Hyloris Pharmaceuticals Sa · EURONEXT:HYL
Hyloris Pharmaceuticals Sa — Investor Presentation (September 2024)
28 slides from Hyloris Pharmaceuticals Sa's investor presentation, September 2024
Slide 1: Investor Presentation
Click to edit Master title style • Edit Master text styles • Second level • Third level • Fourth level • Fifth level Investor Presentation September 2024 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 Reformulating and Repurposing Global portfolio growing to 30 value-added medicines, focusing existing chemical entities cardiovascular and other on unmet medical needs value-added assets Based in Liège, Belgium High yield, lower risk, Founded in 2012 Q
Slide 4: Executive Management Team
Executive Management Team Our team consists of 40+ people, 11 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
Commercialized with partner Intended to be commercialised by Hyloris in the U.S. Intended to be commercialised with partner Broad, innovative cardiovascular portfolio Clinical Product Route of Administration Indication Formulation Regulatory Filing Target Market Development CARDIOVASCULAR (CV) PORTF
Slide 10: Other value-added portfolio
Commercialized with partner Intended to be commercialised with partner Other value-added portfolio Route of Clinical Product Indication Formulation Regulatory Filing Target Market Administration Development Maxigesic® IV IV Post-operative pain Up to 7 years Co-development with AFT Pharmaceuticals Po
Slide 11: Recent pipeline additions
Click to edit Master title style • Edit Master text styles • Second level • Third level • Fourth level • Fifth level Recent pipeline additions 10
Slide 12: 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 13: 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 14: 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 15: Marketed products
Click to edit Master title style • Edit Master text styles • Second level • Third level • Fourth level • Fifth level Marketed products 14
Slide 16: 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 17: 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 18: Other portfolio highlights
Click to edit Master title style • Edit Master text styles • Second level • Third level • Fourth level • Fifth level Other portfolio highlights 17
Slide 19: 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 15mL prefilled syringe with a dual mode of action: controlled Ph2 trials • Alkalinised lidocaine: penetrates bladder wal
Slide 20: 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 21: PTX-252
PTX-252 Indication: Acute Myeloid Leukemia & Small Cell Lung Cancer • Based on breakthrough research • Chelating agents bind to metal ions to extract them from the body More toxic metals in AML patients • Detoxifying the cancer-promoting micro-environment = higher mortality • Efficacy of chemo incre
Slide 22: Milrinone Extended Release
Milrinone Extended Release Indication: Late-stage heart failure with LVAD • Orphan drug status in the U.S. (patients with LVAD) • #1 cause of hospitalization in people >65 years • Shortcomings of Milrinone IV • High cost of care, low quality of life (repeated hospital admission) • Not approved for l
Slide 23: Investment highlights
Click to edit Master title style • Edit Master text styles • Second level • Third level • Fourth level • Fifth level Investment highlights 22
Slide 24: Financial highlights
Financial highlights (in € thousand) 2023 2022* % change Key factors Revenues 2,087 900 +132% Revenue Other revenue & income 2,127 1,487 +43% ▪ Increased royalties and out-licensing income contribute more to current topline Total revenue & other income 4,214 2,387 +77% ▪ Additional non-dilutive fund
Slide 25: The Hyloris Share
The Hyloris Share Major shareholdings Analyst coverage Broker Analyst Rating Stijn Van Rompay 27,65% (Founder & CEO) Degroof Petercam David Seynnaeve BUY Thomas Jacobsen (Founder & CBDO) 44,33% Scorpiaux BV Kepler Cheuvreux Christophe Dombu BUY Nick Reunbrouck Pieter van Rompay 13,78% KBC Securities
Slide 26: Latest News and Anticipated Value Inflection Milestones
Latest News and Anticipated Value Inflection Milestones Clinical Regulatory Commercial Multiple regulatory submissions Maxigesic®IV • Miconazole/DB: positive Phase 2 - expected (IND & NDA), both in and • U.S. launch in February 2024 • Valaciclovir OS positive results – outside the US such as Dofetil
Slide 27: Investment case
Investment case Multiple shots 19 on goal Innovative, Lower risk patented, as we start value-added from drug existing candidates in the Potential game changer, ≤ 7 years to drugs pipeline 3 patented products with partners geared for growth market Ambition to become the reference in Committed to ≤ €7
Slide 28: Listed on Euronext Brussels
Listed on Euronext Brussels ISIN-CODE: BE0974363955 investorrelations@hyloris.com Q&A
Hyloris Pharmaceuticals — Investor Presentation (September 2024) on 6ix