Glaukos Corporation · NYSE:GKOS
Glaukos — iDose TR FDA Approval Conference Call & Webcast (December 2023)
24 slides from Glaukos's conference presentation, Dec 14, 2023
Slide 1: FDA Approval Conference Call & Webcast
(travoprost intracameral implant 75 mcg) FDA Approval CONFERENCE CALL & WEBCAST December 14, 2023 © 2023 Glaukos Corporation Page 1
Slide 2: Glaukos Participants
Glaukos Participants Tom Burns Chairman & CEO Joe Gilliam President & COO Alex Thurman Sr. VP & Chief Financial Officer Tomas Navratil, Ph.D. Chief Development Officer Chris Lewis VP, Investor Relations & Corporate Affairs © 2023 Glaukos Corporation Page 2
Slide 3: 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 4: iDose TR is approved by the FDA
iDose® TR is approved by the FDA 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 © 2023 Glaukos Corporation Page 4
Slide 5: iDose TR: Groundbreaking Glaucoma Advancement
iDose TR: Groundbreaking Glaucoma Advancement Designed to provide 24/7, continuous, long-duration drug <0.5mm therapy to address ubiquitous patient non-compliance with topical medications 1.8mm Unique Drug Formulation 75 mcg of a novel, proprietary, preservative-free travoprost formulation; ~25,000x
Slide 6: iDose TR Prescribing Information
iDose TR Prescribing Information CLINICAL TRIALS – EFFICACY INDICATIONS AND USAGE In the first 3 months following administration, iDose TR demonstrated an IOP change from baseline of -6.6 to -8.4 mmHg in the study eye of patients with a mean baseline IOP of 24 mmHg. iDose TR is a iDose TR demonstrat
Slide 7: iDose TR 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 Topical medications are the dominant treatment Complex dosing regimens, instillation difficulties and plan for the roughly 18M US eyes1 affected by chr
Slide 8: iDose TR Phase 3 Data Validates Game-Changing Potential
iDose TR: Phase 3 Data Validates Game-Changing Potential IOP REDUCTIONS FROM BASELINE OBSERVED DURING IOP VALUES ON PRE-STUDY PGAs, AFTER PGA WASHOUT, AND AT 3 MONTHS OF iDOSE TR FIRST 3 MONTHS1 24 In-Study iDose • 125 subjects across both Phase 3 trials iDose TR Timolol 0.5% BID 22 Pre-study 23.8 T
Slide 9: iDose TR: Phase 3 & Phase 2b Data Confirm Long Duration
iDose TR: Phase 3 & Phase 2b Data Confirm 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 TOP
Slide 10: iDose TR 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 levels were above CMAX Open label, single-center study MEAN TFA CONCENTRATIONS concentration of TFA (1.78 ng/mL) to determine in-patient drug
Slide 11: iDose TR: 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 most No adverse events of periorbital fat Up to 70% incidence common ocular adverse
Slide 12: iDose TR: Building a Robust Body of Published Clinical Evidence
iDose TR: Building a Robust Body of Published Clinical Evidence 1 Article published and available online ahead of print at https://pubmed.ncbi.nlm.nih.gov/38060092 (iDose TR Ph2b 3-year follow up results) 12 submissions to leading medical journals currently accepted, under review or in process 16+ e
Slide 13: 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 14: iDose TR Extensive Development Journey – Major Milestones
iDose TR Extensive Development Journey – Major Milestones 2008-2013 2014-2018 2019-2023 Dedicated 15+ years from ideation to Conducted foundational Proof of Concept Enrolled 1,150 subjects in commercialization (POC) and Phase 2 clinical trials rigorous Phase 3 clinical trials Formulated unique, pote
Slide 15: iDose TR Extensive Development Journey – Manufacturing Buildout
iDose TR Extensive Development Journey – Manufacturing Buildout State-of-the-art nanomanufacturing facilities and equipment, meeting appropriate regulatory, CMC and ISO 7 guidelines Manufacturing Facilities San Clemente, CA Multi-year effort to establish approximately 134K sq ft of manufacturing, wa
Slide 16: iDose TR – Preparing for Commercialization
iDose TR – Preparing for Commercialization Glaukos has become a leader in micro-scale manufacturing, with +20 years of experience, and using ISO 7 manufacturing environment with terminal sterilization © 2023 Glaukos Corporation Page 16
Slide 17: iDose TR Commercial Launch Strategy
iDose TR Commercial Launch Strategy Apply for permanent J-Code Anticipate permanent Accelerate marketing J-code in 2H 2024 investments as universe of Annual Methodical, controlled launch trained surgeons expands Opportunity of commences and market access is established ~1M eyes* Surgeon training beg
Slide 18: iDose TR Commercial Launch Strategy
iDose TR Commercial Launch Strategy Leverage large, well-established US glaucoma Initially positioned for patients who can commercial organization receive strong clinical benefit from this unique therapy: Non-compliant glaucoma patients Glaucoma patients who are intolerant to topical ~70 academi
Slide 19: Procedural Pharmaceuticals – Range of Annual WAC Pricing (Per Eye)
Procedural Pharmaceuticals – Range of Annual WAC Pricing (Per Eye) At a WAC price of $13,950, iDose TR is among the most cost-effective procedural pharmaceuticals in ophthalmology when annualized based on its design to deliver up to 3-years of drug therapy1 $3,000 and below $5,000 $10,000 $15,000 $2
Slide 20: Enabling Patient Access is Critical
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 © 2023 Glaukos Corporation Page 20
Slide 21: Corporate Philanthropy – iDose Your Dose
Corporate Philanthropy – iDose Your Dose PROGRAM We created the iDose Your Dose philanthropic initiative. For every iDose TR sold, Glaukos pledges to make available an equal number of iDose TR units for qualifying charitable donation requests around the globe.* MISSION Provide broad patient access t
Slide 22: 2023 and 2024 Revenue Guidance
2023 and 2024 Revenue Guidance $307-$310 Affirmed FY2023 revenue guidance range MILLION Highly preliminary FY2024 revenue guidance that factors in iDose launch plans, MIGS combo-cataract and iStent infinite $350-$360 landscape, as well as International Glaucoma and Corneal Health expectations MILLIO
Slide 23: Innovation is at the core of everything we do
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 24: © 2023 Glaukos Corporation Page 24
© 2023 Glaukos Corporation Page 24
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