Glaukos Corporation · NYSE:GKOS
Glaukos — Investor Presentation (August 2024)
23 slides from Glaukos's investor presentation, Aug 9, 2024
Slide 1: Investor Presentation August 2024
Investor Presentation August 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 $600+ 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: 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: Groundbreaking Glaucoma Advancement
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: iDose TR Pharmacokinetic Clinical Study Results
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 5492 classification) effective 4/1 Permanent J-code (J7355) effective 7/1 Accelerate marketing investments
Slide 14: Commercial Launch Strategy
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 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 18: 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 19: Solid Financial & Operational Footing to Support Growth Plans
Solid Financial & Operational Footing to Support Growth Plans © 2024 Glaukos Corporation 19 NET SALES1 (in millions) 2022 2023 $315 $283 30%+ 10-year CAGR 52% 27% 21% SALES MIX (2Q 2024) US Glaucoma Corneal Health Int’l Glaucoma 1 FY2024: Net sales guidance as of 7/31/2024 2 2Q 2024 gross margin adj
Slide 20: 2024: The Future is Now
2024: The Future is Now © 2024 Glaukos Corporation 20 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 21: 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 22: © 2024 Glaukos Corporation 22
© 2024 Glaukos Corporation 22
Slide 23: Appendix: GAAP to Non-GAAP Reconciliation - 2Q 2024
Appendix © 2024 Glaukos Corporation 23 2Q 2024 GAAP Amort. of Dev 2Q 2024 Non-GAAP Gross Margin Tech Intangibles Gross Margin Net Sales $ 95,690 $ 95,690 COGS $ 22,550 $ (5,523) $ 17,027 Gross Profit $ 73,140 $ 5,523 $ 78,663 Gross Margin 76% 82% GAAP to Non-GAAP Reconciliation - 2Q 2024