Aerie Pharmaceuticals — Investor Presentation (May 2022)
28 slides from Aerie Pharmaceuticals's investor presentation, May 25, 2022
Slide 1: An Emerging Leader in Ophthalmology
Exhibit 99.1 AERIE An Emerging Leader in Ophthalmology Ma y 2 0 2 2 For Investor Use Only 1
Slide 2: Disclaimer
Disclaimer The information in this presentation regarding Aerie Pharmaceuticals, Inc. (the “Company” or “Aerie”) does not contain all of the information that a potential investor should review before investing in Aerie shares. The descriptions of Aerie in this presentation are qualified in their ent
Slide 3: An Emerging Leader in Ophthalmology
An Emerging Leader in Ophthalmology ® ® Rocklatan /Rhopressa Growing Glaucoma franchise: Growing Commercial • U.S.: Q1:22 Net Product Revenue of $29.8MM; 2022 guidance: $130-140MM Franchise • ROW: Partnership with Santen: EU: Approved; Japan: In Phase 3 AR-15512 Phase 3 study in dry eye disease (DED
Slide 4: Novel Mechanisms for Products/Pipeline
Novel Mechanisms for Products/Pipeline 1 Glaucoma: ROCK inhibition Wet AMD : Pan-VEGF-R inhibitor To provide a unique improvement Angiogenesis inhibitor in fluid outflow To reduce thickening and growth of leaky blood vessels Dry Eye: TRPM8 agonist To increase tear production 2 DME : Bioerodible dexa
Slide 5: Aerie Product Pipeline Targets Attractive Commercial Markets
Aerie Product Pipeline Targets Attractive Commercial Markets ® Two Phase 3 Ready Programs plus “PRINT ” Technology Platform Product/Indication R&D Phase 1 Phase 2 Phase 3 Marketed Status/Next Steps On the Market in U.S. ® Rocklatan / Approved in EU, Phase 3 in Japan, ® Rhopressa : Phase 4 program un
Slide 6: Aerie 2.0: Strategic pillars for long-term success
Aerie 2.0: Strategic pillars for long-term success Growing Attractive Late- Strong Financial Commercial Stage Pipeline Position Franchise Reducing our annual net cash Driving sustainable growth of Making smart choices with burn rate to maintain a solid the commercial business capital in advancing ou
Slide 7: Glaucoma: ~$3B U.S. Market, Unique MOA: Rock inhibition
1 Glaucoma: ~$3B U.S. Market Unique MOA: Rock inhibition THE PROBLEM Reduced • Stiffening trabecular meshwork reduces normal drainage fluid • Increased intraocular pressure (IOP) can damage the optic nerve outflow and lead to vision loss Increased intraocular pressure THE OPPORTUNITY • 34MM prescrip
Slide 8: Glaucoma Franchise Refreshed Brand Positioning
Glaucoma Franchise Refreshed Brand Positioning • First Line • Unsurpassed Efficacy -- Superior to Latanoprost • Consistent and powerful lowering of IOP • Unique MOA that is relevant and complementary to other agents 8 For Investor Use Only
Slide 9: Rocklatan: One Powerful Drop
® Rocklatan ® One Powerful Drop Starts with Rocklatan ® Rocklatan (netarsudil/latanoprost combo) is the only product to demonstrate superiority to 1,2 latanaprost in U.S. Phase 3 trials. NO REPORTED SYSTEMIC EFFECTS ® ® Patent coverage (Rocklatan & Rhopressa ) through 2034 3 Data suggest for every 1
Slide 10: Rhopressa: A unique MOA that delivers powerful and consistent reductions in IOP
® Rhopressa A unique MOA that delivers powerful and consistent reductions in IOP Delivers an additional ~ 20% IOP reduction regardless of current regimen or baseline 1,2 pressure. 1. Zaman F, Gieser SC, Schwartz GF, Swan C, Williams JM. A multicenter, open-label study of netarsudil for the reduction
Slide 11: U.S. Commercial Strategy Focused on Driving Earlier Adoption
U.S. Commercial Strategy Focused on Driving Earlier Adoption in Appropriate Patients Eye Care Practitioner Patient Payor Support includes co-pay card Focus on top prescribers, Broad formulary coverage for commercially insured representing >70% of the paves the way for increased pull patients glaucom
Slide 12: Global Studies and Medical Affairs Program
Global Studies and Medical Affairs Program Intended to support generation of meaningful clinical data and improved patient outcomes nd 2 Phase 3 Registration Trial Underway in Japan led by Santen: st • Positive results from 1 Phase 3 trial reported by Aerie in October 2021 nd • A 2 confirmatory Phas
Slide 13: Dry Eye: ~$1.6B U.S. Market, MOA: TRPM8 agonism
1 Dry Eye: ~$1.6B U.S. Market MOA: TRPM8 agonism Inadequate THE PROBLEM tear production • The need for a chronic treatment that can provide rapid and more & quality effective relief of Dry Eye symptoms TRPM8 receptor THE OPPORTUNITY • 30MM patients (18MM diagnosed) • <10% treated by Rx TRPM8 agonism
Slide 14: Summary of Phase 2b COMET-1 Dry Eye Disease Study
Summary of Phase 2b COMET-1 Dry Eye Disease Study Evaluation of 2 doses of AR-15512 vs. vehicle in 369 participants with dry eye disease 14 For Investor Use Only SAFETY • The study demonstrated a good tolerability TOP LINE RESULTS profile with no systemic or serious adverse • While previously chosen
Slide 15: Phase 2b Sign: AR-15512 increased tear production
