BioNTech (BNTX) Company Report

BioNTech SE hosted an Innovation Series R&D Day on November 11, 2025, providing an overview of its strategy and clinical progress.
The company increased its 2025 revenue guidance to €2.6-2.8 billion (from €1.7-2.2 billion) and reported €16.7 billion in cash, cash equivalents, and securities as of September 30, 2025.
BioNTech has over 20 phase 2 and 3 oncology trials and 30+ novel-novel combination cohorts currently underway.
Pumitamig combined with chemotherapy showed encouraging efficacy in a Phase 2 study for 1L ES-SCLC, with a cORR of 85.0% and mPFS of 6.3-7.0 months in global cohorts (data cut-off August 7, 2025).
Key upcoming data readouts in 2025 include results for Pumitamig in 1L/2L TNBC, Gotistobart in 2L sq NSCLC, BNT324/DB-13113 in CC and PROC, and BNT326/YL2024 in HR+HER2-null or low BC.

Nov 12, 2025, 12:45 PM

6-K

BioNTech Details Oncology Pipeline Expansion and Updated Financial Guidance

BNTX

New Projects/Investments

Guidance Update

M&A

BioNTech is re-focusing on oncology with a multi-modal strategy encompassing immunomodulators, targeted therapies (ADCs), and mRNA cancer immunotherapy.
The company has over 20 Phase II and Phase III oncology trials ongoing, with its bispecific antibody Promitamyc serving as a pan-tumor backbone in foundational registration trials across non-small cell lung cancer, small cell lung cancer, TNBC, first-line colorectal cancer, and first-line gastric cancer.
BioNTech increased its 2025 revenue guidance to €2.6 billion - €2.8 billion (from €1.7 billion - €2.2 billion) and reported a robust cash position of €16.7 billion in cash and cash equivalents as of the last quarter.
A strategic partnership with BMS for Promitamyc includes a $3.5 billion upfront payment and potential milestones up to $7.6 billion, with pre-commercialization expenses shared 50-50.

Nov 11, 2025, 2:00 PM

Transcript

BioNTech Reports Q3 2025 Financial Results and Updates Full-Year Guidance

BNTX

Earnings

Guidance Update

New Projects/Investments

BioNTech reported revenues of €1,519 million for Q3 2025, an increase from €1,245 million in Q3 2024. The company recorded a net loss of €29 million and basic earnings per share of (€0.12) for Q3 2025.
As of September 30, 2025, BioNTech maintained a strong balance sheet with approximately €16.7 billion in total cash and cash equivalents plus security investments.
The company increased its full-year 2025 revenue guidance to €2,600 – €2,800 million and reduced its expenditures guidance for R&D, SG&A, and capital expenditure.
BioNTech made significant progress in its oncology pipeline, advancing Pumitamig with registrational Phase 3 trials in lung and breast cancer, progressing late-stage trials for mRNA cancer immunotherapies (FixVac and iNeST), and advancing Trastuzumab pamirtecan towards BLA submission.
Regulatory approvals were received for the variant-adapted COVID-19 vaccine, COMIRNATY, in the U.S., Europe, UK, and Japan.

Nov 3, 2025, 1:00 PM

Presentation

BioNTech Reports Q3 2025 Results and Updates Full-Year Guidance

BNTX

Earnings

Guidance Update

New Projects/Investments

BioNTech reported Q3 2025 total revenues of EUR 1,519 million, an increase from EUR 1,245 million in Q3 2024, largely due to $700 million recognized from the BMS collaboration. The company recorded a net loss of EUR 29 million for the quarter.
For the full-year 2025, BioNTech increased its revenue guidance to EUR 2.6 billion-EUR 2.8 billion while lowering R&D expense guidance to EUR 2 billion-EUR 2.2 billion, reflecting active portfolio management and efficiencies. The company still expects a loss for the 2025 financial year.
In its oncology pipeline, pumitamig advanced enrollment in two global registration trials in lung cancer and is on track to initiate a TNBC phase III in 2025. The BLA submission for trastuzumab-pamirtecan (TPEM) is now planned for 2026, a delay from the original end of 2025, due to ongoing discussions with the FDA.

Nov 3, 2025, 1:00 PM

Transcript

BioNTech Reports Q3 2025 Results, Updates Full-Year Guidance, and Provides Pipeline Updates

BNTX

Earnings

Guidance Update

New Projects/Investments

BioNTech reported total revenues of EUR 1,519 million for Q3 2025, an increase from EUR 1,245 million in Q3 2024, largely due to the recognition of $700 million from the BMS collaboration.
The company posted a net loss of EUR 29 million and a basic and diluted loss per share of EUR 0.12 for Q3 2025, contrasting with a net income of EUR 198 million and EPS of EUR 0.82 in the comparative prior year period.
BioNTech updated its full-year 2025 financial guidance, raising revenue expectations to EUR 2.6 billion-EUR 2.8 billion while lowering R&D expenses to EUR 2 billion-EUR 2.2 billion, SG&A expenses to EUR 550 million-EUR 650 million, and capital expenditures to EUR 200 million-EUR 250 million. The company anticipates reporting a loss for the 2025 financial year.
The Biologics License Application (BLA) submission for trastuzumab-pamirtekan (TPEM, BNT323) is now planned for 2026, a delay from the original target of end of 2025, attributed to ongoing discussions with the FDA for additional data requirements.
In Q3 2025, BioNTech made significant clinical progress with pomitamic (BNT327), advancing enrollment in two global lung cancer registration trials and remaining on track to initiate a TNDC phase 3 trial this year, with potential first launches before the end of the decade.

