8-K
GLAUKOS Corp (GKOS)
8-K
2021-03-04
For: 2021-03-04
View Original
Added on
April 12, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 4, 2021
Glaukos Corporation
(Exact name of registrant as specified in its charter)
| Delaware | 001-37463 | 33-0945406 | ||
|---|---|---|---|---|
| (State or other jurisdiction | | (Commission | | (I.R.S. Employer |
| of incorporation) | | File Number) | | Identification No.) |
| 229 Avenida Fabricante San Clemente , California | **** | 92672 |
|---|---|---|
| | | |
| (Address of principal executive offices) | **** | (Zip Code) |
Registrant’s telephone number, including area code: ( 949 ) 367-9600
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class: | **** | Trading Symbol | **** | Name of each exchange on which registered: |
|---|---|---|---|---|
| Common Stock | | GKOS | | New York Stock Exchange |
Item 7.01. Regulation FD Disclosure.
Glaukos Corporation (the “Company”) intends to present the materials attached as Exhibit 99.1 to this Current Report on Form 8-K (the “Investor Presentation”) from time to time in presentations to investors and other stakeholders. The Investor Presentation will also be available on the investor page of the Company’s website at http://investors.glaukos.com.
The information contained in this Item 7.01 and in the accompanying Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
|---|---|---|
| 99.1 | Investor Presentation, dated March 2021 | |
| 104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| GLAUKOS CORPORATION<br>(Registrant) | ||
|---|---|---|
| | | |
| By: | /s/ Joseph E. Gilliam | |
| Name: Joseph E. Gilliam | ||
| Title: Chief Financial Officer and Senior Vice President, Corporate Development |
Date: March 4, 2021
Exhibit 99.1
| 1 © 2021 Glaukos Corporation<br>March 2021 |
|---|
| 2 © 2021 Glaukos Corporation<br>Disclaimer<br>All statements other than statements of historical facts included in this presentation that address activities, events or developments that we expect, believe or anticipate<br>will or may occur in the future are forward-looking statements. These statements are based on management’s current expectations, assumptions, estimates and beliefs.<br>Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about<br>future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and<br>many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this<br>presentation. These potential risks and uncertainties that could cause actual results to differ materially from those described in forward-looking statements include,<br>without limitation, uncertainties regarding the duration and severity of the COVID-19 pandemic and its impact on our business or the economy generally; our ability to<br>continue to generate sales of our commercialized products and develop and commercialize additional products; our dependence on a limited number of third-party<br>suppliers, some of which are single-source, for components of our products; the occurrence of a crippling accident, natural disaster, pandemic or other disruption at our<br>primary facility, which may materially affect our manufacturing capacity and operations; securing or maintaining adequate coverage or reimbursement by third-party<br>payors for procedures using the iStent, the iStent inject, our corneal cross-linking products or other products in development of our products; our ability to properly train,<br>and gain acceptance and trust from, ophthalmic surgeons in the use of our products; our ability to compete effectively in the highly competitive and rapidly changing<br>medical device industry and against