Phase 2b Sign: AR-15512 demonstrated a statistically significant & dose dependent increase in tear production, a validated endpoint and acceptable for registration of product * p < 0.0001 * p < 0.0001 * p < 0.0001 * p < 0.0026 % Responders (>10mm): Unanesthetized Schirmer Score Data on file: Aerie P
Slide 16: Phase 2b Symptoms: AR-15512 improvement at Day 14
Phase 2b Symptoms: AR-15512 demonstrated statistically significant improvement at Day 14; continued improvement over time vs. a validated endpoint Symptoms: SANDE score Data on file: Aerie Pharmaceuticals 16 AR-15512 is a development stage product candidate and is not approved by any regulatory agen
Slide 17: Phase 3 Program for AR-15512 for Dry Eye Disease
Phase 3 Program for AR-15512 for Dry Eye Disease Targeting a 2024 NDA Filing COMET-2 COMET-3 COMET-4 Efficacy Efficacy Safety Subjects Individuals with dry eye disease Participants ~460 ~460 ~255 Location ~20 U.S. Sites ~20 U.S. Sites ~10 U.S. Sites Treatment AR-15512 (0.003%) or AR-15512 vehicle St
Slide 18: Phase 3 COMET-2 and COMET-3 Efficacy Trial Design
Phase 3 “COMET-2” and “COMET-3” Efficacy Trial Design Multicenter, vehicle-controlled, double-masked, randomized trial: NCT05285644, NCT05360966 Screening Phase: Randomized Registrational Endpoints: Treatment Day -14 Primary: Sign: % Phase: Responders (≥10mm): Unanesthetized Schirmer Study start: Sc
Slide 19: Phase 3 Program for AR-15512: Registrational Studies and NDA
Phase 3 Program for AR-15512 for Dry Eye Disease THREE REGISTRATIONAL STUDIES NDA PACKAGE & TARGET FILING • Two Efficacy Studies: COMET-2 & COMET-3 • NDA Package: COMET-2, COMET-3, COMET-4 • One Safety Study: COMET-4 • Target NDA Filing: 2024 PHASE 3 DATA READ OUT DIFFERENTIATED CHARACTERISTICS • CO
Slide 20: DME: ~$2B U.S. Market, MOA: bioerodible dexamethasone retinal implant
1 MOA: bioerodible DME: ~$2B U.S. Market dexamethasone retinal impact Macular THE PROBLEM edema • Inflammation and thickening of the macula (macular edema) • Can lead to loss of vision CURRENT TREATMENT • Angiogenesis inhibitors & steroids. Patients & providers are dissatisfied with frequent high-co
Slide 21: AR-1105 CF2 demonstrated up to 6 months of efficacy
Phase 2 AR-1105 CF2 demonstrated up to 6 months of efficacy on improving visual acuity 9 Mean Change in 6 Visual Acuity 1 (ETDRS Letters) 3 0 Baseline Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 CF2 Randomized (n=22) Source: Table 14.2.1.2.1; error bars are SEM Data on file: Aerie Pharmaceutical
Slide 22: AR-1105 Phase 2 Proof-of-Concept Data Support Next Steps
AR-1105 Phase 2 Proof-of-Concept Data Support Next Steps Up to 6 months efficacy: improved visual acuity and reducing macular edema Phase 2 Efficacy Data Both formulations well tolerated; no unexpected findings Phase 2 Safety Data Adverse events consistent with other corticosteroids & intravitreal i
Slide 23: Wet AMD: ~$4B U.S. Market, MOA: selective pan-VEGF inhibitor
1 Wet AMD: ~$4B U.S. Market MOA: selective pan-VEGF inhibitor THE PROBLEM • Abnormal blood vessel growth (angiogenesis) that leaks fluid or Blood vessel blood into the macula, decreasing vision growth, leakage THE OPPORTUNITY 2-4 • 11MM people have some form of AMD (U.S.) • ~1.5MM treated CURRENT TR
Slide 24: Positive AR-14034 Preclinical Data Support Planned IND Filing Q4:22
Positive AR-14034 Preclinical Data Support Planned IND Filing Q4:22 ® Axitinib is a highly-selective Pan-VEGF blocker (Pfizer’s INLYTA ) Preclinical POC Data Preclinical data supports target 12-month release profile Pre-clinical Safety Data No ocular safety concerns Status IND-enabling studies under
Slide 25: Partnership Opportunities
Partnership Opportunities Santen Glaucoma Agreement ® ® • Rocklatan / Rhopressa • Japan, East Asia, Europe, China, India, the Middle East, CIS* countries, Africa, parts of Latin America and the Oceania countries Other International Opportunities • AR-15512, AR-1105, AR-14034 Leverage Manufacturing •
Slide 26: 2022 Planned Activities and Guidance
2022 Planned Activities and Guidance AR-15512 Dry Eye ✓ Glaucoma Franchise ✓ ASCRS/ARVO Women in Ophthalmology, AAO COMET-4 (Q4:22) Refreshed branding 17 abstracts/posters Commercial presence/potential abstracts H1:2022 H2:2022 ® ✓ Rocklatan Phase 4 Program ✓ AR-15512 Dry Eye AR-15512 Dry Eye AR-140
Slide 27: Aerie 2.0: Strategic pillars for long-term success
Aerie 2.0: Strategic pillars for long-term success Growing Attractive Late- Strong Financial Commercial Stage Pipeline Position Franchise Reducing our annual net cash Driving sustainable growth of Making smart choices with burn rate to maintain a solid the commercial business capital in advancing ou
Slide 28: An Emerging Leader in Ophthalmology
An Emerging Leader in Ophthalmology Carolyn McAuliffe Hans Vitzthum [email protected] www.aeriepharma.com For Investor Use Only
Aerie Pharmaceuticals — Investor Presentation (May 2022) on 6ix