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BioNTech Announces Fourth Quarter and Full Year 2025 Financial Results and Corporate Update

On March 10, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported financial results for the three months and full year ended December 31, 2025 and provided an update on its corporate progress.

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"2025 was a year of strong execution and pipeline momentum, marked by substantial progress in delivering on our strategy. We advanced our oncology pipeline by moving multiple programs into late-stage development and initiated trials assessing novel-novel combination approaches with the aim of delivering differentiated therapeutic profiles," said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "With our unique pipeline and strong financial position, we remain committed to leveraging our pioneering position in the immuno-oncology space with next-generation agents designed to elevate outcomes for patients with cancer. 2026 is poised to be a pivotal year with multiple readouts expected across our portfolio, representing a significant step toward our objective of becoming a multi-product company by 2030."

Financial Review for Fourth Quarter and Full Year 20253

in millions €,
except per share data Full Year 2025 Full Year 2024
IFRS Results Adjusted Results3 IFRS Results Adjusted Results3
Revenues 2,869.9 2,869.9 2,751.1 2,751.1
Net profit / (loss) (1,136.1) (117.1) (665.3) 121.7
Diluted earnings / (loss) per share (4.70) (0.48) (2.77) 0.50

in millions €,
except per share data Fourth Quarter 2025 Fourth Quarter 2024
IFRS Results Adjusted Results3 IFRS Results Adjusted Results3
Revenues 907.4 907.4 1,190.0 1,190.0
Net profit / (loss) (305.0) (79.5) 259.5 432.4
Diluted earnings / (loss) per share (1.25) (0.33) 1.08 1.79

Revenues for the three months ended December 31, 2025 were €907.4 million, compared to €1,190.0 million for the comparative prior year period. For the year ended December 31, 2025, revenues were €2,869.9 million, compared to €2,751.1 million for the comparative prior year period. The quarterly year-on-year decrease was primarily driven by lower sales of the Company’s COVID-19 vaccines due to reduced market demand. The full year revenue increase was primarily driven by revenues related to BioNTech’s collaboration with Bristol Myers Squibb Company ("BMS") that were recognized in the third quarter of 2025.

Research and development ("R&D") expenses were €505.4 million for the three months ended December 31, 2025, compared to €611.8 million for the comparative prior year period. For the year ended December 31, 2025, R&D expenses were €2,104.9 million, compared to €2,254.2 million for the comparative prior year period. Both quarterly and full year year-on-year decreases were mainly driven by cost savings resulting from active portfolio management and positive effects resulting from our pumitamig cost sharing with BMS, partly offset by the acceleration of late-stage trials for immuno-oncology ("IO") and antibody-drug conjugate ("ADC") development programs.

Adjusted R&D expenses were €505.4 million for the three months ended December 31, 2025, compared to €530.3 million for the comparative prior year period. For the year ended December 31, 2025, adjusted R&D expenses were €2,019.5 million, compared to €2,172.7 million for the comparative prior year period. For 2025 and 2024, the Company’s adjusted R&D expenses exclude impairments.

Sales, general and administrative ("SG&A") expenses7 were €217.9 million for the three months ended December 31, 2025, compared to €132.1 million for the comparative prior year period. For the year ended December 31, 2025, SG&A expenses were €624.4 million, compared to €599.0 million for the comparative prior year period. Both quarterly and full year year-on-year increases were mainly driven by our ongoing commercial build-up, partly offset by lower costs for external services.

Other operating result was negative €173.6 million during the three months ended December 31, 2025, compared to negative €54.0 million for the comparative prior year period. For the year ended December 31, 2025, other operating result was negative €903.7 million compared to negative €670.9 million for the prior year period. Both quarterly and full year year-on-year decreases were primarily driven by expenses from settlements of contractual disputes, expenses in connection with our pipeline prioritization and foreign exchange differences.

