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 MARCH 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 March 10, 2025, BioNTech SE (the “Company”) issued a press release announcing its full year 2024 financial results and corporate update and details of a conference call to be held at 8:00 am EDT on March 10, 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.
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| BioNTech SE | | | |
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| 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: March 10, 2025
EXHIBIT INDEX
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| Exhibit | Description of Exhibit |
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| 99.1 | |
| 99.2 | |
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BioNTech Announces Fourth Quarter and Full Year 2024 Financial Results and Corporate Update
•Advanced oncology pipeline including more than 20 active Phase 2 and Phase 3 clinical trials with a strategic focus on two priority pan-tumor programs: next-generation immunomodulator candidate BNT327 and mRNA cancer immunotherapies
•Multiple data readouts expected in 2025 and 2026 aimed at providing clinical proof of BioNTech’s pipeline strategy and advancing the Company towards becoming a diversified multi-product oncology portfolio company by 2030
•Completed acquisition of Biotheus securing full control of next-generation immunomodulator candidate BNT327, a bispecific antibody targeting PD-L1 and VEGF-A*
•Successfully launched JN.1- and KP.2-adapted COVID-19 vaccines across different countries and regions and maintained global market leadership
•Fourth quarter and full year 2024 revenues of €1.2 billion and €2.8 billion**, respectively
•Full year 2024 net loss of €0.7 billion and diluted loss per share of €2.77 ($3.00)1
•Cash and cash equivalents plus security investments of €17.4 billion as of December 31, 20242
•Expects 2025 total revenues between €1.7 billion and €2.2 billion
Conference call and webcast scheduled for March 10, 2025, at 8:00 a.m. EDT (1:00 p.m. CET)
MAINZ, Germany, March 10, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today reported financial results for the three months and full year ended December 31, 2024, and provided an update on its corporate progress.
“From the very beginning, BioNTech’s vision has been to translate our science into survival and become an immunotherapy powerhouse. In 2024, we made significant progress towards our vision through important oncology pipeline advancements, including the initiation of global Phase 3 clinical trials for our anti-PD-L1/VEGF-A bispecific antibody candidate BNT327 and key data updates from our mRNA cancer immunotherapy programs,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “We expect 2025 to be a data-rich year with multiple important updates from our priority programs, which we believe have disruptive potential and could improve the standard of care, if successfully developed and approved.”
Financial Review for Fourth Quarter and Full Year 2024 Financial Results
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in millions €, except per share data | | | Fourth Quarter 2024 | | | Fourth Quarter 2023 | | | Full Year 2024 | | | Full Year 2023 |
Total revenues | | | 1,190.0 | | | 1,479.0 | | | 2,751.1 | | | 3,819.0 |
Net profit / (loss) |
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| 259.5 |
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| 457.9 |
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| (665.3) |
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| 930.3 |
Diluted earnings / (loss) per share |
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| 1.08 |
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| 1.88 |
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| (2.77) |
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| 3.83 |
Total revenues reported were €1,190.0 million for the three months ended December 31, 2024, compared to €1,479.0 million for the comparative prior year period. For the year ended December 31,
* All target abbreviations are compiled in an abbreviation directory at the end of this press release.
** All numbers in this press release have been rounded.
2024, revenues were €2,751.1 million, compared to €3,819.0 million for the comparative prior year period. The decrease in revenues was primarily driven by lower sales of the Company’s COVID-19 vaccines due to reduced market demand. In addition, write-downs by BioNTech’s collaboration partner Pfizer Inc. (“Pfizer”) significantly reduced the Company’s gross profit share which negatively influenced its revenues.
Cost of sales were €243.5 million for the three months ended December 31, 2024, compared to €179.1 million for the comparative prior year period. For the year ended December 31, 2024, cost of sales were €541.3 million, compared to €599.8 million for the comparative prior year period. Cost of sales were influenced by COVID-19 vaccine sales and inventory write-downs and scrapping.
Research and development (“R&D”) expenses were €611.8 million for the three months ended December 31, 2024, compared to €577.8 million for the comparative prior year period. For the year ended December 31, 2024, R&D expenses were €2,254.2 million, compared to €1,783.1 million for the comparative prior year period. R&D expenses were mainly influenced by advancing clinical studies for the Company’s late-stage oncology product candidates. Further contributions to the increase came from higher personnel expenses resulting from an increase in headcount.
Sales, general and administrative (“SG&A”)3 expenses, in total, amounted to €132.1 million for the three months ended December 31, 2024, compared to €142.3 million for the comparative prior year period. For the year ended December 31, 2024, SG&A expenses were €599.0 million, compared to €557.7 million for the comparative prior year period. SG&A expenses were mainly influenced by the setup and enhancement of commercial IT platforms and personnel expenses resulting from an increase in headcount.
Other operating results amounted to negative €54.0 million during the three months ended December 31, 2024, compared to negative €53.6 million for the comparative prior year period. For the year ended December 31, 2024, other operating result amounted to negative €670.9 million compared to negative €188.0 million for the prior year period. The decrease was mainly due to the settlement of contractual disputes and related expenses to such disputes and other litigations. The amounts for contractual disputes are net of the related reimbursements expected to be received.
Income taxes were accrued with an amount of €41.7 million in tax expenses for the three months ended December 31, 2024, compared to €205.3 million in accrued tax expenses for the comparative prior year period. For the year ended December 31, 2024, income taxes were realized with an amount of €12.4 million in tax income for the year ended December 31, 2024, compared to €255.8 million of accrued tax expenses for the comparative prior year period.
Net profit was €259.5 million for the three months ended December 31, 2024, compared to €457.9 million net profit for the comparative prior year period. For the year ended December 31, 2024, net loss was €665.3 million, compared to a net profit of €930.3 million for the comparative prior year period.
Cash and cash equivalents plus security investments2 as of December 31, 2024, reached €17,359.2 million, comprising of €9,761.9 million in cash and cash equivalents, €6,536.2 million in current security investments and €1,061.1 million in non-current security investments.
Diluted earnings per share was €1.08 for the three months ended December 31, 2024, compared to €1.88 for the comparative prior year period. For the year ended December 31, 2024, diluted loss per share was €2.77, compared to diluted earnings per share of €3.83 for the comparative prior year period.
