Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Investor Presentation (December 2021)
34 slides from Hyperion Defi's investor presentation, Dec 6, 2021
Slide 1: Making it Possible | December 2021
Making it Possible | December 2021
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
eyenovia.com 2 Eyenovia at a Glance We have designed our microdose array print (MAP Œ ) technology to improve the lives of patients with ophthalmic diseases and disorders • Advanced options for diseases and disorders with no or few existing therapies • Therapies that reduce patient burden due to tol
Slide 4: Late-Stage Therapeutics Pipeline
eyenovia.com LATE - STAGE THERAPEUTICS PIPELINE Mydcombi Πfor mydriasis / pupil dilation: - Under FDA review MicroPine for pediatric progressive myopia: - Phase 3 CHAPERONE study full enrollment expected 2022 MicroLine for presbyopia / improved near vision: - Phase 3 VISION - 1 study successfully c
Slide 5: Eyenovia Leadership Team
eyenovia.com 4 Eyenovia Leadership Team Sean Ianchulev, MD, MPH CEO, CMO and Co - Founder John Gandolfo CFO Michael Rowe COO Jennifer Clasby CVP Regulatory, Clinical and Quality Malini Batheja VP, Pharmaceutical R&D Norbert Lowe VP Sales & Marketing Beth Scott VP, Medical Affairs
Slide 6: 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 5 Potential pipeline expansion activities leveraging Optejet ® technology are ongoing * Estimate only |. 1 Ou
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 touch ocular surface 2 More dif
Slide 8: Optejet benefits: precise dosing, efficacy, safety, ease of use
eyenovia.com 7 Precise, Physiological Dosing Directly coats the cornea with ~80% less exposure to drug and preservative toxicity (based on 8µL dose). 1 Designed to eliminate drug overflow for a more comfortable patient experience. Efficacy Demonstrated statistical and clinical benefit in IOP reducti
Slide 9: Optejet | Significant Clinical Experience and Validation
eyenovia.com 8 Optejet ® | Significant Clinical Experience and Validation Seven Phase 2 or Phase 3 clinical trials to date featured in dozens of publications and major meetings including ASCRS, AAO, AAOpt , OIS and EYEcelerator .
Slide 10: Optejet | Reduced Systemic Levels
eyenovia.com 9 Optejet ® | Clinical Experience and Validation 0 50 100 150 200 250 300 350 PE 2.5% PE 10% PE 10% μ D Plasma PE ( pg /ml) 101.6 316.3 201.5 p = 0.003 p = 0.021 Drugs in traditional eyedroppers can enter systemic blood circulation and may cause significant side effects . 1 Microdose de
Slide 11: Optejet | Demonstrated Benefits in Multiple Phase 3 Studies
eyenovia.com 10 Microdosing a fixed combination of tropicamide - phenylephrine had a superior mydriatic effect compared to either component formulation 1 MICRODOSE EFFICACY 1. Wirta DL, Walters TR, Flynn WJ, Rathi S, Ianchulev T. Mydriasis with micro - array print touch - free tropicamide+phylephrin
Slide 12: 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 11 Optejet ® | Impressive Treatment Compliance 1 Data on file with Eyenovia. 2 Naito, 2018; Patel, 1995; Winfield, 1990 3 Matsui, 1997 Real Improvement in Real
Slide 13: Optejet Platform | Potential High-Value Opportunities
eyenovia.com 12 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.
Slide 14: What is Presbyopia?
eyenovia.com 13 What is Presbyopia? Etiology • The progressive loss of ability to focus on nearby objects • Non - preventable, age - related hardening of the lens Sources: Mayo Clinic Presbyopia Overview. Wollfsohn et al. Prog Retin Eye Res. Fernandez et al. J Ophthalm . Accessed December 2018 Sympt
Slide 15: Presbyopia | There Exists a Significant Unmet Need
eyenovia.com 14 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 • Majority of presbyopia patients have never had to wear
Slide 16: Why Pilocarpine?
