Synklino announces publication in American Journal of Transplantation highlighting proof-of-concept for SYN002 in eliminating CMV in human kidneys

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Synklino announces publication in American Journal of Transplantation highlighting proof-of-concept for SYN002 in eliminating CMV in human kidneys

Synklino announces publication in American Journal of Transplantation highlighting proof-of-concept for SYN002 in eliminating CMV in human kidneys

Preclinical data demonstrate >90% reduction in human cytomegalovirus (HCMV) reactivation from latency, establishing proof-of-concept for SYN002 in human kidneys
Data published in the American Journal of Transplantation and to be presented as a poster at the Cutting Edge of Transplantation (CEoT) Summit, Scottsdale, Arizona, 26–28 February 2026
Regulatory clearance granted by both UK MHRA and Health Canada for a Phase 1 clinical trial of SYN002, with Canadian study to be conducted independently by Dr. Atul Humar at UHN, Toronto

COPENHAGEN, Denmark, Feb. 25, 2026 (GLOBE NEWSWIRE) — Synklino A/S, a Danish biotechnology company pioneering transformative therapies to improve kidney transplantation outcomes through better CMV prevention, today announces the publication of a preclinical study in the American Journal of Transplantation. The study titled Inhibition of cytomegalovirus reactivation by ex vivo treatment of human kidneys with the SYN002 immunotoxin is available on open access here.

The preclinical data published in the American Journal of Transplantation will be presented in the form of a poster at the Cutting Edge of Transplantation (CEoT) Summit held in Scottsdale, Arizona, from 26–28 February 2026.

The poster will include data on the safety and feasibility of the administration of SYN002 to human kidneys during normothermic machine perfusion (NMP), as well as data on the efficacy of eliminating latently infected cells from the treated kidneys. The data provide compelling proof-of-concept that SYN002 is highly efficacious and safe and that the use of SYN002 in this setting can be expected to provide clinical benefit. In the treated kidneys, reactivation from latency was reduced by >90%, compared with no reduction in the control group.

Ian McGowan, MD PhD, Chief Medical Officer, Synklino, commented: “The publication of these data in the American Journal of Transplantation represents an important validation of our approach. Despite standard of care prophylaxis, approximately 30% of patients who receive a CMV-positive donor organ still experience CMV reactivation. These findings demonstrate that SYN002 has the potential to fundamentally change how CMV is managed in transplantation, by intervening at the donor organ level before transplantation takes place.”

Establishment of the proof-of-concept follows regulatory clearance granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for a Phase 1 clinical trial of SYN002 in kidney transplantation. In Canada, Health Canada has granted regulatory clearance for an investigator-sponsored Phase 1 study to be conducted independently by Dr. Atul Humar at the Ajmera Transplant Centre, University Health Network (UHN), Toronto, one of the world’s leading transplant centres, with first patient enrolment expected in April 2026.

Thomas Kledal, Chief Executive Officer, Synklino, said: “We are highly encouraged by the preclinical data which establish proof-of-concept for SYN002 in eliminating CMV from donor kidneys prior to transplantation. Following the recent CTA approvals in both the UK and Canada, these data add to our momentum in our mission to advance SYN002 into the clinic and bring a much-needed treatment to kidney transplant patients. This is a pivotal time for us, and we are looking forward to the next major milestones.”

For further information please contact:

Optimum Strategic Communications
Mary Clark | Isabelle Abdou | Vareen Outhonesack
Email: Synklino@optimumcomms.com
Tel: +44 20 3922 0900

About Synklino
Synklino is a Danish biotechnology company pioneering transformative therapies to improve kidney transplantation outcomes through better CMV prevention. Our first-in-class breakthrough drug candidate, SYN002, is a therapeutic fusion protein designed to eliminate both active and latent CMV infection in donated organs through ex vivo organ perfusion, offering a proactive and life-changing therapy for immunocompromised transplant recipients. Following regulatory CTA approval, SYN002 is expected to enter clinical development in kidney transplantation in the second quarter of 2026.

Background

Cytomegalovirus (CMV) is the main agent involved in infectious complications following transplant surgery, and a major risk for morbidity and increased hospital readmissions. CMV is a chronic viral infection found in more than 60% of humans worldwide. A healthy individual’s immune system confines the virus to an inactive but persistent state; however, in transplant patients with suppressed immune systems, CMV emerges from latency and significantly impacts morbidity and mortality. CMV increases transplant costs by up to 50% due to long-term hospitalizations and requires difficult courses of treatment. CMV-infected organs constitute a key risk for CMV infection and complications in all transplant recipients at the time of transplantation, regardless of the recipient’s CMV status. No currently marketed or pipeline drugs can cure CMV, and current drugs can be associated with the risk of developing resistance to CMV-therapies.

SYN002 is a therapeutic fusion protein, uniquely targeting both latent and lytic CMV- infected cells. SYN002 is expected to be highly efficacious and potent compared to standard of care antiviral therapeutics which only target active (lytic) infection. Given the compound’s unique mechanism of action, SYN002 has the potential to eliminate the risk of CMV infection in immunocompromised transplant recipients who would otherwise receive a CMV-infected organ. In preclinical studies SYN002 has been shown to be fast-acting with full efficacy anticipated within the few hours that the organ is treated ex vivo (pre transplantation).

Ex vivo organ perfusion is the treatment of an organ after it has been removed from the donor, and prior to transplantation. Ex vivo organ care has evolved from storage on ice into dynamic reconditioning using machine perfusion. Continuous flushing of donor organs with fluids during machine perfusion allows enhanced preservation with assessment of critical organ function parameters. Organ perfusion enables improvements in organ function by supplementing blood products or solutions that contain important nutrients, cells, and therapeutics, such as SYN002. Ex vivo machine perfusion increases the number of organs available for transplantation, ultimately improving the chance for a life-saving outcome for patients with end stage renal failure.

Novonesis delivered strong organic sales growth of 7% in 2025

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Novonesis delivered strong organic sales growth of 7% in 2025

Novonesis delivered strong organic sales growth of 7% in 2025

COPENHAGEN, Denmark – February 26, 2026. Novonesis delivered strong organic sales growth of 7% and an adjusted EBITDA margin of 37.1% in 2025. The company expects a good start to 2026 and a good year overall.

Ester Baiget, President & CEO:

“In 2025, we continued to deliver strong organic sales growth. We achieved 7% growth, an adjusted EBITDA margin of 37.1% and a strong cash flow – despite currency headwinds. Growth was broad-based across sales areas and markets, with particularly strong performance in Emerging Markets. As a pure biosolutions player, Novonesis uniquely combines deep understanding of customers, innovation leadership and world-class scale capabilities, driving performance and strengthening resilience. In 2026, we expect another good year, with growth across all sales areas and margin expansion. We continue to execute on our strategy, positioning us to firmly deliver on our 2030 targets and beyond.”

Highlights of our full-year 2025 results:

• Broad-based organic sales growth of 7% (Q4: 4%) including the negative impact of exiting certain countries of ~1%-point (Q4: ~2%-points). Price contributed ~1%-point (Q4: ~1%-point) and sales synergies contributed ~1%-point (Q4: ~1%-point).
• Food & Health at 8% organic sales growth (Q4: 7%) including the negative impact of exiting certain countries of ~3%-points (Q4: ~5%-
points). Planetary Health at 6% organic sales growth (Q4: 2%, including double-digit growth in Energy).
• Emerging Markets grew 9% organically (Q4: 1%) including the exit from certain countries. Developed Markets grew 6% organically (Q4: 6%).
• Adjusted EBITDA margin at 37.1% (Q4: 36.6%), up by 100 bps (Q4: up by 40 bps) including one-off expenses in Q4 and currency headwinds
for both the quarter and the year. Adjusted gross margin at 59.1% (Q4: 59.9%) up by 240bps (Q4: up by 250bps).
• Adjusted net profit increased by 17% (Q4: flat).
• NIBD/EBITDA at 1.9x, and free cash flow before acquisitions at EUR 770.4 million, or 19% of sales.
• Proposed dividend of DKK 4.25/share. DKK 2.25/share interim dividend paid Aug. 27, 2025. 2025 pay-out ratio of 58.4% of adj. net profit.
• 33 new product launches in 2025 (Q4: 14). New innovations launched over the last 5 years made up 25% of sales.
• Achievement of all six environmental and social targets for 2025 and on track for future commitments.
• 2026 outlook: Organic sales growth between 5-7% with a good start to the year expected against a strong 2025 comparable. The outlook includes some uncertainty of potential lower consumer sentiment for the year. The outlook also includes ~1%-point from positive pricing and ~1%-point from sales synergies as well as close to 1%-point negative impact from exiting certain countries. The outlook for the
adjusted EBITDA margin is between 37-38% with an expected margin expansion, including currency headwinds of ~50 bps vs 2025.

Here is the link to the investor call on Novonesis full-year results for 2025: Novonesis Full-year financial statement for 2025 and annual report 2025

Get in touch

Line Fedders
Senior Media Relation Manager

media-relations@novonesis.com
+45 30 77 13 99

Tobias Bjorklund
Head of Investor Relations

tobb@novonesis.com

Attachment

2026-01-12m-2025-highlights_final

Incentive programs for the Executive Leadership Team, the Senior Leadership Team and directors, and other employees

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Incentive programs for the Executive Leadership Team, the Senior Leadership Team and directors, and other employees

Incentive programs for the Executive Leadership Team, the Senior Leadership Team and directors, and other employees

Please read the full announcement in PDF

Attachment

2026_02_LTI

Ethris Part of Consortium to Receive up to EUR 148 Million European Commission Contract to Advance Novel Pandemic Influenza Vaccine

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Ethris Part of Consortium to Receive up to EUR 148 Million European Commission Contract to Advance Novel Pandemic Influenza Vaccine

Ethris Part of Consortium to Receive up to EUR 148 Million European Commission Contract to Advance Novel Pandemic Influenza Vaccine

Initial tender contract of EUR 13 million supports gated advancement into two subsequent competitive phases

MUNICH, Feb. 25, 2026 (GLOBE NEWSWIRE) — Ethris GmbH, a clinical-stage biotechnology company pioneering next-generation RNA therapeutics and vaccines, today announced that the European Health and Digital Executive Agency (HaDEA) has awarded an initial EUR 13 million under a tender contract worth up to EUR 148 million to NOFLU, a vaccine development consortium comprising Ethris and six other European partners. The funding will support the advancement of Ethris’s mRNA vaccine technology as a mucosal vaccine against pandemic influenza.

NOFLU is one of just three programs funded under this competitive pre-commercial procurement framework as part of a broader EU initiative to explore multiple vaccine strategies in parallel.