Shares outstanding as of December 31, 2024, were 239,970,804, excluding 8,581,396 shares held in treasury.
“Through strategic investments in our priority programs like our next-generation immunomodulator candidate BNT327, we strive to meaningfully improve treatments for patients,” said Jens Holstein, CFO of BioNTech. “Our strong financial position enables us to fuel our R&D activities and to prepare for multiple product launches in the coming years. With our targeted investments we aim to create long-term value for the benefit of BioNTech’s stakeholders.”
2025 Financial Year Guidance4
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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.
Planned 2025 Financial Year Expenses and Capex
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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 |
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BioNTech expects to continue to focus investments on R&D and scaling the business for late-stage development and commercial readiness in oncology, while continuing to be cost disciplined. Strategic capital allocation will remain 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 audited consolidated financial statements as of and for the year ended December 31, 2024, can be found in BioNTech’s Annual Report on Form 20-F filed today with the United States Securities and Exchange Commission (“SEC”) and available at www.sec.gov.
Endnotes
1 Calculated applying the average foreign exchange rate for the year ended December 31, 2024, as published by the German Central Bank (Deutsche Bundesbank).
2 Payments associated with the closing of the Biotheus acquisition and with the resolved settlement of a contractual dispute with the National Institutes of Health (“NIH”) are expected to result in a cash outflow of approximately $1.6 billion to be reflected in cash & cash equivalents in the Company’s first quarter 2025 financial results. The settlement payment of $467 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 these settlements, BioNTech expects to be reimbursed approximately $535 million by its partner during 2025 and 2026.
3 Sales, general and administrative expenses (“SG&A”) include sales and marketing expenses as well as general and administrative expenses.
4 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, as well as potential changes to the law or governmental policy, including public health policy, at the state or national level, and evolving public sentiment around vaccines and mRNA technology, in the United States and/or elsewhere. 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 Fourth Quarter 2024, Key Post Period-End Events and 2025 Outlook
Selected Oncology Pipeline Updates
In 2024, the Company’s pipeline continued to mature towards later stages of clinical development with a focus on two priority programs: our investigational next-generation immunomodulator candidate BNT327 and mRNA cancer immunotherapies. BioNTech’s oncology pipeline currently contains over 20 ongoing Phase 2 and 3 clinical trials. In 2025, the Company plans to continue progressing its pipeline towards commercialization, with its first oncology launch expected in 2026.
Next-Generation Immunomodulators
BNT327 is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization.
•In December 2024, BioNTech initiated a global randomized Phase 3 clinical trial (NCT06712355) evaluating BNT327 plus chemotherapy compared to atezolizumab plus chemotherapy in first-line extensive-stage small cell lung cancer (“ES-SCLC”).
•In December 2024, BioNTech initiated a global randomized Phase 2/3 clinical trial (NCT06712316) evaluating BNT327 plus chemotherapy compared to pembrolizumab plus chemotherapy in first-line non-small cell lung cancer (“NSCLC”).
•In December 2024, at the San Antonio Breast Cancer Symposium (“SABCS”), interim data were presented from the Phase 1/2 clinical trial (NCT05918133) evaluating BNT327 in combination with chemotherapy in a cohort of patients with locally advanced, previously untreated triple-negative breast cancer (“TNBC”). In 42 patients, first-line treatment with BNT327 combined with nab-paclitaxel chemotherapy showed encouraging antitumor activity and survival outcomes regardless of PD-L1 status, together with a manageable safety profile.
•A global randomized Phase 3 clinical trial evaluating BNT327 in first-line TNBC is on track to start in 2025.
•Data from the ongoing global Phase 2 dose optimization clinical trials evaluating BNT327 in combination with chemotherapy in first-line small cell lung cancer (“SCLC”) (BNT327-01, NCT06449209) and TNBC (BNT327-02, NCT06449222) are planned to be published in 2025.
•Data from two Phase 2 clinical trials conducted in China in first- and second-line SCLC (NCT05844150, NCT05879068, respectively) are expected to be presented at the European Lung Cancer Congress (“ELCC”) taking place March 26-29, 2025 in Paris, France.
Title: Phase 2 study of the efficacy and safety of BNT327 plus systemic chemotherapy as first-line therapy for ES-SCLC
Presentation Date: March 28, 2025
Poster Number: 302P
Author: Y. Cheng
Title: Updated Phase 2 efficacy and safety results of BNT327 combined with paclitaxel as second-line therapy in SCLC
Presentation Date: March 28, 2025
Poster Number: 332P
Author: Y. Cheng
•First clinical data from the ongoing global Phase 1/2 expansion cohorts (NCT05438329) evaluating the combination of BNT327 and BNT325/DB-1305, a TROP2-targeted antibody-drug conjugate (“ADC”) candidate, are planned to be published in 2025.
•Additional clinical trials exploring novel combinations of BNT327 with the ADC candidates BNT323/DB-1303 (trastuzumab pamirtecan) targeting HER2, BNT324/DB-1311 targeting B7-H3 or BNT326/YL202 targeting HER3 are planned to start in 2025.
BNT316/ONC-392 (gotistobart) is an anti-CTLA-4 monoclonal antibody candidate being developed in collaboration with OncoC4, Inc. (“OncoC4”).
•In December 2024, the U.S. Food and Drug Administration (“FDA”) lifted the partial clinical hold on the OncoC4-sponsored Phase 3 clinical trial (PRESERVE-003; NCT05671510) evaluating the efficacy and safety of BNT316/ONC-392 as monotherapy in patients with metastatic NSCLC that progressed under previous PD-(L)1-inhibitor treatment. Based on the available clinical trial data and upon alignment with the FDA, the companies will solely continue enrollment of patients with squamous NSCLC.
mRNA Cancer Immunotherapies
Autogene cevumeran (BNT122/RO7198457) and BNT111 are investigational immunotherapies for the treatment of cancer based on BioNTech’s systemically administered uridine mRNA-lipoplex technology.
Autogene cevumeran is an individualized neoantigen-specific mRNA cancer immunotherapy candidate being developed in collaboration with Genentech, Inc. (“Genentech”), a member of the Roche Group (“Roche”).
