8-K
GLAUKOS Corp (GKOS)
8-K
2021-11-22
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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): November 22, 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) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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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 November 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: November 22, 2021
Exhibit 99.1
| 1 © 2021 Glaukos Corporation<br>Investor Relations<br>Presentation<br>NOVEMBER 2021 |
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| 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<br>anticipate will or may occur in the future are forward-looking statements. These statements are based on management’s current expectations, assumptions,<br>estimates and beliefs. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on<br>current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of<br>which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by<br>forward-looking statements in this presentation. These potential risks and uncertainties that could cause actual results to differ materially from those described in<br>forward-looking statements include, without limitation, uncertainties regarding the duration and severity of the COVID-19 pandemic and its impact on our business or<br>the economy generally; our ability to continue to generate sales of our commercialized products and develop and commercialize additional products; our dependence<br>on a limited number of third-party suppliers, some of which are single-source, for components of our products; the occurrence of a crippling accident, natural disaster,<br>pandemic or other disruption at our primary facility, which may materially affect our manufacturing capacity and operations; securing or maintaining adequate<br>coverage or reimbursement by government or third-party payors for procedures using the iStent, the iStent inject W, our corneal cross-linking products or other<br>products in development; our ability to properly train, and gain acceptance and trust from, ophthalmic surgeons in the use of our products; our ability to compete<br>effectively in the highly competitive and rapidly changing medical device industry and against current and future competitors (including MIGS competitors); our<br>compliance with federal, state and foreign laws and regulations for the approval and sale and marketing of our products and of our manufacturing processes; the<br>lengthy and expensive clinical trial process and the uncertainty of timing and outcomes from any particular clinical trial; the risk of recalls or serious safety issues with<br>our products and the uncertainty of patient outcomes; our ability to protect, and the expense and time-consuming nature of protecting, our intellectual property<br>against third parties and competitors and the impact of any claims against us for infringement or misappropriation of third party intellectual property rights and any<br>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 June 30, 2021, which was filed with the SEC on August 5, 2021, and our<br>Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, which was filed with the SEC on November 8, 2021. Our filings with the SEC are available in<br>the Investor Section of our website at www.glaukos.com or at www.sec.gov. In addition, information about the risks and benefits of our products is available on our<br>website at www.glaukos.com. All forward-looking statements included in this presentation are expressly qualified in their entirety by the foregoing cautionary<br>statements. You are cautioned not to place undue reliance on the forward-looking statements in this presentation, which speak only as of the date hereof. We do not<br>undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as<br>may be required under applicable securities law. |
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| 3 © 2021 Glaukos Corporation<br>$46<br>…<br>$438<br>$104<br>2021<br>2015<br>87%<br>75%<br>2021<br>2014<br>GROSS MARGIN1<br>CASH & EQUIVALENTS (IN MILLIONS) 2<br>1 FY2014 GAAP & non-GAAP gross margin; 3Q 2021 GAAP gross margin of 79% was adjusted for certain Avedro merger-related accounting and other adjustments - see Appendix for details; 2 2015 as of 6/30/2015 (post-IPO);<br>2021 as of 9/30/2021; Includes cash, short-term investments and restricted cash;<br>Building a World-Class Global Infrastructure & Company<br>2014<br>2021<br>COUNTRIES WITH DIRECT SALES<br>2<br>17<br>REVENUE MIX<br>Q3 2015<br>20%<br>US Glaucoma<br>Int’l Glaucoma<br>Corneal Health<br>6-Yr CAGR:<br>30%<br>2014 2020<br>TOTAL NET SALES (IN MILLIONS)<br>Q3 2021<br>2021 33<br>2015<br>300+<br>PEER-REVIEWED PUBLICATIONS<br>2014 Disclosed Pipeline:<br>Glaucoma programs,<br>including 1 pharma program<br>2021 Disclosed Pipeline: Spans<br>glaucoma, corneal health and<br>retinal disease, including 11<br>pharma programs<br>4<br>16<br>PIPELINE PROGRAMS<br>Significant Progress Continues Since 2015 IPO<br>$225<br>58%<br>22%<br>20% |
