihood that they narrow the US recommendation to a risk base. And I wonder if you could talk about that meeting. What you anticipate the vote will be? And if they do narrow it, what that might -- how that might impact your COVID-19 vaccine sales in the US?

A: Ryan Richardson said they will track the outcome closely. The majority of vaccinations in the US have gone to older 65-plus populations and immunocompromised, and base scenario is around 20% vaccination rates continuing.

Q: On 327, you also highlight potential to kind of combine with other modalities, including ADCs and cell therapies. So, wanted to ask, what are the key factors driving the selections of these specific combinations? And what is the overall kind of rationale for these kind of combinations?

A: Ugur Sahin said the portfolio has three categories suitable for combination therapies: IO pipeline, mRNA vaccines/immunotherapies, and ADC portfolio. Combination with ADCs aims to reduce tumor burden and benefit from immunogenic cell mediated by ADCs while building on bispecific's effects.

Q: Hey, guys. This is [Nishant] (ph) on for Geoff, and thanks for the question. So, on 327, you also highlight potential to kind of combine with other modalities, including ADCs and cell therapies. So, wanted to ask, what are the key factors driving the selections of these specific combinations? And what is the overall kind of rationale for these kind of combinations?

A: Ugur Sahin stated the portfolio has three categories suitable for combination therapies: IO pipeline, mRNA vaccines/immunotherapies, and ADC portfolio. Combination with ADCs aims to reduce tumor burden and benefit from immunogenic cell mediated by ADCs while building on bispecific's effects.

Q: Hi. This is [Karina] (ph) for Asthika. Thanks for taking the question. I have the question on the initial AACR data for BNT327, which was combined with top two ADC. There was notable rate of stomatitis, which included Grade 3 events. How do you plan to manage this toxicity going forward? And was this also observed with other ADCs from DualityBio?

A: Ugur Sahin said the stomatitis rate in the combination was comparable to that of BNT325 alone, with no additional additive toxicity.