Glaukos Corporation · NYSE:GKOS
Glaukos — Investor Day (September 2017)
131 slides from Glaukos's investor day presentation, Sep 14, 2017
Slide 1: Investor Day
Investor Day September 2017 1 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation 1
Slide 2: MIGS and Beyond: Delivering Novel Surgical & Pharmaceutical Glaucoma Therapy
MIGS AND BEYOND Delivering Novel Surgical & Pharmaceutical Glaucoma Therapy 2 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 3: Disclaimer
Disclaimer All statements other than statements of historical facts included in this presentation approval processes as we develop additional products and penetrate foreign that address activities, events or developments that we expect, believe or anticipate markets; the impact of any product liabil
Slide 4: Investor Day Presenters and Panelists
Investor Day Presenters and Panelists Glaukos Management Guest Surgeons Tom Burns, President & CEO Eric Donnenfeld MD Chris Calcaterra, COO John Berdahl MD Joe Gilliam, CFO & SVP Corporate Development Dave Haffner, SVP New Technologies Hal Heitzmann PhD, SVP Applied Research & Engineering Jeff Wells
Slide 5: Agenda
Agenda SUBJECT T IM E Transforming Glaucoma Therapy 8:05 Our Solutions Portfolio 8:20 Q&A Session 1 9:20 Break 9:50 Our Market Opportunity 10:10 Our Global Commercialization 10:30 Platform Development & Summary 10:50 Q&A Session 2 11:10 5 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporat
Slide 6: Transforming Glaucoma Therapy
MIGS A N D B EYON D Transforming Glaucoma 6 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation Therapy
Slide 7: Glaukos is Transforming Glaucoma Therapy
Glaukos is Transforming Glaucoma Therapy OUR MISSION To pioneer and lead the global glaucoma market with micro-scale injectable therapies that advance the standard-of-care and enrich the lives and treatment alternatives for glaucoma patients worldwide. OUR STRATEGY Grow Deliver Extend Transition US
Slide 8: Building The MIGS Market
Building The MIGS Market 1999 2001-Current 2001-Current 2004-Current 2009-Current 2012-Current Intuitive Answer to Engineering Market-Expanding Clinical & Regulatory Transforming the Strategic Commercial Unmet Need Perseverance Pipeline Excellence Algorithm Execution Recognized Overcame significant
Slide 9: GKOS – June 24, 2015
GKOS – June 24, 2015 Proceeds enabled accelerated investments in our pipeline and global expansion 9 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 10: Demonstrated Financial Performance
Demonstrated Financial Performance Total Net Sales (in millions) 87% $45 $40 $35 $30 Gross Margin* $25 $20 $15 $10 $5 $0 Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016 Q1 2017 Q2 2017 $104M Cash & Short-Term Equivalents
Slide 11: Key Numbers
Key Numbers $5b 300k 15 200+ 4 $5 billion 300,000+ iStents 15 countries 200+ issued, 4 new Glaukos global implanted with direct licensed or glaucoma products glaucoma globally Glaukos sales pending Glaukos currently being market served operations patents evaluated by FDA Progress Since IPO Key Metri
Slide 12: Building MIGS Marketplace and Investing for the Future
Building MIGS Marketplace and Investing for the Future Revised Net Sales Overcoming Headwinds Guidance: Commercial insurance coverage Q3: $38-40M Hurricanes Irma / Harvey FY 2017: $155-160M Australia Competition Noridian 12 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 13: Open-Angle Glaucoma
Open-Angle Glaucoma Disease is chronic, progressive, irreversible and largely asymptomatic Typically associated with elevated intraocular pressure (IOP) Elevated IOP causes optic nerve damage and leads to vision loss NORMAL VISION Reducing IOP is only proven treatment WITH GLAUCOMA 13 | Investor Day
Slide 14: Bypassing the Trabecular Meshwork
Bypassing the Trabecular Meshwork Early ex vivo experiments and mathematical models showed EV that a single long-lasting patent X trabecular bypass could improve conventional outflow facility, resulting in reductions in IOP Bypass AC TM SC CC Grant M. Arch Ophthalmology 1963 Zhou J. Journal of Glauc
Slide 15: Targeted Trabecular Bypass Placement
Targeted Trabecular Bypass Placement A majority of aqueous veins are found in the inferonasal quadrant A single trabecular bypass in that location accesses the majority of aqueous veins Areas of high segmental outflow are recognized by aqueous vein locations and regions of meshwork hyperpigmentation
Slide 16: First-Ever Micro-Invasive Glaucoma Surgery Device
First-Ever Micro-Invasive Glaucoma Surgery Device FDA approved in 2012; implanted in conjunction with cataract surgery Smallest device known to be implanted in the human body (1.0 mm x 0.33 mm) Heparin-coated stent, pre-loaded in inserter Ergonomic rail design protects and accesses underlying collec
Slide 17: Real-World Clinical Experience: Western Europe (3-Year Data)
Real-World Clinical Experience: Western Europe (3-Year Data) iStent + Cataract Surgery Consistent cohort (n=39) US PIVOTAL achieved 36% reduction 23.4 iSTENT STATS in mean medicated IOP 24 and 86% reduction in Preop Mean IOP mm Hg medicated mean meds 20 mean IOP of 18.7 mm Hg 14.9 At M12, 16 14.3 13
Slide 18: Real-World Clinical Experience: Western Europe (5-Year Data)
