Hyloris Pharmaceuticals Sa · EURONEXT:HYL
Hyloris Pharmaceuticals Sa — FY2023 Earnings Presentation
24 slides from Hyloris Pharmaceuticals Sa's earnings presentation, Mar 14, 2024
Slide 1: 2023 Annual Results and 2024 Outlook
2023 Annual Results and 2024 Outlook Presented by Stijn Van Rompay, CEO and Jean-Luc Vandebroek, CFO 14 March 2024
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
Agenda • Company Overview • Commercial Highlights Stijn Van Rompay • Research and Development Updates Chief Executive Officer • Financial Position • Anticipated Milestones (15 months) • Q&A Jean-Luc Vandebroek Chief Financial Officer 3
Slide 4: Corporate Overview
Corporate Overview
Slide 5: Focus on patented value-added medicines
Focus on patented value-added medicines Unique features for the benefit of Patients New Indications New chemical entities and biologicals “Low risk of failure, low barriers to Reinventing Physicians entry” Combinations existing medicines Efficacy, safety, new use, compliance, “Traditional drug disco
Slide 6: Cardiovascular portfolio
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 Partnered in the US with AltaThera Aspirin IV IV Acute coronary syndrom
Slide 7: Other value-added portfolio
Other value-added portfolio Route of Formulation and Clinical Product Indication Regulatory Filing Target Market Administration Manufacturing Development OTHER VALUE-ADDED (OVA) PORTFOLIO* Up to 7 years Maxigesic® IV IV Post-operative pain Partnered with AFT Pharmaceuticals Podofilox Gel Topical Ext
Slide 8: Commercial Highlights
Commercial Highlights
Slide 9: A year of U.S. FDA approvals, strategic out-licensing deals, and commercial sales
A year of U.S. FDA approvals, strategic out-licensing deals, and commercial sales Podofilox Gel 0.5% / Genital and Perianal Warts • Hyloris’ development partner, Padagis US LLC, received marketing authorization by the U.S. FDA in December 2023 • First generic option for Condylox® 0.5% ($9M in U.S. s
Slide 10: U.S. Highlights: Maxigesic IV expands into new markets in 2023
Maxigesic® IV expands into new markets in 2023 9 Marketing 13 Marketing 14 Commercial Authorizations Applications Launches U.S. Highlights • Marketing authorization granted by U.S. FDA in October 2023 • Launched early 2024 under the tradename Combogesic® IV by Hikma Pharmaceuticals • Milestone Payme
Slide 11: Three candidates added to pipeline: HY-091, HY-090, HY-088
Three candidates within the €7M1/7 years criteria added to pipeline HY-091 a novel topical treatment candidate for Vulvar Lichen Sclerosus (VLS) VLS is a chronic inflammatory condition affecting an estimated 3% of women, causing severe pain, itching, and discomfort, significantly impacting their qua
Slide 12: Research & Development Updates
Research & Development Updates
Slide 13: Enhanced capabilities drive efficiency
Enhanced capabilities drive efficiency R&D lab at the Montlegia Science park was officially opened in June 2023 Several key recruitments made to optimize the R&D team 13
Slide 14: Cardiovascular product candidates steadily progressing towards submission
Cardiovascular product candidates steadily progressing towards submission Aspirin IV / Reduced Morbidity and Mortality from Cardiovascular Events • Manufacturing of registration batches completed • Stability study is ongoing Milrinone ER / Advanced Heart Failure Patients with Left Ventricular Device
Slide 15: 2023 Highlights for other value-added programs
2023 Highlights for other value-added programs Tranexamic Acid Oral Mouth Rinse / Excessive Bleeding in a Select Population • Phase 3 trial began in November 2023 • First patient was enrolled in early 2024 • LPLV expected around year-end Miconazole/Domiphen Bromide / Recurrent Vulvovaginal Candidias
Slide 16: Financial Position 2023
Financial Position 2023
Slide 17: Financial Highlights
Financial Highlights Key factors (in € thousand) 2023 2022* % change Total revenue & other income 4,406 2,386 +85% Revenue Revenues 2,814 1,951* +44% Increased royalties and out-licensing income Additional non-dilutive funding from a U.S. state Other revenue & income 1,592 4351 266% government a
Slide 18: Restatement and clarification of HY-088 acquisition and HY-038 divestment
Restatement* and clarification of HY-088 acquisition and HY-038 divestment Consolidated statement of financial position Per 31 December 2022 Impact of Restatement Divested HY-038 to QliniQ for €1 million in December 2022 (in € thousands) As previously Adjustment As restated • HY-038 considered a hig
Slide 19: Anticipated Selected Milestones (15 Months)
Anticipated Selected Milestones (15 Months)
Slide 20: Anticipated value inflection milestones
Anticipated value inflection milestones Ambition to expand the product portfolio to ~30 assets by 2025 pathway Clinical Regulatory Commercial Expecting to submit several Maxigesic®IV • Miconazole/DB: second INDs in the US • First sales in the US in clinical trial to begin by Anticipating multiple ND
Slide 21: Q&A
Q&A
Slide 22: Contact us
Contact us investorrelations@hyloris.com Boulevard Patience et Beaujonc N°3/1 4000 Liège, Belgium T: +32 (0)4 346 02 07 | E: contact@hyloris.com 22
Slide 23: Appendix
Appendix
Slide 24: Restatement and clarification of HY-088 acquisition and HY-038 divestment
Restatement* and clarification of HY-088 acquisition and HY-038 divestment 24
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