8-K
GLAUKOS Corp (GKOS)
8-K
2023-08-18
For: 2023-08-18
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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): August 18, 2023
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.) |
| One Glaukos Way Aliso Viejo , California | **** | 92656 |
|---|---|---|
| | | |
| (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 August 2023 | |
| 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/ Alex R. Thurman | |
| Name: Alex R. Thurman | ||
| Title: Senior Vice President & Chief Financial Officer |
Date: August 18, 2023
Exhibit 99.1
| Investor<br>Presentation<br>August 2023 |
|---|
| 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; the impact of general macroeconomic conditions including foreign currency fluctuations; the reduced physician fee and ASC facility fee reimbursement<br>rate finalized by CMS for 2022 and 2023 for procedures utilizing the Company’s iStent family of products and its impact on our U.S. combo-cataract glaucoma revenue;<br>our ability to continue to generate sales of our commercialized products and develop and commercialize additional products; our dependence on a limited number of<br>third-party suppliers, some of which are single-source, for components of our products; the occurrence of a crippling accident, natural disaster, pandemic or other<br>disruption at our primary facility, which may materially affect our manufacturing capacity and operations; securing or maintaining adequate coverage or<br>reimbursement by government or third-party payors for procedures using the iStent®, the iStent inject® W, iAccess, iPRIME, iStent infinite, our corneal cross-linking<br>products or other products in development; our ability to properly train, and gain acceptance and trust from, ophthalmic surgeons in the use of our products; our<br>ability to compete effectively in the highly competitive and rapidly changing medical device industry and against current and future technologies (including MIGS<br>technologies); our compliance with federal, state and foreign laws and regulations for the approval and sale and marketing of our products and of our manufacturing<br>processes; the lengthy and expensive clinical trial process and the uncertainty of timing and outcomes from any particular clinical trial or regulatory approval<br>processes; the risk of recalls or serious safety issues with our products and the uncertainty of patient outcomes; our ability to protect, 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 infringement or<br>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 (SEC), including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, which was filed with the SEC on August 2, 2023. Our<br>filings with the SEC are available in the Investor Section of our website at www.glaukos.com or at www.sec.gov. In addition, information about the risks and benefits of<br>our products is available on our website at www.glaukos.com. All forward-looking statements included in this presentation are expressly qualified in their entirety by<br>the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this presentation, which speak only as of the<br>date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events<br>or otherwise, except as may be required under applicable securities law.<br>© 2023 Glaukos Corporation 2 |
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| WE’LL GO FIRST<br>Innovation is at the core of everything we do. At Glaukos, we<br>push the limits of science and technology to solve unmet needs<br>in chronic eye diseases.<br>© 2023 Glaukos Corporation 3 |
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| Our Core Strategy<br>1. BIG IDEAS<br>2. SIGNIFICANT CLINICAL NEED<br>3. SPECIALIZED R&D TEAMS<br>4. EXPERIENCED SALES ORGANIZATION<br>5. PROVEN MARKET BUILDER<br>6. EFFICIENT GLOBAL OPERATIONS<br>Designed to drive long-term growth and value creation<br>© 2023 Glaukos Corporation 4 |