current and future competitors (including MIGS competitors); our compliance with federal, state and foreign laws and regulations for<br>the approval and sale and marketing of our products and of our manufacturing processes; the lengthy and expensive clinical trial process and the uncertainty of timing<br>and outcomes from any particular clinical trial; the risk of recalls or serious safety issues with our products and the uncertainty of patient outcomes; our ability to protect,<br>and the expense and time-consuming nature of protecting, our intellectual property against third parties and competitors and the impact of any claims against us for<br>infringement or misappropriation of third party intellectual property rights and any related litigation; and our ability to service our indebtedness.<br>These and other known risks, uncertainties and factors are described in detail under the caption “Risk Factors” and elsewhere in our filings with the Securities and<br>Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which was filed with the SEC on November 5, 2020 and<br>our Annual Report on Form 10-K for 2020, which was filed with the SEC on March 1, 2021. Our filings with the SEC are available in the Investor Section of our website at<br>www.glaukos.com or at www.sec.gov. In addition, information about the risks and benefits of our products is available on our website at www.glaukos.com. All forward-<br>looking statements included in this presentation are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue<br>reliance on the forward-looking statements in this presentation, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify<br>these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law. |
| --- |
| 3 © 2021 Glaukos Corporation<br>1 FY2014 GAAP & non-GAAP gross margin; FY 2020 GAAP gross margin of 59% was adjusted for certain Avedro merger-related accounting and other adjustments - see Appendix for details; 2 2015 as of 6/30/2015 (post-IPO); 2020 as of<br>12/31/2020; Includes cash, short-term investments and restricted cash<br>Building a World-Class Global Infrastructure & Company<br>Significant Progress Continues Since 2015 IPO<br>83%<br>75%<br>2020<br>2014<br>GROSS MARGIN1<br>CASH & EQUIVALENTS (IN MILLIONS)2<br>2014<br>2020<br>COUNTRIES WITH DIRECT SALES<br>2<br>17<br>$414<br>$104<br>2020<br>2015<br>REVENUE BY GEOGRAPHY US<br>Int’l<br>77%<br>23%<br>2020<br>REVENUE BY FRANCHISE<br>2015<br>94%<br>6% 100%<br>80%<br>20%<br>2015 2020<br>Glaucoma<br>Corneal Health<br>$46<br>$225 6-Yr CAGR:<br>30%<br>2014 2020<br>TOTAL NET SALES (IN MILLIONS)<br>2020<br>$55<br>$32<br>$65<br>$73<br>Q1 Q2 Q3 Q4 |
| --- |
| 4 © 2021 Glaukos Corporation<br>2020: Major Accomplishments that Advanced our Growth Strategy<br>ESTABLISHED<br>CORNEAL HEALTH<br>FRANCHISE<br>SUCCESSFUL<br>LAUNCH OF<br>ISTENT INJECT W<br>SWIFT &<br>EFFECTIVE COVID<br>RESPONSE<br>STRENGTHENED<br>BALANCE SHEET<br>COMPLETED<br>GLOBAL SYSTEMS<br>TRANFORMATION<br>INTERNATIONAL<br>SALES GROWTH<br>& APPROVALS<br>ADVANCED<br>MARKET-<br>EXPANDING<br>PIPELINE<br>CONTINUED TO<br>OPTIMIZE<br>REIMBURSEMENT<br>Completed seamless<br>integration of Avedro business,<br>delivering record Photrexa<br>revenue and KXL placements<br>Providing surgeons optimized<br>stent visualization, streamlined<br>implantation and procedural<br>predictability with iStent inject W<br>Executing plans designed to<br>ensure safe work environments<br>for employees while meeting<br>customer needs and reducing<br>annual costs by ~$25M<br>Reported strong international<br>sales related to recent<br>expansion efforts; received<br>new regulatory