MAY 1, 2024

GLAUKOS CORPORATION (NYSE: GKOS)

FIRST QUARTER 2024 IN REVIEW

Important Information

This document is intended to be read by investors in advance of regularly scheduled quarterly conference calls and was designed to provide a review of Glaukos Corporation's recent financial and operational performance and general business outlook.

Please see "Forward-Looking Statements" and "Statement Regarding Use of Non-GAAP Financial Measures" in the "Additional Information" section of this document.

Conference Call Information

Date:

May 1, 2024

Time:

4:30 p.m. ET / 1:30 p.m. PT

Dial-in numbers:

1-888-210-2212 (U.S.), 1-646-960-0390 (International)

Confirmation ID:

7935742

Live webcast:

Events page at the Glaukos Investor Relations website at

http://investors.glaukos.comor at thislink.

Webcast replay:

A replay of the webcast will be archived on the Glaukos Investor Relations website

following completion of the call.

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MAY 1, 2024

FIRST QUARTER 2024 FINANCIAL RESULTS SUMMARY

Business Description

Disease Categories

Revenue (Growth)

Gross Margin (Non- GAAP)

Cash & Cash

Equivalents, Short-

Term Investments,

and Restricted Cash

FY2024 Sales

Guidance

Ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel, dropless platform therapies designed to disrupt the conventional standard of care and improve outcomes for patients suffering from chronic eye diseases

Glaucoma

Corneal Health

Retinal Disease

1Q 2024

$85.6 million

(+16% reported and constant currency vs. 1Q 2023)

1Q 2024

~83%

(versus ~83% in 1Q 2023)

$278.7 million as of March 31, 2024 (versus $301.3 million as of December 31, 2023)

FY 2024 global consolidated revenues of $357 - $365 million expected (versus $350 - $360 million previously)

See "Statement Regarding Use of Non-GAAP Financial Measures" and the Non-GAAP reconciliations included within the Additional Information section of this document. Reconciliations for each of constant currency revenue growth, Non-GAAP Gross Margin, and the other non-GAAP financial measures disclosed in this document to the most directly comparable GAAP financial measure are provided.

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MAY 1, 2024

Revenue Performance & Commercial Overview

Global Consolidated Revenue Performance

Glaukos reported record first quarter net revenues of $85.6 million that were up 16% on a reported and constant currency basis versus 1Q 2023. Our first quarter performance reflected continued solid execution across our global Glaucoma and Corneal Health franchises.

Franchise Revenue Performance

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MAY 1, 2024

U.S. Glaucoma

Our first quarter U.S. Glaucoma net revenues were approximately $42.0 million, representing year-over- year growth of 20% versus 1Q 2023 driven by iStent infinite® and our overall iStent® portfolio.

During the first quarter, we also commenced initial commercial launch activities for iDose® TR, our revolutionary, micro-invasive, injectable therapy designed to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. iDose TR is a first-of-its-kind intracameral procedural pharmaceutical designed to deliver glaucoma drug therapy for up to three years.

International Glaucoma

Our first quarter International Glaucoma record net revenues were approximately $25.2 million, representing year-over-year reported growth of 20%, or 21% on a constant currency basis, versus 1Q 2023. The strong growth internationally during the first quarter was broad-based as we continue to scale our international infrastructure and increasingly drive MIGS forward as the standard of care in each region and every major market in the world.

We remain in the early stages of expanding our IG initiatives globally ahead of what we hope will be supported by a healthy cadence of new product approvals and expanding market access in the years to come.

Corneal Health

Our first quarter Corneal Health net revenues were approximately $18.4 million, representing year-over- year growth of 4% versus 1Q 2023, including U.S. Photrexa® sales of $15.1 million, which increased 7% year-over-year. These first quarter results do include, in particular, the impact of our entry as a company into the Medicaid Drug Rebate Program (MDRP). These dynamics were anticipated and will continue to impact Photrexa realized revenues going forward.

We continue to focus on expanding access for keratoconus patients suffering from this rare disease.

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MAY 1, 2024

Additional Commercial Updates & Commentary

We have had several additional positive commercial updates worth highlighting here:

  • Advanced commercial launch activities in the U.S. for iStent infinite in the first quarter of 2024 o Interventional glaucoma efforts and improved facility economics driving increased
    utilization of iStent infinite in standalone procedures for patients that have failed prior medical and surgical therapy
    o Focused on key market access initiatives to support consistent and dependable professional fee payment, with five of the seven MACs now including CPT code 0671T on their latest fee schedules
  • Commenced initial commercial launch activities for iDose TR
  1. Initial targeted wave of 15 surgeons all successfully completed their initial iDose TR procedures during 1Q 2024; the early feedback and outcomes have been very positive
    1. As a reminder, these early access surgeons provide valuable insight to our training and field teams that helps to optimize training and skill transfer to our salesforce and surgical community, supporting our expanded training and broader launch efforts over the course of 2024
  • Achieved several positive reimbursement developments designed to support fulsome coverage and payment for the iDose TR procedural pharmaceutical over time
    1. First, CMS assigned a unique, permanent J-code for iDose TR, J7355, set to become effective on July 1, 2024. This new J-code, once effective, is expected to increase patient access here in the U.S. and should provide more streamlined, consistent, and dependable

coverage and payment for iDose TR as we advance and ultimately accelerate our initial commercial launch activities.

