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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 4, 2024

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

(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))

Title of each class:

    

Trading Symbol

    

Name of each exchange on which registered:

Common Stock

GKOS

New York Stock Exchange

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.  

Item 2.02. Results of Operations and Financial Condition.

On November 4, 2024, Glaukos Corporation (the “Company”) issued a press release announcing its financial results for the third quarter ended September 30, 2024. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

The information contained in this Item 2.02 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 (the “Securities Act”), except as shall be expressly set forth by specific reference in such filing.

Item 7.01. Regulation FD Disclosure.

A Quarterly Summary containing supplemental business and financial information for the Company’s third quarter ended September 30, 2024 is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein. A copy of the Quarterly Summary is also available in the “Financials & Filings” section of the Company’s investor relations website at https://investors.glaukos.com.

The information contained in this Item 7.01 and in the accompanying Exhibit 99.2 shall not be deemed filed for purposes of Section 18 of the Exchange Act, or incorporated by reference in any filing under the Exchange Act or the Securities Act, 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

 

Press Release of Glaukos Corporation, dated November 4, 2024

99.2

Quarterly Summary of Glaukos Corporation for the third quarter ended September 30, 2024

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
(Registrant)  

 

By:

/s/ Alex R. Thurman

 

 

Name:

Alex R. Thurman 

 

 

Title:

Senior Vice President & Chief Financial Officer

Date: November 4, 2024

Exhibit 99.1

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FOR IMMEDIATE RELEASE

Contact:

Chris Lewis

Vice President, Investor Relations & Corporate Affairs

(949) 481-0510

clewis@glaukos.com

Glaukos Announces Third Quarter 2024 Financial Results

Aliso Viejo, CA – November 4, 2024 – Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced financial results for the third quarter ended September 30, 2024. Key highlights for the third quarter of 2024 include:

Record net sales of $96.7 million increased 24% year-over-year.
Glaucoma record net sales of $76.0 million increased 30% year-over-year.
Corneal Health net sales of $20.6 million increased 5% year-over-year.
Gross margin of approximately 77% and non-GAAP gross margin of approximately 82%.
Raised 2024 net sales guidance to $377 million to $379 million, compared to $370 million to $376 million previously.

“Our record third quarter results reflect successful global execution of our key strategic plans and continued strong momentum in our business,” said Thomas Burns, Glaukos chairman and chief executive officer. “We continue to successfully advance our robust pipeline of novel, dropless platform technologies designed to meaningfully advance the standard of care and improve outcomes for patients suffering from chronic eye diseases.”

Third Quarter 2024 Financial Results

Net sales in the third quarter of 2024 of $96.7 million increased 24%, compared to $78.0 million in the same period in 2023.

Gross margin for the third quarter of 2024 was approximately 77%, compared to approximately 76% in the same period in 2023. Non-GAAP gross margin for the third quarter of 2024 was approximately 82%, compared to approximately 83% in the same period in 2023.

Selling, general and administrative (SG&A) expenses for the third quarter of 2024 increased 18% to $64.0 million, compared to $54.2 million in the same period in 2023. Non-GAAP SG&A expenses for the third quarter of 2024 increased 18% to $63.3 million, compared to $53.5 million in the same period in 2023.

GAAP and non-GAAP research and development (R&D) expenses for the third quarter of 2024 increased 4% to $34.7 million, compared to $33.3 million in the same period in 2023.

Loss from operations in the third quarter of 2024 was $24.7 million, compared to operating loss of $28.0 million in the third quarter of 2023. Non-GAAP loss from operations in the third quarter of 2024 was $18.4 million, compared to non-GAAP operating loss of $21.8 million in the third quarter of 2023.

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Net loss in the third quarter of 2024 was $21.4 million, or ($0.39) per diluted share, compared to net loss of $30.4 million, or ($0.63) per diluted share, in the third quarter of 2023. Non-GAAP net loss in the third quarter of 2024 was $15.2 million, or ($0.28) per diluted share, compared to non-GAAP net loss of $24.2 million, or ($0.50) per diluted share, in the third quarter of 2023.

