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
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)
35Pharma to be Acquired by GSK to Accelerate Development of HS235, a Potential Best-in-Class Investigational Medicine for Pulmonary Hypertension (PH)
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%.1,2 By 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.
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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
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) 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
25.02.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group. 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 |
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2281094 25.02.2026 CET/CEST
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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
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
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 31st, 2025
Further information BRAIN Biotech AG 3M Report 2025/26:
Financial Calendar: https://www.brain-biotech-group.com/en/investors/financial-publications-calendar/financial-calendar/ +++ Contact Media Dr. Stephanie Konle, PR & Corporate Communications Contact Investor Relations Martina Schuster, Investor Relations
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 LinkedIn: https://www.linkedin.com/company/brainbiotech Threads: https://www.threads.net/@brainbiotechag Bluesky: https://bsky.app/profile/brain-biotech-group.com Youtube: https://www.youtube.com/channel/UCS33HJqku674X22UQ8QIsyg
Biocatalysts Ltd (Production, Distribution) Website: https://www.biocatalysts.com/ LinkedIn: Biocatalysts Ltd on LinkedIn / BRAIN-Biocatalysts Life Science Solutions on LinkedIn
BRAIN Biotech Zwingenberg (Technologies & R&D Services) Website: www.brain-biotech.com LinkedIn: BRAIN Biotech Technologies & Services
AnalyticonDiscovery (R&D) Web: https://ac-discovery.com/ LinkedIn: https://www.linkedin.com/company/analyticon-discovery/
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 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 |
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2280866 25.02.2026 CET/CEST
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
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|
FY 2025 |
FY 2024 |
change |
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|
USD m |
USD m |
USD % |
CC %[1],[2] |
CGR %[3] |
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|
|
|
|
|
|
|
|
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
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:
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:
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 |
|
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 |
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 |
Impair- |
Acquisition or divest-ment of businesses |
Other items |
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.
|
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.
Q4/25 – Closing the year with an outstanding quarter; excellent organic revenue and EBIT growth; excellent operating cashflow.
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 EPS1,4 growth expected in the range of 5% to 10%; Fresenius Kabi7: organic revenue growth3 in the mid- to high-single-digit percentage range; EBIT margin1 of 16.5% to 17.0%. 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 income1,4, 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 income1,4 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 share1,4 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.
Fresenius Helios FY/25: Fresenius Helios delivered organic revenue growth of 7% driven by solid activity growth and favourable pricing in Germany and Spain; 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.
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 EPS1,4) 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
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
Note on the presentation of financial figures
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 General Partner: Fresenius Management SE
25.02.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group. The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
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| 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 |
|
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2281092 25.02.2026 CET/CEST
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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. Formycon announces positive clinical data for Keytruda® biosimilar candidate FYB206 (pembrolizumab)
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. ————– 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: Phone +49 (0) 89 – 86 46 67 149 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 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 |
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2281056 25.02.2026 CET/CEST
