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6-K 1 form6-kq12025earningsprear.htm 6-K Document


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a‑16 OR 15d‑16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
FOR THE MONTH OF MAY 2025

COMMISSION FILE NUMBER 001-39081
BioNTech SE
(Translation of registrant’s name into English)
An der Goldgrube 12
D-55131 Mainz
Germany
+49 6131-9084-0
(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20‑F or Form 40‑F: Form 20‑F ☒ Form 40‑F ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7): ☐




DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K

On May 5, 2025, BioNTech SE (the “Company”) issued a press release announcing its first quarter 2025 financial results and corporate update and details of a conference call to be held at 8:00 am EDT on May 5, 2025 to discuss the results. The press release and the conference call presentation are attached as Exhibits 99.1 and 99.2, respectively, and incorporated by reference herein.
The information contained in Exhibits 99.1 and 99.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, unless expressly set forth by specific reference in such a filing.



SIGNATURE
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

BioNTech SE
By: /s/ Jens Holstein By: /s/ Dr. Sierk Poetting
Name: Jens Holstein Name: Dr. Sierk Poetting
Title: Chief Financial Officer Title: Chief Operating Officer
Date: May 5, 2025



EXHIBIT INDEX




EX-99.1 2 ex991bntxq12025pressreleas.htm EX-99.1 Document
Exhibit 99.1
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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 €0.2 billion2, net loss of €0.4 billion and basic and diluted loss per share of €1.73 ($1.823)
•Maintained strong financial position with €15.9 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 €, except per share data


First Quarter 2025


First Quarter 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 €182.8 million for the three months ended March 31, 2025, compared to €187.6 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 €83.8 million for the three months ended March 31, 2025, compared to €59.1 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 €525.6 million for the three months ended March 31, 2025, compared to €507.5 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.

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Sales, general and administrative (“SG&A”) expenses5, in total, amounted to €120.6 million for the three months ended March 31, 2025, compared to €132.6 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 €29.6 million in tax income for the three months ended March 31, 2025, compared to €16.7 million in realized tax income for the comparative prior year period.

Net loss was €415.8 million for the three months ended March 31, 2025, compared to a net loss of €315.1 million for the comparative prior year period.

Cash and cash equivalents plus security investments as of March 31, 2025, reached €15,854.4 million, 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 ended March 31, 2025, compared to a basic and diluted loss per share of €1.31 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 Confirmed6
Total revenues for the 2025 financial year

€1,700 million - €2,200 million

BioNTech expects its revenues for the full 2025 financial year to be in the range of €1,700 - €2,200 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


€2,600 million - €2,800 million

SG&A expenses


€650 million - €750 million

Capital expenditures for operating activities


€250 million - €350 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.
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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 first-line treatment in ES-SCLC supporting the ongoing global randomized Phase 3 clinical trial ROSETTA Lung-01 (NCT06712355).

◦Preliminary data from the ongoing Phase 2 clinical trial (NCT05879068) evaluating BNT327 in combination with chemotherapy as a second-line treatment in patients with SCLC showed anti-tumor activity, which was observed regardless of prior immuno-oncology treatment, and an acceptable safety profile.

•In April 2025, at the American Association for Cancer Research (“AACR”) Annual Meeting 2025, first data were presented for the novel combination of the PD-L1xVEGF-A bispecific antibody candidate BNT327 with various ADC candidates.

◦Interim data from the ongoing Phase 1/2 clinical trial (NCT05438329) evaluating BNT327 with BNT325/DB-1305, a TROP2-targeting ADC candidate being developed in collaboration with Duality Biologics (Suzhou) Co.
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Ltd. (“DualityBio”), in patients with advanced/metastatic solid tumors showed a manageable safety profile and early signs of anti-tumor activity in a cohort with patients with platinum-resistant ovarian cancer (“PROC”). Across the 13 efficacy evaluable patients with PROC, seven patients achieved partial response and three stable disease. Responses were also observed in patients with non-small cell lung cancer (“NSCLC”) or triple-negative breast cancer (“TNBC”).

•First data from an ongoing Phase 2 clinical trial (NCT05918107) in first-line mesothelioma and two trial-in-progress posters for the ongoing global Phase 3 and Phase 2/3 clinical trials, ROSETTA Lung-01 (NCT06712355) and ROSETTA Lung-02 (NCT06712316) respectively, will be presented at the American Society for Clinical Oncology (“ASCO”) Annual Meeting taking place from May 30 to June 3, 2025 in Chicago, Illinois.

•Abstract title: First report of efficacy and safety results from a Phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line treatment (1L) in unresectable malignant mesothelioma

•Abstract title: A global Phase III, double-blind, randomized trial of BNT327/PM8002 plus chemotherapy (chemo) compared to atezolizumab plus chemo in patients (pts) with first-line (1L) extensive-stage small cell lung cancer (ES-SCLC)

•Abstract title: A global Phase 2/3, randomized, open-label trial of BNT327/PM8002 in combination with chemotherapy (chemo) in first-line (1L) non-small cell lung cancer (NSCLC)

mRNA Cancer Immunotherapies

BNT116 is based on BioNTech’s fully owned, off-the-shelf FixVac platform, and is designed to elicit an immune response to six tumor-associated antigens that were identified to be frequently expressed in NSCLC.

•In April 2025, at the AACR Annual Meeting 2025, preliminary data from a cohort with frail patients were presented from the ongoing Phase 1 clinical trial LuCa-MERIT-1 (NCT05142189) evaluating BNT116 in combination with cemiplimab in patients with PD-L1 positive (TPS≥1%) unresectable Stage III or metastatic Stage IV NSCLC who are not eligible for chemotherapy as first-line treatment. The preliminary data showed anti-tumor activity, consistent immune response induction and a manageable safety profile.

