Glaukos Corporation · NYSE:GKOS
Glaukos — Investor Presentation (March 2023)
32 slides from Glaukos's investor presentation, Mar 1, 2023
Slide 1: Investor Presentation March 2023
Investor Presentation March 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 current e
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 s
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 • iDo
Slide 7: Glaucoma
GLAUCOMA Topical medications are the dominant treatment plan for the roughly 18M US eyes1 affected by glaucoma and ocular hypertension Research2 shows that >90% & 50 ~ % of patients are non-compliant with topical medication use purposely discontinue their medication within 6 months High rates of non
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: dropless innovation across 3 franchises
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 comprehensive 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 C o m b o - C a t a r
Slide 11: iStent infinite clinical trial results
CLINICAL TRIAL RESULTS5 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 providing up t
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 therapy The next major addition to the Interventional Glaucoma arsenal • Designed to provide longest-duration intracameral pharmaceutical; secure and
Slide 13: iDose TR Phase 3 efficacy results
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 IOP Reduc
Slide 14: iDose TR Phase 3 and Phase 2b duration data
Phase 3 and Phase 2b duration data for 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 PH 2B 92% 72% 69% medications of slow
Slide 15: Phase 2b: iDose TR controls IOP in more patients at 3 years
GC-009 Slow-release iDose TR Timolol 0.5% BID % PATIENTS WELL CONTROLLED ON THE SAME OR FEWER TOPICAL IOP-LOWERING Phase 2b: iDose MEDS IN PHASE 2B TRIAL AT 3 YEARS 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 in Phase
Slide 16: iDose TR Phase 3 and Phase 2b safety data
Phase 3 and Phase 2b safety data for iDose TR 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 hyperemia 30%-50% incidence No adver
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 evaluation pe
Slide 18: iDose TR potential to address 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 employed with various subjects across multiple sites with outcomes that were consi
Slide 19: Interventional Glaucoma portfolio
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 planned
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 treatment, 1 i
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 chan
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 OHT
Slide 23: iLution Dry Eye Phase 2a trial
-8.5 -8.2 Trial demonstrated favorable 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 in
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 implant
Slide 25: Retina XR preclinical data
-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 Vascular Leakag
Slide 26: Attractive financial profile provides solid foundation
Attractive financial profile provides solid foundation NET SALES (in millions) 2015 2022 $72 $283 MARGINS 75% 83% 2014 GROSS MARGIN1 2022 $360 2015 $104 2022 CASH AND EQUIVALENTS2 (in millions) 20%+ 7YR CAGR SALES MIX © 2023 Glaukos Corporation 26 1 FY2014 GAAP and non-GAAP gross margin (75%); 2022
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 FACILITY © 2023 Glaukos Corpo
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 with
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-Glaucom
Slide 30: Glaukos: Transforming Vision
GLAUKOS TRANSFORMING VISION
Slide 31: GAAP to Non-GAAP Reconciliation - Full Year 2022
Appendix © 2023 Glaukos Corporation 31 Amort. of Stock-based Dev Tech Comp Exp on Full Year 2022 GAAP Intangibles Replacement Full Year 2022 Non-GAAP Gross Margin Awards Gross Margin Net Sales $ 282,862 $ 282,862 COGS $ 68,979 $ (22,092) $ (74) $ 46,813 Gross Profit $ 213,883 $ 22,092 $ 7 4 $ 236,04
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 Ophthalmol. 2005;140(4): 598-606 3 Malihi M, Moura, Filho ER, Hodge DO,