Adjusted other operating result was €21.4 million during the three months ended December 31, 2025, compared to negative €1.6 million for the comparative prior year period. For the year ended December 31, 2025, other operating result was negative €0.6 million compared to negative €13.5 million for the prior year period. For fiscal years 2025 and 2024, our quarterly and full year adjusted other operating results exclude expenses in connection with the settlements of legal proceedings. In addition, our quarterly and full year adjusted other operating results during fiscal year 2025 exclude employee-related costs in connection with our pipeline prioritization and a bargain purchase.

Net loss was €305.0 million for the three months ended December 31, 2025, compared to a net income of €259.5 million for the comparative prior year period. For the year ended December 31, 2025, net loss was €1,136.1 million, compared to a net loss of €665.3 million for the comparative prior year period.

Adjusted net loss was €79.5 million for the three months ended December 31, 2025, compared to an adjusted net profit of €432.4 million for the comparative prior year period. For the year ended December 31, 2025, adjusted net loss was €117.1 million, compared to an adjusted net profit of €121.7 million for the comparative prior year period.

Diluted loss per share was €1.25 for the three months ended December 31, 2025, compared to diluted earnings per share of €1.08 for the comparative prior year period. For the year ended December 31, 2025, diluted loss per share was €4.70, compared to diluted loss per share of €2.77 for the comparative prior year period.

Adjusted diluted loss per share was €0.33 for the three months ended December 31, 2025, compared to adjusted diluted earnings per share of €1.79 for the comparative prior year period. For the year ended December 31, 2025, adjusted diluted loss per share was €0.48, compared to adjusted diluted earnings per share of €0.50 for the comparative prior year period.

Cash, cash equivalents and security investments as of December 31, 2025 were €17,235.6 million, comprising €7,675.4 million in cash and cash equivalents, €7,158.5 million in current security investments disclosed as financial assets and €2,401.7 million in non-current security investments disclosed as financial assets.

Shares outstanding as of December 31, 2025 were 251,325,340, excluding 7,702,147 shares held in treasury.

"Our strong financial position fuels and de-risks our R&D activities as we prepare for multiple product launches in the coming years. Our financial discipline, active portfolio management and targeted investments will continue to drive innovation and create long-term value for BioNTech’s stakeholders," said Ramón Zapata, Chief Financial Officer at BioNTech.

2026 Financial Year Guidance6:

Revenues for the 2026 financial year €2,000 – €2,300 m

In 2026, BioNTech anticipates lower COVID-19 vaccine revenues compared to 2025, driven by declines in both the European and United States markets. The United States continues to be a competitive and dynamic market, where as a result, lower revenues are expected. In Europe, we expect lower revenues as we defend our market share and begin managing the transition of multi-year contracts. In Germany, specifically, BioNTech recognizes direct sales of its COVID-19 vaccines as revenue. Hence, the anticipated declines in the Company’s sales of COVID-19 vaccines in the country will have a direct impact on its topline, whereas revenues outside of Germany only affect the Company’s topline as part of the 50% gross profit split with our partner Pfizer Inc. ("Pfizer"). Per the outlined partnership terms, revenues from the collaboration with BMS in 2026 are expected to be broadly in line with 2025. Revenues from the pandemic preparedness contract with the German government and service businesses are expected to remain stable.

Planned 2026 Financial Year Adjusted Expenses6:

Adjusted R&D expenses €2,200 – €2,500 m
Adjusted SG&A expenses €700 – €800 m

BioNTech will continue to focus investments on R&D and scaling the business for late-stage development and commercial readiness in oncology, while remaining cost-disciplined. Strategic capital allocation will continue to foster innovation and be a key driver of the Company’s trajectory. As part of BioNTech’s strategy, the Company may continue to evaluate appropriate corporate development opportunities with the aim of driving sustainable long-term growth and creating future value.

The full audited consolidated financial statements as of and for the year ended December 31, 2025, can be found in BioNTech’s Annual Report on Form 20-F filed today with the U.S. Securities and Exchange Commission ("SEC") and available at www.sec.gov.

