Glaukos Corporation · NYSE:GKOS
Glaukos — Investor Presentation (November 2021)
28 slides from Glaukos's investor presentation, Nov 22, 2021
Slide 1: Investor Relations Presentation November 2021
1 © 2021 Glaukos Corporation Investor Relations Presentation NOVEMBER 2021
Slide 2: Disclaimer
2 © 2021 Glaukos Corporation 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. These statements are ba
Slide 3: Building a World-Class Global Infrastructure & Company
3 © 2021 Glaukos Corporation $46 … $438 $104 2021 2015 87% 75% 2021 2014 GROSS MARGIN1 CASH & EQUIVALENTS (IN MILLIONS) 2 1 FY2014 GAAP & non-GAAP gross margin; 3Q 2021 GAAP gross margin of 79% was adjusted for certain Avedro merger-related accounting and other adjustments - see Appendix for details
Slide 4: Our Strategy For Long-Term Growth & Profitability
4 © 2021 Glaukos Corporation Micro-Scale Surgical Devices Pharmaceuticals Biosensors Ocular Hypertension to Refractory Disease Glaucoma Corneal Health Keratoconus Ocular Surface Disease Refractive Conditions Retinal Disease Wet AMD DME RVO MAJOR PLATFORMS THERAPEUTIC CLASSES Our Strategy For Long-Te
Slide 5: Serving the Clinical Needs of Large Patient Populations
5 © 2021 Glaukos Corporation 1 Estimate based on Glaukos algorithm of physician preference and combination therapy, utilization; assumes full product portfolio availability to physician, except pre-clinical products (iDose TREX, iDose Rock, IOP Sensor); 2 Company estimates of US opportunity; 3 Marke
Slide 6: Glaucoma: 2021 Key Objectives
6 © 2021 Glaukos Corporation Ocular Hypertension to Refractory Disease Glaucoma SUBMIT ISTENT INFINITE TO FDA COMPLETE IDOSE TR PHASE 3 TRIAL ENROLLMENT R&D PROGRESS ON IDOSE TREX & IDOSE ROCK LAUNCH PRESERFLO & CONTINUE IPRIME DEVELOPMENT 2021 KEY OBJECTIVES ~18M eyes in US, growing 3%/yr1 ~36M eye
Slide 7: Glaucoma Micro-Surgical Portfolio
7 © 2021 Glaukos Corporation Glaucoma Micro-Surgical Portfolio ™ iStent infinite, iStent SA, iPRIME and PreserFlo are not approved by the FDA Designed to address full range of disease progression and facilitate combination therapies Creates 2 pathways for fluid outflow Creates 3 pathways for fluid o
Slide 8: iStent infinite: Powerful Standalone MIGS Indication
8 © 2021 Glaukos Corporation iStent infinite: Powerful Standalone MIGS Indication Three wide-flange stents preloaded in injector system that facilitates placement across ~6 clock hours of Schlemm’s canal US IDE open-label, single-arm study in a standalone procedure 72 subjects with open-angle glauco
Slide 9: iStent infinite Clinical Trial: Significant IOP Reduction
9 © 2021 Glaukos Corporation iStent infinite Clinical Trial: Significant IOP Reduction 76% of subjects achieved 20% or greater reduction in mean diurnal IOP from baseline on same or lower ocular hypotensive medication burden Highly favorable safety profile (no explants, infections or device-related
Slide 10: iStent infinite: Viable Alternative to More Complex Procedures
10 © 2021 Glaukos Corporation iStent infinite: Viable Alternative to More Complex Procedures Three-stent injectable will offer new compelling treatment option in standalone procedure with highly favorable safety profile Clinical data suggest iStent infinite may help patients with open- angle glaucom
Slide 11: Santen PreserFlo MicroShunt
11 © 2021 Glaukos Corporation Santen PreserFlo MicroShunt 8.5 mm tube made of biocompatible material (SIBS); standalone, ab-externo procedure to filter fluid from anterior chamber to subconjunctival space Designed to treat late-stage, refractory glaucoma Attractive alternative to trabeculectomy, tub
Slide 12: Introducing iPRIME
12 © 2021 Glaukos Corporation Introducing iPRIME™ iPRIME is a minimally invasive viscoelastic delivery system that further supports the needs of physicians and patients This complementary technology further expands Glaukos’ broad portfolio of innovative ophthalmic solutions Late-stage development pr
Slide 13: iDose TR
13 © 2021 Glaukos Corporation • Designed to provide longest duration intracameral pharmaceutical; secure and anchored design; facile implantation and exchange • Membrane designed to elute specially formulated travoprost, a commonly prescribed topical prostaglandin • Phase 3 clinical trial enrollment
Slide 14: Sustained-Release Pharmaceuticals: iDose TR Phase 2 Data
14 © 2021 Glaukos Corporation Sustained-Release Pharmaceuticals: iDoseTR iDose TR is not approved by the FDA Average Reduction in IOP PHASE 2 CLINICAL DATA AT 24 MONTHS* 154-patient, multi-center, randomized, double-blind trial Evaluated 2 iDose models with two different travoprost elution rates, co
Slide 15: Sustained-Release Pharmaceuticals: iDose TR 24-Month Results
