Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Investor Presentation (January 2024)
30 slides from Hyperion Defi's investor presentation, Jan 31, 2024
Slide 1: We Are the Optejet Company
January 2024 We Are the Optejet® Company Developing and commercializing ophthalmic drug - device therapeutics with Optecare Ρ services in large markets with high unmet needs EYEN - COM - V2 - 0021
Slide 2: Forward-looking Statements
Forward - looking Statements Except for historical information, all the statements, expectations and assumptions contained in this presentation are forwar d - l ooking statements. Forward - looking statements include, but are not limited to, statements that express our intentions, beliefs, expecta t
Slide 3: Eyenovia (NASDAQ:EYEN) is the Optejet Company
3 • Designed to address issues with ease - of - use and dosing precision • Delivers efficacy while improving tolerability and reducing side effects 1 • Digital Optecare Œ capabilities 2 Optejet ® with microdose array print technology • Patented digital device platform technology • Unique, class - le
Slide 4: Today's Eyedropper Bottle Designed for manufacturing ease, not patient use
4 Today’s Eyedropper Bottle Designed for manufacturing ease, not patient use Over the past 125 years, changes in eyedropper design have done little to improve the usability of topical ophthalmic medications 1800’s Glass Pipette 1900’s Glass Pipette with Bulb and Separate Vial Today Integrated Bottle
Slide 5: Introducing the Optejet
5 Introducing the Optejet ® Optejet® with replaceable drug cartridge Spray nozzle with 109 laser - drilled ports Shutter Activation button Ergonomic design Proprietary, pre - filled drug cartridge manufactured by Eyenovia Optejet is a drug - device combination product manufactured with a sterile - f
Slide 6: Ergonomic Design to Improve Usability
6 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 patient’s eye surface and medication can drip down their face Op
Slide 7: Laboratory-Proven Cartridge Thoroughly Tested to Demonstrate Sterile Drug Delivery
7 Laboratory - Proven Cartridge Thoroughly Tested to Demonstrate Sterile Drug Delivery RESULTS: Using the 1x10 6 microbial growth challenge protocol, Optejet met the passing criteria. • All test units did not show growth for the 28 - day simulated use • All positive control units showed growth • All
Slide 8: The Optejet Delivers 80% Less Drug Volume Than Eye Droppers
8 The Optejet Delivers 80% Less Drug Volume Than Eye Droppers Sufficient for efficacy while improving benefits from reducing excessive exposure to both drugs and preservatives 1,2 1 Wirta D. et al, Presentation at 2019 ASCRS meeting | 2 Ianchulev T. et al, Therapeutic Delivery 2018 | 3 Hamrah , P. e
Slide 9: Optejet Digital Technology is Optecare
9 Optejet Digital Technology is Optecare Ρ The Optejet ® is capable of automatically tracking usage OPTECARE: Multiple Benefits for All Stakeholders PATIENT • Reminders to take medicine • Ability to track compliance progress • Opportunity for brand - specific encouragement • May be monetized through
Slide 10: Broad Intellectual Property Portfolio
10 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 11: MydCombi: The First FDA-Approved Product with Optejet Technology
11 Spray nozzle with 109 laser - drilled ports Mist button Proprietary, pre - filled and replaceable drug cartridge containing tropicamide and phenylephrine Fill button Base Unit with rechargeable battery Cartridge Base Proprietary, pre - filled drug cartridge manufactured by Eyenovia MydCombi Ρ The
Slide 12: The Office-Based and Surgical Pupil Dilation Market $250 Million Opportunity
12 The Office - Based and Surgical Pupil Dilation Market $250 Million Opportunity 1 in the United States 1. $200M annual sales of pharmaceutical mydriatic products used during 108M office - based exams ($2 * 100M) + $50M of single bott le mydriatic agents used cataract replacement surgery ($12.5 x 4
Slide 13: First and only FDA approved ophthalmic spray for mydriasis
13 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. • Nearly all (94%) subject eyes a
Slide 14: MydCombi: Speed and simplicity with each spray
14 MydCombi Ρ Speed and simplicity with each spray 1 Indication: MYDCOMBI (tropicamide 1% and phenylephrine HCl 2.5%) ophthalmic spray is indicated to induce mydriasis for routin e d iagnostic procedures and in conditions where short term pupil dilation is desired. IMPORTANT SAFETY INFORMATION. CONT
Slide 15: Testimonials
15 Testimonials “My staff and the patients love the technology. MydCombi provides good dilation without the burning associated with in - office dilation.” Edward Rubinchik , MD SmartEyeCare - NY “MydCombi is a no brainer. Patients tolerated the medication better due to the Optejet device, and it sav
Slide 16: Late-Stage Development Pipeline