Antibody-Drug Conjugates

BNT324/DB-1311 is an B7H3-targeted ADC candidate that is being developed in collaboration with DualityBio. The program has received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of patients with advanced castration-resistant prostate cancer (“CRPC”) whose disease has progressed while undergoing or after undergoing standard systemic regimens. In addition, the program has received Orphan Drug designation from the FDA for the treatment of patients with advanced esophageal squamous cell carcinoma.

•Preliminary data from the ongoing Phase 1/2 clinical trial (NCT05914116) evaluating BNT324/DB-1311 in patients with advanced solid tumors, including patients with previously treated castration-resistant prostate cancer (“CRPC”), will be presented at the 2025 ASCO Annual Meeting.

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•Abstract title: DB‑1311/BNT324 (a novel B7H3 ADC) in patients with heavily pretreated castrate-resistant prostate cancer (CRPC)

BNT325/DB-1305 is a TROP2-targeted ADC candidate that is being developed in collaboration with DualityBio. BNT325/DB-1305 received Fast Track designation from the FDA for the treatment of patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.

•In March 2025, at the Society of Gynecologic Oncology (“SGO”) Annual Meeting, preliminary data were presented from an ongoing Phase 1/2 clinical trial (NCT05438329) evaluating BNT325/DB-1305 in signal-seeking cohorts across various cancer indications, including PROC. The data from a cohort of patients with PROC showed a manageable safety profile and early signs of anti-tumor activity.

Corporate and Commercial Update for the First Quarter 2025

•Earlier today, BioNTech announced that the Supervisory Board has appointed Ramón Zapata-Gomez to the Management Board as Chief Financial Officer (“CFO”) effective July 1, 2025. He will join BioNTech from Novartis AG’s global biomedical research organization where he has been serving as CFO since 2022. Ramón Zapata will succeed Jens Holstein, who, as previously planned and announced, will retire at the end of his term on June 30, 2025.

•In February 2025, BioNTech completed the acquisition of Biotheus, obtaining full global rights to BNT327 and to all other candidates from Biotheus’ pipeline, as well as to its in-house antibody generation platform and bispecific ADC capability. The transaction amounted to an upfront consideration of $800 million, plus additional performance-based payments of up to $150 million.

•BioNTech and Pfizer developed, manufactured and delivered their JN.1 and KP.2-adapted COVID-19 vaccines, which have received multiple regulatory approvals, including full approvals, authorizations for emergency or temporary use, or marketing authorizations, in more than 40 countries and regions. BioNTech is now focused on preparing for variant strain vaccine adaptation to be ready for commercial launch ahead of the upcoming 2025/2026 vaccination season, pending approvals.

Upcoming Investor and Analyst Events

•Annual General Meeting: May 16, 2025
•Innovation Series R&D Day: November 11, 2025

Conference Call and Webcast Information

BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, May 5, 2025, at 8:00 a.m. EDT (2:00 p.m. CEST) to report its financial results and provide a corporate update for the first quarter of 2025.

To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN number will be provided.

The slide presentation and audio of the webcast will be available via this link.

Participants may also access the slides and the webcast of the conference call via the “Events & Presentations” page of the Investor section of the Company’s website at www.BioNTech.com. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.
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About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron.

For more information, please visit www.BioNTech.com.


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.
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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.


CONTACTS

Investor Relations
Michael Horowicz
Investors@biontech.de

Media Relations
Jasmina Alatovic
Media@biontech.de

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Target Overview
Anti-PD-(L)1
Anti-programmed cell death protein (death-ligand) 1
PD-L1
Programmed death-ligand 1
TROP2
Trophoblast cell-surface antigen 2
VEGF-A
Vascular endothelial growth factor A



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Interim Condensed Consolidated Statements of Profit or Loss










Three months ended
March 31,










2025


2024
(in millions €, except per share data)


(unaudited)


(unaudited)
Revenues


182.8


187.6
Cost of sales


(83.8)


(59.1)
Research and development expenses


(525.6)


(507.5)
Sales and marketing expenses


(13.7)


(15.6)
General and administrative expenses


(106.9)


(117.0)
Other operating expenses


(48.5)


(23.9)
Other operating income


61.6


28.3
Operating loss


(534.1)


(507.2)
Finance income


122.6


180.1
Finance expenses


(33.9)


(4.7)
Loss before tax


(445.4)


(331.8)
Income taxes


29.6


16.7
Net loss


(415.8)


(315.1)
Loss per share






Basic and diluted loss per share


(1.73)


(1.31)



9


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Interim Condensed Consolidated Statements of Financial Position










March 31,


December 31,
(in millions €)


2025


2024
Assets


(unaudited)



Non-current assets






Goodwill


375.9


380.6
Other intangible assets


1,511.2


790.4
Property, plant and equipment


1,026.1


935.3
Right-of-use assets


241.9


248.1
Contract assets


7.9


9.8
Other financial assets


2,285.8


1,254.0
Other non-financial assets


22.6


26.3
Deferred tax assets


85.5


81.7
Total non-current assets


5,556.9


3,726.2
Current assets






Inventories


254.4


283.3
Trade and other receivables


956.5


1,463.9
Contract assets


10.0


10.0
Other financial assets


3,924.9


7,021.7
Other non-financial assets


234.3


212.7
Income tax assets


60.5


50.0
Cash and cash equivalents


10,184.9


9,761.9
Total current assets


15,625.5


18,803.5
Total assets


21,182.4


22,529.7







Equity and liabilities






Equity






Share capital


248.6


248.6
Capital reserve


1,447.4


1,398.6
Treasury shares


(8.2)