15 © 2021 Glaukos Corporation Sustained-Release Pharmaceuticals: iDoseTR iDose patients experienced robust IOP-lowering over 24 months with continuous 24/7 compliance Over 24 months, iDose and timolol control groups progressed with similar number of protocol- mandated medications added iDose 24-mont
Slide 16: iDose TR Average IOP % Reduction from Baseline
16 © 2021 Glaukos Corporation Average IOP % Reduction from Baseline PHASE 2 CLINICAL DATA AT 24 MONTHS* iDose TR is not approved by the FDA 5 10 15 20 25 30 35 30% 28% 29% I O P % R e d u c t i o n f r o m B a s e l i n e iDose FE iDose SE Timolol 0.5% BID *Calculated using all IOP observations thro
Slide 17: iDose TR Designed to Address Shortcomings of Existing Therapies
17 © 2021 Glaukos Corporation Designed to address primary shortcomings of existing glaucoma topical and intracameral therapeutics Patients are generally poorly compliant with IOP-lowering eye drops iDose design implies 100% compliance once administered Improved compliance with glaucoma medications h
Slide 18: Sustained-Release Pharmaceuticals: Next Generation
18 © 2021 Glaukos Corporation iDose TR, iDose TREX and iDose ROCK are not approved by the FDA ® INTENDED DISEASE STATE Ocular Hypertension to Refractory OAG Substantial increase in drug payload, with potential to double the duration-of-effect vs first-generation iDose TR Same external dimensions, ti
Slide 19: Corneal Health: 2021 Key Objectives
19 © 2021 Glaukos Corporation 2021 KEY OBJECTIVES PREPARE FOR EPI- ON NDA FILING IN 2022 BEGIN CLINICAL TRIALS FOR EPI-ON NEXT GEN GENERATE FIRST CLINICAL DRY EYE CANDIDATE Common symptoms include burning, itching, foreign body sensation, stinging, dryness, transient blurring, swelling, ocular fatig
Slide 20: Corneal Health Pharmaceutical Platform: iLink
20 © 2021 Glaukos Corporation Corneal Health Pharmaceutical Platform: iLink Epoxia (Epi-on) Photrexa (Epi-off) Single-application, bio-activated topical pharmaceutical solution Uses photo-activation to create bonds between corneal collagen fibers Excellent efficacy and safety profile, extensive clin
Slide 21: iLink Epi-on Phase 3 Trial Achieved Primary Efficacy Outcome
21 © 2021 Glaukos Corporation iLink Epi-on Phase 3 Trial Achieved Primary Efficacy Outcome -1.0D Achieved primary efficacy outcome by demonstrating Kmax treatment effect of Well-tolerated procedure (majority of adverse events were mild and transient in nature; no change in corneal endothelial cell c
Slide 22: Corneal Health Pharmaceuticals: Eyelid Transdermal Platform
22 © 2021 Glaukos Corporation Corneal Health Pharmaceuticals: Eyelid Transdermal Platform Proprietary cream-based formulation applied to outer skin surface of the upper eyelids Anatomy of the eyelid with targeted sites Not approved by the FDA Patented, cream-based formulation designed to be applied
Slide 23: Retinal Disease: 2021 Key Objective
23 © 2021 Glaukos Corporation 2021 KEY OBJECTIVE MOVE FIRST RETINAL DISEASE PROGRAM INTO CLINIC Retinal disease affects ~28M people in the US AMD and diabetic eye disease make up 89% of this patient population Progressive disease characterized by degeneration of the macula, the portion of the retina
Slide 24: Retinal Disease Programs
24 © 2021 Glaukos Corporation Triamcinolone Acetonide SR RVO & DME Formulations developed to release triamcinolone acetonide for up to 6 months Microscope and SEM images of implants 1 Multi-Kinase Inhibitor SR Wet AMD, RVO & DME Developing a multi-kinase inhibitor small molecule sustained-release de
Slide 25: Product and Candidate Pipeline
25 © 2021 Glaukos Corporation PRODUCT/CANDIDATE PLATFORM / PRODUCT TYPE PATIENT STATUS Micro-Surgical Devices iStent Trabecular Bypass Stents Approved iStent inject / iStent inject W Trabecular Bypass Stents Approved iStent SA Trabecular Bypass Stents Pivotal IDE Trial iStent infinite Trabecular Byp
Slide 26: Delivering a Deep Pipeline of Disruptive Therapies
26 © 2021 Glaukos Corporation MARKET OPPORTUNITY 2015-2020 2021-22 2023-24 2025+ iStent iStent inject iStent inject W iLink Epi-off PreserFlo iStent infinite Delivering a Deep Pipeline of Disruptive Therapies iStent SA iDose TREX iDose Rock iLink Epi-on Next Gen Dry Eye Therapy Presbyopia Therapy De
Slide 27: GAAP to Non-GAAP Reconciliation - 3Q 2021
27 © 2021 Glaukos Corporation Appendix Amort. of Stock-based Dev Tech Comp Exp on 3Q 2021 GAAP Intangibles Replacement 3Q 2021 Non-GAAP Gross Margin Awards Gross Margin Net Sales 74,710 $ 74,710 $ COGS 15,370 $ (5,523) $ (180) $ 9,667 $ Gross Profit 59,340 $ 5,523 $ 180 $ 65,043 $ Gross Margin 79% 8
Slide 28: 28 © 2021 Glaukos Corporation
28 © 2021 Glaukos Corporation