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BioNTech Navigates Shifting Landscape with Focus on Oncology and Vaccine Adaptation; Q1 Revenue Flat

MAINZ, Germany, May 5, 2025 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX), today revealed its financial results for the three months ending March 31, 2025, and offered insights into its strategic advancements.

The biotech firm, a global player in next-generation immunotherapy, continues to prioritize the progression of its oncology pipeline, specifically focusing on two key pan-tumor programs: the next-generation immunomodulator BNT327, a bispecific antibody targeting PD-L1 and VEGF-A, and its mRNA cancer immunotherapies. Furthermore, BioNTech is preparing for the development and commercial launch of a variant-adapted COVID-19 vaccine for the 2025/2026 season.

“During the first quarter of 2025, we demonstrated continued execution against our strategic focus areas, highlighted by data updates for our PD-L1xVEGF-A bispecific antibody candidate BNT327 and the progress in clinical evaluation of our focus programs and combination treatment approaches,” stated Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “We will continue to focus on our key strategic programs as we remain steadfast in our vision to translate our science into survival for patients in need.”

**Key Financial Highlights for Q1 2025:**

* Continued oncology pipeline advancement with a strategic focus on key programs.
* Multiple clinical updates across the oncology pipeline, highlighting BioNTech’s combination strategy, including initial data for BNT327 in combination with antibody-drug conjugates (“ADCs”).
* Development and commercial preparation for a 2025/2026 season variant-adapted COVID-19 vaccine.
* First quarter 2025 revenues of €0.2 billion, with a net loss of €0.4 billion and basic and diluted loss per share of €1.73 ($1.82).
* Maintained a strong financial position with €15.9 billion in cash, cash equivalents, and security investments as of March 31, 2025.
* Full year 2025 financial guidance confirmed.

**Financial Review for First Quarter 2025**

BioNTech reported revenues of €182.8 million for the three months ending March 31, 2025, slightly down from €€187.6 million in the same period the previous year. The revenue stream for Q1 2025 was primarily fueled by BioNTech’s COVID-19 vaccine collaboration.

The cost of sales saw an uptick to €83.8 million for the three months ending March 31, 2025, relative to €59.1 million the previous year. This shift was mainly due to the positive impact of an inventory revaluation in the first quarter of 2024.

Research and development (“R&D”) spending reached €525.6 million for the three months ending March 31, 2025, an increase from €507.5 million in the prior year. This increase was largely attributed to advancing late-stage clinical studies for candidates within BioNTech’s ADC and antibody portfolio.

Sales, general, and administrative (“SG&A”) expenses totaled €120.6 million for the three months ended March 31, 2025, a decrease from €132.6 million in the comparative prior year period, driven by a reduction in external services.

Income taxes showed a tax income of €29.6 million for the three months ending March 31, 2025, compared to €16.7 million in the prior year.

The net loss for the three months ending March 31, 2025, reached €415.8 million, an increase from the €315.1 million net loss in the comparative prior year period.

Cash and cash equivalents, combined with security investments, stood at €15,854.4 million as of March 31, 2025, comprising €10,184.9 million in cash and cash equivalents, €3,542.0 million in current security investments, and €2,127.5 million in non-current security investments.

Basic and diluted loss per share was €1.73 for the three months ending March 31, 2025, compared to a basic and diluted loss per share of €1.31 for the comparative prior year period.

As of March 31, 2025, the total shares outstanding were 240,392,622, excluding 8,159,578 shares held in treasury.

“Our revenues for the first quarter reflect the seasonal demand for COVID-19 vaccines and are in line with our expectations,” stated Jens Holstein, CFO of BioNTech. “BioNTech’s robust financial position empowers us to pursue our strategic goal of evolving into a leading biotech company with multiple oncology products by 2030.”

**2025 Financial Year Guidance Confirmed**

BioNTech anticipates total revenues for the fiscal year 2025 to fall between €1,700 million – €2,200 million. The revenue phasing for 2025 is expected to be similar to 2024, with the majority of revenue generated in the final three to four months of the year. The revenue guidance is predicated on the following assumptions: relatively stable vaccination rates, pricing levels, and market share compared to 2024; estimated inventory write-downs and other charges by BioNTech’s collaboration partner; anticipated revenues from a pandemic preparedness contract with the German government; and anticipated revenues from the BioNTech Group service businesses.

The company expects to spend between €2,600 million and €2,800 million on R&D expenses, and €650 million to €750 million on SG&A expenses. Capital expenditures for operating activities are expected to range from €250 million to €350 million.

