Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Investor Day (February 2019)
42 slides from Hyperion Defi's investor day presentation, Feb 27, 2019
Slide 1: Making it Possible: Analyst & Investor Lunch
Making it Possible Analyst & Investor Lunch February 27, 2019
Slide 2: Agenda
Agenda 1. Brief overview of Eyenovia 2. Recent updates and accomplishments 3. Micro Stat MIST - 1 and MIST - 2 results 4. Discussion on in - office efficiency with Micro Stat with Robert Stapper, Director of Research at Keystone Research 5. Manufacturing strategy 6. Commercial strategy 7. Future opp
Slide 3: 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 4: Eyenovia: Building the Smart Eye Care Company of the Future
Eyenovia: Building the Smart Eye Care Company of the Future • Specialty ophthalmic bio - pharma with a smart, microdose therapeutic technology platform called Optejet™ • Unique patented piezo - print technology designed to enable new indications in high - value disease targets • Breakthrough treatme
Slide 5: Eyenovia: Building the Smart Eye Care Company of the Future (Updated Plan)
Eyenovia: Building the Smart Eye Care Company of the Future • Specialty ophthalmic bio - pharma with a smart, microdose therapeutic technology platform called Optejet™ • Unique patented piezo - print technology designed to enable new indications in high - value disease targets • Breakthrough treatme
Slide 6: Strategy Aligned with Near, Mid and Long Term Opportunities
5 Eyenovia: Strategy Aligned with Near, Mid and Long Term Opportunities 2017 2018 2019 2020 2021 2022 2023 2024 Micro Stat Mydriasis Micro Prost CACG, OAG, OHT Micro Pine Progressive Myopia Expected FDA approval 2021 Expected FDA approval 2020 Phase III results by 2023 Sources: Analyst reports; Eyen
Slide 7: Micro Stat for Pharmacologic Mydriasis
• Indispensable part of: – Comprehensive Eye Exam – Diabetic Retinal Exam – Macular Degeneration Retinal Exam – Retinopathy of Prematurity Screening • Current eyedropper paradigm use two medications, which can overdose the eye (100µL vs 7 µL) 1 – Phenylephrine 2.5% (1 - 2 drops) and Tropicamide 1% (
Slide 8: Why should we be concerned about overdosing with eye drops?
Why should we be concerned about overdosing with eye drops? • Many ophthalmic drugs are compounds that were designed for cardiovascular or other systemic effect (beta blockers, phenylephrine and others) • When these drugs are overdosed to eye, they can seep into systemic circulation through periocul
Slide 9: Micro Stat: Two Phase III Registration Studies
• Double - masked, active - controlled, cross - over design • Primary EP: Mean change in pupil diameter at 35 minutes vs baseline • Powered at 90% for each study, assuming 54 evaluable subjects 8 Micro Stat : Two Phase III Registration Studies • MIST - 1 (N=64 randomized):µD phenylephrine - tropicam
Slide 10: MIST-1 Results: Primary Endpoint Analysis
1. Met primary efficacy endpoint of pupil dilation change from baseline at 35 minutes 2. Statistically larger 35 minute dilation for Micro Stat vs components 3. Additional outcomes: • 94% of eyes achieved 6 mm or greater pupil dilation at 35 minutes compared with 78% and 1.6% for the tropicamide - o
Slide 11: MIST-2 Results: Primary Endpoint Analysis
1. Met primary efficacy endpoint of pupil dilation change from baseline at 35 minutes 2. Micro Stat was clinically and statistically superior to placebo in terms of mydriatic effect 3. Additional outcomes: • 93% of eyes achieved 6 mm or greater pupil dilation • 68% of eyes achieved 7 mm or more pupi
Slide 12: MIST-2 Results: MicroStat achieved significant dilation at 35 minutes
Pupil Diameter by Treatment at Baseline and 35 Minutes (PP Population) 11 MIST - 2 Results: MicroStat achieved significant dilation at 35 minutes
Slide 13: MicroStat: Key take-aways
Phase III results 1. Significant, prompt mydriasis achieved with microdose fixed - combination Phen - Trop 2. MicroStat achieved superior efficacy over single - agent components 3. Mydriasis >6 mm achieved in >93% of patients - Clinically meaningful for both office retinal exam and surgical dilation
Slide 14: MicroStat: Key take-aways (Phase II context)
Additional context from our Phase II trial • Phenylephrine is a cardioactive drug and micro - dosing reduced systemic exposure 13 MicroStat: Key take - aways
Slide 15: Robert Stapper, Director of Research at Keystone Research
• Discussion on how Micro Stat can improve in office efficiency and economics and the ease of use of Optejet, patient satisfaction and what it means for in office usage 14 Robert Stapper, Director of Research at Keystone Research