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| invested in R&D since 2018<br>5 distinct platforms<br>generating disruptive,<br>dropless innovations<br>across 3 franchises<br>$400M<br>14<br>Disclosed pipeline<br>programs in 2023 vs. 4<br>in 2015<br>invested in R&D since 2018<br>OUR BIG IDEAS<br>Develop novel<br>dropless<br>therapies to<br>disrupt legacy<br>topical eye drop<br>therapies<br>plagued by<br>rampant patient<br>non<br>-adherence<br>© 2023 Glaukos Corporation<br>5 |
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| GLAUCOMA<br>Topical medications are the<br>dominant treatment plan for the<br>roughly 18M US eyes1 affected by<br>glaucoma and ocular hypertension<br>Research2<br>shows that<br>>90 %<br>& 50 ~<br>%<br>of patients are non-compliant with topical<br>medication use<br>purposely discontinue<br>their medication within<br>6 months<br>High rates of non-compliance and non-adherence to topical<br>medications contribute to<br>disease progression<br>Even patients diagnosed and treated with topical medication regimens<br>can suffer significant disease progression3<br>Landmark glaucoma studies show that<br>Early surgical intervention can slow disease progression more effectively<br>than medical therapy4<br>The current “meds-first, give-ground” disease progression<br>algorithm must be challenged<br>The conventional glaucoma patient journey is being re-examined<br>1 topical<br>med<br>2 topical<br>meds<br>SLT +<br>topical<br>meds<br>3+<br>topical<br>meds<br>Filtering<br>surgery<br>Aqueous<br>shunt<br>Marked by long recovery periods, serious<br>complications and high failure rates<br>© 2023 Glaukos Corporation 6 |
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| INTERVENTIONAL<br>GLAUCOMA<br>Proactive glaucoma<br>management via predictive<br>diagnostics, active patient<br>monitoring and procedural<br>intervention earlier in the<br>treatment paradigm to:<br>• Improve patient management<br>• Preserve visual function<br>• Slow disease progression<br>• Reduce or eliminate the need<br>for topical medications and/or<br>invasive incisional surgery<br>Interventional Glaucoma represents<br>Glaukos’ founding promise to radically alter<br>the conventional treatment algorithm<br>MIGS therapies safely and effectively slow the<br>progression of glaucoma and reduce drug burden<br>Targets 24/7 foundational IOP control with minimal<br>side effects or drawbacks<br>1<br>2 Benign nature of MIGS therapies compels surgeons to<br>consider Interventional Glaucoma therapy far earlier<br>3 Improved quality of life for glaucoma patient<br>© 2023 Glaukos Corporation 7 |
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| INTERVENTIONAL<br>GLAUCOMA<br>Trabecular Bypass<br>Sustained-Release<br>Viscodelivery<br>Goniotomy<br>Subconjunctival<br>With the only comprehensive<br>glaucoma portfolio<br>Glaukos is uniquely positioned to<br>address this important unmet<br>need and lead development of<br>the Interventional Glaucoma<br>opportunity<br>C o m b o - C a t a r a c t S t a n d a l o n e<br>Creates 3 pathways for up to 240° of fluid<br>outflow coverage; failed prior medical and<br>surgical therapy<br>Creates 2 pathways for fluid<br>outflow; wider flange enhances<br>ease of use and visibility<br>C o m b o - C a t a r a c t o r S t a n d a l o n e<br>Precision blade designed to cut<br>trabecular meshwork tissue<br>Viscoelastic delivery system<br>designed to deliver exceptional<br>surgical control and precision<br>Designed to provide 24/7,<br>long-duration, sustained<br>release of travoprost directly<br>into the anterior chamber<br>Ab-externo Phase 3 (NDA filed)<br>subconjunctival device<br>Customized therapy based on disease stage severity<br>iDose TR and PreserFlo are not approved by the FDA; iAccess and iPRIME have not been cleared by the FDA to reduce IOP in the treatment of glaucoma © 2023 Glaukos Corporation 8 |
