Glaukos Corporation · NYSE:GKOS

Glaukos — Investor Presentation (December 2015)

33 slides from Glaukos's investor presentation, Dec 2, 2015

  1. Slide 1: Forward-looking statements

    2 All statements other than statements of historical facts that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements containe

  2. Slide 2: Transforming glaucoma therapy

    3 is transforming glaucoma therapy LARGE MARKET Growing $5.1bn global opportunity1 UNMET NEED Significant drawbacks of current treatments DEMONSTRATED EXECUTION Broad reimbursement and highly successful launch JUST THE BEGINNING Advanced portfolio of micro-scale injectable therapies 1 Market Scope e

  3. Slide 3: Aging Population Drives Glaucoma Prevalence

    US GLAUCOMA POPULATION1 Reducing IOP is the only proven treatment for glaucoma Aging Population Drives Glaucoma Prevalence 1 Market Scope estimates for glaucoma prevalence; excludes ocular hypertension 2 Market Scope estimates for total global glaucoma market Typically associated with elevated intra

  4. Slide 4: How The Eye's Drainage System Works

    5 How The Eye’s Drainage System Works Elevated IOP occurs when aqueous humor outflow through the trabecular meshwork and into Schlemm’s canal is reduced due to degeneration and obstruction Secondary outflow pathway is the suprachoroidal space

  5. Slide 5: Conventional Glaucoma Treatment Options

    6 Conventional Glaucoma Treatment Options Laser Prescription Eye Drops 01 High non-compliance rates Complex, frequent and lifelong dosing regimens; adverse side effects Recurring expense for patient and payor 02 Effects dissipate within 1-5 years Repeat procedures less effective Medication may still

  6. Slide 6: iStent vs. Conventional Surgery

    7 Conventional Surgery iStent vs. Conventional Surgery

  7. Slide 7: Our Solution Portfolio: Transformational Shift to Micro-Scale Injectable Therapy

    9 Our Solution Portfolio: Transformational Shift to Micro-Scale Injectable Therapy RESTORE FLOW FURTHER ENHANCE FLOW COMBINATION DRUG & FLOW iStent Inject, iStent Supra and iDose are not currently approved by the FDA iStent Inject® Injectable 2-stent therapy for combo-cataract and standalone procedu

  8. Slide 8: First & Only FDA-Approved MIGS Device

    Indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure in adult patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication. 10 Smallest FDA-approved medical device known to be implanted in the human body First & O

  9. Slide 9: Comprehensive Clinical Results

    11 Comprehensive Clinical Results

  10. Slide 10: US Pivotal Trial Results

    12 p = 0.004 p = 0.010 Primary Endpoint IOP < 21 mm Hg w/o meds Secondary Endpoint IOP > 20% mm Hg w/o meds iStent + Cataract Surgery (n=117) AT 12 MONTHS US Pivotal Trial Results FDA Approved June 2012: iStent Shown to Reduce IOP Cataract Surgery Only (n=123) First prospective, randomized, open lab

  11. Slide 11: Single iStent + Cataract Surgery Achieves <15 mm Hg Through 3 Years

    13 Compelling Clinical Results: Single iStent + Cataract Surgery Achieves <15 mm Hg Through 3 Years Consecutive series of 62 eyes; decision to implant based on patient desire to reduce topical meds and intent to offer surgical treatment with lowest risk In consistent cohort of 39 eyes followed throu

  12. Slide 12: iStent Outcome Analysis

    14 Compelling Clinical Results: iStent Outcome Analysis Surgeon # Eyes at Preop Mean Preop IOP (mm Hg) Preop IOP < 15 mm Hg # (%) Mean Preop Meds # Eyes at M12 (% of preop eyes followed) Mean M12 IOP (mm Hg) M12 IOP < 15 mm Hg # (%) Mean M12 Meds Surgeon A 30 18.8 8 (27%) 1.5 30 (100%) 14 27 (90%) 0

  13. Slide 13: Long-term Efficacy Shown in International Study

    15 Compelling Clinical Results: Long-term Efficacy of iStent + Cataract Surgery Shown in International Study + CATARACT SURGERY Prospective, non-comparative, uncontrolled, non-randomized, interventional case series study of 19 patients with uncontrolled mild to moderate OAG using 1 or more topical g

  14. Slide 14: IOP-Lowering Capability of 1, 2 and 3 iStents

    16 Compelling Clinical Results: International Study Shows IOP-Lowering Capability of 1, 2 and 3 iStents Prospective, randomized study of 119 OAG patients with preoperative unmedicated IOP of 22-38 mm Hg Safety data similar across all stent groups Demonstrates potential to titrate treatment based on

  15. Slide 15: IOP-Lowering Capability of 1, 2 and 3 iStents

    17 Compelling Clinical Results: International Study Shows IOP-Lowering Capability of 1, 2 and 3 iStents Prospective, randomized study of 119 OAG patients with preoperative unmedicated IOP of 22-38 mm Hg Safety data similar across all stent groups IOP < 15 mm Hg IOP < 18 mm Hg IOP > 20% % of eyes Dem

  16. Slide 16: International Study of 2 Stents in Standalone Procedure

    The iStent is approved in the European Union and certain other international markets for use either in combination with cataract surgery or as a standalone procedure in phakic and pseudophakic eyes. In the United States, the iStent is indicated for use in conjunction with cataract surgery for the re

