Hyloris Pharmaceuticals Sa · EURONEXT:HYL
Hyloris Pharmaceuticals Sa — Investor Presentation (January 2023)
22 slides from Hyloris Pharmaceuticals Sa's investor presentation, January 2023
Slide 1: Corporate Presentation: Reformulating the Future
Reformulating the Future Corporate Presentation January 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 • Hyloris currently employs 35 people, 6 nationalities Stijn Van
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 LVAD: battery-operated, mechanical surgically implanted pump, which helps the left ventricle of the heart pump blood • Our high barrier generic products, TXA RTU, HY-016 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: a long series of unmet medical needs
Pipeline Expansion : a long series of unmet medical needs January 2023: HY-088 in hypophosphatemia (oral liquid) • Affects 5% of hospitalized patients, always related to underlying condition • Direct treatment of mineral deficiency for subpopulation during and/or after hospital stay November 2022: H
Slide 12: Pipeline Expansion: a long series of unmet medical needs
Pipeline Expansion : a long series of unmet medical needs November 2021: Plecoid Agents (IV) in Acute Myeloid Leukemia and Small Cell Lung Cancer • Chelating agents to detoxify the cancer-promoting micro-environment • Concomitant with SOC chemotherapy, potentially offering a boost and prolonged surv
Slide 13: 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 (n=18) Alkalinised lidocaine
Slide 14: 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 15: 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 16: 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 17: Consistently Delivered on Our Promises since IPO in June 2020
Consistently Delivered on Our Promises since IPO in June 2020 Hyloris - Stock Price Performance 20,00 Deal for chelating 18,00 agents in AML/SCLC Maxigesic IV: Hikma deal U.S. and Deal for Aspirin IV expansion into South Positive Phase 16,00 Maxigesic IV Product America and Europe 1 data HY-004 appr
Slide 18: 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 Jacob Mekhael Buy Thomas Jacobsen Degroof Petercam David Seynnaeve Buy (Founder & CBDO); 13,06
Slide 19: Financial Highlights: H1 2022
Financial Highlights: H1 2022 (in € thousand) H1 2022 H1 2021 Variance Total revenue and income 1,229 1,145 7% • Revenues: Operating expenses -5,986 -9,016 -34% • Recurrent growth mainly driven by Research and development expenses -4,712 -1,560 202% Maxigesic IV and Sotalol IV royalties General and
Slide 20: Anticipated Value Inflection Milestones in the next 12 months
Anticipated Value Inflection Milestones in the next 12 months Clinical Regulatory Commercial • Starting pivotal PK clinical trial for • Commercial partnership(s) Dofetilide IV and HY-029 • Continued roll-out of Maxigesic® IV and Sotalol IV • Starting Phase 2 clinical trial for • Atomoxetine: impleme
Slide 21: 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 22: investorrelations@hyloris.com
Listed on Euronext Brussels ISIN-CODE: BE0974363955 investorrelations@hyloris.com \ 21
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