Glaukos Corporation · NYSE:GKOS
Glaukos — Investor Presentation (September 2018)
29 slides from Glaukos's investor presentation, Sep 5, 2018
Slide 1: September 2018
September 2018 1 © 2018 Glaukos Corporation 1
Slide 2: Disclaimer
Disclaimer All statements other than statements of historical facts included in this presentation that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis
Slide 3: Glaukos is Transforming Glaucoma Therapy
Glaukos is Transforming GlaucomaTherapy OUR MISSION To pioneer and lead the global glaucoma market micro-scale injectable therapies that advance the with standard-of-care and enrich the lives and treatment alternatives for glaucoma patients worldwide. 3 © 2018 Glaukos Corporation
Slide 4: 2018 Key Objectives
2018 Key Objectives Driving MIGS towards the global standard of care while advancing a transformational future Obtain FDA approval and commence US commercial launch of iStent inject® Begin patient enrollment of key pivotal studies Drive increased penetration markets in our international Expand our p
Slide 5: Demonstrated Financial Performance
Demonstrated Financial Performance Total Net (in millions) Sales 86% Q2 2018 Gross Margin 159.3 $120M Cash & Short-Term Equivalents* * As of 6/30/2018 5 © 2018 Glaukos Corporation 2017 2018 2016 2015 2014 2013 40.143.2 Q1 Q2 4-Yr CAGR: 66% 114.4 71.7 45.6 21.0
Slide 6: MIGS and Beyond
MIGSANDBEYOND Delivering Novel Surgical & Pharmaceutical Glaucoma Therapy 6 © 2018 Glaukos Corporation
Slide 7: Current OAG Treatment Algorithm
Current OAG Treatment Algorithm Ocular Hypertension IOP of 21-30 mm Hg IOP is measured in millimeters of mercury (mm Hg). Normal IOP in healthy eyes ranges from 10-21 mm Hg. 1 Target IOP 20% Ļ IURP EDVHOLQH; ” 18 PP Hg Treatment 0-1 med Open-Angle Glaucoma Progression Refractory OAG Uncontrolled IOP
Slide 8: Portfolio of Micro-Scale Injectable Therapy
Portfolio of Micro-Scale Injectable Therapy OCULAR HYPERTENSION Injectable drug delivery implant; sustained drug therapy for extended periods TM REFRACTORY Envision use alone or in combination with other MIGS devices OAG Progression MILD OCULAR HYPERTENSION ADVANCED MODERATE MILD MODERATE ADVANCED R
Slide 9: Estimated Cadence of Major New U.S. Product Introductions
5 in 5: Estimated Cadence of Major New U.S. Product Introductions OCULAR HYPERTENSION 2021-22 TM REFRACTORY OAG Progression MILD OCULAR HYPERTENSION ADVANCED MODERATE MILD MODERATE ADVANCED REFRACTORY Addressing full range of glaucoma disease states and progression 2012 2020-21 TM 2018 ® 2023 2020 i
Slide 10: iDose Travoprost: First-of-a-Kind Intraocular Drug Delivery Device
iDoseTM Travoprost: First-of-a-Kind Intraocular Drug Delivery Device Retaining Cap OCULAR HYPERTENSION TM Elution Membrane REFRACTORY Drug Reservoir OAG Progression MILD Titanium implant (1.8 mm x 0.5 mm) designed for continuous drug delivery directly into anterior chamber ADVANCED MODERATE Scleral
Slide 11: iDose Travoprost US Phase II: Preliminary Efficacy Results
iDoseTM Travoprost US Phase II: Preliminary Efficacy Results Average IOP reductions through Month 12 ranging from 7.9 to 8.5 mmHg in the implant arms Average IOP Reductions from Baseline through Month 12* 9.0 8.5 8.4 8.4 8.5 8.2 7.9 8.0 Represents 32-33% reduction in the implant arms 7.6 7.5 7.0 6.5
Slide 12: iDose Travoprost US Phase II: Mean Number of Meds
iDoseTM Travoprost US Phase II: Preliminary Efficacy Results Mean number of meds Mean 1.00 Number of Medications at Month 12 were and 0.54 for the implant arms 0.56 0.90 0.80 0.72 0.70 Favorable safety profile with no hyperemia reported either implant arm 0.60 0.50 in 0.40 0.30 0.20 0.10 0.00 Week 1
Slide 13: iDose Travoprost: Micro-Scale Rx Injectable Therapy
iDoseTM Travoprost: Micro-Scale Rx Injectable Therapy Medical Needs Address high rates of patient non-adherence with topical glaucoma regimens Provide sufficient duration of effect with favorable risk profile iDose Clinical Goals To achieve non-inferiority IOP reduction (comparable results) to exist
Slide 14: iDose Travoprost Procedure
iDoseTM Travoprost Procedure iDose Travoprost is an unapproved drug and limited by US law to investigational use 14 © 2018 Glaukos Corporation
Slide 15: Combination-Cataract Therapy for Mild to Moderate OAG