“This expert EU consortium in vaccine development, manufacturing, and immunological science is collaborating to ensure society has a system in place for viral pandemic preparedness,” said Carsten Rudolph, Ph.D., Founder and Chief Executive Officer of Ethris. “We believe Ethris’ differentiated mRNA vaccine technology holds huge potential to support this effort and help contain influenza pandemics by halting viral replication in the airways. The consortium research will build on previous positive clinical proof-of-concept studies with our technology.”

Unlike traditional systemic vaccines, the mRNA vaccine under evaluation is designed to trigger a robust immune response directly at the site of influenza entry, with potential to reduce viral transmission. It uses Ethris’ stabilized, non-immunogenic RNA formulation to ensure both safety and optimal performance.

The consortium includes seven organisations from across Europe: Ethris and Evonik in Germany; NIVI Development (the Novo Nordisk Foundation Initiative for Vaccines and Immunity), Statens Serum Institut and Bavarian Nordic in Denmark; ECRAID in the Netherlands; and VisMederi in Italy. It brings together complementary expertise spanning mRNA formulation and delivery, preclinical research, clinical trial execution, and immunological assessment.

Else Marie Agger, Chief Executive Officer of NIVI Development, added, “The consortium is delighted to contribute to the EU’s efforts to strengthen influenza pandemic preparedness through a new European consortium and an innovative Phase 1 program. The selection of the consortium reflects confidence in our innovative approach to inducing an immune response in the airways combined with an ambitious early-stage clinical development plan.”

The full program represents a staged approach supporting preclinical through market authorization activities within 98 months. The initial EUR 13 million contract will fund a first phase focused on generating early clinical safety data through a Phase 1 clinical study, with progression to two additional phases subject to further review and evaluation within the EU framework. The program could potentially secure up to EUR 35 million for a Phase 2 and EUR 100 million for a Phase 3, in total up to EUR 148 million.

The Phase 1 trial will assess safety, feasibility and immunological responses, including a comparative evaluation of intramuscular and intranasal administration routes, and will be conducted at Gentofte Hospital in Copenhagen.

The NOFLU consortium was established as a response to the HaDEA tender for development of next generation vaccines against influenza. The partners have a bold ambition to advance clinical implementation in an integrated setup, reflecting a shared commitment to scientific rigour, operational excellence, and public health impact of a novel vaccine concept.

About Ethris
Ethris, a clinical-stage biotechnology company, has paved a new path from genes to therapeutic proteins, using its proprietary RNA and lipidoid nanoparticle technology platform to discover, design and develop innovative therapies. With more than a decade as an mRNA pioneer, Ethris is a global leader in delivering stabilized mRNAs directly to the respiratory system via optimised formulation and nebulisation technologies. The company is rapidly advancing its mRNA pipeline of immuno-modulation, protein replacement therapies, and differentiated vaccines, with the ultimate goal of improving patients’ lives.

For more information, visit www.ethris.com

Ethris contact:
Dr. Philipp Schreppel
+49 89 244 153 042
schreppel@ethris.com

35Pharma to be Acquired by GSK to Accelerate Development of HS235, a Potential Best-in-Class Investigational Medicine for Pulmonary Hypertension (PH)

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35Pharma to be Acquired by GSK to Accelerate Development of HS235, a Potential Best-in-Class Investigational Medicine for Pulmonary Hypertension (PH)

35Pharma to be Acquired by GSK to Accelerate Development of HS235, a Potential Best-in-Class Investigational Medicine for Pulmonary Hypertension (PH)

Acquisition includes HS235, a potentially best-in-class activin signalling inhibitor in clinical development for treatment of cardiopulmonary diseases
HS235 offers potential to treat pulmonary hypertension (PH) patients while reducing the risk of bleeding and providing unique metabolic benefits compared to existing therapies

MONTREAL, Feb. 25, 2026 (GLOBE NEWSWIRE) — 35Pharma, a Canada-based, private, clinical-stage biopharmaceutical company specialised in the development of novel protein-based therapeutics today announced it has entered into an agreement with GSK plc (GSK), under which GSK will acquire all of the outstanding equity interests in 35Pharma. The acquisition includes HS235, a potential best-in-class investigational medicine that has completed phase I healthy volunteer clinical trials with studies to start imminently in pulmonary arterial hypertension (PAH) and pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF).

PH is a progressive, life-shortening disease marked by high blood pressure in the lungs. Early symptoms are breathlessness, fatigue and chest pain leading to heart failure as the disease progresses. It affects approximately 82 million people worldwide across multiple disease forms, yet treatment options remain limited and the five‑year survival rate is only around 50%.^1,2By 2032, the global market for PH therapies is forecast to reach $18 billion, with activin signalling inhibitors expected to account for 50% of this.³

HS235 targets the activin receptor signalling pathway, a clinically validated therapeutic target in PAH. HS235 is designed with enhanced selectivity, reducing binding to BMP9 and BMP10 – ligands associated with adverse events such as bleeding and telangiectasia (broken blood vessels). By potentially lowering the risk of bleeding, HS235 may address a key limitation in current PH treatment, particularly as a significant proportion of patients require concomitant anticoagulant or antiplatelet therapy.

The underlying mechanism of HS235 offers the potential for broad metabolic benefits, including fat-selective weight loss, preservation of lean mass, and improved insulin sensitivity, supported by beneficial changes in inflammation and adipokines (fat hormones) observed in early clinical studies. These attributes may offer additional clinical and commercial value given the high prevalence of obesity and insulin resistance in the PH population.

Ilia Tikhomirov, CEO, 35Pharma, said: “In recent years, we witnessed a revolution in our understanding of pulmonary hypertension and how this life-threatening disease could be reversed. We are pleased to be combining our efforts with GSK, a leader in respiratory and inflammatory drivers of disease, who shares our vision of HS235’s potential to transform the treatment of this debilitating condition.”

Tony Wood, Chief Scientific Officer, GSK, said: “Pulmonary hypertension affects millions of people worldwide, yet patients are underserved. We’re delighted to add HS235 to our pipeline, a potential best-in-class medicine with a differentiated profile to reduce risk of bleeding and provide potential metabolic benefits clinically relevant to PH patients. HS235’s potential protective effects on vascular function, alongside potential benefits on fat-derived markers of metabolism and inflammation, also offer new development opportunities within our RI&I portfolio to achieve broader coverage across the metabolic, inflammatory, vascular and fibrotic drivers of multiple chronic diseases that affect the lung, liver and kidney.”

Maureen O’Connor, CSO, 35Pharma, said: “HS235 is a unique and potentially best-in-class agent that we designed guided by the most recent advances in the field. This acquisition reflects the exceptional work of our team in building the scientific and clinical capabilities to discover and advance HS235 through clinical proof of biology in healthy volunteers. We are proud to collaborate with GSK to accelerate development of this medicine which could help millions of patients affected by pulmonary hypertension, a life-threatening group of diseases.”

Financial considerations
Under the terms of the agreement, GSK will acquire 100% of the equity of 35Pharma Inc. for $950 million, payable in cash at closing.

This transaction is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US and the Competition Act in Canada, along with a filing under the Investment Canada Act.

Advisors
Centerview Partners LLC acted as financial advisor to 35Pharma and Cooley LLP served as US legal counsel and Stikeman Elliott LLP as Canadian legal counsel. J.P. Morgan Securities LLC also provided financial advice to 35Pharma.

About pulmonary hypertension
There are different types of PH such as Pulmonary Arterial Hypertension (PAH) and PH due to Heart Failure with preserved Ejection fraction (PH-HFpEF). PH is treated in specialised academic centres by pulmonologists and cardiologists, where PH programs sit within larger lung, respiratory and critical care centres. Around 82 million people worldwide are affected by PH and in the US, the addressable patient population for PAH and PH-HFpEF is approximately 100,000 people.^1,4,5

About 35Pharma Inc.
35Pharma is a clinical-stage biopharmaceutical company developing novel TGF-beta superfamily therapeutics. 35Pharma’s lead candidate, HS235, is being developed for the treatment of cardiopulmonary diseases with clinical trials initiated in Pulmonary Arterial Hypertension and PH due to Heart Failure with preserved Ejection fraction. For more information visit www.35pharma.com.

About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at www.gsk.com.

Contact
Julia Schoelermann, VP Corporate Development
ir@35pharma.com

References
1. Humbert, M. et al. (2022) 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension, European Heart Journal, 43(38), pp. 3618–3731. doi:10.1093/eurheartj/ehac237.
2. Caravita S, Faini A, D’Araujo SC, et al. Clinical phenotypes and outcomes of pulmonary hypertension due to left heart disease: Role of the pre-capillary component. PLOS ONE. 2018;13(6):e0199164. doi:10.1371/journal.pone.0199164.
3. Evaluate Pharma consensus estimate; accessed Feb 2026.
4. Leary, Peter J et al. The Lancet Respiratory Medicine, Volume 13, Issue 1, 69-79.
5. GSK Internal data.

Pentixapharm Receives FDA “Study May Proceed” Letters for Dual Theranostic INDs in CXCR4-Based Hemato-Oncology Program

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Pentixapharm Holding AG

/ Key word(s): Study

Pentixapharm Receives FDA “Study May Proceed” Letters for Dual Theranostic INDs in CXCR4-Based Hemato-Oncology Program

25.02.2026 / 08:00 CET/CEST

The issuer is solely responsible for the content of this announcement.

Pentixapharm Receives FDA “Study May Proceed” Letters for Dual Theranostic INDs in CXCR4-Based Hemato-Oncology Program

U.S. Investigational New Drug (IND) applications for radiotheranostic pair PentixaFor and PentixaTher became active following completion of the FDA 30-day review period.
Proposed phase I/II trial designed to confirm the suitability of CXCR4-directed radiotherapy for bone marrow conditioning in patients undergoing stem cell transplant.
Overall aim is to complement or reduce conventional chemotherapy for acute myeloid leukemia (AML) and multiple myeloma (MM) patients.

Berlin, Germany – February 25, 2026 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech developing novel radiopharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day safety review of two Investigational New Drug (IND) applications for the Company’s CXCR4-targeted theranostic program in hemato-oncology and confirmed that the proposed clinical study may proceed.

The two IND submissions support the single PENTHERA Phase I/II protocol, which evaluates the combined use of PentixaFor imaging and [⁹⁰Y]Y-PentixaTher as targeted bone marrow conditioning prior to stem cell transplantation in patients with acute myeloid leukemia (AML) and multiple myeloma (MM).

Hematopoietic Stem cell transplantation remains the only potentially curative treatment option for many patients with these hematologic malignancies, yet conventional conditioning regimens rely on highly toxic chemotherapy and/or total body irradiation. Pentixapharm’s CXCR4-directed radiopharmaceutical approach is designed to enable more biologically targeted conditioning while delivering antitumor activity with precision.

