Hyloris Pharmaceuticals Sa · EURONEXT:HYL
Hyloris Pharmaceuticals Sa — Investor Presentation (May 2022)
24 slides from Hyloris Pharmaceuticals Sa's investor presentation, May 9, 2022
Slide 1: Corporate Presentation
Reformulating the Future Corporate Presentation May 9th 2022
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 • Hyloris currently employs 21 people, 6 nationalities Stijn Van
Slide 4: New Drug Development: an Expensive, Slow, and Risky Process
New Drug Development: an Expensive, Slow, and Risky Process 15,000 drugs in R&D pipeline in 2018 60 new drugs hit the market in 2018 ~15 years and ~$1Bn cost on average ~10% of candidates entering clinical development eventually make it to market High Unmet Medical Needs Pharmaprojects 2019; Wouters
Slide 5: We do things differently
We do things differently 4
Slide 6: 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 5
Slide 7: 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 8: 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 9: Hyloris: Key Investment Highlights
Hyloris: Key Investment Highlights Growth Pillars 1 14 patented product 2 in the 2 products on the market with Patients, partners, physicians portfolio partners and KOLs Spread across stages and Build own, lean, commercial Real-world data and payors’ indications organisation in the U.S. input Expand
Slide 10: Putting Healthcare Needs at the Centre of Therapy Design
Putting Healthcare Needs at the Centre of Therapy Design UNMET MEDICAL NEEDS 9
Slide 11: 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 12: Broad, Innovative Portfolio: Expand to ~30 Assets by 2024
Broad, Innovative Portfolio*: Expand to ~30 Assets by 2024 Route of Formulation and Clinical Regulatory Target Product Indication Administration Manufacturing Development Filing Market CARDIOVASCULAR (CV) PORTFOLIO Up to 7 years Sotalol IV IV Atrial fibrillation Launched in U.S./partnered with AltaT
Slide 13: 2021 Pipeline Expansion: All Unmet Medical Needs
2021 Pipeline Expansion : All Unmet Medical Needs 1) Miconazole and Domiphen Bromide in recurring Vulvo Vaginal Candidiasis (topical cream) • Dual fungidical activity based on a known antimycotic and a repurposed potentiator • Unique mode of action • Ongoing clinical trial with FPFV in November 2021
Slide 14: Alenura: Novel, Dual MOA Candidate to IC/PBS
4) Alenura: Novel, Dual MOA Candidate to IC/PBS K+ Alkalinized lidocaine • Alenura 15mL prefilled syringe: unique combination of High dose Heparin K+ alkalinised lidocaine + heparin to use as instillation product • Proven efficacy in 2 controlled Phase 2 trials Study 104 Alkalinised lidocaine: penet
Slide 15: 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 16: 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 17: 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 18: Consistently Delivered on Our Promises since IPO in June 2020
Consistently Delivered on Our Promises since IPO in June 2020 Stock Price Evolution 20 Deal for chelating Maxigesic IV: Maxigesic IV: Hikma deal U.S. and agents in AML/SCLC 18 approval in 8 EU expansion into South America and Deal for Aspirin IV Alenura Deal countries Europe Deal for Milrinone ER Ma
Slide 19: Shareholders' Information
Shareholders’ Information Major shareholders Stijn Van Rompay (Founder Bank Analyst Rating & CEO); 26,42% Other holders; Berenberg Beatrice Allen Buy 40,40% KBC Securities Jeroen Van den Bossche Buy Kempen Christophe Beghin Buy Thomas Jacobsen (Founder & CBDO); Hyloris is followed by the analysts li
Slide 20: Financial Highlights: Year end 2021
Financial Highlights: Year end 2021 (in € thousand) FY 2021 FY 2020 % change Revenues 3,096 175 1669% • Revenues: growth mainly driven by Maxigesic IV and Sotalol IV Operating expenses (13,337) (3,626) 149% R&D expenses (5,056) (3,413) 48% • Operating expenses: G&A expenses (2,900) (3,662) (20.8%) •
Slide 21: Core Assets: Anticipated Value Inflection Milestones in 2022
Core Assets: Anticipated Value Inflection Milestones in 2022 Clinical Regulatory Commercial • Starting and completing pivotal PK clinical trial for Aspirin IV • Commercial partnership(s) • Maxigesic® IV: PDUFA date 30 • Starting pivotal PK clinical trial for June 2022 • Continue roll-out of Maxigesi
Slide 22: 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 141 Innovative, patented, value
Slide 23: Unique Value Proposition
Unique Value Proposition • Two commercial products with long runway for growth. • Broad product candidate portfolio (6 cardiovascular and 6 other value added) supporting long-term growth. • Strategic objective to expand to ~30 product (candidates) by 2024, primarily repurposed. • Lean and smart oper
Slide 24: investorrelations@hyloris.com
investorrelations@hyloris.com \ 23
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