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| 12-MONTH CLINICAL TRIAL RESULTS5<br>76<br>≥<br>% of subjects achieved 20%<br>or greater reduction in<br>mean IOP on same or<br>lower medication burden<br>50% of subjects achieved 30%<br>or greater reduction in<br>mean IOP<br>First-ever micro-invasive implantable device<br>for standalone glaucoma treatment<br>• Three micro-stents designed to provide up to 240° of sustained, 24/7 outflow<br>• Pivotal trial results confirm highly favorable efficacy and safety profile<br>• FDA cleared in 2022 for use in patients with OAG uncontrolled on prior<br>medical and surgery therapy; phased US launch underway<br>• Supported by decades-long track record of successful iStent technology use<br>in combo-cataract procedures<br>Most difficult to treat patients with<br>average of 3.1 IOP-lowering<br>medications at baseline who had<br>already failed on average of 2 prior<br>glaucoma surgeries<br>20+<br>Years of iStent clinical<br>experience<br>250+<br>Peer-reviewed publications<br>on iStent technology<br>1 Million+<br>iStent devices implanted<br>worldwide<br>© 2023 Glaukos Corporation 9 |
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| Designed to address<br>ubiquitous patient non-adherence to and<br>chronic side effects<br>associated with topical<br>medications by<br>providing 24/7, long-duration therapy<br>The next major addition to the<br>Interventional Glaucoma arsenal<br>• Designed to provide long-duration<br>intracameral pharmaceutical; secure and<br>anchored design; facile implantation and<br>exchange<br>• Membrane elutes specially formulated<br>travoprost, a commonly prescribed topical<br>prostaglandin, providing 100% compliance<br>• NDA submission in February 2023; PDUFA<br>date set for December 22, 2023<br>• Estimated annual US opportunity of 3M eyes6<br>Minimally-invasive<br>implant designed to<br>deliver proprietary<br>formulation of travoprost<br>iDose TR is not approved by the FDA © 2023 Glaukos Corporation 10 |
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| In 2 pivotal trials, iDose<br>TR fast- and slow-release doses achieved<br>pre-specified primary<br>efficacy endpoints as<br>agreed upon with US<br>FDA (non-inferiority to<br>topical timolol through<br>3 months)<br>IOP Reductions from Baseline (mmHg)<br>8.5<br>6.6<br>7.7<br>6.5<br>6.7<br>8.4<br>6.8<br>7.2<br>Slow-release iDose TR Timolol 0.5% BID<br>IOP REDUCTIONS FROM BASELINE<br>OBSERVED DURING FIRST 3 MONTHS1<br>• 1,150 subjects randomized<br>across both Phase 3 trials<br>• Mean baseline IOP of ~24<br>mmHg in each study<br>• ~81% of slow-release iDose TR<br>subjects had open-angle<br>glaucoma; 19% ocular<br>hypertension<br>• 67% of slow-release iDose TR<br>subjects were on at least 1 IOP-lowering medication at<br>screening, including 23% of<br>subjects that were on 2 or more<br>Phase 3 data achieves primary efficacy endpoints<br>1 mmHg range represents IOP reduction means across the six U.S. FDA pre-specified timepoints of 8AM and 10AM at Day 10, Week 6 and Month 3 ; iDose TR is not approved by the FDA © 2023 Glaukos Corporation 11 |
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| First-of-its-kind real-world effectiveness<br>data further validates<br>the game-changing<br>potential of iDose TR<br>IOP (mmHg)<br>10<br>12<br>14<br>16<br>18<br>20<br>22<br>24<br>Pre-Study PGA After Washout<br>(Remove pre-study<br>PGA)<br>iDose Month 3<br>18.0<br>mmHg 16.7<br>mmHg<br>23.8<br>mmHg<br>IOP VALUES ON PRE-STUDY PGAs, AFTER PGA<br>WASHOUT, AND AFTER 3 MONTHS OF IDOSE TR • 125 subjects across both Phase 3<br>trials were on a single PGA IOP-lowering med at screening<br>• After 4-week washout (PGAs<br>removed), IOP rose to 23.8<br>mmHg, thus showing pre-study<br>PGA efficacy of -5.8 mmHg<br>• After iDose TR administration,<br>IOP decreased to 16.7 mmHg at<br>3 months, thus showing iDose TR<br>in-study efficacy of -7.1 mmHg<br>• iDose TR demonstrated 1.3<br>mmHg statistically significant<br>superior IOP-lowering vs pre-study PGAs (p = 0.0003)<br>iDose TR demonstrated statistically significant superior<br>IOP-lowering vs pre-study PGAs in sub-group analysis of<br>combined Phase 3 trials<br>iDose TR is not approved by the FDA © 2023 Glaukos Corporation 12<br>Pre-study<br>PGAs:<br>-5.8 mmHg<br>In-Study iDose TR:<br>-7.1 mmHg<br>(Δ 1.3 mmHg vs pre-study PGAs,<br>p = 0.0003) |
