Hyloris Pharmaceuticals Sa · EURONEXT:HYL
Hyloris Pharmaceuticals Sa — KBC Conference 2025
33 slides from Hyloris Pharmaceuticals Sa's conference presentation, Sep 25, 2025
Slide 1: Investor Presentation
Click to edit Master title style • Edit Master text styles • Second level • Third level • Fourth level • Fifth level Investor Presentation 25 September 2025 0
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation has been prepared by, and is the sole responsibility of, Hyloris Pharmaceuticals SA (the "Company") for discussions with investors in relation to the Company and its group. For the purposes of this notice, “presentation” means this document, oral presenta
Slide 3: Hyloris at a glance
Hyloris at a glance Becoming a market leader in value-added medicines, focusing on unmet medical needs Reformulating and Repurposing existing chemical entities Global portfolio growing to 30 cardiovascular and other value-added assets High yield, lower risk is our DNA patient-centric developments Fo
Slide 4: Executive Management Team
Executive Management Team Our team consists of 50+ people, 15 nationalities In-depth knowledge of regulatory affairs, market access and the capital markets; involved in > 80 approved drugs, executed >300 licensing transactions; established track record of shareholder value creation Stijn Van Rompay
Slide 5: Our Focus: Patented Value-Added Medicines
Our Focus: Patented Value-Added Medicines Unique features to the benefit of Patients New Indications NCEs and biologicals Reinventing “No risk of failure, low Physicians barriers to entry” existing medicines Combinations Efficacy, safety, new use, compliance, onset of action, drug titration, conveni
Slide 6: Faster innovation
Faster innovation Traditional model for NCEs and Biologics Average Drug discovery & Preclinical development Clinical development Regulatory submission & Approval 15 years Repurposing model Up to Feasibility, formulation & production Pre-clinical & Clinical development Regulatory submission & Approva
Slide 7: Peak Sales of Value-Added 505(b)(2) Products
Peak Sales of Value-Added 505(b)(2) Products Average peak sales (million $) of 505(b)(2) products in each approval year Product name 2019 Sales 2013 to 2018 (N=78 launched products) Avycaz $117M 300 Belbuca $98M REFORMULATED Vasostrict $531M 250 Abraxane $1,200M $202 million 200 Restasis $1,188M Neo
Slide 8: To Drive Continuous Growth and Create Shareholders' Value
To Drive Continuous Growth and Create Shareholders’ Value Acquisition and in-licensing of product Continuously growing diversified product candidates based on portfolio characterised by Clear scientific and medical rationale based on physicians’input Fast market adoption Approved, well-known molecul
Slide 9: Broad, innovative cardiovascular portfolio
Optimal commercialization strategy currently under Commercialized with partner Intended to be commercialised with partner evaluation. Broad, innovative cardiovascular portfolio Route of Clinical Regulatory Filing and Target Product Indication Formulation Administration Development approval Market Up
Slide 10: Other value-added portfolio
Commercialized with partner Intended to be commercialised with partner Other value-added portfolio Route of Clinical Regulatory Filing and Product Indication Formulation Target Market Administration Development approval Up to 7 years Maxigesic® IV IV Post-operative pain Co-development with AFT Pharm
Slide 11: Other value-added portfolio, cont'd
Commercialized with partner Intended to be commercialised with partner Other value-added portfolio, cont'd Route of Clinical Regulatory Filing and Target Product Indication Formulation Administration Development approval Market Up to 7 years Pantoprazole RTU Injection GERD and EE WW Ondansetron E.R.
Slide 12: Recent pipeline additions
Click to edit Master title style • Edit Master text styles • Second level • Third level • Fourth level • Fifth level Recent pipeline additions 11
Slide 13: HY-090 Indication: Burning Mouth Syndrome (BMS)
HY-090 Indication: Burning Mouth Syndrome (BMS) • BMS is a complex chronic disorder characterized by pain in the oral cavity without clinically causative lesions • Other symptoms are burning sensation, dysgeusia (distorted taste), xerostomia (dry mouth), itching and other dysesthesias (pruritus, bur
Slide 14: HY-091 Indication: Vulvar Lichen Sclerosus (VLS)
HY-091 Indication: Vulvar Lichen Sclerosus (VLS) • Chronic, inflammatory disease with an enormous impact on quality of life with an increased risk of depression, anxiety, and suicidal thoughts • Pruritic white plaques with epidermal atrophy and scarring of the anogenital area. Patients experience di
Slide 15: HY-095 Equine Gastric Ulcer Syndrome
HY-095 Brand leader 188 MUSD Indication: Equine Gastric Ulcer Syndrome (EGUS) in sales • Very prevalent condition: Ulcers in the lining of the stomach • 30% of all horses (up to 90% in racehorses) • Current standard of care: Oral administration daily for 4 to 6 weeks of a proton pump inhibitor (PPI)
Slide 16: Pantoprazole RTU injection
Pantoprazole RTU injection Indication: Gastroesophageal reflux disease (GERD) and Erosive Esophagitis (EE) • Key option in managing severe acid related conditions, including bleeding peptic ulcers and erosive esophagitis • Currently only available as a lyophilized product for infusion • Hyloris' ver
Slide 17: Ondansetron Extended-Release Tablet
Ondansetron Extended-Release Tablet Indication: Prevention of nausea related to CINV/RINV • Once-daily, proprietary, bimodal extended-release oral tablet formulation of ondansetron (covering 24 hours) • Sustained relief from nausea and vomiting associated with chemotherapy, radiotherapy, and post-op
Slide 18: HY-094 Ferric for injection
HY-094 Ferric for injection Indication: Iron Deficiency Anemia (IDA) Global Intravenous Iron Drugs Market Size 2023 to 2034 (USD Billion) 9 • Innovative NCE injectable iron therapy designed to overcome limitations of 8 current treatments for better convenience and tolerability 7 • Targeting global i
Slide 19: Suramin IV
Suramin IV Indication: Human African Trypanosomiasis (HAT) • An acute neglected parasitic disease transmitted by tsetse flies, fatal if left untreated. Also known as East-African Sleeping Sickness • Suramin IV has been the standard of care in Africa for >100 years but was never approved in the U.S.
