Hyloris Pharmaceuticals Sa · EURONEXT:HYL
Hyloris Pharmaceuticals Sa — FY2022 Earnings Presentation
16 slides from Hyloris Pharmaceuticals Sa's earnings presentation, Mar 1, 2023
Slide 1: Annual Results 2022
Reformulating the Future Annual Results 2022 Webcast presentation Stijn Van Rompay, CEO Jean-Luc Vandebroek, CFO
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: Agenda for Today's Call
Agenda for Today’s Call • New product candidates • Commercial milestones • Pipeline expansion • Financial position • Expected milestones (12 months) • Q&A
Slide 4: 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 5: Pipeline expansion: ~30 Assets before 2025
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 6: Pipeline expansion: ~30 Assets before 2025
Pipeline expansion: ~30 Assets before 2025 HY-088 – January 2023 Oral liquid Indication: Phosphate deficiency (hypophosphatemia) Unmet medical need: No approved treatment exists today • Phosphate deficiency is mostly asymptomatic • Severe condition can be life threatening (respiratory or heart failu
Slide 7: 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 8: 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 9: Pipeline expansion: ~30 Assets before 2025
Pipeline expansion: ~30 Assets before 2025 14 + 3 PRODUCT 2 COMMERCIAL PRODUCTS CANDIDATES KOL / PARTNER ACQUISITION AND NETWORK IN-LICENSING DESK RESEARCH REAL WORLD DATA AND SURVEYS FDA-APPROVABLE OFF-LABEL USE 9
Slide 10: Maxigesic IV: Significant Growth of Commercial Footprint
Maxigesic IV: Significant Growth of Commercial Footprint Germany, Austria, France, Italy,, Norway, Netherlands, … : + strong local distribution partners Launched Central & Eastern U.S.: NDA Europe, Balkans: Countries H1 2023 H1 2020 submission licensed expected South-Korea, Africa & Middle East: Ind
Slide 11: Commercial highlights
Commercial highlights Sotalol IV Tranexamic Acid RTU HY-038 • Further commercial efforts to • Out-licensing agreements • €1 million out-licensing fee accelerate commercial roll-out in the of non-core generic asset • 1 European country United States • Increased focus on • 1 Southeast Asian country va
Slide 12: Financial Highlights 2022
Financial Highlights 2022 (in € thousand) 2022 2021 % change Key Factors Revenue 2,951 3,096 -4.7% • Revenues: Cost of sales -94 -107 / • Increased royalties in 2022 contribute R&D (10,151) (5,056) 100.8% more to current topline G&A (3,517) (2,900) 21.3% • Out-licensing fee of €1 million (HY-038) Ot
Slide 13: Financial position December 2022
Financial position 31 December 2022 ▪ Net cash burn of €6.5 million in 2022 - Cash position end of 2022 amounted to €43.5 million. ▪ Assuming additional out-licensing, commercial success of Maxigesic and Sotalol IV, additional non-dilutive funding and milestones payments, the Company is sufficiently
Slide 14: 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 Submission before summer Commercial partnership(s) phase 2 clinical trial 2023 • Out-licensing deal(s) • Miconazole/DB:
Slide 15: Q&A
Q&A
Slide 16: investorrelations@hyloris.com
investorrelations@hyloris.com
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