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| Phase 3 and Phase 2b duration data for iDose TR<br>iDose TR:<br>The data<br>that matters<br>to doctors,<br>patients and<br>payors<br>AT 12 MONTHS AT 24 MONTHS AT 36 MONTHS<br>PH 3<br>93% Percentage of slow-release iDose TR<br>subjects well-controlled<br>on the same or fewer<br>IOP-lowering topical<br>PH 2B<br>92% 72% 69% medications<br>of slow-release iDose TR subjects in the Phase 3 trials<br>were completely free of IOP-lowering topical<br>medications at 12 months<br>81%<br>iDose TR is not approved by the FDA © 2023 Glaukos Corporation 13 |
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| GC-009<br>Slow-release iDose TR Timolol 0.5% BID<br>% PATIENTS WELL CONTROLLED ON THE<br>SAME OR FEWER TOPICAL IOP-LOWERING<br>Phase 2b: iDose MEDS IN PHASE 2B TRIAL AT 3 YEARS<br>TR arm controls<br>IOP in more<br>patients vs<br>eyedrop arm at<br>3 years<br>69%<br>45%<br>2,190 eye drops administered per<br>eye per 3-yr protocol in Phase 2b<br>control arm vs one administration<br>of iDose TR (for subjects free of<br>topical medication at 3-yrs)<br>vs<br>2,190<br>1<br>iDose TR is not approved by the FDA © 2023 Glaukos Corporation 14 |
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| Phase 3 and Phase 2b safety data for iDose TR<br>iDose TR:<br>The data<br>that matters<br>to doctors,<br>patients and<br>payors<br>iDose TR<br>Topical PGAs Ph 3 Trials<br>1 Year<br>Ph 2b Trial<br>3 Years<br>No adverse events of periorbital<br>fat atrophy Up to 70% incidence<br>Very low or no conjunctival<br>hyperemia 30%-50% incidence<br>No adverse events of corneal<br>endothelial cell loss<br>Very low or no incidence of iris<br>color change ~20% incidence<br>iDose TR is not approved by the FDA © 2023 Glaukos Corporation 15 |
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| • Prospective, multi-center trial to<br>evaluate safety of exchange procedure<br>• Study enrolled 33 subjects previously<br>implanted in iDose TR Phase 2b study<br>• Subject’s study eye underwent surgical<br>exchange with slow-release iDose TR<br>model, with 12-month follow-up<br>• Average overall extended evaluation<br>period of 5+ years<br>Exchange study’s positive<br>data set included in NDA<br>submission to enable<br>repeat dosing<br>No clinically meaningful changes in corneal<br>endothelial cell counts over 5+ years<br>No patient in the exchange study exhibited adverse event of<br>endothelial cell loss (≥30% loss) over extended evaluation period<br>Exchange trial conducted<br>on re-administration of<br>iDose TR<br>0<br>500<br>1000<br>1500<br>2000<br>2500<br>3000<br>Ph2b Baseline Ph2b 3 Years Re-dosing<br>Baseline (4.2<br>Years)<br>2nd Dose 1 Year<br>(5.2 Years)<br>Corneal Endothelial Cell Density<br>(cells/mm2<br>)<br>iDose TR is not approved by the FDA © 2023 Glaukos Corporation 16 |
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| iDose TR has<br>potential to<br>address rampant<br>problem of<br>patient non-compliance with<br>topical glaucoma<br>medications<br>iDose TR is not approved by the FDA<br>As part of the Phase 3 trials, in-office administration of iDose<br>TR was employed with various subjects across multiple sites<br>with outcomes that were consistent with the Phase 3 trials<br>In-office administration<br>Clinical trial efficacy data<br>In Phase 3 trials, 93% of subjects were well-controlled and 81% of subjects were<br>completely free of IOP-lowering medications at 12 months; Phase 2b trial revealed<br>69% of subjects still well-controlled at 36 months<br>Exchange trial data<br>Clinical trial safety data<br>Low or no incidence of side effects that are common to topical IOP-lowering<br>medications; no adverse events related to corneal endothelial cell loss<br>Prospective, multi-center exchange trial including 33 Phase 2b subjects demonstrated<br>safety profile at 12 months<br>iDose TR is not approved by the FDA © 2023 Glaukos Corporation 17 |
