Glaukos Corporation · NYSE:GKOS
Glaukos — Investor Presentation (January 2023)
32 slides from Glaukos's investor presentation, Jan 10, 2023
Slide 1: Investor Presentation January 2023
Investor Presentation January 2023
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 curre
Slide 3: 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. © 2023 Glaukos Corporation 3
Slide 4: Our Core Strategy
Our Core Strategy 1. BIG IDEAS 2. SIGNIFICANT CLINICAL NEED 3. SPECIALIZED R&D TEAMS 4. EXPERIENCED SALES ORGANIZATION 5. PROVEN MARKET BUILDER 6. EFFICIENT GLOBAL OPERATIONS Designed to drive long - term growth and value creation © 2023 Glaukos Corporation 4
Slide 5: 2022: Strong execution, performance and milestone achievement
NEW R&D PROGRAMS 2022: Strong execution, performance and milestone achievement despite headwinds • Completed iLution DED and presbyopia Phase 2a trials • Advanced several pre - clinical R&D programs • New HQ, cornea innovation center and novel hybrid pharma mfg facility • Expanded infrastructure and
Slide 6: 2023: Continued progress to advance our strategy
2023: Continued progress to advance our strategy CORE FRANCHISES NEW R&D PROGRAMS NEAR - TERM PIPELINE • Develop standalone MIGS market • Combo - cataract execution • International glaucoma, iLink market - building initiatives take hold Expanding Core Offering & Potential New Pharma Programs on Deck
Slide 7: Glaucoma
GLAUCOMA Topical medications are the dominant treatment plan for the roughly 18M US eyes 1 affected by glaucoma and ocular hypertension Research 2 shows that > 90 % & 50 ~ % of patients are non - compliant with topical medication use purposely discontinue their medication within 6 months High rates
Slide 8: Interventional Glaucoma
INTERVENTIONAL GLAUCOMA Proactive glaucoma management via predictive diagnostics, active patient monitoring and procedural intervention earlier in the treatment paradigm to: • Improve patient management • Preserve visual function • Slow disease progression • Reduce or eliminate the need for topical
Slide 9: Our Big Ideas
invested in R&D since 2018 5 distinct platforms generating disruptive, dropless innovations across 3 franchises $400M 14 Disclosed pipeline programs in 2023 vs. 4 in 2015 invested in R&D since 2018 OUR BIG IDEAS Develop novel dropless therapies to disrupt legacy topical eye drop therapies plagued by
Slide 10: Interventional Glaucoma portfolio
INTERVENTIONAL GLAUCOMA Trabecular Bypass Goniotomy Viscodelivery Sustained - Release Subconjunctival With the only comprehensive glaucoma portfolio Glaukos is uniquely positioned to address this important unmet need and lead development of the Interventional Glaucoma opportunity Combo - Cataract St
Slide 11: Clinical Trial Results: iStent infinite
CLINICAL TRIAL RESULTS 5 76 ≥ % of subjects achieved 20% or greater reduction in mean IOP on same or lower medication burden 50 % of subjects achieved 30% or greater reduction in mean IOP First - ever micro - invasive implantable device for standalone glaucoma treatment • Three micro - stents provid
Slide 12: iDose TR
Designed to address ubiquitous patient non - adherence to and chronic side effects associated with topical medications by providing 24/7, long - duration, robust efficacy with minimal side effects The next major addition to the Interventional Glaucoma arsenal • Designed to provide longest - duration
Slide 13: iDose TR Phase 3 primary efficacy
In 2 pivotal trials, iDose TR fast - and slow - release doses achieved pre - specified primary efficacy endpoints as agreed upon with US FDA (non - inferiority to topical timolol through 3 months) Positive Phase 3 trial results expected to support upcoming NDA submission for slow - release iDose TR
Slide 14: Phase 3 and Phase 2b data validate long duration of iDose TR
Phase 3 and Phase 2b data validates long duration of iDose TR iDose TR: The data that matters to doctors, patients and payors AT 12 MONTHS AT 24 MONTHS AT 36 MONTHS PH 3 93% Percentage of slow - release iDose TR subjects well - controlled on the same or fewer IOP - lowering topical medications PH 2B
Slide 15: Phase 2b: iDose TR controls IOP in more patients at 3 years
GC - 009 Timolol 0.5% BID Slow - release iDose TR % PATIENTS WELL CONTROLLED ON THE SAME OR FEWER TOPICAL IOP - LOWERING MEDS IN PHASE 2B TRIAL AT 3 YEARS Phase 2b: iDose TR arm controls IOP in more patients vs eyedrop arm at 3 years 69% 45% 2,190 eye drops administered per eye per 3 - yr protocol i
Slide 16: iDose TR safety profile
Phase 3 and Phase 2b data confirm iDose TR’s highly favorable safety profile iDose TR: The data that matters to doctors, patients and payors iDose TR Topical PGAs Ph 3 Trials 1 Year Ph 2b Trial 3 Years No adverse events of periorbital fat atrophy Up to 70% incidence Very low or no conjunctival hyper
Slide 17: iDose TR exchange trial