Real-World Clinical Experience: Western Europe (5-Year Data) iStent + Cataract Surgery Case series showed 16% reduction in mean medicated IOP; after 42% mean follow-up of 54 Remained medication free months, 42% of patients 20 19.4 were medication free 17.4 Mean IOP mm Hg 16.5 16.3 16.1 15.9 16.1 16
Slide 19: Real-World Clinical Experience: US (2-Year Data)
Real-World Clinical Experience: US (2-Year Data) iStent + Cataract Surgery Consistent cohort of 107 OAG eyes followed through 2 years achieved 56% mean IOP reduction of Reduction in mean # of 22% and 56% reduction 24 meds in mean medications 19.3 Mean IOP mm Hg 20 16.4 16.4 16.3 15.7 15.2 16 12 Preo
Slide 20: Delivering Novel Surgical & Pharmaceutical Glaucoma Therapy
Delivering Novel Surgical & Pharmaceutical Glaucoma Therapy Potential to transform glaucoma therapy with MIGS and sustained delivery Rx therapies Elegant micro-invasive solutions to address rampant non-adherence issues in glaucoma Algorithm-based therapeutic approach that utilizes drugs and devices
Slide 21: Our Solutions Portfolio
MIGS A N D B EYON D Our Solutions Portfolio 21 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 22: Current OAG Treatment Algorithm
Current OAG Treatment Algorithm Ocular Hypertension IOP is measured in millimeters of mercury (mm Hg). IOP of 21-30 mm Hg Normal IOP in healthy eyes ranges from 10-21 mm Hg. 1 Target IOP Treatment 20% ↓ from baseline; 0-1 med ≤ 18 mm Hg Open-Angle Refractory OAG 5 Glaucoma 2 Mild OAG Uncontrolled IO
Slide 23: Portfolio of Micro-Scale Injectable Therapy
Portfolio of Micro-Scale Injectable Therapy OCULAR HYPERTENSION Injectable drug delivery implant; sustained drug therapy for extended periods REFRACTORY Envision use alone or in combination with other MIGS devices OAG MILD Progression ADVANCED MODERATE OCULAR MILD MODERATE ADVANCED REFRACTORY HYPERT
Slide 24: Portfolio of Micro-Scale Injectable Therapy: Estimated US Commercialization
Portfolio of Micro-Scale Injectable Therapy: Estimated US Commercialization OCULAR HYPERTENSION 2022-23 REFRACTORY OAG MILD Progression ADVANCED MODERATE OCULAR MILD MODERATE ADVANCED REFRACTORY HYPERTENSION Addressing full range of 2020-21 glaucoma disease states and progression 2020-21 2H 2018 201
Slide 25: Glaukos Pharmaceuticals
B EYON D MIGS Glaukos Pharmaceuticals 25 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 26: Beyond MIGS: Micro-Scale Rx Injectable Therapy Platform
Beyond MIGS: Micro-Scale Rx Injectable Therapy Platform OCULAR HYPERTENSION Injectable drug delivery implant; sustained drug therapy for extended periods REFRACTORY Envision use alone or in combination with other MIGS devices OAG MILD Progression ADVANCED MODERATE OCULAR MILD MODERATE ADVANCED REFRA
Slide 27: Understanding the Problem
Understanding the Problem Tom Non-adherence to topical Statistics1 Reasons1 Value of Adherence glaucoma medications is ubiquitous to Therapy2 Reasons for patient non- 10-25% of newly prescribed Complex dosing regimens, Lowering IOP is the only proven adherence are varied patients don’t refill their
Slide 28: iDose Travoprost: First-of-a-Kind Intraocular Drug Delivery Device
iDose Travoprost: First-of-a-Kind Intraocular Drug Delivery Device Retaining OCULAR Cap HYPERTENSION Elution Membrane REFRACTORY Drug Reservoir OAG MILD Progression Titanium implant (1.8 mm x 0.5 mm) designed for continuous drug delivery directly into anterior ADVANCED MODERATE chamber Filled with p
Slide 29: Critical iDose Travoprost Milestones
Critical iDose Travoprost Milestones 01 02 03 Select and formulate unique, Develop micro-scale elution Attain proof-of-concept in potent and long-lasting system that could deliver cynomolgus monkey and in prostaglandin analog that predictable levels of micro-elution first pilot human studies convert
Slide 30: iDose Travoprost Procedure
iDose Travoprost Procedure iDose is not approved by the FDA. 30 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 31: iDose Travoprost Exchange (Removal) Procedure
iDose Travoprost Exchange (Removal) Procedure iDose is not approved by the FDA. 31 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 32: iDose Travoprost
iDose Travoprost Travoprost is highly Travoprost free acid is Intracameral delivery may Why choose effective prostaglandin biologically active at very minimize side effects Travoprost as analog low concentrations associated with topical prostaglandin analogs basis for • Typical IOP reduction with •
Slide 33: US Topical Glaucoma Medication Market Share
US Topical Glaucoma Medication Market Share Prostaglandin analogs are Prostaglandins most common first-line Beta Blockers medication for management of IOP Alpha Agonists 13% Combination Drugs Class consists of Other latanoprost, bimatoprost, 10% travoprost and tafluprost 53% 16% 8% Market Scope – Gl
Slide 34: Micro-Scale Rx Injectable Therapy Platform
Micro-Scale Rx Injectable Therapy Platform Our approach to Medical Needs Clinical Goals creating the optimal To achieve non-inferiority IOP 01. Compliance solution and defining reduction (comparable results) success 02. Duration to existing topical glaucoma therapies 03. Favorable benefit-to-risk To
Slide 35: iDose Travoprost International Pilot Study
