Hyloris Pharmaceuticals SA · EURONEXT:HYL
Hyloris Pharmaceuticals SA — Investor Presentation (October 2021)
44 slides from Hyloris Pharmaceuticals SA's investor presentation, October 2021
Slide 1: Reformulating the Future: Corporate Presentation
Reformulating the Future Corporate Presentation October 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: Investment Highlights
Investment Highlights Our Mission Our Vision Our Values Entrepreneurship, patient- Creating value by rethinking and Become the reference in value- centred care, commitment, reinventing existing medications added medicines mutual respect Growth Pillars 11 patented product 2 products on the market wit
Slide 4: Rethinking, Reinventing, Optimising Existing Medications
Rethinking, Reinventing, Optimising Existing Medications To improve overall therapy outcomes REFORMULATING Changing dose and/or route of administration REPURPOSING/ New therapeutic uses REPOSITIONING For the benefit of patients, physicians, payors 3
Slide 5: Patented Value-Added Medicines: Pharma's Sweet Spot
Patented Value-Added Medicines: Pharma’s Sweet Spot Reinventing existing medications to improve therapy outcomes New Chemical Unique Features Entities & Biologicals New indication, combination, reformulation Patented value-added medicines: Optimised existing medicines Efficacy, safety, new use, comp
Slide 6: 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 7: Putting Healthcare Needs at the Centre of Therapy Design
Putting Healthcare Needs at the Centre of Therapy Design UNMET MEDICAL NEEDS 6
Slide 8: To Drive Continuous Growth and Create Shareholders' Value
To Drive Continuous Growth and Create Shareholders’ Value Acquisition and in-licensing of product candidates Continuously growing diversified product based on portfolio characterised by Clear scientific and medical rationale Fast market adoption based on physicians’input Approved, well-known molecul
Slide 9: 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 Maximum 7 years on average Sotalol IV IV Atrial fibrillation Launched in U.S./partner
Slide 10: Our Portfolio: Added-Value for all Stakeholders
Our Portfolio*: Added-Value for all Stakeholders Product IP Indication Key Benefits and Value Proposition Shorter hospital stay; fast onset of action; lower overall healthcare cost; facilitate antiarrhythmic therapy for patients Sotalol IV ’34-’38; granted Atrial fibrillation unable to swallow table
Slide 11: Sourcing Product Opportunities Via Multiple Channels
Sourcing Product Opportunities Via Multiple Channels 11 PRODUCT CANDIDATES 2 COMMERCIAL PRODUCTS KOL / PARTNER ACQUISITION AND NETWORK IN-LICENSING DESK RESEARCH REAL WORLD DATA AND SURVEYS FDA-APPROVABLE OFF-LABEL USE 10
Slide 12: Powerful R&D Engine: Leveraging our Network of Partners
Powerful R&D Engine: Leveraging our Network of Partners Development cost-to-market (≤ €7M*) Commercialisation In-house Outsourced Commercial manufacturing Regulatory Product interactions selection Product development API sourcing Time-to-market (≤ 7 years) Note: bubble size indicates relative amount
Slide 13: Flexible, Hybrid Earnings and Commercialisation Model
Flexible, Hybrid Earnings and Commercialisation Model CARDIOVASCULAR FRANCHISE OTHER VALUE-ADDED PORTFOLIO • Lean and efficient U.S. sales team targeting • Out-licensing to commercial partners across ~2,700 hospital-affiliated cardiologists various geographies • Exploit existing regulatory package f
Slide 14: Financial Highlights: Period Ending June 2021
Financial Highlights: Period Ending 30 June 2021 (in € thousand) HY 2021 HY 2020 % change Key Factors Revenue and other income 1,145 102 1,023% • Revenues: growth mainly driven by Maxigesic IV recognised income from Revenues 838 82 922% milestones Other income 307 20 1,435% • Operating expenses: imp
Slide 15: Selected Case Studies
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Slide 16: Coronary Artery Disease and Acute Coronary Syndrome