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| 4 © 2021 Glaukos Corporation<br>Micro-Scale Surgical<br>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<br>Our Strategy For Long-Term Growth & Profitability<br>Creating a Unique Vision Care Leader |
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| 5 © 2021 Glaukos Corporation<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<br>Rock, IOP Sensor); 2 Company estimates of US opportunity; 3 Market Scope estimates<br>$13BEst. of global opportunity1<br>$23B Est. of US opportunity for keratoconus ($3B) and<br>iLink for presbyopia ($15B), and est. of global<br>annual dry eye market ($5.1B)2,3<br>$13B Est. of global annual market size3<br>Serving the Clinical Needs of Large Patient Populations<br>Our Strategy For Long-Term Growth & Profitability<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>THERAPEUTIC CLASSES |
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| 6 © 2021 Glaukos Corporation<br>Ocular<br>Hypertension to<br>Refractory Disease<br>Glaucoma<br>SUBMIT ISTENT<br>INFINITE TO FDA<br>COMPLETE IDOSE TR<br>PHASE 3 TRIAL<br>ENROLLMENT<br>R&D PROGRESS ON<br>IDOSE TREX &<br>IDOSE ROCK<br>LAUNCH PRESERFLO<br>& CONTINUE IPRIME<br>DEVELOPMENT<br>2021 KEY OBJECTIVES<br>~18M<br>eyes in US,<br>growing 3%/yr1<br>~36M<br>eyes in targeted<br>OUS regions2<br>Ocular hypertension and primary open-<br>angle glaucoma affect<br>+<br>1 Based on company analysis of Market Scope, Medicare Claims and IMS Health Compliance data; 2 Market Scope prevalence data for Western Europe, Japan and Other Wealthy Nations (Canada, Australia, New Zealand,<br>South Korea, Taiwan, Singapore, Hong Kong, UAE and Estonia), assuming 1.8 bilateral glaucoma rate. 3 Leske MC et al Arch Ophthalmol 2003<br>Vision loss is irreversible;<br>controlling IOP is only known<br>treatment; reducing IOP by 1<br>mmHg has been shown to reduce<br>disease progression by ~10%3<br>6 © 2021 Glaukos Corporation |
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| 7 © 2021 Glaukos Corporation<br>Glaucoma Micro-Surgical Portfolio<br>™<br>iStent infinite, iStent SA, iPRIME and PreserFlo are not approved by<br>the FDA<br>Designed to address full range of disease progression and facilitate combination therapies<br>Creates 2<br>pathways for<br>fluid outflow<br>Creates 3 pathways<br>for fluid outflow<br>across 6 clock hours<br>of Schlemm’s canal<br>Like iStent inject<br>W; but for use in<br>pseudophakic<br>patients<br>Ab-externo device for<br>late-stage glaucoma<br>Licensed from Santen<br>in Americas & Australia<br>Creates<br>pathway for<br>fluid outflow<br>INTENDED DISEASE STATE<br>Mild to Moderate Advanced to Refractory<br>Combo-Cataract Standalone<br>Creates 2 pathways for<br>fluid outflow; wider<br>flange enhances ease<br>of use and visibility<br>Industry’s broadest<br>offering of micro-<br>surgical stents<br>designed for long-<br>term IOP and<br>medication burden<br>reduction<br>Viscoelastic delivery device<br>+<br>Microsurgical tool<br>with enhanced<br>control For use during ophthalmic surgery |
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| 8 © 2021 Glaukos Corporation<br>iStent infinite: Powerful Standalone MIGS Indication<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 in a<br>standalone procedure<br>72 subjects with open-angle glaucoma<br>uncontrolled by prior surgical;<br>enrollment completed Oct 2019<br>Our focus is on patient achievement of<br>20% or greater reduction in mean<br>diurnal IOP from baseline at 12 months<br>on same or lower ocular hypotensive<br>medication burden<br>Targeting FDA approval in 1H 2022<br>US CLINICAL TRIAL<br>iStent infinite is not approved by the FDA<br>Photo courtesy of George R. Reiss MD |
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| 9 © 2021 Glaukos Corporation<br>iStent infinite Clinical Trial: Significant IOP Reduction<br>76% of subjects achieved 20% or<br>greater reduction in mean<br>diurnal IOP from baseline<br>on same or lower ocular<br>hypotensive medication<br>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<br>average of 2 prior<br>glaucoma 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 from<br>baseline |
