GLAUKOS Corp 8-K, filed Aug 9, 2024
GLAUKOS Corp (GKOS)
About this 8-K
GLAUKOS Corp filed this 8-K on August 9, 2024.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
|
| |||
(State or other jurisdiction | | (Commission | | (I.R.S. Employer |
of incorporation) | | File Number) | | Identification No.) |
| ||
| | |
(Address of principal executive offices) |
| (Zip Code) |
Registrant’s telephone number, including area code: (
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: |
| |
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 |
| |
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 | |
| | |
| By: | /s/ Alex R. Thurman |
|
| Name: Alex R. Thurman |
|
| Title: Senior Vice President & Chief Financial Officer |
Date: August 9, 2024
| Investor Presentation August 2024 |
| Disclaimer All statements other than statements of historical facts included in this presentation that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. These statements are based on management’s current expectations, assumptions, 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 current expectations about 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 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 presentation. These potential risks and uncertainties that could cause actual results to differ materially from those described in forward-looking statements include, without limitation, uncertainties regarding the impact of the COVID-19 pandemic or other health crises on our business; our ability to successfully commercialize our iDose TR therapy; the impact of general macroeconomic conditions including foreign currency fluctuations; our dependence 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, or other disruption at our primary facility, which may materially affect our manufacturing capacity and operations; securing or maintaining adequate coverage or reimbursement by government or third-party payors for procedures using the iStent®, the iStent inject® W, iAccess, iPRIME, iStent infinite, iDose® TR, our corneal cross-linking products or other products in development, and our compliance with the requirements of participation in federal healthcare programs such as Medicare and Medicaid; our ability to properly train, and gain acceptance and trust from, ophthalmic surgeons in the use of our products; our 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 lengthy and expensive clinical trial process and the uncertainty of timing and outcomes from any particular clinical trial or regulatory approval processes; the risk of recalls or serious safety issues with our products and the uncertainty of patient outcomes; our ability to protect our information systems against cyber threats and cybersecurity incidents, and to comply with state, federal and foreign data privacy laws and regulations; 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 misappropriation of third party intellectual property rights and any related litigation; and our ability to service our indebtedness. 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 Exchange Commission (SEC), including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, which was filed with the SEC on August 2, 2024. Our 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 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 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 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 or otherwise, except as may be required under applicable securities law. © 2024 Glaukos Corporation 2 |
| The iDose® TR Journey © 2024 Glaukos Corporation 3 of research and development to bring iDose TR from ideation to commercialization 15+ YEARS $600+ MILLION invested in R&D since 2018 to advance iDose TR and other innovations, representing 30%+ of revenues 1150 SUBJECTS studied in Phase 3 FDA iDose TR clinical trials that met both CDRH and CDER requirements 134K SQ FEET build-out of iDose TR manufacturing facilities that meet appropriate regulatory, CMC and ISO 7 guidelines 100K+ PAGES in NDA submission to CDRH and CDER for FDA approval of iDose TR Nearly two decades of investment and commitment |
