Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Investor Presentation (August 2024)
38 slides from Hyperion Defi's investor presentation, Aug 23, 2024
Slide 1: Our Vision is to Improve Yours
August 2024 Our Vision is to Improve Yours With topical ophthalmic therapies that are easier to use and easier to live with 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 forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, str
Slide 3: Eyenovia: Our Vision is to Improve Yours
3 Eyenovia: Our Vision is to Improve Yours Designed for ease of use, enhanced tolerability, and compliance through digital technology Optejet® : Topical Eye Medication Platform Technology • Mydcombi for pupil dilation • Clobetasol for post-surgical inflammation and pain FDA-Approved Products • Cyclo
Slide 4: Recent and Near-Term Anticipated Corporate Highlights
4 Recent and Near-Term Anticipated Corporate Highlights 3Q 2024 MydCombi Launch 4Q 2024 Optejet Gen-2 Clinical Plan to FDA 30-day review prior to starting bridging study in early 2025 Clobetasol Launch to 500 Offices Advanced topical steroid with desirable efficacy, safety and dosing profile Expecte
Slide 5: MicroPine Is Our Premier Near-Term Opportunity in Pediatric Progressive Myopia
Recognized 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 Major Clinical Milestone expected 4Q 2024 In-House Manufacturing CMO manufactures drug products Device and Sterile Fill and Finish by Eyenovia S
Slide 6: Progressive Myopia is a Global Epidemic That Can Lead to Vision Loss
6 • Begins in early childhood, with genetic link or environmental factors1 • Elongation of the eye with morbidity and vision problems2 • Currently no FDA-approved drug therapies to slow myopia progression 1 Jones LA, Sinnott LT, Mutti DO, Mitchell GL, Moeschberger ML, Zadnik K. Parental history of m
Slide 7: Children at High Risk for Vision Loss Without Effective Intervention
7 Approximately 5 Million 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 1.25 1.5 1.75
Slide 8: Lenses are Today the Only FDA-Approved Treatment
8 Lenses are Today the Only FDA-Approved Treatment 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 is
Slide 9: Atropine eyedrops have been observed to slow myopia progression in children
9 Atropine eyedrops have been observed to slow myopia progression in children1 1. Chia A, Chua WH, Cheung YB, et al. Atropine for the treatment of childhood Myopia: Safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology 2012;119:347-354 ATOM-1 Resu
Slide 10: Eye Doctors are using Compounded Atropine Off-label to Treat Myopia Patients
Eye Doctors are using Compounded Atropine Off-label 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 Hygiene Changes Single Vi
Slide 11: MicroPine Target Product Profile
11 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 ocular surface • Very low systemic exposure, an important consid
Slide 12: CHAPERONE: The Single Phase Trial Required for FDA Approval
12 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 self-administered with the Optejet as one spray in e
Slide 13: Treatment Compliance via the Optecare System is What Makes MicroPine Special
● Only MicroPine comes with built-in Optecare 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 succe
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 2025 2026 2027 File NDA If positive and statistically significant, meet with FDA and continue with one-year additional safety study Output from Analysis of ~240 Patients Potential Approval
Slide 16: Introducing the Optejet
16 • Designed to address issues with ease-of-use and dosing precision • Delivers efficacy while improving tolerability and reducing side effects1 • Digital Optecare capabilities2 Optejet® with microdose array print technology • Patented digital device platform technology • Unique, class-leading drug
Slide 17: The Optejet Consists of a Replaceable Cartridge and Durable Base
17 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 “print
Slide 18: The Optejet Delivers 80% Less Drug Volume Than Eye Droppers
18 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 19: Optejet Digital Technology is Optecare
19 Optejet Digital Technology is Optecare 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 app
Slide 20: Broad Intellectual Property Portfolio
20 Broad Intellectual Property Portfolio • Key claims covered with multiple patents – 18 US Patents Issued; 8 pending – 89 foreign issued; 33 pending – Many in effect to 2041 • Clinical data and regulatory approval adds another layer of IP
Slide 21: Multiple Collaborations and Licensing Opportunities In Large Markets
21 Multiple Collaborations and 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.trans
Slide 22: Three Product Candidates Addressing Distinct Market Segments in Dry Eye
22 Three Product Candidates Addressing Distinct Market Segments in Dry Eye with the Optejet EYEN-510 MNP Cyclosporine EYEN-520 Fonadelpar EYEN-530 Clobetasol Foundational Therapy Adjunctive Therapy Flare-Ups Faster-acting Immunomodulator inhibiting the production of cytokines involved in the regulat
Slide 23: Clobetasol Propionate Ophthalmic Suspension 0.05% FDA-Approved
23 Clobetasol Propionate Ophthalmic Suspension 0.05% FDA-APPROVED For the treatment of post-operative inflammation and pain following ocular surgery This presentation is not an advertisement for clobetasol propionate.