eyenovia.com 15 Why Pilocarpine? A well - known and established drug Pilocarpine has been demonstrated to constrict the pupil of the eye and create a “pinhole” effect that increases the depth of field . Onset 10 - 30 minutes, with duration of action 4 - 8 hours ‒ The most frequently reported adverse
Slide 17: MicroLine Product Profile
eyenovia.com 16 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 18: VISION-1 Study Design
eyenovia.com 17 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 separatel
Slide 19: 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 2% 0% Instillation Discomfort 2% 0% Brow ache 2% 0% 0 50 100 Upon Instillation 30 minutes post dose Patient
Slide 20: Post-Study Survey Indicates Strong Preference for MicroLine
eyenovia.com 19 Post - Study Survey Indicates Strong Preference for MicroLine 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 $30 - $35 a month is not an
Slide 21: VISION-2 Study Design
eyenovia.com 20 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 1H 2022 » Phase 3 double - masked, placebo - controlled, cross - over superiority trial » microdosed pilocarpine 2%
Slide 22: Pediatric progressive myopia
eyenovia.com 21 • 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 23: Standard of Care for myopia
eyenovia.com Current treatment options for myopia include: – Eyeglasses – Contact Lenses – Orthokeratology – Atropine Atropine 0.01% must be compounded by a specialty pharmacy and is not approved by the FDA for myopia control. It is not covered by insurance and can cost $100 per bottle for a 3 - mon
Slide 24: Chaperone Study Design
eyenovia.com 23 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 25: MydCombi for Mydriasis
eyenovia.com 24 MydCombi for 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) Pharmacologic mydriasis (pupil dilation) is part of the comprehen
Slide 26: MydCombi among the first drug-device combination products for pupil dilation
eyenovia.com 25 MydCombi Πamong the first drug - device combination products for pupil dilation If approved, the only fixed combination of the two leading mydriatic medications in the US Administered with the push of a button, saving up to ten minutes of technician time 1 Touch - free, comfortable
Slide 27: MydCombi has a Superior Mydriatic Effect vs. Single Agents
eyenovia.com 26 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 28: MydCombi Launch Expenses vs. a Typical Ophthalmic Drug Launch
eyenovia.com 11 FTE for $2.2 million Calling on large group practices in largest population centers for 50% reach at launch Sales Team 100 FTE for $20.0 million Calling on 18,000 doctors across the US for 80% reach at launch Not needed. Product is a diagnostic bought by the practice. Managed Care Gr
Slide 29: Arctic Vision strategic partnership
eyenovia.com Validating partnership for the development and commercialization of MydCombi Π, MicroPine and MicroLine 28 Strategic Partnerships to Potentially Extend Commercial Reach Upfront payment: $4M Potential milestone payments and reimbursed development costs: $41.75M Commercial supply terms o
Slide 30: Bausch Health strategic partnership for MicroPine
eyenovia.com Strategic partnership for the development and commercialization of MicroPine 29 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 31: Available Licensing Opportunities
eyenovia.com 30 Available Licensing Opportunities MydCombi MicroLine MydCombi MicroLine MicroPine Canada United States Central America South America Europe Australia New Zealand Africa Russia Middle East Currently under license for all products TERRITORY AVAILABILITY
Slide 32: Intellectual Property
eyenovia.com 31 Intellectual Property Technology that has Multiple Layers of IP, Clinical and Regulatory Protection 13 U.S. Patents Issued 84 . O.U.S. Patents Issued Volume delivered, method of delivery, speed of delivery, data capture Various patent coverage in effect until late 2031 Provisional pa
Slide 33: Financial Snapshot
eyenovia.com 32 Nasdaq: EYEN Common Shares Outstanding 26.0M Equity Grants Outstanding Under Stock Plans 4.3M Warrants 1.2M Fully Diluted Shares 31.5M Cash $21.4M Debt $7.3M All figures as of September 30, 2021 Financial Snapshot
Slide 34: Board of Directors
eyenovia.com Board of Directors 33 Dr. Fred Eshelman Chairman Founder and former CEO of PPDI, founding chairman of Furiex Pharmaceuticals, and founder of Eshelman Ventures Dr. Ernest Mario Board Member Former Chairman and CEO of Reliant Pharmaceuticals, ALZA, and Glaxo Holdings Dr. Curt LaBelle Boar