| Revolutionary, micro-invasive, injectable treatment for the full range of glaucoma disease severity First-ever long-duration procedural pharmaceutical designed to deliver up to 3 years of glaucoma drug therapy © 2024 Glaukos Corporation 4 iDose TR is FDA-approved Our pioneering journey is just beginning |
| iDose TR: Groundbreaking Glaucoma Advancement Insertion System Precision-engineered to facilitate straightforward implantation Fixed and Stable Securely anchored into scleral tissue for drug elution directly into the anterior chamber Designed to provide 24/7, continuous, long-duration drug therapy to address ubiquitous patient non-compliance with topical medications <0.5mm 1.8mm © 2024 Glaukos Corporation 5 Unique Drug Formulation 75 mcg of a novel, proprietary, preservative-free travoprost formulation; ~25,000x more concentrated than leading PGA medications (0.004% in Travatan Z) Novel Membrane Nanoporous, ethylene-vinyl acetate (EVA) membrane designed for continuous drug elution iDose TR is a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) INDICATIONS AND USAGE |
| iDose TR: Addresses Important Clinical Needs Topical medications are the dominant treatment plan for the roughly 18M US eyes1 affected by glaucoma and ocular hypertension Research2 shows that >90% of patients are non-compliant with medication use ~50% purposely discontinue their medication(s) within 6 months & High rates of non-compliance and non-adherence to topical medications contribute to disease progression Complex dosing regimens, instillation difficulties and chronic side effects associated with topical meds undermine patient compliance and quality of life • Hyperemia • Periorbital fat atrophy • Ocular surface disease • Hyperchromia © 2024 Glaukos Corporation 6 1 Based on company analysis of Market Scope, Medicare Claims and IMS Health Compliance data. 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 |
| iDose TR: Phase 3 Data Validates Game-Changing Potential IOP Reductions from Baseline (mmHg) 8.5 6.6 7.7 6.5 6.7 8.4 6.8 7.2 Timolol 0.5% BID iDose TR In 2 pivotal trials (1,150 subjects randomized across both trials), iDose TR achieved pre-specified primary efficacy endpoints as agreed upon with US FDA (non-inferiority to topical timolol through 3 months) Statistically significant superior IOP-lowering vs pre-study PGAs in sub-group analysis of combined Phase 3 trials IOP VALUES ON PRE-STUDY PGAs, AFTER PGA WASHOUT AND AT 3 MONTHS OF iDOSE TR IOP (mmHg) 10 12 14 16 18 20 22 24 Pre-Study PGA After Washout (Remove pre-study PGA) 18.0 mmHg 16.7 mmHg 23.8 mmHg Pre-study PGAs: -5.8 mmHg In-Study iDose TR: -7.1 mmHg (Δ 1.3 mmHg vs pre-study PGAs, p = 0.0003) • 125 subjects across both Phase 3 trials were on single PGA IOP-lowering med at screening • After 4-week washout, IOP rose to 23.8 mmHg, showing pre-study PGA efficacy of -5.8 mmHg • After iDose TR administration, IOP decreased to 16.7 mmHg at 3 months, showing iDose TR in-study efficacy of -7.1 mmHg • iDose TR demonstrated 1.3 mmHg statistically significant superior IOP-lowering vs pre-study PGAs (p = 0.0003) Month 3 IOP REDUCTIONS FROM BASELINE OBSERVED DURING FIRST 3 MONTHS1 © 2024 Glaukos Corporation 7 1 mmHg range represents IOP reduction means across the 6 US FDA pre-specified timepoints of 8AM and 10AM at Day 10, Week 6 and Month 3 |
