BioNTech Returns to Q3 Profit, Narrows 2026 Revenue Outlook

BioNTech SE (NASDAQ: BNTX) returned to an IFRS profit in the third quarter of 2026 as revenue from its Bristol Myers Squibb partnership supported results, while the company narrowed its full-year revenue outlook by raising the lower end of the range. The biotechnology group also advanced its oncology strategy, including plans to move a pumitamig combination into Phase 3 development.

Revenue totaled €1.29 billion for the quarter, down from €1.52 billion a year earlier. BioNTech reported IFRS operating profit of €125 million, compared with a €47 million operating loss in the third quarter of 2025, while net profit reached €185 million, or €0.73 per diluted share, versus a net loss of €29 million, or €0.12 per share.

On an adjusted, non-IFRS basis, operating profit was €381 million and net profit was €441 million, equivalent to diluted earnings of €1.76 per share. That compared with adjusted operating profit of €734 million and adjusted net profit of €753 million, or €3.11 per diluted share, in the prior-year period.

Quarterly IFRS research and development expenses increased to €748 million from €565 million, reflecting BioNTech’s continued investment in its pipeline. Adjusted R&D expenses were €579 million, up from €479 million. Selling, general and administrative expenses rose to €179 million from €149 million.

For the first nine months of 2026, revenue declined to €1.51 billion from €1.96 billion in the corresponding period of 2025. IFRS R&D spending rose to €1.86 billion from €1.60 billion, while adjusted R&D expenses increased to €1.58 billion from €1.51 billion. SG&A expenses were €527 million, compared with €407 million.

BioNTech recorded a year-to-date IFRS operating loss of €1.50 billion and a net loss of €1.17 billion, or €4.63 per share. The adjusted operating loss was €948 million, while the adjusted net loss was €616 million, or €2.44 per share. As of September 30, the company held €16.16 billion in cash, cash equivalents and security investments.

Revenue outlook narrowed

BioNTech now expects full-year 2026 non-IFRS revenue of €1.7 billion to €1.9 billion, compared with its previous range of €1.6 billion to €1.9 billion. Guidance for adjusted R&D expenses remains unchanged at €2.0 billion to €2.3 billion, while adjusted SG&A expenses are still expected to be between €700 million and €800 million.

The guidance excludes risks that are not yet known or quantifiable and incorporates disclosed effects from licensing arrangements, collaborations and mergers and acquisitions.

Oncology combinations move toward pivotal development

BioNTech highlighted progress in building a multi-product oncology portfolio, with a particular focus on lung and breast cancers. The company said a combination of pumitamig, a PD-L1 and VEGF-A bispecific antibody partnered with Bristol Myers Squibb, and a TROP2-directed antibody-drug conjugate will advance into a global Phase 3 trial in first-line triple-negative breast cancer.

In Phase 1/2 data, pumitamig combined with BNT325 produced a confirmed objective response rate of 76.7% and a disease-control rate of 96.7% among 30 first-line triple-negative breast cancer patients. The planned ROSETTA Breast-01 study, being conducted in collaboration with Gilead, will compare pumitamig plus sacituzumab govitecan with placebo plus sacituzumab govitecan.

BioNTech also presented early data for pumitamig combined with elfetabart drozuntecan, a B7H3-targeted antibody-drug conjugate partnered with DualityBio. The combination generated a 70.4% objective response rate across 71 small-cell lung cancer patients, including 92.3% in 13 first-line patients. The company characterized the safety profile as manageable, with limited overlap between toxicities associated with the two agents, though the findings remain early-stage.

Separately, gotistobart produced median overall survival of 18.5 months, compared with 10 months for docetaxel, in a non-pivotal portion of a Phase 3 study in previously treated squamous non-small cell lung cancer. The result corresponded to a 44% reduction in the risk of death. BioNTech said the observed safety profile was consistent with earlier findings. A pivotal Phase 3 study of gotistobart monotherapy remains underway, with a first interim analysis expected in 2026.

Not all pipeline updates were positive. The Phase 2/3 study of BNT113 in first-line HPV16-positive head and neck cancer did not meet its progression-free survival endpoint at an interim analysis, although the trial is continuing to evaluate overall survival. A Phase 3 primary analysis of trastuzumab pamirtecan in chemotherapy-naive, hormone receptor-positive, HER2-low breast cancer met its progression-free survival endpoint but showed only a modest improvement. BioNTech and DualityBio are also still discussing plans for a potential biologics license application for trastuzumab pamirtecan in HER2-expressing endometrial cancer.

Several expected readouts have shifted because of data maturity, while one first-line microsatellite-stable colorectal cancer readout is no longer expected in 2026 following an increase in the trial’s enrollment target. BioNTech’s clinical plans remain subject to trial execution, data quality, regulatory review and partner participation. The company also identified uncertainty around future COVID-19 vaccine demand, competition, pricing and coverage negotiations, trade-policy developments, manufacturing scale-up and potential safety findings as material risks.