EX-99.2 3 gkos-20250430xex99d2.htm EX-99.2

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APRIL 30, 2025

GLAUKOS CORPORATION (NYSE: GKOS)

FIRST QUARTER 2025 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: April 30, 2025

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

Dial-in numbers: 1-800-715-9871 (U.S.), 1-646-307-1952 (International)

Confirmation ID: 5255602

Live webcast:

Events page at the Glaukos Investor Relations website at http://investors.glaukos.com or at this link.

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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APRIL 30, 2025

FIRST QUARTER 2025 FINANCIAL RESULTS SUMMARY

Business Description

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

Disease Categories

Glaucoma

Corneal Health

Retinal Disease

Revenue (Growth)

1Q 2025

$106.7 million

(+25% reported and +26% constant currency vs. 1Q 2024)

Gross Margin (Non-GAAP)

1Q 2025

~82%

(versus ~83% in 1Q 2024)

Cash & Cash Equivalents, Short-Term Investments, and Restricted Cash

$303.4 million as of March 31, 2025 (versus $323.6 million as of December 31, 2024)

FY2025 Sales Guidance

FY 2025 global consolidated revenues of $475 - $485 million expected

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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APRIL 30, 2025

Revenue Performance & Commercial Overview

Global Consolidated Revenue Performance

Glaukos reported record first quarter net revenues of $106.7 million that were up 25% on a reported basis, or 26% on a constant currency basis, versus 1Q 2024. Our first quarter record results reflect a sustained growth acceleration in our business with the strong performance driven by iDose® TR adoption, and both our U.S. and International Glaucoma franchises overall.

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Franchise Revenue Performance

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APRIL 30, 2025

U.S. Glaucoma

Our record first quarter U.S. Glaucoma net revenues were approximately $59.1 million, representing year-over-year growth of 41% versus 1Q 2024 driven by growing contributions from iDose TR.

During the first quarter, we successfully advanced execution of our detailed launch plans for iDose TR, a first-of-its-kind intracameral procedural pharmaceutical that was designed to continuously deliver glaucoma drug therapy for up to three years. Most importantly, clinical outcomes and product feedback from a growing number of cases and trained surgeons continue to be very positive and reaffirm our view that with the launch of iDose TR, we have the potential to reshape glaucoma management as we know it today.

International Glaucoma

Our record first quarter International Glaucoma net revenues were approximately $29.0 million, representing year-over-year growth of 15% on a reported basis, or 19% on a constant currency basis, versus 1Q 2024. 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 major market in the world.

We remain in the early stages of expanding our IG and product portfolio initiatives globally ahead of anticipated new product approvals and expanding market access in the years to come. As previously discussed, we expect the trialing of new competitive products in some of our major international markets may become an increasing headwind as we progress through 2025.

Corneal Health

Our first quarter Corneal Health net revenues were approximately $18.5 million, representing year-over-year growth of 1% versus 1Q 2024, including U.S. Photrexa® net sales of $15.4 million. As discussed throughout 2024, these first quarter results reflect the continued impact to Photrexa realized revenues as a result of our entry as a company into the Medicaid Drug Rebate Program (MDRP).

We will continue to focus on expanding access for keratoconus patients suffering from this rarely diagnosed disease.

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APRIL 30, 2025

Additional Commercial Updates & Commentary

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

Advanced commercial launch activities in the U.S. for iDose TR
oGrowing number of trained surgeons and accounts
oExpanding utilization of the installed active surgeon base
oBroadening and streamlining market access among MACs, commercial, and Medicare Advantage payors
oExpanded set of peer-reviewed literature, now consisting of 12 different peer-reviewed publications highlighting iDose TR as a transformative new treatment alternative for patients suffering with glaucoma and ocular hypertension
oAccelerating marketing investments to support increased patient awareness and education
Advanced commercial launch activities in the U.S. for iStent infinite
oInterventional glaucoma education efforts and improved facility reimbursement driving increased access for and utilization of iStent infinite in standalone procedures for patients that have failed prior medical and surgical therapy
oFive of the seven MACs implemented finalized LCDs that provide coverage for iStent infinite consistent with FDA approval and based upon our coverage reconsideration requests (effective November 2024)
Commenced initial preparatory planning for potential EpioxaFDA approval and commercial launch

