Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Investor Presentation (September 2023)
31 slides from Hyperion Defi's investor presentation, Sep 20, 2023
Slide 1: September 2023
September 2023 EYEN-COM-V2-0012
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: Changes in eyedropper design have 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 wh
Slide 7: Minimal Sufficient Dosing May Improve Therapeutic Index
6 Minimal Sufficient Dosing May Improve Therapeutic Index 1 Wirta D. et al, Presentation at 2019 ASCRS meeting | 2 Ianchulev T. et al, Therapeutic Delivery 2018 | 3 Hamrah, P. et al. Cytotoxicity Evaluation for BAK-preserved Latanoprost Delivered By Drop vs. Microdose Array Print Technology. ARVO 20
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 • Opportunity for brand-specific encouragement PHY
Slide 9: Target Market
Target Market Optejet Targeted Differentiation United States Addressable Population United States Market $USD* China Addressable Population US Status Licensee PROPRIETARY Pupil dilation (Mydriasis) Ease of use, well tolerated, less systemic absorption, fast recovery time Procedures: 108M1 $250M 650M
Slide 10: MydCombi for pupil dilation and mydriasis
9 • MydCombi is the first and only FDA-approved fixed-dose combination 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 ocular surgery – Estima
Slide 11: MydCombi: Speed and simplicity with each spray
10 MydCombi™ Speed and simplicity with each spray 1 Indication: MYDCOMBI (tropicamide 1% and phenylephrine HCl 2.5%) ophthalmic spray is indicated to induce mydriasis for routine diagnostic procedures and in conditions where short term pupil dilation is desired. IMPORTANT SAFETY INFORMATION. CONTRAI
Slide 12: MydCombi Product Overview
11 MydCombi Product Overview First and only FDA Approved ophthalmic spray for mydriasis • Two Phase 3 clinical trials evaluated the efficacy of MYDCOMBI for achievement of mydriasis. • MYDCOMBI was statistically superior to tropicamide administered alone and phenylephrine administered alone. • Nearl
Slide 13: APP13007 Breakthrough formulation science for ophthalmic steroids
12 AP13007 is Formosa’s APNT™ formulation of clobetasol propionate ophthalmic nanosuspension APP13007 Breakthrough formulation science for ophthalmic steroids1 APNT™ (Active Pharmaceutical Nanoparticle Technology) is designed to reduce particle size leading to improved dissolution, bioavailability,
Slide 14: APP13007 Phase 3 study CPN-301 results
13 • CPN-301, A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of APP13007 for the Treatment of Inflammation and Pain after Cataract Surgery • 395 subjects of which 180 on active, 197 on placebo completed the study – Mean age 68 Y
Slide 15: APP13007 Results from the first of two completed phase 3 studies
14 • Adverse events occurred in 21% of active and 20% of placebo subjects – There was one serious adverse event in the placebo arm • Adverse events occurring in the study eye in 2% of subjects or more: – Anterior chamber inflammation (4% in active, 2% in placebo) – Corneal oedema (2% in active, 5% i
Slide 16: FDA PDUFA date in March 2024 for APP13007
15 FDA PDUFA date in March 2024 for the Treatment of Inflammation and Pain after Cataract Surgery APP13007 A potent steroid with a future in the Optejet • Short and mid-term revenue opportunity ($1.3B market) • Synergistic commercialization with MydCombi 2024 Post-ocular surgery treatment 2027 • Pot
Slide 17: APP13007 A potential for multiple indications
16 October 2023 FDA Meeting 2024 2027 March 2026 NDA filing Dry eye phase 3 studies March 2024 PDUFA Potential dry eye program 2025 May 2024 APP13007 National Launch January 2027 Dry eye approval Post surgical pain and inflammation 2026 AP13007 A potential for multiple indications
Slide 18: Apersure for Presbyopia
17 Apersure™ for Presbyopia • Presbyopia is the age-related loss of near vision that occurs as the lens becomes inelastic • 18 million people aged 40 – 55 in the US have presbyopia, with roughly half never having to use glasses earlier in their lives • Apersure is a lifestyle product designed to avo
Slide 19: Apersure Phase clinical results
18 Apersure™ 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. placebo3,5 – Well-tolerated with fewer than 2% of patients reporting moderate hyperemia4 , instillation discomfort, or brow ache •
Slide 20: Apersure is the invisible second pair of glasses
19 Apersure™ is the invisible second pair of glasses • Existing and future presbyopia eye drops do not fit with the business model of optometrists who use eye glass frames as a revenue source for their practice • With Apersure, optometrists can sell this Optejet based product alongside glasses as an
Slide 21: Apersure market receptivity, size and pricing
20 Apersure™ 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. (2022, September 30). Population of the U.S. by sex and age 2021. Statista. Retrie
Slide 22: Apersure NDA Timeline
21 Apersure NDA Timeline NDA Filing Targeted for YE 2024 March 28th 2023 FDA Meeting 2024 Gen-2 Line Validation Q2 to Q3 Gen-2 Registration Filling Q1 Drug Manufacturing Q4 2025 NDA Filing YE 2024 12-month Registration Stability Q1 2024 to Q2 2025
Slide 23: MicroPine for Delaying Progression of Myopia in Children
22 • 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 Delaying Progression of Myopia in Childr
Slide 24: MicroPine for Delaying Progression of Myopia in Children
23 • Precision-dosed atropine spray developed specifically for children – Easy, daily use by children1 – Lower drug volume exposure to enhance comfort and minimize systemic exposure – Can communicate with smart devices to track treatment adherence and provide family reminders • Compliance data shows
Slide 25: MicroPine: A Pediatric Therapy Designed with Children in Mind
24 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 26: Multiple Commercialization Partners
25 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 Licenses – MicroPine, MicroLine and MydCombi licensed for Greater China and South Korea; clini
Slide 27: Broad Intellectual Property Portfolio
26 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 28: Financial Snapshot (June 2023)
27 Financial Snapshot (June 2023)* Nasdaq: EYEN Common Shares Outstanding 38.2M Equity Grants Outstanding Under Stock Plans 5.3M Warrants 6.1M Fully Diluted Shares 49.6M Cash $17.5M Debt $15.8M * Does not include $12M capital raise August 2023
Slide 29: Experienced Leadership Team
28 Experienced Leadership Team Bren Kern Chief Operating Officer Michael Rowe Chief Executive Officer John Gandolfo Chief Financial Officer
Slide 30: Upcoming Potential Milestones
29 National launch of MydCombi Approval of APP13007 Planned Apersure NDA Filing Q1 2024 Q2 2024 Q3 2024 Q4 2024 National launch of APP13007 Upcoming Potential Milestones
Slide 31: Investment Summary
30 • Optejet platform technology with ergonomic design facilitates ease of use and delivers precise doses – Addresses many long-term unmet clinical needs surrounding the use of conventional eye drops – Protected with a strong intellectual property portfolio • Eyenovia owns a pipeline of products in