approvals in<br>Australia and Japan<br>Worked proactively with<br>multiple entities to ensure<br>reimbursement coverage and<br>payment, including upcoming<br>combo-cataract MIGS<br>transition to Category I<br>Completed iStent infinite FDA<br>trial, continued enrollment in<br>Phase 3 iDoseTR trials and<br>made progress on multiple<br>pre-clinical R&D programs<br>Completed $288M<br>convertible debt offering,<br>further strengthening our<br>balance sheet and ability to<br>invest in future growth<br>Enterprise-wide upgrades<br>designed to enhance<br>business activities and<br>support long-term growth |
| --- |
| 5 © 2021 Glaukos Corporation<br>Our Strategy for Long-Term Growth & Profitability<br>Creating a Unique Vision Care Leader<br>Micro-Scale<br>Surgical Devices<br>Pharmaceuticals<br>Biosensors<br>Ocular Hypertension<br>to Refractory Disease Glaucoma<br>Corneal<br>Health<br>Keratoconus<br>Ocular Surface Disease<br>Refractive Conditions<br>Retinal<br>Disease<br>Wet AMD<br>DME<br>RVO<br>MAJOR PLATFORMS THERAPEUTIC CLASSES |
| --- |
| 6 © 2021 Glaukos Corporation<br>Our Strategy for Long-Term Growth & Profitability<br>Serving the Clinical Needs of Large Patient Populations<br>1 Estimate based on Glaukos algorithm of physician preference and combination therapy, utilization; assumes full product portfolio availability to physician, except pre-clinical products (iDose TREX, iDose Rock, IOP Sensor); 2 Company estimates<br>of US opportunity; 3 Market Scope estimates<br>Ocular Hypertension<br>to Refractory Disease Glaucoma<br>Corneal<br>Health<br>Keratoconus<br>Ocular Surface Disease<br>Refractive Conditions<br>Retinal<br>Disease<br>Wet AMD<br>DME<br>RVO<br>$13B Est. of global opportunity1<br>$23B Est. of US opportunity for keratoconus ($3B) and<br>iLink for presbyopia ($15B), and est. of US annual<br>dry eye market ($2.4B)2,3<br>$13B Est. of global annual market size3<br>THERAPEUTIC CLASSES |
| --- |
| 7 © 2021 Glaukos Corporation<br>Ocular<br>Hypertension to<br>Refractory<br>Disease<br>Glaucoma<br>Key 2121 Glaucoma Catalysts<br>SUBMIT ISTENT<br>INFINTE PMA-S<br>TO FDA<br>COMPLETE IDOSE<br>TR PHASE 3 TRIAL<br>R&D PROGRESS<br>ON IDOSE TREX<br>& IDOSE ROCK<br>LAUNCH<br>PRESERFLO &<br>CONTINUE IPRIME<br>DEVELOPMENT |
| --- |
| 8 © 2021 Glaukos Corporation<br>iStent infinite: Powerful Standalone MIGS Indication<br>FDA Submission Set for 1H 2021; Targeting Late 2021 Approval<br>Three wide-flange stents<br>preloaded in injector system<br>that facilitates placement<br>across ~6 clock hours of<br>Schlemm’s canal<br>US IDE open-label, single-arm study<br>in a standalone procedure<br>72 subjects with open-angle<br>glaucoma uncontrolled by prior<br>surgical or medical therapy;<br>enrollment completed Oct 2019<br>Our focus is on patient achievement<br>of 20% or greater reduction in mean<br>diurnal IOP from baseline at 12<br>months on same or lower ocular<br>hypotensive medication burden<br>US CLINICAL TRIAL<br>iStent infinite is not approved by the FDA<br>Photo courtesy of George R. Reiss MD |
| --- |
| 9 © 2021 Glaukos Corporation<br>iStent infinite: Significant IOP Reduction in Severe Patients<br>FDA Submission Set for 1H 2021; Targeting Late 2021 Approval<br>76% of subjects achieved 20%<br>or greater reduction in<br>mean diurnal IOP from<br>baseline on same or lower<br>ocular hypotensive<br>medication burden<br>Highly favorable safety profile<br>(no explants, infections or device-related interventions or hypotony)<br>iStent infinite is not approved by the FDA<br>13% Most difficult to<br>treat glaucoma<br>patients<br>Average of 3.1 IOP<br>lowering medications<br>at baseline<br>Already failed average<br>of 2 prior glaucoma<br>surgeries<br>≥50% of subjects achieved 30% or<br>greater reduction in mean<br>diurnal IOP from baseline<br>mean reduction in<br>medication burden<br>from baseline |