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APRIL 30, 2025

2025 Revenue Guidance Reaffirmed

Glaukos expects full-year 2025 global consolidated net sales of $475 - $485 million. This guidance attempts to take into consideration:

Potential growing contributions from iDose TR as reimbursement confidence grows and broader IG initiatives take hold over the course of the year
Potential growing contributions from iStent infinite as broader IG initiatives take hold
Headwinds within our U.S. Glaucoma stent business associated with the final MIGS LCDs in 5 of the 7 MACs
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
The expiration of the Hydrus® Microstent (Alcon) royalty on April 26, 2025
Potential headwinds within our U.S. Corneal Health franchise associated with our entry as a company into the MDRP
The sunsetting of the year-over-year growth tailwind associated with the new French Health Authority rebate agreement
The latest foreign currency exchange spot rates as of our 1Q 2025 earnings call on April 30, 2025
Combo-cataract MIGS competition globally
Global macroeconomic environment and associated uncertainties, which at this time are difficult to predict

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APRIL 30, 2025

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-erodible sustained-release pharmaceuticals

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APRIL 30, 2025

Key R&D and Pipeline Updates

We are continuing to prudently invest in and advance our fulsome pipeline of core novel platforms, supported by more than $700 million investment into our R&D programs since 2018 alone. Recent updates in our pipeline include:

Announced FDA acceptance for review of NDA submission for Epioxa™ (Epi-on) (February 2025)
oPDUFA date set for October 20, 2025
Commenced 510(k) pivotal study for PRESERFLO MicroShunt (April 2025)
Advancing Phase 2b/3 clinical program for iDose TREX, our next-generation iDose therapy
Submitted labeling supplement and advancing dialogue with the FDA regarding the re-administration of iDose TR
Advancing various Phase 4 studies for iDose TR
Advancing patient enrollment in PMA pivotal trial for iStent infinite in mild-to-moderate glaucoma patients
Advancing patient enrollment in first-in-human Retina XR clinical development program for IVT multi-kinase inhibitor in wet AMD patients (GLK-401), where we now also have an open U.S. FDA IND
Advancing Phase 2 clinical program for third-generation iLink therapy
Preparing to commence Phase 2 clinical trial for iLution™ Blepharitis by end of 2025

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APRIL 30, 2025

Product / Pipeline Chart

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APRIL 30, 2025

Other Financial Performance Overview

As a reminder, we discuss our financial performance on a non-GAAP basis and summarize our GAAP performance. We encourage investors to review our GAAP to non-GAAP reconciliation which can be found in our earnings press release, the Additional Information section contained herein, as well as the Investor Relations section of our website.

First quarter 2025 financial performance summary:

2024: 83%

∆: -40 bps

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Gross Margin

(Non-GAAP)

1Q 2025: 82%

1Q 2024: 83%

YoY ∆: -40 bps

Please note that our non-GAAP adjustments to cost of goods sold include substantial amounts related to Avedro acquisition accounting

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SG&A

(Non-GAAP)

1Q 2025: $70.7M

1Q 2024: $61.3M

YoY ∆: +15%

+3% sequential increase vs $68.6M in 4Q 2024
YoY and QoQ increases primarily reflects commercial and G&A investments globally and new product launch activities

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R&D

(Non-GAAP)

1Q 2025: $32.4M

1Q 2024: $30.7M

YoY ∆: +5%

(11%) sequential decline vs $36.5M in 4Q 2024
YoY increase reflects continued investment in and advancement of R&D programs

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SG&A + R&D

(Non-GAAP)

1Q 2025: $103.0M

1Q 2024: $92.0M

YoY ∆: +12%

(2%) sequential decrease vs $105.1M in 4Q 2024
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Earnings