  17. Slide 17: Dual Physiologic Outflow in Failed Trab Patients

    19 Compelling Combination Clinical Results: International Study of Dual Physiologic Outflow in Failed Trab Patients + + 1 Medication 49% mean IOP reduction sustained through 1 year 100% of patients met primary endpoint of > 20% reduction in IOP at 12 months Underscores power of combining Schlemm’s c

  18. Slide 18: Clinical Research Program Statistics

    15 2 17 20 Prospective clinical trials currently underway Phase IV post-approval studies currently underway Total company-sponsored clinical trials currently underway Clinical Research Program Statistics 38 Articles published in peer-reviewed journals

  19. Slide 19: Global Commercial Operations

    21 Global Commercial Operations

  20. Slide 20: Commercial Performance of iStent Since US FDA Approval

    22 Highly successful launch of new market medical device in ophthalmology 100% Medicare Administrator Coverage within 7 months of commercial launch Strong growth rates in revenue, surgeon adoption and US sales force manpower 100,000+ commercial iStents sold Delivered 80%+ gross margins in 2015 Estab

  21. Slide 21: Q3 2015 Financial & Operational Performance

    37 45 23 in Q3 2014 in Q3 2015 TOTAL NET SALES (in millions) 22% year-over-year growth in domestic sales organization 57% year-over-year growth in net sales Q3 2015 Financial & Operational Performance: Growth Reflects iStent Adoption Trends Avg. Number of US Sales Reps $12.1 $19.0 $0 $2 $4 $6 $8 $10

  22. Slide 22: US Reimbursement Coverage

    24 Received category III CPT code in 2008 to describe implantation of MIGS device Separate physician payment approximately $500 higher for combination cataract / iStent procedure than cataract surgery alone Percent of Medicare Administrative Contractors (MACs) that cover iStent procedure Percent of

  23. Slide 23: iStent Currently Approved for Use in 20+ Countries

    25 Current & planned regional sales HQ Distributor markets Direct markets Potential to convert to direct sales in additional markets, based on device coding and coverage policies iStent Currently Approved for Use in 20+ Countries

  24. Slide 24: Strong Competitive Advantages

    26 Market Founder / First Mover Intellectual Property Clinical & Regulatory R&D / Manufacturing Approximately 180 issued, pending or exclusively licensed patents Related to devices and methods for procedures initiated from within the anterior chamber Continued lead on other potential MIGS players; e

  25. Slide 25: Financial Summary

    27 Year ended December 31 ($ in millions) 2013 2014 Net sales $20.9 $45.6 Gross profit 18.4 34.1 Gross margin 87.9% 75.0% SG&A 17.1 28.1 R&D 15.5 19.2 Total opex 32.6 47.3 Operating loss ($14.2) ($13.2) Strong net sales growth driven by competitive market position, broad reimbursement and expanding

  26. Slide 26: Growth Strategies: Establishing MIGS as OAG Standard of Care

    29 Increase US iStent adoption through expansion of sales force and reimbursement coverage Growth Strategies: Establishing MIGS as OAG Standard of Care 01 Secure FDA approvals with expanded indications for iStent pipeline products 02 Develop and commercialize iDose drug delivery pipeline 03 Extend g

  27. Slide 27: Growth Strategies

    Growth Strategies: Establishing MIGS as OAG Standard of Care 01 02 03 #£4«04 Increase US iStent ‘Secure FDA approvals Develop and Extend global reach of ‘adoption through expansion _with expanded commercialize Dose MIGS-based platform of sales force and Indications for IStent ‘drug delivery pipeline

  28. Slide 28: Addendum About the Pipeline

    31 Addendum About the Pipeline

  29. Slide 29: Our Solution Portfolio: iStent Inject

    32 2-stent injectable therapy for combo-cataract and standalone procedures Our Solution Portfolio: iStent Inject Trabecular Micro-Bypass Stent Approximately one-third the size of iStent; relies on similar method of action to restore outflow and reduce IOP For minor surgical suite or in-office proced

  30. Slide 30: Our Solution Portfolio: iDose

    33 iDose Sustained drug delivery directly into anterior chamber Our Solution Portfolio: iDose Targeted drug delivery system releases prostaglandin directly into the anterior chamber (prostaglandins are most frequently used drug for reducing IOP) Designed to be pre-loaded into a small-gauge needle an

  31. Slide 31: Our Solution Portfolio: iStent Supra

    34 Our Solution Portfolio: iStent Supra Suprachoroidal Micro-Bypass Stent Accesses secondary outflow pathway for further IOP reduction Designed for use alone or in combination with iStent or iStent Inject for even lower target IOP International study showed iStent Supra achieved a 30% pressure reduc

  32. Slide 32: Our Solution Portfolio: iStent Supra

    Our Solution Portfolio: iStent Supra Suprachoroidal Micro-Bypass Stent iJtent SUPRA Accesses secondary outflow pathway for further IOP reduction Designed for use alone _International study US IDE combo-cataract CE mark Europe rin combination with showed iStent Supra_—_trial underway {Stent or Stent

  33. Slide 33: Glaukos MIGS

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