Glaukos Corporation · NYSE:GKOS
Glaukos — Investor Presentation (January 2024)
24 slides from Glaukos's investor presentation, January 2024
Slide 1: Investor Presentation January 2024
Investor Presentation January 2024
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. These statements are based on management’s current e
Slide 3: The iDose TR Journey
The iDose® TR Journey Nearly two decades of investment and commitment 134K SQ FEET $500+ build-out of MILLION iDose TR manufacturing facilities that meet 100K+ invested in R&D appropriate PAGES 1150 since 2018 to regulatory, CMC and advance iDose TR in NDA ISO 7 guidelines submission to and other in
Slide 4: iDose TR is FDA-approved
iDose TR is FDA-approved Our pioneering journey is just beginning Revolutionary, micro-invasive, injectable treatment for the full range of glaucoma disease severity First-ever long-duration procedural pharmaceutical designed to deliver up to 3 years of glaucoma drug therapy © 2024 Glaukos Corporati
Slide 5: iDose TR: Groundbreaking Glaucoma Advancement
iDose TR: Groundbreaking Glaucoma Advancement Designed to provide 24/7, continuous, long- <0.5mm duration drug therapy to address ubiquitous patient non-compliance with topical medications 1.8mm INDICATIONS AND USAGE iDose TR is a prostaglandin analog indicated for the reduction of intraocular Uniqu
Slide 6: Addresses Important Clinical Needs
iDose TR: Addresses Important Clinical Needs High rates of non-compliance and non-adherence to topical medications contribute to disease progression Complex dosing regimens, Topical medications are the dominant treatment instillation difficulties and plan for the roughly 18M US eyes1 affected by chr
Slide 7: Phase 3 Data Validates Game-Changing Potential
iDose TR: Phase 3 Data Validates Game-Changing Potential IOP REDUCTIONS FROM BASELINE OBSERVED DURING FIRST IOP VALUES ON PRE-STUDY PGAs, AFTER PGA WASHOUT AND AT 3 MONTHS OF iDOSE TR 3 MONTHS1 iDose TR 24 Timolol 0.5% BID In-Study iDose • 125 subjects across both Phase 3 trials Pre-study 23.8 TR: w
Slide 8: Phase 3 & Phase 2b Data Confirms Long Duration of iDose TR
iDose TR: Phase 3 & Phase 2b Data Confirms Long Duration 81% of iDose TR subjects in the Phase 3 trials were completely free of IOP-lowering topical medications at 12 months % OF iDOSE TR SUBJECTS WELL-CONTROLLED1 ON THE SAME OR FEWER IOP- % PATIENTS WELL CONTROLLED1 ON THE SAME OR FEWER LOWERING TO
Slide 9: Pharmacokinetic Clinical Study Results
iDose TR: Pharmacokinetic Clinical Study Results iDose TR shown to deliver therapeutically relevant and durable drug concentrations through 24 months MEAN TFA CONCENTRATIONS Mean TFA levels were above CMAX Open label, single-center study concentration of TFA (1.78 ng/mL) to determine in-patient drug
Slide 10: Phase 3 & Phase 2b Results Show Excellent Safety
iDose TR: Phase 3 & Phase 2b Results Show Excellent Safety PHASE 3 AND PHASE 2B SAFETY DATA FDA APPROVAL: PRESCRIBING SAFETY INFORMATION Ph 3 Trials Ph 2b Trial Topical PGAs 1 Year 3 Years In controlled studies, the No adverse events of Up to 70% incidence most common ocular adverse periorbital fat
Slide 11: iDose TR: Major Addition to Interventional Glaucoma Arsenal
iDose TR: Major Addition to Interventional Glaucoma Arsenal Up to 240° of powerful outflow coverage for patients who failed prior medical and Designed to provide 24/7 long-duration sustained release of travoprost surgical therapy directly into the anterior chamber; for full range of disease progress
Slide 12: iDose TR: Launch Strategy to Follow Proven Glaukos Playbook
iDose TR: Launch Strategy to Follow Proven Glaukos Playbook REVOLUTIONIZING G L A U C O M A T H E R A P Y 2012-Today: Glaukos pioneers 2023+: Glaukos launches first- combo-cataract MIGS ever micro-invasive implantable treatment class, establishing device for standalone glaucoma new standard of glauc
