BioNTech Announces First Quarter 2025 Financial Results and Corporate Update

   -- Continued oncology pipeline advancement with a strategic focus on two 
      priority pan-tumor programs: next-generation immunomodulator BNT327, a 
      bispecific antibody targeting PD-L1 and VEGF-A1, and mRNA cancer 
      immunotherapies 
   -- Presented multiple clinical updates across oncology pipeline underlining 
      BioNTech's combination strategy in oncology with first data presented for 
      the novel combination of BNT327 plus antibody-drug conjugates ("ADCs") 
   -- Development and commercial preparation for a 2025/2026 season 
      variant-adapted COVID-19 vaccine 
   -- First quarter 2025 revenues of EUR0.2 billion2, net loss of EUR0.4 
      billion and basic and diluted loss per share of EUR1.73 ($1.823) 
   -- Maintained strong financial position with EUR15.9 billion in cash, cash 
      equivalents and security investments as of March 31, 20254 
   -- Full year 2025 financial guidance confirmed 

Conference call and webcast scheduled for May 5, 2025, at 8:00 a.m. EDT (2:00 p.m. CEST)

MAINZ, Germany, May 5, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") today reported financial results for the three months ended March 31, 2025 and provided an update on its corporate progress.

"In 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," said 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."

Financial Review for First Quarter 2025

 
 
in millions EUR, except per share     First Quarter  First Quarter 
 data                                      2025           2024 
                                      -------------  ------------- 
Revenues                                      182.8          187.6 
                                      -------------  ------------- 
Net loss                                    (415.8)        (315.1) 
                                      -------------  ------------- 
Basic and diluted loss per share             (1.73)         (1.31) 
                                      -------------  ------------- 
 

Revenues reported were EUR182.8 million for the three months ended March 31, 2025, compared to EUR187.6 million for the comparative prior year period. Revenues during the first quarter of 2025 were mainly driven by revenues derived from BioNTech's COVID-19 vaccine collaboration.

Cost of sales were EUR83.8 million for the three months ended March 31, 2025, compared to EUR59.1 million for the comparative prior year period. The change was mainly due to a positive impact of an inventory revaluation in the first quarter of 2024.

Research and development ("R&D") expenses were EUR525.6 million for the three months ended March 31, 2025, compared to EUR507.5 million for the comparative prior year period. The increase was mainly driven by progressing late-stage clinical studies for candidates in BioNTech's ADC and antibody portfolio.

Sales, general and administrative ("SG&A") expenses(5) , in total, amounted to EUR120.6 million for the three months ended March 31, 2025, compared to EUR132.6 million for the comparative prior year period. The decrease was primarily driven by a reduction in external services.

Income taxes were realized with an amount of EUR29.6 million in tax income for the three months ended March 31, 2025, compared to EUR16.7 million in realized tax income for the comparative prior year period.

Net loss was EUR415.8 million for the three months ended March 31, 2025, compared to a net loss of EUR315.1 million for the comparative prior year period.

Cash and cash equivalents plus security investments as of March 31, 2025, reached EUR15,854.4 million, comprising EUR10,184.9 million in cash and cash equivalents, EUR3,542.0 million in current security investments and EUR2,127.5 million in non-current security investments.

Basic and diluted loss per share was EUR1.73 for the three months ended March 31, 2025, compared to a basic and diluted loss per share of EUR1.31 for the comparative prior year period.

Shares outstanding as of March 31, 2025, 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," said 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(6)

 
Total revenues for the 2025 financial    EUR1,700 million - EUR2,200 
 year                                     million 
-------------------------------------    --------------------------- 
 

BioNTech expects its revenues for the full 2025 financial year to be in the range of EUR1,700 - EUR2,200 million and revenue phasing similar to 2024, primarily concentrated in the last three to four months, driving the full year revenue figure. The revenue guidance assumes: relatively stable vaccination rates, pricing levels and market share compared to 2024; estimated inventory write-downs and other charges by BioNTech's collaboration partner Pfizer that negatively influence BioNTech's revenues; anticipated revenues from a pandemic preparedness contract with the German government; and anticipated revenues from the BioNTech Group service businesses. Potential changes to the law or governmental policy, including tariffs and public health policy, and evolving public sentiment worldwide, could further negatively impact our anticipated revenues and expenses.

Planned 2025 Financial Year Expenses and Capex

 
R&D expenses                            EUR2,600 million - EUR2,800 
                                         million 
----------------------------------      --------------------------- 
SG&A expenses                           EUR650 million - EUR750 
                                         million 
                                        --------------------------- 
Capital expenditures for operating      EUR250 million - EUR350 
 activities                              million 
                                        --------------------------- 
 

BioNTech expects to continuously 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 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 create future value.

The full interim unaudited condensed consolidated financial statements can be found in BioNTech's Report on Form 6-K for the period ended March 31, 2025, filed today with the United States Securities and Exchange Commission ("SEC") and available at www.sec.gov.

Endnotes

(1) All abbreviations are compiled in an abbreviation directory at the end of this press release.

(2) All numbers in this press release have been rounded.

(3) Calculated applying the average foreign exchange rate for the three months ended March 31, 2025, as published by the German Central Bank (Deutsche Bundesbank).

(4) A settlement payment of $400 million related to a contractual dispute with the University of Pennsylvania is expected to be reflected in the Company's second quarter 2025 financial results. In connection with this and another settlement with the National Institutes of Health ("NIH"), BioNTech expects to be reimbursed approximately $535 million by its collaboration partner during 2025 and 2026. Reimbursement payments have begun with the first payment received by BioNTech in the first quarter of 2025.

(5) Sales, general and administrative expenses ("SG&A") include sales and marketing expenses as well as general and administrative expenses.

(6) Financial guidance excludes external risks that are not yet known and/or quantifiable, including, but not limited to the effects of ongoing and/or future legal disputes and related activities, certain potential one-time effects and charges related to portfolio prioritization. It includes effects identified from licensing arrangements, collaborations or potential M&A transactions to the extent disclosed and may be subject to update. The Company does not expect to report a positive net income figure for the 2025 financial year.

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

Selected Oncology Pipeline Updates

Next-Generation Immunomodulators

BNT327, formerly also known as PM8002, is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization.

   -- In March 2025, at the European Lung Cancer Congress ("ELCC"), preliminary 
      data from two Phase 2 clinical trials conducted in China in first-line 
      extensive-stage small cell lung cancer ("ES-SCLC") and second-line small 
      cell lung cancer ("SCLC") were presented. 
 
   -- 
 
          -- Preliminary data from the ongoing single-arm, open-label Phase 2 
             clinical trial (NCT05844150) evaluating BNT327 in combination with 
             chemotherapy as a first-line treatment in patients with ES-SCLC 
             showed anti-tumor activity and an acceptable safety profile with 
             no new safety signals beyond those typically described for 
             chemotherapy agents and anti-PD-(L)1 and anti-VEGF monotherapies. 
             These data were the first presented for BNT327 as a potential 

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