iDose Travoprost International Pilot Study International pilot, proof-of-concept, prospective study Part I 10 non-sighted patients implanted; Endothelial cell density (ECD) measurements taken after planned explants showed negligible ECD loss; demonstrated feasibility of implant and replace concept P
Slide 36: US iDose Travoprost: Standards for Efficacy and Choice of Comparator
US iDose Travoprost: Standards for Efficacy and Choice of Comparator Standard for Efficacy Choice of – US FDA Comparator …For the pivotal trials, “efficacy would be Ophthalmic Company Pivotal Trial Approval demonstrated by either equivalence or superiority to Brand/API Comparator Date the comparator
Slide 37: Recent Timolol IOP Results Appear Superior to Prior Trials
Recent Timolol IOP Results Appear Superior to Prior Trials Travatan 0.004% Pivotal Trial Data (Study C97-72) Aerie Pharmaceuticals* April 23, 2015 28.0 27.4 Timoptic 0.5% 25.8 Netarsudil (Rhopressa 0.2%) misses 26.0 25.3 non-inferiority endpoint to timolol 0.5% 24.0 at 3 months in Rocket 1 Phase III
Slide 38: Prostaglandins Shown to Reduce IOP 7-8 mm Hg
Prostaglandins Shown to Reduce IOP 7-8 mm Hg Travatan 0.004% Pivotal Trial Data (Study C97-72) Travatan Z Package Insert 28.0 27.4 25.8 “In clinical trials...Travatan or Travatan 26.0 25.3 Travatan 0.004% Timoptic 0.5% Z dosed once daily in the evening 27.2 24.0 25.5 demonstrated 7-8 mm Hg reduction
Slide 39: US Phase II iDose Travoprost Study Design
US Phase II iDose Travoprost Study Design Duration • 12-week unmask, 3-year study follow-up Fast Elution Implant+ Selected Inclusion Criteria Placebo Eye • ≥ 18 years of age, phakic or pseudophakic Drops • Diagnosis of mild to moderate open-angle glaucoma, or ocular hypertension, on 0 to 3 meds • Ba
Slide 40: iDose Travoprost US Phase II: Preliminary Efficacy Results (n=154)
iDose Travoprost US Phase II: Preliminary Efficacy Results (n=154) Mean IOP Subjects without Additional Medications 40 through Week 12 35 30 98% 96% 100% 100% 25 88% 90% 85% 82% 82% 82% 20 80% 74% 15 70% 10 60% Baseline Week 2 Week 6 Week 12 50% Fast Elution Slow Elution Timolol 0.5% 40% 30% 20% Imp
Slide 41: iDose Travoprost US Phase II: Preliminary Efficacy Results
iDose Travoprost US Phase II: Preliminary Efficacy Results Average IOP Average IOP Reductions from Baseline* reductions through 12 weeks post-op 10.0 9.5 ranging from 8.0 to 9.0 8.7 8.7 8.2 8.5 8.0 9.5 mm Hg in the 8.0 7.5 7.5 7.6 implant arms 7.0 6.0 5.0 4.0 3.0 2.0 1.0 0.0 Week 2 Week 6 Week 12 Fa
Slide 42: iDose Travoprost US Phase II: Preliminary Efficacy Results
iDose Travoprost US Phase II: Preliminary Efficacy Results Average percentage Percent IOP Reductions through Week 12* IOP reductions 40% 37% through Week 12 in 35% 35% 34% 33% 33% 32% 31% implant arms ranging 30% 30% 30% from 32% to 37% 25% 20% 15% 10% 5% 0% Week 2 Week 6 Week 12 n= 51 54 49 51 54 4
Slide 43: iDose Travoprost US Phase II: Preliminary Efficacy Results
iDose Travoprost US Phase II: Preliminary Efficacy Results Average IOP Average IOP Reductions at Months 6 to 9* reductions at Months 9.0 6 and 9 ranging from 8.4 8.5 8.3 7.9 to 8.4 mm Hg 8.0 8.0 7.9 7.5 7.0 6.5 6.0 5.5 5.0 Month 6 Month 9 n=73 n=43 Fast Elution Slow Elution *Calculated using all IOP
Slide 44: iDose Travoprost US Phase II: Preliminary Efficacy Results
iDose Travoprost US Phase II: Preliminary Efficacy Results Average IOP Average IOP Reductions through Month 9* reductions through 9 10.0 9.5 months post-op 9.0 8.7 8.7 8.5 8.4 8.2 8.0 8.3 ranging from 7.9 to 8.0 7.9 8.0 9.5 mm Hg 7.0 6.0 5.0 4.0 3.0 2.0 1.0 0.0 Week 2 Week 6 Week 12 Month 6 Month 9
Slide 45: iDose Travoprost US Phase II: Preliminary Efficacy Results
iDose Travoprost US Phase II: Preliminary Efficacy Results Average percent IOP Percent IOP Reductions through Month 9* reductions through 9 40% 37% months post-op in 35% 35% 34% 33% 33% 32% 33% 32% 32% 32% implant arms 30% ranging from 32% to 25% 37% 20% 15% 10% 5% 0% Week 2 Week 6 Week 12 Month 6 M
Slide 46: iDose Travoprost US Phase II: Preliminary Safety Data
iDose Travoprost US Phase II: Preliminary Safety Data Intraoperative Adverse Events Blood Plasma Levels None reported (n=105) All implant samples below level of quantitation (BLQ) for travoprost iDose is not approved by the FDA. 46 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 47: iDose Travoprost US Phase II: Preliminary Safety Data
iDose Travoprost US Phase II: Preliminary Safety Data Post-Op Adverse Totals Excellent safety profile Events Reported > 1% n=154 demonstrated All groups combined Intraocular pressure increased 4 (2.6%) No serious adverse Iritis 4 (2.6%) Decreased BCVA > 2 lines vs baseline 4 (2.6%) events reported D
Slide 48: Safety Data Reported for Topical Hypotensive Agents for Glaucoma
Safety Data Reported for Topical Hypotensive Agents for Glaucoma Travatan Z1 Lumigan 0.01%2 Adverse Events > 1% Package Insert Adverse Events Package Insert Incidence Incidence Ocular hyperemia 30-50% Conjunctival hypermia 31% Decreased visual acuity 5-10% Conjunctival edema, conjunctival 1-4% hemor
Slide 49: Recent Safety Data Reported for Investigational Hypotensive Agents for Glaucoma
Recent Safety Data Reported for Investigational Hypotensive Agents for Glaucoma Bimatoprost SR1 Netarsudil/Latanoprost and Netarsudil2 Post-Op Adverse Totals Post-Op Adverse Netarsudil 0.02%/ Netarsudil 0.02% Events Reported > 5% n=75 Events Reported > 5% Latanoprost n=238 n=244 Conjunctival hyperem
