Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Investor Presentation (March 2024)
35 slides from Hyperion Defi's investor presentation, Mar 19, 2024
Slide 1: We Are the Optejet Company
March 2024 We Are the Optejet® Company Developing and commercializing ophthalmic therapeutics with Optecare 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 forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, str
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 effects1 • Digital Optecare capabilities2 Optejet® with microdose array print technology • Patented digital device platform technology • Unique, class-leading drug
Slide 4: Today's Eyedropper Bottle
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-filled, re
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 Opteje
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 1x106 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 nega
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. et
Slide 9: Optejet Digital Technology is Optecare
9 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 10: Broad Intellectual Property Portfolio
10 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 2031 • Clinical data and regulatory approval adds another layer of IP
Slide 11: MydCombi: 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 The First F
Slide 12: The Office-Based and Surgical Pupil Dilation Market
12 The Office-Based and Surgical Pupil Dilation Market $250 Million Opportunity1 in the United States 1. $200M annual sales of pharmaceutical mydriatic products used during 108M office-based exams ($2 * 100M) + $50M of single bottle mydriatic agents used cataract replacement surgery ($12.5 x 4M) ● T
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 Modern Mydriasis: An Easy Way to Dilate
14 MydCombi 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 routine diagnostic procedures and in conditions where short term pupil dilation is desired. IMPORTANT SAFETY INFORMATION. CONTR
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 saves
Slide 16: Clobetasol Propionate Ophthalmic Suspension 0.05%
16 Clobetasol Propionate Ophthalmic Suspension 0.05% Eyenovia’s Second FDA-Approved Product An Important Advancement in Ocular Post-Surgical Pain and Inflammation Control • Short and mid-term revenue opportunity ($1.3B market) • Synergistic commercialization with MydCombi’s sales force 2024 Post-ocu
Slide 17: Ophthalmology's Newest Steroid: Clobetasol
Available 2H 2024 17 Ophthalmology’s Newest Steroid: Clobetasol 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 Strong efficacy in pain relief and inflammation r
Slide 18: Clobetasol Utilizes APNT Technology
18 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 Active Pharmaceutical Nanoparticle Technology: Increases dissolution • Stable and excellent dispe
Slide 19: Rapid and Sustained Ocular Pain Relief and Clearance of Inflammation
19 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% POD
Slide 20: Ratio of Patients Pain Free at Day 15 Post-Op
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 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 Active Vehicle 20 Ratio of Patient
Slide 21: Ratio of Patients with No Inflammation Day 15 Post Op
0% 10% 20% 30% 40% 50% 60% 70% 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 Active Vehicle 21 Ratio of Patients with No Inf
Slide 22: Very Low Rate of Adverse Reactions
https://clobetasolbid.wpenginepowered.com/wp-content/uploads/2024/03/Clobetasol-Prescribing-Information.pdf 22 Very Low Rate of Adverse Reactions All of Which Occurred in 2% or Fewer Patients Many of these reactions may have been the consequence of the surgical procedure • Eye Inflammation (2%) • Co
Slide 23: Distributed and Priced for Immediate, Broad Access
23 ✓ Two Avenues of Distribution ✓ Direct Ordering from EyenoviaRx.com ✓ E-Prescribing from MedVantx Specialty Pharmacy ✓ Competitive Pricing Regardless of Insurance Status ✓ Non-Substitutable ✓ No Call-Backs to Physicians (Cost Savings to Practice) Distributed and Priced for Immediate, Broad Access
Slide 24: Clobetasol: The New Generation of Ophthalmic Steroid
24 Clobetasol: The New Generation of Ophthalmic Steroid • Powerful Efficacy for Pain and Inflammation Relief Post-Ocular Surgery • Simple BID Dosing Regimen • Adverse Events Infrequent • Competitive Pricing - Regardless of Insurance
Slide 25: Late-Stage Development Pipeline
25 Late-Stage Development Pipeline 1. Zafar, S. et al. (2020) ‘Prescribing patterns and costs associated with postoperative eye drop use in Medicare beneficiaries undergoing cataract surgery’, Ophthalmology, 127(5), pp. 573–581. doi:10.1016/j.ophtha.2019.11.005 2. Richard Edlow, O. (2020) The Myopia
Slide 26: Progressive Myopia is a Global Epidemic
26 • Begins in early childhood, with genetic link1 • Elongation of the eye with morbidity and vision problems2 • 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 risk3 1 Jones LA, Sinnott LT, Mutti D
Slide 27: Treatment Options and Medical Need
27 Treatment Options and Medical Need Drugs in Clinical Trials ● Atropine eyedrops have been observed to slow myopia progression in children3 ● Multiple companies (Sydnexis and Ocumension) are in clinical trials using atropine drops ranging in concentrations from 0.01% to 0.03%. These trials are exp
Slide 28: Pediatric Progressive Myopia: A Potential Market Valued at $1.8B
28 Pediatric Progressive Myopia A Potential Market Valued at $1.8B in the US and Similarly in China Currently under investigation, not FDA approved
Slide 29: Optecare Designed to Improve Treatment Adherence
29 Optecare Designed to Improve Treatment Adherence • 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
Slide 30: MicroPine Planned Development Timeline
30 MicroPine Planned Development Timeline 4Q 2024 2025 2026 2027 2028 If 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 f
Slide 31: 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 incr
Slide 32: Eyenovia: 2024 Key Events
32 Eyenovia: 2024 Key Events Q1 National MydCombi Launch Clobetasol APPROVED Q2 Q3 Q4 MydCombi Post-Marketing Study Results MydCombi Gen-2 Planned FDA Meeting National Clobetasol Launch MicroPine Planned Interim Analysis NovaBay Co-Promote (Avenova®)
Slide 33: Additional Large-Market Opportunities
33 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 $6.1B (Dry Eye Disease Market (Jan 2024) Transparency Market Research. Available at: https://www.transparencymarketresearch.com/sampl
Slide 34: Financial Snapshot (December 2023)
34 Financial Snapshot (December 2023) Nasdaq: EYEN Common Shares Outstanding 45.6M Equity Grants Outstanding Under Stock Plans 5.5M Warrants 10.9M Fully Diluted Shares 62.0M Cash $14.8M Debt $15.6M
Slide 35: Experienced Leadership Team
35 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 Br