Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Investor Presentation (May 2021)
33 slides from Hyperion Defi's investor presentation, May 5, 2021
Slide 1: Making it Possible May 2021
Making it Possible May 2021
Slide 2: Forward-looking statements
Except for historical information, all of the statements, expectations and assumptions contained in this presentation are for war d - looking statements. Forward - looking statements include, but are not limited to, statements that express our intentions, beliefs, expecta tions, strategies, predicti
Slide 3: Investment Highlights
2 Investment Highlights Clinically validated in multiple Phase 2 and Phase 3 studies Late - stage therapeutics pipeline MicroStat ( Mydcombi Π) for mydriasis (pupil dilation): NDA PDUFA date expected October 28 2021 MicroPine for pediatric progressive myopia: Phase 3 CHAPERONE study full enrollment
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 in Markets Valued Over $12.7 Billion
4 Late - Stage Ophthalmic Pipeline for US Registration in Markets Valued Over $12.7 Billion Product Candidate Therapeutic Area Pre - Clinical/ Formulation Phase 1 Phase 2 Phase 3 NDA MydCombi Π( trop+phen ) Pharmacologic Mydriasis MicroLine 1 (pilocarpine) Improvement in near vision in patients wit
Slide 6: Potential Topical US Ophthalmic Market For Platform Technology
5 Potential Topical US Ophthalmic Market For Platform Technology* 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 1 Eliminate contamination fro
Slide 7: 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 8: Optejet Microdose Array Print (MAP) Technology Designed for Optimal Drug Delivery
7 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 9: Optejet: Significant Clinical Experience and Validation
8 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 10: Optejet: Clinical Experience and Validation
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 delivery of pheny
Slide 11: Optejet: Demonstrated Effectiveness in Multiple Phase Studies
10 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 * * p=0.
Slide 12: Optejet: Impressive Treatment Compliance
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 World Use Avera
Slide 13: Optejet Platform: Potential High-Value Opportunities
12 Optejet Platform: Potential High - Value Opportunities Estimated Gross Margins Based on $100/Month Price 1 >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 - devi
Slide 14: MicroLine for Presbyopia
13 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 15: 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 16: People Have Preconceptions About People Who Wear Reading Glasses
15 People Have Preconceptions About People Who Wear Reading Glasses Young Fast Old Smart Attractive Athletic Slow Wealthy Stylish Tired This image was seen as “young,” “athletic,” and “attractive.” This image was seen as “slow,” “tired,” and “smart.” Percentage of Participants Assigning the Descript
Slide 17: Attitudes Towards Wearing Reading Glasses
1 35 19 8 How Long Have You Used Reading Glasses? < 1 Year 1 to 5 Years 6 to 10 Years 11 or More 16 Attitudes Towards Wearing Reading Glasses What One Word Describes How You Feel About Needing to Wear Reading Glasses? Old 40% Annoyed 16% Constrained or Dependent 10% Frustrated or Stressed 10% Slow 5
Slide 18: Pharmacologic Treatment of Presbyopia: Targeting Millions of Patients
17 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 19: MicroLine: Phase 3 Program
18 MicroLine : Phase 3 Program • Two double - masked, placebo - controlled, cross - over superiority trials • Phase 3 ( microdosed pilocarpine dose 1, dose 2 and placebo) • Primary endpoint: binocular distance corrected near visual acuity • First patient enrolled in VISION 1: December 2020 VISION 1
Slide 20: Eyenovia Offers Value Beyond Other Late-Stage Pilocarpine Therapies
19 Eyenovia Offers Value Beyond Other Late - Stage Pilocarpine Therapies 1 Reckner and Associates, 2021 (data on file) 2 VISION - 1 Post - Study Survey MicroLine Compared with the Standard Presbyopia Drop 27% 90% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Up to a 5% Risk Up to a 20% Risk HEADACHE I
Slide 21: Late Stage Presbyopia Competitive Landscape
20 Late Stage Presbyopia Competitive Landscape Source: Company press releases and clinicaltrials.gov
Slide 22: MicroPine for Progressive Myopia
21 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 23: Strategic Partnerships to Potentially Extend Commercial Reach
22 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 24: Future Licensing Opportunities
23 Future Licensing Opportunities MydCombi MicroLine MydCombi MicroLine MicroPine Canada United States Central America South America Europe Australia New Zealand Africa Russia Middle East
Slide 25: 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 26: MydCombi: It Will Make Your Eyes Dilate
25 MydCombi It Will Make Your Eyes Dilate • 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 fewer than 1% of patients experi
Slide 27: MydCombi has a Superior Mydriatic Effect vs. Single Agents
26 MydCombi has a Superior Mydriatic Effect vs. Single Agents Mydriasis >5mm achieved in 88% of patients at 20 minutes, without the delay of instilling multiple drops Prompt Mydriasis Superior Efficacy Office & Surgical Use Modern PowerPoint Presentation MydCombi achieved superior efficacy over sing
Slide 28: MydCombi Launch Expenses: A Fraction of a Typical Ophthalmic Drug Launch
11 FTE for $2.2 million Calling on large group practices in largest population centers for 50% reach at launch Salesforce 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 Group 8 FTE for
Slide 29: Intellectual Property
28 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 30: Financial Snapshot
Financial Snapshot 29 Nasdaq: EYEN Common Shares Outstanding 25.6M Equity Grants Outstanding Under Stock Plans 3.5M Warrants 2.0M Fully Diluted Shares 31.1M Cash $28.4M Debt (PPP loan) $0.5M All figures as of December 31, 2020
Slide 31: Appendix
30 Appendix
Slide 32: 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 33: Making it Possible May 2021
Making it Possible May 2021