Slide 24: 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 herpes
Slide 25: Expected to Provide Near-Term Revenue to Fund Optejet Projects
Expected to Provide Near-Term Revenue to Fund Optejet Projects 25 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%, BID S
Slide 26: Clobetasol Utilizes APNT Technology
26 Clobetasol Utilizes APNT* Technology * https://www.formosapharma.com/technology/ Clobetasol Propionate Ophthalmic Suspension 0.05%, BID Active ingredient is milled down with salts and sugars to nanoparticle size Active Pharmaceutical Nanoparticle Technology: Increases dissolution • Increases bioa
Slide 27: Rapid and Sustained Ocular Pain Relief and Clearance of Inflammation
27 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 81.4% 84.7% 88.5% 47.4% 44.5% 45.8% 0% 20% 40% 60% 80% 100% POD4 POD8 POD15 Percent of Patients with Anterior Chamber Cell Count = 0 at Pos
Slide 28: 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 28 Ratio of Patients
Slide 29: 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 29 Ratio of Patients with No Inflammation Day 15 Post Op (ACC Grade = 0) Summary of Published Studies QD QID 3.5x 3.0x 1.9x 1
Slide 30: Low Rate of Adverse Reactions with Clobetasol
1. https://clobetasolbid.wpenginepowered.com/wp-content/uploads/2024/03/Clobetasol-Prescribing-Information.pdf 30 Low Rate of Adverse Reactions with Clobetasol All of Which Occurred in 2% or Fewer Patients1 Many of these reactions may have been consequences of the surgical procedure Eye Inflammation
Slide 31: Clobetasol Commercial Strategy
Sales force is identifying 500 offices who are ready to prescribe and/or stock clobetasol 31 Clobetasol Commercial Strategy ACTIVATING CUSTOMERS Q3 2024 MINIMIZING BARRIERS TO Rx Pricing similar to current patient out-of-pocket costs No insurance necessary Controlled distribution via e-pharmacy fami
Slide 32: MydCombi Ophthalmic Spray FDA-Approved
32 MydCombi Ophthalmic Spray (1% tropicamide and 2.5% phenylephrine) FDA-APPROVED For short-term in-office or pre-surgical pupil dilation This presentation is not an advertisement for MYDCOMBI.
Slide 33: 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 34: A Milestone for Eyenovia with the First FDA-Approval of Optejet Technology
34 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 (1% tropica
Slide 35: Fast, Effective Pupil Dilation Without the Sting or Mess
35 • Up to eight times less drug used compared with two eye drops • In two Phase 3 studies, pupil dilation achieved by MYDCOMBI was statistically superior to tropicamide or phenylephrine administered alone • Nearly all (94%) subject eyes achieved clinically significant effect compared to 78% of eyes
Slide 36: MydCombi Office Outreach
Target MydCombi offices have been selected based on interest in Optejet technology Offices are introduced to MydCombi and Optejet technology by Key Account Manager Key Account Managers ensure seamless implementation from drop bottles to MydCombi Expanded sales team aiming to introduce MydCombi to 20
Slide 37: Optejet Topical Eye Medication Platform Technology
37 NASDAQ: EYEN Optejet® Topical Eye Medication Platform Technology Major Upcoming Milestone in Pediatric Myopia, a market worth $3B in the US and CHINA Two FDA-approved Products that are being launched by 10-person salesforce Late-Stage Candidates in Dry Eye and Glaucoma, both are multi-billion dol
Slide 38: Financial Snapshot - June 2024
38 Financial Snapshot - June 2024 Nasdaq: EYEN Common Shares Outstanding 55.8M Equity Grants Outstanding Under Stock Plans 7.0M Convertible Notes 2.3M Warrants 10.9M Fully Diluted Shares 76.0M Cash $2.3M Debt (up to $5.0M may be paid through the convertible notes) $14.8M