Glaukos Corporation · NYSE:GKOS
Glaukos — Investor Presentation (November 2018)
30 slides from Glaukos's investor presentation, Nov 16, 2018
Slide 1: November 2018
1 © 2018 Glaukos Corporation 1 November 2018
Slide 2: Forward-looking statements
2 © 2018 Glaukos Corporation 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
Slide 3: Our Mission and Long-term Goal
3 © 2018 Glaukos Corporation We are transforming glaucoma therapy… OUR MISSION TODAY To pioneer and lead the global glaucoma market with micro- scale injectable therapies that advance the standard-of-care and enrich the lives and treatment alternatives for glaucoma patients worldwide. O U R L O N G
Slide 4: 2018 Key Objectives
4 © 2018 Glaukos Corporation 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 in our inter
Slide 5: Demonstrated Financial Performance
5 © 2018 Glaukos Corporation 2013 2014 2015 2016 Total Net Sales (in millions) 86% Q3 2018 Gross Margin $138M Cash & Short-Term Equivalents* * As of 9/30/2018 Demonstrated Financial Performance 21.0 45.6 71.7 114.4 159.3 20182017 40.1 43.2 43.9 Q3Q1 Q2 4-Yr CAGR: 66%
Slide 6: MIGS and Beyond: Delivering Novel Surgical & Pharmaceutical Glaucoma Therapy
6 © 2018 Glaukos Corporation MIGS AND BEYOND Delivering Novel Surgical & Pharmaceutical Glaucoma Therapy
Slide 7: Current OAG Treatment Algorithm
7 © 2018 Glaukos Corporation Ocular Hypertension IOP of 21-30 mm Hg Target IOP 20% ↓ from baseline; ≤ 18 mm Hg Treatment 0-1 med Mild OAG IOP of 25-30 mm Hg with minor optic nerve damage and visual field loss Moderate OAG IOP of > 30 mm Hg with moderate optic nerve damage and visual field loss Advan
Slide 8: Portfolio of Micro-Scale Injectable Therapy
8 © 2018 Glaukos Corporation OAG Progression OCULAR HYPERTENSION MILD MODERATEADVANCED REFRACTORY Addressing full range of glaucoma disease states and progression Injectable drug delivery implant; sustained drug therapy for extended periods Envision use alone or in combination with other MIGS device
Slide 9: 5 in 5: Estimated Cadence of Major New U.S. Product Introductions
9 © 2018 Glaukos Corporation OAG Progression OCULAR HYPERTENSION MILD MODERATEADVANCED REFRACTORY 2021-22 2018 2020 2020-21 5 in 5: Estimated Cadence of Major New U.S. Product Introductions REFRACTORYADVANCEDMODERATEMILDOCULAR HYPERTENSION 2023 iStent SA, iStent Supra, iStent infinite and iDose are
Slide 10: iDose Travoprost: First-of-a-Kind Intraocular Drug Delivery Device
10 © 2018 Glaukos Corporation Drug Reservoir Scleral Anchor Retaining Cap Elution Membrane Titanium implant (1.8 mm x 0.5 mm) designed for continuous drug delivery directly into anterior chamber Filled with proprietary, novel and uber-potent formulation of travoprost; membrane-controlled Fickian elu
Slide 11: iDose Travoprost US Phase II: Preliminary Efficacy Results
11 © 2018 Glaukos Corporation 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 Represents 32-33% reduction in the implant arms Average IOP Reductions from Baseline through Month 12* Fast Elution Slow
Slide 12: iDose Travoprost US Phase II: Mean Number of Medications
12 © 2018 Glaukos Corporation iDoseTM Travoprost US Phase II: Preliminary Efficacy Results Mean Number of Medications Fast Elution Slow Elution Timolol 0.5% n= 51 54 49 50 53 49 35 42 40 25 24 25 iDose Travoprost is an unapproved drug and limited by US law to investigational use 0.22 0.40 0.51 0.56
Slide 13: iDose Travoprost: Micro-Scale Rx Injectable Therapy
13 © 2018 Glaukos Corporation iDoseTM Travoprost: Micro-Scale Rx Injectable Therapy iDose Clinical Goals To achieve non-inferiority IOP reduction (comparable results) to existing topical glaucoma therapies To provide a maximal therapeutic period of IOP control (minimum of 6 months) To minimize side
Slide 14: iDose Travoprost Procedure
14 © 2018 Glaukos Corporation iDoseTM Travoprost Procedure iDose Travoprost is an unapproved drug and limited by US law to investigational use
Slide 15: iDose Travoprost Exchange (Removal) Procedure