Combination-Cataract Therapy for Mild to Moderate OAG OCULAR HYPERTENSION REFRACTORY 4 mm implant, curved to follow ocular anatomy FDA approved in 2012; flagship MIGS device FDA approved in 2018 OAG Progression MILD Two heparin-coated titanium trabecular bypass stents, each providing multi-direction
Slide 16: iStent Real-World Clinical Experience
iStent® Real-World Clinical Experience of Single with Cataract Surgery at 54 months 19.4 20 16 Preop Year 1 Year 2 Year 3 Year 4 Year 5 Final Consistent cohort of 107 OAG eyes followed through 2 years achieved mean IOP reduction of 22% and 56% reduction in mean medications Ferguson J Berdahl J Clini
Slide 17: iStent inject Meets Primary and Secondary Pivotal Trial Endpoints
iStent inject® Meets Primary and Secondary Pivotal Trial Endpoints Additional showed: observed data •20% Reduction in Unmedicated IOP 75.8% Mean Unmedicated Prospective trial with 41 sites and 505 OAG subjects 387 subjects randomized to iStent inject in combination with cataract surgery 118 subjects
Slide 18: Peer-Reviewed Publications on iStent Therapy
inject® or Multiple iStent® 26 Peer-Reviewed Publications on iStent Therapy inject® + iStent inject® + Cataract Surgery iStent Cataract Surgery Reduction in Preop 6 months-1 Preop Postop Retrospective, single-site case series of 179 eyes with varying glaucoma severity and concomitant cataract surger
Slide 19: Facile, Click-and-Release 2-Stent Procedure
Facile, Click-and-Release 2-Stent Procedure iStent inject is not approved by the FDA GLAUK! s· 20 © 2018 Glaukos Corporation
Slide 20: MIGS Standalone Solution for Advanced and Refractory OAG
MIGS Standalone Solution for Advanced and Refractory OAG OCULAR HYPERTENSION REFRACTORY Titratable Stent Therapy TM OAG Progression MILD Three heparin-coated trabecular bypass stents, preloaded into auto injection system ADVANCED MODERATE Enhanced insertion system provides unlimited activations and
Slide 21: MIGS Standalone Solution for Advanced and Refractory OAG
MIGS Standalone Solution for Advanced and Refractory OAG iStent infinite is not approved by the FDA 22 © 2018 Glaukos Corporation
Slide 22: Standalone 2-Stent Therapy for Mild to Moderate OAG
Standalone 2-Stent Therapy for Mild to Moderate OAG OCULAR HYPERTENSION ® REFRACTORY OAG Progression MILD 2 Standalone Stents Two heparin-coated titanium stents, preloaded into auto injection system ADVANCED MODERATE Tapered insertion sleeve yields smooth insertion during closed-chamber procedure in
Slide 23: Market Leader with Market-Expanding Pipeline vs. Single-Product Competitors
Market Leader with Market-Expanding Pipeline vs. Single-Product Competitors Mild to Moderate Alcon CyPassTM • 6.35 mm polyimide shunt implanted ab interno into suprachoroidal space • Approved by FDA in 2016 for combo-cataract procedures; voluntarily withdrawn from market in 2018 Refractory Allergan
Slide 24: Potentially Expanding Our Annual Market Opportunity
Potentially Expanding Our Annual Market Opportunity 7x+ US Annual (eyes) Opportunity* OHT/POAG prevalence: ~18M eyes 8.2M eyes diagnosed and treated Growing 3.5% annually 33% of standalone OHT/POAG population is pseudophakic Combination therapy drives more opportunity for Glaukos portfolio ~ 4.3M ~
Slide 25: MIGS and Beyond Platform Development
MIGSANDBEYOND Platform Development 26 © 2018 Glaukos Corporation
Slide 26: Glaukos Platform Pillars
Glaukos Platform Pillars • MIGS pioneer with unrivaled portfolio of micro-scale glaucoma devices Breakthrough ab interno surgical innovation Deep experience and demonstrated track record in micro-engineering design, assembly and manufacturability Regulatory strategy and market positioning focused on
Slide 27: Glaukos Platform Pillars
Glaukos Platform Pillars • Leveraging unique expertise in micro-mechanical design, assembly and filling processes Building seasoned ocular drug delivery team of 30+ chemists, scientists and engineers from leading pharmaceutical companies Entered into pharmaceutical development agreement with D. West
Slide 28: Glaukos: Key Takeaways
Glaukos: Key Takeaways Delivering novel surgical and pharmaceutical glaucoma therapy Validating iDoseTM drug delivery system and developing new sustained pharmaceuticals platform Extending leadership in MIGS treatment class with industry’s most comprehensive surgical offering Delivering solid cadenc
Slide 29: 30 © 2018 Glaukos Corporation 3
30 © 2018 Glaukos Corporation 3