BioNTech SE Q1 FY2026 earnings call

BioNTech has three priorities in 2026: accelerate late-stage development of oncology assets, build momentum in combination therapy centered around Pumitamic, and shift to tumor-centric clinical development. Highlights in lung cancer: phase 1 B2A data of Pumitamic monotherapy in advanced NSCLC, collaboration with Boehringer Ingelheim for small cell lung cancer, and progress of Gotistobat in squamous NSCLC. In gynecologic cancers, updated data of TPAM in endometrial cancer. mRNA immunotherapies: data from autogen-savumaran and FIGSVAC trials

First quarter 2026 revenues were €118 million, down from €183 million in the same period last year. R&D expenses were €557 million compared to €526 million in the prior year period, driven by higher spending on oncology and ADC programs. SD&A expenses were €151 million compared to €121 million in the prior year period, mainly due to commercial buildup and post-acquisition inclusion of operations from BioNTech China and CureVac

Reaffirms 2026 financial guidance: total revenues expected in range of $2 to $2.3 billion, adjusted R&D expenses $2.2 to $2.5 billion, adjusted SG&A expenses $700 to $800 million. Plans $1 billion share repurchase program and manufacturing network consolidation for cost savings

Forward-looking statements subject to significant risks and uncertainties, including regulatory, market, and clinical trial outcomes

Q: Dana Graybosh asked about statistical design change in Rosetta Lung 02.

A: Changed to PFS as primary endpoint to allocate full alpha on well-accepted endpoint for NSCLC.

Q: Jessica Five asked about differentiation of TPAM in Dynasty Breast O2.

A: Primary endpoint is objective response rate and duration of response, TPAM is strategic asset.

Q: Tazin Ahmad asked about expectations for PUMI plus chemo data at ASCO.

A: Data from phase two part shows efficacy and safety profile.

Q: Akash Tiwari asked about Harmony 3 impact on Rosetta Lung trials.

A: Harmony 3 interim analysis uninformative, no change to strategy.

Q: David Day asked about regulatory pathway with PFS as primary.

A: PFS is earliest and largest endpoint, overall survival is secondary.

Q: Asad Haider asked about capital allocation and revenue progression.

A: Capital allocation supports pipeline and share repurchase, revenue guidance reaffirmed.

Q: Terrence Flynn asked about CEO search and TPAM FDA discussions.

A: CEO search led by supervisory board, TPAM in discussion with FDA.

Q: Evan Seigerman asked about profile of new executive team.

A: Skills in late stage development and commercialization.

Q: Corey Casimov asked about competitor data impact on bar.

A: Competitor data validation, China study not directly translatable.

Q: Mohit Bansal asked about China vs global data confidence.

A: Some data sets show reproducibility.

Q: Yaron Werber asked about catalyst timings and Pumitamic indications.

A: Data readouts on Pumitamic over next 12-18 months, aligned with BMS.

Q: Jeff Meacham asked about TPAM data maturation and HER2 label.

A: No outstanding data requests, goal for broad HER2 label.

Q: Harry Gillis asked about catalyst timings for Gotistobat and FIXVAC.

A: Interim readouts in second half of 2026, positive results documented if achieved