The company ended the third quarter of 2024 with approximately $267.2 million in cash and cash equivalents, short-term investments and restricted cash.

2024 Revenue Guidance

The company expects 2024 net sales to be in the range of $377 million to $379 million based on the latest foreign currency exchange rates.

Webcast & Conference Call

The company will host a conference call and simultaneous webcast today at 1:30 p.m. PT (4:30 p.m. ET) to discuss the results and provide additional information about the company’s financial outlook. A link to the webcast is available on the company’s website at http://investors.glaukos.com. To participate in the conference call, please dial 888-210-2212 (U.S.) or 646-960-0390 (international) and enter Conference ID 7935742. A replay of the webcast will be archived on the company’s website following completion of the call.

Quarterly Summary Document

The company has posted a document on its Investor Relations website under the “Financials & Filings – Quarterly Results” section titled “Quarterly Summary.” This Quarterly Summary document is designed to provide the investment community with a summarized and easily accessible reference document that details the key facts associated with the quarter, the state of the company’s business objectives and strategies and any forward statements or guidance the company may make. This document is provided alongside the company’s earnings press release and is designed to be read by investors before the regularly scheduled quarterly conference call. As such, today’s conference call will be in a format primarily consisting of a questions and answers session, during which Glaukos will address any queries investors have regarding the company’s results. It is the company’s goal that this format will make its quarterly earnings process more efficient and impactful for the investment community going forward.

About Glaukos

Glaukos (www.glaukos.com) is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012. In 2024, Glaukos commenced commercial launch activities for iDose® TR, a first-of-its-kind, long-duration, intracameral procedural pharmaceutical designed to deliver 24/7 glaucoma drug therapy inside the eye for extended periods of time. Glaukos also markets the only FDA-approved corneal cross-linking therapy utilizing a proprietary bio-activated pharmaceutical for the treatment of keratoconus, a rare corneal disorder. Glaukos continues to successfully develop and advance a robust pipeline of novel, dropless platform technologies designed to meaningfully advance the standard of care and improve outcomes for patients suffering from chronic eye diseases.

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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 press release 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 press release. 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 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, 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 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 in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, which was filed with the SEC on August 2, 2024, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, which is expected to be filed with the SEC by November 12, 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 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.

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.

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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; 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 associated 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. See “GAAP to Non-GAAP Reconciliations” for a reconciliation of each non-GAAP measure presented to the comparable GAAP financial measure.

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 “Reported Sales vs. Prior Periods” for a presentation of certain net sales information on a reported, GAAP and a constant currency basis.

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GLAUKOS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except per share amounts)

Three Months Ended

Nine Months Ended

    

September 30,

    

September 30,

    

2024

    

2023

    

2024

    

2023

Net sales

$

96,670

$

78,048

$

277,982

$

232,346

Cost of sales

22,584

18,510

65,392

56,684

Gross profit

74,086

59,538

212,590

175,662

Operating expenses:

Selling, general and administrative

64,000

54,247

192,163

161,034

Research and development

34,746

33,301

99,898

101,706

Acquired in-process research and development

14,229

3,000

Total operating expenses

98,746

87,548

306,290

265,740

Loss from operations

(24,660)

(28,010)

(93,700)

(90,078)

Non-operating income (expense):

Interest income

2,700

2,710

8,611

6,252

Interest expense

(1,663)

(3,398)

(8,468)

(10,205)

Charges associated with convertible senior notes

(18,012)

Other income (expense), net

2,391

(1,709)

(338)

(2,978)

Total non-operating income (expense)

3,428

(2,397)

(18,207)

(6,931)

Loss before taxes

(21,232)

(30,407)

(111,907)

(97,009)

