Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Investor Presentation (June 2024)
42 slides from Hyperion Defi's investor presentation, Jun 4, 2024
Slide 1: We Are the Optejet Company
June 2024 We Are the Optejet® Company Developing and commercializing ophthalmic 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 Corporate Highlights
3 Eyenovia Corporate Highlights 2023 May 2023 FDA approval of MydCombi Œ • Transitioned company to commercial stage • Validates Optejet dispensing technology • $250mm US addressable market 1 3Q 2024 (anticipated) Optejet® Gen - 2 FDA meeting • To confirm regulatory pathway towards drug/device approv
Slide 4: MicroPine Atropine Ophthalmic Metered Spray
MicroPine Atropine Ophthalmic Metered Spray Our Premier Near - Term Opportunity in the Multi - Billion Dollar Pediatric Progressive Myopia Market 4
Slide 5: Unmet Medical Need
Unmet Medical Need Current options are not appropriate for all patients and do not eliminate progression risk $3.0B market in the U.S. and China One of the largest markets in global eyecare Major Clinical Milestone expected in 5 Months CHAPERONE Data Monitoring Committee Review expected in 4Q 2024 5
Slide 6: Progressive Myopia is a Global Epidemic
6 • Begins in early childhood, with genetic link or environmental factors 1 • Elongation of the eye with morbidity and vision problems 2 • Currently no 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 Jon
Slide 7: Approximately 25% of Myopic Children are at High Risk for Vision Loss
7 Approximately 25% of Myopic Children are at High Risk for Vision Loss Without Effective Intervention - 1.4 D Mean Diopters at 9 - Years - Old Donovan L. et al., Myopia progression rates in urban children wearing single - vision spectacles. Optom Vis Sci. 2012 Jan;89(1):27 - 32. 0 0.25 0.5 0.75 1 1
Slide 8: Only FDA-Approved Treatment Today are Lenses
8 Only FDA - Approved Treatment Today are Lenses 1. Optometry and Vision Science94(6):638 - 646, June 2017 2. Int J Health Sci (Qassim). 2013 Nov;7(3):291 - 9. doi : 10.12816/0006057 Approved Devices Over 75% of optometrists, however, feel that using contact lenses in patients under 10 years of age
Slide 9: Pharmaceutical Options: Low-Dose Atropine Shown Effective in Asia
Pharmaceutical Options Atropine eyedrops have been observed to slow myopia progression in children 1 Currently no FDA - approved options Low - Dose Atropine Has Been Shown Effective In Asia 1. Chia A, Chua WH, Cheung YB, et al. Atropine for the treatment of childhood Myopia: Safety and efficacy of 0
Slide 10: Eye Doctors Using Off-Label Atropine from Compounding Pharmacies
Eye Doctors are using Off - Label Atropine from Compounding Pharmacies to Treat Myopia Patients Multifocal Soft Contact Lenses WHICH TREATMENT INTERVENTIONS DO YOU CURRENTLY PRESCRIBE TO MANAGE PROGRESSIVE MYOPIA IN CHILDREN AND ADOLESCENTS? More Time Outdoors Topical Low - Dose Atropine Visual Hygi
Slide 11: MicroPine: Premier Drug+Device Product for Progressive Myopia
MicroPine The Premier Drug+Device Product for Progressive Myopia Target Product Profile • 60% reduction in myopia progression with minimal rebound after one year • One spray per each eye daily; easy enough for children to use without supervision • Comfortable to instill with minimal impact on the oc
Slide 12: CHAPERONE: Single Phase Trial Required for FDA Approval
CHAPERONE The Single Phase 3 Trial Required for FDA Approval • Three arms dosed with 8 microliter ophthalmic spray: placebo, 0.01% and 0.1% atropine • Myopic children in the U.S. between the ages of 3 and 13 at risk for progression • MicroPine given as one spray in each eye at night • Three years to