(Press release, BioNTech, MAR 10, 2026, View Source [SID1234663411])

BioNTech and Co-Founders Announce Plan to Pursue Next-Generation mRNA Innovations in Co-Founders-Led New Company as BioNTech Advances Toward Becoming a Multi-Product Company by 2030

On March 10, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported plans for an independent company to be established and led by BioNTech co-founders Prof. Ugur Sahin, M.D., and Prof. Özlem Türeci, M.D. The new company with distinct resources, operations and funding options, will advance next-generation mRNA innovations. BioNTech plans to contribute related rights and mRNA technologies to the new company to enable and support the prioritized development of next-generation mRNA innovations with disruptive potential. With both companies focusing on their respective strategic priorities, BioNTech expects to maximize value for patients and shareholders alike.

BioNTech is sharpening its strategic focus on the development and commercialization of its growing late-stage pipeline spanning innovative immunomodulator, antibody-drug conjugate ("ADC") and mRNA candidates. Its current clinical pipeline, including previously announced milestones and the COVID-19 vaccine franchise, remains unaffected by the plans for the new company: BioNTech expects to have 15 ongoing Phase 3 clinical trials in oncology by year end. 2026 will also be the first year in which the Company expects multiple late-stage data readouts across major cancer types. The clinical trials and resulting data will inform regulatory and launch plans.

Ugur Sahin and Özlem Türeci will transition into the management of their new company by the end of 2026 after their current service agreements end. BioNTech’s Supervisory Board has initiated an executive search to identify successors for the positions to ensure a smooth transition and seamless execution of BioNTech’s strategy.

"Over the past 18 years, we have built BioNTech from a start-up into a global biopharmaceutical company with a strong and diversified pipeline. During the COVID-19 pandemic, we expanded beyond oncology to develop the first approved mRNA vaccine, helping to protect people worldwide. Today, the company is well positioned to advance its mission and evolve into a commercial multi-product company. None of this would have been possible without the extraordinary dedication of our teams, the trust of our shareholders and Supervisory Board, and the commitment of the partners who have supported us along the way. For us, this is the right time to prepare to hand over the baton," said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "At the same time, Özlem and I are ready to become pioneers once again. Our vision has always been to translate our science into meaningful advances for patients, and we see extraordinary opportunities to unlock the next generation of transformative innovations."

"Over the course of their careers, Ugur and Özlem have established an outstanding track record of innovation. As BioNTech advances multiple late-stage product candidates towards commercialization, we support them in taking the opportunity to apply their strengths and undivided attention to a new venture, dedicated to enabling mRNA-based technologies to reach their full potential," said Helmut Jeggle, Chairman of the BioNTech Supervisory Board. "We believe that this plan will be additive for both, BioNTech and the new company, as it aims to allow each organization to drive meaningful impact for patients. We look forward to working together with their new company on potential combination therapy approaches, setting the stage for continued success."

BioNTech co-founders and mRNA technology pioneers Prof. Ugur Sahin, M.D., and Prof. Özlem Türeci, M.D., will establish their third biotechnology company following the foundation of Ganymed Pharmaceuticals in 2001 and BioNTech in 2008. As a next-generation mRNA company, it is aimed at pioneering cutting-edge platform technologies and advancing the research and development of mRNA-based innovations with disruptive potential. To this end, BioNTech plans to contribute related rights and mRNA technologies to the new company on an arm’s length basis in exchange for a minority stake and other forms of consideration such as milestones and royalties. It aims to benefit both companies by providing them with opportunities to collaborate on combination approaches involving their respective product candidates, with the potential to create new complementary or synergistic treatment strategies. A binding agreement is expected to be signed by the end of the first half of 2026 after which further details will be communicated by BioNTech.

(Press release, BioNTech, MAR 10, 2026, View Source [SID1234663410])

bioAffinity Technologies Announces Initiation of Large-Scale Longitudinal Clinical Study for Its Noninvasive CyPath® Lung Cancer Diagnostic

On March 10, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on non-invasive diagnostics and early cancer detection, reported initiation of the Company’s planned large-scale, longitudinal clinical study for CyPath Lung, its noninvasive diagnostic test for the detection of early-stage lung cancer.