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| PRODUCT PATIENT STATUS<br>COMBO- CATARACT<br>iStent / iStent inject /<br>iStent inject W Mild-to-Moderate Glaucoma with Cataract Approved<br>(2012 / 2018 / 2020)<br>STANDALONE<br>iStent infinite Glaucoma<br>(failed on prior medical and surgical therapy) FDA cleared<br>iStent infinite Glaucoma<br>(label expansion) IDE open<br>PreserFlo Advanced-Refractory Glaucoma OUS approved<br>US IDE planned<br>iDose TR OHT-Glaucoma NDA filed<br>PDUFA date: 12/22/23<br>iDose TREX OHT-Glaucoma Pre-clinical<br>iDose ROCK OHT-Glaucoma Pre-clinical<br>iLution Travoprost OHT-Glaucoma IND open<br>iAccess Precision Goniotomy FDA cleared<br>iPRIME Viscodelivery FDA cleared<br>INTERVENTIONAL<br>GLAUCOMA PORTFOLIO<br>Addressing the full range of<br>glaucoma progression<br>iAccess and iPRIME have not been cleared by the FDA to reduce IOP in the treatment of glaucoma © 2023 Glaukos Corporation 18 |
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| iLINK PLATFORM<br>Bio-activated corneal cross-linking<br>therapy for keratoconus, a sight-threatening, life-altering disease<br>with typical onset in adolescence<br>First and only FDA-approved bio-activated pharmaceutical<br>therapy shown to slow or halt progression of keratoconus.<br>Without effective treatment, 1 in 5 progressive<br>keratoconus patients may require corneal transplant.7,8<br>73 98<br>of corneal grafts fail within 20 years<br>and 30 years, respectively7,8<br>&<br>% %<br>PRODUCT/ PROGRAM PATIENT STATUS<br>Photrexa (Epi-off) Keratoconus Approved<br>(2016)<br>Epioxa (Epi-on) Keratoconus<br>1<br>st Phase 3 trial completed;<br>2<br>nd Phase 3 confirmatory<br>trial enrollment completed<br>iLink Third-Generation Keratoconus Phase 2<br>iVeena Keratoconus Phase 1<br>COMMERCIAL PRODUCTS & DISCLOSED PIPELINE PROGRAMS<br>© 2023 Glaukos Corporation 19 |
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| -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<br>change in corneal endothelial cell counts over course of trial)<br>determined as<br>prospectively defined least<br>square mean Kmax change<br>from baseline in treated<br>arm vs. placebo arm at 6<br>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<br>arm demonstrating ability<br>of Epi-on to halt or reduce<br>disease progression<br>98%<br>After initial 6-month<br>follow-up,<br>of placebo-randomized<br>patients elected to cross-over to Epi-on treatment;<br>for these patients, data<br>showed Kmax<br>improvement mean<br>change of 0.3D at 6<br>months post-treatment<br>Demonstrated ability to halt or reduce keratoconus<br>progression (n=279 eyes)<br>Epi-On is designed to<br>reduce treatment time<br>and complexity,<br>improving patient<br>comfort and recovery<br>time<br>Kmax<br>is the point of highest<br>corneal curvature, measured<br>in Diopters (D)<br>Epioxa<br>(Epi-on)<br>1<br>st Phase 3<br>trial<br>achieved<br>primary<br>endpoints<br>Epi-on is not approved by the FDA © 2023 Glaukos Corporation 20 |
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| iLUTION PLATFORM<br>Transdermal dropless therapy with<br>the potential to treat a variety of<br>chronic eye diseases and disorders<br>PRODUCT/ PROGRAM PATIENT STATUS<br>iLution Dry Eye Dry Eye Phase 2<br>iLution Presbyopia Presbyopia Phase 2<br>iLution Blepharitis Demodex Blepharitis Pre-clinical<br>iLution Travoprost OHT - Glaucoma IND open<br>DISCLOSED PIPELINE PROGRAMS<br>Lacrimal Function Unit: integrated system<br>comprising the lacrimal glands, ocular<br>surface (cornea, conjunctiva and<br>meibomian glands) and lids, and the<br>sensory and motor nerves that connect<br>them.<br>Potential target sites for iLution formulations<br>Eyelid delivery offers potential for easier administration,<br>faster onset of action, fewer side effects and other benefits<br>vs prescription eye drops used to treat dry eye disease and<br>other conditions, contributing to better compliance.<br>© 2023 Glaukos Corporation 21 |