(8.6)
Retained earnings


18,682.2


19,098.0
Other reserves


(1,443.4)


(1,325.5)
Total equity


18,926.6


19,411.1
Non-current liabilities






Lease liabilities, loans and borrowings


237.5


214.7
Other financial liabilities


150.9


46.9
Provisions


20.8


20.9
Contract liabilities


182.9


183.0
Other non-financial liabilities


85.1


87.5
Deferred tax liabilities


44.1


42.4
Total non-current liabilities


721.3


595.4
Current liabilities






Lease liabilities, loans and borrowings


55.5


39.5
Trade payables and other payables


443.8


426.7
Other financial liabilities


443.4


1,443.4
Income tax liabilities


5.4


4.5
Provisions


121.9


144.8
Contract liabilities


294.5


294.9
Other non-financial liabilities


170.0


169.4
Total current liabilities


1,534.5


2,523.2
Total liabilities


2,255.8


3,118.6
Total equity and liabilities


21,182.4


22,529.7



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Interim Condensed Consolidated Statements of Cash Flows










Three months ended
March 31,










2025


2024
(in millions €)


(unaudited)


(unaudited)
Operating activities






Net loss


(415.8)


(315.1)
Income taxes


(29.6)


(16.7)
Loss before tax


(445.4)


(331.8)
Adjustments to reconcile profit before tax to net cash flows:






Depreciation and amortization of property, plant, equipment, intangible assets and right-of-use assets


42.8


38.3
Share-based payment expenses


22.1


16.3
Net foreign exchange differences


48.3


(28.7)
(Gain) / Loss on disposal of property, plant and equipment


(0.1)


Finance income excluding foreign exchange differences


(122.6)


(174.9)
Finance expense excluding foreign exchange differences


7.9


4.7
Government grants


(14.5)


(9.1)
Other non-cash (income) / loss


(14.3)


Unrealized (gain) / loss on derivative instruments at fair value through profit or loss


(11.3)


1.7
Working capital adjustments:






Decrease in trade and other receivables, contract assets and other assets


520.7


498.2
Decrease in inventories


33.8


12.3
Decrease in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions


(971.0)


(288.0)
Interest received and realized gains from cash and cash equivalents


118.6


199.4
Interest paid and realized losses from cash and cash equivalents


(3.1)


(3.7)
Income tax paid


(12.2)


(258.8)
Share-based payments


(3.6)


(2.4)
Government grants received


23.2


9.2
Net cash flows used in operating activities


(780.7)


(317.3)
Investing activities






Purchase of property, plant and equipment


(48.9)


(58.5)
Proceeds from sale of property, plant and equipment


0.5


Purchase of intangible assets and right-of-use assets


(569.2)


(78.4)
Acquisition of subsidiaries and businesses, net of cash acquired


(78.5)


Investment in other financial assets


(2,507.7)


(4,895.1)
Proceeds from maturity of other financial assets


4,450.6


2,727.6
Net cash flows from / (used in) investing activities


1,246.8


(2,304.4)
Financing activities






Repayment of loans and borrowings


(4.5)


Payments related to lease liabilities


(9.3)


(7.8)
Net cash flows used in financing activities


(13.8)


(7.8)
Net increase / (decrease) in cash and cash equivalents


452.3


(2,629.5)
Change in cash and cash equivalents resulting from exchange rate differences


(16.1)


6.8
Change in cash and cash equivalents resulting from other valuation effects


(13.2)


(64.4)
Cash and cash equivalents at the beginning of the period


9,761.9


11,663.7
Cash and cash equivalents as of March 31


10,184.9


8,976.6

11

EX-99.2 3 ex992bntxq12025presentat.htm EX-99.2 ex992bntxq12025presentat
May 5th, 2025 1st Quarter 2025 Financial Results & Corporate Update Exhibit 99.2


 
2 This Slide Presentation Includes Forward-Looking Statements This presentation 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, referred to as COMIRNATY where approved for use under full or conditional marketing authorization, 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 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 trials, and the registrational potential of any 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 presentation 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 presentation in the event of new information, future developments or otherwise. Furthermore, certain statements contained in this presentation relate to or are based on studies, publications, surveys and other data obtained from third-party sources and BioNTech’s own internal estimates and research. While BioNTech believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, any market data included in this presentation involves assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. While BioNTech believes its own internal research is reliable, such research has not been verified by any independent source. In addition, BioNTech is the owner of various trademarks, trade names and service marks that may appear in this presentation. Certain other trademarks, trade names and service marks appearing in this presentation are the property of third parties. Solely for convenience, the trademarks and trade names in this presentation may be referred to without the ® and TM symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. An abbreviation directory of defined terms can be found at the end of the presentation.