| --- |
| 10 © 2021 Glaukos Corporation<br>iStent infinite: Viable Alternative to More Complex Procedures<br>Three-stent injectable will offer new compelling treatment option<br>in standalone procedure with highly favorable safety profile<br>Clinical data suggest iStent infinite may help patients with open-<br>angle glaucoma uncontrolled by prior surgical or medical therapy<br>Expect surgeons – glaucoma specialists and comprehensive<br>ophthalmologists – to gravitate to iStent infinite before<br>proceeding to tissue-destructive procedures<br>iStent infinite is not approved by the FDA |
| --- |
| 11 © 2021 Glaukos Corporation<br>Santen PreserFlo MicroShunt<br>An Alternative to Trabeculectomy & Tube Shunts<br>8.5 mm tube made of biocompatible material (SIBS); standalone,<br>ab-externo procedure to filter fluid from anterior chamber to<br>subconjunctival space<br>Designed to treat late-stage, refractory glaucoma<br>Attractive alternative to trabeculectomy, tubes, XEN and ExPress<br>• Demonstrated IOP reduction (30+%) and medication burden reduction<br>(2.4 meds) in pivotal study1<br>Favorable safety, efficacy and post-op care profile<br>Glaukos is exclusive partner in US and Australia<br>• FDA approval pending<br>• Anticipate US launch in 2021<br>• Will utilize established Category I CPT code (66183)<br>Santen PreserFlo is not approved by the FDA 1 Santen press release issued Aug 30, 2019 |
| --- |
| 12 © 2021 Glaukos Corporation<br>Introducing iPRIME™<br>A New Viscodelivery System from Glaukos<br>iPRIME is a minimally invasive<br>viscoelastic delivery system that further<br>supports the needs of physicians and<br>patients<br>This complementary technology further<br>expands Glaukos’ broad portfolio of<br>innovative ophthalmic solutions<br>Development-stage program, not FDA-<br>approved<br>iPRIME is not approved by the FDA or commercially available<br>A viscoelastic<br>delivery system for<br>use in Schlemm’s<br>canal |
| --- |
| 13 © 2021 Glaukos Corporation<br>Glaucoma Micro-Surgical Portfolio<br>Comprehensive, Tissue-Sparing Offering Designed to Address Full Range of Disease Progression &<br>Facilitate Combination Therapies<br>Creates 2<br>pathways for<br>fluid outflow<br>Creates 3<br>pathways for fluid<br>outflow across 6<br>clock hours of<br>Schlemm’s canal<br>Like iStent inject<br>W; but for use in<br>pseudophakic<br>patients<br>Ab-externo device<br>for late-stage<br>glaucoma<br>Santen’s exclusive<br>US partner<br>INTENDED DISEASE STATE<br>Mild to Moderate Advanced to Refractory<br>flexible microcatheter along with inserting viscoelastic to disconnect potential adhesions and debris in the canal and distal collector channels<br>Creates<br>pathway for<br>fluid outflow<br>Combo-Cataract Standalone<br>™<br>™<br>Creates 2 pathways<br>for fluid outflow;<br>wider flange<br>enhances ease of<br>use and visibility<br>Viscoelastic delivery<br>system for use in<br>Schlemm’s canal<br>iStent infinite, iStent SA, iPRIME and PreserFlo are not approved by the FDA |
| --- |
