Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Investor Presentation (April 2022)
35 slides from Hyperion Defi's investor presentation, Apr 4, 2022
Slide 1: Making it Possible | April 2022
Making it Possible | April 2022
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: - Planned NDA submission 3Q 2022 MicroPine for pediatric progressive myopia: - Phase 3 CHAPERONE study now managed by Bausch+Lomb MicroLine for presbyopia / improved near vision: - Phase 3 VISION - 1 study suc
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, Development Malini Batheja VP, Pharmaceutical R&D Norbert Lowe VP Sales & Marketing Beth Scott VP, Regulatory and Medical Affairs
Slide 6: Late-Stage Ophthalmic Pipeline for US Registration
eyenovia.com 5 Product C a n d i d ate T h e r ap e ut i c Area Phase 3 NDA MydComb i Π1 (trop+phen) P h armac o l og ic Mydriasis $250M+ US market opportunity* M IS T - 1 M IS T - 2 MicroLine 1 (pilocarpine) Presbyopia ~$7.7B US market opportunity 2 VISION - 1 VISIO N - 2 MicroPine 3 (atropine) Pr
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: Precise, Physiological Dosing
eyenovia.com 7 Precise, Physiological Dosing Directly coats the cornea which we believe reduces exposure to drug and preservative toxicity (based on 8µL dose) by more than 75%. 1 Designed to eliminate drug overflow for a more comfortable patient experience. Efficacy Demonstrated statistical and clin
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 | Clinical Experience and Validation
eyenovia.com 9 Optejet ® | Clinical Experience and Validation 0 50 100 150 200 250 300 350 PE 2.5% PE 10% PE 10% μD Plasma PE (pg/ml) p = 0.021 316.3 201.5 p = 0.003 101.6 Drugs in traditional eyedroppers can enter systemic blood circulation and may cause significant side effects . 1 Microdose deliv
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 | Minimal Conjunctival Tissue Impact
eyenovia.com 11 Optejet ® | Minimal Conjunctival Tissue Impact Delivering preserved medication without the associated harm to ocular tissues Cell viability, cytotoxicity, apoptosis (cell membrane integrity and ATP (measure of metabolic activity) were all similar to the non - preserved drop and signi
Slide 13: 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 A v er age of complian ce rates from published ophth almic studies 2 Av erage of compl iance rates from published pedi atric studies 3 12 Optejet ® | Impressive
Slide 14: Optejet Platform | Potential High-Value Opportunities
eyenovia.com 13 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 15: Presbyopia | There Exists a Significant Unmet Need
eyenovia.com 14 Presbyopia | There Exists a Significant Unmet Need • MicroLine provides near vision without the appearance and inconvenience of reading glasses • Sight. Unseen. 1 Estimate from DelveInsight Presbyopia report; December 2020 18 million people 40 - 55 years of age who never previously n
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 D isco m fort 2% 0% Brow ache 2% 0% Very Little Discomfort 0 50 1 00 Upon Instillation 3
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 exp
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 2Q 2022 » Phase 3 double - masked, placebo - controlled, cross - over superiority trial » microdosed pilocarpine 2%
Slide 22: 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
Slide 24: MicroPine Product Profile
eyenovia.com 23 MicroPine Product Profile Clinically meaningful and significant effectiveness 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
Slide 25: Chaperone Study Design
eyenovia.com 24 Chaperone Study Design CHAPERONE S creenin g : Age 3 - 12 With Pediatric Myopia Patients Randomized (N=~420) MicroPine Dose 1 (0.1% atropine) Placebo MicroPine Dose 1 (0.01% atropine) 36 m o 12 m o Patients are then re - randomized to the same or an alternative treatment arm and foll
Slide 26: MydCombi for Mydriasis
eyenovia.com 25 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 27: MydCombi among the first drug-device combination products for pupil dilation
eyenovia.com 26 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 28: MydCombi has a Superior Mydriatic Effect vs. Single Agents
eyenovia.com 27 MydCombi has a Superior Mydriatic Effect vs. Single Agents Presented by S. Rathi et al, American Academy of Optometry Annual Meeting, 2020 p=0.0 1 83 Prompt Mydriasis Mydriasis >5mm achieved in 88% of patients at 20 minutes, without the delay of instilling multiple drops Superior Eff
Slide 29: MydCombi Launch Expenses: A Fraction of a Typical Ophthalmic Drug Launch
eyenovia.com Big Eye Pharma 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.
Slide 30: Strategic Partnerships to Potentially Extend Commercial Reach (Arctic Vision)
eyenovia.com Validating partnership for the development and commercialization of MydCombi Π, MicroPine and MicroLine 29 Strategic Partnerships to Potentially Extend Commercial Reach Upfront payment: $4M Potential milestone payments and reimbursed development costs: $41.75M Commercial supply terms o
Slide 31: Strategic Partnerships to Potentially Extend Commercial Reach (Bausch Health)
eyenovia.com Strategic partnership for the development and commercialization of MicroPine 30 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 32: Available Licensing Opportunities
eyenovia.com 31 Available Licensing Opportunities M y d C ombi MicroLine M y d C ombi MicroLine MicroPine C anada United States Central America South America Europe Australia New Zealand Afr i ca R ussia Middle East Currently under license for all products TERRITORY AVAILABILITY
Slide 33: Intellectual Property
eyenovia.com 32 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 patents in effect until late 2031 Provisional patents fi
Slide 34: Financial Snapshot
eyenovia.com 33 Nasdaq: EYEN Common Shares Outstanding 31.7M Equity Grants Outstanding Under Stock Plans 4.3M Warrants 7.9M Fully Diluted Shares 43.9M Cash $27.3M Debt $7.3M All figures as of December 21, 2021 Financial Snapshot
Slide 35: Board of Directors
eyenovia.com Dr. Anthony Sun Board Member CEO, Zentalis Pharmaceuticals, Inc. Board of Directors 34 Dr. Curt LaBelle Board Member Managing Director of GHIF venture fund and Co - Founder of Eyenovia Kenneth Lee Jr. Lead Director General partner of Hatteras Venture Partners Dr. Sean Ianchulev Chairman