Slide 50: iDose Travoprost US Phase II: Summary and Next Steps
iDose Travoprost US Phase II: Summary and Next Steps US Phase II Preliminary Results Next Steps Efficacy End of Phase II meeting with FDA to be • Initial efficacy demonstrated through 12-week endpoint scheduled for Q4 2017 • To date, continued efficacy of ~30% IOP reduction from • Discussion of Phas
Slide 51: Ocular Hypotensive Sustained-Release Landscape
Ocular Hypotensive Sustained-Release Landscape Decades-long industry efforts to Product (Company) Description Development Stage Duration address non-adherence with Bimatoprost SR Biodegradable implant Phase I/II Designed to release drug sustained-release glaucoma for 6 months (Allergan) therapies ha
Slide 52: Glaukos Surgical
MIGS Glaukos Surgical 52 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 53: Portfolio of Micro-Scale Injectable Therapy
Portfolio of Micro-Scale Injectable Therapy OCULAR HYPERTENSION REFRACTORY OAG MILD Progression ADVANCED MODERATE OCULAR MILD MODERATE ADVANCED REFRACTORY HYPERTENSION Injectable 2-stent therapy for standalone procedures Injectable 2-stent therapy for combo- cataract procedures Single stent therapy
Slide 54: Current US Combination-Cataract and Future Standalone Market
Current US Combination-Cataract and Future Standalone Market Estimate the current US combination cataract MIGS market to be roughly 1/10th the size of the potential standalone MIGS market Standalone Combination Cataract 54 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 55: Combination-Cataract Therapy for Mild to Moderate OAG
Combination-Cataract Therapy for Mild to Moderate OAG OCULAR HYPERTENSION REFRACTORY OAG MILD Progression Two heparin-coated titanium trabecular bypass stents preloaded into auto injection ADVANCED MODERATE system Provides enhanced procedural ease with ability to enter the eye once to implant both s
Slide 56: Combination-Cataract Therapy for Mild to Moderate OAG
Combination-Cataract Therapy for Mild to Moderate OAG iStent Inject is not approved by the FDA. 56 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 57: iStent inject: Combination-Cataract Therapy for Mild to Moderate OAG
iStent inject: Combination-Cataract Therapy for Mild to Moderate OAG US Regulatory Status Enrollment and 2-year follow-up in 500-patient pivotal trial complete Expect to file full PMA by YE 2017; estimated FDA approval in 2H 2018 OUS Regulatory Status Currently available in multiple international ma
Slide 58: Clinical Performance of iStents with Cataract Surgery
Clinical Performance of 2 iStents with Cataract Surgery All subjects had IOP not well 2 iStents + Cataract controlled on medication or Comparative Case Series (n=28) well controlled with substantial (≥ 3) medication 6 20 burden 5 17.3 64% Stent implantation conducted 16 Reduction in 13.4 13.3 13.5 1
Slide 59: Portfolio of Micro-Scale Injectable Therapy
Portfolio of Micro-Scale Injectable Therapy OCULAR HYPERTENSION REFRACTORY OAG MILD Progression ADVANCED MODERATE OCULAR MILD MODERATE ADVANCED REFRACTORY HYPERTENSION Injectable 2-stent therapy for standalone procedures Injectable 2-stent therapy for combo- cataract procedures Single stent therapy
Slide 60: Standalone 2-Stent Therapy for Mild to Moderate OAG
Standalone 2-Stent Therapy for Mild to Moderate OAG OCULAR HYPERTENSION REFRACTORY OAG MILD Progression Two heparin-coated titanium stents, preloaded into auto injection system Central Inlet ADVANCED MODERATE Tapered insertion sleeve yields smooth insertion during closed- chamber procedure Ability t
Slide 61: Facile, Closed-Chamber, Click-and-Release 2-Stent Procedure
Facile, Closed-Chamber, Click-and-Release 2-Stent Procedure iStent SA is not approved by the FDA. 61 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 62: iStent SA: Standalone 2-Stent Therapy for Mild to Moderate OAG
iStent SA: Standalone 2-Stent Therapy for Mild to Moderate OAG IDE Initial Trial Regulatory Strategy 75 phakic and Potential to broaden inclusion pseudophakic OAG patients criteria by evaluating only randomized to receive pseudophakic OAG stents or SLT Goal is for timely entry into US Narrow inclusi
Slide 63: Titratable Therapy with Injectable Trabecular Bypass Stents
Titratable Therapy with Injectable Trabecular Bypass Stents International study of Mean IOP at 18 Months without OAG patients (n=119) Glaucoma Medication with unmedicated IOP 1 Stent of 22-38 mm Hg 26 2 Stent 3 Stent Patients randomized to 22 receive 1, 2 or 3 stents mm Hg 18 in standalone 15.9 proc
Slide 64: Clinical Results of 2 iStents in a Standalone Procedure
Clinical Results of 2 iStents in a Standalone Procedure International, 2 Standalone Stents* Mean IOP prospective study 26 24.4 All patients (n=57) on 1 preoperative glaucoma 22 19.5 medication mm Hg At 24 months, 98% 18 achieved ≥ 20% 14.3 14.6 14.4 14.1 14.2 reduction in 14 unmedicated IOP vs basel
Slide 65: Portfolio of Micro-Scale Injectable Therapy
Portfolio of Micro-Scale Injectable Therapy OCULAR HYPERTENSION REFRACTORY OAG MILD Progression ADVANCED MODERATE OCULAR MILD MODERATE ADVANCED REFRACTORY HYPERTENSION Accesses secondary outflow pathway; envision use primarily in combination with other MIGS devices iStent Supra is not approved by th