| 14 © 2021 Glaukos Corporation<br>Sustained-Release Pharmaceuticals<br>The Next Stage in Glaucoma Therapy<br>• Designed to provide longest duration intracameral pharmaceutical;<br>secure and anchored design; facile implantation and exchange<br>• Membrane designed to elute specially formulated travoprost, a<br>commonly prescribed topical prostaglandin<br>• Phase 3 clinical trials underway<br>iDose<br>1 Market opportunity estimates based on Glaukos algorithm of physician preference and combination therapy, utilization; assumes full product portfolio availability to physician, except pre-clinical products (iDose TREX, iDose Rock, IOP Sensor)<br>Topical drugs subject to significant<br>issues of patient non-adherence,<br>impositions to quality-of-life and<br>ocular surface disease and toxicity<br>Unmet need and appetite among<br>glaucoma specialists and<br>ophthalmologists for sustained-<br>release pharmaceutical<br>alternatives<br>Current mobile, intracameral bio-<br>erodible implants limited by<br>endothelial cell loss, labeling<br>restrictions and relatively short<br>durations of activity<br>CLINICAL NEED<br>• AMA approved Cat III codes for<br>implantation, removal and re-<br>implantation of drug delivery system<br>into anterior chamber, effective 7/21<br>• Estimated annual US opportunity of<br>3M eyes1<br>Ocular Hypertension to Refractory OAG<br>iDose TR is not approved by the FDA |
| --- |
| 15 © 2021 Glaukos Corporation<br>Sustained-Release Pharmaceuticals: iDoseTR<br>Alternative to Topical Medications, Addressing Non-Adherence & Other Drawbacks<br>iDose TR is not approved by the FDA<br>Average Reduction in IOP<br>PHASE 2 CLINICAL DATA AT 24 MONTHS*<br>154-patient, multi-center,<br>randomized, double-blind trial<br>Evaluated 2 iDose models with<br>two different travoprost elution<br>rates, compared to topical timolol<br>ophthalmic solution, 0.5%<br>Primary efficacy endpoint of non-<br>inferiority to topical timolol<br>Subjects diagnosed with mild to<br>moderate OAG or ocular<br>hypertension, on 0 to 3 meds<br>with baseline IOP between 21<br>mmHg and 36 mmHg<br>Additional medications were<br>added if IOP was above 18<br>mmHg<br>Month 3 Month 6 Month 9 Month 12 Month 18 Month 24<br>5.0<br>6.0<br>7.0<br>8.0<br>9.0<br>7.5 7.5 7.6 7.6 7.6<br>7.8 7.7 7.7 7.6 7.5 7.5 7.4<br>8.3<br>8.1 8.0<br>7.8 7.7<br>7.9<br>mmHg<br>iDose FE iDose SE Timolol 0.5% BID<br>*Calculated using all IOP observations through each data point weighted equally, no imputations for mandated medications<br>PHASE 2 CLINICAL TRIAL<br>n = 51 54 49 51 54 49 49 54 49 49 53 48 49 52 48 47 50 46 |
| --- |
| 16 © 2021 Glaukos Corporation<br>Sustained-Release Pharmaceuticals: iDoseTR<br>Alternative to Topical Medications, Addressing Non-Adherence & Other Drawbacks<br>iDose patients experienced robust IOP-lowering over 24<br>months with continuous 24/7 compliance<br>Over 24 months, iDose and timolol control groups<br>progressed with similar number of protocol-mandated<br>medications added<br>iDose 24-month data validate favorable safety profile and<br>duration of IOP-lowering effect<br>iDose TR is not approved by the FDA |
| --- |
| 17 © 2021 Glaukos Corporation<br>Sustained-Release Pharmaceuticals: iDoseTR<br>Alternative to Topical Medications, Addressing Non-Adherence & Other Drawbacks<br>Average IOP % Reduction from Baseline<br>PHASE 2 CLINICAL DATA AT 24 MONTHS*<br>iDose TR is not approved by the FDA<br>5<br>10<br>15<br>20<br>25<br>30<br>35<br>30%<br>28% 29%<br>IOP % Reduction from Baseline<br>iDose FE iDose SE Timolol 0.5% BID<br>*Calculated using all IOP observations through each data point weighted equally, no imputations for mandated medications<br>Average IOP reduction from baseline was 29% and<br>28% for the fast- and slow-release iDose TR arms,<br>respectively, versus 30% for the timolol control arm at<br>24 months<br>n = 47 50 46<br><br>5<br>10<br>15<br>20<br>25<br>30<br>35<br>13%<br>20%<br>23%<br>% of Patients<br>iDose FE iDose SE Timolol 0.5% BID<br>n = 47 50 46<br>Proportion of Subjects with ≥ 40% IOP Reduction from Baseline<br>PHASE 2 CLINICAL DATA AT 24 MONTHS*<br>IOP reduction from baseline of at least 40% was<br>shown in 23% and 20% of patients for the fast- and<br>slow-release iDose TR arms, respectively, versus 13%<br>of patients for the timolol control arm at 24 months |