Op Loss (Non-GAAP)

1Q 2025 ($15.2M)

1Q 2024: ($32.8M)

Net Loss (Non-GAAP)

1Q 2025: ($12.6M)

1Q 2024: ($34.6M)

Diluted EPS (Non-GAAP)

1Q 2025: ($0.22)

1Q 2024: ($0.70)

Included in non-GAAP loss from operations, non-GAAP net loss and non-GAAP EPS for the first quarter of 2024 is an acquired in-process R&D (IPR&D) charge of $11.7 million, which caused the non-GAAP loss per diluted share to have an additional loss of ($0.24) in the first quarter of 2024
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CapEx

1Q 2025: $1.9M

1Q 2024: $1.0M

YoY ∆: +$0.9M

Capital expenditures moderated to levels more consistent with historical norms

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Cash

1Q 2025: $303.4M

4Q 2024: $323.6M

QoQ ∆: ($20.2M)

Operating expenses and payout of annual cash bonuses

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APRIL 30, 2025

Other Important Updates

ØThe Company announced the release of its 2024 Sustainability Report (April 2025)
oThe report highlights the company’s continued commitment and progress on our key corporate sustainability initiatives.
oFor additional information and highlights, please see Glaukos’ 2024 Sustainability Report, which can be found on the company’s website here.

ØThe Company filed its 2025 Proxy Statement ahead of its 2025 Annual Meeting scheduled to be held on Thursday, May 29, 2025, at 9AM PT (April 2025)
oFor additional information, please see Glaukos’ 2025 Proxy Statement on the company’s website here.

ØWe continue to be active on the business development front with a focus on transactions that support our existing organic growth initiatives.
oOne such example of this is our recently announced expanded collaboration with Radius XR and Topcon Healthcare that enables us to accelerate our global efforts to bring the tools and software solutions needed to democratize the diagnosis of glaucoma and in turn create more efficient care networks for patients afflicted with this lifelong disease.

ØGiven the ongoing conversations around tariff and geopolitical issues, we wanted to highlight that we manufacture and source our products primarily within the U.S., and as such, expect minimal direct exposure to the most recently implemented tariff-related policies. That said, the tariff dynamics obviously remain highly fluid. As such, we will continue to closely monitor the situation given the overall instability in the marketplace and global macroeconomic uncertainties.  

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APRIL 30, 2025

Additional Information

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APRIL 30, 2025

Forward-Looking Statements

This communication contains “forward-looking statements” within the meaning of federal securities laws. 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, our ability to successfully commercialize our iDose TR therapy; the impact of general macroeconomic conditions including foreign currency fluctuations and future public health crises on our business; our ability to continue to generate sales of our commercialized products and develop and commercialize additional products; 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 third-party payors for procedures using the iStent, the iStent inject W, iAccess, 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 Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on February 25, 2025, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, which we expect to file on or before May 12, 2025. 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 press release 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 press release, 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.

