-- Five additional pivotal trials for pumitamig initiated during 2026 in
collaboration with Bristol Myers Squibb
-- Oncology pipeline strength and combination strategy highlighted through
multiple clinical data updates, including pumitamig, gotistobart and
antibody-drug conjugate programs
-- Catalyst-rich year ahead with six late-stage pipeline data readouts
expected across immunomodulators, antibody-drug conjugate and mRNA cancer
immunotherapies
-- COVID-19 2026/2027 season variant-adapted vaccine development and
commercial preparation underway
-- Operational efficiency to be enhanced through manufacturing footprint
consolidation, supporting strategic capital allocation to further advance
its growing oncology pipeline toward commercialization
-- First quarter 2026 revenues of EUR118.1 million1, net loss of
EUR531.9 million (adjusted2 net loss of EUR494.6 million), with diluted
loss per share of EUR2.10 ($2.463) (adjusted2 diluted loss per share of
EUR1.95 ($2.283))
-- Reaffirmed full year 2026 financial guidance and strong financial
position continue to de-risk execution with cash, cash equivalents and
security investments of EUR16.8 billion4
-- Share repurchase program of up to $1.0 billion over twelve months planned
Conference call and webcast scheduled for May 5, 2026, at 8:00 a.m. ET (2:00 p.m. CET)
MAINZ, Germany, May 5, 2026 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") today reported financial results for the three months ended March 31, 2026 and provided an update on its corporate progress.
"In the first quarter, we made substantial progress in executing towards our oncology strategy, highlighted by data presentations from our priority pan-tumor program pumitamig as well as our versatile antibody-drug conjugate portfolio. Simultaneously, we continue to broaden our clinical programs to include novel-novel combinations in order to inform the optimal set-up for registrational combination trials and maximize the potential of our pipeline," said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "We will continue to focus on accelerating our key strategic programs as we remain steadfast in our vision to translate our science into survival for patients living with cancer."
Financial Review for First Quarter 2026
First Quarter 2026 First Quarter 2025
in millions
EUR, except
per share IFRS Adjusted IFRS Adjusted
data Results Results(2) Results Results(2)
----------- ---------- ----------- ----------
Revenues 118.1 118.1 182.8 182.8
----------- ---------- ----------- ----------
Net loss (531.9) (494.6) (415.8) (430.8)
Diluted loss
per share (2.10) (1.95) (1.73) (1.79)
-------------- ----------- ---------- ----------- ----------
Revenues for the first quarter of 2026 were EUR118.1 million, compared to EUR182.8 million for the comparative prior year period. The decrease was primarily driven by lower revenues of BioNTech's COVID-19 vaccines.
Research and development ("R&D") expenses were EUR557.0 million for the first quarter of 2026, compared to EUR525.6 million for the comparative prior year period. R&D expenses were mainly driven by higher expenses for the development of immuno-oncology ("IO") and antibody-drug conjugate ("ADC") programs, in particular pumitamig and gotistobart, as well as costs from operations of entities acquired during 2025, BioNTech China (previously Biotheus) and CureVac, and an impairment of an intangible asset. These effects were partly offset by lower R&D expenses related to the Company's COVID--19 vaccine collaboration with Pfizer Inc. ("Pfizer").
Adjusted R&D expenses were EUR527.1 million for the first quarter of 2026, compared to EUR525.6 million for the comparative prior year period. For the first quarter of 2026, adjusted R&D expenses exclude the impairment of an intangible asset.
Sales, general and administrative ("SG&A") expenses(5) were EUR150.8 million for the first quarter of 2026, compared to EUR120.6 million for the comparative prior year period. The increase was mainly driven by the ongoing commercial build-up and the inclusion of operations of entities acquired in 2025, BioNTech China (previously Biotheus) and CureVac. These costs were partly offset by a reduction in external services.
Net loss was EUR531.9 million for the first quarter of 2026, compared to a net loss of EUR415.8 million for the comparative prior year period.
Adjusted net loss was EUR494.6 million for the first quarter of 2026, compared to an adjusted net loss of EUR430.8 million for the comparative prior year period.
