BioNTech SE SEC Filings

BioNTech SE reported sharply lower COVID-19 revenue and larger losses for the three and six months ended June 30, 2026, while advancing its oncology pipeline and updating guidance. Q2 2026 revenue was €105.6 million and net loss €820.8 million, with diluted loss per share of €3.24. First-half revenue was €223.7 million and net loss €1,352.7 million, mainly reflecting reduced demand for COVID-19 vaccines and higher R&D and SG&A spending.

The company cut its 2026 revenue outlook to €1.6–1.9 billion from €2.0–2.3 billion and trimmed adjusted R&D guidance to €2.0–2.3 billion, while keeping adjusted SG&A at €700–800 million. BioNTech ended June with €16.6 billion in cash and investments and has repurchased 1,693,056 ADSs under its up-to-$1.0 billion buyback. It received European Commission approval for an XFG variant-adapted COVID-19 vaccine and now counts 14 ongoing pivotal oncology trials, including for pumitamig, gotistobart and multiple antibody-drug conjugates. The Supervisory Board has appointed Guido Oelkers as next CEO, to take office by February 1, 2027, succeeding Prof. Ugur Sahin.

BioNTech SE announced that its Supervisory Board has appointed Guido Oelkers, Ph.D. to the Management Board as Chief Executive Officer, succeeding Prof. Ugur Sahin, M.D. Oelkers will take office by February 1, 2027 at the latest, following a comprehensive selection process.

Oelkers currently serves as CEO of Swedish Orphan Biovitrum AB, where he more than quadrupled revenues over financial years 2017 to 2026 and strengthened its late-stage pipeline. Prof. Sahin and Chief Medical Officer Prof. Özlem Türeci will transition to manage a new independent company, while BioNTech continues searching for a new CMO.

BioNTech SE’s Amendment No. 2 to its 2025 annual report is described as being filed solely to re-present the complete Item 17 financial statements with Ernst & Young’s audit opinions bearing a corrected date, update EY’s consent, and refresh the most recent practicable share count; it does not modify previously reported financial data or reflect events after March 10, 2026.

For 2025, BioNTech reports revenues of €2,869.9 million and a net loss of €1,136.1 million, compared with a loss of €665.3 million in 2024 and profit of €930.3 million in 2023. Cash and cash equivalents were €7,675.4 million, with total assets of €21,988.6 million and equity of €19,224.2 million as of December 31, 2025. The year includes business combinations such as the Biotheus acquisition for €280.1 million and the CureVac acquisition for €400.1 million, adding significant intangible assets.

EY issues unqualified opinions on both the consolidated IFRS financial statements and internal control over financial reporting as of December 31, 2025, noting critical audit matters around revenue recognition for COVID‑19 collaboration sales and the Bristol Myers Squibb collaboration, legal contingencies, and valuation of acquired intangibles. Internal control work excludes Biotheus Inc. and CureVac B.V., which together represent about 6% of total assets and no 2025 revenue.

BioNTech SE, together with Pfizer, reports that the European Commission has granted marketing authorization for their 2026-2027 COVID-19 vaccine formula targeting the XFG variant, for active immunization of individuals 6 months of age and older.

The authorization, based on EMA Emergency Task Force and CHMP assessments, applies across all 27 EU Member States plus Iceland, Liechtenstein and Norway. Data cited indicate the monovalent XFG-adapted vaccine elicits strong immune responses against multiple contemporary SARS-CoV-2 lineages and maintains a favorable safety and efficacy profile. Pfizer and BioNTech have already begun manufacturing at risk and expect shipments to start soon to support seasonal vaccination campaigns. The partners note that more than five billion doses of their COVID-19 vaccines have been distributed globally and that they have submitted data for the updated vaccine to regulators worldwide.

BioNTech SE filed a Form 3 identifying Iris Katharina Low-Friedrich as a director of the company. The filing reports no insider transactions or holdings, with all transaction counts and share amounts shown as zero.

BioNTech SE director Susanne Schaffert has filed a Form 3, which is an initial statement of beneficial ownership for company insiders. This filing lists her as a director and does not report any stock purchases, sales, or other share transactions.

BioNTech SE has launched a share buyback program for its American Depositary Shares (ADSs) with a total value of up to USD 1.0 billion. The program covers ADSs listed on the U.S. Nasdaq Global Select Market and runs from June 8, 2026 through May 6, 2027.

The company expects to use repurchased ADSs to satisfy obligations in the ordinary course of business, enhance capital efficiency and maintain financial flexibility. The program is carried out under an AGM authorization that permits acquiring up to 10% of share capital, capped at 24.9 million shares, and is structured to comply with EU regulations and U.S. Rules 10b-18 and 10b5-1.

BioNTech and Bristol Myers Squibb reported interim Phase 2 data from the global ROSETTA Lung-02 trial of the investigational bispecific immunomodulator pumitamig plus chemotherapy in previously untreated advanced non-small cell lung cancer.

Among 40 response-evaluable patients with a median follow-up of 9.0 months, pumitamig plus chemotherapy achieved confirmed objective response rates of 57.1% in non-squamous and 68.4% in squamous disease, with a disease control rate of 100%. At the lower evaluated dose, response rates rose to 63.6% and 72.7% respectively, and response rates were high across PD-L1 expression levels, including 100% in patients with PD-L1 TPS ≥ 50%. Safety was described as manageable, with grade ≥ 3 treatment-related adverse events in 48.8% of patients, pumitamig-related in 23.3%, leading to discontinuation in 9.3%. Pumitamig is moving into an extensive Phase 3 program in NSCLC and other tumor types.

BioNTech SE is using the 2026 ASCO Annual Meeting to showcase progress in its late-stage oncology pipeline. The company will present new clinical data and trial updates for key assets, including the bispecific immunomodulator pumitamig and the CTLA-4 antibody gotistobart, plus several antibody-drug conjugate programs.

Interim Phase 2 data from the global Phase 2/3 ROSETTA Lung-02 trial in first-line non-small cell lung cancer showed encouraging anti-tumor activity for pumitamig plus chemotherapy and are informing the ongoing pivotal Phase 3 part. Phase 2 data for gotistobart in heavily pre-treated, platinum-resistant ovarian cancer showed durable anti-tumor activity and clinically meaningful overall survival with a manageable safety profile.

Overall, BioNTech highlights more than 25 Phase 2 and Phase 3 trials, including 13 pivotal studies and multiple novel-novel combination trials across major tumor types, underscoring a broad late-stage oncology strategy spanning immunomodulators, ADCs, and mRNA cancer immunotherapies.