| iDose TR: Phase 3 & Phase 2b Data Confirms Long Duration AT 12 MONTHS AT 24 MONTHS AT 36 MONTHS PH 3 93% PH 2B 92% 72% 69% of iDose TR subjects in the Phase 3 trials were completely 81% free of IOP-lowering topical medications at 12 months % OF iDOSE TR SUBJECTS WELL-CONTROLLED1 ON THE SAME OR FEWER IOP-LOWERING TOPICAL MEDICATIONS % PATIENTS WELL CONTROLLED1 ON THE SAME OR FEWER TOPICAL IOP-LOWERING MEDS IN PHASE 2B TRIAL AT 3 YEARS 69% 45% Timolol 0.5% BID © 2024 Glaukos Corporation 8 1 Well-controlled patients were prospectively defined in the clinical study protocol as those with IOP ≤ 18 mmHg in the Phase 2B trial. In the Phase 3 trials, they were defined as those with IOP ≤ 22 mmHg, or > 22 and ≤ 25 mmHg with a reduction of ≥ 20% from baseline. Patients above these values were treated with the addition of a topical IOP-lowering medication |
| iDose TR shown to deliver therapeutically relevant and durable drug concentrations through 24 months iDose TR: Pharmacokinetic Clinical Study Results Open label, single-center study to determine in-patient drug elution rate and aqueous humor (AH) exposure to travoprost free acid (TFA) 210 iDose TR patients were followed for 3-24 months At pre-determined timepoints, iDose TR was removed and analyzed for remaining levels of travoprost in the implants. AH was collected and analyzed for TFA concentrations 5.0 3.7 5.6 2.0 2.2 3.8 3.3 3 Months 6 Months 12 Months 15 Months 18 Months 21 Months 24 Months ng/mL MEAN TFA CONCENTRATIONS Mean TFA levels were above CMAX concentration of TFA (1.78 ng/mL) determined after the dosing of topical travoprost; levels were also above efficacious TFA level (95 pg/mL) estimated after intracameral implant dosing of travoprost 79% 70% 50% 39% 35% 28% 16% 3 Months 6 Months 12 Months 15 Months 18 Months 21 Months 24 Months AVG AMOUNT OF TRAVOPROST REMAINING FOLLOWING EXPLANTATION % Of Travoprost At 24 months, iDose TR implants still contained 16% of the travoprost drug product Data abstract presented at ARVO 2024 Annual Meeting © 2024 Glaukos Corporation 9 |
| Ph 3 Trials 1 Year Ph 2b Trial 3 Years Topical PGAs No adverse events of periorbital fat atrophy Up to 70% incidence Very low conjunctival hyperemia 30%-50% incidence No adverse events of corneal endothelial cell loss Very low or no incidence of iris color change ~20% incidence iDose TR: Phase 3 & Phase 2b Results Show Excellent Safety PHASE 3 AND PHASE 2B SAFETY DATA FDA APPROVAL: PRESCRIBING SAFETY INFORMATION In controlled studies, the most common ocular adverse reactions in 2% to 6% of patients were increases in intraocular pressure, iritis, dry eye, and visual field defects. © 2024 Glaukos Corporation 10 |
| iDose TR: Major Addition to Interventional Glaucoma Arsenal Glaukos is uniquely positioned to lead development of the Interventional Glaucoma opportunity G L A U C O M A T H E R A P Y Designed to provide 24/7 long-duration sustained release of travoprost directly into the anterior chamber; for full range of disease progression Up to 240° of powerful outflow coverage for patients who failed prior medical and surgical therapy C O M B O - C A T A R A C T O N L Y Creates 2 pathways for fluid outflow; wider flange enhances ease of use and visibility OCULAR HYPERTENSION MILD MODERATE ADVANCED REFRACTORY © 2024 Glaukos Corporation 11 |
| iDose TR: Launch Strategy to Follow Proven Glaukos Playbook G L A U C O M A T H E R A P Y © 2024 Glaukos Corporation 12 2012-Today: Glaukos pioneers combo-cataract MIGS treatment class, establishing new standard of glaucoma care Annual US opportunity: ~500K eyes1 2024+: Glaukos introduces the next major advancement in patient-focused Interventional Glaucoma care via execution of our proven strategy for improving treatment paradigms and building durable ophthalmic markets Annual US opportunity: 1M+ eyes1 2023+: Glaukos launches first-ever micro-invasive implantable device for standalone glaucoma treatment, introducing Interventional Glaucoma Annual US opportunity : 200K+ eyes1 (current indication) 1 Company estimates for annual opportunity; based on Glaukos algorithm of physician preference and utilization; iDose TR estimate assumes up to 3-year therapy duration R E V O L U T I O N I Z I N G |