 
Financial Update Jens Holstein, Chief Financial Officer3 Strategic Outlook Ryan Richardson, Chief Strategy Officer4 Oncology Pipeline Update Özlem Türeci, Co-founder & Chief Medical Officer2 1st Quarter 2025 Update Ugur Sahin, Co-founder & Chief Executive Officer1


 
1 1st Quarter 2025 Updates Ugur Sahin, Co-founder & Chief Executive Officer


 
Building a Global Immunotherapy Powerhouse Translating Science into Survival


 
Progress in Q1 2025 Towards Our Strategic Goals 6 BNT327 BNT323/DB-13032 Maintained >50% global COVID-19 vaccine5 market share Corporate Update Completed acquisition of Biotheus, securing global control of BNT327 Appointed Ramón Zapata to Management Board as Chief Financial Officer effective July 1, 2025 mRNA Cancer Immunotherapies Execution in Oncology COVID-19 Leadership Reported Phase 1 data1 for BNT1163 in NSCLC Published two manuscripts for autogene cevumeran4 in Nature and Nature Medicine Presented Phase 2 data1 for BNT327 in 1L SCLC Reported first BNT327+ADC combo data1 with TROP2- targeting ADC, BNT325/DB-13052 Preparing for regulator discussions with planned BLA submission by end of 2025, pending regulatory feedback 1. Phase 1 data for BNT116 (AACR); BNT327 data included: Phase 2 data in ES-SCLC and SCLC (ELCC) and Phase 1/2 data (AACR); 2. Partnered with DualityBio; 3. In collaboration with Regeneron; 4. Partnered with Genentech, a member of the Roche Group; 5. Partnered with Pfizer; 6. Cash and cash equivalents plus security investments as of March 31, 2025, reached €15,854.4 million, comprising €10,184.9 million cash and cash equivalents, €3,542.0 million current security investments and €2,127.5 million non-current security investments, respectively. 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 NIH, BioNTech expects to be reimbursed approximately $535 million by its collaboration partner during 2025 and 2026. Reimbursement payments have begun to be received in the first quarter of 2025. Corporate Development Financials COMIRNATY Strong balance sheet : ~€ 15.9 bn total cash and cash equivalents plus security investments6


 
Space for curative approaches Immunomodulators mRNA cancer immunotherapies Targeted therapies Synergy1 Synergy1 Synergy1 • Focus on the critical IO pathways • Targeting different complementary pathways in cancer immunity cycle may promote a durable anti-tumor effect • Eliminate polyclonal residual disease with multi-antigen and individualized approaches • Polyspecific activity by targeting multiple antigens at once • Establish long-lasting immunological memory to prevent relapses • Precise and potent modalities for fast onset tumor reduction • ADC as potential “augmenters” of immunomodulators and mRNA cancer immunotherapies • Focus on HER2, HER3, TROP2, B7H3 ADCs as combination partners 7 Immunomodulators Targeted therapies mRNA cancer immunotherapies We are Uniquely Positioned to Combine Approaches to Transform Cancer Care 1. Synergistic potential.


 
8 1. Partnered with Genentech, a member of the Roche Group. Our Priorities are Novel mRNA Cancer Immunotherapy and Next-Generation IO-Backbone PD-L1/VEGF-A antibody BNT327 Novel mRNA cancer immunotherapy Potential to become the next-generation IO-backboneNext-generation of personalized cancer therapy targeting tumor associated antigens and cancer mutations FixVac & iNeST1 Our next-generation IO-backbone Resected cancers (adjuvant) Neoadjuvant, 1L advanced/metastatic Late stage, refractory cancers Clinical stage candidates for combination therapy ADCs Cell and gene therapiesIO molecules mRNA immunotherapies


 
2 Oncology Pipeline Update Özlem Türeci, Co-founder & Chief Medical Officer


 
Advancing Towards Commercial Stage in Oncology 1. Partnered with DualityBio. 10 BNT327 BNT323/DB-13031 mRNA Cancer Immunotherapies BNT327 data continue to support potential as a next-generation IO- backbone for combination approaches Updates for off-the-shelf and individualized mRNA cancer immunotherapies expected in 2H 2025 Advance BNT323/DB-13031 towards BLA submission


 
BNT327: Synergistic Targeting of PD-L1 and VEGF Local neutralization of angiogenic and immunosuppressive VEGF-A effects NSCLC IHC1 Bispecific MOA 1. IHC data: Human Protein Atlas. VEGF-A PD-L1 Targeting the TME and blockade of PD-1/PD-L1 signaling Anti-VEGF-A (Fab) Anti-PD-L1 (VHH) VEGF-A dimer in the TME PD-L1 ligand on tumor cells Tumor microenvironment (TME) BNT327 VEGF-A dimer in the TME Anti-VEGF-A (Fab) Anti-PD-L1 (VHH) PD-L1 ligand on tumor cells 11


 
12 Partnered with: 1. DualityBio; 2. MediLink. Accelerating BNT327 Global Clinical Development Explore potential of BNT327 in three waves of focused development • Phase 2 in TNBC • Phase 2 in SCLC • Phase 3 in SCLC (ROSETTA Lung-01) • Phase 2/3 in NSCLC (ROSETTA Lung-02) Ongoing Planned • Phase 3 in TNBC (ROSETTA Breast-01) for 2025 3 Broaden2 Combine1 Establish Ongoing Planned BNT327 + chemo: Establish in combination with CTx in potential fast-to-market indications BNT327 + ADC: Explore expansion to novel combinations with ADCs in high unmet need indications BNT327 + novel assets: Broaden to further indications • Phase 1/2 with BNT323/DB-13031 (HER2) • Phase 1/2 with BNT324/DB-13111(B7H3) • Phase 1/2 with BNT326/YL2022 (HER3) • Additional combinations in 2025+ • Phase 1/2 with BNT325/DB-13051 (TROP2) in solid tumors Portfolio of 20+ clinical oncology assets in-house • Combine with IO bispecifics • Combine with cell therapies • Combine with novel ADCs