Acute Coronary Syndrome Coronary Artery Disease and Acute Coronary Syndrome Coronary Artery Disease Acute Coronary Syndrome (ACS) ~2 million patients/year in U.S. • Acute myocardial infarction (heart attack) • Unstable angina (chest pain) © University of Chicago Medicine #1 cause of death in the U.S
Slide 17: Potential Solution to Overcome Limitations of Oral Aspirin
Acute Coronary Syndrome Potential Solution to Overcome Limitations of oral Aspirin Oral Aspirin Aspirin IV: first-in-class IV acetylsalicylic acid • Slow onset of action: max. effect only after 1-2 hours • Fast onset of action: avoid further heart tissue damage • Bioavailability of 40-50% and highly
Slide 18: Aspirin IV U.S.: Partnership with Rhoshan Pharmaceuticals
Acute Coronary Syndrome Aspirin IV U.S.: Partnership with Rhoshan Pharmaceuticals To address unmet needs in acute coronary syndrome (ACS): • Can result in heart attack or unstable angina • Higher risk of mortality 24 hours post heart attack • Need for novel products with fast onset of action and con
Slide 19: Heart Failure: #1 Cause of Hospitalisation in people >65 years
Advanced Heart Failure 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
Slide 20: HF Classification and Disease Management
Advanced Heart Failure 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, exercis
Slide 21: IV Milrinone: Positive Inotrope = Increases Contractility
Advanced Heart Failure 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 approve
Slide 22: Oral Milrinone: Our Potential Solution in LVAD RHF Patients
Advanced Heart Failure 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 te
Slide 23: Oral Milrinone: Partnership with The Baker Institute
Advanced Heart Failure 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
Slide 24: Unmet Needs in Severe and rVVC
Recurring Vulvovaginal Candidiasis 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 d
Slide 25: Miconazole-DB has Potential to Cure Severe and rVVC
Recurring Vulvovaginal Candidiasis 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
Slide 26: High Unmet Needs in Atrial Fibrillation (AF)
Atrial Fibrillation High Unmet Needs in Atrial Fibrillation (AF) Atrial Fibrillation: a life-threatening disease Current treatments could be improved • Characterised by an irregular and often abnormal high heart rate • Blood thinners • Heart rate medicines LIMITATIONS AF mechanism1 • Heart rhythm me
Slide 27: Sotalol IV Offers Benefits to Patients, Physicians and Payors
Atrial Fibrillation Sotalol IV Offers Benefits to Patients, Physicians and Payors Fast onset, particularly Hospital stay monitoring crucial in acute settings significantly reduced $ Significant potential cost reduction Approval Sotalol IV New Label (label extension) Oral sotalol initiation AF increm
Slide 28: Sotalol IV New Label, Strong Support From Medical Community
Atrial Fibrillation Sotalol IV New Label, Strong Support From Medical Community Rhythm drug U.S.-market survey results1, 2, 3 Electrophysiologists Under old label Change from old to new label Under new label Flecainide Flecainide 18.2% Amiodarone 19.2% 19.6% Amiodarone 22.6% Propafenone Propafenone
Slide 29: High Unmet Needs in Post-Operative Pain Management
Post-Operative Pain High Unmet Needs in Post-Operative Pain Management Gap in moderately severe pain care space Current treatment options are suboptimal Post-operative pain management NSAIDS IV Gap in acute care space (in IV) moderately Anesthetics Analgesics Paracetamol IV moderate Opioid IV severe
Slide 30: Maxigesic IV has Potential to Combat the Opioid Crisis
Post-Operative Pain Maxigesic® IV has Potential to Combat the Opioid Crisis Maxigesic® IV: a novel combination of 1000mg paracetamol and 300mg ibuprofen solution for infusion, working in a complementary way to reduce both pain and inflammation and lower the use of opioid rescue medication Paracetamo
Slide 31: Outlook and Conclusion
Outlook and Conclusion
Slide 32: Core Assets: Anticipated Value Inflection Milestones in 2021