Nov 3, 2025, 1:00 PM

Transcript

BioNTech Reports Q3 2025 Results and Updates Full-Year Guidance

BNTX

Earnings

Guidance Update

New Projects/Investments

BioNTech reported Q3 2025 revenues of EUR 1,519 million, an increase from EUR 1,245 million in Q3 2024, primarily driven by $700 million from the BMS collaboration. The company recorded a net loss of EUR 29 million and a basic and diluted loss per share of EUR 0.12 for the quarter.
The company increased its full-year 2025 revenue guidance to EUR 2.6 billion-EUR 2.8 billion (from EUR 1.7 billion-EUR 2.2 billion), mainly due to the recognition of the $700 million from the BMS collaboration.
BioNTech also lowered its full-year 2025 R&D expense guidance by EUR 600 million to a new range of EUR 2 billion-EUR 2.2 billion, and SG&A expense guidance by EUR 100 million to EUR 550 million-EUR 650 million. The company expects to report a loss for the 2025 financial year.
The BLA submission for trastuzumab-pamirtekan (TPEM) is now planned for 2026, a delay from the previously guided end of 2025, due to ongoing discussions with the FDA.
Progress continues on key oncology programs, including pomitamic, with enrollment advancing in two global registration trials in lung cancer and a phase 3 initiation in TNBC on track for this year, targeting first potential launches before the end of the decade.

Nov 3, 2025, 1:00 PM

Transcript

BioNTech Raises 2025 Revenue Outlook

BNTX

Guidance Update

Revenue Acceleration/Inflection

New Projects/Investments

BioNTech SE has raised its full-year 2025 revenue forecast to between €2.6 billion and €2.8 billion, primarily due to a $700 million payment from its partnership with Bristol-Myers Squibb (BMS).
The company's third-quarter revenue grew 22% to €1.52 billion, partly driven by progress in its oncology portfolio, including positive interim data for the bispecific antibody candidate pumitamig in lung cancer trials.
BioNTech is strategically shifting its focus from declining COVID-19 vaccine revenues to cancer therapies, planning additional pivotal trials for pumitamig in colorectal and gastric cancers in 2026.
Concurrently, BioNTech lowered its expense guidance for 2025, with research and development expenses now projected between €1.8 billion and €2.2 billion.

Nov 3, 2025, 11:53 AM

Bloomberg

BioNTech Reports Q3 2025 Financial Results and Announces CureVac Takeover Bid

BNTX

Earnings

M&A

Revenue Acceleration/Inflection

BioNTech SE reported total revenues of €1,518.9 million for the three months ended September 30, 2025, and a net loss of €28.7 million for the period. For the nine months ended September 30, 2025, total revenues were €1,962.5 million, resulting in a net loss of €831.1 million and basic loss per share of €3.45.
COVID-19 vaccine revenues decreased by 23% to €853.3 million in Q3 2025 compared to Q3 2024, while revenues from out-licensing increased by €613.0 million due to an upfront payment from a global strategic partnership with Bristol-Myers Squibb Company.
As of September 30, 2025, the company maintained a strong liquidity position with cash and cash equivalents of €10,092.9 million. Subsequent to the reporting period, BioNTech commenced a public exchange offer for all outstanding shares of CureVac N.V., implying an aggregate equity value of approximately $1.25 billion.

Nov 3, 2025, 11:50 AM

6-K

BioNTech Announces Third Quarter 2025 Financial Results and Increased Full-Year Revenue Guidance

BNTX

Earnings

Guidance Update

Product Launch

BioNTech reported Q3 2025 revenues of €1.5 billion, a net loss of €28.7 million, and a basic and diluted loss per share of €0.12.
The company's financial position was strengthened to €16.7 billion in cash, cash equivalents, and security investments as of September 30, 2025, partly due to a $1.5 billion payment from its Bristol Myers Squibb partnership.
BioNTech increased its full-year 2025 revenue guidance to €2.6-2.8 billion and lowered expense guidance ranges for R&D, SG&A, and capital expenditures.
The company launched its variant-adapted COVID-19 vaccine for the 2025/2026 vaccination season and reported encouraging interim Phase 2 data for its bispecific antibody candidate pumitamig (BNT327/BMS986545), with plans for additional pivotal trials.

Nov 3, 2025, 11:49 AM

6-K

BioNTech and Pfizer Receive U.S. FDA Approval for New COVID-19 Vaccine

BNTX

Product Launch

BioNTech SE and Pfizer Inc. announced on August 27, 2025, that the U.S. Food and Drug Administration (FDA) has approved their LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1).
The vaccine is approved for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
Shipping of the LP.8.1-adapted vaccine will begin immediately, with availability in U.S. pharmacies, hospitals, and clinics in the coming days.

Aug 27, 2025, 12:00 AM

6-K

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