Diluted loss per share was EUR2.10 for the first quarter of 2026, compared to a diluted loss per share of EUR1.73 for the comparative prior year period.
Adjusted diluted loss per share was EUR1.95 for the first quarter of 2026, compared to adjusted diluted loss per share of EUR1.79 for the comparative prior year period.
Cash, cash equivalents and security investments as of March 31, 2026, were EUR16,763.3 million, comprising EUR9,939.4 million in cash and cash equivalents, EUR4,696.9 million in current security investments disclosed as financial assets and EUR2,127.0 million in non-current security investments disclosed as financial assets.
Shares outstanding as of March 31, 2026, were 252,884,261, excluding 6,143,226 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 Ramón Zapata, Chief Financial Officer at BioNTech. "We are committed to a diligent capital allocation strategy that empowers us to pursue our goal of evolving into a leading biopharmaceutical company with multiple oncology products by 2030."
Reaffirmed 2026 Financial Year Guidance(6) :
Revenues for the 2026 financial year EUR2,000 -- EUR2,300 m --------------------------------- ----------------------
In 2026, BioNTech anticipates lower COVID-19 vaccine revenues compared to 2025, driven by declines in both the European and United States markets. The United States continues to be a competitive and dynamic market, where, as a result, lower revenues are expected. In Europe, the Company expects lower revenues as it defends its market share and begins managing the transition away from multi-year contracts. In Germany specifically, BioNTech recognizes direct sales of its COVID-19 vaccines as revenue. Hence, the anticipated declines in sales of COVID-19 vaccines in Germany will have a direct impact on the Company's topline, whereas revenues outside of Germany only affect the Company's topline as part of the 50% gross profit split with its partner Pfizer. Per the outlined partnership terms, revenues from the collaboration with Bristol Myers Squibb Company ("BMS") in 2026 are expected to be broadly in line with 2025. Revenues from the pandemic preparedness contract with the German government and service businesses are expected to remain stable.
Planned 2026 Financial Year Adjusted Expenses(6) :
Adjusted R&D expenses EUR2,200 -- EUR2,500 m
--------------------------- ----------------------
Adjusted SG&A expenses(5) EUR700 -- EUR800 m
----------------------
BioNTech will continue to 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 foster innovation and 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 creating future value.
Planned Capital Return to Shareholders
The Management Board and Supervisory Board expect to authorize a share repurchase program of BioNTech's American Depositary Shares ("ADSs"), pursuant to which the Company may repurchase ADSs in the amount of up to $1.0 billion over the next twelve months. BioNTech expects to use the repurchased ADSs to satisfy obligations in the ordinary course of business. The program is designed to enhance capital efficiency and support long-term value creation to execute BioNTech's objective to become a multi-product company by 2030.
Manufacturing Footprint Consolidation
BioNTech continues to allocate capital strategically while optimizing capacities broadly to drive operational efficiency and sustainable value creation. To this end, BioNTech plans to align and consolidate its manufacturing network further where excess capacity is expected, due to evolving supply needs, mergers and acquisitions, BioNTech's partners' manufacturing capacities and completion of contracts.
BioNTech plans to exit operations at the manufacturing sites in Idar-Oberstein, Marburg, and Singapore as well as CureVac's sites, affecting up to approximately 1,860 positions in total. The exit from the sites in Idar-Oberstein, Marburg, and Tübingen is planned by the end of 2027, while operations in Singapore are expected to conclude in Q1 2027. For each of these manufacturing sites, BioNTech is exploring divestment options, including a partial or total sale.
BioNTech expects cost savings to ramp up over time, potentially reaching approximately EUR500 million in recurring annual savings upon full implementation of the measures in 2029.(7) These savings are intended to support the Company's capital allocation to further advance its growing oncology pipeline toward commercialization.
BioNTech continues to ensure a robust drug supply via its established manufacturing network. No impact on commercial or clinical supply nor contractual obligations is expected as the affected sites will become underutilized or idle in the next 24 months.
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, 2026, filed today with the United States Securities and Exchange Commission ("SEC") and available at www.sec.gov.
