Aerie Pharmaceuticals — Investor Presentation (September 2022)
30 slides from Aerie Pharmaceuticals's investor presentation, Sep 13, 2022
Slide 1: An Emerging Leader in Ophthalmology
Exhibit 99.1 AERIE An Emerging Leader in Ophthalmology September 2022 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.: Q2:22 Net Product Revenue of $33.3MM; 2022 guidance: $130-140MM Franchise • ROW: Partnership with Santen: EU: Approved; Japan: In Phase 3 AR-15512 Phase 3 COMET-2 and COMET-3 studies i
Slide 4: Novel Mechanisms that Deliver Differentiated Product Profiles
Novel Mechanisms that Deliver Differentiated Product Profiles 2 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
Slide 5: Product Pipeline Targets Attractive Commercial Markets
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., Approved ® Rocklatan / in EU; Studies underway: Phase 3 ® Rhopressa : in Japan; Phase
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 our burn rate to maintain a solid the commercial business capital in advancin
Slide 7: Glaucoma: ~$3B U.S. Market
1 Glaucoma: ~$3B U.S. Market 3 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 IOP THE OPPORTUNITY • 34MM prescriptions annual
Slide 8: Glaucoma Franchise Refreshed Brand Positioning
Glaucoma Franchise Refreshed Brand Positioning • First Line • Unsurpassed Efficacy - Superior to 1,2 Latanoprost • Unique MOA that is relevant and complementary to other agents • Consistent and powerful lowering of IOP 1. Data link: https://rocklatan.com/hcp/ 2. Asrani S, Bacharach J, Holland E, et
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 ) is expected through 2034 3 Data suggest
Slide 10: Rhopressa: A unique MOA that delivers powerful IOP reductions
® 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 1 for commercially insured representing >72% of the paves the way for increased pull glaucoma pres
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 for Rhopressa Underway in Japan led by Santen: st • Positive results from 1 Phase 3 trial reported by Aerie in October 2021 nd • A 2 c
Slide 13: Dry Eye Disease: ~$1.6B U.S. Market
1 Dry Eye Disease: ~$1.6B U.S. Market MOA: TRPM8 agonism Inadequate tear THE PROBLEM production & • Significant need for an effective chronic treatment that can provide quality rapid tear production and better relief of dry eye disease symptoms TRPM8 receptor THE OPPORTUNITY • 30MM patients (18MM di
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 profile TOPLINE RESULTS with no systemic or serious adverse events • While previously
Slide 15: Phase 2b Sign: AR-15512 Tear Production
Phase 2b Sign: AR-15512 demonstrated a statistically significant and dose dependent increase in tear 1 production, a validated endpoint and acceptable for registration of product * p < 0.0001 100 * p < 0.0001 * * * p < 0.0001 * p < 0.0026 86.1 75 82.5 * * % Responders 66.1 63.3 (>10mm): 50 Unanesthe
Slide 16: Phase 2b Symptoms: AR-15512 Improvement
Phase 2b Symptoms: AR-15512 demonstrated statistically significant improvement at Day 14; continued 1 improvement over time vs. a validated endpoint Symptoms: SANDE score 1. Wirta DL, Senchyna M, Lewis AE, Evans DG, McLaurin EB, Ousler GW, Hollander DA, ‘A randomized, vehicle-controlled, Phase 2b st
Slide 17: Phase 1 Trial to Confirm the Primary Endpoint
Phase 1 Trial to Confirm the Primary Endpoint for the Phase 3 COMET Studies Trial Objective Trial Design Trial Results • The Phase 1 trial was designed • 40 participants with dry eye • The Phase 1 trial replicated the to validate the unanesthetized disease were randomized 1:1 unanesthetized Schirmer
Slide 18: Phase 1 Data Replicated Phase 2b; Anesthesia Interferes with MOA
Phase 1 Trial to Confirm the Primary Endpoint for the Phase 3 COMET Studies Phase 2b Data Replicated Anesthesia Interferes with AR-15512 MOA % Responders (≥10 mm) % Responders (≥10 mm) Unanesthetized Schirmer p < 0.00001 Phase 2b Result Phase 1 Result 0.003% AR-15512 83% 95% Vehicle 26% 15% Differen
Slide 19: Phase 3 Program for AR-15512 Targeting a 2024 NDA Filing
Phase 3 Program for AR-15512 for Dry Eye Disease Targeting a 2024 NDA Filing 1 2 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 vehicl
Slide 20: COMET-2 and COMET-3 Efficacy Trial Design
Phase 3 “COMET-2” and “COMET-3” Efficacy Trial Design Multi-center, vehicle-controlled, double-masked, randomized trial: NCT05285644, NCT05360966 Screening Phase: Randomized Registrational Endpoints: Day -14 Treatment Primary: Sign: Phase: % Responders (≥10mm): Unanesthetized Schirmer’s Both trials
Slide 21: Phase 3 Program for AR-15512: Three Registrational Studies
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 EXPECTED PHASE 3 DATA READ OUT DIFFERENTIATED CHARACTERIS
Slide 22: DME: ~$2B U.S. Market
1 MOA: bioerodible DME: ~$2B U.S. Market dexamethasone retina implant 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 23: AR-1105 Demonstrated up to 6 Months of Efficacy
Phase 2 1 AR-1105 CF2 demonstrated up to 6 months of efficacy on improving visual acuity Mean Change in Visual Acuity 2 (ETDRS Letters) 1. Data on file: Aerie Pharmaceuticals 2. Error bars are SEM 23 AR-1105 is a development stage product candidate and is not approved by any regulatory agency For In
Slide 24: 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 25: Wet AMD: ~$5B U.S. Market
1 Wet AMD: ~$5B 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 2,3,4 • 11MM people have some form of AMD (U.S.) • ~1.5MM treated CURRENT
Slide 26: Positive AR-14034 Preclinical Data Support Planned IND Filing
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 Preclinical Safety Data No ocular safety concerns Status IND-enabling studies underw
Slide 27: Partnership Opportunities
Partnership Opportunities Santen Glaucoma Agreements ® ® • Rocklatan / Rhopressa • Japan, East Asia, Europe, China, India, the 1 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 28: 2022 Planned Activities and Guidance
2022 Planned Activities and Guidance AR-15512 Dry Eye ✓ Glaucoma Franchise Women in Ophthalmology, AAO ✓ ASCRS/ARVO 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-14
Slide 29: 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 our burn rate to maintain a solid the commercial business capital in advancin
Slide 30: An Emerging Leader in Ophthalmology
An Emerging Leader in Ophthalmology Carolyn McAuliffe Hans Vitzthum [email protected] www.aeriepharma.com For Investor Use Only
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