In Europe and the US alone, AML and MM together account for more than 25,000 stem cell transplantations annually, each requiring a conditioning regimen prior to transplant.

“The U.S. INDs provide important regulatory validation of our CXCR4-targeted approach and support its advancement in the stem cell transplant setting, combining PentixaFor imaging with [⁹⁰Y]Y-PentixaTher,” said Dirk Pleimes, CEO of Pentixapharm. “AML and MM are significant hematologic malignancies where transplantation remains central to treatment. We believe that targeted bone marrow conditioning has the potential to offer a differentiated strategy within this established chemotherapy-based paradigm. This regulatory milestone also builds on our ongoing investigator-initiated clinical studies in AML in Europe.”

The Company will determine the timing of future clinical studies under the IND in accordance with its broader portfolio prioritisation and resource planning.

About Acute Myeloid Leukemia (AML) and Multiple Myeloma (MM)
AML and MM are serious hematologic malignancies associated with high relapse rates and ongoing unmet medical need. In eligible patients, stem cell transplantation represents a potentially curative treatment option. Conditioning therapy prior to transplantation, designed to reduce residual disease and prepare the bone marrow for engraftment, is an established component of the procedure. Conventional conditioning regimens typically rely on intensive chemotherapy and/or external beam radiation, which act systemically and may be associated with significant off-target toxicity.

About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops precision diagnostics and therapeutics in oncology and cardiology to transform patient care. Its clinical pipeline is anchored by CXCR4-targeted PET-CT programs, including a Phase 3-ready candidate for the improved diagnosis of hypertensive patients with primary aldosteronism, which is intended to enable targeted treatment of the underlying causes of hypertension. CXCR4-based developments also include pioneering therapeutic programs in hematological cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-checkpoint marker over-expressed in multiple hard-to-treat cancers. Complemented by CXCR4 and CD24 intellectual property protection and a reliable isotope supply chain, Pentixapharm is poised to deliver meaningful patient benefit and sustainable growth in one of the fastest-growing areas of precision medicine.

Pentixapharm Investor and Media Contact
ir@pentixapharm.com

25.02.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.

Language:	English
Company:	Pentixapharm Holding AG
	Robert-Rössle-Straße 10
	13125 Berlin
	Germany
E-mail:	info@pentixapharm.com
Internet:	https://www.pentixapharm.com/
ISIN:	DE000A40AEG0
WKN:	A40AEG
Listed:	Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate BSX
EQS News ID:	2281094


End of News	EQS News Service

2281094 25.02.2026 CET/CEST

BRAIN Biotech announces 3M 25/26 results and breakthrough at BioIncubator company SolasCure: Aurase Wound Gel showing strong clinical evidence of superior debridement and healing in chronic wounds

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BRAIN Biotech AG

/ Key word(s): Quarterly / Interim Statement/Study results

BRAIN Biotech announces 3M 25/26 results and breakthrough at BioIncubator company SolasCure: Aurase Wound Gel showing strong clinical evidence of superior debridement and healing in chronic wounds

25.02.2026 / 07:30 CET/CEST

The issuer is solely responsible for the content of this announcement.

BRAIN Biotech announces 3M 25/26 results and breakthrough at BioIncubator company SolasCure: Aurase Wound Gel showing strong clinical evidence of superior debridement and healing in chronic wounds

Aurase shows dual action on chronic wound debridement and healing
SolasCure preparing fund raising for clinical phase 2b/3
Sequential growth forecasted in the next quarters for BRAINBiocatalysts

ZWINGENBERG, Germany, February 25, 2026 – BRAIN Biotech AG, a leading provider of specialty enzymes and innovative biosolutions for industry, has published its financial figures for the first three months of the fiscal year 2025/26.

BRAIN Biotech Group generated Q1 revenue of € 11.9 million compared to € 13.1 million in the same period of the previous year, a decrease of 9.0 %. The group strongly improved the adjusted EBITDA to € 0.3 million from € -0.7 million in the same period last year, reflecting the strong performance of the BRAINBioIncubator segment. The BRAINBioIncubator segment benefitted from a milestone income of € 1.0 million from the deucrictibant program. The core segment BRAINBiocatalysts had the expected slow start to the year but is forecasted to show sequential growth over the next quarters.

The company today announced very positive news on its BRAINBioIncubator participation SolasCure. SolasCure is an independent clinical development company in which BRAIN Biotech holds a 35 % stake and additional production rights to the active pharmaceutical ingredient (API) tarumase. SolasCure has now successfully completed an extension study of Phase 2a clinical development. The treatment of chronic wounds with Aurase^® Wound Gel which combines a hydrogel with the enzymatic active ingredient tarumase shows both a 22 times more effective wound debridement and a 7 times accelerated healing compared to the current standard of care in the control group. SolasCure sees a total addressable market for the advanced treatment of chronic wounds of around US$ 4.3 billion in the US alone.

With this positive clinical data, SolasCure is now seeking a larger financing round to secure funding for the next steps in clinical development. Adriaan Moelker, CEO BRAIN Biotech, comments: “I am really thrilled by the clinical data the SolasCure team has been able to demonstrate. There is a large global need for innovation in advanced wound care. Aurase Wound Gel has demonstrated to accelerate wound debridement and healing at the same time and has therefore the potential to become a best-in-class first line treatment for chronic wounds with a large addressable market. We at BRAIN Biotech are very proud to have invented this enzyme and to be an active partner in its commercialization.”

Development of the segments

Revenues in the core segment BRAINBiocatalysts (enzymes, microorganisms and ingredients) decreased by 16.3 % from € 11.9 million to € 10.0 million in the reporting period. This decrease is largely attributable to lower sales of baking enzymes and to the beverage industry. The company is currently commissioning a new state-of-the-art joint production site in the Netherlands. The move and combination of production sites to and within the Netherlands was one root cause of lower sales in the quarter next to lower general customer demand. BRAIN Biotech Group expects to finalize commissioning of the new plant during Q2 2025/26. Adjusted EBITDA in the BRAINBiocatalysts segment decreased from € 0.8 million to € 0.5 million, mainly due to lower revenues and negative product mix effects. The company is forecasting sequential revenue growth for the BRAINBiocatalysts segment over the next quarters after the soft start in Q1.

Revenues within the BRAINBioIncubator segment (research-intensive R&D projects with industrial partners and own projects) rose strongly by € 0.7 million to € 1.9 million from € 1.2 million in the previous year. The company has been able to harvest a major milestone payment of € 1.0 million from the deucrictibant project for the treatment of hereditary angioedema. Milestone income in combination with lower personnel costs significantly improved adjusted EBITDA to € 0.7 million (€ – 0.7 million last year).

The BRAIN Biotech Holding mainly includes personnel expenses and other expenses for Group administration, further development of the BRAIN Biotech Group, stock exchange listing costs, group financing and M&A activities. The adjusted EBITDA for the holding was slightly lower at € -0.9 million compared to the previous year and fully within the budget planning.

Outlook

For the financial year 2025/26, BRAIN Biotech AG maintains its outlook for the core segment BRAINBiocatalysts with expected sales around last year’s level and an associated adjusted EBITDA margin of around 10 %. The company upgrades its guidance for the segment BRAINBioIncubator to a positive adjusted EBITDA (previously around break-even). It maintains its view that revenues in this segment are expected to grow markedly, targeting around € 5 million in the financial year.

Key financial data for the first three months of the fiscal year 2025/26

	3M	3M
(in € million)	2025/26	2024/25
Revenues	11.9	13.1
BRAINBiocatalysts	10.0	11.9
BRAINBioIncubator	1.9	1.2
Total operating performance¹	13.0	12.8
Adjusted EBITDA²	0.3	-0.7
EBITDA	-0.3	-1.5
Operating cash flow	-2.1	-3.3

	31.12.2025	30.09.2025
Cash and cash equivalents	5.1	6.2

1 Revenues + change in inventories + other income including R&D grants

2 The reconciliation from adjusted to unadjusted EBITDA can be found in the 3M report for the period ended December 31^st, 2025

Further information

BRAIN Biotech AG 3M Report 2025/26:
https://www.brain-biotech-group.com/en/investors/financial-publications-calendar/financial-reports/

Financial Calendar:

https://www.brain-biotech-group.com/en/investors/financial-publications-calendar/financial-calendar/

+++

Contact Media

Dr. Stephanie Konle, PR & Corporate Communications
Phone: +49 6251 9331-70
Email: stk@brain-biotech.com

Contact Investor Relations

Martina Schuster, Investor Relations
Phone: +49 6251 9331-69
Email: ms@brain-biotech.com

BRAIN Biotech

The BRAIN Biotech Group is a leader in researching, developing, and producing specialty enzymes, focusing on the food and life sciences industries. In addition, the group develops microbial production strains and scalable bioprocesses for the economic production of specialty enzymes and other proteins. BRAIN Biotech also offers customized biological solutions to the industry for more sustainable products and efficient processes.

BRAIN Biotech AG is the parent company of the BRAIN Biotech Group. The company´s activities are divided into two business segments: BRAINBiocatalysts (development, production, and distribution of specialty enzymes, microorganisms, and ingredients) and BRAINBioIncubator (research-intensive development projects and pharmaceuticals).

BRAIN Biotech operates its own fermentation facilities in the UK and has additional production sites in continental Europe and the US. BRAIN Biotech AG has been listed on the Frankfurt Stock Exchange since February 9, 2016 (Ticker symbol: BNN; ISIN: DE0005203947 / WKN: 520394). In the 2024/25 fiscal year, the group generated revenue of € 49.6 million with around 280 employees. For more information, visit: www.brain-biotech-group.com.

The BRAIN Biotech Group on social media and on the internet:

BRAIN Biotech Gruppe

Web: www.brain-biotech-group.com

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Website: https://www.biocatalysts.com/

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Disclaimer

This press release contains forward-looking statements. These statements reflect the current views, expectations, and assumptions of the management of BRAIN Biotech AG, and are based on information currently available to the management.

Forward-looking statements are no guarantees of future performance, and entail both known and unknown risks as well as uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Numerous factors exist that could influence the future performance of and future developments at BRAIN Biotech AG and the BRAIN Biotech Group. Such factors include, but are not limited to, changes in the general economic and competitive environment, risks associated with capital markets, currency exchange rate fluctuations, changes in international and national laws and regulations, in particular with respect to tax laws and regulations, as well as other factors.

BRAIN Biotech AG does not undertake any obligation to update or revise any forward-looking statements.

25.02.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.

