Hyloris Pharmaceuticals SA

M&A Activity • Oct 28, 2025

Hyloris and Orion Partner to Bring Tranexamic Acid RTU to Key European Markets

• Exclusive License and Supply Agreement Grants Orion Rights to Commercialize Tranexamic Acid RTU Across Key European Markets

Liège, Belgium – 28 October 2025 – 07:00 CET – Regulated Information – Inside information - Hyloris Pharmaceuticals SA ("Hyloris") (Euronext Brussels: HYL), the specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces that it has entered into an exclusive license and supply agreement with Orion Corporation ("Orion"). The agreement grants Orion the rights to register, market, and commercialize Tranexamic Acid Intravenous Premix RTU (TXA RTU) in major European markets including Spain, Germany, France, Poland, the Nordics, Austria, and the Baltics, with Hyloris serving as the sole supplier of the finished product. Hyloris will be eligible to receive milestone payments tied to contract signing, product launch, and cumulative sales achievements, alongside a recurring revenue stream from product supply.

Tranexamic Acid for injection is currently approved to prevent and treat bleeding in a variety of clinical settings. Hyloris' TXA RTU presentation improves ease of use by eliminating the need for preadministration dilution, offering a convenient, time-saving alternative that may streamline treatment and improve patient outcomes. Within the defined European territories, demand for safe, efficient, and ready-to-use hospital therapies remains strong, particularly in surgical and trauma settings where speed and reliability are critical.

"This partnership with Orion represents an important strategic milestone for Hyloris," said Stijn van Rompay and Thomas Jacobsen, Co-CEOs of Hyloris. "By combining Hyloris' development capabilities with Orion's strong regulatory expertise and established commercial presence, we are ideally positioned to accelerate patient access to TXA RTU across Europe. This collaboration reflects our shared commitment to delivering innovative, ready-to-use medicines through trusted partnerships that create lasting value for patients, healthcare providers, and shareholders alike."

About Hyloris Pharmaceuticals

Hyloris is the specialty biopharma company focused on innovating, reinventing, and optimizing existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors.

The Company's development strategy primarily focuses on leveraging established regulatory pathways, such as the FDA's 505(b)2 pathway in the U.S or equivalent regulatory frameworks in other regions which are specifically designed for pharmaceuticals for which safety and efficacy of the molecule have already been established. This approach can reduce the clinical burden required for market entry, and significantly shorten the development timelines, leading to reduced development costs and risks.

Press Release Regulated Information – Inside information

Hyloris has built a broad development portfolio of 26 products, including 23 reformulated and/or repurposed value-added medicines that have the potential to offer significant advantages over existing alternatives. Two products are currently in early phases of commercialization in collaboration with commercial partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative pain treatment. In addition to its core strategic focus, the Company has 2 high barrier generic products approved in the U.S. and 1 high barrier generic product in development.

Hyloris is based in Liège, Belgium and listed on Euronext Brussels (XBRU:HYL).

For more information, visit www.hyloris.com and follow-us on LinkedIn.

About Orion Corporation

Orion is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. In 2024 Orion's net sales amounted to EUR 1,542 million and the company employed about 3,700 professionals worldwide, dedicated to building wellbeing. Orion's A and B shares are listed on Nasdaq Helsinki.

For more information, please visit www.orionpharma.com.

For more information, contact Hyloris Pharmaceuticals:

Stijn Van Rompay, co-CEO stijn.vanrompay@hyloris.com

Thomas Jacobsen, co-CEO thomas.jacobsen@hyloris.com 32 (0)4 346 02 07

Press Release Regulated Information – Inside information

Disclaimer and forward-looking statements

Hyloris means "high yield, lower risk", which relates to the 505(b)(2) regulatory pathway for product approval on which the Company focuses, but in no way relates or applies to an investment in the Shares. Certain statements in this press release are "forward-looking statements." These forwardlooking statements can be identified using forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties, and other factors, many of which are beyond the Company's control, that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

This press release contains information about a product under development and is not intended as a promotional statement. The product mentioned is subject to regulatory approval and is not currently available for sale. Please consult licensed medical professionals for healthcare decisions.