Core Assets: Anticipated Value Inflection Milestones in 2021 Clinical Regulatory Commercial HY-004: start Phase 1 Tranexamic Acid RTU: marketing Partnership Purna Female application in U.S. Healthcare for MCZ-DB • Atomoxetine: start + results pivotal • Maxigesic IV: FDA acceptance of Maxigesic IV: d
Slide 33: Potential Game Changer, Geared for Growth
Potential Game Changer, Geared for Growth MULTIPLE SHOTS ON GOAL COMMERCIAL PORTFOLIO ≤ 7 years to market 2 patented products with partners ≤ €7 million average cost to market Addressing unmet needs Lower risk as we start from existing drugs Build U.S. commercial team Innovative, patented, value- Re
Slide 34: investorrelations@hyloris.com
investorrelations@hyloris.com \ 33
Slide 35: Addendum
Addendum \ 34
Slide 36: Average Peak Sales of Value-Added 505(b)(2) Products
Average Peak Sales of Value-Added 505(b)(2) Products Average peak sales (million $) of 505(b)(2) products in each approval year 2013 to 2018 (N=78 launched products) 300 250 $202 million 200 150 100 50 0 2013 2014 2015 2016 2017 2018 All Years Approval years https://www.pharmexec.com/view/505b2-path
Slide 37: Performance of Select Number of 505(b)(2) Products
Performance of Select Number of 505(b)(2) Products Product name What changed in 505(b)(2) Indication Company 2019 Sales Avycaz New combination Complicated intra-abdominal and urinary tract infections Allergan (AbbVie) $117M Belbuca New dosage form Chronic pain BioDelivery Sciences $98M REFORMULATED
Slide 38: Increasing Use of 505(b)(2) Pathway in the Industry
Increasing Use of 505(b)(2) Pathway in the Industry NDA approvals in 2019 by pathway 505(b)(2) approvals (2003-2019) 75 6% 63 64 44 43 43 45 45 38% 38 37 39 56% 35 33 29 27 29 19 505(b)2 approvals 505(b)1 approvals Undetermined 505(b)(2) approvals by route of administration 505(b)2 approvals by type
Slide 39: Value-Added 505(b)(2) Landscape
Value-Added 505(b)(2) Landscape Geographical spread of 505(b)(2) (tentative) approvals 2015-2018 (# 221) Top-3 applicants 2015-2018: # of 505(b)(2) Country Company approvals 12 7 4 Select Listed Competitors: # of 505(b)(2) approvals Country Company Formulation route 2011 - 2019 3 IV (infusion) 2 Inj
Slide 40: Shareholders' Information
Shareholders’ Information Major shareholders Stijn Van Rompay (Founder Bank Analyst Rating & CEO); 26.42% Other holders; KBC Securities Lenny Van Steenhuyse Buy 40.36% Jeroen Van den Bossche Kempen René Wouters Buy Berenberg Beatrice Allen Buy Thomas Jacobsen Hyloris is followed by the analysts list
Slide 41: Hyloris Founders have an Impressive Industry Track Record
Hyloris Founders have an Impressive Industry Track Record 2005 acquired for €218M by Founded by Leon & Stijn Van Rompay Generics and Pharmacy Sales & Devices 2013 acquired for up to $305M by Founded by Stijn Van Rompay & François Fornieri Women’s Health 2015 Uteron shareholders sold Estelle® for >€2
Slide 42: Executive Management Team
Executive Management Team • In-depth knowledge of regulatory affairs, market access and the capital markets; involved in > 80 approved drugs, executed >250 licensing transactions; established track record of shareholder value creation • Hyloris currently employs 23 people, 7 nationalities Stijn Van
Slide 43: Board of Directors
Board of Directors Stefan Yee Marc Foidart4 Chairman, Non-Executive Director Independent Director PE Group Stijn Van Rompay1 Carolyn Myers Chief Executive Officer, Executive Director Independent Director Bioensemble Ltd. Thomas Jacobsen2 James Gale Chief Business Development Officer, Executive Direc
Slide 44: 2020 has Set Strong Foundations for Value-Creation
2020 has Set Strong Foundations for Value-Creation R&D - Regulatory Commercial Corporate • Sotalol IV: U.S. approval • Raised €79.54M expanded label Maxigesic IV: • Strengthened management • Maxigesic IV: approvals in 17 EU team countries; Phase 3 completed • Licensed in >100 countries • Further bui
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