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| 10 © 2021 Glaukos Corporation<br>iStent infinite: Viable Alternative to More Complex Procedures<br>Three-stent injectable will offer new compelling treatment<br>option in standalone procedure with highly favorable safety<br>profile<br>Clinical data suggest iStent infinite may help patients with open-<br>angle glaucoma uncontrolled by prior surgical therapy<br>Expect surgeons – glaucoma specialists and comprehensive<br>ophthalmologists – to gravitate to iStent infinite as attractive<br>late-stage procedure<br>Expect iStent infinite implantation to be reimbursed under<br>newly established Category III CPT code (0671T)<br>iStent infinite is not approved by the FDA |
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| 11 © 2021 Glaukos Corporation<br>Santen PreserFlo MicroShunt<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<br>reduction (2.4 meds) in pivotal study1<br>Favorable safety, efficacy and post-op care profile<br>Development and license agreement provides Glaukos with<br>exclusive commercialization and development rights in US,<br>Australia, New Zealand, Canada, Brazil, Mexico and remainder of<br>Latin America<br>Approved in Canada and Australia<br>Santen PreserFlo is not approved by the FDA 1 Santen press release issued Aug 30, 2019 |
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| 12 © 2021 Glaukos Corporation<br>Introducing iPRIME™<br>iPRIME is a minimally invasive viscoelastic<br>delivery system that further supports the<br>needs of physicians and patients<br>This complementary technology further<br>expands Glaukos’ broad portfolio of<br>innovative ophthalmic solutions<br>Late-stage development program, not FDA-<br>approved<br>Anticipated to be reimbursed under<br>Category I CPT code (66174)<br>iPRIME is not approved by the FDA or commercially available<br>A viscoelastic<br>delivery system |
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| 13 © 2021 Glaukos Corporation<br>• Designed to provide longest duration intracameral pharmaceutical; secure<br>and anchored design; facile implantation and exchange<br>• Membrane designed to elute specially formulated travoprost, a commonly<br>prescribed topical prostaglandin<br>• Phase 3 clinical trial enrollment and<br>randomization completed June 2021<br>iDose<br>1 Market opportunity estimates based on Glaukos algorithm of physician preference and combination therapy, utilization; assumes full<br>product portfolio availability to physician, except pre-clinical products (iDose TREX, iDose Rock, IOP Sensor)<br>Topical drugs subject to<br>significant issues of patient non-<br>adherence, impositions to<br>quality-of-life and ocular surface<br>disease and toxicity<br>Unmet need and appetite<br>among glaucoma specialists and<br>ophthalmologists for sustained-<br>release pharmaceutical<br>alternatives<br>Current mobile, intracameral<br>bio-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 implantation,<br>removal and re-implantation of drug delivery<br>system into anterior chamber, effective 7/21<br>• Estimated annual US opportunity of 3M eyes1<br>Ocular Hypertension to Refractory OAG<br>iDose TR is not approved by the FDA<br>The Next Stage in Glaucoma Therapy<br>Sustained-Release Pharmaceuticals: iDoseTR |
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| 14 © 2021 Glaukos Corporation<br>Sustained-Release Pharmaceuticals: iDoseTR<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 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>m<br>m<br>H<br>g<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<br>Alternative to Topical Medications, Addressing Non-Adherence & Other Drawbacks |
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| 15 © 2021 Glaukos Corporation<br>Sustained-Release Pharmaceuticals: iDoseTR<br>iDose patients experienced robust IOP-lowering over<br>24 months with continuous 24/7 compliance<br>Over 24 months, iDose and timolol control groups<br>progressed with similar number of protocol-<br>mandated medications added<br>iDose 24-month data validate favorable safety profile<br>and duration of IOP-lowering effect<br>iDose TR is not approved by the FDA |
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| 16 © 2021 Glaukos Corporation<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>I<br>O<br>P<br><br>%<br><br>R<br>e<br>d<br>u<br>c<br>t<br>i<br>o<br>n<br><br>f<br>r<br>o<br>m<br><br>B<br>a<br>s<br>e<br>l<br>i<br>n<br>e<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 28% for<br>the fast- and slow-release iDose TR arms, respectively,<br>versus 30% for the timolol control arm at 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>%<br><br>o<br>f<br><br>P<br>a<br>t<br>i<br>e<br>n<br>t<br>s<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 shown<br>in 23% and 20% of patients for the fast- and slow-<br>release iDose TR arms, respectively, versus 13% of<br>patients for the timolol control arm at 24 months<br>Sustained-Release Pharmaceuticals: iDoseTR |
