Hyloris Pharmaceuticals Sa · EURONEXT:HYL
Hyloris Pharmaceuticals Sa — FY2021 Earnings Presentation
32 slides from Hyloris Pharmaceuticals Sa's earnings presentation, Mar 16, 2022
Slide 1: 2021 Full Year Results
Reformulating the Future 2021 Full Year Results 16th of March 2022
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 • Hyloris: geared for growth • Business update • Financial results Full Year 2021 • Outlook for 2022 • Q&A \2
Slide 4: Rethinking, Reinventing, Optimising Existing Medications
Rethinking, Reinventing, Optimising Existing Medications To improve overall therapy outcomes REFORMULATING Changing dose or route of administration REPURPOSING/ Finding new indications REPOSITIONING For the benefit of patients, physicians, payors 3
Slide 5: Faster Innovation at Considerably Lower Costs and Risks
Faster Innovation at Considerably Lower Costs and Risks Discovery, pre- Regulatory clinical Clinical Development submission & development decision 15 YEARS ON AVERAGE “Traditional Pharma-Biotech Model” $1.3 BILLION COSTS ON AVERAGE Feasibility, Regulatory Clinical formulation, submission & Developme
Slide 6: 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 7: Hyloris: Key Investment Highlights
Hyloris: Key Investment Highlights Growth Pillars 1 15 patented product 2 products on the market with Patients, partners, physicians candidates in the pipeline partners and KOLs Spread across stages and Build own, lean, commercial Real-world data and payors’ indications organisation in the U.S. inpu
Slide 8: Broad, Innovative Portfolio: Expand to ~30 Assets by 2024
Broad, Innovative Portfolio*: Expand to ~30 Assets by 2024 Route of Formulation and Clinical Regulatory Target Product Indication Administration Manufacturing Development Filing Market CARDIOVASCULAR (CV) PORTFOLIO Up to 7 years Sotalol IV IV Atrial fibrillation Launched in U.S./partnered with AltaT
Slide 9: Two Commercialised Products
Two Commercialised Products Maxigesic® IV: Significant Growth of Commercial Footprint Sotalol IV: Expanded Sales Force to Foster Growth 8
Slide 10: Maxigesic IV: Significant Growth of Commercial Footprint
Maxigesic® IV: Significant Growth of Commercial Footprint + strong local distribution partners – Global coverage and gradual roll-out Countries 2022 Licensed 100+ Registered 33 Launched 7 • Launched in South Korea, Panama, Germany and Austria • Europe: additional licenses and approvals • License agr
Slide 11: Sotalol IV: Expanded Sales Force to Foster Growth
Sotalol IV: Expanded Sales Force to Foster Growth • Expansion of AltaThera’s sales force to accelerate roll-out in the U.S. Fast onset, particularly crucial in acute AF settings Hospital stay monitoring significantly reduced $ Significant potential cost reduction Oral sotalol initiation AF increment
Slide 12: 4 innovative product candidates added in the portfolio
4 innovative product candidates added in the portfolio 1. Unmet Needs in Severe and recurrent vulvovaginal candidiasis (rVVC) 2. Oral Milrinone capsule in heart failure (HF) with left ventricular assist device (LVAD) 3. AlenuraTM for treatment of acute pain in interstitial cystisis (IC) and bladder
Slide 13: 1. Unmet Needs in Severe and rVVC
1. Unmet Needs in Severe and rVVC Vulvovaginal candidiasis (VVC) • Infection caused by Candida sp. yeast • Causes irritation, vaginal discharge and intense itchiness Pain, • Affects 50% of all women during their life depression, shame, isolation, fear • ~175 million drug products sold/year Current m
Slide 14: Miconazole-DB has Potential to Cure Severe and rVVC
Miconazole-DB has Potential to Cure Severe and rVVC WELL-KNOWN ANTIMYCOTIC REPURPOSED MOLECULE MICONAZOLE (MCZ) DOMIPHEN BROMIDE (DB) Prevents growth of fungus Potentiator for fungicidal activity Domiphen-bromide: anti-septic; identified as a miconazole potentiator through drug DUAL screening of lar
Slide 15: Deal Structure and Next Steps
Deal Structure and Next Steps Purna Female Healthcare (PFH) • Belgian based spin-off (Purna Pharmaceuticals and Creafund). • Completed early-stage R&D activities with University of Antwerp and KU Leuven, including all pre-clinical work and responsible for further product development, clinical trials
Slide 16: 2. Heart Failure: #1 Cause of Hospitalisation in people >65 years
2. Heart Failure: #1 Cause of Hospitalisation in people >65 years Heart failure (HF) occurs when the heart is unable to pump enough blood through the body Causes and Risk Factors Symptoms 2 Types HFrEF (thin, weak heart muscle) HFpEF (thick, stiff heart muscle) Heart failure with reduced ejection fr
Slide 17: HF Classification and Disease Management
