Hyloris Pharmaceuticals Sa · EURONEXT:HYL
Hyloris Pharmaceuticals Sa — Investor Presentation (April 2023)
24 slides from Hyloris Pharmaceuticals Sa's investor presentation, April 2023
Slide 1: Reformulating the Future – Corporate presentation
Reformulating the Future Corporate presentation April 2023
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: Executive Management Team
Executive Management Team • In-depth knowledge of regulatory affairs, market access and the capital markets; involved in > 80 approved drugs, executed >250 licensing transactions; established track record of shareholder value creation • Our team consists of 37 people, 11 nationalities Stijn Van Romp
Slide 4: Rethinking, Reinventing, Optimising Existing Medications
Rethinking, Reinventing, Optimising Existing Medications To improve overall therapy outcomes REFORMULATING Changing dose and/or route of administration REPURPOSING/ New therapeutic uses REPOSITIONING For the benefit of patients, physicians, payors 3
Slide 5: Patented Value-Added Medicines: Pharma's Sweet Spot
Patented Value-Added Medicines: Pharma’s Sweet Spot New indications, combi- nations, reformulations New Chemical Entities Unique Features & Biologicals Patented value-added 505(b)(2) medicines: Optimised existing medicines Efficacy, safety, new use, compliance, onset of action, drug titration, conve
Slide 6: Average Peak Sales of Value-Added 505(b)(2) Products
Average 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,
Slide 7: Putting Healthcare Needs at the Centre of Therapy Design
Putting Healthcare Needs at the Centre of Therapy Design UNMET MEDICAL NEEDS 6
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
Broad, innovative cardiovascular portfolio Up to 7 years Up to 7 years • Our high barrier generic products, TXA RTU, HY-016 LVAD: battery-operated, mechanical surgically implanted pump, which helps the left ventricle of the heart pump blood and Fusidic Acid Cream have not been included in the above
Slide 10: Value-added portfolio, commercialized with partners
Value-added portfolio, commercialized with partners Licensed in >100 countries TXA: tranexamic acid ADHD: attention deficit hyperactivity disorder • Our high barrier generic products, TXA RTU, HY-016 Miconazole-DB: miconazole-domiphen bromide ; and Fusidic Acid Cream have not been included in the ab
Slide 11: Pipeline expansion: HY-083 Nasal Administration
Pipeline expansion: ~30 Assets before 2025 HY-083 Nasal Administration Indication: Idiopathic rhinitis (chronic rhinitis without a known cause) Unmet medical need: providing first reliable treatment Symptoms: Runny nose, stuffy nose, sneezing fits without a medical diagnosis (allergies, infection, i
Slide 12: Pipeline expansion: Alenura
Pipeline expansion: ~30 Assets before 2025 Alenura Instillation Proven pain reduction in 2 controlled Ph2 trials Indication: Interstitial Cystitis/Bladder Pain Syndrome Unmet medical need: no approved treatment for acute pain flares & restoration of bladder wall Study 104 • Defect in inner lining of
Slide 13: Pipeline expansion: Plecoid Agents
Pipeline expansion: ~30 Assets before 2025 More toxic metals in AML patients Plecoid Agents = higher mortality Intravenous infusion Indication: Acute Myeloid Leukemia & Small Cell Lung Cancer Unmet medical need: increase survival rate for leukemia patients undergoing chemotherapy Based on breakthrou
Slide 14: Pipeline expansion: Miconazole and Domiphen Bromide
Pipeline expansion: ~30 Assets before 2025 Miconazole and Domiphen Bromide Topical cream Miconazole Domiphen Bromide Indication: severe and recurrent Vulvo Vaginal Candidiasis (rVVC) (Antimycotic) (Repurposed molecule) Unmet medical need: no approved topical treatment options for recurring VVC Stron
Slide 15: Pipeline expansion: Milrinone Extended Release
Pipeline expansion: ~30 Assets before 2025 Milrinone Extended Release Oral capsule Indication: Late-stage heart failure Unmet medical need: patient-friendly oral formulation of Milrinone IV to improve quality of life and significantly reduce cost of care • Orphan drug status in the U.S. • #1 cause o
Slide 16: Robust IP Portfolio: Extended Period of Exclusivity
Robust IP Portfolio: Extended Period of Exclusivity • Broad portfolio: exclusivity through 2039 in key pharma markets across the globe; orphan indications • Wide range of protection: dosages, formulations, indications, methods for preparing a composition, manufacturing methods • Additional layer of
Slide 17: Powerful R&D Engine: Leveraging our Network of Partners
Powerful R&D Engine: Leveraging our Network of Partners Development cost-to-market (≤ €7M*) Commercialisation In-house Outsourced Commercial manufacturing Regulatory Product interactions selection Product development API sourcing Time-to-market (≤ 7 years) Note: bubble size indicates relative amount
Slide 18: Flexible, Hybrid Earnings and Commercialisation Model
Flexible, Hybrid Earnings and Commercialisation Model CARDIOVASCULAR FRANCHISE OTHER VALUE-ADDED PORTFOLIO • Lean and efficient U.S. sales team targeting • Out-licensing to commercial partners across ~2,700 hospital-affiliated cardiologists various geographies • Exploit existing regulatory package f
Slide 19: Shareholders' Information
Shareholders’ Information MAJOR SHAREHOLDERS Stijn Van Rompay Bank Analyst Rating (Founder & CEO); 27,42% Berenberg Beatrice Allen Buy Other holders; KBC Securities Jeroen Van den Bossche Buy 44,33% Kempen Suzanne van Voorthuizen Buy Thomas Jacobsen Degroof Petercam David Seynnaeve Buy (Founder & CB
Slide 20: Financial Highlights 2022
Financial Highlights 2022 (in € thousand) 2022 2021 % change Key Factors • Revenues: Revenue 2,951 3,096 -4.7% Cost of sales -94 -107 / • Increased royalties in 2022 contribute more to current topline R&D (10,151) (5,056) 100.8% • Out-licensing fee of €1 million (HY-038) G&A (3,517) (2,900) 21.3% Ot
Slide 21: Anticipated Value Inflection Milestones in the next 12 months
Anticipated Value Inflection Milestones in the next 12 months Clinical Regulatory Commercial • AlenuraTM starting multiple • Maxigesic® IV in the U.S. trials, among which four-arm submitted in April 2023 Commercial partnership(s) phase 2 clinical trial ➔ Potential NDA approval before • Out-licensing
Slide 22: Hyloris ESG: 3 Imperatives with 14 goals
Hyloris ESG: 3 Imperatives with 14 goals Once we identified the UN Agenda for Sustainable Development goals and targets that were authentic to our mission, we organized our commitments under three imperatives. Imperative I Imperative II Imperative III Commitment to Commitment to Commitment to the Go
Slide 23: Potential Game Changer, Geared for Growth
Potential Game Changer, Geared for Growth MULTIPLE SHOTS ON GOAL COMMERCIAL PORTFOLIO ≤ 7 years to market 2 patented products with partners ≤ €7 million average cost to market Addressing unmet needs Lower risk as we start from existing drugs Build U.S. commercial team 161 Innovative, patented, value
Slide 24: Q&A
Listed on Euronext Brussels Q&A ISIN-CODE: BE0974363955 investorrelations@hyloris.com
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