| --- |
| 18 © 2021 Glaukos Corporation<br>Sustained-Release Pharmaceuticals: iDoseTR<br>Alternative to Topical Medications, Addressing Non-Adherence & Other Drawbacks<br>Designed to address primary shortcomings of existing glaucoma topical and<br>intracameral therapeutics<br>Patients are generally poorly<br>compliant with IOP-lowering eye<br>drops<br>iDose design implies 100%<br>compliance once administered<br>Improved compliance with glaucoma<br>medications has been associated<br>with better outcomes in glaucoma<br>disease<br>iDose offers fixed placement to<br>improve the safety for corneal<br>endothelium<br>1,460<br>Subjects received one<br>administration of iDose<br>vs approximately<br>eye drops per eye in the<br>control arm with twice-a-<br>day timolol over 24<br>months per protocol<br>greater* IOP<br>reduction<br>Subjects who were on one pre-<br>study IOP-lowering medication at<br>screening had<br>over 24 months on iDose TR vs<br>the pre-study IOP-lowering eye<br>drops<br>iDose subjects in fast-<br>and slow-elution arms<br>had<br>clinically significant<br>corneal endothelial cell<br>loss, no serious corneal<br>adverse events, and no<br>conjunctival hyperemia<br>adverse events to date<br>no<br>iDose TR is not approved by the FDA * For subjects on a single pre-study medication, iDose TR demonstrated incremental IOP reduction at 24 months of 1.1 mmHg and 1.5 mmHg versus pre-study IOP<br>for slow and fast eluting arms, respectively |
| --- |
| 19 © 2021 Glaukos Corporation<br>iDose TR, iDose TREX and iDose ROCK are not approved by the FDA<br>®<br>Sustained-Release Pharmaceuticals: iDose Platform<br>Next Generation iDose TREX & iDose ROCK<br>INTENDED DISEASE STATE<br>Ocular Hypertension to Refractory OAG<br>Substantial increase in drug payload, with potential to double the<br>duration-of-effect vs first-generation iDose TR<br>Same external dimensions, titanium material, elution rate, anchor<br>design and implantation procedure as first-generation iDose TR<br>Uses travoprost formulation identical to first-generation iDose TR<br>J-code structure provides opportunity for additional reimbursement vs<br>iDose TR<br>®<br>Leveraging iDose platform technology to develop sustained-release<br>system for rho kinase inhibitors<br>Evaluating multiple compounds with plan to select candidate for<br>advancement into clinical trials<br>® |
| --- |
| 20 © 2021 Glaukos Corporation<br>Creating a<br>Vision Care<br>Leader |
| --- |
| 21 © 2021 Glaukos Corporation<br>Ocular Hypertension<br>to Refractory Disease Glaucoma<br>Corneal<br>Health<br>Keratoconus<br>Ocular Surface Disease<br>Refractive Conditions<br>Retinal<br>Disease<br>Wet AMD<br>DME<br>RVO<br>SUBMIT ISTENT<br>INFINTE PMA-S<br>TO FDA<br>LAUNCH<br>PRESERFLO &<br>CONTINUE IPRIME<br>DEVELOPMENT<br>COMPLETE<br>IDOSE TR<br>PHASE 3<br>TRIAL<br>R&D PROGRESS<br>ON IDOSE TREX<br>& IDOSE ROCK<br>PREPARE FOR<br>EPI-ON NDA<br>FILING IN 2022<br>BEGIN CLINCAL<br>TRIALS FOR<br>EPI-ON NEXT<br>GEN<br>GENERATE<br>FIRST CLINICAL<br>DRY EYE<br>CANDIDATE<br>MOVE FIRST<br>RETINAL DISEASE<br>PROGRAM INTO<br>CLINIC<br>2021: Key Catalysts to Drive the Business Forward |
| --- |