Language:	English
Company:	BRAIN Biotech AG
	Darmstädter Straße 34-36
	64673 Zwingenberg
	Germany
Phone:	+49 (0) 62 51 / 9331-0
Fax:	+49 (0) 62 51 / 9331-11
E-mail:	ir@brain-biotech.com
Internet:	www.brain-biotech.com
ISIN:	DE0005203947
WKN:	520394
Listed:	Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate BSX
EQS News ID:	2280866


End of News	EQS News Service

2280866 25.02.2026 CET/CEST

Sandoz delivers strong full-year results; guidance for 2026 reflects an expected acceleration in growth

Posted on by

Basel, February 25, 2026 – Sandoz (SIX: SDZ; OTCQX: SDZNY), the global leader in affordable medicines, today presents its financial results for the full year and net sales for the fourth quarter of 2025.

FINANCIAL RESULTS

	FY 2025	FY 2024	change
	USD m	USD m	USD %	CC %^[1]^,^[2]	CGR %^[3]

Net sales	11,086	10,357	7%	5%	6%
Generics	7,794	7,504	4%	2%	2%
Biosimilars	3,292	2,853	15%	13%	18%

Core EBITDA	2,405	2,080	16%	14%
Core EBITDA margin	21.7%	20.1%
Core diluted earnings per share	USD 3.64	USD 2.71	34%	33%
Management free cash flow	1,547	1,112	39%
Core return on invested capital	14.5%	12.3%

Richard Saynor, Chief Executive Officer of Sandoz, said: “Our strong financial results in 2025 demonstrate the excellent headway we’re making. It was a year marked by the progress of our industry-leading pipeline, a record number of launches and significant investment in securing our biosimilars leadership for years to come. Our unrelenting focus on top-line growth, profitability and cash generation positions Sandoz well to deliver even more for patients and shareholders.

“We will build on this momentum in 2026. Alongside our launch program, we plan to extend patient access, expand the pipeline and make further efficiency gains. As we cement our leadership in affordable medicines, we have an excellent platform to meet the unprecedented opportunities ahead and deliver strong results in a high-growth, attractive market.”

FINANCIAL HIGHLIGHTS

FY 2025 net sales of USD 11.1 billion
- Up by 5% at CC and 7% in USD in the year, with volume growth of 8%; on a CGR basis, net sales grew by 6%
- Biosimilar sales up by 13% at CC in the year and by 18% at CGR; generics growth of 2% at CC and CGR
- The biosimilar share of total net sales increased to 30% (FY 2024: 28%)
- The 10 largest-selling medicines grew by a combined 10% at CC in the year and represented 33% of net sales
- In the fourth quarter, net sales of USD 3.0 billion represented growth of 6% at CC and 12% in USD; on a CGR basis, net sales grew by 7% in the quarter
Core EBITDA-margin expansion in FY 2025 of 160 basis points to 21.7%, driven by a favorable mix of sales, operational efficiencies and cost discipline
Core diluted earnings per share in the year up by 33% at CC to USD 3.64, mainly benefitting from growth in core net income
Management free cash flow, defined as free cash flow adjusted for one-off items, amounted to USD 1.5 billion (FY 2024: USD 1.1 billion), with the increase primarily driven by the growth in core EBITDA
A core return on invested capital (ROIC) of 14.5% in FY 2025 (FY 2024: 12.3%), principally a result of the strong growth in core operating income
A proposed dividend per share of CHF 0.80^[4] (FY 2024: CHF 0.60), representing 27% of core net income
Full-year 2026 guidance of mid-to-high single-digit net-sales growth^[5] and core EBITDA-margin expansion of around 100 basis points

BUSINESS HIGHLIGHTS

2025 was a milestone year for Sandoz, marked by a wave of launches across biosimilars and generics, significant progress on the transformation journey and strong financial results. The biosimilars business continued to perform strongly, supported by major launches:

Pyzchiva® (ustekinumab) was launched in the US in February 2025, offering new treatment options for around 12 million patients with chronic inflammatory diseases such as psoriasis and psoriatic arthritis. The rollout included a full suite of dosing options and extended stability compared to the reference medicine

The Pyzchiva autoinjector was launched in Europe in May 2025, the first ustekinumab biosimilar in Europe available in a pre-filled pen, with an improved self-administration experience supporting better treatment adherence and quality of life

Wyost® & Jubbonti® (denosumab) were launched in the US in June 2025 as the first FDA^[6]-approved interchangeable denosumab biosimilars, providing affordable treatment options for osteoporosis and cancer-related skeletal events, cementing Sandoz’s leadership in oncology and immunology biosimilars

Tyruko® (natalizumab) was launched in the US in November 2025 as the first and only multiple-sclerosis biosimilar, approved for all indications of the reference medicine

Afqlir® (aflibercept) was launched in Europe in November 2025, offering an affordable-treatment option for retinal diseases such as neovascular age-related macular degeneration, expanding Sandoz’s presence in the ~USD 15 billion anti-VEGF^[7] market

Wyost & Jubbonti were launched in Europe in December 2025

In November 2025, Sandoz signed a global license agreement with EirGenix Inc. to commercialize a proposed biosimilar of pertuzumab for HER2‑positive early and metastatic breast cancer, a market worth approximately USD 4.1 billion^[8], strengthening the Company’s oncology portfolio and complementing its trastuzumab biosimilars.

In December 2025, Sandoz completed the strategic acquisition of Just-Evotec Biologics EU SAS, including a site in Toulouse, France, expanding in-house development and manufacturing capabilities. In addition, Sandoz acquired an indefinite license to Just-Evotec Biologics, Inc.’s cutting-edge continuous-manufacturing technology. These acquisitions complemented ongoing investments in Slovenia, as Sandoz builds a vertically integrated European biosimilar development and manufacturing network.

In 2025, Sandoz increased the availability of affordable medicines through several important generic launches, including rivaroxaban in Germany, expanding access to high-quality antithrombotic treatment options with multiple dosage forms. In September 2025, Sandoz launched its iron-sucrose injection in the US, broadening access to affordable treatment for iron-deficiency anemia in patients with chronic kidney disease and complementing its injectable iron-therapy portfolio.

The Sandoz pipeline is industry‑leading, with 27 biosimilar assets and around 400 generics in development, targeting around USD 420 billion in originator sales. In 2025, the pipeline benefited from positive shifts in regulatory streamlining across key biosimilar programs – developments that are expected to deliver meaningful advantages for both patients and Sandoz.

FULL-YEAR 2026 GUIDANCE

Sandoz anticipates an acceleration of net-sales growth in 2026, partly reflecting the expected performance of recently launched biosimilars. This growth, alongside a favorable movement in the mix of sales, further operating efficiencies and cost discipline, is expected to result in expansion in the core EBITDA margin.

As a result, the Company provides its financial guidance for 2026:

Net sales to grow at CC by a mid to high single-digit percentage

Core EBITDA-margin expansion of around 100 basis points

No material contribution from any potential launch of generic semaglutide is expected in 2026, while overall pricing is expected to decline by a low to mid single‑digit percentage. The guidance excludes any impacts of unforeseen events or unconfirmed developments, including the imposition of new tariffs emanating from the US government.

PENICILLINS: TRADE DISTORTION

As part of its vertically integrated penicillins production, the Company sells certain amounts of active pharmaceutical ingredients (APIs) to other businesses. The imposition of tariffs by the US government in 2025 led to reduced exports from China to the US, prompting Chinese suppliers to significantly lower global prices for key penicillin APIs, including 6‑Aminopenicillanic acid (6‑APA), the foundational compound for all penicillins. This price decline coincided with an increase in global market supply. These dynamics adversely impacted the Sandoz generics net-sales performance in H2 2025; a similar impact is expected in the first half of 2026. No imminent return to prior market conditions is anticipated.

The recently announced introduction of a minimum import price of 6‑APA in India is expected to curb the inflow of low‑priced imports, primarily from China, and support the domestic fermentation‑based antibiotic production in India. This risks a diversion of the supply of low-cost 6-APA towards Europe, which continues to depend on Asia for key intermediates.

CONFERENCE CALL

A conference call and webcast for investors and analysts will begin today at 9.30am CET. Details can be found here, with the accompanying presentation here.

NOTES

The performance shown in this announcement covers the twelve-month period ended December 31, 2025
(FY 2025), the six-month period ended December 31, 2025 (H2 2025) and the three-month period ended December 31, 2025 (Q4 2025), compared to the twelve-month period ended December 31, 2024 (FY 2024), the six-month period ended December 31, 2024 (H2 2024) and the three-month period ended December 31, 2024 (Q4 2024), respectively. Commentary is based on the performance in FY 2025, unless stated otherwise. In this announcement, ‘Company’ refers to Sandoz Group AG. Over one billion patients were reached by Sandoz in 2025, including an estimated 0.2 billion patients reached through API sales.

INTEGRATED ANNUAL REPORT

Sandoz published its Integrated Annual Report 2025 today, which can be found here.

CALENDAR

The Company intends to publish its first-quarter sales update on April 29, 2026.

CONTACTS

Media Relations

Investor Relations

global.mediarelations@sandoz.com

investor.relations@sandoz.com

Alex Kalomparis

+41 79 279 02 85

Craig Marks

+44 7818 942 383

Gregor Rodehueser

+49 170 574 3200

Tamara Hackl

+41 79 790 52 17

Danja Spring

+41 79 156 74 88

Silvia Siegfried

+41 79 795 90 61

DISCLAIMER

This media release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information section of the 2025 Integrated Annual Report.

ABOUT SANDOZ

Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 colleagues of 100 nationalities work together to ensure over one billion patients are reached by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 medicines addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. In 2026, Sandoz celebrates 20 years of pioneering biosimilars, 80 years of antibiotics manufacturing and 140 years of heritage.

FULL-YEAR AND FOURTH-QUARTER NET SALES

NET SALES BY BUSINESS

FY 2025

	FY 2025	% of	FY 2024		change
	USD m	net sales	USD m	USD %	CC %	CGR %

Generics	7,794	70%	7,504	4%	2%	2%
Biosimilars	3,292	30%	2,853	15%	13%	18%
Net sales	11,086	100%	10,357	7%	5%	6%

Net sales amounted to USD 11.1 billion, reflecting growth of 5% at CC and 6% at CGR. Volumes grew by 8%, partly offset by price erosion of 3%. Net-sales growth was primarily driven by the strong performance of biosimilars, which continued to benefit from an extensive pipeline and launch program.

Generics overview

Net sales of generics amounted to USD 7.8 billion, reflecting growth of 2% at CC and CGR. Generics represented 70% of net sales in the year (FY 2024: 72%).

The increase in net sales of generics in Europe of 2% at CC and CGR was driven by the impact of launches in 2024 and 2025. International net sales of generics grew by 2% at CC and by 4% at CGR, after adjusting for the 2024 divestment of the Sandoz business in China; sales benefited from continued price increases and launches. In North America, net sales of generics were stable at CC and CGR, with the impact of strong levels of competition offset by the impact of the successful Q4 2024 US launch of paclitaxel, as well as a good performance in Canada.