•In December 2024, the first patient was treated in a global randomized Phase 2 clinical trial (IMCODE004; NCT06534983) evaluating autogene cevumeran in combination with nivolumab compared to nivolumab alone as an adjuvant treatment in high-risk muscle-invasive urothelial carcinoma (“MIUC”).
•In January 2025, a manuscript summarizing the results of a Phase 1 clinical trial (NCT03289962) evaluating autogene cevumeran in combination with atezolizumab in patients with advanced solid tumors was published in Nature Medicine (Lopez et al., 2025). In February 2025, a manuscript denoting follow up data from an investigator-initiated Phase 1 clinical trial (NCT04161755, Rojas et al., 2023) evaluating autogene cevumeran in combination with atezolizumab in patients with pancreatic ductal adenocarcinoma (“PDAC”) in an adjuvant treatment setting was published in Nature (Sethna et al., 2025).
•First data from the ongoing global randomized Phase 2 clinical trial (NCT04486378) evaluating autogene cevumeran as an adjuvant treatment compared to watchful waiting after
standard of care chemotherapy in resected circulating tumor DNA+ (“ctDNA”) stage II (high-risk) and III colorectal cancer (“CRC”) are anticipated in late 2025 or early 2026.
BNT111 is based on BioNTech’s fully owned, off-the-shelf FixVac platform, and encodes four melanoma-associated antigens.
•BioNTech plans to present data from the ongoing Phase 2 clinical trial (BNT111-01; NCT04526899) at a medical conference in 2025. In 2024, an initial topline readout was provided noting that the clinical trial had met its primary efficacy outcome measure, demonstrating a statistically significant improvement in overall response rate (“ORR”) in patients with anti-PD-(L)1 refractory/relapsed, unresectable stage III or IV melanoma treated with BNT111 in combination with cemiplimab as compared to historical control in this treatment setting.
Antibody-Drug Conjugates
BNT323/DB-1303 (trastuzumab pamirtecan) is an ADC candidate targeting HER2 that is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”).
•BNT323/DB-1303 is being evaluated in a Phase 1/2 clinical trial (NCT05150691) in patients with advanced/unresectable, recurrent or metastatic HER2-expressing solid tumors. Data from patients with HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) advanced endometrial carcinoma are expected in 2025. A confirmatory Phase 3 clinical trial (NCT06340568) is planned to start in 2025.
•Preparation of a potential Biologics License Application (“BLA”) submission for BNT323/DB-1303 as a second line or subsequent therapy in HER2-expressing advanced endometrial cancer in 2025.
BNT324/DB-1311 is an ADC candidate targeting B7-H3 that is being developed in collaboration with DualityBio. The program has received Fast Track designation from the FDA for the treatment of patients with advanced castration-resistant prostate cancer (“CRPC”) who have progressed on or after standard systemic regimens and Orphan Drug designation for the treatment of patients with advanced esophageal squamous cell carcinoma.
•In December 2024, preliminary data from the first-in-human, open-label Phase 1/2 clinical trial (NCT05914116) were presented at the 2024 European Society for Medical Oncology (“ESMO”) Asia Congress, demonstrating encouraging efficacy and a manageable safety profile across a range of advanced solid tumors.
Cell Therapies
BNT211 consists of a CAR-T cell product candidate targeting CLDN6-positive solid tumors in combination with a CAR-T cell-amplifying RNA cancer immunotherapy encoding CLDN6.
•In January 2025, the FDA granted Regenerative Medicine Advanced Therapy (“RMAT”) designation for BNT211. The RMAT designation is designed to expedite the development and review process for promising pipeline products, including cell therapies.
•A pivotal Phase 2 clinical trial in patients with testicular germ cell tumors is expected to start in 2025 based on encouraging clinical activity observed in this patient population in the ongoing Phase 1 clinical trial (NCT04503278). The Phase 1 clinical trial is ongoing to evaluate BNT211 in other CLDN6+ cancer types, including NSCLC and gynecologic cancers.
Selected Infectious Diseases Pipeline Updates
BioNTech and Pfizer developed, manufactured and delivered JN.1- and KP.2-adapted COVID-19 vaccines which received multiple regulatory approvals and marketing authorizations in more than 40 countries and regions. In 2024, BioNTech and Pfizer delivered approximately 180 million variant-adapted COVID-19 vaccine doses worldwide.
BioNTech and Pfizer continue to invest in the research and development of next-generation and combination COVID-19 vaccine candidates.
Corporate Update for the Fourth Quarter 2024 and Key Post Period-End Events
•In November 2024, BioNTech signed an agreement to acquire Biotheus and obtain 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. The acquisition was completed in February 2025.
Upcoming Investor and Analyst Events
•Sustainability Report 2024 Publication: March 24, 2025
•Annual General Meeting: May 16, 2025
•Innovation Series AI Day: October 1, 2025
•Innovation Series R&D Day: November 18, 2025
Conference Call and Webcast Information
BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, March 10, 2025, at 8:00 a.m. EDT (1:00 p.m. CET) to report its financial results and provide a corporate update for the fourth quarter and full year 2024.
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.