Endnotes
(1) All numbers in this press release have been rounded.
(2) In addition to BioNTech's results determined in accordance with International Financial Reporting Standards ("IFRS"), or IFRS Accounting Standards, or IFRS results, BioNTech reports certain adjusted, non-IFRS measures used internally as a supplemental measure of the Company's business performance (each referred to with the prefix "Adjusted" or, as a whole, "Adjusted Results"). The calculation of these measures and the adjusted results as a whole is based on the concepts of the applicable IFRS Accounting Standards, but includes certain adjustments. Reconciliation of the adjusted results to BioNTech's measures based on IFRS Accounting Standards and more information can be found at the end of this press release and in BioNTech's Report on Form 6-K for the period ended March 31, 2026, filed on May 5, 2026, which is available at www.sec.gov. While non-IFRS measures may offer additional insights, BioNTech's non-IFRS measures are not, and should not be viewed as, a substitute for their most directly comparable IFRS Accounting Standards measures, and should always be considered alongside the Company's financial statements prepared in accordance with IFRS Accounting Standards.
(3) Calculated applying the average foreign exchange rate for the three months ended March 31, 2026, as published by the German Central Bank (Deutsche Bundesbank).
(4) As of March 31, 2026.
(5) Sales, general and administrative expenses ("SG&A") include sales and marketing expenses as well as general and administrative expenses. Adjusted SG&A expenses include adjusted sales and marketing expenses as well as adjusted general and administrative expenses.
(6) Excludes risks that are not yet known and/or quantifiable and related activities. Includes effects identified from licensing arrangements, collaborations and Merger & Acquisitions ("M&A") transactions to the extent disclosed. The guidance is based on non-IFRS measures and excludes certain effects compared to measures based on IFRS Accounting Standards. More information can be found in BioNTech's Report on Form 6-K for the period ended March 31, 2026, filed on May 5, 2026, which is available at www.sec.gov.
(7) Expected savings relative to BioNTech's 2025 cost base and CureVac's 2026 budget; do not reflect partially offsetting costs for Contract Development and Manufacturing Organizations ("CDMO") use or transfer to other sites; and exclude exit costs, which will be recorded as incurred.
(8) An overview of abbreviations of target structures and indications is compiled in a directory at the end of this press release.
Select Oncology Pipeline Updates
Next-Generation Immunomodulators and Combinations
Pumitamig (BNT327/BMS986545) is an investigational bispecific immunomodulator combining PD-L1(8) checkpoint inhibition with VEGF-A neutralization that is being developed in collaboration with BMS.
-- In the first quarter of 2026, the following pivotal trials evaluating
pumitamig were initiated:
-- A global Phase 3 clinical trial in patients with first-line
triple-negative breast cancer ("TNBC") (ROSETTA Breast-01;
NCT07173751).
-- A global Phase 2/3 clinical trial in first-line microsatellite
stable colorectal cancer ("MSS-CRC") (ROSETTA
CRC-203; NCT07221357).
-- A global Phase 2/3 clinical trial in first-line gastric cancer
(ROSETTA Gastric-204; NCT07221149).
-- A global Phase 3 clinical trial (ROSETTA Lung-201; NCT07361497) is
being conducted to evaluate pumitamig compared to durvalumab
following concurrent chemoradiation therapy in patients with
unresectable stage III non-small cell lung cancer ("NSCLC").
-- A global Phase 3 clinical trial (ROSETTA Lung-202; NCT07361510) is
being conducted to evaluate pumitamig compared to pembrolizumab as
a first-line treatment for patients with advanced PD-L1 >= 50%
NSCLC.
-- A global Phase 2/3 clinical trial (ROSETTA Lung-02; NCT06712316) is
ongoing to evaluate pumitamig in combination with chemotherapy compared
to pembrolizumab and chemotherapy in patients with first-line NSCLC. The
Phase 3 part of the trial is currently recruiting. Data from the Phase 2
part of the trial are expected at the American Society of Clinical
Oncology ("ASCO") Annual Meeting 2026 (May 29 - June 2, 2026).
