Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Investor Presentation (December 2020)
28 slides from Hyperion Defi's investor presentation, Dec 1, 2020
Slide 1: Making it Possible
Making it Possible December 2020
Slide 2: Forward-looking statements
Except for historical information, all of 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, predictio
Slide 3: Investment Highlights
2 Investment Highlights Clinically validated in multiple Phase 2 and Phase 3 studies Late - stage therapeutics pipeline MicroStat ( Mydcombi ™) for mydriasis (pupil dilation) - Phase 3 studies completed, planned NDA submission in 2020 MicroLine for presbyopia (improved near vision) - Phase 3 studies
Slide 4: Leadership Team
3 Leadership Team Dr. Sean Ianchulev , MD, MPH CEO, CMO and Co - Founder • Head of ophthalmology research and directed development and FDA approval of Lucentis, most successful ophthalmic drug for Genentech • Iantech founder for cataract device approved by FDA in 2016 and inventor of Intra - operati
Slide 5: Late-Stage Ophthalmic Pipeline for US Registration
4 Late - Stage Ophthalmic Pipeline for US Registration Product Candidate Therapeutic Area Pre - Clinical/ Formulation Phase 1 Phase 2 Phase 3 NDA MydCombi ™ ( trop+phen ) Pharmacologic Mydriasis MicroLine 1 (pilocarpine) Improvement in near vision in patients with presbyopia MicroPine 2 (atropine) R
Slide 6: Standard Eyedroppers Have Limited Therapeutic Approaches
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 difficult to use
Slide 7: Optejet Microdose Array Print (MAP) Technology Designed for Optimal Drug Delivery
6 Optejet Microdose Array Print (MAP) Technology Designed for Optimal Drug Delivery 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.
Slide 8: Optejet: Significant Clinical Experience and Validation
7 Optejet : Significant Clinical Experience and Validation Five 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 9: Optejet: Clinical Experience and Validation
8 Optejet : Clinical Experience and Validation 0 50 100 150 200 250 300 350 PE 2.5% PE 10% PE - 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 delivery of phenyle
Slide 10: Optejet: Demonstrated Effectiveness in Multiple Phase Studies
9 Optejet : Demonstrated Effectiveness in Multiple Phase 3 Studies Microdosing a fixed combination of tropicamide - phenylephrine had a superior mydriatic effect compared to either component formulation 1 Microdose Efficacy 1 Wirta , D. Presented at ASCRS Annual Meeting, 2019, San Diego CA
Slide 11: Optejet Platform: Potential High-Value Opportunities
10 Optejet Platform: Potential High - Value Opportunities Estimated Gross Margins Based on $100/Month Price >90% Next - Generation Ophthalmic Therapeutics • Eyenovia’s microdose therapeutics follow the 505(b)(2) registration pathway and are not currently regulated as medical devices or drug - device
Slide 12: Potential Topical US Ophthalmic Market For Platform Technology
11 Potential Topical US Ophthalmic Market For Platform Technology* ~$650M ~$1.4B ~$1.6B ~$3.0B Lifestyle Enhancement Glaucoma: ~$3 Billion 3 Prescription Dry Eye: ~$1.6 Billion 2 Anti - Inflammatories: ~$1.4 Billion 1 Reduce IOP spikes due to high doses of steroids. Anti - Infectives: ~$650 Million
Slide 13: MicroLine for Presbyopia
12 MicroLine for 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 Symptoms • Te
Slide 14: Pilocarpine: Dual Action Mechanism Improves Near Vision
Pilocarpine: Dual Action Mechanism Improves Near Vision Pin - Hole Effect Improves Near Vision 1 Pilocarpine Topical Near Vision Effect 2 Pilocarpine Topical Near Vision Effect 3 1 Seminars in Ophthalmology, 2019; 34(2): 106 – 114 2 Ophthalmol Ther (2016) 5:63 – 73 3 Ophthalmol Ther (2019) 8:31 – 39
Slide 15: Pharmacologic Treatment of Presbyopia: Targeting Millions of Patients
14 Pharmacologic Treatment of Presbyopia: Targeting Millions of Patients Who “Never Wore Glasses” • Majority of presbyopia patients have never had to wear glasses prior to having difficulty with near vision • Having to wear glasses can be an inconvenience and an outward signal of aging • A “no glass
Slide 16: Eyenovia Offers Value Beyond Other Late-Stage Pilocarpine Therapies
15 Eyenovia Offers Value Beyond Other Late - Stage Pilocarpine Therapies 1 Wirta, D. et al., Presentation at 2019 ASCRS annual meeting 2 Pasquale L. et al., Clinical Ophthalmology 2018 3 Ianchulev T. et al, Therapeutic Delivery 2018 Traditional Eye Drops Eyenovia is differentiated from competitors t
Slide 17: MicroLine: Phase 3 Program
16 MicroLine : Phase 3 Program • Two double - masked, placebo - controlled, cross - over superiority trials • Phase 3 ( microdosed pilocarpine 1.0%, 2.0% and placebo) • Primary endpoint: binocular distance corrected near visual acuity VISION 1 Screening: Age 40 – 60 With Presbyopia VISION 2 Screenin
Slide 18: MicroPine for Progressive Myopia
17 MicroPine for Progressive Myopia • 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 lo
Slide 19: Strategic Partnerships to Potentially Extend Commercial Reach
18 Strategic Partnerships to Potentially Extend Commercial Reach Bausch Health Modern PowerPoint Presentation Arctic Vision Validating partnership for the development and commercialization of MicroPine and MicroLine Upfront payment: $4M Potential milestone payments and reimbursed development costs:
Slide 20: Future Licensing Opportunities
19 Future Licensing Opportunities MydCombi / MicroLine MydCombi / MicroLine / MicroPine Canada United States Central America South America Europe Australia New Zealand Africa Russia Middle East
Slide 21: MydCombi for Mydriasis
• Pharmacologic mydriasis (pupil dilation) is part of the comprehensive eye exam • Estimated 80 million office - based comprehensive and diabetic eye exams and 4 million ophthalmic surgical dilations performed annually in the United States • Essential for diabetic retinopathy, glaucoma and retina di
Slide 22: MydCombi Does So Much with So Little
21 MydCombi Does So Much with So Little • 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 application with less than 2% of patients experienc
Slide 23: MydCombi has a Superior Mydriatic Effect vs. Single Agents
22 MydCombi has a Superior Mydriatic Effect vs. Single Agents Significant, prompt mydriasis achieved with microdose fixed - combination Phen - Trop Prompt Mydriasis Superior Efficacy Office & Surgical Use Modern PowerPoint Presentation MydCombi achieved superior efficacy over single - agent componen
Slide 24: Intellectual Property
23 Intellectual Property An additional barrier is the clinical and regulatory hurdles a competitor would have to meet to gain approval for an 8µ dose Worldwide patents are granted on the dispenser, the drop size, velocity of delivery and data capture from the base unit are in effect until late 2031
Slide 25: Financial Snapshot
Financial Snapshot 24 Nasdaq: EYEN Common Shares Outstanding 24.9M Equity Grants Outstanding Under Stock Plans 3.5M Warrants 2.3M Fully Diluted Shares 30.7M Cash $22.9M Pro - forma cash as of Nov. 10, 2020 $31.0M Debt None All figures as of September 30, 2020, except pro - forma cash
Slide 26: Appendix
25 Appendix
Slide 27: Board of Directors
Board of Directors 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 Board Member Managin
Slide 28: Making it Possible
Making it Possible December 2020