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APRIL 30, 2025

Statement Regarding Use of Non-GAAP Financial Measures

To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles ("GAAP"), the Company uses certain non-GAAP historical financial measures. Management makes adjustments to the GAAP measures for items (both charges and gains) that (a) do not reflect the core operational activities of the Company, (b) are commonly adjusted within the Company's industry to enhance comparability of the Company's financial results with those of its peer group, or (c) are inconsistent in amount or frequency between periods (albeit such items are monitored and controlled with equal diligence relative to core operations) (“Non-GAAP Purposes”). The Company uses the term "Non-GAAP" to exclude certain expenses, gains and losses to achieve the Non-GAAP purposes, including external acquisition-related costs incurred to effect a business combination; amortization of intangible assets acquired in a business combination, asset purchase transaction or other contractual relationship; impairment of goodwill and intangible assets; certain in-process R&D charges; fair value adjustments to contingent consideration liabilities and pre-acquisition contingencies arising from a business combination; integration and transition costs related to business combinations; fair market value adjustments to inventories acquired in a business combination or asset purchase transaction; restructuring charges, duplicative operating expenses, or asset write-offs (or reversals) associated with exiting or significantly downsizing a business; unusual non-recurring expenses associated with inventory write-downs; gain or loss from the sale of a business; gain or loss on the mark-to-market adjustment, impairment, or sale of long-term investments; mark-to-market adjustments on derivative instruments that hedge income or expense exposures in a future period; significant legal litigation costs and/or settlement expenses or proceeds; legal and other associated expenses that are both unusual and significant related to governmental or internal inquiries; expenses, acceleration of amortization of debt issuance costs and gain or loss on debt extinguishment with the exchange or redemption of convertible senior notes; and significant discrete income and other tax adjustments related to transactions as well as changes in estimated acquisition-date tax effects associated with business combinations, and the impact from implementation of tax law changes and settlements; and any other adjustment that is determined to be appropriate and consistent with the Non-GAAP Purposes. See “Primary GAAP to Non-GAAP Reconciliations” for a reconciliation of each non-GAAP measure presented to the comparable GAAP financial measure.  Beginning in the second quarter of 2022, we no longer exclude certain upfront and contingent milestone payments in connection with collaborative and licensing arrangements and certain in-process R&D charges for non-GAAP reporting and disclosure purposes.

In addition, in order to remove the impact of fluctuations in foreign currency exchange rates, the Company also presents certain net sales information on a constant currency basis, which represents the outcome that would have resulted had exchange rates in the current period been the same as the average exchange rates in effect in the comparable prior period.  See “Additional GAAP to Non-GAAP Reconciliations” for a presentation of certain net sales information on a reported, GAAP and a constant currency basis.

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APRIL 30, 2025

GAAP Income Statement

GLAUKOS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except per share amounts)

    

Three Months Ended
March 31,

    

2025

    

2024

Net sales

$

106,664

$

85,622

Cost of sales

 

24,316

 

20,258

Gross profit

 

82,348

 

65,364

Operating expenses:

Selling, general and administrative

 

70,673

 

61,975

Research and development

 

32,353

 

30,726

Acquired in-process research and development

 

 

11,729

Total operating expenses

 

103,026

 

104,430

Loss from operations

 

(20,678)

 

(39,066)

Non-operating income (expense):

Interest income

 

3,076

 

3,083

Interest expense

 

(1,163)

 

(3,450)

Other income (expense), net

 

945

 

(1,028)

Total non-operating income (expense)

 

2,858

 

(1,395)

Loss before taxes

 

(17,820)

 

(40,461)

Income tax provision

 

326

 

377

Net loss

$

(18,146)

$

(40,838)

Basic and diluted net loss per share

$

(0.32)

$

(0.82)

Weighted-average shares outstanding used to compute basic and diluted net loss per share

 

56,637

 

49,580

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APRIL 30, 2025

GAAP Balance Sheet

GLAUKOS CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except par values)

    

March 31,

    

December 31,

    

2025

    

2024

(unaudited)

Assets

Current assets:

Cash and cash equivalents

$

114,252

$

169,626

Short-term investments

 

184,444

 

149,289

Accounts receivable, net

 

71,531

 

60,744

Inventory

 

59,460

 

57,678

Prepaid expenses and other current assets

 

14,857

 

12,455

Total current assets

 

444,544

 

449,792

Restricted cash

 

4,733

 

4,733

Property and equipment, net

 

96,810

 

97,867

Operating lease right-of-use asset

 

32,176

 

30,254

Finance lease right-of-use asset

 

41,213

 

41,816

Intangible assets, net

 

257,869

 

263,445

Goodwill

 

66,134

 

66,134

Deposits and other assets

 

22,699

 

20,715

Total assets

$

966,178

$

974,756

Liabilities and stockholders' equity

Current liabilities:

Accounts payable

$

15,825

$

13,026

Accrued liabilities

 

52,704

 