 
BNT327 Combined With Chemotherapy Indicated Encouraging Efficacy in 1L TNBC Irrespective of PD-L1 Status in Phase 1/2 Study 1. Incidence from SEER (US); Zentrum für Krebsregisterdaten (DE); Globocan (ES); Sante Publique (FR); AIOM (IT); Cancer Research UK . 2 Benchmark study: KEYNOTE-355 as reported in Cortes, J, et al. New England Journal of Medicine,. 2022. 3. The above information is not based on head-to-head trials between BioNTech’s investigational candidates and other products or product candidates. Furthermore, definitive conclusions cannot be drawn from cross-trial comparisons or anticipated data, as they may be confounded by various factors, and should be interpreted with caution. 4. Obtained from subgroup analysis. 5. mPFS for CPS < 10 subgroup from Cortes, J. et al. Lancet, 2020. Unmet medical need remains high for patients with TNBC Patients with Stage IV TNBC1 have a 5-year survival rate of 10% We believe BNT327 has the potential to become a first-line treatment option for patients with TNBC3, including those currently not addressed by existing IO therapies Benchmark2 comparator data by PD-L1 expression level (Keynote-355) Cortes, J, et al., New England Journal of Medicine, 2022 1L TNBC (CPS <10)4,5 1L TNBC (CPS ≥ 10) Benchmark regimen Chemo Pembro + Chemo ORR 35 % 53 % Median PFS 5.7 months 9.7 months Median OS 15.2 months 23.0 months The above data are not based on a head-to-head study comparing BioNTech’s investigational products with other products/candidates - no conclusions can be drawn. Phase 1/2 Study (NCT05918133)​: Interim overall survival Jiong Wu et al. presented at SABCS 2024 ITT population (n=42)​ Confirmed ORR (95% CI) 73.8 % (58.0, 86.1) Median PFS (95% CI) 13.5 months (9.4, 19.3) 12-month OS rate (95% CI) 80.8 % (65.3, 89.9)​ 18-month OS rate (95% CI) 69.7 % (52.7, 81.6)​ A manageable safety profile was observed, with no new safety signals beyond those typically described for nab-paclitaxel and anti- PD-1/PD-L1 and anti-VEGF monotherapies.​ 13


 
BNT327 Combined With Chemotherapy Indicated Encouraging Efficacy in 1L ES-SCLC in Phase 2 Study 1. Incidence from: SEER data for diagnosed SCLC incidence in US; Cancer Research UK; Zentrum für Krebsregisterdaten; Sante Publique; AIOM; EPDATA. 2. Benchmark study: IMpower133 as reported in L. Horn et al., New England Journal of Medicine, 2018 3. The above information is not based on head-to-head trials between BioNTech’s investigational candidates and other products or product candidates. Furthermore, definitive conclusions cannot be drawn from cross- trial comparisons or anticipated data, as they may be confounded by various factors, and should be interpreted with caution. Unmet medical need remains high for patients with ES-SCLC Patients with ES-SCLC1 have a 5-year survival rate of 3% We believe BNT327 has the potential to become a new first-line treatment option for patients with ES-SCLC3 Benchmark2 comparator data (IMpower133) L. Horn et al., New England Journal of Medicine, 2018 1L ES-SCLC Benchmark regimen Atezo + Chemo ORR 60% Median PFS 5.2 months Median OS 12.3 months The above data are not based on a head-to-head study comparing BioNTech’s investigational products with other products/candidates - no conclusions can be drawn. Phase 2 Study (NCT05844150)​: Emerging efficacy profile Ying Cheng et al. presented at ELCC 2025 ITT population (n=48)​ Confirmed ORR (95% CI) 85.4 % (72.2, 93.9) Median PFS (95% CI) 6.9 months (4.34, 8.21) Median OS (95% CI) OS events, n (%) 16.8 months (14.3, --)​ 17 (35.4) 12-month OS rate (95% CI) 72.7 % (57.6, 83.1)​ A manageable safety profile was observed, with no new safety signals beyond those typically described for chemotherapy agents and anti-PD-(L)1 and anti-VEGF monotherapies. 14


 
Treatment outcomes vary based on histology and PD-L1 levels in 1L NSCLC patients without actionable genomic alterations 7% 8% 10% 11% 37% 44% 46% 37% US EU5 Stage IV Stage III Stage II Stage I Non-Small Cell Lung Cancer is One of the Highest Incidence Cancers Globally1 15 1. Globocan – Cancer Tomorrow; 2. CancerMPact® 2024 Treatment Architecture EU5 and US; Note that 5-year survival reported includes all comer NSCLC population ie including with actionable genetic alterations; 3. Ganti AK, et al., Update of Incidence, Prevalence, Survival, and Initial Treatment in Patients With Non-Small Cell Lung Cancer in the US. JAMA Oncology, 2021 Dec; 4. Mansour MSI et al., PD-L1 Expression in Non-Small Cell Lung Cancer Specimens: Association with Clinicopathological Factors and Molecular Alterations, International Journal of Molecular Sciences, 2022 Apr 19;23(9):4517; 5. Saez de Gordoa, K. et al. PD-L1 Expression in Non-Small Cell Lung Cancer: Data from a Referral Center in Spain. Diagnostics 2021, 11, 1452; 6. Garassino MC, et al. Pembrolizumab Plus Pemetrexed and Platinum in Nonsquamous Non-Small-Cell Lung Cancer: 5-Year Outcomes From the Phase 3 KEYNOTE-189 Study. Journal of Clinical Oncology, 2023 Apr 10;41(11):1992-1998; 7. Silvia Novello et al., Pembrolizumab Plus Chemotherapy in Squamous Non–Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study, Journal of Clinical Oncology, 41, 1999-2006(2023). ~415k 2030 U.S., EU4, U.K. NSCLC projected incidence1 NSCLC Staging distribution2 Non-squamous (~ 70%)3 Squamous (~ 30%)3 PD-L1 ≥ 50% (~ 25 - 30%)4,5 5-year OS: 30% (KN-189)6 5-year OS: 23% (KN-407)7 PD-L1 1 - 49% (~ 30 - 40%)4,5 5-year OS: 20% (KN-189)6 5-year OS: 21% (KN-407)7 PD-L1 < 1% (~ 30 - 40%)4,5 5-year OS: 10% (KN-189)6 5-year OS: 11% (KN-407)7