| 22 © 2021 Glaukos Corporation<br>Corneal Health Pharmaceutical Platform: iLink<br>Epi-on<br>(Epioxa)<br>Photrexa<br>(Epi-off)<br>Single-application, bio-activated topical<br>pharmaceutical solution shown to halt keratoconus<br>progression<br>Uses photo-activation to create bonds between<br>corneal collagen fibers<br>Excellent efficacy and safety profile, extensive clinical<br>evidence and long-term (10-year) follow-up1<br>Product-specific J-Code; favorable reimbursement for<br>95%+ of commercial lives covered<br>Epi-on<br>Next-Gen<br>Second-generation treatment for keratoconus<br>Designed to reduce treatment time and<br>complexity, improving patient comfort and<br>recovery time<br>Uses stronger UVA irradiation protocol and<br>“boost” goggles to increase oxygen availability<br>Targeting NDA filing in 2022<br>New laser system, personalized treatment<br>algorithm and proprietary chemical entity<br>Designed to further enhance iLink therapy<br>for keratoconus<br>Evaluating potential for treating other<br>conditions<br>Not approved by the FDA Not approved by the FDA<br>1 Raiskup, et al., Corneal collagen crosslinking with riboflavin and ultraviolet-A<br>light in progressive keratoconus: Ten-year results. J Cataract Refract Surg,<br>2015 ; |
| --- |
| 23 © 2021 Glaukos Corporation<br>iLink Epi-on Phase 3 Clinical Trial Achieved Primary Efficacy Outcome<br>Demonstrated Ability to Halt or Reduce Keratoconus Progression<br>-1.0D<br>Achieved primary efficacy<br>outcome by demonstrating<br>Kmax treatment effect of<br>Well-tolerated procedure<br>(majority of adverse events were mild and transient in nature; no change in corneal endothelial cell<br>counts over course of trial)<br>Epi-on is not approved by the FDA<br>Multi-center, randomized, placebo-controlled<br>pivotal trial designed to evaluate safety and<br>efficacy of Epi-on therapy in impeding<br>progression of and/or reducing Kmax in eyes<br>with progressive keratoconus<br>Kmax is objective measurement of the<br>steepest corneal curvature based on corneal<br>topography; increasing Kmax denotes<br>corneal steepening and keratoconus<br>progression<br>279-eye study (189 in treatment arm; 90 in<br>control arm)<br>Following 6-month follow-up, patients<br>randomized to placebo were able to receive<br>Epi-on treatment<br>All patients followed another 6 months for<br>safety and efficacy evaluations<br>PHASE 3 CLINICAL TRIAL<br>determined as prospectively<br>defined least square mean<br>Kmax change from baseline<br>in treated arm vs. placebo<br>arm at 6 months<br>(p = 0.0004) 0.2D<br>In treatment arm, Kmax<br>improved<br>compared to worsening in<br>Kmax by 0.8D in placebo<br>arm and demonstrating<br>ability of Epi-on to halt or<br>reduce disease progression<br>98%<br>After initial 6-month follow-<br>up,<br>of placebo-randomized<br>patients elected to cross-over<br>to Epi-on treatment; for these<br>patients, data showed<br>Kmax improvement mean<br>change of 0.3D at 6 months<br>post-treatment |
| --- |
| 24 © 2021 Glaukos Corporation<br>Corneal Health Pharmaceutical Platform: Eyelid Ophthalmic Drug Delivery<br>Topical Therapy for Treatment of Dry Eye & Other Ocular Disorders<br>Proprietary cream-based formulation applied to<br>outer skin surface of the upper eyelids<br>Anatomy of the eyelid with targeted sites<br>Intratus not approved by the FDA<br>Patented, cream-based formulation designed to be applied<br>to upper eyelid for delivery at the lacrimal functional unit for<br>treating dry eye<br>Easier administration than topical eye drops, potentially<br>better patient compliance<br>Currently investigating possible applications for glaucoma<br>and other ocular disorders<br>Dry Eye / Ocular Surface Disease |
| --- |