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| 17 © 2021 Glaukos Corporation<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<br>glaucoma medications has been<br>associated with better outcomes<br>in glaucoma 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<br>iDose vs approximately<br>eye drops per eye in<br>the control arm with<br>twice-a-day timolol<br>over 24 months per<br>protocol<br>greater* IOP<br>reduction<br>Subjects who were on one pre-<br>study IOP-lowering medication<br>at screening had<br>over 24 months on iDose TR<br>vs the pre-study IOP-<br>lowering eye 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<br>* 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 for slow and fast eluting arms, respectively<br>Sustained-Release Pharmaceuticals: iDoseTR |
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| 18 © 2021 Glaukos Corporation<br>iDose TR, iDose TREX and iDose ROCK are not approved by the FDA<br>®<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>®<br>Sustained-Release Pharmaceuticals: Next Generation |
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| 19 © 2021 Glaukos Corporation<br>2021 KEY OBJECTIVES<br>PREPARE FOR EPI-<br>ON NDA FILING IN<br>2022<br>BEGIN CLINICAL<br>TRIALS FOR EPI-ON<br>NEXT GEN<br>GENERATE FIRST<br>CLINICAL DRY EYE<br>CANDIDATE<br>Common symptoms include burning,<br>itching, foreign body sensation,<br>stinging, dryness, transient blurring,<br>swelling, ocular fatigue, redness and<br>photophobia; can significantly impact<br>quality of life. Disease affects<br>>700M<br>people worldwide<br>Dry Eye<br>Gradual loss of focusing ability that<br>begins around age 40 and continues<br>to worsen with age; can cause<br>headaches, eye strain and visual<br>fatigue, making reading and other<br>near vision tasks difficult and tiring.<br>Presbyopia affects<br>>90M<br>people in the US<br>Presbyopia<br>~1.1M<br>US eyes; 32K added annually<br>Keratoconus<br>Bilateral corneal ectasia resulting<br>in irregular astigmatism and loss<br>of visual function, with onset in<br>teenage years; marked by<br>corneal steepening and thinning.<br>Disease affects<br>Keratoconus<br>Ocular Surface Disease<br>Refractive Conditions<br>Corneal<br>Health<br>Keratoconus: Company estimates; Dry Eye: Market Scope estimate; Presbyopia US Census data for 45+ population 19 © 2021 Glaukos Corporation |
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| 20 © 2021 Glaukos Corporation<br>Corneal Health Pharmaceutical Platform: iLink<br>Epoxia (Epi-on) Photrexa (Epi-off)<br>Single-application, bio-activated<br>topical pharmaceutical solution<br>Uses photo-activation to create<br>bonds between corneal collagen<br>fibers<br>Excellent efficacy and safety profile,<br>extensive clinical evidence and long-<br>term (10-year) follow-up3<br>Product-specific J-Code; favorable<br>reimbursement for 97%+ of<br>commercial lives covered<br>Epi-on Next-Gen<br>Second-generation treatment for<br>keratoconus<br>Designed to reduce treatment<br>time and complexity, improving<br>patient comfort and recovery<br>time<br>Uses stronger UVA irradiation<br>protocol and “boost” goggles to<br>increase oxygen availability<br>Targeting NDA filing in 2022<br>New laser system,<br>personalized treatment<br>algorithm and proprietary<br>chemical entity<br>Designed to further<br>enhance iLink therapy for<br>keratoconus<br>Evaluating potential for<br>treating other conditions<br>3 Raiskup, et al., Corneal collagen crosslinking with riboflavin and ultraviolet-A light in progressive keratoconus: Ten-year results. J Cataract Refract<br>Surg, 2015<br>Epoxia (Epi-on) and Epi-on Next Gen are not approved by the FDA<br>1 Pramanik S, Musch DC, Sutphin JE, Farjo AA. Extended<br>long-term outcomes of penetrating keratoplasty for<br>keratoconus. Ophthalmology. 2006;113(9):1633-1638.;<br>2 Maharana PK, Agarwal K, Jhanji V, Vajpayee RB. Deep<br>anterior lamellar keratoplasty for keratoconus: a<br>review. Eye Contact Lens. 2014;40(6):382-389.<br>iLink is first and only FDA-approved<br>corneal cross-linking procedure<br>(CXL) that slows or halts progressive<br>keratoconus<br>Left untreated, 1 in 5 progressive<br>keratoconus patients may require<br>corneal transplant; more than half<br>could need multiple transplants<br>within 20 years1,2<br>Integration of Avedro CXL business<br>now complete; comprises<br>approximately 20% of net quarterly<br>sales |