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 broad 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, 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 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 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; 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 20-F for the period ended December 31, 2024 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
Target abbreviation directory
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Anti-PD-(L)1 | Anti-programmed cell death protein (death-ligand) 1 |
B7-H3 | B7 Homolog 3 |
CLDN6 | Antigen Claudin 6 |
CTLA-4 | Cytotoxic T-lymphocyte–associated antigen 4 |
HER2 | Human Epidermal Growth Factor Receptor 2 |
HER3 | Human Epidermal Growth Factor Receptor 3 |
PD-L1 | Programmed death-ligand 1 |
TROP2 | Trophoblast cell-surface antigen 2 |
VEGF-A | Vascular endothelial growth factor A |
Consolidated Statements of Profit or Loss
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| | | | | | | | | | | | |
| | | Three months ended December 31, | | | Years ended December 31, |
| | | | | | | | | | | | |
| | | 2024 | | | 2023 | | | 2024 | | | 2023 |
(in millions €, except per share data) |
| | (unaudited) | | | (unaudited) | | |
| | |
|
Revenues |
| | 1,190.0 | | | 1,479.0 | | | 2,751.1 | | | 3,819.0 |
Cost of sales |
| | (243.5) | | | (179.1) | | | (541.3) | | | (599.8) |
Research and development expenses |
| | (611.8) | | | (577.8) | | | (2,254.2) | | | (1,783.1) |
Sales and marketing expenses |
| | (21.3) | | | (18.0) | | | (67.9) | | | (62.7) |
General and administrative expenses |
| | (110.8) | | | (124.3) | | | (531.1) | | | (495.0) |
Other operating expenses |
| | (91.6) | | | (57.6) | | | (811.5) | | | (293.0) |
Other operating income |
| | 37.6 | | | 4.0 | | | 140.6 | | | 105.0 |
Operating profit / (loss) |
| | 148.6 | | | 526.2 | | | (1,314.3) | | | 690.4 |
Finance income |
| | 165.2 | | | 162.2 | | | 664.0 | | | 519.6 |
Finance expenses |
| | (12.6) | | | (25.2) | | | (27.4) | | | (23.9) |
Profit / (Loss) before tax |
| | 301.2 | | | 663.2 | | | (677.7) | | | 1,186.1 |
Income taxes |
| | (41.7) | | | (205.3) | | | 12.4 | | | (255.8) |
Net profit / (loss) |
| | 259.5 | | | 457.9 | | | (665.3) | | | 930.3 |
Earnings / (Loss) per share |
| |
| | |
| | |
| | |
|
Basic earnings / (loss) per share |
| | 1.08 | | | 1.90 | | | (2.77) | | | 3.87 |
Diluted earnings / (loss) per share |
| | 1.08 | | | 1.88 | | | (2.77) | | | 3.83 |
Consolidated Statements of Financial Position
| | | | | | | | | | | | | | | | | | | | |
| | | | | | |
| | | December 31, | | | December 31, |
(in millions €) | | | 2024 | | | 2023 |
Assets | | |
| | | |
Non-current assets | |
|
| | |
|
Goodwill | |
| 380.6 | | | 362.5 |
Other intangible assets | |
| 790.4 | | | 804.1 |
Property, plant and equipment | |
| 935.3 | | | 757.2 |
Right-of-use assets | |
| 248.1 | | | 214.4 |
Contract assets |
|
| 9.8 |
|
| — |
Other financial assets | |
| 1,254.0 | | | 1,176.1 |
Other non-financial assets | |
| 26.3 | | | 83.4 |
Deferred tax assets | |
| 81.7 | | | 81.3 |
Total non-current assets | |
| 3,726.2 | | | 3,479.0 |
Current assets | |
|
| | |
|
Inventories | |
| 283.3 | | | 357.7 |
Trade and other receivables | |
| 1,463.9 | | | 2,155.7 |
Contract assets | |
| 10.0 | | | 4.9 |
Other financial assets | |
| 7,021.7 | | | 4,885.3 |
Other non-financial assets | |
| 212.7 | | | 280.9 |
Income tax assets | |
| 50.0 | | | 179.1 |
Cash and cash equivalents | |
| 9,761.9 | | | 11,663.7 |
Total current assets | |
| 18,803.5 | | | 19,527.3 |
Total assets | |
| 22,529.7 | | | 23,006.3 |
| | | | | | |
Equity and liabilities | |
|
| | |
|
Equity | |
|
| | |
|
Share capital | |
| 248.6 | | | 248.6 |
Capital reserve | |
| 1,398.6 | | | 1,229.4 |
Treasury shares | |
| (8.6) | | | (10.8) |
Retained earnings | |
| 19,098.0 | | | 19,763.3 |
Other reserves | |
| (1,325.5) | | | (984.6) |
Total equity | |
| 19,411.1 | | | 20,245.9 |
Non-current liabilities | |
|
| | |
|
Lease liabilities, loans and borrowings | |
| 214.7 | | | 191.0 |
Other financial liabilities | |
| 46.9 | | | 38.8 |
Provisions | |
| 20.9 | | | 8.8 |
Contract liabilities | |
| 183.0 | | | 398.5 |
Other non-financial liabilities | |
| 87.5 | | | 13.1 |
Deferred tax liabilities | |
| 42.4 | | | 39.7 |
Total non-current liabilities | |
| 595.4 | | | 689.9 |
Current liabilities | |
|
| | |
|
Lease liabilities, loans and borrowings | |
| 39.5 | | | 28.1 |
Trade payables and other payables | |
| 426.7 | | | 354.0 |
Other financial liabilities | |
| 1,443.4 | | | 415.2 |
Income tax liabilities | |
| 4.5 | | | 525.5 |
Provisions | |
| 144.8 | | | 269.3 |
Contract liabilities | |
| 294.9 | | | 353.3 |
Other non-financial liabilities | |
| 169.4 | | | 125.1 |
Total current liabilities | |
| 2,523.2 | | | 2,070.5 |
Total liabilities | |
| 3,118.6 | | | 2,760.4 |
Total equity and liabilities | |
| 22,529.7 | | | 23,006.3 |
Consolidated Statements of Cash Flows
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | Three months ended December 31, | | | Years ended December 31, |
| | | | | | | | | | | | |
| | | 2024 | | | 2023 | | | 2024 | | | 2023 |
(in millions €) |
| | (unaudited) | | | (unaudited) | | |
| | |
|
Operating activities |
| |
| | |
| | |
| | |
|
Net profit / (loss) |
| | 259.5 | | | 457.9 | | | (665.3) | | | 930.3 |
Income taxes |
| | 41.7 | | | 205.3 | | | (12.4) | | | 255.8 |
Profit / (Loss) before tax |
| | 301.2 | | | 663.2 | | | (677.7) | | | 1,186.1 |
Adjustments to reconcile profit before tax to net cash flows: |
| |
| | |
| | |
| | |
|
Depreciation and amortization of property, plant, equipment, intangible assets and right-of-use assets |