Biosimilars overview

Net sales of biosimilars amounted to USD 3.3 billion in the year, reflecting growth of 13% at CC and 18% at CGR; biosimilars represented 30% of total net sales (FY 2024: 28%).

Strong Europe biosimilars net-sales growth of 14% at CC and CGR reflected several good performances, including Pyzchiva, Binocrit® (epoetin alfa) and Hyrimoz® (adalimumab). Afqlir, Wyost & Jubbonti were launched in Europe in Q4 2025. International biosimilar net-sales growth of 30% at CC and CGR reflected strong contributions from Omnitrope® (somatropin) and Hyrimoz. Wyost & Jubbonti were launched in Q3 2025 in the International region. North America biosimilar net sales grew by 2% at CC and by 19% at CGR, with the difference reflecting the withdrawal of Cimerli® (ranibizumab) in Q1 2025. The strong underlying performance was partly a result of the successful launch of Wyost & Jubbonti in Q2 2025. Tyruko was launched in the US in Q4 2025.

Q4 2025

	Q4 2025	% of	Q4 2024		change
	USD m	net sales	USD m	USD %	CC %	CGR %

Generics	2,095	69%	1,946	8%	2%	2%
Biosimilars	934	31%	769	21%	16%	20%
Net sales	3,029	100%	2,715	12%	6%	7%

Net sales for the fourth quarter were USD 3.0 billion, reflecting growth of 6% at CC and 7% at CGR. Volumes grew by 9%, partly offset by price erosion of 3%.

NET SALES BY REGION

FY 2025

	FY 2025	% of	FY 2024		change
	USD m	net sales	USD m	USD %	CC %	CGR %

Europe	5,936	54%	5,363	11%	6%	6%
International	2,713	24%	2,557	6%	7%	9%
North America	2,437	22%	2,437	0%	0%	5%
Net sales	11,086	100%	10,357	7%	5%	6%

Europe overview

Net sales in Europe in the year amounted to USD 5.9 billion, reflecting growth of 6% at CC and CGR. Europe net sales of generics increased by 2% at CC and CGR, with biosimilars up by 14% at CC and CGR. Notable growth included that from Pyzchiva, Binocrit and Hyrimoz.

International overview

Net sales in International in the year amounted to USD 2.7 billion, with growth of 7% at CC and 9% at CGR. International net sales of generics grew by 2% at CC and by 4% at CGR, with biosimilars up by 30% at CC and CGR. The performance was supported by strong sales of Omnitrope and Hyrimoz.

North America overview

Net sales in North America in the year amounted to USD 2.4 billion, reflecting a stable performance at CC. Growth at CGR, namely excluding the impact of the acquisition of Cimerli, amounted to 5%. Generics net sales in the year were stable at CC and CGR, with the effects of strong levels of competition offset by the impact of the successful 2024 US launch of paclitaxel, as well as a good performance in Canada. North America biosimilar net sales grew by 2% at CC and by 19% at CGR.

Q4 2025

	Q4 2025	% of	Q4 2025		change
	USD m	net sales	USD m	USD %	CC %	CGR %

Europe	1,574	52%	1,367	15%	6%	6%
International	770	25%	653	18%	14%	14%
North America	685	23%	695	-1%	-2%	2%
Net sales	3,029	100%	2,715	12%	6%	7%

The table of net sales by region and by business can be found in the Supplementary financial information.

The North America performance in the fourth quarter was adversely affected by the impact of a one-time generics gross-to-net adjustment in Q4 2024.

FY 2025 OPERATING RESULTS

	FY 2025	FY 2024	change
	USD m	USD m	USD %	CC %

Net sales	11,086	10,357	7%	5%
Gross profit	5,284	4,926	7%	5%
EBITDA	1,980	820	nm^[9]	nm
Operating income	1,425	307	nm	nm

Core gross profit	5,613	5,253	7%	5%
Core gross profit margin (%)	50.6%	50.7%
Core EBITDA	2,405	2,080	16%	14%
Core EBITDA margin (%)	21.7%	20.1%
Core operating income	2,094	1,821	15%	13%
Core operating income margin (%)	18.9%	17.6%

Core gross profit amounted to USD 5.6 billion (FY 2024: USD 5.3 billion), resulting in a core gross-profit margin of 50.6% (FY 2024: 50.7%). A favorable mix of sales, reflecting double-digit biosimilars growth, and operational improvements were offset by the impacts of inflation on the cost of goods sold and price erosion.

Core EBITDA was USD 2.4 billion (FY 2024: USD 2.1 billion), resulting in a core EBITDA margin of 21.7% (FY 2024: 20.1%). The increase in the margin was partly driven by the impacts of cost discipline on selling, general & administrative expenses and favorable other income and expenses, partly offset by growth in development & regulatory investment.

EBITDA was USD 1,980 million (FY 2024: USD 820 million). Core adjustments of EBITDA in the year were USD 425 million (FY 2024: USD 1,260 million). These adjustments primarily reflected separation costs of USD 336 million, costs of the rationalization of internal manufacturing sites of USD 92 million, software-implementation cost-accounting impacts of USD 43 million and favorable effects from adjustments for legal costs of USD 58 million.

FY 2025 NON-OPERATING RESULTS

	FY 2025	FY 2024	change
	USD m	USD m	USD %	CC %

Net financial result	(218)	(318)	31%	36%
Income taxes	(293)	12	nm	nm
Net income	914	1	nm	nm
Diluted earnings per share	USD 2.09	USD 0.00	nm	nm

Core net financial result	(219)	(325)	33%	36%
Core income taxes	(286)	(320)	11%	12%
Core effective tax rate (%)	15.3%	21.4%
Core net income	1,589	1,176	35%	33%
Core diluted earnings per share	USD 3.64	USD 2.71	34%	33%

The core net financial result was an expense of USD 219 million (FY 2024: expense of USD 325 million). The decline reflected an improved net-currency result, as well as lower net interest expenses mainly driven by the repayment of EUR and USD term loans and local debt.

The core effective tax rate was 15.3% (FY 2024: 21.4%), a reflection of changes in the mix of profit, adjustments to provisions for uncertain tax positions and the reorganization of the intellectual-property structure within the Company.

Core net income of USD 1.6 billion (FY 2024: USD 1.2 billion) primarily reflected an increase in core operating income, and a decline in the core net financial result and in core income taxes.

Core diluted earnings per share of USD 3.64 (FY 2024: USD 2.71) benefited from an increase in core net income. The weighted average number of shares diluted was 436.8 million as of December 31, 2025, versus 434.0 million as of December 31, 2024.

CASH FLOW

	FY 2025	FY 2024	change
	USD m	USD m	USD m

Net cash flows from operating activities	1,594	656	938
Cash flows used for capital expenditures	(711)	(554)	(157)
Other investing cash flows	(9)	(4)	(5)
Free cash flow	874	98	776

Payments for legal settlements, fees and expenses	663	29	634
Payments from restructuring provisions	128	40	88
Separation costs	336	348	(12)
Separation-related capital expenditures	90	89	1
Other payments and receipts^[10]	(544)	508	(1,052)
Management free cash flow	1,547	1,112	435

Sandoz generated net cash flows from operating activities of USD 1,594 million (FY 2024: USD 656 million). This was mainly driven by an increase in operating income and stable net working-capital levels versus December 31, 2024.

Cash flows used for capital expenditures were USD 711 million (FY 2024: USD 554 million), reflecting an increase in purchases of property, plant & equipment and intangible assets. This included the Company’s ongoing investments in Slovenia, namely a new biosimilar drug-substance production center in Lendava, a biosimilar-development center in Ljubljana and a new production plant in Brnik. It also included separation-related investments in facilities and technology.

Free cash flow amounted to USD 874 million (FY 2024: USD 98 million). The improvement was mainly due to increased net cash flows from operating activities, partly offset by the growth in cash flows used for net capital expenditures.

Management free cash flow, defined as free cash flow adjusted for one-off items, amounted to
USD 1,547 million (FY 2024: USD 1,112 million). The performance was primarily a result of the growth in core EBITDA.

CAPITAL RESOURCES

	Dec 31 2025	Dec 31 2024	change
	USD m	USD m	USD m

Inventories	2,845	2,800	45
Trade receivables	2,508	2,205	303
Trade payables	(1,850)	(1,519)	(331)
Net working capital	3,503	3,486	17

Non-current financial debts and derivative financial instruments	4,700	4,390	310
Current financial debts and derivative financial instruments	614	145	469
Total financial debts	5,314	4,535	779

Derivative financial instruments	(12)	(15)	3
Cash and cash equivalents	(1,739)	(1,191)	(548)
Total current financial assets	(1,751)	(1,206)	(545)

Net debt	3,563	3,329	234
Net debt to core EBITDA ratio	1.5x	1.6x
Core ROIC (%)	14.5%	12.3%

Net working capital remained broadly stable year‑on‑year, despite strong sales growth. Total inventories increased by USD 45 million, with lower levels of inventory more than offset by currency-translation effects. Trade receivables increased by USD 303 million, with trade payables up by USD 331 million, primarily reflecting currency-translation effects.

Non-current financial debts and derivative financial instruments increased by USD 310 million, a reflection of the issuance of three bonds in the first half of 2025, totalling EUR 500 million and CHF 400 million, respectively and currency-translation effects. This was partly offset by the repayment of USD 750 million equivalent in USD and EUR term loans, as well as the reclassification of USD 504 million from non-current to current financial debts of a CHF-denominated bond, maturing in 2026.

Current financial debts and derivative financial instruments increased by USD 469 million, primarily a result of the reclassification of USD 504 million from non-current to current financial debts.

Cash and cash equivalents increased by USD 548 million, as cash generated from operating activities and proceeds from the issuance of non-current financial debts were partly offset by the repayment of term loans, the annual dividend payment, purchases of property, plant & equipment, purchases of intangible assets and the acquisition of Just-Evotec Biologics EU SAS.

As a result, net debt increased to USD 3,563 million (December 31, 2024: USD 3,329 million), mainly driven by currency-translation effects of USD 442 million. Excluding these effects, net debt amounted to USD 3,121 million. An increase in core ROIC to 14.5% (FY 2024: 12.3%) was a result of strong growth in core operating income and a lower core effective tax rate.

DIVIDEND

A dividend of CHF 0.60 per share in respect of the 2024 financial year was approved by the Annual General Meeting on April 15, 2025, and paid. A dividend proposal of CHF 0.80 per share in respect of the 2025 financial year, representing 27% of core net income, is subject to approval at the Annual General Meeting on April 9, 2026.