HF Classification and Disease Management As the condition gets worse, the heart muscle pumps less blood to the organs, and the patient moves toward the next stage of heart failure STAGE MANAGEMENT STRATEGY STAGE A: • Urge lifestyle modification (e.g. diet, weight loss, exercise) At risk for developi
Slide 18: IV Milrinone: Positive Inotrope = Increases Contractility
IV Milrinone: Positive Inotrope = Increases Contractility CARDIOPULMONARY EFFECTS: • Increased contractibility and heart rate. • Increased stroke volume and ejection fraction. • Increased cardiac output. • Decreased peripheral and pulmonary vascular resistance. Currently approved for use as an inter
Slide 19: Oral Milrinone: Our Potential Solution in LVAD RHF Patients
Oral Milrinone: Our Potential Solution in LVAD RHF Patients Epidemiology IV Milrinone: shortcomings • Cumbersome, limiting patients’ QoL • High readmission rates post discharge Oral Milrinone • High cost of care Orphan Drug Status in U.S. in LVAD RHF • Not approved for long term use • Novel, orally
Slide 20: Oral Milrinone: Partnership with The Baker Institute
Oral Milrinone: Partnership with The Baker Institute To develop and commercialise a novel, patient-friendly oral formulation of Milrinone to meaningfully improve the lives of patients with advanced HF and significantly reduce cost of care Scope Financial terms Responsibilities • HYL to acquire world
Slide 21: 3. Alenura for treatment of acute pain in IC/BPS – Large market
3. AlenuraTM for treatment of acute pain in IC/BPS – Large market % US of Adult Population (IC/BPS Prevalence) • Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS) is a condition that results in recurring discomfort or pain in the bladder and 7,00% surrounding pelvic region. 6,50% 6,00% • IC/BPS
Slide 22: Cause of damage, inflammation and pain
Cause of damage, inflammation and pain Healthy bladder Diseased bladder Loss of the protective GAG layer exposes the urothelium to toxic components in urine, including potassium that can infiltrate underlying tissue causing damage, inflammation and pain 21
Slide 23: Novel, dual mode of actions candidate to IC/PBS
Novel, dual mode of actions 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 Alkalinised lidocaine: penet
Slide 24: Deal Structure and Next Steps
Deal Structure and Next Steps • Vaneltix will be responsible for the further development, manufacturing, regulatory affairs and commercialisation of AlenuraTM in collaboration with Hyloris. • Hyloris will provide staged investments up to USD 6.7 Mio for Phase 2, manufacturing and regulatory related
Slide 25: 4. Plecoid Agents when chemotherapy is not enough
4. Plecoid™ Agents when chemotherapy is not enough • Acute Myeloid Leukemia (AML) is a relatively rare disease with a worldwide incidence of about 160.000 cases1. For patients above 20 years old, the 5-year survival rate is around 26%2. In the US, there is an estimate of 20.050 new cases of AML in 2
Slide 26: Toxic Metals in Tumour Micro-Environment Impact Survival
Toxic Metals in Tumour Micro-Environment Impact Survival • Significant elevations of toxic metals have been detected in the bone marrow and blood of patients with Acute Myeloid Leukemia (AML) . • High levels of toxic metals are associated with inferior survival. Overall survival in AML patients with
Slide 27: Plecoid Agents: Partnership with Pleco
Plecoid™ Agents: Partnership with Pleco First-in-class product to boost chemotherapy: • Based on breakthrough research • Designed to detoxify the cancer-promoting micro-environment • Strong IP protection • Achieved clinical proof-of-concept in AML patients Scope Financial terms Responsibilities • HY
Slide 28: Financial Highlights: Year end 2021
Financial Highlights: Year end 2021 (in € thousand) FY 2021 FY 2020 % change Revenues 3,096 175 1669% • Revenues: growth mainly driven by Maxigesic IV and Sotalol IV Operating expenses (13,337) (3,626) 149% R&D expenses (5,056) (3,413) 48% • Operating expenses: G&A expenses (2,900) (3,662) (20.8%) •
Slide 29: Core Assets: Anticipated Value Inflection Milestones in 2022
Core Assets: Anticipated Value Inflection Milestones in 2022 Clinical Regulatory Commercial • Starting and completing pivotal PK clinical trial for Aspirin IV • Commercial partnership(s) • Maxigesic® IV: PDUFA date 30 • Starting pivotal PK clinical trial for June 2022 • Continue roll-out of Maxigesi
Slide 30: Unique Value Proposition
Unique Value Proposition • Two commercial products with long runway for growth. • Broad product candidate portfolio (6 cardiovascular and 7 other value added) supporting long-term growth. • Strategic objective to expand to ~30 product (candidates) by 2024, primarily repurposed. • Lean and smart oper
Slide 31: Q&A
Q&A \ 30
Slide 32: Contact us: investorrelations@hyloris.com
Contact us: investorrelations@hyloris.com
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