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| 21 © 2021 Glaukos Corporation<br>iLink Epi-on Phase 3 Trial Achieved Primary Efficacy Outcome<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 counts<br>over course of trial)<br>Epi-on is not approved by the FDA<br>Multi-center, randomized, placebo-<br>controlled pivotal trial designed to evaluate<br>safety and efficacy of Epi-on therapy in<br>impeding progression of and/or reducing<br>Kmax in eyes with progressive keratoconus<br>Kmax is objective measurement of the<br>steepest corneal curvature based on<br>corneal topography; increasing Kmax<br>denotes corneal steepening and<br>keratoconus 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<br>receive 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 in<br>treated arm vs. placebo arm at<br>6 months<br>(p = 0.0004)<br>0.2D<br>In treatment arm, Kmax<br>improved<br>compared to worsening in<br>Kmax by 0.8D in placebo arm<br>and demonstrating ability of<br>Epi-on to halt or reduce<br>disease progression<br>98%<br>After initial 6-month follow-up,<br>of placebo-randomized patients<br>elected to cross-over to Epi-on<br>treatment; for these patients, data<br>showed Kmax improvement mean<br>change of 0.3D at 6 months post-<br>treatment<br>Demonstrated Ability to Halt or Reduce Keratoconus Progression |
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| 22 © 2021 Glaukos Corporation<br>Corneal Health Pharmaceuticals: Eyelid Transdermal Platform<br>Proprietary cream-based formulation applied to outer<br>skin surface of the upper eyelids<br>Anatomy of the eyelid with targeted sites<br>Not approved by the FDA<br>Patented, cream-based formulation designed to be<br>applied to upper eyelid for delivery at the lacrimal<br>functional unit for treating dry eye<br>Easier administration than topical eye drops,<br>potentially better patient compliance<br>Currently investigating possible applications for dry<br>eye, presbyopia, glaucoma and other ocular disorders<br>Dry Eye / Ocular Surface Disease |
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| 23 © 2021 Glaukos Corporation<br>2021 KEY OBJECTIVE<br>MOVE FIRST RETINAL<br>DISEASE PROGRAM<br>INTO CLINIC<br>Retinal disease affects<br>~28M<br>people in the US<br>AMD and diabetic eye disease<br>make up<br>89%<br>of this patient population<br>Progressive disease characterized by<br>degeneration of the macula, the portion of the<br>retina responsible for sharp central vision and<br>color perception; AMD is the leading cause of<br>severe vision loss among people over 60 in<br>wealthy nations<br>AMD<br>Market Scope estimates for patient population<br>Retinal<br>Disease<br>Wet AMD<br>DME<br>RVO<br>23 © 2021 Glaukos Corporation |
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| 24 © 2021 Glaukos Corporation<br>Triamcinolone Acetonide SR<br>RVO & DME<br>Formulations developed to release triamcinolone<br>acetonide for up to 6 months<br>Microscope and SEM images<br>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 system<br>Formulations developed for 6 to 12 months<br>release<br>Prototype 4-month implant demonstrated 4<br>months of promising efficacy in a<br>translational model of persistent retinal<br>vessel leakage following a single intravitreal<br>injection<br>2<br>% Released<br>Anti-VEGF SR<br>Wet AMD, RVO & DME<br>Developing sustained release, hydrogel-based,<br>erodible implant with protein stabilization<br>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 |
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| 25 © 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 FDA Submission 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 Transdermal Platform Pre-clinical<br>Presbyopia Candidate Eyelid Transdermal Platform Pre-clinical<br>Demodex Mites Candidate Eyelid Transdermal Platform 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>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<br>Pipeline currently includes 16<br>candidates, plus additional<br>undisclosed programs<br>Our Strategy for Long-Term Growth & Profitability<br>Demodex blepharitis |
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| 26 © 2021 Glaukos Corporation<br>MARKET OPPORTUNITY<br>2015-2020 2021-22 2023-24 2025+<br>iStent<br>iStent inject<br>iStent inject W<br>iLink Epi-off<br>PreserFlo<br>iStent infinite<br>Delivering a Deep Pipeline of Disruptive Therapies<br>iStent SA<br>iDose TREX<br>iDose Rock<br>iLink Epi-on Next Gen<br>Dry Eye Therapy<br>Presbyopia Therapy<br>Demodex Therapy<br>Retinal Disease Programs<br>IOP Sensor<br>iDose TR<br>iLink Epi-on |
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| 27 © 2021 Glaukos Corporation<br>Appendix<br>Amort. of Stock-based<br>Dev Tech Comp Exp on<br>3Q 2021 GAAP Intangibles Replacement 3Q 2021 Non-GAAP<br>Gross Margin Awards Gross Margin<br>Net Sales 74,710 $ 74,710 $<br>COGS 15,370 $ (5,523) $ (180) $ 9,667 $<br>Gross Profit 59,340 $ 5,523 $ 180 $ 65,043 $<br>Gross Margin 79% 87%<br>GAAP to Non-GAAP Reconciliation - 3Q 2021 |
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| 28 © 2021 Glaukos Corporation |
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