• Prospective, multi - center trial to evaluate safety of exchange procedure • Study enrolled 33 subjects previously implanted in iDose TR Phase 2b study • Subject’s study eye underwent surgical exchange with slow - release iDose TR model, with 12 - month follow - up • Average overall extended evalu
Slide 18: iDose TR potential to address patient non-compliance
iDose TR has potential to address rampant problem of patient non - compliance with topical glaucoma medications iDose TR is not approved by the FDA As part of the Phase 3 trials, in - office administration of iDose TR was successfully employed with various subjects across multiple sites with outcome
Slide 19: Interventional Glaucoma portfolio: product and patient status
PRODUCT PATIENT STATUS COMBO - CATARACT iStent / iStent inject / iStent inject W Mild - to - Moderate Glaucoma with Cataract Approved (2012 / 2018 / 2020) STANDALONE iStent infinite Glaucoma (failed on prior medical and surgical therapy) FDA cleared iStent infinite Glaucoma (label expansion) IDE pla
Slide 20: iLink Platform
iLINK PLATFORM Bio - activated corneal cross - linking therapy for keratoconus, a sight - threatening, life - altering disease with typical onset in adolescence First and only FDA - approved bio - activated pharmaceutical therapy shown to slow or halt progression of keratoconus. Without effective tr
Slide 21: Epioxa Phase 3 results
- 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 counts over course of trial) determined as prospectively defined least square mean Kmax c
Slide 22: iLution Platform
iLUTION PLATFORM Transdermal dropless therapy with the potential to treat a variety of chronic eye diseases and disorders PRODUCT/ PROGRAM PATIENT STATUS iLution Dry Eye Dry Eye Phase 2 iLution Presbyopia Presbyopia Phase 2 iLution Blepharitis Demodex Blepharitis Pre - clinical iLution Travoprost OH
Slide 23: iLution Dry Eye Phase 2a trial
- 8.5 - 8.2 Trial demonstrated excellent safety and tolerability • 98% of patients completed the trial • No ocular adverse events occurring at incidence of 5% or greater Improvement in the quality of tear film (tear break - up time sign) with corresponding improvement in quality of vision (reduction
Slide 24: Retina XR Platform
RETINA XR PLATFORM Addressing the significant drawbacks of conventional therapies for retinal diseases PRODUCT/ PROGRAM PATIENT STATUS IVT Multi - Kinase Inhibitor AMD, DME, RVO Pre - clinical IVT Triamcinolone DME Pre - clinical DISCLOSED PIPELINE PROGRAMS Targeting biodegradable, small - molecule
Slide 25: Retina XR data supports first-in-human trial in 2023
- 8.5 - 8.2 Retina XR: Data supports expedited first - time - in - human trial in 2023 20+ months of vascular leakage prevention in rabbit model of AMD IVT multi - kinase inhibitor continues to demonstrate robust and durable effect in vivo 0 5 10 15 20 25 30 35 40 0 100 200 300 400 500 600 700 Vascu
Slide 26: Attractive financial profile provides solid foundation
Attractive financial profile provides solid foundation NET SALES 1 ( in millions ) 2015 TTM 3Q 22 $72 $285 MARGINS 75% 84% 2014 GROSS MARGIN 2 2022 $371 $104 2015 2022 CASH AND EQUIVALENTS 3 (in millions) 20%+ 7YR CAGR SALES MIX Q3 2015 Q3 2022 US Glaucoma Corneal Health Int’l Glaucoma © 2023 Glauko
Slide 27: Efficient, scalable global platform supports growth
Efficient, scalable global platform supports growth 2015 2023 65 275+ GLOBAL COMMERCIAL PERSONNEL COUNTRIES WITH DIRECT SALES 2014 2 2023 17 Complemented by distributor and hybrid models in 35 additional countries NEW STATE - OF - THE - ART HYBRID PHARMACEUTICAL MANUFACTURING FACILIT Y © 2023 Glauko
Slide 28: Our Current Portfolio
MARGINS OUR CURRENT PORTFOLIO Disrupting treatment paradigms with dropless therapies that address important needs 14 disclosed pipeline programs across 5 distinct platforms © 2023 Glaukos Corporation 28 PRODUCT PATIENT GLAUCOMA iStent / iStent inject / iStent inject W Mild - to - Moderate Glaucoma w
Slide 29: Our Future Portfolio
MARGINS PRODUCT PATIENT GLAUCOMA iStent / iStent inject / iStent inject W Mild - to - Moderate Glaucoma with Cataract iStent infinite Glaucoma Standalone (failed on prior therapy) iStent infinite Glaucoma Standalone (label expansion) PreserFlo Advanced - Refractory Glaucoma Standalone iDose TR OHT -
Slide 30: Glaukos: Transforming Vision
GLAUKOS TRANSFORMING VISION
Slide 31: GAAP to Non-GAAP Reconciliation - 3Q 2022
Appendix Amort. of Stock-based Dev Tech Comp Exp on 3Q 2022 GAAP Intangibles Replacement 3Q 2022 Non-GAAP Gross Margin Awards Gross Margin Net Sales 71,269 $ 71,269 $ COGS 16,861 $ (5,523) $ (13) $ 11,325 $ Gross Profit 54,408 $ 5,523 $ 13 $ 59,944 $ Gross Margin 76% 84% GAAP to Non-GAAP Reconciliat
Slide 32: References
References 1 Based on company analysis of Market Scope, Medicare Claims and IMS Health Compliance data 2 Nordstrom BL, Friedman DS, Mozaffari E, Quigley H, Walker AM. Persistence and adherence with topical glaucoma therapy. Am J Op hthalmol. 2005;140(4): 598 - 606 3 Malihi M, Moura, Filho ER, Hodge