SUPPORTING FINANCIAL INFORMATION

2025 NET SALES

BY BUSINESS


	H1 2025	change		H2 2025	change		FY 2025	change
	USD m	USD %	CC %	USD m	USD %	CC %	USD m	USD %	CC %
Generics	3,736	1%	1%	4,058	7%	2%	7,794	4%	2%
Biosimilars	1,496	11%	12%	1,796	19%	14%	3,292	15%	13%
Net sales	5,232	4%	4%	5,854	10%	6%	11,086	7%	5%

BY REGION
	H1 2025	change		H2 2025	change		FY 2025	change
	USD m	USD %	CC %	USD m	USD %	CC %	USD m	USD %	CC %
Europe	2,832	8%	6%	3,104	14%	6%	5,936	11%	6%
International	1,284	1%	5%	1,429	11%	9%	2,713	6%	7%
North America	1,116	-2%	-1%	1,321	2%	2%	2,437	0%	0%
Net sales	5,232	4%	4%	5,854	10%	6%	11,086	7%	5%

BY REGION AND BUSINESS: H2

	H2 2025	H2 2024	change
	USD m	USD m	USD %	CC %	CGR %

Europe	3,104	2,729	14%	6%	6%
Generics	2,095	1,888	11%	3%	3%
Biosimilars	1,009	841	20%	11%	11%
International	1,429	1,288	11%	9%	9%
Generics	1,135	1,058	7%	5%	5%
Biosimilars	294	230	28%	30%	30%
North America	1,321	1,293	2%	2%	6%
Generics	828	854	-3%	-3%	-3%
Biosimilars	493	439	12%	12%	27%
Net sales	5,854	5,310	10%	6%	7%
Thereof:
Total generics	4,058	3,800	7%	2%	2%
Total biosimilars	1,796	1,510	19%	14%	18%

BY REGION AND BUSINESS: FY

	FY 2025	FY 2024	change
	USD m	USD m	USD %	CC %	CGR %

Europe	5,936	5,363	11%	6%	6%
Generics	4,036	3,769	7%	2%	2%
Biosimilars	1,900	1,594	19%	14%	14%
International	2,713	2,557	6%	7%	9%
Generics	2,154	2,113	2%	2%	4%
Biosimilars	559	444	26%	30%	30%
North America	2,437	2,437	0%	0%	5%
Generics	1,604	1,622	-1%	0%	0%
Biosimilars	833	815	2%	2%	19%
Net sales	11,086	10,357	7%	5%	6%
Thereof:
Total generics	7,794	7,504	4%	2%	2%
Total biosimilars	3,292	2,853	15%	13%	18%

QUARTERLY 2025 NET SALES

BY BUSINESS


	Q1 2025	change		Q2 2025	change		Q3 2025	change		Q4 2025	change
	USD m	USD %	CC %	USD m	USD %	CC %	USD m	USD %	CC %	USD m	USD %	CC %
Generics	1,809	-3%	0%	1,927	5%	2%	1,963	6%	3%	2,095	8%	2%
Biosimilars	671	8%	11%	825	15%	12%	862	16%	13%	934	21%	16%
Net sales	2,480	0%	3%	2,752	8%	5%	2,825	9%	6%	3,029	12%	6%

BY REGION


	Q1 2025	change		Q2 2025	change		Q3 2025	change		Q4 2025	change
	USD m	USD %	CC %	USD m	USD %	CC %	USD m	USD %	CC %	USD m	USD %	CC %
Europe	1,372	3%	7%	1,460	12%	6%	1,530	12%	6%	1,574	15%	6%
International	590	-8%	-2%	694	11%	11%	659	4%	4%	770	18%	14%
North America	518	-1%	1%	598	-4%	-3%	636	6%	7%	685	-1%	-2%
Net sales	2,480	0%	3%	2,752	8%	5%	2,825	9%	6%	3,029	12%	6%

QUARTERLY 2024 NET SALES

BY BUSINESS


	Q1 2024	change		Q2 2024	change		Q3 2024	change		Q4 2024	change
	USD m	USD %	CC %	USD m	USD %	CC %	USD m	USD %	CC %	USD m	USD %	CC %
Generics	1,869	0%	1%	1,835	-1%	1%	1,854	3%	4%	1,946	1%	4%
Biosimilars	623	21%	21%	720	35%	37%	741	36%	37%	769	23%	25%
Net sales	2,492	5%	6%	2,555	7%	9%	2,595	11%	12%	2,715	7%	9%

BY REGION


	Q1 2024	change		Q2 2024	change		Q3 2024	change		Q4 2024	change
	USD m	USD %	CC %	USD m	USD %	CC %	USD m	USD %	CC %	USD m	USD %	CC %
Europe	1,326	4%	2%	1,308	2%	3%	1,362	13%	12%	1,367	7%	8%
International	642	4%	12%	627	5%	9%	635	2%	8%	653	0%	6%
North America	524	6%	6%	620	22%	23%	598	17%	18%	695	13%	14%
Net sales	2,492	5%	6%	2,555	7%	9%	2,595	11%	12%	2,715	7%	9%

FY 2025: RECONCILIATION FROM IFRS RESULTS TO CORE RESULTS

(USD millions unless indicated otherwise)	IFRS results	Amortization of intangible assets^[11]	Impair- ments ^[12]	Acquisition or divest-ment of businesses and related items^[13]	Other items ^[14]	Core results
Net sales	11,086	–	–	–	–	11,086
Other revenues	71	–	–	–	–	71
Cost of goods sold	(5,873)	214	16	–	99	(5,544)
Gross profit	5,284	214	16	–	99	5,613
Selling, general and administration	(2,529)	–	–	–	67	(2,462)
Development and regulatory	(1,050)	–	2	–	2	(1,046)
Other income	353	–	–	(10)	(200)	143
Other expense	(633)	–	–	12	467	(154)
Operating income^[15]	1,425	214	18	2	435	2,094
Interest expense	(220)	–	–	–	–	(220)
Other financial income and expense	2	–	–	–	(1)	1
Income before taxes	1,207	214	18	2	434	1,875
Income taxes^[16]	(293)					(286)
Net income	914					1,589
Basic earnings per share (USD)	2.12					3.68
Diluted earnings per share (USD)	2.09					3.64

^[1] Constant currencies.

^[2] Non-IFRS measures are defined in the Supplementary financial information section of the Integrated Annual Report 2025.

^[3] Sandoz defines the comparable growth rate (CGR) as the growth rate of net sales at CC excluding the effects of material acquisitions and divestments. In the case of divestments, net sales are excluded for the corresponding period. Similarly, for acquisitions, the relevant net sales are excluded for the corresponding period. Material acquisitions and divestments are transactions in scope of significant transactions in the Company’s consolidated financial statements. Sandoz believes the presentation of CGR is meaningful for management and investors to evaluate the performance of the business over time.

^[4] Subject to approval at the Annual General Meeting on April 9, 2026.

^[5] At CC.

^[6] US Food & Drug Administration.

^[7] Vascular endothelial growth factor.

^[8] Evaluate Pharma, Summary: worldwide sales (last accessed November 2025).

^[9] Not meaningful.

^[10] In FY 2025, other payments and receipts included the disbursements from qualified settlement funds relating to government generic-pricing antitrust investigations, antitrust class actions, opioid litigations in the US, and the payment for a technology acquisition from Just-Evotec Biologics, Inc. In
FY 2024, other payments and receipts included two deposited settlement amounts of USD 233 million and USD 275 million, related to government generic-pricing antitrust investigations and antitrust class actions in the US.

^[11] Amortization of intangible assets: cost of goods sold includes the amortization of rights to currently marketed products and other production-related intangible assets.

^[12] Impairments: cost of goods sold and development and regulatory include impairment charges related to intangible assets.

^[13] Acquisition or divestment of businesses and related items: other income includes a release related to the China business divestment; other expense includes costs related to the Just-Evotec Biologics EU SAS acquisition.

^[14] Other items: cost of goods sold, other income and other expense include the Company-wide rationalization of manufacturing sites; cost of goods sold, selling general and administration, development and regulatory, other income and other expense include the separation costs related to the spin-off; cost of goods sold, selling general and administration, development and regulatory, other income and other expense include the costs related to the transformation program and other restructuring charges; other income and other expense include legal-related charges and adjustments to contingent consideration; selling, general and administration includes software implementation cost accounting impacts; other expense includes an onerous contract adjustment; other financial income and expense includes the net monetary impacts on the restatement of non-monetary items for subsidiaries in hyperinflationary economies.

^[15] For further breakdown of core adjustments by category, refer to table ‘Reconciliation from IFRS operating income to core net income’.

^[16] Taxes on the adjustments between IFRS and core results take into account, for each individual item included in the adjustment, the tax rate that will finally, be applicable to the item based on the jurisdiction where the adjustment will finally have a tax impact. Generally, this results in amortization and impairment of intangible assets and acquisition-related restructuring and integration items having a full tax impact. There is usually a tax impact on other items, although this is not always the case for items arising from legal settlements in certain jurisdictions. Due to these factors and the differing applicable tax rates in the various jurisdictions, the tax on the total adjustments of USD 668 million to arrive at the core results before tax amounts to USD -7 million. The average tax rate on the adjustments was not meaningful.

#FutureFresenius: REJUVENATE in action – Delivering accelerated performance for long-term value creation; 2025 yet another year of strong delivery

Posted on by

Fresenius SE & Co. KGaA

/ Key word(s): Annual Results

#FutureFresenius: REJUVENATE in action – Delivering accelerated performance for long-term value creation; 2025 yet another year of strong delivery

25.02.2026 / 06:45 CET/CEST

The issuer is solely responsible for the content of this announcement.

#FutureFresenius: REJUVENATE in action – Delivering accelerated performance for long-term value creation; 2025 yet another year of strong delivery

FY/25 – Strong organic revenue and excellent Core EPS growth; REJUVENATE phase spurs profitable growth, drives stronger balance sheet, and creates significant value.

Group revenue¹ at €22,554 million with organic growth of 7%^1,2 reflecting the consistent execution across Fresenius Kabi and Fresenius Helios.
Group EBIT¹ at €2,595 million with 6%³ growth in constant currency driven in particular by Fresenius Kabi’s Growth Vectors and the strong performance of Fresenius Helios in Spain; Group EBIT margin¹ at 11.5% despite significant headwinds.
Core EPS^1,4increased by 12%³ in constant currency to €2.87 based on strong operating results and significantly decreased interest expense.
Structural EBIT margin ambition increased for Fresenius Kabi to 17 to 19% (previously 16 to 18%)
Constant currency Core EPS growth^1,4 established as new guidance metric is expected to be in the range of 5 to 10% in FY/26; organic revenue growth² projected to be in the range of 4 to 7% in FY/26.
Net debt/EBITDA ratio improved by 30 bp to 2.7x^1,5, well within the self-imposed target corridor of 2.5 to 3.0x; driven by cash flow delivery leading to significant debt reduction.
Dividend proposal of €1.05 per share; year-on-year increase of 5%, in line with the Company’s dividend payout ratio of 30 to 40%.