62,099

Total current liabilities

 

68,529

 

75,125

Operating lease liability

 

36,321

 

33,936

Finance lease liability

 

69,159

 

69,463

Deferred tax liability, net

 

6,918

 

6,928

Other liabilities

 

21,292

 

22,373

Total liabilities

 

202,219

 

207,825

Stockholders' equity:

Preferred stock, $0.001 par value; 5,000 shares authorized; no shares issued and outstanding as of March 31, 2025 and December 31, 2024

Common stock, $0.001 par value; 150,000 shares authorized; 56,769 and 56,472 shares issued and 56,741 and 56,544 shares outstanding at March 31, 2025 and December 31, 2024, respectively

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56

Additional paid-in capital

 

1,525,014

 

1,509,831

Accumulated other comprehensive income

 

2,605

 

2,615

Accumulated deficit

 

(763,585)

 

(745,439)

Less treasury stock (28 shares as of March 31, 2025 and December 31, 2024)

 

(132)

 

(132)

Total stockholders' equity

 

763,959

 

766,931

Total liabilities and stockholders' equity

$

966,178

$

974,756

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APRIL 30, 2025

Primary GAAP to Non-GAAP Reconciliations

GLAUKOS CORPORATION

GAAP to Non-GAAP Reconciliations

(in thousands, except per share amounts and percentage data)

(unaudited)

Q1 2025

Q1 2024

    

GAAP

    

Adjustments

    

Non-GAAP

    

GAAP

    

Adjustments

    

Non-GAAP

    

Cost of sales

$

24,316

$

(5,523)

(a)

$

18,793

$

20,258

$

(5,523)

(a)

$

14,735

Gross Margin

 

77.2

%  

 

5.2

%  

82.4

%  

 

76.3

%  

 

6.5

%  

 

82.8

%

Operating expenses:

 

  

 

  

 

  

 

  

 

  

 

  

 

Selling, general and administrative

$

70,673

$

$

70,673

$

61,975

$

(705)

(b)

$

61,270

Loss from operations

$

(20,678)

$

5,523

$

(15,155)

$

(39,066)

$

6,228

$

(32,838)

Net loss

$

(18,146)

$

5,523

(c)

$

(12,623)

$

(40,838)

$

6,228

(c)

$

(34,610)

Basic and diluted net loss per share

$

(0.32)

$

0.10

$

(0.22)

$

(0.82)

$

0.12

$

(0.70)


(a)

Cost of sales adjustment related to amortization of developed technology intangible assets associated with the acquisition of Avedro, Inc. (Avedro) of $5.5 million in Q1 2025 and Q1 2024.

(b)

Avedro acquisition-related amortization expense of customer relationship intangible assets.

(c)

Includes total tax effect for non-GAAP pre-tax adjustments. For non-GAAP adjustments associated with the U.S., the tax effect is $0 given the Company's U.S. taxable loss positions in both 2025 and 2024.

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APRIL 30, 2025

Additional GAAP to Non-GAAP Reconciliations

Reported Sales vs. Prior Periods (in thousands)

 

Year-over-Year Percent Change

Quarter-over-Quarter Percent Change

 

    

1Q 2025

    

1Q 2024

    

4Q 2024

    

Reported

    

Operations (1)

    

Currency (2)

    

Reported

    

Operations (1)

    

Currency (2)

 

International Glaucoma

$

29,009

$

25,238

$

27,869

 

14.9

%  

18.7

%  

(3.8)

%

4.1

%  

5.8

%  

(1.7)

%

Total Net Sales

$

106,664

$

85,622

$

105,499

 

24.6

%  

25.7

%  

(1.1)

%

1.1

%  

1.6

%  

(0.5)

%


(1)

Operational growth excludes the effect of translational currency

(2)

Calculated by converting the current period numbers using the prior period’s average foreign exchange rates

For Non-GAAP disclosures associated with the company’s past quarterly results, included with respect to the sequential comparisons included herein, please see reconciliations here.

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