BioNTech SE Q2 FY2025 earnings call

• Ugur welcomed Doug and Ramón, and noted Ryan Richardson's upcoming departure. - Strategy focuses on oncology with priority programs BNT327 (PD-L1/VEGF-A bispecific) and mRNA immunotherapies (FixVac & iNeST). - Collaborated with BMS on BNT327, with global 50-50 co-development and co-commercialization. - Clinically, BNT327 has ongoing trials in multiple cancer types, including small cell lung cancer, non-small cell lung cancer, and triple-negative breast cancer. - Dosed first patients in BNT327 ADC combination studies. - Strengthened mRNA platform via acquisition of CureVac. - Prepared for global commercial rollout of new variant-adapted COVID-19 vaccine. - Expanded partnership with UK govt for R&D of innovative medicines.

For the second quarter of 2025, total revenues were approximately EUR 261 million, compared to EUR 129 million in the second quarter of 2024, driven by higher COVID-19 vaccine collaboration revenues. Research and development expenses were EUR 509 million in Q2 2025 vs. EUR 585 million in the prior year, primarily due to reprioritization of clinical trials. SG&A expense was EUR 138 million in Q2 2025 vs. EUR 184 million in the prior year, mainly from reduced external services. Net loss was EUR 387 million in Q2 2025 vs. EUR 808 million in the prior year. The company maintained a strong financial position with EUR 16 billion in cash plus security investments. The COVID-19 vaccine franchise and oncology programs are key segments, with BNT327 and mRNA immunotherapies being priority pan-tumor programs.

• 2025 revenue guidance: EUR 1.7 billion to EUR 2.2 billion, phasing weighted towards last 3-4 months. - R&D expenses expected: EUR 2.6 billion to EUR 2.8 billion, SG&A: EUR 650 million to EUR 750 million, CapEx: EUR 250 million to EUR 350 million. - Anticipates lower COVID-19 vaccination rates in US but similar market share and pricing. - Anticipates upfront cash payment of USD 1.5 billion from BMS collaboration in 2025, plus up to USD 7.6 billion in milestones. - Development and manufacturing costs with BMS shared 50-50, profits/losses equally shared upon commercialization.

• Risks related to COVID-19 vaccine market dynamics, including shifting policy, international trade, and public sentiment impacting revenues and expenses. - Uncertainties around the impact of regulatory and public health changes on clinical trial progress and commercialization of oncology programs.

Q: About vaccine development, specifically in the US and combination therapies.

A: Ryan Richardson noted COVID-19 vaccine business is a priority, with lower vaccination rates expected but similar market share and pricing assumed. Next-gen vaccines and combinations are being explored.

Q: On BNT327 trial doses and data release.

A: Ozlem Tureci mentioned details on doses for trials later this year, with top line data for small cell lung cancer study to be shared in September.

Q: On BNT327 in frontline TNBC and TROP2 ADC.

A: Ugur Sahin discussed BNT327 in TNBC and the potential of TROP2 ADC in combo with PD-1.

Q: On R&D spend evolution post BMS deal.

A: Ramón Zapata-Gomez said R&D spend will increase for priority programs like BNT327, mRNA immunotherapies, and ADCs.

Q: On FixVac's melanoma trial and ESMO presentation.

A: Ozlem Tureci said ESMO will present efficacy data for BNT111, including objective response rate, OS, and safety data.

Q: On competition for BNT327 vs Pfizer's asset.

A: Ugur Sahin stated the mechanism of BNT327 is more complex and will be presented in detail later, emphasizing synergistic activities in the tumor microenvironment.