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Fresenius SE & Co. KGaA / Key word(s): Personnel Fresenius Supervisory Board extends ahead of schedule CEO Michael Sen’s contract by five years — Christian Pawlu to join Management Board for Fresenius Helios effective July 1, 2026 25.02.2026 / 06:00 CET/CEST The issuer is solely responsible for the content of this announcement. Fresenius Supervisory Board extends ahead of schedule CEO Michael Sen’s contract by five years — Christian Pawlu to join Management Board for Fresenius Helios effective July 1, 2026 The Fresenius Supervisory Board has unanimously extended ahead of schedule the mandate of CEO Michael Sen (57) by five years. This will help to ensure continuity in the company’s leadership for the next phase in its #FutureFresenius strategy. His contract will now run until 2031. Wolfgang Kirsch, Chair of the Supervisory Board of Fresenius, said: “Michael Sen has been instrumental in driving the company’s development with #FutureFresenius in the past three years. Today, Fresenius is more innovative and relevant – well positioned to leverage the significant opportunities in the healthcare industry. Michael Sen and his team have placed Fresenius on a growth path offering long-term profitability that benefits all stakeholders. We want to maintain this continuity. Both the Supervisory Board and I personally look forward to continuing our collaboration in the coming years.” “I would like to thank the Supervisory Board for its trust and look forward to continuing to work with all Supervisory Board members, my management team, and our outstanding employees as well as our customers, partners, and shareholders. Over the past few years, we have made the company more innovative while remaining focused on delivering profitable growth. Today, Fresenius is more relevant than ever before. We want to continue this success story. In times of fundamental change shaped by rapid advances in new technologies such as AI and a transactional world order, we bear even greater responsibility as a leading global healthcare company. Now more than ever, our goal is to provide high-quality, reliable healthcare while making healthcare systems even more efficient and resilient,” adds Michael Sen, CEO of Fresenius. Dr. Christian Pawlu succeeds Robert Möller The Fresenius Supervisory Board has also unanimously appointed Dr. Christian Pawlu (48) to the Fresenius Management Board, effective July 1, 2026. He will oversee the businesses of Fresenius Helios, which includes the two private hospital chains, Quirónsalud in Spain and Helios Kliniken in Germany. He will succeed Robert Möller (59) on the Management Board, who will establish the company’s Office of the Management in Berlin and Brussels. “On behalf of the Supervisory Board, I would like to sincerely thank Robert Möller for the excellent cooperation and successful leadership of Fresenius Helios in recent years. Through the formation of medical clusters and the focus on digitalization and excellent patient care, the two hospital chains are excellently positioned in Germany and Spain. I am therefore delighted that Robert Möller will continue to contribute his expertise to the company,” says Wolfgang Kirsch. He adds: “With Christian Pawlu, we have been able to acquire a physician and strategist with a broad international network for the Group’s Management Board. I am especially pleased that we could find an outstanding internal candidate who has already contributed significantly to the hospital business as Chief Operating Officer of Fresenius Helios. I wish Christian Pawlu a strong start in his new role.” Michael Sen (57) has been CEO of Fresenius since October1, 2022. He is also Chairman of the Supervisory Board of the listed dialysis provider Fresenius Medical Care. In April 2021, Michael Sen was appointed CEO of Fresenius Kabi. Before joining Fresenius, he was a member of the Management Board at SiemensAG, responsible for the healthcare and energy business. He took Siemens Healthineers public during this time. Prior to this, he was Chief Financial Officer at the energy group E.ON SE. Dr. Christian Pawlu has been Chief Operating Officer (COO) of Helios in Germany since March 2025, and in September 2025 expanded his responsibilities as COO of Fresenius Helios including Helios in Germany and Quirónsalud in Spain. Prior to this, he served as Head of Corporate Development at Fresenius after joining Fresenius Kabi in Bad Homburg as Head of Corporate Development in April 2021. From 2022 to 2025, he was a member of the Supervisory Board of the Fresenius subsidiary mAbxience, based in Spain. In his early career, Christian Pawlu was a member of Sandoz Group AG’s Executive Board, CEO of a private high-tech start-up, and a partner at McKinsey & Company management consultancy. # # #
Fresenius SE & Co. KGaA (Frankfurt/Xetra: FRE) is a global healthcare company headquartered in Bad Homburg v. d. Höhe, Germany. 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. 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 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: | 2281090 |
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2281090 25.02.2026 CET/CEST
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EQS Newswire / 25/02/2026 / 11:12 UTC+8 Suzhou, China, February 24, 2026 — CF PharmTech, Inc. (HKEX: 2652.HK) (“CF PharmTech” or the “Company”) today announced that the Investigational New Drug (“IND”) application for ICF004, the Company’s internally developed first-in-class (FIC) inhaled dry powder candidate for the treatment of pulmonary fibrosis (a Class 1 chemical drug candidate), has been accepted by the National Medical Products Administration of China (“NMPA”). The acceptance of the ICF004 IND application marks a key step forward in the Company’s innovative drug research and development efforts and an important milestone in advancing translational innovation based on the Company’s complex respiratory formulation and precision delivery platform. The Company believes progress in the ICF004 program not only supports the clinical development value of a standalone pipeline asset, but also demonstrates its ability to translate high-barrier delivery and formulation platform capabilities into innovative drug clinical development assets. Addressing Unmet Needs in PF-ILD: Resolving Efficacy-Tolerability Dilemma ICF004 is intended for the treatment of Progressive Fibrosing Interstitial Lung Disease (“PF-ILD”), a disease area that includes life-threatening indications such as Idiopathic Pulmonary Fibrosis (“IPF”) and Progressive Pulmonary Fibrosis (“PPF”). PF-ILD