Hyloris Pharmaceuticals Sa · EURONEXT:HYL
Hyloris Pharmaceuticals Sa — H1 2023 Earnings Presentation
16 slides from Hyloris Pharmaceuticals Sa's earnings presentation, Sep 7, 2023
Slide 1: H1 results & business outlook
7 September 2023 H1 results & business outlook 1
Slide 2: Disclaimer
Disclaimer 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 presentation, any questi
Slide 3: Agenda for today's call
Agenda for today’s call • Company strategy • Commercial products • R&D progress • Financial position • Selection of expected milestones • Q&A
Slide 4: Patented Value-Added Medicines: Pharma's Sweet Spot
Patented Value-Added Medicines: Pharma’s Sweet Spot New indications, combinations, reformulations New Chemical Entities Unique Features & Biologicals Patented value-added 505(b)(2) medicines: Optimised existing medicines Off-patent Efficacy, safety, new use, compliance, onset ethical of action, drug
Slide 5: Strategic pillars driving value
Strategic pillars driving value Cardio portfolio Value-added portfolio Pipeline expansion • Multiple targeted U.S. submission • Multiple clinical trials, regulatory • Exploring solutions to dates starting in 2024, making 2025 submissions and out-licensing underserved medical needs a pivotal year dea
Slide 6: Commercial products H1 2023
Commercial products H1 2023 Sotalol IV Maxigesic® IV • PDUFA goal date* 17 October 2023 • Volume increase year-over-year ➔ Opioid pandemic in the U.S.: chronic usage found in • Royalty percentages attributed on an annually 9%** of post-operative patients calculated step-up basis ensure higher percen
Slide 7: 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 H1 2023 H1 2020 Europe, Balkans: Countries U.S.: PDUFA date: 17 Oct licensed & multiple approvals South-Korea, Africa &
Slide 8: 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 9: 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 10: Nasal spray targeting widespread nasal symptoms
HY-083 Nasal spray targeting widespread nasal symptoms Indication: Idiopathic rhinitis - chronic rhinitis without a known cause Symptoms: Runny nose, stuffy nose, sneezing fits without a medical diagnosis (allergies, infection, inflammation, …) • Impacting quality of life daily (sleep patterns, drow
Slide 11: No approved oral treatment available
HY-088 No approved oral treatment available Indication: Phosphate deficiency (hypophosphatemia) • Severe condition can be life threatening (respiratory or heart failure) • Rich body of clinical data exists of widely used but unapproved treatment • Always linked to underlying condition • Direct treat
Slide 12: 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 13: Cashflow H1 2023
Cashflow H1 2023 • Net cash position of €39,2 million on 30 June 2023 • Sufficiently capitalized for all expected R&D expenditures related to the current product candidates* (*) Assuming continued strategic out-licensing, commercial success for Maxigesic® IV and Sotalol IV, additional non-dilutive f
Slide 14: Upcoming events – Interact with Hyloris' top management
Upcoming events – Interact with Hyloris' top management Date Location Event 27-29 September 2023 Munich, Germany Biotech on Tap 2023 5 October 2023 Paris, France Investor Day 9 October 2023 Antwerp, Belgium De Belegger On Tour 24-25 October 2023 Barcelona, Spain CPHI 6-8 November 2023 Munich, German
Slide 15: Anticipated Value Inflection Milestones
Anticipated Value Inflection Milestones Clinical Regulatory Commercial • AlenuraTM : ongoing recruitment for • First sales of Maxigesic® IV in the 4-arm clinical study • Maxigesic® IV PDUFA goal date: 17 U.S. leading to ~$2 million October 2023 milestone payment • Miconazole/DB: Phase 2 read-out of
Slide 16: Q&A
Listed on Euronext Brussels Q&A ISIN-CODE: BE0974363955 investorrelations@hyloris.com
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