Q4/25 – Closing the year with an outstanding quarter; excellent organic revenue and EBIT growth; excellent operating cashflow.

Group revenue¹ at €5,875 million with organic growth of 9%^1,2driven by contributions from both, Fresenius Kabi and Fresenius Helios.
Group EBIT¹ at €713 million with constant currency growth of 13%³ on the back of the continued powerful operating performance at Fresenius Kabi and the expected strong acceleration at Fresenius Helios; Group EBIT margin¹ improved by 40 bp to 12.1%.
Core EPS^1,4 growth in constant currency of 16%³ further accelerated to €0.78, driven by consistent operating strength and lower interest expenses.
Operating cashflow of €1,340 million, a year-on-year increase of 36% driven by disciplined capex spending and focus on net working capital at Fresenius Kabi, and Fresenius Helios successfully driving receivables collection.

Michael Sen, CEO of Fresenius: “2025 was a pivotal year for Fresenius. With disciplined execution of our #FutureFresenius strategy and a strong performance from Team Fresenius, we met our upgraded full-year guidance by delivering another quarter of competitive growth, increasing organic revenue by 9%, EBIT by 13% and Core EPS by 16% at constant currency. 2025 capped a year of continued momentum across the Company: We further strengthened the balance sheet, and upgraded our guidance, while preparing the business through targeted investment for the next phase of growth. All of this leads to a proposed dividend of €1.05 per share, underscoring our commitment to creating shareholder value.

With #FutureFresenius we have transformed our Company, positioning ourselves to deliver future success in a new world order. Looking ahead, we enter 2026 with strong foundations and clear priorities. We are confident in our ability to deliver profitable, sustainable growth with the guidance of organic revenue growth of 4% to 7% and constant currency Core EPS growth of 5% to 10%, while continuing to create long term value across the healthcare ecosystem for patients, customers, partners, and shareholders.”

Guidance for Fiscal Year 2026¹

Fresenius Group⁶: organic revenue growth² in the range of 4% to 7%; constant currency Core EPS^1,4 growth expected in the range of 5% to 10%;
EBIT margin⁹ of ~11.5%.

Fresenius Kabi⁷: organic revenue growth³ in the mid- to high-single-digit percentage range; EBIT margin¹ of 16.5% to 17.0%.
Structural EBIT margin¹ ambition raised to 17% to 19% (previously 16% to 18%) following Kabi’s rigorous strategy execution leading to consistent margin expansion over the past several years.

Fresenius Helios⁸: organic revenue growth in the mid-single-digit percentage range; EBIT margin of 10.0% to 10.5%.

Assumptions to guidance: The company acknowledges that the prevailing trends of fast-moving macroeconomic and geopolitical environment continue, resulting in increased volatility and a higher level of operational uncertainty. The guidance does not take into account potential extreme scenarios that could affect the company, its peers, and the healthcare sector as a whole. Potential implications of the United States Supreme Court ruling as of February 20, 2026, are currently being evaluated but cannot be fully assessed at this stage and are hence not reflected in the FY/26 guidance.

Dividend proposal of €1.05 per share reflects capital allocation priorities

Fresenius remains fully commitment to delivering attractive shareholder returns. For fiscal year 2025, the Company will propose a dividend of €1.05 per share. This corresponds to a payout ratio of 37%, at the upper half of the 30% to 40% range of core net income^1,4, as specified in the Fresenius Financial Framework.

Fresenius Group – Business development FY and Q4/2025

FY/25: Strong performance despite significant macroeconomic headwinds; twice upgraded guidance delivered.

Organic revenue¹ grew 7%² reaching the top-end of the 5% to 7% guide while the 6%³ constant currency Group EBIT growth before special items secured the midpoint of the guided range of 4% to 8%. The Company achieved this despite significant headwinds including the impact from the absence of energy relief funding at Fresenius Helios, the Volume Based Procurement (VBP) of the nutrition product Ketosteril in China at Fresenius Kabi, as well as FX effects and U.S. tariffs.

Q4/25: Closing the year with an outstanding quarter which led to an increase of Group organic revenue¹ growth of 9%² and revenues reaching €5,875 million.

Group EBIT before special items amounted to €713 million, a significant acceleration with an increase of 13%³ in constant currency fuelled by Fresenius Kabi’s continued powerful operating performance and the expected strong development at Fresenius Helios. The strong acceleration at Helios is due to the very strong top-line development and was supported by strong execution on the Performance Program in Q4/25 as well as the positive effects from the surcharge on invoices of publicly insured patients recognized under other operating income. At Kabi, the operating leverage and additional productivity gains more than compensated the impact from the VBP of the nutrition product Ketosteril in China, and some targeted investments.

Group EBIT margin¹ improved by 40 bp to 12.1%.

Group Core net income^1,4 increased by 16%³ in constant currency to €440 million strongly outpacing revenue growth. The good operating performance of both, Fresenius Kabi and Fresenius Helios, further productivity gains as well as the decreased year-over-year interest expenses drove this performance.

Group Core earnings per share^1,4 rose by 16%³ in constant currency to €0.78.

Operating Companies – Business development FY and Q4/25

Fresenius Kabi

FY/25: Consistent financial performance delivered over the course of the year with excellent organic revenue growth of 7% at the top-end of the structural growth band and an EBIT margin expansion of 70 bps to 16.4%.

Q4/25: Strong finish to the year with organic growth well above the structural growth band of 4% to 7%; Growth Vectors driving the performance headed by continued Biopharma strength; EBIT margin reflects targeted investments, and year-end effects.

Organic revenue growth of 10%² in Q4 driven by the Growth Vectors and led by Biopharma with strong product roll-outs; revenue rose to €2,214 million, making it the highest quarterly revenue amount in Fresenius Kabi’s history; growth as reported was significantly impacted by currency translation effects, primarily from the US Dollar and the Argentinian Peso.

Growth Vectors with 16% organic revenue² growth; Biopharma 97%, MedTech 5%, and Nutrition 5%
- Biopharma revenue: €265 million, mainly driven by the tocilizumab biosimilar Tyenne ramp up in Europe and the U.S.; uptake of Otulfi with first sales from the exclusive distribution agreement with CivicaScript in the U.S.
- MedTech revenue: €425 million with broad-based growth across all regions and segments, Transfusion & Cell Therapy (TCT) and Infusion and Nutrition Systems (INS) both showed solid growth.
- Nutrition revenue: €602 million driven by strong underlying growth in Europe and Latin America; more than offset the impact from the VBP tender on nutrition product Ketosteril in China.
Pharma revenue: €922 million, organic revenue increased by 2%² driven by Europe, with good volumes and price mix; U.S. volume growth more than compensated for pricing pressures.
EBIT¹ of Fresenius Kabi increased to €349 million or 7%³ at constant currency. The performance reflected the operating leverage and the benefit of productivity gains that more than offset the impact of the Ketosteril tender in China and the adverse impact from U.S. tariffs, particularly in MedTech. The performance in the quarter also reflected targeted investments. The EBIT margin¹ was 15.8%.
EBIT¹ of the Growth Vectors increased by 19%³ in constant currency and amounted to €199 million; EBIT margin¹ improved by 70 bps to 15.4%, making further progress toward Kabi’s structural margin band target.
EBIT¹ of Pharma increased 2%³ in constant currency to €189 million driven by Europe and the U.S. as well as by ongoing cost efficiencies. EBIT margin¹ at 20.5%.

Fresenius Helios

FY/25: Fresenius Helios delivered organic revenue growth of 7% driven by solid activity growth and favourable pricing in Germany and Spain;
EBIT margin¹ of 9.8% consistent with the target for FY/25.

Q4/25: Fresenius Helios with very strong organic revenue growth and outstanding year-on-year margin improvement.

8% organic revenue growth in Q4 mainly driven by year-over-year activity levels increase at both, Helios Germany and Helios Spain, and positive pricing; revenue increased by 8% in constant currency to €3,546 million.

Helios Germany’s organic revenue growth at 6%, reflecting good admission growth and positive pricing; revenues at €2,055 million.
Helios Spain with organic revenue growth of 11% to €1,491 million driven by strong activity levels and end-of-year payor settlements.
EBIT¹ of Fresenius Helios at €416 million with 22% growth at constant currency. The acceleration at Helios reflects the very strong top-line development and was fuelled by the significant ramp up of the Performance Program in Q4/25 and the positive effects from the surcharge on invoices of publicly insured patient in Germany recognized under other operating income. EBIT margin¹ of Fresenius Helios improved by 130 bp to 11.7%.
EBIT¹ of Helios Germany increased by 52% to €194 million reflecting the significant ramp up of the Performance Program in Q4/25 and the positive effects from the surcharge on invoices of publicly insured patient in Germany; EBIT margin¹ improved by 280 bp to 9.4% compared to Q4/2024.
EBIT¹ of Helios Spain increased by 6% in constant currency to €224 million; EBIT margin¹ at 15.0% reflects some year-end effects as well as the good topline development.
Helios Performance Programme delivering substantial cost savings in Q4/25 adding up to the expected roughly €100 million contributions in FY/25.