BioNTech plans to continuously invest in R&D and scale operations for late-stage development, aiming for commercial readiness in oncology, while maintaining disciplined cost-management. Strategic capital allocation remains a core driver of the Company’s strategy.

A conference call and webcast are scheduled for May 5, 2025, at 8:00 a.m. EDT (2:00 p.m. CEST) to discuss these results in detail.

**Operational Review for the First Quarter 2025, Key Post Period-End Events and 2025 Outlook**

***Selected Oncology Pipeline Updates***

*Next-Generation Immunomodulators*

**BNT327**, a bispecific antibody candidate, combines PD-L1 checkpoint inhibition with VEGF-A neutralization. Preliminary data from Phase 2 clinical trials in China, presented at the European Lung Cancer Congress (“ELCC”), showed promising results in extensive-stage small cell lung cancer (ES-SCLC) and second-line small cell lung cancer (“SCLC”). Additional data will be presented at the upcoming American Society for Clinical Oncology (“ASCO”) Annual Meeting.

*mRNA Cancer Immunotherapies*

**BNT116**, based on BioNTech’s FixVac platform, aims to elicit an immune response to six tumor-associated antigens frequently expressed in NSCLC. Preliminary data from a Phase 1 trial presented at the AACR Annual Meeting 2025 revealed encouraging anti-tumor activity and a manageable safety profile.

*Antibody-Drug Conjugates*

**BNT324/DB-1311**, a B7H3-targeted ADC candidate developed with DualityBio, has received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of castration-resistant prostate cancer (“CRPC”). Preliminary data from the ongoing Phase 1/2 clinical trial, will be available at the 2025 ASCO Annual Meeting.

**BNT325/DB-1305**, a TROP2-targeted ADC candidate also developed with DualityBio, received Fast Track designation from the FDA for platinum-resistant ovarian cancer.

**Corporate and Commercial Update for the First Quarter 2025**

BioNTech’s Supervisory Board has appointed Ramón Zapata-Gomez as Chief Financial Officer (“CFO”), effective July 1, 2025, succeeding Jens Holstein, who will retire as planned. The acquisition of Biotheus was completed, giving BioNTech full global rights to BNT327 and other pipeline candidates. BioNTech and its collaboration partner, Pfizer, are focused on variant strain vaccine adaptation, preparing for commercial launch ahead of the upcoming 2025/2026 vaccination season, pending approvals.

**Forward-Looking Statements**

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech’s expected revenues and net profit/(loss) related to sales of BioNTech’s COVID-19 vaccine in territories controlled by BioNTech’s collaboration partners, particularly for those figures that are derived from preliminary estimates provided by BioNTech’s partners; the rate and degree of market acceptance of BioNTech’s COVID-19 vaccine and, if approved, BioNTech’s investigational medicines; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment and expected regulatory recommendations to adapt vaccines to address new variants or sublineages; the initiation, timing, progress, results, and cost of BioNTech’s research and development programs, including BioNTech’s current and future preclinical studies and clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of studies or clinical trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations; BioNTech’s expectations regarding potential future commercialization in oncology, including goals regarding timing and indications; the targeted timing and number of additional potentially registrational clinical trials, and the registrational potential of any clinical trial BioNTech may initiate; discussions with regulatory agencies; BioNTech’s expectations with respect to intellectual property; the impact of BioNTech’s collaboration and licensing agreements; the development, nature and feasibility of sustainable vaccine production and supply solutions; the deployment of AI across BioNTech’s preclinical and clinical operations; BioNTech’s expectations with respect to tariff policy; BioNTech’s estimates of revenues, research and development expenses, selling, general and administrative expenses and capital expenditures for operating activities; BioNTech’s expectations regarding upcoming payments relating to litigation settlements; BioNTech’s expectations for upcoming scientific and investor presentations; and BioNTech’s expectations of net profit / (loss). In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events, and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, projected data release timelines, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; BioNTech’s pricing and coverage negotiations regarding its COVID-19 vaccine with governmental authorities, private health insurers and other third-party payors; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; the impact of tariffs and escalations in trade policy; competition from other COVID-19 vaccines or related to BioNTech’s other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; the ability of BioNTech’s COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech’s and its counterparties’ ability to manage and source necessary energy resources; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s development candidates and investigational medicines; the impact of COVID-19 on BioNTech’s development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market BioNTech’s COVID-19 vaccine and, if approved, its product candidates; BioNTech’s ability to manage its development and related expenses; regulatory and political developments in the United States and other countries; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time.

You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended March 31, 2025 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.