Glaukos Corporation · NYSE:GKOS
Glaukos — Investor Presentation (January 2024)
24 slides from Glaukos's investor presentation, Jan 9, 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 © 2024 Glaukos Corporation 3 of research and development to bring iDose TR from ideation to commercialization 15+ YEARS $500+ MILLION invested in R&D since 2018 to advance iDose TR and other innovations, representing 30%+ of revenues 1150 SUBJECTS studied in Phase 3 FDA iDose T
Slide 4: Revolutionary, micro-invasive, injectable treatment for glaucoma; iDose TR is FDA-approved
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 Corporation 4 iDose TR is FDA-approved Our pioneering journey is just begin
Slide 5: iDose TR design and drug formulation
iDose TR: Groundbreaking Glaucoma Advancement Insertion System Precision-engineered to facilitate straightforward implantation Fixed and Stable Securely anchored into scleral tissue for drug elution directly into the anterior chamber Designed to provide 24/7, continuous, long-duration drug therapy t
Slide 6: Addresses Important Clinical Needs
iDose TR: Addresses Important Clinical Needs Topical medications are the dominant treatment plan for the roughly 18M US eyes1 affected by glaucoma and ocular hypertension Research2 shows that >90% of patients are non-compliant with medication use ~50% purposely discontinue their medication(s) within
Slide 7: Phase 3 Data Validates Game-Changing Potential
iDose TR: Phase 3 Data Validates Game-Changing Potential IOP Reductions from Baseline (mmHg) 8.5 6.6 7.7 6.5 6.7 8.4 6.8 7.2 Timolol 0.5% BID iDose TR In 2 pivotal trials (1,150 subjects randomized across both trials), iDose TR achieved pre-specified primary efficacy endpoints as agreed upon with US
Slide 8: Phase 3 & Phase 2b Data Confirms Long Duration
iDose TR: Phase 3 & Phase 2b Data Confirms Long Duration AT 12 MONTHS AT 24 MONTHS AT 36 MONTHS PH 3 93% PH 2B 92% 72% 69% of iDose TR subjects in the Phase 3 trials were completely 81% free of IOP-lowering topical medications at 12 months % OF iDOSE TR SUBJECTS WELL-CONTROLLED1 ON THE SAME OR FEWER
Slide 9: Pharmacokinetic Clinical Study Results through 24 months
iDose TR shown to deliver therapeutically relevant and durable drug concentrations through 24 months iDose TR: Pharmacokinetic Clinical Study Results Open label, single-center study to determine in-patient drug elution rate and aqueous humor (AH) exposure to travoprost free acid (TFA) 210 iDose TR p
Slide 10: iDose TR: Phase 3 & Phase 2b Results Show Excellent Safety
Ph 3 Trials 1 Year Ph 2b Trial 3 Years Topical PGAs No adverse events of periorbital fat atrophy Up to 70% incidence Very low conjunctival hyperemia 30%-50% incidence No adverse events of corneal endothelial cell loss Very low or no incidence of iris color change ~20% incidence iDose TR: Phase 3 & P
Slide 11: Major Addition to Interventional Glaucoma Arsenal
iDose TR: Major Addition to Interventional Glaucoma Arsenal Glaukos is uniquely positioned to lead development of the Interventional Glaucoma opportunity G L A U C O M A T H E R A P Y Designed to provide 24/7 long-duration sustained release of travoprost directly into the anterior chamber; for full
Slide 12: Launch Strategy to Follow Proven Glaukos Playbook
iDose TR: Launch Strategy to Follow Proven Glaukos Playbook G L A U C O M A T H E R A P Y © 2024 Glaukos Corporation 12 2012-Today: Glaukos pioneers combo-cataract MIGS treatment class, establishing new standard of glaucoma care Annual US opportunity: ~500K eyes1 2024+: Glaukos introduces the next m
Slide 13: Commercial Launch Strategy
iDose TR: Commercial Launch Strategy Methodical, controlled launch commences Surgeon training begins, focused on glaucoma specialists Establishment of Cat III CPT code (0660T) for facility (APC classification) Anticipate permanent J-code in 2H 2024 Accelerate marketing investments as universe of tra
Slide 14: Commercial Launch Strategy: target patients
iDose TR: Commercial Launch Strategy Initially positioned for patients who can most benefit from this unique therapy: ✓ Non-compliant glaucoma patients ✓ Glaucoma patients who are intolerant to topical glaucoma drops ✓ Glaucoma patients with underlying co-morbidities (e.g., dry eye) ✓ Glaucoma patie
Slide 15: Enabling Patient Access is Critical
iDose TR: Enabling Patient Access is Critical REIMBURSEMENT LIAISON • Patient Counseling • Benefit Verification • Denials and Appeals • BV Portal • Billing and Coding Support • Policy Reviews CO-PAY ASSISTANCE PROGRAM SPECIALTY PHARMACY BILLING & CODING SUPPORT © 2024 Glaukos Corporation 15
Slide 16: iDose TR Exemplifies the Power of our Novel Platforms
iStent Micro-Scale iDose Sustained-Release iLin k Bio-Activat e d iLution Eyelid Delivery Retina XR Bio-Erodible IVT Ocular Hypertension and Open-Angle Glaucoma Dry Eye Keratoconus Glaucoma Presbyopia Blepharitis AMD DME RVO iDose TR Exemplifies the Power of our Novel Platforms © 2024 Glaukos Corpor
Slide 17: Key Pipeline Milestones Achieved in 2023
Key Pipeline Milestones Achieved in 2023 PROGRAM PATIENT CLINICAL BENEFIT 2023 MILESTONE ACHIEVED GLAUCOMA iStent infinite Mild-to-Moderate Glaucoma MIGS therapy Commenced PMA pivotal trial iDose TR OHT-Glaucoma Sustained, long-duration drug therapy FDA approval iLution Travoprost (GLK-311) OHT-Glau
Slide 18: Key Pipeline Milestone Targets for 2024
Key Pipeline Milestone Targets for 2024 PROGRAM PATIENT CLINICAL BENEFIT 2024 MILESTONE TARGET GLAUCOMA iStent infinite Mild-to-Moderate Glaucoma MIGS therapy Advance enrollment in PMA pivotal trial PRESERFLO MicroShunt Advanced-Refractory Glaucoma Ab-externo device for late-stage glaucoma Commence
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 © 2024 Glaukos Corporation 20 NET SALES1 (in millions) 2022 2023 $313+ $283 20% 8-year CAGR 49% 26% 25% SALES MIX (Q3 2023) US Glaucoma Corneal Health Int’l Glaucoma 1 FY2023: Preliminary, unaudited net sales expected to be in excess of $
Slide 21: 2024: The Future is Now
2024: The Future is Now © 2024 Glaukos Corporation 21 Major 2023 accomplishments … …position us for pivotal year in 2024! Interventional Glaucoma (IG) introduced, realizing Glaukos’ founding promise to radically improve the conventional treatment paradigm with standalone therapies that slow progress
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: Appendix: GAAP to Non-GAAP Reconciliation - 3Q 2023
Appendix © 2024 Glaukos Corporation 24 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% GAAP to Non-GAAP Reconciliation - 3Q 2023