BioNTech's Q3 2025: Contradictions Emerge on R&D Strategy, BNT327 Trials, and BLA Timelines

Date of Call: November 3, 2025

Financials Results

• Revenue: EUR 1.519 billion, up from EUR 1.245 billion prior year; includes recognition of USD 700 million from BMS in Q3 2025
• EPS: EUR (0.12) basic & diluted loss per share vs prior-year basic EPS EUR 0.82 and diluted EPS EUR 0.81

Guidance:

• 2025 revenue guidance increased to $2.6B–$2.8B (prior $1.7B–$2.2B), driven by BMS collaboration recognition of USD 700M.
• R&D expense guidance lowered by EUR 600M to EUR 2.0B–2.2B, reflecting phasing and portfolio prioritization.
• SG&A guidance reduced by $100M to $550M–$650M.
• Capital expenditures for operating activities reduced to $200M–$250M.
• Company expects to report a net loss in 2025 while investing in oncology transition.

Business Commentary:

* Revenue Growth and COVID-19 Vaccine Sales: - BioNTech reported revenue of $1.519 billion for Q3 2025, driven by USD 700 million from the BMS collaboration. - Revenue growth was primarily from the BMS collaboration, with COVID-19 vaccine sales stable but lower than previous years.

• Research & Development Expenses and Strategic Focus:
• Research and development expenses were approximately EUR 565 million, slightly higher than the previous year.

• The increase is due to the initiation of late-stage trials, but expenses are also being managed through active portfolio prioritization.

• Pumitamig's Clinical Progress:

• BioNTech advanced Pumitamig, especially in lung cancer trials, with enrollment for global registrational trials progressing.

• This is part of their strategy to establish Pumitamig as a standard of care across various tumor types.

• mRNA Cancer Immunotherapy Updates:

• BioNTech presented data from Phase II trials for BNT111 and Autogene cevumeran in melanoma and lung cancer.
• The trials show potential in adjuvant settings, where tumor burden is low, suggesting efficacy and highlighting the role of AI in drug development.

Sentiment Analysis:

Overall Tone: Positive

• Management highlighted strong clinical progress (advance of multiple Phase II/III programs and locked Phase III dose for Pumitamig), raised 2025 revenue guidance to $2.6B–$2.8B, and reported EUR 16.7B cash balance enabling oncology investment; CFO also signaled disciplined cost management via lower R&D/SG&A guidance.

Q&A:

• Question from Tazeen Ahmad (BofA Securities): How are you thinking about the market opportunity for MSS CRC and first-line gastric cancer and how your product can be differentiated from current treatments?
  Response: VEGF‑A + PD‑L1 bispecific has a strong biological rationale and the company believes this combination can improve clinical benefit in MSS colorectal and first‑line gastric cancer.

• Question from Terence Flynn (Morgan Stanley): Can you share more color on the delay in the BLA filing for BNT323 (gating factors)? And does the new R&D guidance reflect BNT327 expenses assumed by BMS or other prioritizations?
  Response: R&D guidance reduction reflects phasing and prioritization (not a cut to BNT327 spend); BNT323 BLA timing shifted into 2026 due to ongoing FDA discussions and need for additional follow‑up/analyses.

• Question from Daina Graybosch (Leerink Partners): Why pursue Establish/Expand/Elevate sequential approach for Pumitamig instead of simultaneous multi‑arm Phase IIIs with ADC combos to leapfrog competitors?
  Response: The three‑wave activities run in parallel but chemo‑based combinations are prioritized for speed to start and be first to market, while ADC combination data are being generated concurrently to inform later pivotal choices.

• Question from Nick Jennings (Goldman Sachs) on behalf of Asad: With the TNBC Phase III initiating, what Phase II details will you present at SABCS and will they increase confidence in Phase III success?
  Response: They will present additional Phase II efficacy, safety and dose data at SABCS to inform Phase III planning.

• Question from Manoj Eradath (Jefferies) for Akash: Given recent changes in analyses in other trials, is ROSETTA‑02 sufficiently powered for PFS/OS and will you change trial design?
  Response: Management continuously reevaluates statistical analysis plans as new data emerge and will review ROSETTA‑02 in light of relevant external updates.

• Question from Yaron Werber (TD Cowen): Will you file BNT323 for breast cancer next year or is endometrial still the first submission; what was FDA feedback?
  Response: Endometrial remains the planned first submission but has been pushed into 2026 due to pre‑BLA discussions and follow‑up analyses; the breast cancer Phase III is ongoing with readout later in 2026.

• Question from Mohit Bansal (Wells Fargo): KOLs note bispecifics may be stronger VEGF inhibitors but not necessarily PD‑1; how important is PD‑1 potency for observed PFS/OS signals?
  Response: Management's confidence in the bispecific class is increasing—preclinical data show robust dual activity, PD‑L1 targeting aids tumor‑microenvironment delivery, and clinical signals show PFS benefit with improving durability, but Phase III data remain decisive.