-- Pumitamig is also being evaluated in additional solid tumor indications,
including first-line hepatocellular carcinoma ("HCC"), second-line
glioblastoma ("GBM"), first-line pancreatic ductal adenocarcinoma
("PDAC") and first-line renal cell carcinoma ("RCC") in various Phase 1/2
and Phase 2 trials, both as monotherapy and in combination with standard
of care.
-- BioNTech has several signal-seeking clinical trials ongoing evaluating
pumitamig with the Company's proprietary assets. These trials will inform
the dose selection for pumitamig and explore anti-tumor activity in
multiple tumors for later-stage development. Multiple data readouts from
these combinations are expected in 2026.
-- In April 2026, BioNTech and Boehringer Ingelheim announced a clinical
trial collaboration to assess the safety, tolerability and early clinical
activity of pumitamig in combination with obrixtamig (BI 764532),
Boehringer Ingelheim's investigational DLL3/CD3 T--cell engager, in
extensive--stage small cell lung cancer ("ES-SCLC"). Under the agreement,
BioNTech will supply pumitamig and Boehringer Ingelheim will be the
regulatory sponsor of the Phase 1b/2 trial.
Gotistobart (BNT316/ONC-392) is a tumor microenvironment-selective regulatory T cell depletion candidate that targets CTLA-4 and is being developed in collaboration with OncoC4, Inc. ("OncoC4").
-- A global Phase 3 clinical trial (PRESERVE-003; NCT05671510) is ongoing to
evaluate the efficacy and safety of gotistobart as monotherapy in
patients with metastatic squamous NSCLC that progressed under previous
platinum-based chemotherapy and PD-(L)1-inhibitor treatment.
-- In March 2026, updated data from the non-pivotal dose-confirmation stage,
the first of two stages of the global Phase 3 clinical trial, were
presented at the European Lung Cancer Congress ("ELCC"). Gotistobart
demonstrated a clinically meaningful overall survival benefit compared to
standard of care chemotherapy and a manageable safety profile in patients
with squamous NSCLC whose disease had progressed following anti-PD-(L)1
therapy and platinum-based chemotherapy.
-- Based on current event accrual projections, interim data from the pivotal
stage of the two-stage Phase 3 clinical trial are expected in 2026.
-- In January 2026, gotistobart received Orphan Drug Designation from the
U.S. Food and Drug Administration ("FDA") for the treatment of squamous
NSCLC. In 2022, gotistobart received Fast Track Designation from the FDA
for the treatment of patients with metastatic NSCLC whose disease
progressed on prior anti-PD-(L)1 therapy.
Antibody-Drug Conjugates
Trastuzumab pamirtecan (BNT323/DB-1303) is an ADC candidate targeting HER2 that is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio").
-- A Phase 1/2 clinical trial (NCT05150691) is being conducted to evaluate
trastuzumab pamirtecan in patients with advanced HER2-expressing tumors.
A potentially registrational cohort with HER2-expressing (IHC3+, 2+, 1+
or ISH-positive) patients with recurrent endometrial cancer ("EC") is
fully recruited.
-- In April 2026, updated data from this trial were presented at the Society
of Gynecologic Oncology ("SGO") Annual Meeting. Trastuzumab pamirtecan
demonstrated encouraging clinical efficacy across all HER2 expression
levels and regardless of prior immunotherapy treatment. The safety
profile in patients with pretreated advanced or metastatic EC was
manageable and generally consistent with that of HER2-targeted biologics.
-- BioNTech and DualityBio plan to file a biologics license application
("BLA") in 2026, subject to regulatory feedback.
-- A Phase 3 trial (FERN-EC-01, NCT06340568) is being conducted to evaluate
trastuzumab pamirtecan compared to investigator's choice of chemotherapy
in patients with advanced and HER2-expessing recurrent EC.
-- A global Phase 3 clinical trial (DYNASTY-Breast02, NCT06018337) to
evaluate trastuzumab pamirtecan in patients with HR-positive, HER2-low
metastatic breast cancer is ongoing. Based on current event accrual
projections, data are expected in 2026.
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