Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Investor Presentation (August 2022)
28 slides from Hyperion Defi's investor presentation, Aug 10, 2022
Slide 1: Making it Possible | August 2022
Making it Possible | August 2022
Slide 2: Forward-looking statements
eyenovia.com 1 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, strategies, pre
Slide 3: Eyenovia at a Glance
2 Eyenovia at a Glance Our Optejet® Microdose Array Print (MAP™) technology is designed to improve the lives of patients and enhance the practice of optometry and ophthalmic medicine. Our commercial model is designed to maximize the value of our assets while maintaining an efficient cost structure f
Slide 4: Investment Highlights: Late-Stage Therapeutics Pipeline
eyenovia.com LATE-STAGE THERAPEUTICS PIPELINE MydCombi™ for mydriasis / pupil dilation: - Planned NDA submission 4Q 2022 MicroPine for pediatric progressive myopia: - Phase 3 CHAPERONE IND transferred to Bausch+Lomb MicroLine for presbyopia / improved near vision: - Phase 3 VISION-1 study successful
Slide 5: Late-Stage Ophthalmic Pipeline for US Registration
eyenovia.com Product Candidate Therapeutic Area Phase 3 NDA MydCombi™ 1 (trop+phen) Pharmacologic Mydriasis MicroLine1 (pilocarpine) Presbyopia MicroPine3 (atropine) Progressive Myopia 4 Potential pipeline expansion activities leveraging Optejet® technology are ongoing * Estimate only |. 1 Out-licen
Slide 6: Eyenovia Leadership Team
eyenovia.com 5 Eyenovia Leadership Team Malini Batheja VP, Pharmaceutical R&D Norbert Lowe VP, Commercial Beth Scott VP, Regulatory and Medical Affairs Bren Kern SVP, Operations John Gandolfo CFO Greg Bennett VP Clinical Operations CRR Michael Rowe CEO
Slide 7: Standard Eyedroppers Have Limited Therapeutic Approaches
eyenovia.com Potential overexposure to drug and preservatives • Conventional droppers can overdose the eye by as much as 300%+1 • Known to cause ocular and systemic side effects1 Protruding tip may create cross-contamination risk • More than 50% of administrations unintentionally touch ocular surfac
Slide 8: Optejet: Precise, Physiological Dosing
eyenovia.com 7 Precise, Physiological Dosing Directly coats the cornea, reducing overexposure to drug as well as preservative toxicity.1 Designed to eliminate drug overflow for a more comfortable patient experience. Efficacy Demonstrated statistical and clinical benefit in IOP reduction, pharmacolog
Slide 9: Optejet Maintains Ocular Surface Integrity
eyenovia.com 8 Optejet® | Maintains Ocular Surface Integrity Minimizing Ocular Stress 1Tufts University Study 2022, Data on File 2Study completed 2022, Data on File Minimizes Impact of Preservatives on Ocular Tissues Results of a human conjunctival cell line assay study with Tufts Medical Center ind
Slide 10: Optejet Impressive Treatment Compliance
eyenovia.com 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0 5 10 15 20 25 Six-Month Daily Treatment Compliance 28 Children Age 6 – 13 YO1 9 Optejet® | Impressive Treatment Compliance 1 Data on file with Eyenovia. 2Naito, 2018; Patel, 1995; Winfield, 1990 3Matsui, 1997 Meaningful Improvement in Real W
Slide 11: Optejet Platform: Potential High-Value Opportunities
10 Optejet® Platform | Potential High-Value Opportunities Estimated Gross Margins Based on $100/Month Price1 Next-Generation Ophthalmic Therapeutics • Eyenovia's microdose therapeutics are regulated as drug-device combination products, with primary mode of action being the drug. Primary oversight is
Slide 12: Presbyopia: Significant Unmet Need
eyenovia.com 11 Presbyopia | There Exists a Significant Unmet Need 1 Estimate from DelveInsight Presbyopia report; December 2020 18 million people 40-55 years of age who never previously needed glasses suffer from presbyopia in the US alone • Presbyopia is the age-related loss of near vision that oc
Slide 13: MicroLine Product Profile
eyenovia.com 12 MicroLine Product Profile Effective at restoring functional vision, such as the ability to read a menu or cell phone Ability to use “as needed” without chronic dosing Rapid onset of action Easy to administer Comfortable instillation with low incidence of brow or headache to drive pat
Slide 14: VISION-1 Study Design
eyenovia.com 13 VISION-1 Study Design • Phase 3, double-masked, placebo-controlled, cross-over superiority trial – Microdosed pilocarpine 1%, 2% and placebo ophthalmic sprays • Primary endpoint: mesopic high-contrast binocular DCNVA gain at 120 minutes post-treatment – Analyzed separately for 2 coho
Slide 15: Key Safety Outcomes; VISION-1 Met Primary Endpoint