Footnotes

¹ Before special items

² Organic growth rate adjusted for accounting effects related to Argentina hyperinflation

³ Growth rate adjusted for Argentina hyperinflation

⁴ Excluding Fresenius Medical Care

⁵ At average exchange rates for both net debt and EBITDA; pro forma closed

acquisitions/divestitures, including lease liabilities, including Fresenius Medical Care

dividend, net debt adjusted for the valuation effect of the exchangeable bond

⁶ 2025 base: €22,554 million (revenue), €2.87 (Core EPS^1,4)

⁷ 2025 base: €8,612 million (revenue) and €1,413 million (EBIT)

⁸ 2025 base: €13,550 million (revenue) and €1,328 million (EBIT)

⁹ This metric (EBIT margin) is provided solely for modelling purposes and does not form part of the official guidance; 2025 Base: €2,595 million

Group figures Q4 and FY/25

		Q4/25	Q4/24	Growth	Growth	Q1-4/25	Q1-4/24	Growth	Growth
					cc				cc


Revenue

Group¹	€m	5.875	5.526	6%	8%	22.554	21.526	5%	6%

Fresenius Kabi¹	€m	2.214	2.148	3%	9%	8.612	8.414	2%	6%
MedTech	€m	425	424	0%	5%	1.610	1.568	3%	6%
Nutrition	€m	602	614	-2%	5%	2.396	2.399	0%	5%
Biopharma	€m	265	144	84%	97%	871	611	43%	51%
Growth vectors	€m	1.292	1.182	9%	16%	4.877	4.578	7%	11%
Pharma	€m	922	966	-5%	0%	3.735	3.835	-3%	0%
Kabi Corporate	€m	0	0	—	—	0	0	—	—

Fresenius Helios	€m	3.546	3.273	8%	8%	13.550	12.739	6%	7%
Helios Germany	€m	2.055	1.937	6%	6%	8.121	7.662	6%	6%
Helios Spain	€m	1.491	1.336	12%	11%	5.429	5.077	7%	7%
Helios Corporate	€m	0	0	—	—	0	0	—	—

Group Corporate	€m	115	105	10%	10%	392	373	5%	5%

Organic revenue growth

Group¹	%	9%	7%			7%	8%

Fresenius Kabi¹	%	10%	9%			7%	10%
MedTech	%	5%	7%			6%	6%
Nutrition	%	5%	21%			5%	13%
Biopharma	%	97%	39%			51%	76%
Growth vectors	%	16%	18%			11%	16%
Pharma	%	2%	0%			2%	3%

Fresenius Helios	%	8%	6%			7%	6%
Helios Germany	%	6%	6%			6%	5%
Helios Spain	%	11%	6%			7%	8%

EBIT

Group¹	€m	713	646	10%	13%	2.595	2.489	4%	6%

Fresenius Kabi¹	€m	349	340	3%	7%	1.413	1.319	7%	9%
Growth vectors	€m	199	174	14%	19%	743	635	17%	20%
Pharma	€m	189	198	-5%	2%	813	771	5%	9%
Kabi Corporate	€m	-39	-32			-143	-87

Fresenius Helios	€m	416	339	23%	22%	1.328	1.288	3%	3%
Helios Germany	€m	194	128	52%	52%	662	660	0%	0%
Helios Spain	€m	224	211	6%	6%	669	629	6%	7%
Helios Corporate	€m	-2	0			-3	-1

Group Corporate	€m	-52	-33	-58%	-52%	-146	-118	-24%	-24%

EBIT margin

Group	%	12,1%	11,7%			11,5%	11,6%
Fresenius Kabi	%	15,8%	15,8%			16,4%	15,7%
Growth vectors	%	15,4%	14,7%			15,2%	13,9%
Pharma	%	20,5%	20,5%			21,8%	20,1%
Fresenius Helios	%	11,7%	10,4%			9,8%	10,1%
Helios Germany	%	9,4%	6,6%			8,2%	8,6%
Helios Spain	%	15,0%	15,8%			12,3%	12,4%


Net Income


Net Interest	€m	-77	-97	21%	19%	-324	-433	25%	25%
Income Tax	€m	-174	-154	-13%	-14%	-582	-532	-9%	-11%
Net income ex FMC¹ (Core net income¹)	€m	440	390	13%	16%	1.619	1.461	11%	12%
EPS ex FMC¹ (Core EPS¹)	€/share	0,78	0,69	13%	16%	2,87	2,59	11%	12%

Operating cash flow^2,5	€m	1.340	982	36%		2.606	2.474	5%
Free Cash Flow^3,5	€m	966	580	67%		1.285	1.679	-23%
Net debt/EBITDA⁴						2.7x	3.0x
ROIC	%					6,6%	6,2%

Employees (December 31)						178.394	176.486	1%

Before special items
¹Growth rate adjusted for Argentina Hyperinflation
²Continuing operations
³FCF after acquisitions, dividends and lease liabilities (continuing operations)
⁴At average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures, including lease liabilities,
including Fresenius Medical Care dividend, net debt adjusted for the valuation effect of the exchangeable bond.
⁵ Prior year figures have been adjusted due to the gradual exit from Fresenius Vamed.

Conference call and Audio webcast

As part of the publication of the Q4 and FY 2025 results, a conference call will be held on February 25, 2026 at 1:30 p.m. CET / 7:30 a.m. EST. All investors are cordially invited to follow the conference call in a live audio webcast at https://www.fresenius.com/investors. Following the call, a replay will be available on our website.

Press Contact

Friederike Segeberg Timo Lindemann
Group Communications Group Communications
Fresenius SE & Co. KGaA Fresenius SE & Co. KGaA
Else-Kröner-Straße 1 Else-Kröner-Straße 1
61352 Bad Homburg, Germany 61352 Bad Homburg, Germany
M +49 (0) 175 9627751 M +49 (0) 151 15515324
Friederike.Segeberg@fresenius.com Timo.Lindemann@fresenius.com

Note on the presentation of financial figures

If no timeframe is specified, information refers to Q4/2025.
Consolidated results for Q4 and FY 2025 as well as for Q4 and FY 2024 include special items. An overview of the results for Q4 and FY 2025 – before and after special items – is available on our website.
Growth rates in constant currency of Fresenius Kabi are adjusted. Adjustments relate to the hyperinflation in Argentina. Accordingly, constant currency growth rates of the Fresenius Group are also adjusted.
Information on the performance indicators is available on our website at https://www.fresenius.com/alternative-performance-measures.

Fresenius SE & Co. KGaA (Frankfurt/Xetra: FRE) is a global healthcare company headquartered in Bad Homburg v. d. Höhe, Germany. In the 2025 fiscal year, Fresenius generated €22.6 billion in annual revenue. Fresenius currently counts over 178,000 employees. The Fresenius Group comprises the operating companies Fresenius Kabi and Fresenius Helios as well as an investment in Fresenius Medical Care. With around 140 hospitals and countless outpatient facilities, Fresenius Helios is the leading private hospital operator in Germany and Spain, treating around 27 million patients every year. Fresenius Kabi’s product portfolio touches the lives of 450 million patients annually and includes a range of highly complex biopharmaceuticals, clinical nutrition, medical technology, and intravenous generic drugs and fluids. Fresenius was established in 1912 by the Frankfurt pharmacist Dr. Eduard Fresenius. After his death, Else Kröner took over management of the company in 1952. She laid the foundations for a global enterprise that today pursues the goal of improving people’s health. The largest shareholder is the non-profit Else Kröner Fresenius Foundation, which is dedicated to advancing medical research and supporting humanitarian projects.

For more information visit the Company’s website at www.fresenius.com.

Visit our media center: www.fresenius.com/media-center

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, the availability of financing and unforeseen impacts of international conflicts. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.

Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Wolfgang Kirsch

General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany / Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Michael Sen (Chairman), Pierluigi Antonelli, Sara Hennicken, Robert Möller, Dr. Michael Moser
Chairman of the Supervisory Board: Wolfgang Kirsch

25.02.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.

Language:	English
Company:	Fresenius SE & Co. KGaA
	Else-Kröner-Straße 1
	61352 Bad Homburg v.d.H.
	Germany
Phone:	+49 (0)6172 608-2485
Fax:	+49 (0)6172 608-2488
E-mail:	ir-fre@fresenius.com
Internet:	www.fresenius.com
ISIN:	DE0005785604
WKN:	578560
Indices:	DAX
Listed:	Regulated Market in Dusseldorf, Frankfurt (Prime Standard), Munich; Regulated Unofficial Market in Hamburg, Hanover, Stuttgart, Tradegate BSX; Luxembourg Stock Exchange
EQS News ID:	2281092


End of News	EQS News Service

2281092 25.02.2026 CET/CEST

Formycon announces positive clinical data for Keytruda® biosimilar candidate FYB206 (pembrolizumab)

Posted on by

Formycon AG

/ Key word(s): Study results/Study

Formycon announces positive clinical data for Keytruda® biosimilar candidate FYB206 (pembrolizumab)

25.02.2026 / 06:30 CET/CEST

The issuer is solely responsible for the content of this announcement.

Press Release // February 25, 2026

Formycon announces positive clinical data for Keytruda^® biosimilar candidate FYB206 (pembrolizumab)

Dahlia PK study demonstrates pharmacokinetic equivalence of FYB206 (pembrolizumab) with the reference drug Keytruda^®
Positive clinical data from the pivotal study underline Formycon’s strong position among the leading developers of a pembrolizumab biosimilar
Focus on completing development and preparing the regulatory dossiers

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, „Formycon“) announces that the pivotal Dahlia pharmacokinetic study (PK study) has successfully met its primary study objective. The randomized, double-blind, multicenter clinical PK study demonstrated pharmacokinetic equivalence (bioequivalence) of FYB206 (pembrolizumab) with the oncology blockbuster drug Keytruda^®1.

Dr. Andreas Seidl, Chief Scientific Officer of Formycon AG, comments: “Reaching this important milestone in our clinical development program in such a short time reflects our exceptional scientific expertise as well as our strong capabilities in efficiently conducting clinical trials. The positive results of the Dahlia PK study for our biosimilar candidate FYB206 underline our position as one of the leading biosimilar developers for this important biologic drug. They confirm the strategy of our streamlined clinical development program as well as the high quality of our study design and management. We are now one step closer to making FYB206 available worldwide as quickly as possible and improving access to this essential therapy.”

At the beginning of 2025, Formycon and the US Food and Drug Administration (FDA) had agreed on a streamlined clinical strategy that aims to sufficiently demonstrate the therapeutic comparability of FYB206 with the reference drug Keytruda^®, based on comprehensive analytical data and data from the Dahlia PK study. Having achieved the primary study objective, Formycon is now focusing on completing all development activities to finalize the documents for regulatory approval. The company is working closely with the regulatory authorities to make FYB206 available as soon as possible after the exclusivity of the reference drug expires. In the meantime, patients from the Dahlia study will continue to be treated to ensure optimum clinical care.

Pembrolizumab is a humanized monoclonal antibody that belongs to the class of immune checkpoint inhibitors and is used to treat various types of cancer. Due to this broad range of indications in oncology, global sales of Keytruda^® in 2025 increased by 7% year-on-year to US$ 31.7 billion.² Keytruda^® thus maintains its top position among the world’s best-selling drugs.

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¹ Keytruda^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.
² https://www.merck.com/news/merck-highlights-progress-advancing-broad-diverse-pipeline/

About Formycon:

Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich and listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com/

About Biosimilars:

Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Phone +49 (0) 89 – 86 46 67 149
Fax + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com
www.formycon.com

Disclaimer:

This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

25.02.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.

Language:	English
Company:	Formycon AG
	Fraunhoferstraße 15
	82152 Planegg-Martinsried
	Germany
Phone:	+49 89 864667 100
Fax:	+49 89 864667 110
E-mail:	ir@formycon.com
Internet:	www.formycon.com
ISIN:	DE000A1EWVY8, NO0013586024
WKN:	A1EWVY, A4DFJH
Listed:	Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate BSX; Oslo
EQS News ID:	2281056


End of News	EQS News Service

2281056 25.02.2026 CET/CEST

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Formycon announces positive clinical data for Keytruda® biosimilar candidate FYB206 (pembrolizumab)