| iDose TR: Commercial Launch Strategy Methodical, controlled launch commences Surgeon training begins, focused on glaucoma specialists Establishment of Cat III CPT code (0660T) for facility (APC 5492 classification) effective 4/1 Permanent J-code (J7355) effective 7/1 Accelerate marketing investments as universe of trained surgeons expands and market access is established Establishment of Cat III CPT code (0660T) for pro fees (MAC by MAC) © 2024 Glaukos Corporation 13 Commercial production underway at state-of-the-art nano-manufacturing facility Robust body of peer-reviewed clinical evidence builds with first publication of 12+ planned journal articles WAC pricing established, positioning iDose TR among the most cost-effective procedural pharmaceuticals in ophthalmology1 Permanent J-Code application submitted 1 When annualized based on its design to deliver up to 3 years of drug therapy; Berdahl, JP et al, Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP-Lowering Medication Burden in Patients with Open-Angle Glaucoma or Ocular Hypertension, Drugs December 2023; https://pubmed.ncbi.nlm.nih.gov/38060092 Thorough surgeon training and timely market access are keys to successful execution in 2024 |
| iDose TR: Commercial Launch Strategy Initially positioned for patients who can most benefit from this unique therapy: ✓ Non-compliant glaucoma patients ✓ Glaucoma patients who are intolerant to topical glaucoma drops ✓ Glaucoma patients with underlying co-morbidities (e.g., dry eye) ✓ Glaucoma patients who have physical limitations that impede their ability to utilize eye drops ✓ Glaucoma patients who are seeking to reduce drug burden and/or have experienced decreased quality-of-life related to topical drug use Leverage large, well-established US glaucoma commercial organization Regional business and ~70 academic managers Total US glaucoma 100+ commercial personnel © 2024 Glaukos Corporation 14 |
| iDose TR: Enabling Patient Access is Critical REIMBURSEMENT LIAISON • Patient Counseling • Benefit Verification • Denials and Appeals • BV Portal • Billing and Coding Support • Policy Reviews CO-PAY ASSISTANCE PROGRAM SPECIALTY PHARMACY BILLING & CODING SUPPORT © 2024 Glaukos Corporation 15 |
| iStent Micro-Scale iDose Sustained-Release iLin k Bio-Activat e d iLution Eyelid Delivery Retina XR Bio-Erodible IVT Ocular Hypertension and Open-Angle Glaucoma Dry Eye Keratoconus Glaucoma Presbyopia Blepharitis AMD DME RVO iDose TR Exemplifies the Power of our Novel Platforms © 2024 Glaukos Corporation 16 $600M+ 14 Disclosed pipeline programs in 2024 vs. 4 in 2015 invested in R&D since 2018 Five distinct technology platforms capable of generating multiple new dropless therapies designed to disrupt conventional treatment paradigms |
| Key Pipeline Milestone Targets for 2024 PROGRAM PATIENT CLINICAL BENEFIT 2024 MILESTONE TARGET GLAUCOMA iStent infinite Mild-to-Moderate Glaucoma MIGS therapy Advance enrollment in PMA pivotal trial PRESERFLO MicroShunt Advanced-Refractory Glaucoma Ab-externo device for late-stage glaucoma Commence US IDE trial in 2024 / 2025 iDose TREX OHT-Glaucoma Increased drug payload designed to extend duration-of-effect Commence Phase 3 trial by end of 2024 iLution Travoprost (GLK-311) OHT-Glaucoma Transdermal drug delivery; potential for improved compliance vs topical drops Complete Phase 2a trial CORNEA Epioxa (Epi-on) Keratoconus Reduced treatment time and complexity for improved patient comfort and recovery Submit NDA by end of 2024 iLink 3rd Generation Keratoconus Customized treatment algorithms and laser-based UV light source Fully enroll Phase 2 trials RETINA IVT Multi-Kinase Inhibitor (GLK-401) AMD, DME, RVO Biodegradable, sustained-release implant; potential to reduce treatment burdens vs conventional therapies Fully enroll first-in-human clinical development program © 2024 Glaukos Corporation 17 |