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| -8.5<br>-8.2<br>Trial demonstrated favorable safety and tolerability<br>• 98% of patients completed the trial<br>• No ocular adverse events occurring at incidence of<br>5% or greater<br>Improvement in the quality of tear film (tear break-up<br>time sign) with corresponding improvement in quality<br>of vision (reduction in blurred vision symptom) was<br>observed<br>The topline trial outcome provides promising early<br>read-out on potentially differentiated efficacy of<br>iLution dropless therapy for dry eye disease<br>iLution Dry Eye (GLK-301) Phase 2a Trial:<br>218 dry eye patients<br>were studied for 28<br>days with additional 14-<br>day safety follow-up<br>~55 patients/arm in<br>each of the 3 doses of<br>GLK-301 vs placebo<br>GLK-301 Phase 2a first-time-in-human results show<br>promise to progress to Phase 2b trial<br>GLK-301A Placebo<br>43%<br>22%<br>TEAR BREAK-UP TIME, PERCENT<br>CHANGE FROM BASELINE AT DAY 28<br>GLK-301A Placebo<br>BLURRED VISION IMPROVEMENT IN VAS<br>CHANGE FROM BASELINE AT DAY 28<br>27<br>19<br>iLution Dry Eye is not approved by the FDA © 2023 Glaukos Corporation 22 |
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| RETINA XR PLATFORM<br>Addressing the significant<br>drawbacks of conventional<br>therapies for retinal diseases<br>PRODUCT/ PROGRAM PATIENT STATUS<br>IVT Multi-Kinase Inhibitor AMD, DME, RVO Pre-clinical<br>IVT Triamcinolone DME Pre-clinical<br>DISCLOSED PIPELINE PROGRAMS<br>Targeting biodegradable, small-molecule implant with<br>sustained efficacy, designed to address shortcomings of<br>conventional injections that impose tremendous<br>treatment burdens on patients and contribute to lack of<br>compliance<br>28<br>Million People<br>89%<br>AMD & Diabetic<br>Eye Disease<br>In the US, retinal disease<br>affects approximately 28M<br>people; AMD and diabetic<br>eye disease make up 89% of<br>this patient population10<br>Monthly or bi-monthly anti-VEGF<br>injections are standard of care for<br>AMD, DME and RVO but studies<br>show that<br>39%<br>of patients are lost to follow-up within<br>2 years9<br>© 2023 Glaukos Corporation 23 |
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| -8.5<br>-8.2<br>Retina<br>XR:<br>Data<br>supports<br>expedited<br>first-time-in-human trial<br>in 2023<br>20+ months of vascular leakage prevention in rabbit model of AMD<br>IVT multi-kinase inhibitor continues to<br>demonstrate robust and durable effect in vivo<br>0<br>5<br>10<br>15<br>20<br>25<br>30<br>35<br>40<br>0 100 200 300 400 500 600 700<br>Vascular Leakage Score<br>Days<br>Placebo Implant<br>2 MKI Implants<br>1 MKI Implant<br>© 2023 Glaukos Corporation 24 |
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| Attractive<br>financial<br>profile<br>provides<br>solid<br>foundation<br>NET SALES<br>(in millions)<br>2015 2022<br>$72<br>$283<br>MARGINS<br>75% 82%<br>2014<br>GROSS MARGIN1<br>2023 $310<br>2015 $104<br>2023<br>CASH AND EQUIVALENTS2<br>(in millions)<br>20%+<br>7YR CAGR<br>SALES MIX<br>© 2023 Glaukos Corporation 25 1 FY2014 GAAP and non-GAAP gross margin (75%); 2023 represents 2Q23; 2Q23 GAAP gross margin of 75% was adjusted for certain Avedro merger-related accounting and other adjustments - see Appendix for details<br>2 2015 as of 6/30, 2023 as of 6/30<br>49%<br>28%<br>23%<br>2Q<br>2023<br>94%<br>6%<br>2015<br>US Glaucoma<br>Corneal Health<br>Int’l Glaucoma |
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| Efficient,<br>scalable<br>global<br>platform<br>supports<br>growth<br>2015 2023<br>65 275+<br>GLOBAL COMMERCIAL<br>PERSONNEL<br>COUNTRIES WITH DIRECT SALES<br>2014<br>2<br>2023<br>17<br>Complemented by<br>distributor and<br>hybrid models in 35<br>additional countries<br>NEW STATE-OF-THE-ART HYBRID PHARMACEUTICAL MANUFACTURING FACILITY<br>© 2023 Glaukos Corporation 26 |