Income tax provision

177

37

885

873

Net loss

$

(21,409)

$

(30,444)

$

(112,792)

$

(97,882)

Basic and diluted net loss per share

$

(0.39)

$

(0.63)

$

(2.18)

$

(2.03)

Weighted average shares used to compute

basic and diluted net loss per share

55,037

48,675

51,804

48,284

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GLAUKOS CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except par values)

    

September 30,

    

December 31,

2024

2023

(unaudited)

Assets

Current assets:

Cash and cash equivalents

$

100,143

$

93,467

Short-term investments

162,330

201,964

Accounts receivable, net

56,408

39,850

Inventory

59,895

41,986

Prepaid expenses and other current assets

18,506

18,194

Total current assets

397,282

395,461

Restricted cash

4,733

5,856

Property and equipment, net

98,581

103,212

Operating lease right-of-use assets

27,321

27,146

Finance lease right-of-use asset

42,365

44,180

Intangible assets, net

269,418

282,956

Goodwill

66,134

66,134

Deposits and other assets

20,709

15,469

Total assets

$

926,543

$

940,414

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$

11,103

$

13,440

Accrued liabilities

60,581

60,574

Total current liabilities

71,684

74,014

Convertible senior notes

56,759

282,773

Operating lease liability

30,656

30,427

Finance lease liability

69,712

70,538

Deferred tax liability, net

7,143

7,144

Other liabilities

22,080

13,752

Total liabilities

258,034

478,648

Stockholders’ equity:

Preferred stock, $0.001 par value; 5,000 shares authorized; no shares issued or outstanding

Common stock, $0.001 par value; 150,000 shares authorized; 55,122 and 49,148 shares issued and 55,094 and 49,120 shares outstanding as of September 30, 2024 and December 31, 2023, respectively

55

49

Additional paid-in capital

1,377,825

1,059,751

Accumulated other comprehensive income

2,620

1,165

Accumulated deficit

(711,859)

(599,067)

Less treasury stock (28 shares as of September 30, 2024 and December 31, 2023)

(132)

(132)

Total stockholders’ equity

668,509

461,766

Total liabilities and stockholders’ equity

$

926,543

$

940,414

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GLAUKOS CORPORATION

GAAP to Non-GAAP Reconciliations

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

(unaudited)

Q3 2024

Q3 2023

    

GAAP

    

Adjustments

    

Non-GAAP

    

GAAP

    

Adjustments

    

Non-GAAP

Cost of sales

$

22,584

$

(5,523)

(a)

$

17,061

$

18,510

$

(5,523)

(a)

$

12,987

Gross Margin

76.6

%  

5.8

%  

82.4

%  

76.3

%  

7.1

%  

83.4

%

Operating expenses:

Selling, general and administrative

$

64,000

$

(705)

(b)

$

63,295

$

54,247

$

(705)

(b)

$

53,542

Loss from operations

$

(24,660)

$

6,228

$

(18,432)

$

(28,010)

$

6,228

$

(21,782)

Net loss

$

(21,409)

$

6,228

(c)

$

(15,181)

$

(30,444)

$

6,228

(c)

$

(24,216)

Basic and diluted net loss per share

$

(0.39)

$

0.11

$

(0.28)

$

(0.63)

$

0.13

$

(0.50)


(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.
(b)Avedro acquisition-related amortization expense of customer relationship intangible assets of $0.7 million.
(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 2024 and 2023.