| | 165.4 | | | 78.8 | | | 298.0 | | | 183.4 |
Share-based payment expenses |
| | 23.5 | | | 14.2 | | | 100.9 | | | 51.4 |
Net foreign exchange differences |
| | (32.1) | | | 66.3 | | | (109.5) | | | (298.0) |
(Gain) / Loss on disposal of property, plant and equipment |
| | (0.1) | | | 0.2 | | | (0.3) | | | 3.8 |
Finance income excluding foreign exchange differences |
| | (149.7) | | | (162.2) | | | (648.5) | | | (519.6) |
Finance expense excluding foreign exchange differences |
| | 12.6 | | | 3.4 | | | 27.4 | | | 7.9 |
Government grants |
| | (4.7) | | | 5.4 | | | (31.5) | | | 2.4 |
Unrealized (gain) / loss on derivative instruments at fair value through profit or loss |
| | 3.9 | | | (21.2) | | | 4.6 | | | 175.5 |
Working capital adjustments: |
| |
| | |
| | |
| | |
|
Decrease in trade and other receivables, contract assets and other assets |
| | (879.9) | | | (288.0) | | | 387.7 | | | 5,374.0 |
Decrease in inventories |
| | 19.9 | | | 58.0 | | | 74.5 | | | 81.9 |
Increase in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions |
| | 167.7 | | | 412.8 | | | 758.4 | | | 118.9 |
Interest received and realized gains from cash and cash equivalents |
| | 121.6 | | | 91.8 | | | 474.9 | | | 258.2 |
Interest paid and realized losses from cash and cash equivalents |
| | (6.6) | | | (1.7) | | | (13.5) | | | (5.4) |
Income tax paid |
| | (198.4) | | | (65.1) | | | (389.2) | | | (482.9) |
Share-based payments |
| | (10.9) | | | (5.0) | | | (154.5) | | | (766.2) |
Government grants received |
| | 3.3 | | | — | | | 106.0 | | | — |
Net cash flows from operating activities |
| | (463.3) | | | 850.9 | | | 207.7 | | | 5,371.4 |
Investing activities |
| |
| | |
| | |
| | |
|
Purchase of property, plant and equipment |
| | (66.6) | | | (83.8) | | | (286.5) | | | (249.4) |
Proceeds from sale of property, plant and equipment |
| | 0.7 | | | 0.1 | | | 1.2 | | | (0.7) |
Purchase of intangible assets and right-of-use assets |
| | (24.5) | | | (106.5) | | | (165.8) | | | (455.4) |
Acquisition of subsidiaries and businesses, net of cash acquired |
| | — | | | — | | | — | | | (336.9) |
Investment in other financial assets |
| | (2,068.8) | | | (3,418.2) | | | (12,370.3) | | | (7,128.4) |
Proceeds from maturity of other financial assets |
| | 2,765.9 | | | 913.3 | | | 10,740.2 | | | 1,216.3 |
Net cash flows used in investing activities |
| | 606.7 | | | (2,695.1) | | | (2,081.2) | | | (6,954.5) |
Financing activities |
| |
| | |
| | |
| | |
|
Proceeds from loans and borrowings |
| | — | | | 0.2 | | | — | | | 0.3 |
Repayment of loans and borrowings |
| | — | | | — | | | (2.3) | | | (0.1) |
Payments related to lease liabilities |
| | (7.3) | | | (12.3) | | | (43.6) | | | (40.3) |
Share repurchase program |
| | — | | | (0.8) | | | — | | | (738.5) |
Net cash flows used in financing activities |
| | (7.3) | | | (12.9) | | | (45.9) | | | (778.6) |
Net increase / (decrease) in cash and cash equivalents |
| | 136.1 | | | (1,857.1) | | | (1,919.4) | | | (2,361.7) |
Change in cash and cash equivalents resulting from exchange rate differences |
| | 13.6 | | | (15.4) | | | 14.8 | | | (14.5) |
Change in cash and cash equivalents resulting from other valuation effects |
| | (12.4) | | | 40.4 | | | 2.8 | | | 164.8 |
Cash and cash equivalents at the beginning of the period |
| | 9,624.6 | | | 13,495.8 | | | 11,663.7 | | | 13,875.1 |
Cash and cash equivalents as of December 31 |
| | 9,761.9 | | | 11,663.7 | | | 9,761.9 | | | 11,663.7 |
March 10, 2025 4th Quarter and Full Year 2024 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 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; and 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; 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 20-F for the period ended December 31, 2024, 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 4th Quarter and FY 2024 Highlights Ugur Sahin, Co-founder & Chief Executive Officer1
1 4th Quarter and FY 2024 Highlights Ugur Sahin, Co-founder & Chief Executive Officer
Building a Global Immunotherapy Powerhouse Translating Science into Survival
6 1. Partnered with Genentech, a member of the Roche Group; 2. Phase 2 data were reported for BNT111 (PR, 30 July 2024), Phase 1/2 and Phase 2 data for BNT113 (ESMO), Phase 1 data for BNT116 (AACR); BNT327 data included: Phase 1/2 in TNBC (ESMO, SABCS) and Phase 2 in NSCLC (ASCO). 3. In collaboration with Regeneron; 4. Partnered with Pfizer; 5. Consists of cash and cash equivalents of €9,761.9 million, current security investments of €6,536.2 million and non- current security investments of €1,061.1 million, as of December 31, 2024. Payments associated with the closing of the Biotheus acquisition and with the resolved settlement of a contractual dispute with the NIH are expected to result in a cash outflow of approximately $1.6 billion to be reflected in cash & cash equivalents in the first quarter of 2025. The settlement payment of $467 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 these settlements, BioNTech expects to be reimbursed approximately $535 million by its partner during 2025 and 2026. Advancing Toward Our Vision: Key Achievements in 2024 Secured global control of BNT327, expanded pipeline and strengthened in-house immunotherapy capabilities mRNA cancer immunotherapies BNT327 Corporate development COVID-19 and infectious disease vaccines Financial strength Initiated a new Phase 2 trial evaluating autogene cevumeran1 and reported data2 for BNT1113, BNT113 and BNT1163 Presented multiple datasets2 for BNT327 and announced pivotal trials targeting unmet needs in SCLC, TNBC, and NSCLC Maintained leading COVID-19 vaccine4 market share globally and progressed early-stage infectious disease pipeline Delivered a strong balance sheet : ~€ 17.4 bn total cash and cash equivalents plus security investments as of December 31, 20245