Slide 13: Treatment Compliance via Optecare is What Makes MicroPine Special
● Only MicroPine comes with built - in Optecare Ρ technology to track and communicate patient compliance data ● In CHAPERONE, the daily treatment compliance of the first 28 subjects was well above what was predicted ● Treatment adherence and compliance is typically a primary determinant of therapy s
Slide 14: Potential Peak Sales of Over One Billion Dollars
14 Potential Peak Sales of Over One Billion Dollars 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 Number of Potential Users 5,000,000 5,050,000 5,100,500 5,151,505 5,203,020 5,255,050 5,307,601 5,360,677 5,414,284 5,468,426 Approx. Market Share 0.5% 1% 2% 4% 6% 7% 8% 9% 10% 10% Cartridge Units 1
Slide 15: MicroPine Planned Development Timeline
15 MicroPine Planned Development Timeline 4Q 2024 2026 2027 2028 2025 I f Positive But Not Yet Statistically Significant, Continue Study Until Sufficient Patients Reach Endpoint File NDA File NDA If Positive and Statistically Significant, Meet with FDA to Potentially Stop Enrollment and Submit Data
Slide 16: Optejet Digital Ophthalmic Metered Spray Device
Optejet® Digital Ophthalmic Metered Spray Device The Only FDA - Approved Ophthalmic Digital Drug Delivery Platform June 2024
Slide 17: Introducing the Optejet Gen-2
17 • 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 - l
Slide 18: Optejet Replaceable Cartridge and Durable Base
18 The Optejet ® Consists of a Replaceable Cartridge (COGS of $20) and Durable Base Spray nozzle with 109 laser - drilled ports Shutter Activation button Ergonomic design Proprietary, pre - filled drug cartridge manufactured by Eyenovia Optejet uses technology similar to that of Inkjet printers to “
Slide 19: Ergonomic Design to Improve Usability
19 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 O
Slide 20: Device Thoroughly Tested to Ensure Sterile Drug Delivery
20 Device Thoroughly Tested to Ensure 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 negative control units did
Slide 21: Optejet Delivers 80% Less Drug Volume Than Eye Droppers
21 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.
Slide 22: Optejet Digital Technology is Optecare
22 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 throug
Slide 23: Broad Intellectual Property Portfolio
23 Broad Intellectual Property Portfolio • Key claims covered with multiple patents – 18 US Patents Issued; 8 pending – 89 foreign issued; 33 pending – Many in effect beyond 2041 • Clinical data and regulatory approval adds another layer of IP
Slide 24: Multiple Licensing Opportunities in Large Markets
24 Multiple Licensing Opportunities in Large Markets 1. Estimates from IQVIA Sales Data | 2. Eyenovia Estimates chronic dry eye is 90% and acute is 10% of total dry eye market of $6 .1B (Dry Eye Disease Market (Jan 2024) Transparency Market Research. Available at: https://www.transparencymarketresea
Slide 25: Gen-2 Planned Development Timeline
25 Gen - 2 Planned Development Timeline 3Q 2024 2H 2025 1H 2026 2H 2026 1H 2025 Construct Gen - 2 Registration Materials for MydCombi and Place on Stability File sNDA Move Forward with Collaboration Agreements in Dry Eye and Glaucoma FDA Meeting on Gen - 2 Validation Plans Approval Potential Phase 3
Slide 26: Clobetasol Propionate Ophthalmic Suspension 0.05%
Clobetasol Propionate Ophthalmic Suspension 0.05% FDA - APPROVED For the treatment of post - operative inflammation and pain following ocular surgery 26 This presentation is not an advertisement for clobetasol propionate.
