Welcome to our dedicated page for BioNTech SE SEC filings (Ticker: BNTX), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Our SEC filing database is enhanced with expert analysis from Rhea-AI, providing insights into the potential impact of each filing on BioNTech SE's stock performance. Each filing includes a concise AI-generated summary, sentiment and impact scores, and end-of-day stock performance data showing the actual market reaction. Navigate easily through different filing types including 10-K annual reports, 10-Q quarterly reports, 8-K current reports, proxy statements (DEF 14A), and Form 4 insider trading disclosures.
Designed for fundamental investors and regulatory compliance professionals, our page simplifies access to critical SEC filings. By combining real-time SEC filing updates, Rhea-AI's analytical insights, and historical stock performance data, we provide comprehensive visibility into BioNTech SE's regulatory disclosures and financial reporting.
BioNTech SE (BNTX) reports that, together with Pfizer, it has received U.S. FDA approval of a supplemental Biologics License Application for the 2026‑2027 COVID‑19 vaccine formula targeting the XFG variant, marketed as COMIRNATY XFG. The vaccine is authorized for adults 65 years and older, and for individuals 5 through 64 years who have at least one underlying condition that places them at high risk for severe COVID‑19 outcomes.
The approval is supported by a cumulative package of clinical, non‑clinical and real‑world data on COMIRNATY’s safety and effectiveness, plus manufacturing and non‑clinical data showing that the XFG‑adapted vaccine generated strong immune responses against circulating SARS‑CoV‑2 variants including XFG, XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1. BioNTech states that shipments for the upcoming season will begin immediately across U.S. pharmacies, hospitals and clinics, and notes that more than five billion doses of COMIRNATY have been distributed globally to date. The companies also highlight extensive safety monitoring and outline numerous forward‑looking risks related to commercial demand, regulatory decisions and competitive dynamics.
BioNTech SE (BNTX) announced that it will present new clinical data from its lung cancer development program at the IASLC 2026 World Conference on Lung Cancer in Seoul from September 12-15, 2026. The presentations will focus on key assets pumitamig (BNT327/BMS986545), gotistobart (BNT316/ONC-392), the B7H3-targeted ADC elfetabart drozuntecan (BNT324/DB-1311), and the mRNA cancer immunotherapy BNT116.
Highlights include first global data for a novel-novel combination of pumitamig, a PD-(L)1xVEGF bispecific immunomodulator, with elfetabart drozuntecan in advanced or metastatic SCLC and NSCLC, and updated overall survival data from stage 1 of the Phase 3 PRESERVE-003 trial of gotistobart in metastatic squamous NSCLC after PD-(L)1 progression. BioNTech reports a diversified lung cancer pipeline with 16 ongoing clinical trials, including five Phase 3 and two novel-novel combination trials.
BioNTech SE reported revenue of €223.7 million for the six months ended June 30, 2026 and a net loss of €1,352.7 million, or €5.34 per share. COVID‑19 vaccine revenue was €118.8 million, down from €286.3 million a year earlier, mainly due to lower dose volumes, while other revenues were largely driven by a German pandemic preparedness contract.
An operating loss of €1,625.6 million reflected higher R&D spending of €1,108.0 million and significant pipeline prioritization charges, including €126.9 million of intangible impairments and €96.1 million of property, plant and equipment impairments tied to manufacturing footprint consolidation. Provisions rose to €293.5 million, including €133.3 million for restructuring. Despite the loss, liquidity remained strong with €9,741.0 million in cash and €16,634.2 million in cash, cash equivalents and security investments. The company repurchased 1,693,056 ADSs for €131.8 million and announced that Guido Oelkers will succeed Prof. Ugur Sahin as CEO by February 1, 2027.
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.