Hyloris Pharmaceuticals Sa · EURONEXT:HYL
Hyloris Pharmaceuticals Sa — Investor Presentation (October 2023)
24 slides from Hyloris Pharmaceuticals Sa's investor presentation, Oct 4, 2023
Slide 1: Corporate Presentation
Corporate Presentation 4 October 2023 – Geneva Stijn Van Rompay Jean-Luc Vandebroek CEO, co-founder CFO 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 Global portfolio growing to 30 cardio and other value-added assets Reformulating and Repurposing existing chemical entities High yield, lower risk, patient-centric developments €350 mio market cap
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: Our Focus: Patented Value-Added Medicines
Our Focus: Patented Value-Added Medicines New indications, combinations, reformulations New Chemical Entities Unique Features & Biologicals Reinventing existing medicines Off-patent Efficacy, safety, new use, compliance, onset ethical of action, drug titration, convenience compounds and Key Benefits
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: 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 8: 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 40+ people, 11 nationalities Stijn Van Rom
Slide 9: Tackling the #1 cause of death in the world
Tackling the #1 cause of death in the world Cardiovascular portfolio • Focus on the American market • Hospital products used by a limited number of specialists ➔ Relatively small salesforce ➔ Commercial approach: cost efficiency throughout • Multiple pivotal clinical studies to be started in 2023 an
Slide 10: Broad, innovative cardiovascular portfolio
Broad, innovative cardiovascular portfolio Formulation and Clinical Product Route of Administration Indication Regulatory Filing Target Market Manufacturing Development CARDIOVASCULAR (CV) PORTFOLIO Up to 7 years Sotalol IV IV Atrial fibrillation Up to 7 years Launched in U.S./partnered with AltaThe
Slide 11: Other value-added portfolio
Other value-added portfolio Route of Formulation and Clinical Product Indication Regulatory Filing Target Market Administration Manufacturing Development Up to 7 years Maxigesic® IV IV Post-operative pain Licensed in >100 countries/partnered with AFT Pharmaceuticals Tranexamic Acid OR Oral Liquid Sp
Slide 12: Maxigesic IV
Maxigesic IV Marketed in over 20 countries, U.S. approval expected very soon Higher pain relief with faster onset than SoC Indication: Post-operative pain Pain intensity (VAS score) • Novel, unique intravenous combination of 1.000mg Paracetamol IV + 300mg Ibuprofen IV • Alternative to opioid pain re
Slide 13: Alenura™
Alenura™ No approved treatment for acute pain flares & restoration of bladder wall Indication: Interstitial Cystitis/Bladder Pain Syndrome Proven pain reduction in 2 controlled Ph2 trials • Defect in inner lining of the bladder = chronic, recurring discomfort & pain • Alenura 15mL prefilled syringe
Slide 14: Miconazole and Domiphen Bromide
Miconazole and Domiphen Bromide No approved topical treatment options for severe VVC Indication: severe and recurrent Vulvo Vaginal Candidiasis (rVVC) Half of all women experience VVC in their lifetime Miconazole Domiphen Bromide (Antimycotic) (Repurposed molecule) • Severe or recurring cases - 20%
Slide 15: Milrinone Extended Release
Milrinone Extended Release Patient-friendly oral capsule of Milrinone IV Indication: Late-stage heart failure • 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 hosp
Slide 16: HY-083 for Idiopathic Rhinitis
HY-083 for Idiopathic Rhinitis Providing the first reliable treatment starting from a known molecule Indication: Idiopathic rhinitis - chronic rhinitis without a known cause Symptoms: Runny nose, stuffy nose, sneezing fits without a medical diagnosis (allergies, infection, inflammation, …) • Impacti
Slide 17: Plecoid Agents
Plecoid Agents Increasing chemotherapy response rate for leukemia patients Indication: Acute Myeloid Leukemia & Small Cell Lung Cancer More toxic metals in AML patients = higher mortality Based on breakthrough research • Chelating agents bind to metal ions to extract them from the body • Detoxifying
Slide 18: 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 19: 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 20: Financial Highlights H1 2023
Financial Highlights H1 2023 Key Factors (in € thousand) H1 2023 H1 2022 % change • Revenues: Total revenue & other income 2,391 1,229 +95% • Increased royalties and out-licensing income contribute more to current topline Cost of sales (46) (61) / • Additional non-dilutive funding from a U.S. state
Slide 21: Shareholders’ Information
Shareholders’ Information MAJOR SHAREHOLDERS Stijn Van Bank Analyst Rating Rompay (Founder & Berenberg Beatrice Allen Buy CEO); 27,65%1 KBC Securities Jacob Mekhael Buy Other holders; 44,33% Kempen Suzanne van Voorthuizen Buy Thomas Degroof Petercam David Seynnaeve Buy Jacobsen (Founder & CBDO); Kep
Slide 22: Anticipated Value Inflection Milestones
Anticipated Value Inflection Milestones Clinical Regulatory Commercial • AlenuraTM : ongoing recruitment for • Maxigesic® IV PDUFA goal date: 17 • First sales of Maxigesic® IV in the 4-arm clinical study October 2023 U.S. leading to ~$2 million milestone payment • Miconazole/DB: Phase 2 read-out • M
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, valu
Slide 24: Q&A
Listed on Euronext Brussels ISIN-CODE: BE0974363955 Q&A investorrelations@hyloris.com
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