eyenovia.com Key Safety Outcomes All AEs were Transient in Nature 1 Resolved by 3 hours post-dose 2 Cohort of subjects with baseline DCNVA < 0.6 logMAR MicroLine Placebo Moderate Hyperemia1 2% 0% Instillation Discomfort 2% 0% Brow ache 2% 0% 0 50 100 Upon Instillation 30 minutes post dose Patient Co
Slide 16: Post-Study Surveys Indicate Strong Preference for MicroLine
15 Post-Study Surveys Indicates Strong Preference for MicroLine MARKET RESEARCH 2 - December 2020 In a separate study among 100 presbyopic patients and 100 optometrists ✓ Most likely users were between 40 and 55 years old in the top half of household incomes ✓ A price of approximately $100 for 80 do
Slide 17: VISION-2 Study Design
eyenovia.com 16 VISION-2 Study Design VISION 2 Screening: Age 40 – 55 With Presbyopia Patients Randomized (N=~139) MicroLine Dose 1 (2% pilocarpine) Placebo Topline data anticipated 2H 2022 ➢ Phase 3 double-masked, placebo-controlled, cross-over superiority trial ➢ microdosed pilocarpine 2% and plac
Slide 18: Progressive Myopia Disease Background
eyenovia.com 17 • Back-of-the-eye disease • Mostly begins in early childhood, with a genetic link to myopic parents1 • Pathologic elongation of sclera/retina which can lead to significant morbidity and visual sequelae2 • Retinal detachment • Myopic retinopathy • Vision loss • Quality of life • Curre
Slide 19: MicroPine Product Profile
eyenovia.com 18 MicroPine Product Profile Clinically meaningful and significant effectiveness at preventing myopia progression versus placebo Ability for children to reliably use, once daily per eye Comfortable to instill, minimal impact on the ocular surface Minimal local side effects and systemic
Slide 20: Chaperone Study Design
eyenovia.com 19 Chaperone Study Design CHAPERONE Screening: Age 3-12 With Pediatric Myopia Patients Randomized (N=~420) MicroPine Dose 1 (0.1% atropine) Placebo MicroPine Dose 1 (0.01% atropine) 36mo 12mo *Strategic partnership with Bausch Health for the development and commercialization of MicroPin
Slide 21: Diagnostic Mydriasis
eyenovia.com 20 Diagnostic Mydriasis 1 $200M annual sales of pharmaceutical mydriatic products used during 100M office-based exams ($2 * 100M) + $50M of single bottle mydriatic agents used cataract replacement surgery ($12.5 x 4M) Diagnostic mydriasis (pupil dilation) is part of the comprehensive ey
Slide 22: MydCombi among first drug-device combinations for pupil dilation
eyenovia.com 21 MydCombi™ among the first drug-device combination products for pupil dilation If approved, the only fixed drug combination of the two leading mydriatic medications in the US Device administered with the push of a button, saving up to ten minutes of technician time1 Touch-free, comfor
Slide 23: MydCombi Superior Mydriatic Effect vs. Single Agents
eyenovia.com 22 MydCombi has a Superior Mydriatic Effect vs. Single Agents Presented by S. Rathi et al, American Academy of Optometry Annual Meeting, 2020 p=0.0183 Prompt Mydriasis Mydriasis >5mm achieved in 88% of patients at 20 minutes, without the delay of instilling multiple drops Superior Effic
Slide 24: Arctic Vision Strategic Partnership
eyenovia.com Validating partnership for the development and commercialization of MydCombi™, MicroPine and MicroLine 23 Strategic Partnerships to Potentially Extend Commercial Reach Upfront payment: $4M Potential milestone payments and reimbursed development costs: $41.75M Commercial supply terms or
Slide 25: Bausch Health Strategic Partnership for MicroPine
eyenovia.com Strategic partnership for the development and commercialization of MicroPine 24 Strategic Partnerships to Potentially Extend Commercial Reach Upfront payment: $10M Potential milestone payments and reimbursed development costs: $50M Reimbursed development costs associated with Phase 3 CH
Slide 26: Intellectual Property
eyenovia.com 25 Intellectual Property Technology that has Multiple Layers of IP, Clinical and Regulatory Protection 15 U.S. Patents Issued; 12 Pending 87 O.U.S. Patents Issued; 36 Pending Volume delivered, method of delivery, speed of delivery, data capture Various patents in effect until late 2031
Slide 27: Financial Snapshot
eyenovia.com 26 Nasdaq: EYEN Common Shares Outstanding 33.6M Equity Grants Outstanding Under Stock Plans 5.0M Warrants 6.1M Fully Diluted Shares 44.7M Cash $29.4M Debt $12.0M All figures as of June 30 2022 Financial Snapshot
Slide 28: Board of Directors
eyenovia.com Board of Directors 27 General partner of Hatteras Venture Partners Kenneth Lee Jr. Lead Director Managing Director, Equity Capital Markets at Suntrust Robinson Humphrey Charles Mather IV Independent Director Ophthalmologist-in-Chief Wills Eye Hospital Julia Haller, MD Independent Direct