 
BNT327 Indicates Single Agent Activity in 1L NSCLC in Phase 1b/2a Study 16 1. Benchmark study: KEYNOTE-024 as reported in Reck, M. et al. New England Journal of Medicine, 2016; 2. The above information is not based on head-to-head trials between BioNTech’s investigational candidates and other products or product candidates. Furthermore, definitive conclusions cannot be drawn from cross-trial comparisons or anticipated data, as they may be confounded by various factors, and should be interpreted with caution Phase 1b/2a (NCT05918445); Cohort 1: 1L NSCLC (EGFR & ALK WT) Wu, C. et al. presented at ASCO 2024 1L NSCLC mono tx (cohort 1, n=17): ORR 47%, DCR 100%, mPFS 13.6 months Comparable ORR in PD-L1 1–49% (n=9) and PD-L1 ≥50% (n=8) PD-L1 ≥50% PD-L1 1–49% SD PR 60 40 20 0 −20 −40 −60 −80 B e s t c h a n g e f ro m b a s e lin e ( % ) 0 50 SD PD PR On Treatment 30 10 −10 −30 −50 −70 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 C h a n g e f ro m b a s e lin e ( % ) Months Data cut off date: 2024-03-15 Benchmark1 comparator data Indication Benchmark2 regimen ORR mPFS mOS 1L NSCLC (PD-L1 > 50%) Pembrolizumab monotherapy 45% 7.7 months 26.3 months The above data are not based on a head-to-head study comparing BioNTech’s investigational products with other products/candidates - no conclusions can be drawn. . BNT327 indicated manageable safety in this patient population. Safety events were consistent with those described for anti-PD-L1 and anti-VEGF monotherapy.


 
1:1 ROSETTA Lung-02 – Our First Global Registrational Trial in NSCLC Key eligibility criteria • Treatment naïve Stage IIIB/IIIC or IV NSCLC • RECIST 1.1 measurable disease • ECOG PS 0 or 1 • PD-L1 all-comers Stratification factors Phase 3 • PD-L1 (negative, 1-49%, ≥50%) • Brain metastasis (Y/N) • Region (East Asia vs RoW) 1:1 BNT327 DL1 + Carboplatin + Pemetrexed followed by BNT327 DL1 + Pemetrexed BNT327 DL2 + Carboplatin + Pemetrexed followed by BNT327 DL2 + Pemetrexed Four cycles BNT327 selected DL + Carboplatin + Pemetrexed followed by BNT327 + Pemetrexed Four cycles Pembrolizumab 200 mg Q3W + Carboplatin + Pemetrexed followed by pembrolizumab + Pemetrexed BNT327 DL1 + Carboplatin + Paclitaxel followed by BNT327 DL1 Four cycles BNT327 selected DL + Carboplatin + Paclitaxel followed by BNT327 BNT327 DL2 + Carboplatin + Paclitaxel followed by BNT327 DL2 Four cycles Pembrolizumab 200 mg Q3W + Carboplatin + Paclitaxel followed by pembrolizumab Substudy A (non-squamous NSCLC) 1:1 Substudy B (squamous NSCLC) Phase 2 (n=40) Phase 3 (n=942) A Phase 2/3, multisite, randomized global trial of BNT327 in combination with chemotherapy in first-line non-small cell lung cancer (NCT06712316) 1:1 Key endpoints (Phase 3) Primary: PFS, OS Secondary: ORR, DOR, Safety 17


 
Related Program Indication Content BNT327 1L NSCLC Phase 2/3 TiP (ROSETTA Lung-02) BNT327 1L SCLC Phase 3 TiP (ROSETTA Lung-01) BNT327 1L Mesothelioma Phase 2 data BNT3161 2L+ Melanoma Phase 2 data BNT3161 2L+ CRPC Phase 1 data BNT324/DB-13112 2L+ CRPC Phase 2 data BNT142 CLDN6+ Solid Tumors Phase 1/2 data BioNTech at ASCO 2025 18 1. Partnered with 1. OncoC4; 2. DualityBio. Across portfolio Data for making informed decisions about the direction of further development


