Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Investor Presentation (August 2021)
32 slides from Hyperion Defi's investor presentation, Aug 11, 2021
Slide 1: Making it Possible August 2021
Making it Possible August 2021
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, prediction
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 - operativ
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 Phase 3 NDA MydCombi Π(trop+phen) Pharmacologic Mydriasis MicroLine 1 (pilocarpine) Presbyopia MicroPine 3 (atropine) Progressive Myopia Potential pipeline expansion activi
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 phenylep
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 DL, Walters TR, Flynn WJ, Rathi S, Ianchulev T. Mydriasis with micr
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 Averag
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 20 18 Symptoms • Te
Slide 15: MicroLine Achieves Primary Endpoint in Phase 3
14 MicroLine Achieves Primary Endpoint in Phase 3 May 2021: Phase 3 VISION - 1 trial achieves primary endpoint Statistically significant proportion of subjects in treatment arm achieved three - line or more improvement in distance corrected near visual acuity Well tolerated with only mild adverse ev
Slide 16: VISION-1 Study Design
15 VISION - 1 Study Design » Double - masked, placebo - controlled, cross - over superiority trial » Phase 3 (microdosed pilocarpine 1%, 2% and placebo) » Primary endpoint: mesopic, high contrast binocular distance corrected near visual acuity VISION 1 Screening: Age 40 – 60 With Presbyopia Enrollme
Slide 17: VISION-1 Met Primary Endpoint
VISION - 1 Met Primary Endpoint Formulation is Well - Tolerated and Comfortable Key Safety Outcomes All AEs were Mild and Transient in Nature 1 Resolved by 3 hours post - dose MicroLine Placebo Moderate Hyperemia 1 2% 0% Instillation Discomfort 2% 0% Brow ache 2% 0% 0 50 100 Upon Instillation 30 min
Slide 18: VISION-2 Study Design
17 VISION - 2 Study Design VISION 2 Enrollment (N=~120) MicroLine Dose 1 (2% pilocarpine) Placebo Topline data anticipated mid - 2022 » Double - masked, placebo - controlled, cross - over superiority trial » Phase 3 (microdosed pilocarpine 2% and placebo) » Primary endpoint: mesopic, high contrast b
Slide 19: There Exists a Significant Unmet Need in Presbyopia
18 There Exists a Significant Unmet Need in Presbyopia 18 million people 40 - 55 years of age who never previously needed glasses suffer from presbyopia in the US alone A 7.7 billion dollar 1 addressable market • Majority of presbyopia patients have never had to wear glasses prior to having difficul
Slide 20: MicroLine Product Profile
19 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 patient satisfac
Slide 21: Late-Stage Presbyopia Competitive Landscape
20 Late - Stage Presbyopia Competitive Landscape Source: Company press releases and clinicaltrials.gov Company API Trial Primary EP Outcome Status Pilocarpine 2% VISION - 1 (40 - 60 YO) Gain of 3 lines or more in mesopic, high contrast, binocular (DCNVA) at Hour 2 vs. placebo (vehicle) Met primary E
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
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 comprehensive eye ex
Slide 26: MydCombi: Mydriasis Made Modern
25 MydCombi Œ Mydriasis Made Modern • 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 experiencing
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, and are in effect until late
Slide 30: Financial Snapshot
Financial Snapshot 29 Nasdaq: EYEN Common Shares Outstanding 25.9M Equity Grants Outstanding Under Stock Plans 4.4M Warrants 1.2M Fully Diluted Shares 31.6M Cash $27.2M Debt $7.5M All figures as of June 30, 2021
Slide 31: 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 32: Making it Possible August 2021
Making it Possible August 2021