Slide 27: Safety Information
Safety Information IMPORTANT SAFETY INFORMATION: Clobetasol Propionate Ophthalmic Suspension 0.05% is indicated for the treatment of post - operative inflammation and pain following ocular surgery. CONTRAINDICATIONS: Most active viral diseases of the cornea and conjunctiva, including epithelial herp
Slide 28: Expected to Provide Near-Term Revenue to Fund Optejet Projects
Expected to Provide Near - Term Revenue to Fund Optejet Projects 28 Ophthalmology’s First New Steroid in 15 Years Physicians now have access to a well - characterized steroid with an advantageous profile * https://www.formosapharma.com/technology/ Clobetasol Propionate Ophthalmic Suspension 0.05%, B
Slide 29: Clobetasol Utilizes APNT Technology
29 Clobetasol Utilizes APNT* Technology * https://www.formosapharma.com/technology/ Clobetasol Propionate Suspension 0.05%, BID Active ingredient is milled down with salts and sugars to nanoparticle size A ctive P harmaceutical N anoparticle T echnology: Increases dissolution • Stable and excellent
Slide 30: Rapid and Sustained Ocular Pain Relief and Clearance of Inflammation
30 77.3% 82.3% 90.6% 43.7% 42.6% 42.1% 0% 20% 40% 60% 80% 100% POD4 POD8 POD15 Rapid and Sustained Ocular Pain Relief and Clearance of Inflammation Percent of Patients with Complete Resolution of Pain at Post - Operative Days 4, 8, and 15 85.4% 87.0% 86.5% 51.4% 46.5% 49.7% 0% 20% 40% 60% 80% 100% P
Slide 31: Ratio of Patients Pain-Free at Day 15 Post-Op
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 1.5% Dexamethasone 0.05% Clobetasol 0.1% Dexamethasone + DuraSite 0.1 % Inveltys 0.5% Lotemax 0.05% Durezol % of Patients Pain Free Day 15 A Larger Separation Between Active and Placebo Groups May Not Be Indicative of Relative Efficacy 31 Ratio of Patients
Slide 32: Ratio of Patients with No Inflammation Day 15 Post-Op
0% 10% 20% 30% 40% 50% 60% 70% 1.5% Dexamethasone 0.05% Clobetasol1 0.1% Dexamethasone + DuraSite2 0.1 % Inveltys3 0.5% Lotemax4 0.05% Durezol5 % of Patients Pain Free Day 15 A Larger Separation Between Active and Placebo Groups May Not Be Indicative of Relative Efficacy 32 Ratio of Patients with No
Slide 33: Low Rate of Adverse Reactions with Clobetasol
33 1. https://clobetasolbid.wpenginepowered.com/wp - content/uploads/2024/03/Clobetasol - Prescribing - Information.pdf Low Rate of Adverse Reactions with Clobetasol All of Which Occurred in 2% or Fewer Patients 1 Many of these reactions may have been consequences of the surgical procedure • E ye I
Slide 34: NovaBay Co-Promotion
● NovaBay and Eyenovia are co - promoting Avenova and Clobetasol ● NovaBay salesforce will support Clobetasol sales in geographies not covered by Eyenovia’s salesforce ● Eyenovia will promote Avenova with their salesforce ● No additional promotional cost, with each company earning a percentage of in
Slide 35: MydCombi Ophthalmic Spray
MydCombi Ρ Ophthalmic Spray (1% tropicamide and 2.5% phenylephrine) FDA - APPROVED For short - term in - office or pre - surgical pupil dilation 35 This presentation is not an advertisement for MYDCOMBI.
Slide 36: Safety Information
Safety Information IMPORTANT SAFETY INFORMATION: MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% is indicated to induce mydriasis for routine diagnostic procedures and in conditions where short term pupil dilation is desired. CONTRAINDICATIONS: Known hypersensitivity
Slide 37: MydCombi: Modern Mydriasis
37 MydCombi Ρ Modern Mydriasis: An Easy Way to Dilate 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. C
Slide 38: MydCombi: First FDA-Approved Product with Optejet Technology
38 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 39: Office-Based and Surgical Pupil Dilation Market
39 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 40: First and Only FDA-Approved Ophthalmic Spray for Mydriasis
40 First and only FDA - approved ophthalmic spray for mydriasis • Two Phase 3 clinical trials evaluated the efficacy of MYDCOMBI for achievement of mydriasis. • Pupil dilation achieved by MYDCOMBI was statistically superior to tropicamide administered alone and phenylephrine administered alone. • Ne
Slide 41: Financial Snapshot (March 2024)
41 Financial Snapshot (March 2024) Nasdaq: EYEN Common Shares Outstanding 47.4M Equity Grants Outstanding Under Stock Plans 6.3M Convertible Notes 2.3M Warrants 10.9M Fully Diluted Shares 66.9M Cash $8.0M Debt $15.6M
Slide 42: Experienced Leadership Team
42 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