Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Investor Presentation (May 2023)
27 slides from Hyperion Defi's investor presentation, May 11, 2023
Slide 1: May 2023
May 2023
Slide 2: Forward-looking Statements
1 Forward-looking Statements Except for historical information, all the statements, expectations and assumptions contained in this presentation are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, s
Slide 3: Eyenovia at a Glance
2 • Horizontal delivery • Precision dose • Digital compliance capabilities Eyenovia at a Glance Eyenovia (NASDAQ | EYEN) is a US Based Medical Device and Ocular Therapeutics Company Optejet® with microdose array print technology • Patented digital device platform technology • Exciting and diverse pr
Slide 4: Eyedropper design has done little to improve usability
3 Over the past 125 years, changes in eyedropper design have done little to improve the usability of topical ophthalmic medications Today’s Eyedropper Bottle Designed for Manufacturing Ease, Not Patient Ease 1800’s Glass Pipette 1900’s Glass Pipette with Bulb and Separate Vial Today Integrated Bottl
Slide 5: Introducing the Optejet
Introducing the Optejet® Optejet is a drug-device combination product manufactured with a sterile-filled, replaceable drug cartridge 4 Optejet® with replaceable drug cartridge Spray nozzle with 109 laser-drilled ports Shutter Activation button Ergonomic design Proprietary, pre-filled drug cartridge
Slide 6: Ergonomic Design to Improve Usability
5 Ergonomic Design to Improve Usability Horizontal delivery, push button dosing and no protruding tip Eye Dropper Bottle administration requires head-tilting, squeezing, and reliance on gravity Eye Dropper Bottle tips can touch the eye surface Optejet® has a recessed nozzle, protected by a shutter w
Slide 7: Precision Dosing to Improve Therapeutic Index
6 Precision Dosing to Improve Therapeutic Index 1 Wirta D. et al, Presentation at 2019 ASCRS meeting | 2 Ianchulev T. et al, Therapeutic Delivery 2018 | 3 Results of a human conjunctival cell line assay study with Tufts Medical Center indicate that the impact of preserved medications delivered with
Slide 8: Optejet Digital Technology to Improve Delivery of Care
7 Optejet Digital Technology to Improve Delivery of Care The Optejet® is capable of automatically tracking usage Remote Patient Monitoring: More Data May Benefit All Parties PATIENT • Reminders to take medicine • Ability to track compliance progress • Confidence in medication usage PHYSICIAN • Abili
Slide 9: Product Pipeline
Target Market Drug Optejet Differentiation Addressable Population* Status Notes Proprietary Pupil dilation (Mydriasis) Office Efficiency, ease of use, patient experience 108M FDA Approved May 2023 Alternative to glasses for early presbyopia Ease of use, convenience, less exposure to pilocarpine 3.5M
Slide 10: MydCombi for Pupil Dilation / Mydriasis
9 MydCombi™ for Pupil Dilation / Mydriasis • MydCombi is the first and only FDA-approved FDC ophthalmic spray indicated for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired • Pupil dilation (mydriasis) is part of a comprehensive eye exam and o
Slide 11: MydCombi Product Overview
10 MydCombi™ Product Overview First and only FDA Approved Ophthalmic Spray for Mydriasis MydCombi administered as one metered spray Two Phase 3 clinical trials evaluated the efficacy of MYDCOMBI for achievement of mydriasis. In MIST-1, the mean change in pupil diameter was 4.7 mm with MYDCOMBI, 4.1
Slide 12: MydCombi Product Availability Q3 2023
Product Availability Q3 2023 MydCombi™ Product Availability MydCombi.com Website
Slide 13: MicroLine for Presbyopia
12 MicroLine for Presbyopia • Presbyopia is the age-related loss of near vision that occurs as the lens becomes inelastic (hold the menu further away) • 18 million people aged 40 – 55 in the US have presbyopia, with roughly half never having to use glasses earlier in their lives • MicroLine is a lif
Slide 14: MicroLine Phase 3 Clinical Results
13 MicroLine Phase 3 Clinical Results • Vision-1 1 and Vision-2 2 clinical studies – 6.0x more patients achieved ≥ 3-line gain on a vision chart in the active group vs. placebo3 – Well-tolerated with fewer than 2% of patients reporting adverse events – 65% of patients reported seeing improvement in