Slide 13: iDose TR: Commercial Launch Strategy
iDose TR: Commercial Launch Strategy Methodical, controlled Anticipate Accelerate marketing Commercial production underway launch commences permanent J-code investments as at state-of-the-art nano- in 2H 2024 universe of trained manufacturing facility Surgeon training begins, surgeons expands Robust
Slide 14: iDose TR: Commercial Launch Strategy
iDose TR: Commercial Launch Strategy Leverage large, well-established US glaucoma Initially positioned for patients who can most commercial organization benefit from this unique therapy: Non-compliant glaucoma patients Glaucoma patients who are intolerant to topical ~70 Regional business and aca
Slide 15: Enabling Patient Access is Critical
iDose TR: Enabling Patient Access is Critical BILLING & SPECIALTY CODING • Patient Counseling PHARMACY SUPPORT • Benefit Verification • Denials and Appeals • BV Portal REIMBURSEMENT LIAISON CO-PAY • Billing and Coding ASSISTANCE Support • Policy Reviews PROGRAM © 2024 Glaukos Corporation 15
Slide 16: iDose TR Exemplifies the Power of our Novel Platforms
iDose TR Exemplifies the Power of our Novel Platforms Ocular Hypertension and Five distinct technology platforms capable Open-Angle Glaucoma of generating multiple new dropless therapies designed to disrupt conventional treatment paradigms $500M invested in R&D since 2018 AMD DME RVO 14 Disclosed pi
Slide 17: Key Pipeline Milestones Achieved in 2023
Key Pipeline Milestones Achieved in 2023 PROGRAM PATIENT CLINICAL BENEFIT 2023 MILESTONE ACHIEVED GLAUCOMA Mild-to-Moderate iStent infinite Glaucoma MIGS therapy Commenced PMA pivotal trial Q4 iDose TR OHT-Glaucoma Sustained, long-duration drug therapy FDA approval Q4 iLution Travoprost Transdermal
Slide 18: Key Pipeline Milestone Targets for 2024
Key Pipeline Milestone Targets for 2024 PROGRAM PATIENT CLINICAL BENEFIT 2024 MILESTONE TARGET GLAUCOMA Mild-to-Moderate Advance enrollment in PMA iStent infinite MIGS therapy Glaucoma pivotal trial PRESERFLO Advanced-Refractory Ab-externo device for late-stage glaucoma Commence US IDE trial in 2024
Slide 19: One of the Most Formidable Pipelines in Ophthalmology
One of the Most Formidable Pipelines in Ophthalmology PRODUCT PATIENT STATUS iStent / iStent inject / iStent inject W Mild-to-Moderate Glaucoma with Cataract FDA Approved (2012, 2018, 2020) iStent infinite Glaucoma (failed on prior therapy) FDA Cleared (2022) iStent infinite Glaucoma (label expansio
Slide 20: Solid Financial & Operational Footing to Support Growth Plans
Solid Financial & Operational Footing to Support Growth Plans NET SALES 1 GLOBAL INFRASTRUCTURE GROSS MARGIN 2 83% (in millions) $350-360 (Q3 2023) 17 275 $313+ $283 + 20% 8-year CAGR Countries with Global commercial direct operations personnel 2022 2023 2024 SPECIALIZED MANUFACTURING SALES MIX HEAL
Slide 21: 2024: The Future is Now
2024: The Future is Now Major 2023 accomplishments … …position us for pivotal year in 2024! iDose TR approved; completion of new manufacturing facilities with unblemished PAI; US Enable iStent infinite adoption in standalone commercial team readied for launch procedures for patients with advanced di
Slide 22: We'll Go First
WE’LL GO FIRST Innovation is at the core of everything we do. At Glaukos, we push the limits of science and technology to solve unmet needs in chronic eye diseases.
Slide 23: © 2024 Glaukos Corporation 23
© 2024 Glaukos Corporation 23
Slide 24: GAAP to Non-GAAP Reconciliation - 3Q 2023
Appendix GAAP to Non-GAAP Reconciliation - 3Q 2023 3Q 2023 GAAP Amort. of Dev 3Q 2023 Non-GAAP Gross Margin Tech Intangibles Gross Margin Net Sales $ 78,048 $ 78,048 COGS $ 18,510 $ (5,523) $ 12,987 Gross Profit $ 59,538 $ 5,523 $ 65,061 Gross Margin 76% 83% © 2024 Glaukos Corporation 24