7 1. Partnered with Genentech, a member of the Roche Group. 2025 Will Be an Important Year for Our Oncology Portfolio 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, ctDNA+) Neoadjuvant, 1L advanced/metastatic Late stage, refractory cancers Clinical stage candidates for combination therapy ADCs Cell and gene therapiesIO molecules mRNA immunotherapies Important Readouts for Priority Programs in 2025
Biotheus Acquisition Provides Opportunity to Accelerate BNT327 Development Acceleration and expansion of BNT327 development Establishment of clinical development capability in Mainland China Full pipeline and platform ownership Manufacturing site supporting initial launch cGMP manufacturing facility with multiple 2000L bioreactors Comprehensive E2E bispecific antibody discovery and development capabilities 6 clinical stage assets Pre-clinical ADC pipeline ~80-person clinical development organization in China with demonstrated execution ability Global control of BNT327 development and commercialization program Expedite execution of BNT327 + ADC development plans Advancing BNT327 in multiple indications, aiming for first-to-market approvals Anti-VEGF-A Anti-PD-L1 VHH 8
2 Oncology Pipeline Update Özlem Türeci, Co-founder & Chief Medical Officer
Building an Oncology Pipeline Focused on Late-Stage Programs with Transformational Potential 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-L1+ HNC, + pembrolizumab Autogene cevumeran (BNT122/RO7198457)1 1L adv. melanoma, + 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 NEW BNT327 (PD-L1 x VEGF-A) 1L NSCLC, + CTx NEW 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 PLANNEDBNT327 (PD-L1 x VEGF-A) 2L NEN, + CTx7 10
BNT327: Synergistic Targeting of PD-L1 and VEGF Local neutralization of angiogenic and immunosuppressive VEGF-A effects Selected NSCLC IHC2 Bispecific MOA Combined tumor targeting1 1. Khan KA Nat Rev Clin Oncol 2018; 2. IHC data: Human Protein Atlas. VEGF-A PD-L1 Targeting the TME and block of PD- 1/PD-L1 signaling by anti-PD-L1 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 2/3 in NSCLC • Phase 3 in SCLC Ongoing Planned • Phase 3 in TNBC 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
Program Setting Study BNT327 1L ES-SCLC Phase 2 BNT327 2L ES-SCLC Phase 2 Small Cell Lung Cancer is One of Our Priority Indications for Clinical Development of BNT327 Response Efficacy Evaluation Population ITT (n=36) IO-naïve (n=22) IO- treated (n=14) ORR, % 61.1 72.7 42.9 DCR, % 86.1 81.8 92.9 -90 -70 -50 -30 -10 10 30 50 70 PD SD PR CR SCLC Incidence1 By 2030: ~60k in U.S., EU4, U.K. High unmet need for ES-SCLC patients as long-term survival outcomes remain very poor Phase 2 (NCT05879068): BNT327 Combined with Paclitaxel Shows Efficacy in 2L SCLC Ying Cheng et al. Presented at ESMO 2023. Poster#1992P 5-year survival2 • ES-SCLC: 3% • Limited-stage SCLC: 20% 1.Incidence from: SEER data for diagnosed SCLC incidence in US; Cancer Research UK; Zentrum für Krebsregisterdaten; Sante Publique; AIOM; EPDATA. 2.Statistics from Dayen et al (2019); CancerMPact® Patient Metrics US & EU5, accessed February 2024. *Due to limited survival data in EU5, U.S. survival data is reported; 13
14 1 Partnered with Genentech, a member of the Roche Group. 2 Antigens vary across programs; 3. T-cell responses analyzed by ex vivo multimer staining analysis in blood. Individual patient samples (blood and tissue) Artificial intelligence-driven neoantigen prediction On-demand tailored RNA manufacturing Individualized immuno- therapy Mapping of mutations Fixed combination of shared tumor antigens2 Multi-antigen approach tailored to each indication Neoantigens Individualized therapy Multiple shared antigens Off-the-shelf therapy iNeST1 FixVac individualized Neoantigen- Specific immunotherapy Fixed Antigen Vaccine ANTIGEN 1 ANTIGEN 2 ANTIGEN 3 ANTIGEN 4 Strong vaccine- induced ,poly- epitope ex vivo CD8+ T-cell responses across different cancer types3 10.3% 10.1% HPV16-E7 Head & Neck Cancer BNT113, HARE40 trial Mutant Neoantigen TNBC, BNT114 TNBC-MERIT trial 5% MAGE-A3 Melanoma, BNT111, Lipo-MERIT trial 2.1% NY-ESO-1 Melanoma , BNT111, Lipo-MERIT trial mRNA- lipoplex platform Leveraging Our Leadership in mRNA to Fully Exploit Cancer Immunotherapy Target Space with Two Approaches Described in Castle et al., Cancer Res 2011 Described in Sahin et al., Nature 2017
Multiple Clinical Trials Demonstrate Execution Across iNeST and FixVac Portfolios 15 1. Partnered with Genentech, a member of the Roche Group; 2. In collaboration with Regeneron. Individualized immunotherapy: iNeST FixVac Autogene cevumeran (BNT122/RO7198457) 1 BNT1112 BNT113 BNT116 Adjuvant 1L R/R R/R 1L Multiple settings MIUC Phase 2 CRC Phase 2 PDAC Phase 2 Melanoma Phase 2 Solid tumors Phase 1 Melanoma Phase 2 HPV16+ HNSCC Phase 2 NSCLC Phase 1 & 2 + Nivolumab Monotherapy + Atezolizumab + mFOLFIRINOX + Pembrolizumab + Atezolizumab + Cemiplimab + Pembrolizumab Monotherapy, + Cemiplimab or CTx or aCTLA4 Recruitment ongoing Recruitment ongoing Data presented from epi sub-study at ASCO 2024 and from biomarker sub-study at ESMO-GI 2024 Recruitment ongoing Data presented from investigator-initiated Ph 1 trial at ASCO 2022 & AACR 2024 and published (Rojas et al., Nature 2023) Follow up published in February 2025 (Sethna et al., Nature 2025) Study completed Ph 1 data on prototype vaccine published (Sahin et al., Nature 2017) Primary endpoint (significant PFS improvement) not met. Numerical OS benefit trend observed. Data expected at future medical meeting. Enrollment completed Data presented at AACR 2020. Data published (Lopez et al., Nature Medicine 2025) Enrollment completed Positive topline data announced in 2024 Data presented from Ph 1 at multiple conferences incl. SITC 2021 and published (Sahin et al., Nature 2020) Recruitment ongoing Ph 2 data presented at multiple conferences incl. ESMO-IO 2022 Data from safety run-in of Ph 2 trial and Ph 1/2 IIT presented at ESMO 2024 Recruitment ongoing in Ph 2 in 1L NSCLC2 Ph 1 trial ongoing Data presented at SITC 2023, AACR 2024 , and SITC 2024