Slide 15: MicroLine: Presbyopia Treatment that May Enhance Office Economics
14 MicroLine The Only Presbyopia Treatment with the Optejet that May Enhance Office Economics 1. Population of 40-55YO in the US = 60.8MA , 35% of this population has never needed corrected visionB, assumes product will work for 33% of the remaining population A. Published by Erin Duffin, & 30, S. (
Slide 16: ODs Believe MicroLine Will Win Presbyopia Market
29.75% 25.13% 18.19% 14.52% 12.41% MicroLine - Eyenovia Vuity - Abbvie CSF-1 - Orasis Acelcedine - Lenz Therapeutics Nyxol and Pilocarpine - Ocuphire 15 In a market research survey consisting of 100 Optometrists across the US, they were asked to review existing and late-stage pharmacologic products
Slide 17: MicroLine NDA Timeline
16 MicroLine NDA Timeline NDA Filing Targeted for Q1 2025 March 28th 2023 FDA Meeting 2024 Gen-2 Line Validation Q2 to Q3 Gen-2 Registration Filling Q1 Drug Manufacturing Q4 2025 NDA Filing Q1 12-month Registration Stability Q1 2024 to Q2 2025
Slide 18: MicroPine for Childhood Myopic Maculopathy
17 • Begins in early childhood, with genetic link1 • Elongation of sclera/retina with morbidity and vision problems2 • Urgent need for FDA-approved drug therapies to slow myopia progression • Atropine may slow myopia progression by at least 60%3 MicroPine for Childhood Myopic Maculopathy Progression
Slide 19: MicroPine for Childhood Myopic Maculopathy: Compliance
18 • Precision-dosed atropine spray developed specifically for children – Easy, daily use by children1 – Lower drug volume exposure to enhance comfort and minimize systemic exposure – Potential for pairing with smart devices to track treatment adherence and provide family reminders • Compliance data
Slide 20: MicroPine: A Pediatric Therapy Designed with Children in Mind
19 MicroPine A Pediatric Therapy Designed with Children in Mind Market Receptivity Very high to the device due to the potential benefits it may offer; well accepted by children in the CHAPERONE study Potential Market Size If one assumes the annual cost of these drugs is $2,400, then with 1.9 million
Slide 21: Multiple Commercialization Partners
20 Multiple Commercialization Partners Arctic Vision – A China-based ophthalmic biotech focusing on breakthrough therapies, with a leading portfolio covering pre-clinical stage to commercial stage products Bausch+Lomb – One of the world's largest suppliers of contact lenses, lens care products, pres
Slide 22: Potential Long Term Income Stream
21 Potential Long Term Income Stream Arctic Vision – MicroPine, MicroLine and MydCombi licensed for Greater China and South Korea; clinical study enrollment underway Bausch+Lomb – MicroPine licensed for the US and Canada License agreements with a total value of over $90M in potential payments + roya
Slide 23: Formosa APNT Technology Collaboration
22 • Eyenovia gains access to Formosa’s APNT™ formulation technology which opens several new and large market indications for potential expansion of our own development pipeline • APNT ™ (Active Pharmaceutical Nanoparticle Technology) works to reduce particle size leading to improved dissolution, bi
Slide 24: Broad Intellectual Property Portfolio
23 Broad Intellectual Property Portfolio • Key claims covered with multiple patents – 16 US Patents Issued; 1 pending – 95 foreign issued; 32 pending – Many in effect beyond 2031 • Clinical data and regulatory approval adds another layer of IP
Slide 25: Financial Snapshot (March 2023)
24 Financial Snapshot (March 2023) Nasdaq: EYEN Common Shares Outstanding 37.9M Equity Grants Outstanding Under Stock Plans 5.6M Warrants 6.1M Fully Diluted Shares 49.7M Cash $18.5M Debt $10.9M
Slide 26: Experienced Leadership Team
25 Experienced Leadership Team Bren Kern Chief Operating Officer For more details, please visit our website Michael Rowe Chief Executive Officer John Gandolfo Chief Financial Officer
Slide 27: Investment Summary
26 • Optejet® platform technology with ergonomic design facilitates ease of use and delivers precise doses – Addresses many problems of conventional eye drops – Protected with a strong intellectual property portfolio • Eyenovia owns a pipeline of products in large therapeutic categories – With multi