is characterized by progressively worsening respiratory symptoms and irreversible decline in lung function, and is generally associated with poor prognosis. Using IPF as a representative condition, publicly available data indicate a median survival of approximately 2.8 years and a 5-year survival rate below 40%, underscoring the substantial clinical burden of disease. Oral therapies have been approved globally for the treatment of IPF. Public clinical data and real-world evidence suggest that, while existing therapies may slow decline in lung function to some extent, some patients still face limited survival benefit, significant adverse-event burden, and treatment interruption or discontinuation. For patients coping with both disease progression and treatment-related side effects, there remains an urgent global need for next-generation therapies that can better balance safety, efficacy, and long-term treatment adherence. The Company believes the development rationale for ICF004 is grounded in these unmet needs. The program seeks to explore new delivery and therapeutic pathways on top of existing treatment approaches, with the goal of improving the therapeutic window and patient outcomes. Improving Therapeutic Window Through the Integration of Mechanism Exploration and Formulation Innovation Through Local Targeted Delivery Based on the Company’s current development strategy, ICF004 uses an inhaled dry powder delivery route designed to deliver the drug directly to lung lesion areas, thereby increasing local pulmonary exposure while minimizing systemic exposure to the extent possible, in pursuit of a better balance between efficacy and safety. The Company positions ICF004 as a candidate integrating mechanism exploration and formulation innovation, and continues to conduct mechanistic research and translational validation around fibrosis-related pathological processes, including inflammation, oxidative stress, and fibroblast activation. Preclinical Findings Demonstrate Differentiated Pulmonary Exposure Profile Supporting Development Strategy According to the Company’s completed preclinical studies, ICF004 demonstrated differentiated distribution characteristics between lung tissue exposure and systemic blood exposure following inhaled administration. In relevant studies, the Company observed a significant exposure differential between lung and blood, supporting the project’s subsequent development strategy centered on improving target-organ exposure efficiency and reducing systemic exposure burden through local targeted delivery. In addition, the Company observed anti-fibrotic activity trends for ICF004 in relevant preclinical models. These findings provide supportive information for subsequent clinical development; however, whether they will translate into clinical efficacy and safety advantages in humans remains to be verified in future clinical trials. Platform Validation: Extending from Complex Formulation to Innovative Drug Translational Capability and Strategic Significance The acceptance of the ICF004 IND application marks the first time one of the Company’s innovative drug programs has entered the regulatory acceptance stage. The Company believes the strategic significance of this progress is reflected primarily in the following areas:
Leveraging its capabilities in inhalation delivery, device engineering, regulatory registration, and industrialization, CF PharmTech continues to advance a multi-layered product portfolio and explore opportunities in delivery-enabled innovative drug development across broader disease areas. Next Steps The Company will continue to advance subsequent clinical development activities for ICF004 in accordance with NMPA requirements, including clinical start-up preparation, subject enrollment arrangements, and phased data readouts. At the same time, the Company will prudently evaluate strategic pathways such as independent development and collaborative development based on the project’s clinical progress, resource allocation, and external partnership opportunities, and will fulfill information disclosure obligations in a timely manner in accordance with applicable regulatory requirements. Important Risks and Disclaimers Innovative drug R&D involves high investment, long development timelines, and significant risks. Uncertainties remain in the subsequent clinical development, regulatory review and approval, and commercialization process of ICF004. The Company reminds investors to exercise rational judgment and be mindful of the risks associated with investing. About CF PharmTech CF PharmTech focuses on the development of complex formulations, small nucleic acid and liposomal drugs, and precision delivery technologies in key therapeutic areas such as respiratory diseases, and has capabilities in inhalation delivery, device engineering, regulatory registration, and industrialization. The Company is advancing a multi-layered product portfolio based on these platform capabilities and continues to explore clinical translation opportunities in innovative drug development. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements, including but not limited to statements relating to the development, clinical progress, regulatory review, and potential commercialization of ICF004, and the Company’s strategic plans and expectations. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Such risks and uncertainties include, but are not limited to, risks related to clinical development, regulatory approval, commercialization, market conditions, and other factors. Readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to update any forward-looking statements, except as required by applicable law or regulation.
25/02/2026 Dissemination of a Financial Press Release, transmitted by EQS News. Media archive at www.todayir.com |