Slide 66: Suprachoroidal Stent Accesses Secondary Outflow Pathway
Suprachoroidal Stent Accesses Secondary Outflow Pathway OCULAR HYPERTENSION REFRACTORY Titanium Sleeve Inlet OAG Retention MILD Progression Features 4 mm implant, curved to follow ocular anatomy ADVANCED MODERATE Lumen sized for optimal flow and minimal trauma Heparin-coated inter-lumen Outlet desig
Slide 67: iStent SUPRA: Accessing the Suprachoroidal Space
iStent SUPRA: Accessing the Suprachoroidal Space Clinical Profile Optimal Use Regulatory Status Accesses secondary outflow Enhancement to trabecular Enrollment of 505-patient pathway; large theoretical stents in progressive cases pivotal trial complete; 2-year resorptive area for drainage where lowe
Slide 68: Portfolio of Micro-Scale Injectable Therapy
Portfolio of Micro-Scale Injectable Therapy OCULAR HYPERTENSION REFRACTORY OAG MILD Progression ADVANCED MODERATE OCULAR MILD MODERATE ADVANCED REFRACTORY HYPERTENSION Injectable 3-stent therapy for standalone procedures iStent infinite is not approved by the FDA. 68 | Investor Day | September 14, 2
Slide 69: MIGS Solution for Advanced and Refractory OAG
MIGS Solution for Advanced and Refractory OAG OCULAR HYPERTENSION REFRACTORY OAG MILD Progression Three heparin-coated trabecular bypass stents, identical to iStent SA ADVANCED MODERATE Enhanced insertion system provides unlimited activations and smooth implantation of each stent across 5-6 clock ho
Slide 70: MIGS Solution for Advanced and Refractory OAG
MIGS Solution for Advanced and Refractory OAG iStent infinite is not approved by the FDA. 70 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 71: Titratable Therapy with Injectable Trabecular Bypass Stents
Titratable Therapy with Injectable Trabecular Bypass Stents International study of Mean IOP at 18 Months without OAG patients (n=119) Glaucoma Medication with unmedicated IOP of 22-38 mm Hg 26 1 Stent Patients randomized to 2 Stent receive 1, 2 or 3 stents 22 3 Stent in standalone mm Hg procedure; f
Slide 72: Early Clinical Performance of 3-Stent Solution
Early Clinical Performance of 3-Stent Solution All patients had prior 3 iStents in Standalone Surgery Single-Site Case Series (n=30) glaucoma surgery, including 27 28.42 30 trabeculectomies 2 25 1.83 Mean IOP declined 1.5 20 52% to 13.68 mm Hg Mean # of meds 14.73 at 12 months mm Hg 14.17 13.42 13.6
Slide 73: iStent infinite Refractory Clinical Trial
iStent infinite Refractory Clinical Trial Clinical protocol to follow ANSI guidance Proposal for Standalone procedure in phakic and n=65, followed pseudophakic refractory OAG patients for 1 year Will propose inclusion of POAG, PEX and PDS patients uncontrolled either after failed incisional surgerie
Slide 74: Optimizing MIGS Performance
Optimizing MIGS Performance 74 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 75: Intelligent Placement of Trabecular Stents
Intelligent Placement of Trabecular Stents Optimizing Stent Placement Collector channels and aqueous veins are not distributed uniformly around the limbus Targeting collector channels may further improve current favorable efficacy profile of trabecular stents 75 | Investor Day | September 14, 2017 |
Slide 76: Intelligent Placement of Trabecular Bypass Stents
Intelligent Placement of Trabecular Bypass Stents 76 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 77: Combining Novel Technologies
MIGS A N D B EYON D Combining Novel Technologies 77 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 78: Combination Glaucoma Therapy: A Factual Review
Combination Glaucoma Therapy: A Factual Review Combination Number of Medications First-Line Therapy by % of Patients (US) by Drug Class (US) Medication Therapy Prostaglandins Beta Blockers Alpha Agonists Widely used to increase outflow Combination Drugs and/or reduce production of Other aqueous humo
Slide 79: MIGS Combination Glaucoma Therapy
MIGS Combination Glaucoma Therapy Combination MIGS Therapy Drug Delivery Multiple combinations capable of restoring outflow through both the conventional and uveoscleral pathways Expect iStent SA (or iStent infinite) and iDose Travoprost Trabecular Bypass to ultimately be combination of choice Trabe
Slide 80: Clinical Results Show Benefit of Combination Therapy
Clinical Results Show Benefit of Combination Therapy 2 Stents + Topical Travoprost Mean IOP Over Time (n=53) Drug Delivery 30 24.9 (After med washout) 25 Trabecular Bypass mm Hg 20 19.7 16.6 Trabecular Bypass (After med washout) 15 13.0 12.9 12.7 12.4 12.9 10 Preop Baseline M1 M3 M6 M12 M13 M18 OAG
Slide 81: Clinical Results Show Benefit of Combination Therapy
Clinical Results Show Benefit of Combination Therapy 2 Stents + Topical Travoprost Mean IOP Over Time (n=39) Drug Delivery 30 25.3 (After med washout) Trabecular Bypass 25 mm Hg 22.2 20 17.1 Trabecular Bypass (After med washout) 15 14.0 13.8 13.2 13.0 11.8 10 SCR BL M1 M3 M6 M12 M13 M18 OAG subjects
Slide 82: Portfolio of Micro-Scale Injectable Therapy: Beyond 2020
Portfolio of Micro-Scale Injectable Therapy: Beyond 2020 + / Drug Delivery Combination Therapy Trabecular Bypass OCULAR MILD MODERATE ADVANCED REFRACTORY HYPERTENSION Trabecular Bypass Expect combination therapy to emerge first among pseudophakic iStent Inject, iStent SA, iStent infinite are not OAG