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| MARGINS<br>OUR CURRENT<br>PORTFOLIO<br>Disrupting treatment<br>paradigms with<br>dropless therapies that<br>address important<br>needs<br>14 disclosed pipeline<br>programs across 5<br>distinct platforms<br>© 2023 Glaukos Corporation 27<br>PRODUCT PATIENT<br>GLAUCOMA<br>iStent / iStent inject / iStent inject W Mild-to-Moderate Glaucoma with Cataract<br>iStent infinite Glaucoma Standalone (failed on prior therapy)<br>CORNEA<br>Photrexa (Epi-off) Keratoconus<br>OTHER SURGICAL<br>iAccess Precision Goniotomy<br>iPRIME Viscodelivery |
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| MARGINS<br>PRODUCT PATIENT<br>GLAUCOMA<br>iStent / iStent inject / iStent inject W Mild-to-Moderate Glaucoma with Cataract<br>iStent infinite Glaucoma Standalone (failed on prior therapy)<br>iStent infinite Glaucoma Standalone (label expansion)<br>PreserFlo Advanced-Refractory Glaucoma Standalone<br>iDose TR OHT-Glaucoma Standalone<br>iDose TREX OHT-Glaucoma Standalone<br>iDose ROCK OHT-Glaucoma Standalone<br>iLution Travoprost OHT-Glaucoma<br>CORNEA<br>Photrexa (Epi-off) Keratoconus<br>Epioxa (Epi-on) Keratoconus<br>iLink Third-Generation Keratoconus<br>iVeena Keratoconus<br>iLution Dry Eye Dry Eye<br>iLution Presbyopia Presbyopia<br>iLution Blepharitis Demodex Blepharitis<br>RETINA<br>IVT Multi-Kinase Inhibitor AMD, DME, RVO<br>IVT Triamcinolone DME<br>OTHER SURGICAL<br>iAccess Precision Goniotomy<br>iPRIME Viscodelivery<br>OUR FUTURE<br>PORTFOLIO<br>Disrupting treatment<br>paradigms with<br>dropless therapies that<br>address important<br>needs<br>Advancing existing and<br>currently undisclosed<br>platforms and programs<br>© 2023 Glaukos Corporation 28 |
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| Appendix<br>© 2023 Glaukos Corporation 30<br>2Q 2023 GAAP Amort. of Dev 2Q 2023 Non-GAAP<br>Gross Margin Tech Intangibles Gross Margin<br>Net Sales $ 80,399 $ 80,399<br>COGS $ 20,103 $ (5,523) $ 14,580<br>Gross Profit $ 60,296 $ 5,523 $ 65,819<br>Gross Margin 75% 82%<br>GAAP to Non-GAAP Reconciliation - 2Q 2023 |
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| References<br>1 Based on company analysis of Market Scope, Medicare Claims and IMS Health Compliance data<br>2 Nordstrom BL, Friedman DS, Mozaffari E, Quigley H, Walker AM. Persistence and adherence with topical glaucoma therapy. Am J Ophthalmol. 2005;140(4): 598-606<br>3 Malihi M, Moura, Filho ER, Hodge DO, Sit AJ. Long-term trends in glaucoma-related blindness in Olmsted County, MN Ophthalmology. 2014;121(1):134–41<br>4 Lichter PR, Musch DC, Gillespie BW, et al. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to<br>medications or surgery. Ophthalmology. 2001;108(11):1943-1953<br>5 US IDE open-label, single-arm study in a standalone procedure; 72 subjects, including 61 with OAG uncontrolled by prior surgery and 11 uncontrolled by maximally<br>tolerated medical therapy<br>6 Market opportunity estimates based on Glaukos algorithm of physician preference and combination therapy, utilization; assumes full product portfolio availability to<br>physician, except pre-clinical products (iDose TREX, iDose Rock, etc)<br>7 Pramanik S, Musch DC, Sutphin JE, Farjo AA. Extended long-term outcomes of penetrating keratoplasty for keratoconus. Ophthalmology. 2006;113(9):1633-1638<br>8 Maharana PK, Agarwal K, Jhanji V, Vajpayee RB. Deep anterior lamellar keratoplasty for keratoconus: a review. Eye Contact Lens. 2014;40(6):382-389<br>9 Long-term Experience With Intravitreal Anti-VDGF Treatment in Patients with AMD: Analysis of IRIS Registry Database (presented at 39th Annual Meeting of the<br>American Society of Retina Specialists by Theodore Leng, MD)<br>10 Market Scope, 2019<br>..<br>© 2023 Glaukos Corporation 31 |
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