  1. Second, CMS assigned the CPT codes that are designed to be used to cover the procedural component of iDose TR, 0660T and 0661T, to ambulatory payment classification, or APC, 5492, effective April 1, 2024. This translates into a national average facility fee of nearly $3,900 in the HOPD setting and more than $2,000 in the ASC setting.
  1. Third, we have participated in several initial education meetings with MACs as part of our

efforts to secure professional fee coverage and payment over the course of 2024.

  1. Fourth, we successfully entered into the MDRP.

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MAY 1, 2024

    1. And fifth, we have successfully commenced early initiatives to secure coverage for commercial and Medicare Advantage plans, efforts that we plan to accelerate in the second half of 2024 after the J-code is effective.
  • Secured several international regulatory approvals, including for iStent infinite in Australia and Brazil and for PRESERFLO® MicroShunt in Brazil and several additional Latin American countries

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MAY 1, 2024

2024 Revenue Guidance Raised to Reflect Strong Start to the Year

Glaukos now expects full-year 2024 global consolidated net sales of $357 - $365 million, up from its previous guidance of $350 - $360 million. This upwardly revised guidance attempts to take into consideration:

  • Potential growing contributions from iStent infinite
  • Potential growing contributions from iDose TR, which are expected to be modest in the first half of 2024 and more back-end weighted in the latter part of 2024 into 2025
  • Potential ordering pattern volatility within our U.S. Glaucoma franchise during the first half of 2024 due to uncertainty associated with MAC LCDs
  • The continued estimated impact on U.S. Glaucoma volumes related to professional fee reimbursement for combination-cataract trabecular bypass surgery versus other more invasive alternatives
  • Potential headwinds within our U.S. Corneal Health franchise associated with our entry as a company into the MDRP
  • The latest foreign currency exchange spot rates as of our 1Q 2024 earnings call on May 1, 2024
  • Combo-cataractMIGS competition globally

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MAY 1, 2024

Research & Development / Pipeline Overview

Pipeline Summary

Our five key dropless technology therapy platforms designed to disrupt traditional treatment paradigms and generate cascades of future innovation are as follows:

  • iStent® micro-scale surgical devices
  • iDose® sustained-release procedural pharmaceuticals
  • iLution™ transdermal pharmaceuticals
  • iLink® bio-activated pharmaceuticals
  • Retina XR bio-erodiblesustained-release pharmaceuticals

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MAY 1, 2024

Key R&D and Pipeline Updates

We are continuing to prudently invest in and advance our fulsome pipeline of core novel platforms, supported by approximately $600 million of investment into our R&D programs since 2018 alone. Recent updates in our pipeline include:

  • Announced FDA approval of iDose TR (4Q 2023)
    1. Commenced initial commercial launch activites for iDose TR (1Q 2024)
  • Advancing patient enrollment in PMA pivotal trial for iStent infinite in mild-to-moderate glaucoma patients
  • Advancing patient enrollment in first-in-humanRetina XR clinical development program for IVT multi-kinase inhibitor in wet AMD patients (GLK-401)
  • Advancing patient enrollment in Phase 2a clinical trial for iLution™ Travoprost; initial data readout expected later this year
  • Progressing towards trial completion in second half of 2024 for second Phase 3 confirmatory pivotal trial for Epioxa (Epi-on)
    1. Phase 3 confirmatory trial results together with already-completed first Phase 3 trial expected to support targeted NDA submission for Epioxa by the end of 2024
  • Advancing patient enrollment in two Phase 2 trials for third-generationiLink therapy
  • PRESERFLO MicroShunt
    1. U.S. Investigation Device Excemption (IDE) application open; targeting clinical study commencement in 2024
    1. Ongoing regulatory submissions and approvals in Latin America
  • Preparing to commence Phase 3 clincial trial for iDose TREX, our next-generationiDose therapy, by the end of 2024

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MAY 1, 2024

Product / Pipeline Chart

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Disclaimer

Glaukos Corporation published this content on 01 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 02 May 2024 10:43:07 UTC.