Slide 83: Portfolio of Micro-Scale Injectable Therapy: First-Line Therapy Beyond 2020
Portfolio of Micro-Scale Injectable Therapy: First-Line Therapy Beyond 2020 Drugs remain predominant first-line therapy Many ophthalmologists are drugophiles; expect Drug Delivery indication, duration and payor coverage to drive iDose utilization Trabecular Bypass OCULAR MILD MODERATE ADVANCED REFRA
Slide 84: Portfolio of Micro-Scale Injectable Therapy: Enhancement Beyond 2020
Portfolio of Micro-Scale Injectable Therapy: Enhancement Beyond 2020 Drug Delivery Trabecular Bypass OCULAR MILD MODERATE ADVANCED REFRACTORY HYPERTENSION Trabecular Bypass iStent Inject, iStent SA and iDose are not approved by the FDA. 84 | Investor Day | September 14, 2017 | © 2017 Glaukos Corpora
Slide 85: Panel Discussion – Glaukos Solutions Portfolio
Panel Discussion – Glaukos Solutions Portfolio Glaukos Management Guest Surgeons Tom Burns, President & CEO Eric Donnenfeld MD Dave Haffner, SVP New Technologies John Berdahl MD Hal Heitzmann PhD, SVP Applied Research & Engineering Jeff Wells PharmD, SVP Regulatory, Quality & Clinical Affairs 85 | I
Slide 86: 20-Minute Coffee Break
20-Minute Coffee Break 86 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 87: Our Market Opportunity
Our Market Opportunity 87 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 88: Understanding Our Market Opportunity
Understanding Our Market Opportunity OBJECTIVE Combine the latest glaucoma epidemiology, actual claims data and market research to outline the addressable market opportunity across the entire Glaukos product portfolio 88 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 89: Understanding the US Glaucoma Market Opportunity
Understanding the US Glaucoma Market Opportunity Glaucoma Suspects Ocular Hypertension Primary OAG Other Glaucoma • Age, ethnicity, • Elevated IOP • Elevated IOP • Primary closed-angle genetics • No visual field loss or • Visual field loss and glaucoma • 5-10M people in US optic nerve damage optic n
Slide 90: Historical view of POAG and OHT Prevalence
Historical view of POAG and OHT Prevalence Historical survey- Status Quo based population • Numerous population-based surveys studies have and studies shortcomings • Since 1960s, studies have progressively shown higher POAG/OHT prevalence rates each decade Shortcomings • Shift from surveys to detail
Slide 91: Assessing Market Opportunity with Objective Data
Assessing Market Opportunity with Objective Data IMS Health Market Scope We believe Compliance Studies Medicare Claims Data Physician Surveys prevalence to be Glaucoma Cataract larger than Rx Surgery previously estimated Data Data POAG & OHT POAG & OHT Medical Claims Data Medicare & Commercial Claim
Slide 92: Glaucoma Rx Implied POAG Prevalence
Glaucoma Rx Implied POAG Prevalence % of patients % of patients “Compliant” that don’t on meds at patient rate Glaucoma refill 2nd Rx end of year 1 of compliance Rx Data 10-25% 40-60% 70-75% POAG & OHT Implied overall annual Rx usage rate 40-55% Actual Rx units Medication mix rates Diagnosis rates I
Slide 93: Cataract Surgery Implied POAG Prevalence
Cataract Surgery Implied POAG Prevalence Cataract & • Medicare claims analysis Cataract POAG/OHT Surgery Co-morbidity • External consultants analysis Data • Market Scope physician surveys 15-20% POAG & OHT Market Scope POAG & OHT Olmstead Eye Study cataract surgery prevalence rates age distribution
Slide 94: Medical Claims Data Implied POAG Prevalence
Medical Claims Data Implied POAG Prevalence Commercial insurance glaucoma claims by age* 10.4M covered lives POAG & OHT POAG & OHT Remove other Glaucoma vs OHT Uninsured population Medical Claims Data glaucoma upcoding adjustment adjustment Implied 2017 POAG Prevalence ~5.4M people * Required 2 sepa
Slide 95: Putting It All Together: 2017 US POAG Prevalence
Putting It All Together: 2017 US POAG Prevalence Glaucoma Cataract Historical Rx Surgery Population-Based ~4.2M Data Data Surveys POAG & OHT Cataract Surgery ~6-8M Data POAG & OHT Medical Claims Data Glaucoma Rx Data ~4-8M Medical Claims Data ~5.4M ~5.4M Glaukos Estimate 95 | Investor Day | Septembe
Slide 96: Putting It All Together: 2017 US POAG Prevalence
Putting It All Together: 2017 US POAG Prevalence Glaucoma Cataract Glaukos Estimated Rx Surgery Data Data US POAG POAG Prevalence & OHT ~5.4M people POAG & OHT Medical Claims Data ~ 10M POAG & OHT individuals* ~ 18M POAG & OHT eyes* * Based on 0.85 ratio of OHT to POAG; bilateral rate of glaucoma of
Slide 97: 2017 POAG and OHT Prevalence by Disease Stage/Severity
2017 POAG and OHT Prevalence by Disease Stage/Severity Physician discussions and medication burden to 8.3M eyes 9.8M eyes estimate disease stage/severity prevalence OCULAR MILD MODERATE ADVANCED REFRACTORY HYPERTENSION Pseudophakic population based on historic cataract surgery and mortality 52% 25%
Slide 98: Translating Prevalence into Annual Market Opportunity
Translating Prevalence into Annual Market Opportunity 1.7M eyes 6.5M eyes ~18M POAG/OHT eyes > ~8.2M diagnosed and treated eyes Undiagnosed or untreated Size of the underlying Prevalence market by disease stage, Diagnosed and Treated diagnosis and treatment rates S TAG E 1 S TAG E 2 S TAG E 3 S TAG