Slide 20: Marketed products
Click to edit Master title style • Edit Master text styles • Second level • Third level • Fourth level • Fifth level Marketed products 19
Slide 21: 3 commercial products
3 commercial products 1 Maxigesic® IV 2 Sotalol IV 3 Podofilox Gel Novel combination of paracetamol & ibuprofen for short- Intravenous formulation of Topical formulation for term management of mild to moderate acute pain sotalol for atrial fibrillation treatment of genital warts ▪ Marketing authoriz
Slide 22: Maxigesic IV
Maxigesic IV ✓ Licensed in over 100 countries Higher pain relief with faster onset than SoC ✓ Approved in over 50 countries ✓ Marketed in over 30 countries Pain intensity (VAS score) Indication: Short-term management of mild to moderate acute pain Novel, unique intravenous combination of 1.000mg Par
Slide 23: Other portfolio highlights
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Slide 24: Alenura
Alenura Indication: Interstitial Cystitis/Bladder Pain Syndrome • Defect in inner lining of the bladder = chronic, recurring discomfort & pain Proven pain reduction in 2 • Alenura 15 mL container targeting a dual mode of action: controlled Ph2 trials • Alkalinized lidocaine: penetrates bladder wall
Slide 25: HY-083 Indication: Idiopathic Rhinitis
HY-083 Indication: Idiopathic Rhinitis - chronic rhinitis without a known cause • Symptoms: Runny nose, stuffy nose, sneezing fits without a medical diagnosis (allergies, infection, inflammation, …) • Impacting quality of life daily (sleep patterns, drowsiness, irritability, poor concentration) • Mo
Slide 26: PTX-252
PTX-252 Indication: Acute Myeloid Leukemia & Small Cell Lung Cancer • Developed in collaboration with Pleco Therapeutics, PTX 252 is a small molecule designed to extract heavy metals from the body • Metals are involved in the pathophysiology of AML and can impact the More toxic metals in AML patient
Slide 27: Milrinone Extended Release
Milrinone Extended Release Indication: Late-stage heart failure • Orphan drug status in the U.S., targeting patients with right heart failure with an LVAD • #1 cause of hospitalization in people >65 years • Shortcomings of Milrinone IV • High cost of care, low quality of life (repeated hospital admi
Slide 28: Investment highlights
Click to edit Master title style • Edit Master text styles • Second level • Third level • Fourth level • Fifth level Investment highlights 27
Slide 29: Financial highlights
Operating income Financial highlights • Operating income of €3.8 million, down 18% versus H1 2024 due to the temporary absence of milestone payments compared to 2024 (USD 2.1 (in € thousand) HY 2025 HY 2024 % change million milestone relating to Maxigesic® IV in the U.S.), partly offset in Revenues
Slide 30: The Hyloris Share
The Hyloris Share Major shareholdings Analyst coverage Broker Analyst Rating 27,65% Degroof Petercam David Seynnaeve BUY Stijn Van Rompay (Founder & co-CEO) Thomas Jacobsen (Founder, co-CEO & CBDO) 42,35% Scorpiaux BV Kepler Cheuvreux Christophe Dombu BUY Nick Reunbrouck Pieter Van Rompay 13,78% Oth
Slide 31: Latest News and Anticipated Value Inflection Milestones
Latest News and Anticipated Value Inflection Milestones Clinical Regulatory Commercial Completed • Dofetilide IV: positive results pivotal • Regulatory submission in the Maxigesic®IV clinical study U.S. completed for Valacyclovir • Launched. J-code in October 2024 liquid • Alenura: Positive IDMC Com
Slide 32: Investment case
Investment case Multiple shots 20 on goal Innovative, patented, Lower risk value-added as we start drug from candidates existing in the drugs pipeline** Potential game changer, ≤ 7 years to market 3 products commercialized geared for growth Committed to ≤ €7 million Ambition to become the reference
Slide 33: Listed on Euronext Brussels
Listed on Euronext Brussels ISIN-CODE: BE0974363955 investorrelations@hyloris.com