The 2,000-patient longitudinal study is designed to evaluate the clinical performance of the CyPath Lung flow cytometry test as a noninvasive diagnostic that uses sputum samples to detect the presence of lung cancer in high-risk individuals with existing lung nodules six millimeters (mm) to less than 30 mm in diameter identified by lung cancer screening. In an earlier clinical trial, CyPath Lung showed 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients with small pulmonary nodules less than 20mm. Several recent patient case studies demonstrate the test’s ability to detect lung cancer at its curative Stage 1A.

bioAffinity Technologies expects up to 20 clinical study sites, including a dozen Department of Veterans Affairs (VA) medical centers and two of the nation’s largest military hospitals, will participate in the study. Michael J. Morris, MD, pulmonology and critical care physician at Brooke Army Medical Center, is the national Principal Investigator for the study (NCT07168993). The John P. Murtha Cancer Center Research Program (MCCRP), a research program within the Department of Surgery at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, is providing support and funding associated with the trial at several federal facilities.

Physicians currently order CyPath Lung, a laboratory developed test (LDT) offered by bioAffinity Technologies’ subsidiary Precision Pathology Laboratory Services, for their patients with indeterminate lung nodules to determine next steps in patient care.

The longitudinal clinical trial announced today will evaluate FlowPath Lung, a research-use test that uses the same technology and follows the same procedures as CyPath Lung. The different name is simply used to distinguish the investigational assay from the commercially available test.

"As more indeterminate pulmonary nodules are found either incidentally or by routine lung cancer screening, CyPath Lung can fill the diagnostic gap between ‘watchful waiting’ and invasive procedures that carry risk," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies. "As a result, we see growing adoption and use of CyPath Lung by physicians and expect this longitudinal trial to provide additional evidence to support inclusion of our noninvasive test as part of the standard of care for lung cancer screening and diagnosis."

"Initiating this study represents an important milestone for CyPath Lung," said Maria Zannes, President and CEO of bioAffinity Technologies. "By following patients longitudinally across multiple sites, we expect to acquire robust, real-world data that reflects how CyPath Lung may be used to support risk assessment and clinical decision-making aligned with our objective to establish CyPath Lung as a standard of care for evaluating patients at high-risk for early-stage lung cancer."

The study includes participation from several federal facilities to examine the test’s performance in diverse patient populations, including military service members and veterans. Patient enrollment is expected to take up to 18 months with patients followed for up to 24 months or until a definitive diagnosis of cancer or no cancer is determined.

About CyPath Lung

CyPath Lung is a non-invasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.

(Press release, BioAffinity Technologies, MAR 10, 2026, View Source [SID1234663409])

Alligator Bioscience strengthens intellectual property protection for bispecific antibody platform

On March 10, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported that the United States Patent and Trademark Office (USPTO) has granted a patent covering Alligator’s proprietary bispecific antibody format. The granted patent provides protection for the structural design of tetravalent bispecific antibodies capable of dual antigen binding.

The patent covers a versatile antibody architecture designed to enable stable and efficient assembly of bispecific antibodies, including configurations targeting immune modulators and tumor-associated antigens. This platform is intended to support the development of next-generation immunotherapies across a range of oncology indications and combination strategies.

The bispecific antibody format covered by the patent underpins multiple programs within Alligator’s research platform and has already demonstrated external validation. In September 2025, Alligator entered into an evaluation and option agreement covering the RUBY antibody format, highlighting the commercial and strategic interest in Alligator’s antibody engineering capabilities.

"This patent grant strengthens the intellectual property foundation around our bispecific antibody platform and highlights the value of our technology beyond mitazalimab," said Søren Bregenholt, CEO of Alligator Bioscience. "It supports our strategy to build long-term value through our innovative antibody formats, both within our own pipeline and through partnerships, as exemplified by the RUBY agreement."

(Press release, Alligator Bioscience, MAR 10, 2026, View Source [SID1234663408])

Alkermes to Present at the Stifel 2026 Virtual CNS Forum

On March 10, 2026 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a fireside chat at the Stifel 2026 Virtual CNS Forum on Tuesday, March 17, 2026 at 8:30 a.m. ET (12:30 p.m. GMT). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

(Press release, Alkermes, MAR 10, 2026, View Source [SID1234663407])