Slide 99: Translating Prevalence into Annual Market Opportunity (cont’d)
Translating Prevalence into Annual Market Opportunity (cont’d) Glaukos product of choice, monotherapy or in combination, across the disease OCULAR MILD MODERATE ADVANCED REFRACTORY stages HYPERTENSION Monotherapy Combination therapy 99 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 100: 2017 Annual Market Opportunity By Product: Combination Cataract
2017 Annual Market Opportunity By Product: Combination Cataract Combination Cataract Eyes (000s) 900 800 800 700 600 500 600 Combo-cataract = annual 400 opportunity 300 200 100 0 Annual Co-Morbidity iStent Inject and iStent Supra are not approved by the FDA. 100 | Investor Day | September 14, 2017 |
Slide 101: 2017 Annual Market Opportunity By Product: Standalone
2017 Annual Market Opportunity By Product: Standalone 1 Pseudo Eyes 2 Phakic Eyes Topical Rx intolerant 175k 375k Recurring annual therapy Non-compliant Rx patients 550k 1,125k utilized across disease stage continuum Diagnosed and treated Other Rx AEs 425k 875k market prevalence = annual opportunity
Slide 102: 2017 Market Opportunity By Product: Standalone
2017 Market Opportunity By Product: Standalone 1 Pseudo Eyes 2 Phakic Eyes Topical Rx intolerant 100k 175k Standalone procedure = diagnosed and treated population Non-compliant Rx patients 325k 600k Glaukos monotherapy / combination therapy Other Rx AEs 200k 425k algorithm applied Progression / Othe
Slide 103: 2017 Annual Market Opportunity By Product: Standalone
2017 Annual Market Opportunity By Product: Standalone Annual late stage All eyes (pseudo/phakic) procedures (000s) (000s) 140 Tubes/Trabs, etc. = annual opportunity 120 125 800 100 Standalone procedure = 80 diagnosed and treated 60 population 40 775 Glaukos monotherapy / 20 combination therapy 0 Fai
Slide 104: Prevalence Growth
Prevalence Growth Population growth POAG and OHT Prevalence (MM Eyes) and aging Ethnic mix shift 25 20.7M ~3% Annual Growth1 20 18.1M 9.5 15 8.3 10 5 11.2 9.8 0 2017 2022 POAG OHT 1 Over age 40; 3.6% over age 65 104 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 105: Diagnosed and Treated Growth
Diagnosed and Treated Growth Improved diagnosis Dx and Treated Population (MM Eyes) rates driven by technology, available solutions and access to heath care 12 10 9.8M ~ 3.6% Annual Growth1 8.2M 2.0 8 1.7 6 4 7.8 6.5 2 0 2017 2022 POAG OHT 1 Over age 40; 4.4% over age 65 105 | Investor Day | Septemb
Slide 106: Our Global Commercialization
Our Global Commercialization 106 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 107: Expanding our Global Footprint
Expanding our Global Footprint iStent products are currently approved for use in 30+ countries Current & planned regional sales HQ Direct markets (14) Distributor markets 107 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 108: Americas
Americas Direct Sales Reimbursement Commercialization Established Products Status Status Brazil 2017 iStent iStent inject Varying coverage from private and public payors • Surgeon training in early stages • Hub for distributors in other Latin American countries 2016 iStent Efforts underway to secure
Slide 109: US Ophthalmic Physician Community
US Ophthalmic Physician Community Glaucoma Cataract & Comprehensive Specialists Ophthalmic Surgeons Diagnose and monitor glaucoma; Primarily perform cataract and prescribe meds and perform refractive procedures ~1,200 glaucoma laser and MIGS Often also diagnose and monitor procedures glaucoma; presc
Slide 110: Europe
Europe Direct Sales Reimbursement Commercialization Established Products Status Status 2017 France 2014 Germany • Typically government-funded 2017 healthcare Ireland • Current iStent and/or iStent inject 2017 Netherlands iStent coverage varies by country Surgeon training in early iStent inject • NIC
Slide 111: Asia Pacific
Asia Pacific Direct Sales Reimbursement Commercialization Established Products Status Status Australia 2016 iStent iStent inject Interim facility code in place while application is under review Largest MIGS sales organization in Australia 2016 iStent Coverage established by MHLW JGS-approved “koshyk
Slide 112: Competitive Surgical Landscape
Competitive Surgical Landscape Mild to Refractory Moderate Alcon CyPass Allergan XEN • 6.35 mm polyimide shunt • 6 mm collagen shunt implanted implanted ab interno into ab interno into subconjunctival suprachoroidal space space • Approved by FDA in 2016 for • Creates bleb; requires use of combo-cata
Slide 113: Competitive Surgical Landscape
Competitive Surgical Landscape iStent is approx. 1/48th Two iStent inject stents are approx. iStent and iStent inject the size of CyPass 1/73rd the size of CyPass are designed to be as large as required by fluid dynamics – and not CyPass CyPass larger iStent inject iStent Hunter KS, Fjield T, Heitzm
Slide 114: iStent and CyPass Pivotal Trials: Year 1 Mean IOP and Meds
iStent and CyPass Pivotal Trials: Year 1 Mean IOP and Meds Mean IOP Mean # Medications 28.0 3 26.0 24.4 25.4 24.0 Mean # Medications Mean IOP (mm Hg) 22.0 2 20.0 18.7 1.6 18.4 1.4 18.0 16.7 17.0 16.0 1 14.0 12.0 0.2 0.2 10.0 0 Screening IOP Washout IOP 12 Month IOP Screening # Meds 12 Month # Meds C