 
Financial Update Jens Holstein, Chief Financial Officer3


 
Q1 2025 Financial Results 1. Numbers have been rounded; numbers presented may not add up precisely to the totals and may have been adjusted in the table. Presentation of the consolidated statements of profit or loss has been condensed. More information can be found in BioNTech’s Report on Form 6-K for the three months ended March 31, 2025, filed today with the United States Securities and Exchange Commission and available at https://www.sec.gov/; 2. Cash and cash equivalents plus security investments as of March 31, 2025, reached €15,854.4 million, comprising €10,184.9 million cash and cash equivalents, €3,542.0 million current security investments and €2,127.5 million non-current security investments, respectively. 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 NIH, BioNTech expects to be reimbursed approximately $535 million by its collaboration partner during 2025 and 2026. Reimbursement payments have begun to be received in the first quarter of 2025. 20 (in millions €, except per share data)1 2025 2024 Total Revenues 183 188 Cost of sales (84) (59) Research and development expenses (526) (508) Sales and marketing expenses (14) (16) General and administrative expenses (107) (117) Other operating result 14 5 Operating loss (534) (507) Finance result 89 175 Income taxes 29 17 Net loss (416) (315) Loss per share Basic and diluted loss per share (1.73) (1.31) Three months ended March 31 Balance Sheet as of March 31, 2025 €15.9 bn Cash and cash equivalents plus security investments2


 
21 2025 Financial Year Guidance Confirmed1 Guidance considerations • Our revenue guidance assumes relatively stable vaccination rates, pricing and market share as compared to 2024. We also anticipate a revenue phasing similar to 2024 with the last 3-4 months driving the full year revenue figure. However, 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. • Inventory write-downs and other charges are estimated to be ~15% of BioNTech’s share of gross profit from COVID-19 vaccines sales in Pfizer’s territory • Anticipated revenues related to service businesses include InstaDeep, JPT Peptide and IMFS as well as revenues from the German pandemic preparedness agreement Planned FY 2025 revenues Total revenues €1,700 – €2,200 m Planned FY 2025 expenses and capex4 R&D expenses €2,600 – €2,800 m SG&A expenses €650 – €750 m Capital expenditure for operating activities €250 – €350 m FY 2025 Guidance 1. 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.


 
4 Strategic Outlook Ryan Richardson, Chief Strategy Officer


 
23 Partnered with: 1. DualityBio; 2. Pfizer. Strategic Priority Areas in 2025 mRNA Cancer Immunotherapy BNT327 Commercial Readiness in Oncology COVID-19 Vaccine2 » Expect first randomized data in the adjuvant setting (CRC) » Continue to execute 7 ongoing Phase 2 trials and first novel combination trials » Advance 3 global registration- enabling trials in potential fast-to-market indications » Generate first BNT327+ ADC combination datasets » Advance BNT323/DB-13031 towards BLA submission » Continue to build targeted AI-enabled commercialization team in key markets » Maintain global COVID-19 vaccine market leadership » Advance next-gen and combination vaccine programs 2025


 
Save the date Annual General Meeting May 16, 2025 Innovation Series R&D Day November 11, 2025


 
Thank you


 
Appendix


 
27 Partnered with: 1. DualityBio; 2. Genentech, a member of the Roche Group; 3. In collaboration with Regeneron. Selected Pipeline Milestones in 2025 and Beyond Program Indication 2025+ Milestone Next-generation immunomodulator BNT327 1L SCLC China Phase 2 data 1L/2L SCLC Global Phase 2 dose optimization data 1L/2L TNBC Global Phase 2 dose optimization data BNT327 + BNT325/DB-13051 Solid tumors Global Phase 1 data mRNA cancer immunotherapy Autogene cevumeran (BNT122 / RO7198457)2 ctDNA+ adj. CRC Phase 2 data BNT1113 2L+ melanoma Phase 2 data BNT1163 PD-L1 > 1% NSCLC Phase 1 data Targeted therapy BNT3231 2L+ HER2 EC Phase 2 data Regulatory submission


 
BioNTech’s Oncology Pipeline – Phase 2 and Phase 3 Clinical Trials Partnered with: 1. Genentech, member of Roche Group; 2. Genmab; 3. MediLink Therapeutics; 4. OncoC4; 5. DualityBio. 6. In collaboration with Regeneron; 7. Trial ongoing in China only. BNT327 (PD-L1 x VEGF-A) 1L/2L met. TNBC, + CTx BNT316/ONC-392 (gotistobart)4 (CTLA-4) aPD-1/PD-L1 experienced squamous NSCLC BNT323/DB-13035 (trastuzumab pamirtecan) (HER2) HR+/HER2-low met. breast cancer BNT1116 aPD-(L)1-R/R melanoma, + cemiplimab BNT113 1L rel./met. HPV16+ PD-L-1+ HNC, + pembrolizumab Autogene cevumeran (BNT122/RO7198457)1 Adj. ctDNA+ stage II or III CRC BNT1166 1L adv. PD-L1  50% NSCLC, + cemiplimab Autogene cevumeran (BNT122/RO7198457)1 Adj. PDAC, + atezolizumab + mFOLFIRINOX BNT316/ONC-392 (gotistobart)4 (CTLA-4), PROC, + pembrolizumab BNT327 (PD-L1 x VEGF-A) 1L/2L+ (ES-)SCLC, + CTx Autogene cevumeran (BNT122/RO7198457)1 Adj. MIUC, + nivolumab BNT327 (PD-L1 x VEGF-A) 2L SCLC, + CTx7 BNT327 (PD-L1 x VEGF-A) 2L ES-SCLC, + CTx7 BNT327 (PD-L1 x VEGF-A) 1L ES-SCLC + CTx7 BNT327 (PD-L1 x VEGF-A) EGFR TKI experienced, EGFRm NSCLC, + CTx7 BNT327 (PD-L1 x VEGF-A) 1L MPM, + CTx7 BNT327 (PD-L1 x VEGF-A) 1L HCC + CTx7 BNT327 (PD-L1 x VEGF-A) 1L TNBC, + CTx7 Phase 3Phase 2 mRNA immunotherapy Next generation IO Targeted therapy BNT327 (PD-L1 x VEGF-A) 1L SCLC, + CTx BNT327 (PD-L1 x VEGF-A) 1L NSCLC, + CTx BNT327 (PD-L1 x VEGF-A) 1L TNBC, + CTx PLANNED BNT211 (CLDN6) CLDN6+ testicular cancer PLANNED BNT323/DB-13035 (trastuzumab pamirtecan) (HER2) HER2+ endometrial cancer PLANNED BNT327 (PD-L1 x VEGF-A) 2L NEN, + CTx7 BNT323/DB-13035 (trastuzumab pamirtecan) (HER2), multiple solid tumors 28 BNT327 (PD-L1 x VEGF-A) 2L NSCLC, + CTx NEW