B a s e li n e T C R c lo n o ty p e s Post-induction TCR clonotypes (log10) Autogene Cevumeran1 Induces Neoantigen Specific T cells in a Broad Range of Cancers 1. Partnered with Genentech, a member of the Roche Group P: Pre-existing D: De-novo a u to g e n e c e v u m e ra n T R B F re q u e n c y ( % ) a u to g e n e c e v u m e ra n + a te z o li z u m a b T R B F re q u e n c y ( % ) #TCRs 0P 0D n.d. # Neoantigens # Neoantigens Neoantigen-specific TCRs in post-induction blood and on-treatment tumor tissue #TCRs 0P 0D First-in-human study (NCT03289962) in advanced and metastatic solid tumors Autogene cevumeran1 monotherapy (n=30) Combination with atezolizumab (n=183) • Well tolerated safety profile • Strong neoantigen responses across broad spectrum of cancers • Poly-epitopic, long-lasting neoantigen specific responses (CD4+, CD8+) in 71% of patients • Expansion of pre-existing neoantigen T cells as well as induction of de novo T-cell responses • Immune therapy-induced T cells were found in biopsies of post-treatment tumor lesions Lopez et al. Autogene cevumuran with or without atezolizumab in advanced solid tumors, a Phase1 trial. Nature Medicine, 2025 16
Multiple Clinical Trials Demonstrate Execution Across iNeST and FixVac Portfolios 17 1. Partnered with Genentech, a member of the Roche Group; 2. In collaboration with Regeneron. Individualized immunotherapy: iNeST FixVac Autogene cevumeran (BNT122/RO7198457) 1 BNT1112 BNT113 BNT116 Adjuvant 1L R/R R/R 1L Multiple settings MIUC Phase 2 CRC Phase 2 PDAC Phase 2 Melanoma Phase 2 Solid tumors Phase 1 Melanoma Phase 2 HPV16+ HNSCC Phase 2 NSCLC Phase 1 & 2 + Nivolumab Monotherapy + Atezolizumab + mFOLFIRINOX + Pembrolizumab + Atezolizumab + Cemiplimab + Pembrolizumab Monotherapy, + Cemiplimab or CTx or aCTLA4 Recruitment ongoing Recruitment ongoing Data presented from epi sub-study at ASCO 2024 and from biomarker sub-study at ESMO-GI 2024. Recruitment ongoing Data presented from investigator-initiated Ph 1 trial at ASCO 2022 & AACR 2024 and published (Rojas et al., Nature 2023). Follow up published in February 2025 (Sethna et al., Nature 2025). Study completed Ph 1 data on prototype vaccine published (Sahin et al., Nature 2017). Primary endpoint (significant PFS improvement) not met. Numerical OS benefit trend observed. Data expected at future medical meeting. Enrollment completed Data presented at AACR 2020. Data published (Lopez et al., Nature Medicine 2025) Enrollment completed Positive topline data announced in 2024. Data presented from Ph 1 at multiple conferences incl. SITC 2021 and published (Sahin et al., Nature 2020). Recruitment ongoing Ph 2 data presented at multiple conferences incl. ESMO-IO 2022 Data from safety run-in of Ph 2 trial and Ph 1/2 IIT presented at ESMO 2024. Recruitment ongoing in Ph 2 in 1L NSCLC2 Ph 1 trial ongoing. Data presented at SITC 2023, AACR 2024 , and SITC 2024.
18 1. Partnered with Genentech, a member of the Roche Group; 2. Nakamura et al., Nature Medicine, 2024; 3. Jones et al., JAMA Surgery 2019; 4. Conroy et al., JAMA Oncology 2022; 5:. Bajorin et al., 2021 NEJM. Evaluating Autogene Cevumeran1 in the Adjuvant Treatment Setting for Cancers of High Unmet Need Rationale for adjuvant setting Low tumor mass with residual cancer cells Healthier immune system and uncompromised T-cell function Resistance mechanisms, clonal heterogeneity and immune suppression not fully established Pancreatic Ductal Adenocarcinoma (PDAC) 69−75% relapse rate within 5 years after adjuvant therapy3,4 Phase 1 trial ongoing & published Rojas et al., Nature 2023 Sethna et al., Nature 2025 Randomized Phase 2 trial ongoing 11 months median DFS observed in ctDNA+ CRC after surgery2 Reinacher-Schick et al., ASCO 2024 Randomized Phase 2 trial ongoing First data expected in late 2025 / early 2026 Colorectal Cancer (CRC) Unmet medical need 40% of patients relapse within 2 years after adjuvant nivolumab5 Muscle-Invasive Urothelial Cancer (MIUC) FPI in Dec 2024 Randomized Phase 2 trial ongoing Micrometastasis
Financial Update Jens Holstein, Chief Financial Officer3
2024 Financial Execution Highlights1 20 Loss before tax €(2.77) €678m €2.8 bn €17.4 bn Total revenues Diluted loss per share Total cash plus security investments2 1. Numbers are rounded to millions and billions of Euros in accordance with standard commercial practice. 2. Consists of cash and cash equivalents of €9,761.9 million, current security investments of €6,536.2 million and non-current security investments of €1,061.1 million, as of December 31, 2024. Payments associated with the closing of the Biotheus acquisition and with the resolved settlement of a contractual dispute with the NIH are expected to result in a cash outflow of approximately $1.6 billion to be reflected in cash & cash equivalents in the first quarter of 2025. The settlement payment of $467 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 these settlements, BioNTech expects to be reimbursed approximately $535 million by its partner during 2025 and 2026.
