Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Investor Presentation (January 2023)
27 slides from Hyperion Defi's investor presentation, Jan 30, 2023
Slide 1: Making it Possible | February 2023
Making it Possible | February 2023
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,
Slide 3: Eyenovia at a Glance
2 Eyenovia at a Glance Our Optejet ® Microdose Array Print (MAP Œ ) 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 structur
Slide 4: Investment Highlights: Late-Stage Therapeutics Pipeline
eyenovia.com LATE - STAGE THERAPEUTICS PIPELINE MydCombi Πfor mydriasis / pupil dilation: - Potential FDA approval date May 8, 2023 MicroPine for pediatric progressive myopia: - Phase 3 CHAPERONE IND transferred to Bausch+Lomb MicroLine for presbyopia / improved near vision: - Pre - NDA meeting Mar
Slide 5: Late-Stage Ophthalmic Pipeline for US Registration
eyenovia.com Product Candidate Therapeutic Area Phase 3 NDA MydComb i Œ 1 ( trop+phen ) Pharmacologic Mydriasis MicroLine 1 (pilocarpine) Presbyopia MicroPine 3 (atropine) Progressive Myopia 4 Potential pipeline expansion activities leveraging Optejet ® technology are ongoing * Estimate only |. 1 Ou
Slide 6: Eyenovia Leadership Team
eyenovia.com 5 Eyenovia Leadership Team Malini Batheja VP, Pharmaceutical R&D and CMC Regulatory Norbert Lowe VP, Commercial John Gandolfo Chief Financial Officer Bren Kern Chief Operating Officer Greg Bennett VP Clinical Operations and Medical Affairs CRR Michael Rowe Chief Executive Officer Lauren
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 effects 1 Protruding tip may create cross - contamination risk • More than 50% of administrations unintentionally touch ocular su
Slide 8: Optejet Microdose Array Print Technology Designed for Optimal Drug Delivery
eyenovia.com 7 1 Study with TUFTS University 2022, Data on File 2 Pasquale L. et al., Clinical Ophthalmology 2018 3 Wirta D. et al, Presentation at 2019 ASCRS meeting. 4 Ianchulev T. et al, Therapeutic Delivery 2018. 5 Presented at Eyecelerator , July 2021 Optejet ® - Microdose Array Print (MAP Œ )
Slide 9: Optejet Maintains Ocular Surface Integrity
eyenovia.com 8 Optejet ® | Maintains Ocular Surface Integrity Minimizing Ocular Stress 1 Tufts University Study 2022, Data on File 2 Study 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
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 YO 1 9 Optejet ® | Impressive Treatment Compliance 1 Data on file with Eyenovia. 2 Naito, 2018; Patel, 1995; Winfield, 1990 3 Matsui, 1997 Meaningful Improvement in
Slide 11: Optejet Platform: Potential High-Value Opportunities
10 Optejet ® Platform | Potential High - Value Opportunities Estimated Gross Margins Based on $100/Month Price 1 Next - Generation Ophthalmic Therapeutics • Eyenovia's microdose therapeutics are regulated as drug - device combination products, with primary mode of action being the drug. Primary over
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 tha
Slide 13: MicroLine Product Profile
eyenovia.com 12 MicroLine Product Profile Effective at temporarily 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
Slide 14: VISION-1 and VISION-2 Study Design
eyenovia.com 13 VISION 1 and VISION 2 Study Design Phase 3 double - masked, placebo - controlled, cross - over superiority trial Microdosed pilocarpine and placebo ophthalmic sprays Study Design was chosen for efficiency to ‘Dose on Demand’ DCNVA: Distance Corrected Near Visual Acuity DVA: Distance
Slide 15: Key Safety Outcomes
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 Hyperemia 1 0.9% 0% Instillation Discomfort 1.7% 0% Brow ache 2.2% 0% 0 50 100 Upon Instillation 30 minutes post dose P
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 x Most likely users were between 40 and 55 years old in the top half of household incomes x A price of approximately $100 for 80
Slide 17: Pediatric Progressive Myopia
eyenovia.com 16 • Back - of - the - eye disease • Mostly begins in early childhood, with a genetic link to myopic parents 1 • Pathologic elongation of sclera/retina which can lead to significant morbidity and visual sequelae 2 • Retinal detachment • Myopic retinopathy • Vision loss • Quality of life
Slide 18: MicroPine Product Profile
eyenovia.com 17 MicroPine Product Profile Clinically meaningful and significant efficacy 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 absor
Slide 19: CHAPERONE Study Design
eyenovia.com 18 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 MicroP
Slide 20: Diagnostic Mydriasis
eyenovia.com 19 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
Slide 21: MydCombi: Drug-Device Combination for Pupil Dilation
eyenovia.com 20 MydCombi Πamong 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 time 1 Touch - free,
Slide 22: MydCombi Superior Mydriatic Effect vs. Single Agents
eyenovia.com 21 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 23: Strategic Partnership with Arctic Vision
eyenovia.com Validating partnership for the development and commercialization of MydCombi Π, MicroPine and MicroLine 22 Strategic Partnerships to Potentially Extend Commercial Reach Upfront payment: $4M Potential milestone payments and reimbursed development costs: $41.75M Commercial supply terms o
Slide 24: Strategic Partnership with Bausch+Lomb for MicroPine
eyenovia.com Strategic partnership for the development and commercialization of MicroPine 23 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 25: Intellectual Property
eyenovia.com 24 Intellectual Property Technology that has Multiple Layers of IP, Clinical and Regulatory Protection 18 U.S. Patents Issued; 8 Pending 89 O.U.S. Patents Issued; 33 Pending Volume delivered, method of delivery, speed of delivery, data capture Various patents in effect until late 2031 P
Slide 26: Financial Snapshot
eyenovia.com 25 Nasdaq: EYEN Common Shares Outstanding 35.5M Equity Grants Outstanding Under Stock Plans Includes Options and RSUs 5.7M Warrants 6.1M Fully Diluted Shares 47.3M Cash $25.3M 1 Debt $11.1M 1. $7.9M of the cash balance is restricted. All figures as of September 30 2022. Financial Snapsh
Slide 27: Board of Directors
eyenovia.com Board of Directors 26 Managing Director, Equity Capital Markets at STRH Charles Mather IV Independent Director President, The Drone Racing League Rachel Jacobson Independent Director Former President, The US Conference of Mayors Stephen Benjamin, JD Independent Director Co - Founder of