Slide 16: Optejet: Eyenovia's Unique Technology
Optejet: Eyenovia’s Unique Technology Microdosing The micro - droplet achieves precise volumetric control to deliver 6 - 8 µL, which is physiological capacity of tear film Precise, targeted topical delivery Targeted delivery to the ocular surface and cornea, avoiding the conjunctival cul - de - sac
Slide 17: Manufacturing overview
16 Manufacturing overview Reno: Cartridge Manufacturing Reno: Base Manufacturing Particle Sciences: Formulation, Fill/Finished vials, labeled Steris: Terminal Sterilization Catalent for Kit & Pack Supply Clinical Sites
Slide 18: Eyenovia is unlocking value in a multi-billion dollar eye care market
17 Eyenovia is unlocking value in an estimated multi - billion dollar eye care market Technology Capabilities Microdosing of less than 9µL Precise targeted topical delivery to the ocular surface and cornea Beat - the - blink speed of delivery at 80 milliseconds Smart electronics and mobile connectiv
Slide 19: Alignment of unmet need and our value proposition
Micro Pine Alignment of unmet need and our value proposition Eyenovia is making new approaches in topical ophthalmic drug therapy possible through the Optejet platform Eyenovia Vision • Microdosing • Precise, targeted topical delivery • Beat - the - blink speed of delivery • Smart electronics Micro
Slide 20: Development Pipeline
19 Development Pipeline Market Opportunity Preclinical/Formulation Phase I Phase II Phase III Near - Term Milestones Micro Pine* Reduction of Myopia Progression $5B+ Market Phase III Start 2019 Micro Prost* 1 Reduction of Intraocular Pressure in CACG, OAG and OHT $1.5B+ Market Phase III Start 2019 M
Slide 21: Micro Prost: Updated Strategy
• Expanded Micro Prost Phase III program to include chronic angle closure glaucoma (CACG), open angle glaucoma (OAG) and ocular hypertension (OHT) patients • Potential total addressable population of approximately 4 million patients in the U.S. • Optimized trial design to consist of a single Phase I
Slide 22: Micro Tears: Update
• Formulation – Updated formulation for ocular decongestant and anti - pruritic – Will address both lubrication and eye redness relief in order to expand use for more cosmetic applications – Designed to address unmet medical and consumer needs: • lower medication rebound effect 1 • lower preservativ
Slide 23: Micro Tears: Market Research
Two recently completed market research projects • 17 consumers in two, 2 - hour long focus groups in Long Beach, CA – One group of OTC eye drop users, mix of ages (21 - 65 years old, some over 65 years old), mix of male/female, must be people who use artificial tears, eye whiteners, etc. at least on
Slide 24: Consumers reported many advantages of Optejet
• Accurate doses - “it's literally one drop" • Less waste • Less messy • Connects with phone - "it's great to know how much is left" • Less time consuming than drops - "it goes right in" • High tech (particularly younger participants) - "I thought it was super fun, super cool…I think it’s very appea
Slide 25: Optometrists were presented with the Micro Tears profile
24 Optometrists were presented with the Micro Tears profile Tested Product Profile A NASDAQ listed publicly traded ophthalmic pharmaceutical company has an FDA - approved over - the - counter medication for the treatment of ocular redness and itch. The medication is delivered in a patented microdosi
Slide 26: Majority of optometrists were interested in selling Optejet
10% 12% 20% 30% 28% 0% 5% 10% 15% 20% 25% 30% 35% Not at all interested Very little interest Mildly interested Moderately interested Very interested Percentage of Responses to the Question of Initial Interest in the Product as Described 25 Majority of optometrists were moderately to very interested
Slide 27: Medical differentiation was important
26 Medical differentiation was important 0% 4% 12% 48% 36% 0% 10% 20% 30% 40% 50% 60% Not at all important Very little importance Mildly important Moderately important Very important Lower Rate of Rebound from the Decongestant due to Microdosing The added features of lower incidence of rebound from
Slide 28: Optometrist Research: Conclusion
• The retail portion of the business is very important to optometrists – Currently less than 30% sell eye drops due to lack of differentiated products – Majority would be interested in selling Micro Tears • High interest in the MicroTears product profile with a focus on: – Promoting benefits of micr
Slide 29: What is a specialty pharmacy network (SPN)?