| 25 © 2021 Glaukos Corporation<br>Triamcinolone Acetonide SR<br>RVO & DME<br>Formulations developed to release<br>triamcinolone acetonide for up to 6 months<br>Microscope and SEM<br>images of implants<br>1 Multi-Kinase Inhibitor SR<br>Wet AMD, RVO & DME<br>Developing a multi-kinase inhibitor small<br>molecule sustained-release delivery<br>system<br>Formulations developed for 6 to 12<br>months release<br>Prototype 4-month implant demonstrated<br>4 months of promising efficacy in a<br>translational model of persistent retinal<br>vessel leakage following a single<br>intravitreal injection<br>2<br>% Released<br>Anti-VEGF SR<br>Wet AMD, RVO & DME<br>Developing sustained release, hydrogel-<br>based, erodible implant with protein<br>stabilization technology<br>Release rate of anti-VEGF protein verified in<br>animal model of persistent retinal vascular<br>leakage<br>Optimization of delivery system is underway<br>Released<br>Cumulative Released (ug)<br>3<br>Retinal Disease Programs<br>Retina pipeline not approved by the FDA |
| --- |
| 26 © 2021 Glaukos Corporation<br>PRODUCT/CANDIDATE PLATFORM / PRODUCT TYPE PATIENT STATUS<br>Micro-Surgical Devices<br>iStent Trabecular Bypass Stents Approved<br>iStent inject / iStent inject W Trabecular Bypass Stents Approved<br>iStent SA Trabecular Bypass Stents Pivotal IDE Trial<br>iStent infinite Trabecular Bypass Stents PMA-S Pending<br>iPRIME Viscodelivery Class II (TBD)<br>PreserFlo (Santen) Microshunt PMA Submitted<br>Pharmaceuticals<br>iDose TR Sustained-Release System Phase 3<br>iDose TREX Sustained-Release System Pre-clinical<br>iDose ROCK Sustained-Release System Pre-clinical<br>iLink Epi-off (Photrexa) Bio-Activated Approved<br>iLink Epi-on (Epioxa) Bio-Activated Phase 3<br>iLink Epi-on Next Generation Bio-Activated Pre-clinical<br>Dry Eye Candidate Eyelid Drug Delivery Pre-clinical<br>Multi-Kinase Inhibitor SR Bio-Erodible Pre-clinical<br>Triamcinolone Acetonide SR Bio-Erodible Pre-clinical<br>Anti-VEGF SR Bio-Erodible Pre-clinical<br>Biosensors<br>IOP Sensor Implantable sensor Pre-clinical<br>Our Strategy for Long-Term Growth & Profitability<br>Pipeline Currently Includes 14 Candidates, Plus Additional Undisclosed Programs<br>Mild-to-moderate glaucoma w/cataract<br>Mild-to-moderate glaucoma pseudophakic<br>Advanced-to-refractory glaucoma<br>Keratoconus<br>Ocular surface disease<br>OHT-to-moderate glaucoma<br>Refractive disorders<br>Wet AMD<br>DME<br>RVO |
| --- |
| 27 © 2021 Glaukos Corporation<br>MARKET OPPORTUNITY<br>2015-2020 2021-22 2023-24 2025+<br>Delivering a Deep Pipeline of Disruptive Therapies<br>Leveraging Multiple Proprietary Platforms to Serve Large Ophthalmic Markets<br>iStent<br>iStent inject<br>iStent inject W<br>iLink Epi-off<br>PreserFlo<br>iStent infinite<br>Dry Eye Therapy<br>iDose Rock<br>IOP Sensor<br>iLink Epi-on Next Gen<br>Retinal Disease Programs<br>iDose TR<br>iDose TREX<br>iLink Epi-on<br>iStent SA |
| --- |
| 28 © 2021 Glaukos Corporation<br>Appendix<br>Rollout of Amort. Of Inventory Stock-based Reversal of Employee<br>Inventory Dev Tech Write-off Comp Exp on Restructuring Retention/<br>Fair Value Adj Intangibles & iStent Inject Replacement Expenses Family First<br>FY2020 GAAP net of COVID E&O Reserves Awards Credits FY2020 Non-GAAP<br>Gross Margin E&O reversal Gross Margin<br>Net Sales 224,959 $ 224,959 $<br>COGS 91,719 $ (24,712) $ (22,092) $ (6,248) $ (962) $ 106 $ 124 $ 37,935 $<br>Gross Profit 133,240 $ 24,712 $ 22,092 $ 6,248 $ 962 $ (106) $ (124) $ 187,024 $<br>Gross Margin 59% 83%<br>GAAP to Non-GAAP Reconciliation - FY2020 |
| --- |
| 29 © 2021 Glaukos Corporation |
| --- |