Hyloris Pharmaceuticals Sa · EURONEXT:HYL
Hyloris Pharmaceuticals Sa — FY2020 Earnings Presentation
21 slides from Hyloris Pharmaceuticals Sa's earnings presentation, Mar 9, 2021
Slide 1: 2020 Full Year Results
Reformulating the Future 2020 Full Year Results Webcast presentation 9 March 2021
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: Geared for Growth
Geared for Growth Specialty Biopharma Build-out own, U.S., lean commercial Attractive Risk-Reward organisation, focused on cardiologists Euronext Brussels – HYL Broad pipeline* with 11 innovative, value Raised ~€86M to date added candidates plus 2 approved products At the heart of Europe, Belgium Ex
Slide 4: 2020 has Set the Foundation for Future Growth
2020 has Set the Foundation for Future Growth R&D - Regulatory Commercial Corporate • Sotalol IV1: FDA approval of label • Raised €74.54M in gross proceeds expansion Maxigesic IV: through IPO and convertible bonds • Maxigesic IV2: approvals in 17 European • Licensed in >90 countries in Europe, • Str
Slide 5: Broad, Innovative Product Pipeline
Broad, Innovative Product Pipeline* Route of Formulation and Clinical Regulatory Expected Product Indication Administration Manufacturing Development Filing Launch CARDIOVASCULAR PORTFOLIO Sotalol IV IV Atrial fibrillation ’201 Dofetilide IV IV Atrial fibrillation ‘23 Metolazone IV IV Congestive hea
Slide 6: Benefits to Patients, Physicians and Payors
Benefits to Patients, Physicians and Payors Product RoA IP Indication Value Add Shorter hospital stay; fast onset of action; lower overall healthcare cost; facilitate Sotalol IV ’34-’38; granted AF CARDIOVASCULAR PORTFOLIO antiarrhythmic therapy for patients unable to swallow tablets Shorter hospita
Slide 7: Sotalol IV is a Novel, Patented Solution in Atrial Fibrillation
Sotalol IV is a Novel, Patented Solution in Atrial Fibrilation Fast onset, particularly Hospital stay monitoring crucial in acute settings significantly reduced $ Significant potential cost reduction Approved label extension Oral sotalol initiation regimen AF incremental cost saving Cmax achieved in
Slide 8: Sotalol IV, Strong Support From Medical Community
Sotalol IV, Strong Support From Medical Community1 Rhythm drug U.S.-market survey results2,3,4 Under old label Change from old to current label Under current label Electrophysiologists Flecainide Flecainide 18.2% Amiodarone 19.6% Amiodarone 19.2% 22.6% Propafenone Propafenone 12.1% 15.6% 20.7% Drone
Slide 9: Maxigesic IV has Potential to Address the Opioid Epidemic
Maxigesic® IV has Potential to Address the Opioid Epidemic Maxigesic® IV: a novel combination of paracetamol and ibuprofen in an intravenous form, in a 3.3:1 ratio, working in a complementary way to reduce BOTH pain and inflammation Paracetamol Double Ibuprofen blocks the pain message at the source
Slide 10: Maxigesic IV Gaining Momentum
Maxigesic IV Gaining Momentum Post-operative pain management (Countries) Year-end 2020 March 2020 Licensed 90 80 Anesthetics Analgesics Approved 20 3 Sold 3 -- Opioids Non-opioids ▪ Powerful pain management Limited injectable treatment ▪ Potential for devastating side effects options available ▪ Hig
Slide 11: Financial Highlights
Financial Highlights (in € thousand) YE 2020 YE 2019 % change Revenues 175 91 92% R&D expenses (3,413) (4,577) (25%) G&A expenses (2,194) (808) 172% Shares’ issuance related expenses (1,468) - NA Operating result (7,025) (5,274) (25%) Net financial result (120) (508) 76% Net result (7,145) (5,768) (
Slide 12: 2021 started with numerous value-enhancing events
2021 started with numerous value-enhancing events \ 11
Slide 13: Underserved Needs in Severe and rVVC
Underserved Needs in Severe and rVVC Vulvovaginal candidiasis (VVC) • Infection caused by Candida sp. yeast • Causes irritation, vaginal discharge and intense itchiness of the vagina and the vulva • Affects 1 in every 2 women during their life Mindset is defined by pain and suffering Severe and recu
Slide 14: Miconazole-DB has Potential to Cure Severe and rVVC
Miconazole-DB has Potential to Cure Severe and rVVC WELL-KNOWN REPURPOSED MOLECULE ANTIMYCOTIC DOMIPHEN BROMIDE (DB) MICONAZOLE (MCZ) potentiator for fungicidal Prevents growth of fungus activity Domiphen-bromide: anti-septic; identified as a miconazole potentiator through drug DUAL screening of lar
Slide 15: Additional Value-Creating Events
Additional Value-Creating Events HY-004: novel, patented liquid formulation Clinical Started Phase 1 PK and safety study Tranexamic Acid RTU IV: ready-to-use prediluted solution packed in infusion bottles Regulatory Submission of marketing application to the FDA Maxigesic IV: licensed in 8 new EU ma
Slide 16: It is just the beginning
It is just the beginning \ 15
Slide 17: Core Assets - Anticipated Value Inflection Milestones in 2021
Core Assets - Anticipated Value Inflection Milestones in 2021 Clinical Regulatory Commercial HY-004: start Phase 1 PK/safety study Co-development/profit sharing • Maxigesic IV: submission marketing partnership with Purna Female Healthcare application to the U.S. FDA to obtain approval in the U.S. (A
Slide 18: Q&A
Q&A \ 17
Slide 19: Conclusion
se Goncnsion PHARMACEUTICALS
Slide 20: Investment Highlights
Investment Highlights Addressing unmet medical needs in blockbuster markets Powerful • New, high-value formulations and indication for use of existing drugs R&D Sourcing Engine • Strong IP, knowhow and technological innovation • Extensive network of physicians and KOLs to assess scientific and medic
Slide 21: investorrelations@hyloris.com
investorrelations@hyloris.com \ 20
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