28 Go - to - market model: What is a specialty pharmacy network (SPN)? Specialty Pharmacy A Back - up Specialty Pharmacy B Optometry Practice #1 Optometry Practice #2 Optometry Practice #3 $ Eyenovia pays fee for service
Slide 30: Traditional Prescribing Process
Traditional Prescribing Process Source: Pembroke Consulting, 2012 $ Discounts of 2% to 5% Payer discounts and rebates of 20% to 70% to obtain favorable access 29
Slide 31: Traditional distribution can add costs to company and prescribers
• Sales representatives competing for time with the doctors and space in the sample closet • Payments to distributers • Rebates to managed care organizations contracting to cover the product – Branded copays can average $40 - $50 • Prescribers often employ staff at their own expense to manage “call
Slide 32: Closed distribution model (SPN) potentially provides major benefits and cost savings
31 Closed distribution model (SPN) potentially provides major benefits and cost savings Benefits of closed distribution model (SPN) Reduced costs – no wholesaler discounts; no need for large staff at EYEN to manage distribution Customer data sharing – EYEN strives to know who orders and when in orde
Slide 33: Similar programs already exist in eye care
Similar programs already exist in eye care Akorn (Cosopt and Zioptin) Sun Pharma (Xelpros) 32
Slide 34: Micro Stat will use the same SPN as Micro Tears
33 Micro Stat will use the same SPN as Micro Tears
Slide 35: Key Account Directors
34 Key Account Directors
Slide 36: Micro Prost will explore SPN and reimbursement model
• May be available to patients immediately • No discounts to distribution partners – Fee for service to SPN • Cost to patients may be similar to branded copays; less for patients using high - deductible plans • Requires smaller in - house staff to manage • ECPs report a strong preference for consist
Slide 37: Future Opportunities: Presbyopia
36 Future Opportunities: Presbyopia Sources: Mayo Clinic Presbyopia Overview. Wollfsohn et al. Prog Retin Eye Res. Fernandez et al. J Ophthalm. Accessed December 20 18 Etiology • Non - preventable, age - related hardening of the lens Symptoms • Tendency to hold reading material farther away to make
Slide 38: Presbyopia: Prevalent Vision Correction Issue
• Prevalence expected to increase and reach ~123 million by 2020, representing over 1/3 of US population; driven by aging population • Nearly everyone experiences some degree of presbyopia after age 40 • Up to 1/3 of presbyopia sufferers are un - managed • Presbyopia is a significant and emotional e
Slide 39: Current Treatment Options are Exclusively Device-based Modalities
38 Current Treatment Options are Exclusively Device - based Modalities Increasing Invasiveness Reading Glasses (Non - Prescription, Prescription) Visible treatment option Contact Lenses (Bifocal, Mono, Modified Mono, Monovision) May not eliminate need for glasses fully, not indicated if other ocular
Slide 40: Optejet: Highly Differentiated Value Proposition in Presbyopia
39 Optejet: Highly Differentiated Value Proposition in Presbyopia Short - term improvement in vision in patients with presbyopia (3 – 4 hours, for patients who require < 2.0 diopters correction) Microdosing should address issues of brow ache associated with pilocarpine Optejet allows for fast & prec
Slide 41: Ophthalmology Consumer Market Continues to Grow in the US
40 Ophthalmology Consumer Market Continues to Grow in the US Sources: Ophthalmic Single Use Surgical Product Market Report. 2015. MarketScope. Accessed December 2018. Refractive Surgery Premium IOLs Contact Lenses 5.0% 9.5% 6.5% Ophthalmology Consumer Market 2017 - 2023 Projected CAGR (Unit or Proce
Slide 42: Eyenovia Aims to Successfully Launch Four Products in Ophthalmology by 2023
FDA Registration 2023 2021 2020 2019 Population Size Moderate Moderate High High Competitive Position High Medium Medium Low - Medium Value Proposition Designed to maximize treatment success for slowing Pediatric Progressive Myopia Addresses issues of self - instillation, tolerability and compliance