Hyloris Pharmaceuticals Sa · EURONEXT:HYL
Hyloris Pharmaceuticals Sa — KBC Securities Life Sciences Conference 2021
43 slides from Hyloris Pharmaceuticals Sa's conference presentation, Sep 9, 2021
Slide 1: Reformulating the Future
Reformulating the Future KBC Securities Life Sciences Conference 9 September 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: High Unmet Medical Needs
15,000 drugs in development in 2018 60 new drugs hit the market in 2018 High Unmet Medical Needs Pharmaprojects 2019 2
Slide 4: We do things differently
We do things differently 3
Slide 5: Rethinking, Reinventing, Optimising Existing Medications
Rethinking, Reinventing, Optimising Existing Medications To improve overall therapy outcomes REFORMULATING Changing dose or mode of administration REPURPOSING New therapeutic uses For the benefit of patients, physicians, payors 4
Slide 6: Patented Value-Added Medicines: Pharma's Sweet Spot
Patented Value-Added Medicines: Pharma’s Sweet Spot To improve therapy outcomes New Chemical Unique Features Entities & Biologicals Reformulating, repurposing, combinations Patented value-added medicines: Optimised existing medicines Convenience, efficacy, tolerability, Off-patent compliance, onset
Slide 7: Faster Innovation at Much Lower Costs and Risks
Faster Innovation at Much Lower Costs and Risks Discovery, pre- Regulatory clinical Clinical Development submission & development decision 15 YEARS ON AVERAGE “Traditional Pharma-Biotech Model” ~1 BILLION COSTS ON AVERAGE Feasibility, Regulatory Clinical formulation, submission & Development product
Slide 8: Putting Healthcare Needs at the Centre of Therapy Design
Putting Healthcare Needs at the Centre of Therapy Design UNMET MEDICAL NEEDS 7
Slide 9: 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 based on physicians’input Fast market adoption Approved, well-known molecul
Slide 10: Broad, Innovative Portfolio: Expand to ~30 Assets by 2024
Broad, Innovative Portfolio: Expand to ~30 Assets by 2024 Formulation and Clinical Regulatory Expected Product RoA Indication Manufacturing Development Filing Launch CARDIOVASCULAR (CV) PORTFOLIO Maximum 7 years Sotalol IV IV Atrial fibrillation Launched in U.S./partnered with AltaThera ’201 Dofetil
Slide 11: High Unmet Needs in Atrial Fibrillation (AF)
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 medicines Rhythm contr
Slide 12: Sotalol IV Offers Benefits to Patients, Physicians and Payors
Sotalol IV Offers Benefits to Patients, Physicians and Payors Commercial partner AltaThera expanded their sales force in 2021 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
Slide 13: Maxigesic IV has Potential to Combat the Opioid Crisis
Maxigesic® IV has Potential to Combat the Opioid Crisis Maxigesic® IV: a novel combination of 1000mg paracetamol and 300mg ibuprofen solution for infusion Paracetamol Double Ibuprofen blocks the pain message at the source action blocks the pain transmission (in IV form) Phase 3 study results: Faster
Slide 14: Maxigesic IV: Significant Growth of Commercial Footprint
Maxigesic IV: Significant Growth of Commercial Footprint Germany & Austria: launched + strong local distribution partners Nordics: licensed Ireland, U.K., The Netherlands: licensed Eastern Europe: licensed 4 August 31 March U.S.: licensed Korea: Countries Spain, Portugal, France: Greece: licensed 20
Slide 15: 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 16: Flexible, Hybrid Earnings and Commercialisation Model
Flexible, Hybrid Earnings and Commercialisation Model 1. CARDIOVASCULAR FRANCHISE 2. OTHER PORTFOLIO • Lean speciality U.S. sales team targeting • Out-licensing to commercial partners across hospital-affiliated cardiologists various geographies • Exploit existing regulatory package for certain • Cre
Slide 17: Launch of Own IV Cardiovascular Portfolio in the U.S.
Launch of Own IV Cardiovascular Portfolio in the U.S. • Build the right commercial team and manufacturing capabilities • Focus on specialist cardiologists employed by hospitals in key sales territories Key account Hyloris managers Pharma, Inc. Medical science KOL liaisons engagement LAUNCH READINESS
Slide 18: Robust IP Portfolio: Extended Period of Exclusivity
Robust IP Portfolio: Extended Period of Exclusivity • Broad portfolio: exclusivity through 2039 in key pharma markets across the globe • Wide range of protection: dosages, formulations, indications, methods for preparing a composition, manufacturing methods • Additional layer of protection: knowhow,
Slide 19: 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 20: 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 • Atomoxetine: start + results pivotal Maxigesic IV: distribution • Maxigesic IV: marketing applica
Slide 21: 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 22: Questions?
Questions?
Slide 23: investorrelations@hyloris.com
investorrelations@hyloris.com \ 22
Slide 24: Addendum
Addendum: • Background Info Product Pipeline • 505(b)(2) Landscape • Shareholders and Corporate Info \ 23
Slide 25: 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 24
Slide 26: Selected Case Studies
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Slide 27: Unmet Needs in Severe and rVVC
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 • ~175M drug products sold/year Current medicines h
Slide 28: 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 DUAL Domiphen-bromide: anti-septic; identified as a miconazole potentiator through drug FUNGICIDAL scree
Slide 29: High Unmet Needs in Atrial Fibrillation (AF)
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 medicines Rhythm contr
Slide 30: Sotalol IV Offers Benefits to Patients, Physicians and Payors
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 incremental cost saving Cm
Slide 31: 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 32: High Unmet Needs in Post-Operative Pain Management
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 severe mild Opioids
Slide 33: Maxigesic IV has Potential to Combat the Opioid Crisis
Maxigesic® IV has Potential to Combat the Opioid Crisis Maxigesic® IV: a novel combination of 1000mg paracetamol and 300mg ibuprofen solution for infusion Paracetamol Double Ibuprofen blocks the pain message at the source action blocks the pain transmission (in IV form) Phase 3 study results: Faster
Slide 34: Market Landscape Value-Added 505(b)(2) Medicines
Market Landscape Value-Added 505(b)(2) Medicines
Slide 35: Increasing Use of 505(b)(2) Pathway in the Industry
Increasing Use of 505(b)(2) Pathway in the Industry 505(b)(2) approvals (2003-2019) NDA approvals in 2019 by pathway 75 63 64 6% 44 43 43 45 45 35 38 37 39 33 29 27 29 38% 19 56% Repurposed drugs have 150% higher change of success to reach the market 505(b)2 approvals 505(b)1 approvals Undetermined
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: 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 39: Shareholders and Corporate Information
Shareholders and Corporate Information
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% Kempen René Wouters Buy Berenberg Beatrice Allen Buy Thomas Jacobsen Hyloris is followed by the analysts listed above. Please note t
Slide 41: Founders with Impressive Track Record and Industry Expertise
Founders with Impressive Track Record and Industry Expertise 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
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
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