 
PLANNED PLANNED BioNTech’s Oncology Pipeline – Phase 1 and Phase 1/2 Clinical Trials Partnered with: 1. Genentech, member of Roche Group; 2. Genmab; 3. In collaboration with Regeneron; 4. MediLink Therapeutics; 5. OncoC4; 6. DualityBio. 7. Trial ongoing in China only. Phase 1/2Phase 1 BNT211 (CLDN6) Multiple solid tumors BNT312/GEN10422 (CD40x4-1BB) Multiple solid tumors BNT316/ONC-392 (gotistobart)5 (CTLA-4) Multiple solid tumors BNT142 (CD3xCLDN6) Multiple CLDN6-pos. adv. solid tumors BNT325/DB-13056 (TROP-2) Multiple solid tumors BNT324/DB-13116 (B7-H3) Multiple solid tumors BNT116 Adv. NSCLC BNT314/GEN10592 (EpCAMx4-1BB) Multiple solid tumors BNT326/YL2024 (HER3) Multiple solid tumors BNT316/ONC-392 (gotistobart)5 (CTLA-4) mCRPC, + radiotherapy BNT315/GEN10552 (OX40) Multiple solid tumors BNT327 / BNT3256 combination Multiple solid tumors BNT327 (PD-L1 x VEGF-A) 1L TNBC7 BNT327 (PD-L1 x VEGF-A) Multiple solid tumors7 BNT152 + BNT153 (IL-7, IL-2) Multiple solid tumors BNT327 / BNT3213 combination 1L HCC7 BNT3173 Multiple solid tumors BNT322/GEN10562 Multiple solid tumors BNT327 / BNT3236 (trastuzumab pamirtecan) combination Adv. or metastatic breast cancer BNT327 / BNT3246 combination Multiple solid tumors BNT327 / BNT3264 combination Multiple solid tumors PLANNED Autogene cevumeran (BNT122/RO7198457)1 Multiple solid tumors 29 mRNA immunotherapy Next generation IO Targeted therapy


 
Abbreviation Directory n L nth line EU4(5) Includes Germany, France, Italy, Spain (UK) OX40 CD134 AACR American Association for Cancer Research Fab Fragment antigen binding PD Progressive disease ADC Antibody-drug conjugate FixVac Fixed Antigen Vaccine PDAC Pancreatic ductal adenocarcinoma adj. Adjuvant FY Fiscal year PD-(L)1 Programmed cell death protein (ligand) 1 AI Artificial intelligence HCC Hepatocellular carcinoma PFS Progression-free survival AIOM Associazione Italiana di Oncologia Medica HER2 (or 3) Human epidermal growth factor receptor 2 (or 3) PR Partial response ALK Anaplastic large-cell lymphoma kinase HNC Head and neck cancer PROC Platinum-resistant ovarian cancer ASCO American Society of Clinical Oncology HPV Human papilloma virus QxW Every x week(s) BLA Biologics License Applications HR Hormone receptor R&D Research and development CAPEX Capital expenditures IHC Immunohistochemistry RECIST Response Evaluation Criteria in Solid Tumors CD-x Cluster of differentiation IMFS BioNTech Innovative Manufacturing Services RoW Rest of world CI Confidence interval iNeST Individualized NeoAntigen-Specific Therapy R/R Relapsed/refractory CLDN6 Claudin 6 IO Immuno-oncology SABCS San Antonio Breast Cancer Symposium CPS Combined positive score ITT Intention to treat (ES)SCLC (Extensive stage) small cell lung cancer CRC Colorectal cancer JAMA Journal of the American Medical Association SD Stable disease CRPC Castration resistant prostate cancer m Median SEC U.S. Securities and Exchange Commission ctDNA Circulating tumor DNA M&A Merger and acquisitions SEER Surveillance, epidemiology, and end results CTLA Cytotoxic T-lymphocyte-associated protein MIUC Muscle-invasive urothelial carcinoma SG&A Selling, general and administrative expenses CTx Chemotherapy MOA Mechanism of Action TKI Tyrosine kinase inhibitor DCR Disease control rate MPM Malignant pleural mesothelioma TME Tumor microenvironment DL Dose level mRNA Messenger ribonucleic acid TNBC Triple-negative breast cancer DOR Duration of response NCT National clinical trial TROP2 Trophoblast cell-surface antigen 2 EC Endometrial cancer NEN Neuroendocrine neoplasm UK United Kingdom ECOG Eastern Cooperative Oncology Group NIH National Institutes of Health U.S. United States EGFR Epidermal growth factor receptor NSCLC Non-small cell lung cancer VEGF-A Vascular endothelial growth factor A ELCC European Lung Cancer Congress ORR Objective response rate VHH Heavy chain variable EpCAM Epithelial cell adhesion molecule OS Overall survival WT Wild type 30