| One of the Most Formidable Pipelines in Ophthalmology PRODUCT PATIENT STATUS iStent / iStent inject / iStent inject W Mild-to-Moderate Glaucoma with Cataract FDA Approved (2012, 2018, 2020) iStent infinite Glaucoma (failed on prior therapy) FDA Cleared (2022) iStent infinite Glaucoma (label expansion) Active PMA Study PRESERFLO MicroShunt Advanced-Refractory Glaucoma OUS approved / US IDE open iDose TR Ocular Hypertension - Glaucoma FDA Approved (2023) iDose TREX Ocular Hypertension - Glaucoma Pre-Clinical iDose Next Generation Ocular Hypertension - Glaucoma Pre-Clinical iLution Travoprost (GLK-311) Ocular Hypertension - Glaucoma Phase 2 Photrexa (Epi-off) Keratoconus FDA Approved (2016) Epioxa (Epi-on) Keratoconus Phase 3 iLink 3rd Generation Keratoconus Phase 2 iVeena Keratoconus Phase 1 iLution Dry Eye (GLK-301) Dry Eye Phase 2 iLution Presbyopia (GLK-302) Presbyopia Phase 2 iLution Blepharitis Demodex Blepharitis Pre-Clinical IVT Multi-Kinase Inhibitor (GLK-401) AMD, DME, RVO Phase 2 IVT NCE Conjugate (GLK-411) DME Pre-Clinical Radius XR Wearable Patient Engagement & Diagnostic System FDA Cleared iAccess Precision Goniotomy FDA Cleared iPRIME Viscodelivery FDA Cleared GLAUCOMA CORNEA RETINA OTHER © 2024 Glaukos Corporation 18 Designed to disrupt treatment paradigms with dropless therapies that address important needs |
| Solid Financial & Operational Footing to Support Growth Plans © 2024 Glaukos Corporation 19 NET SALES1 (in millions) 2022 2023 $315 $283 30%+ 10-year CAGR 52% 27% 21% SALES MIX (2Q 2024) US Glaucoma Corneal Health Int’l Glaucoma 1 FY2024: Net sales guidance as of 7/31/2024 2 2Q 2024 gross margin adjusted for certain Avedro merger-related accounting and other adjustments - see Appendix for details GROSS MARGIN2 (2Q 2024) GLOBAL INFRASTRUCTURE Countries with 17 direct operations HEALTHY BALANCE SHEET $266 Million Cash and equivalents as of 6/30/2024 SPECIALIZED MANUFACTURING 275 Global commercial personnel + Industry leader in micro-scale manufacturing with +20 years’ experience State-of-the-art facilities that meet regulatory, CMC and ISO 7 guidelines 82% $370-376 2024 |
| 2024: The Future is Now © 2024 Glaukos Corporation 20 Major 2023 accomplishments … …position us for pivotal year in 2024! Interventional Glaucoma (IG) introduced, realizing Glaukos’ founding promise to radically improve the conventional treatment paradigm with standalone therapies that slow progression and reduce drug burden iDose TR approved; completion of new manufacturing facilities with unblemished PAI; US commercial team readied for launch Solid global sales performance from US Glaucoma, Int’l Glaucoma and Corneal Health franchises; continued efficient management of expenses and cash Significant pipeline advances across all technology platforms, including completion of iLution Dry Eye and Presbyopia Phase 2a trials, full enrollment of 2nd Epioxa Phase 3 trial and commencement of new trials for iStent infinite, iLution Travoprost and IVT Multi-Kinase Inhibitor Enable iStent infinite adoption in standalone procedures for patients with advanced disease Stellar execution of iDose TR launch that follows familiar and systematic Glaukos playbook for building durable ophthalmic markets Submit NDA for Epioxa to FDA by YE 2024 and advance pipeline programs across glaucoma, corneal health and retinal disease © 2024 Glaukos Corporation 20 Drive Interventional Glaucoma globally as proactive approach to effectively manage disease progression and improve patients’ qualify of life |
| WE’LL GO FIRST Innovation is at the core of everything we do. At Glaukos, we push the limits of science and technology to solve unmet needs in chronic eye diseases. |
| © 2024 Glaukos Corporation 22 |
| Appendix © 2024 Glaukos Corporation 23 2Q 2024 GAAP Amort. of Dev 2Q 2024 Non-GAAP Gross Margin Tech Intangibles Gross Margin Net Sales $ 95,690 $ 95,690 COGS $ 22,550 $ (5,523) $ 17,027 Gross Profit $ 73,140 $ 5,523 $ 78,663 Gross Margin 76% 82% GAAP to Non-GAAP Reconciliation - 2Q 2024 |