• Question from Malcolm Hoffman (BMO) for Evan: How much of the guidance change reflects stronger COVID results versus BMS collaboration or UK government agreements?
  Response: The revenue guidance uplift is mainly driven by the BMS collaboration recognition; the COVID business is performing in line with expectations and remains broadly unchanged versus prior assumptions.

• Question from Mario Joshua Chazaro Cortes (Evercore ISI): Did you see compelling clinical data to move Pumitamig into gastric cancer or was the decision mechanistic?
  Response: Decision based on emerging clinical signals of responses with chemotherapy and a validated mechanistic rationale for combining anti‑angiogenic and PD‑1/PD‑L1 approaches in gastric cancer.

• Question from Jay Olson (Oppenheimer): Describe the governance with Bristol‑Myers Squibb—who decides and who leads new trials?
  Response: Governance is via a joint steering committee; decisions are collaborative and both partners can initiate combination trials, providing flexibility to run various studies independently or together.

Contradiction Point 1

R&D Spend and Strategy

It involves changes in R&D spending priorities and allocation, which are crucial for understanding the company's strategic focus and resource allocation.

What caused the delay in the BNT323 BLA filing? How does the new R&D guidance account for Bristol-Myers covering part of the BNT327 expenses? - Terence Flynn (Morgan Stanley)

2025Q3: We'll increase investments in priority programs like BNT327 and mRNA cancer immunotherapies. R&D spending outside these areas is expected to decrease. - Ramón Zapata-Gomez(CFO)

How will R&D spending evolve after the BMS collaboration, and how will you allocate future expenses? - Cory William Kasimov (Evercore)

2025Q2: Naturally, we will also increase investment in those programs that are progressing especially well. In other areas, we expect to see a decline in investment. - Ramón Zapata-Gomez(CFO)

Contradiction Point 2

BNT327 Trial and Indication Strategy

It involves the strategic decisions and timing for BNT327 trials and indications, which are critical for the company's development pipeline and market positioning.

Can you explain the governance structure and decision-making process in the BMS collaboration? - Asad Haider (Goldman Sachs)

2025Q3: We expect to move ahead in all these indications in the coming weeks. - Özlem Türeci(CMO)

Has the FDA’s willingness to accept Chinese data changed under new regulations for BNT327 and ADCs? Can you meet Project Optimus requirements soon? - Akash Tewari (Jefferies)

2025Q2: We're discussing and finalizing approvals for 327 trials with the FDA, including both Chinese and Western data. Within weeks, we expect to satisfy requirements and proceed with the go-forward Phase III doses. - Özlem Türeci(CMO)

Contradiction Point 3

BNT323 BLA Filing Timeline

It involves the timeline for BLA submission, which is crucial for regulatory milestones and market expectations.

What is the timeline for submitting the BNT323 BLA and what specific data is required for the submission? - Yaron Werber (TD Cowen)

2025Q3: However, the strategy remains unchanged for both indications (breast and endometrial cancer). - Özlem Türeci(CMO)

What are your thoughts on the second-line EGFR mutant indication for 327, and for 323 in second-line endometrial cancer, what data are expected this year, and what endpoints will support accelerated approval? - Yaron Werber(TD Cowen)

2025Q1: The BLA submission for BNT323 is now expected to be submitted in the third quarter of '25. - Ugur Sahin(CEO)

Contradiction Point 4

ROSETTA Lung-02 Trial Timeline

It involves the timeline for the ROSETTA Lung-02 trial, which is crucial for the development and market approval of BNT327.

When will Phase 2 of the ROSETTA Lung-02 study conclude, and will it proceed formally to Phase 3? - Mohit Bansal (Wells Fargo)

2025Q3: The Phase 2 portion of ROSETTA Lung-02 will be completed later this year, with data to inform the Phase 3 portion, which is expected to start this year. - Özlem Türeci(CMO)

What doses are being studied in the Phase 2 portion of the ROSETTA Lung-02 trial, and when will Phase 2 data be available? - Terence Flynn (Morgan Stanley)

2025Q1: We expect to see some data later this year or early next year. - Özlem Türeci(CMO)

Contradiction Point 5

BNT323 BLA Filing Timeline

It directly impacts the regulatory and approval timeline for a key product, which could affect the company's future revenue and market strategy.

What caused the delay in BNT323's BLA filing? How does the new R&D guidance account for Bristol-Myers covering some BNT327 expenses? - Terence Flynn(Morgan Stanley)

2025Q3: The delay in BNT323 BLA submission is due to ongoing discussions with the FDA to further understand additional data needs, with plans to submit in 2026. - Özlem Türeci(CMO)

Can you provide an update on the timing and data readouts for BNT323, BNT326, and BNT327? - Matthew Harrison(Morgan Stanley)

2024Q4: BNT323 and BNT326 are on track for BLA submissions in 2025. - Ugur Sahin(CEO)