General and administrative expenses (124) (531) Other operating result (54) (671) Operating profit / (loss) 526 (1,314) Sales and marketing expenses (18) (68) Cost of sales (179) (541) Years ended December 31, (495) (188) 690 (63) (600) Research and development expenses (578) (2,254) (1,783) Finance result 137 637 496 Income taxes (205) 12 (256) Net profit / (loss) 458 (665) 930 Earnings / (Loss) per share <blank> Total Revenues 1,479 2,751 3,819 2023 2024 2023 Three months ended December 31, Basic earnings / (loss) per share 1.90 (2.77) 3.87 Diluted earnings / (loss) per share 1.88 (2.77) 3.83 (in millions €, except per share data) 2024 1,190 (244) (612) (21) (111) (54) 149 153 (42) 260 1.08 1.08 <blank><blank> <blank> Q4 and FY 2024 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 20-F for the year ended December 31, 2024, filed today with the United States Securities and Exchange Commission and available at https://www.sec.gov/. 1 21
22 Full Year 2024 Results Compared to Full Year 2024 Financial Guidance FY 2024 revenues Total revenues €2,500 – €3,100 m Expected to be at low end €2,751 m FY 2024 expenses and capex R&D expenses €2,400 – €2,600 m €2,254 m SG&A expenses €600 – €700 m €599 m Capital expenditures for operating activities €300 – €400 m €307 m Guidance November 2024 FY 2024 Results1 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 20-F for the year ended December 31, 2024, filed today with the United States Securities and Exchange Commission and available at https://www.sec.gov/.
23 1. 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, as well as potential changes to the law or governmental policy, including public health policy, at the state or national level, and evolving public sentiment around vaccines and mRNA technology, in the United States and/or elsewhere. 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. 2025 Financial Year Guidance1 Revenue 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. • 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
4 Strategic Outlook Ryan Richardson, Chief Strategy Officer
25 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) » 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
26 Partnered with: 1. DualityBio; 2. Genentech, a member of the Roche Group; 3. In collaboration with Regeneron. Selected Pipeline Milestones for 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 + BNT3251 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
Save the date Annual General Meeting May 16, 2025 Innovation Series Digital & AI Day October 1, 2025 Innovation Series R&D Day November 18, 2025
Thank you
Appendix
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+ PDL-1+ HCN, + pembrolizumab Autogene cevumeran (BNT122/RO7198457)1 1L adv. melanoma, + 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 NEW BNT327 (PD-L1 x VEGF-A) 1L NSCLC, + CTx NEW 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 PLANNEDBNT327 (PD-L1 x VEGF-A) 2L NEN, + CTx7 30
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 BNT323/DB-13036 (trastuzumab pamirtecan) (HER2) Multiple solid tumors BNT324/DB-13116 (B7-H3) Multiple solid tumors BNT221 Refractory metastatic melanoma 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 / PM1009 combination 1L HCC7 mRNA immunotherapy Next generation IO Targeted therapy BNT3173 Multiple solid tumors NEW BNT322/GEN10562 Multiple solid tumors BNT327 / BNT3236 (trastuzumab pamirtecan) combination Multiple solid tumors NEW BNT327 / BNT3246 combination Multiple solid tumors PLANNED BNT327 / BNT3264 combination Multiple solid tumors PLANNED Autogene cevumeran (BNT122/RO7198457)1 Multiple solid tumors 31
Abbreviation Directory n L nth line Fab Fragment antigen binding NY-ESO-1 New York esophageal squamous cell carcinoma-1 AACR American Association for Cancer Research FPI First patient in ORR Objective response rate ADC Antibody-drug conjugate GI Gastrointestinal OS Overall survival adj. Adjuvant cGMP Current Good manufacturing practice PD Progressive disease AI Artificial intelligence HCC Hepatocellular carcinoma PDAC Pancreatic ductal adenocarcinoma AIOM Associazione Italiana di Oncologia Medica HER2 (or 3) Human epidermal growth factor receptor 2 (or 3) PD-L1 Programmed cell death protein ligand 1 ASCO American Society of Clinical Oncology HNC Head and neck cancer PFS Progression-free survival BLA Biologics License Applications HNSCC Head and neck squamous cell carcinoma PR Partial response CLDN6 Claudin 6 HPV Human papilloma virus PROC Platinum-resistant ovarian cancer CPI Checkpoint inhibitor HR Hormone receptor RCC Renal cell carcinoma CR Complete response IHC Immunohistochemistry R&D Research and development CRC Colorectal cancer IIT Investigator initiated trial R/R Relapsed/refractory CRPC Castration resistant prostate cancer iNeST Individualized NeoAntigen-Specific Therapy SABCS San Antonio Breast Cancer Symposium ctDNA Circulating tumor DNA IO Immuno-oncology SG&A Selling, general and administrative expenses CTLA Cytotoxic T-lymphocyte-associated protein ITT Intention to treat SCLC Small cell lung cancer CTx Chemotherapy JAMA Journal of the American Medical Association SD Stable disease DCR Disease control rate MAGE-A3 Melanoma antigen A3 SITC Society of Immunotherapy of Cancer DFS Disease-free survival met Metastatic TCR T-cell receptor DO Dose optimization MIUC Muscle-invasive urothelial carcinoma TKI Tyrosine kinase inhibitor E2E End to end MoA Mechanism of Action TME Tumor microenvironment EC Endometrial cancer MPM Malignant pleural mesothelioma TNBC Triple-negative breast cancer EGFR Epidermal growth factor receptor mRNA Messenger ribonucleic acid TROP2 Trophoblast cell-surface antigen 2 elcc European Lung Cancer Congress NCT National clinical trial UC Urothelial cancer EpCAM Epithelial cell adhesion molecule NEJM The New England Journal of Medicine UK United Kingdom ESMO European Society for Medical Oncology NEN Neuroendocrine neoplasm U.S. United States ES-SCLC Extensive-stage small cell lung cancer NIH National Institutes of Health VEGF-A Vascular endothelial growth factor A EU4 Includes Germany, France, Italy and Spain NSCLC Non-small cell lung cancer VHH Heavy chain variable 32
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