16 Late - Stage Development Pipeline 1. IQVIA Estimates of Ophthalmic Topical Steroid and Steroid Combinations Market 2023 2. Richard Edlow , O. (2020) The Myopia Management Market, Review of Myopia Management. Available at: https://reviewofmm.com/the - myopia - managemen t - market/ 3. Eyenovia Est
Slide 17: APP13007 An Important Advancement in Ocular Post-Surgical Pain and Inflammation Control
17 APP13007 (Clobetasol Propionate Nanosuspension 0.05%, BID) An Important Advancement in Ocular Post - Surgical Pain and Inflammation Control FDA PDUFA date March 2024 • Short and mid - term revenue opportunity ($700 M market) 1 • Synergistic commercialization with MydCombi’s sales force 2024 Post
Slide 18: Technology Enables APP13007's Compelling Profile
18 Technology Enables APP13007’s Compelling Profile The Post - surgical Pain and Inflammation Market Was Valued at $200m in 2022 - High uniformity and purity in particle size - Improved stability - Improved dispersion properties - Improved bioavailability Patented APNT nanolization provides many ben
Slide 19: Rapid and Sustained Ocular Pain Relief and Clearance of Inflammation
19 * Korenfeld ASCRS Presentation 2023 | A Phase 3 Study of APP13007 (Clobetasol Propionate Ophthalmic Nanosuspension 0.05%) to Treat Inflammation and Pain after Cata rac t Surgery 0% 33% 59% 0% 12% 16% 0% 20% 40% 60% 80% POD1 POD8 POD15 INFLAMMATION % of subjects with ACC Grade=0 Sustained to Day 1
Slide 20: Efficacy and Twice-a-Day Dosing Matter Most
20 When it Comes to Post - Surgical Pain and Inflammation Management Efficacy and Twice - a - Day Dosing Matter Most 1. J. Reckner and Associates survey conducted August 2023 with 100 Ophthalmologists performing at least 10 ocular surgeries p er week. Respondents were asked to consider the descripti
Slide 21: All Adverse Events ≥ 2.0%
21 All Adverse Events ≥ 2.0% APP13007 (N=181) Placebo (N=197) Adverse Events n (%) # of Events n (%) # of Events Subjects with ≥ 1 Ocular Adverse Event 29 (16.0%) 33 34 (17.3%) 50 Anterior chamber inflammation 7 (3.9%) 7 3 (1.5%) 3 Corneal oedema 3 (1.7%) 3 10 (5.1%) 10 * Korenfeld ASCRS Presentatio
Slide 22: Progressive Myopia is a Global Epidemic That Can Lead to Vision Loss
22 • Begins in early childhood, with genetic link 1 • Elongation of the eye with morbidity and vision problems 2 • Urgent need for FDA - approved drug therapies to slow myopia progression Affects ~25M children in the US alone, with ~5M considered to have high myopia risk 3 1 Jones LA, Sinnott LT, Mu
Slide 23: Treatment Options and Medical Need
23 Treatment Options and Medical Need Drugs in Clinical Trials ● Atropine eyedrops have been observed to slow myopia progression in children 3 ● Multiple companies (Sydnexis, Vyluma, and Ocumension) are in clinical trials using atropine drops ranging in concentrations from 0.01% to 0.03%. These tria
Slide 24: The Pediatric Progressive Myopia Market is Valued at $1.8B in the US
24 The Pediatric Progressive Myopia Market is Valued at $1.8B in the US and Similarly in China Currently under investigation, not FDA approved
Slide 25: Optecare Designed to Improve Treatment Adherence
25 Optecare Ρ Designed to Improve Treatment Adherence • Precision - dosed atropine spray developed specifically for children • Easy, daily use by children 1 • Lower drug volume exposure to enhance comfort and minimize systemic exposure • Can communicate with smart devices to track treatment adherenc
Slide 26: MicroPine Planned Development Timeline
26 MicroPine Planned Development Timeline 4Q 2024 2026 2027 2028 2025 I f Positive But Not Yet Statistically Significant, Continue Study Until 420 Patients Reach Endpoint File NDA File NDA If Positive and Statistically Significant, Meet with FDA to Potentially Stop Enrollment and Submit Data Output
Slide 27: Eyenovia: 2024 Key Events
27 Eyenovia: 2024 Key Events Q1 National MydCombi Launch APP13007 PDUFA Early March Q2 Q3 Q4 MydCombi ΠPost - Marketing Study Results MydCombi ΠGen - 2 Planned FDA Meeting National APP13007 Launch (Pending Approval) MicroPine Planned FDA Meeting
Slide 28: Additional Large-Market Opportunities
28 Additional Large - Market Opportunities 1. Estimates from IQVIA Sales Data | 2. Eyenovia Estimates chronic dry eye is 90% and acute is 10% of total dry eye market of $2 .36B (North America Dry Eye Syndrome Market – Industry Trends and Forecast to 2030) Data Bridge Market Research. Available at: h
Slide 29: Financial Snapshot (September 2023)
29 Financial Snapshot (September 2023) Nasdaq: EYEN Common Shares Outstanding 42.9M Equity Grants Outstanding Under Stock Plans 5.3M Warrants 13.2M Fully Diluted Shares 61.4M Cash $20.7M Debt $14.1M
Slide 30: Experienced Leadership Team
30 Experienced Leadership Team Bren Kern Chief Operating Officer Michael Rowe Chief Executive Officer John Gandolfo Chief Financial Officer Norbert Lowe VP, Commercial Operations Greg Bennett VP, Clinical Program Strategy and Development Malini Batheja , PhD VP, Pharm R&D and CMC Regulatory Enrico B