15 © 2018 Glaukos Corporation iDoseTM Travoprost Exchange (Removal) Procedure iDose Travoprost is an unapproved drug and limited by US law to investigational use
Slide 16: Combination-Cataract Therapy for Mild to Moderate OAG
16 © 2018 Glaukos Corporation FDA approved in 2018 Two heparin-coated titanium trabecular bypass stents, each providing multi-directional flow Auto-injection inserter allows surgeon to precisely implant stents through single corneal entry point in straightforward, click-and-release motion Combinatio
Slide 17: Real-World Clinical Experience of Single iStent with Cataract Surgery
17 © 2018 Glaukos Corporation Real-World Clinical Experience of Single iStent® with Cataract Surgery Case series showed 16% reduction in mean medicated IOP; after mean follow- up of 54 months, 42% of patients were medication free Arriola-Villalobos P et al British Journal of Ophthalmology 2012 Mean
Slide 18: iStent inject Meets Primary and Secondary Pivotal Trial Endpoints
18 © 2018 Glaukos Corporation Samuelson T, ASCRS 2018 iStent inject® Meets Primary and Secondary Pivotal Trial Endpoints Prospective trial with 41 sites and 505 OAG subjects 387 subjects randomized to iStent inject in combination with cataract surgery 118 subjects randomized to cataract surgery only
Slide 19: Peer-Reviewed Publications on iStent inject or Multiple iStent Therapy
19 © 2018 Glaukos Corporation 26 Peer-Reviewed Publications on iStent inject® or Multiple iStent® Therapy Consecutive case series study in primarily OAG eyes; 81 implanted with iStent inject in combination with cataract surgery Hengerer F. ASCRS 2018 Mean IOP mmHg 22.6 14.8 14.5 14.3 12 16 20 24 28
Slide 20: Facile, Click-and-Release 2-Stent Procedure
20 © 2018 Glaukos Corporation Facile, Click-and-Release 2-Stent Procedure
Slide 21: MIGS Standalone Solution for Advanced and Refractory OAG
21 © 2018 Glaukos Corporation MIGS Standalone Solution for Advanced and Refractory OAG Three heparin-coated trabecular bypass stents, preloaded into auto injection system Enhanced insertion system provides unlimited activations and smooth implantation of each stent across 5-6 clock hours of Schlemm’
Slide 22: MIGS Standalone Solution for Advanced and Refractory OAG
22 © 2018 Glaukos Corporation MIGS Standalone Solution for Advanced and Refractory OAG iStent infinite is not approved by the FDA
Slide 23: Standalone 2-Stent Therapy for Mild to Moderate OAG
23 © 2018 Glaukos Corporation Two heparin-coated titanium stents, preloaded into auto injection system Tapered insertion sleeve yields smooth insertion during closed-chamber procedure in pseudophakic patients Ability to enter the eye once to implant both stents in straightforward click-and- release
Slide 24: Market Leader with Market-Expanding Pipeline vs. Single-Product Competitors
24 © 2018 Glaukos Corporation 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 Ivantis HydrusTM • 8 mm nitinol device implanted ab interno into Schlemm’s canal •
Slide 25: Potentially Expanding Our Annual Market Opportunity
25 © 2018 Glaukos Corporation Potentially Expanding Our Annual Market Opportunity 7x+ 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 * 2017 ma
Slide 26: MIGS and Beyond: Platform Development
26 © 2018 Glaukos Corporation MIGS AND BEYOND Platform Development
Slide 27: Glaukos Platform Pillars: iStent
27 © 2018 Glaukos Corporation Glaukos Platform Pillars iStent inject® iStent® SA iStent infiniteTM iStent Supra® Restoring natural, physiological outflow iStent® • MIGS pioneer with unrivaled portfolio of micro- scale glaucoma devices • Breakthrough ab interno surgical innovation • Deep experience a
Slide 28: Glaukos Platform Pillars: iDose Travoprost
28 © 2018 Glaukos Corporation Glaukos Platform Pillars iDoseTM Travoprost Sustained therapy pharmaceuticals • 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 ph
Slide 29: Glaukos: Key Takeaways
29 © 2018 Glaukos Corporation 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 surgica
Slide 30: 30 © 2018 Glaukos Corporation 3 0
30 © 2018 Glaukos Corporation 3 0