Slide 115: iStent and CyPass Pivotal Trials: Year 2 Mean IOP and Meds
iStent and CyPass Pivotal Trials: Year 2 Mean IOP and Meds Mean IOP Mean # Medications 28.0 3 26.0 25.4 24.4 24.0 Mean # Medications Mean IOP (mm Hg) 22.0 2 1.6 20.0 18.4 18.7 1.4 18.0 17.0 17.1 16.0 1 14.0 12.0 0.2 0.3 10.0 0 Screening IOP Washout IOP 24 Month IOP Screening # Meds 24 Month # Meds C
Slide 116: Platform Development: Delivering Novel Surgical & Pharmaceutical Glaucoma Therapy
PLATFOR M D EVELOPMEN T Delivering Novel Surgical & Pharmaceutical Glaucoma Therapy 116 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 117: Platform Pillars of Hybrid Pharma/Device Leader
Platform Pillars of Hybrid Pharma/Device Leader Restoring natural, IOP diagnostics and physiological outflow management Portfolio of micro-scale flow Goal to provide micro-scale devices for full range of glaucoma Flow MEMS implantable tools for monitoring severity and progression Devices Biosensors
Slide 118: Platform Pillars: Flow Devices
Platform Pillars: Flow Devices iStent & iStent inject • MIGS pioneer with unrivaled portfolio of iStent SA micro-scale glaucoma devices • Breakthrough ab interno surgical innovation iStent infinite Flow Devices • Deep experience and demonstrated track record in micro-engineering design, assembly iSt
Slide 119: Platform Pillars: Drug Delivery
Platform Pillars: Drug Delivery • Leveraging unique expertise in micro-mechanical design, assembly and filling processes Drug • Building seasoned ocular drug delivery team of Delivery chemists, scientists and engineers iDose • Understanding necessary drug characteristics and Travoprost predictabilit
Slide 120: Beyond MIGS: Building the Sustained Delivery Market
Beyond MIGS: Building the Sustained Delivery Market 2010 2011-Current 2015 2016 2017 2017+ Focused Development Engineering/Biologic Manufacturing Strategic Regulatory Favorable iDose Hybrid Pharma/Device Program Perseverance Processes Execution Data Company Recognized drawbacks Overcame significant
Slide 121: Expanding Organizational Capability: Senior-Level Pharmaceutical Team
Expanding Organizational Capability Senior-Level Pharmaceutical Team 30+ Professionals currently comprise Glaukos Pharmaceuticals R&D organization, VP, Applied Research with prior experience at leading pharmaceutical companies 35 years relevant experience, including 10 years at Glaukos, working on f
Slide 122: Chief Medical Officer Among Foremost US Glaucoma Experts
Chief Medical Officer Among Foremost US Glaucoma Experts Chief Medical Officer L. Jay Katz, MD, FACS Completed glaucoma fellowship at Wills Eye Hospital in Philadelphia in 1985 and affiliated with the hospital since that time, currently serving as its director of glaucoma service. Also serves as a p
Slide 123: Expanding Organization Capability
Expanding Organization Capability State-of-the-Art High-Performance LC-MS Equipment Vertical Production Capabilities Automatic Filling Capping Assembly Tray Sealing Packaging 123 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 124: Scope of Opportunity Beyond iDose Travoprost
Scope of Opportunity Beyond iDose Travoprost 01 02 The unique iDose Small-molecule APIs with specific platform characteristics Miniature reservoir contains drug formulation High potency (EC50 or IC50 < 10 nM) Scleral fixation protects against endothelial cell Low aqueous solubility contact Receptor
Slide 125: Platform Pillars: MEMS Biosensors
Platform Pillars: MEMS Biosensors • Combining core competencies in micro-scale ocular devices with micro-electromechanical systems (MEMS) • Developing initial implantable IOP sensor system MEMS designed to record, transmit and report IOP for more Biosensors effective glaucoma disease management • Ge
Slide 126: IOP Micro-Sensor System Overview
IOP Micro-Sensor System Overview Strategy Functionality Utility Opportunity Leverage micro-scale designs Sensor will record (up to once MD can make data-driven Quicker, objective decisions to and clinical data to develop a per hour), transmit (to patient- treatment decision based on maintain or alte
Slide 127: Summary
Summary 127 | Investor Day | September 14, 2017 | © 2017 Glaukos Corporation
Slide 128: Financial Goals
Financial Goals Key Variables Product launch timing and mix Long-term reimbursement trends 2020+ > 80% > 30% US/OUS mix Competition dynamics Manufacturing costs at scale Substantial Market Gross Margin Operating Margin Opportunity Shift Potential Potential 128 | Investor Day | September 14, 2017 | ©
Slide 129: Glaukos: Key Takeaways
Glaukos: Key Takeaways Delivering novel • Validating the narrative of sustained glaucoma drug surgical and delivery pharmaceutical glaucoma • Extending leadership in MIGS treatment class with therapy industry’s most comprehensive surgical offering • Addressing important unmet clinical needs in large
Slide 130: Panel Discussion – Overall Business, Market & Strategy
Panel Discussion – Overall Business, Market & Strategy Glaukos Management Guest Surgeons Tom Burns, President & CEO Eric Donnenfeld MD Chris Calcaterra, COO John Berdahl MD Joe Gilliam, CFO & SVP Corporate Development Jeff Wells PharmD, SVP Regulatory, Quality & Clinical Affairs 130 | Investor Day |
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