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GLAUKOS CORPORATION

GAAP to Non-GAAP Reconciliations

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

(unaudited)

Year-to-Date Q3 2024

Year-to-Date Q3 2023

    

GAAP

    

Adjustments

    

Non-GAAP

    

GAAP

    

Adjustments

    

Non-GAAP

Cost of sales

$

65,392

$

(16,569)

(a)

$

48,823

$

56,684

$

(16,569)

(a)

$

40,115

Gross Margin

76.5

%  

5.9

%  

82.4

%  

75.6

%  

7.1

%  

82.7

%

Operating expenses:

Selling, general and administrative

$

192,163

$

(2,115)

(b)

$

190,048

$

161,034

$

(2,115)

(b)

$

158,919

Loss from operations

$

(93,700)

$

18,684

$

(75,016)

$

(90,078)

$

18,684

$

(71,394)

Non-operating income (expense):

Charges associated with convertible senior notes

$

(18,012)

$

18,012

(c)

$

$

$

$

Net loss

$

(112,792)

$

36,696

(d)

$

(76,096)

$

(97,882)

$

18,684

(d)

$

(79,198)

Basic and diluted net loss per share

$

(2.18)

$

0.71

$

(1.47)

$

(2.03)

$

0.39

$

(1.64)


(a)Cost of sales adjustment related to amortization of developed technology intangible assets associated with the acquisition of Avedro, Inc. (Avedro) of $16.6 million.
(b)Avedro acquisition-related amortization expense of customer relationship intangible assets of $2.1 million.
(c)Expenses associated with the exchange of convertible senior notes, consisting of a non-cash inducement charge of $17.4 million and direct transaction costs of $0.6 million.
(d)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 2024 and 2023.

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Reported Sales vs. Prior Periods (in thousands)

    

    

    

Year-over-Year Percent Change

Quarter-over-Quarter Percent Change

    

3Q 2024

3Q 2023

  

2Q 2024

Reported

    

Operations (1)

    

Currency (2)

    

Reported

    

Operations (1)

    

Currency (2)

  

International Glaucoma

$

24,467

$

20,280

$

26,131

20.6

%  

20.9

%  

(0.2%)

  

(6.4%)

(8.2%)

1.8

%

Total Net Sales

$

96,670

$

78,048

$

95,690

23.9

%  

23.9

%  

(0.0%)

  

1.0%

  

0.5%

  

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

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Exhibit 99.2

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NOVEMBER 4, 2024

GLAUKOS CORPORATION (NYSE: GKOS)

THIRD 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: November 4, 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.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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NOVEMBER 4, 2024

THIRD QUARTER 2024 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)

3Q 2024

$96.7 million

(+24% vs. 3Q 2023)

Gross Margin (Non-GAAP)

3Q 2024

~82%

(versus ~83% in 3Q 2023)

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

$267.2 million as of September 30, 2024 (versus $266.4 million as of June 30, 2024)

FY2024 Sales Guidance

FY 2024 global consolidated revenues of $377 - $379 million expected (versus $370 - $376 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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NOVEMBER 4, 2024

Revenue Performance & Commercial Overview

Global Consolidated Revenue Performance

Glaukos reported record third quarter net revenues of $96.7 million that were up 24% versus 3Q 2023. Our third quarter performance reflected continued solid execution across our global Glaucoma and Corneal Health franchises.  

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Franchise Revenue Performance

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NOVEMBER 4, 2024

U.S. Glaucoma

Our third quarter U.S. Glaucoma net revenues were approximately $51.6 million, representing year-over-year growth of 35% versus 3Q 2023 driven by early but growing contributions from iDose® TR, along with continued strong growth within our overall iStent® portfolio, led by iStent infinite®.

The access for and utilization of iStent infinite for glaucoma patients that have failed medical and surgical therapy continues to expand as our ongoing clinical education efforts and an improving market access landscape take hold.

During the third 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 deliver glaucoma drug therapy for up to three years. The third quarter saw the establishment of a unique J-Code, J7355, for iDose TR, which became effective on July 1, 2024. We have also now expanded access of iDose TR to our entire sales force. More importantly, outcomes and 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 third quarter International Glaucoma net revenues were approximately $24.5 million, representing year-over-year growth of 21%, versus 3Q 2023. The strong growth internationally during the third 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. Consistent with prior quarters this year, our new French CEPS agreement was favorable to our third quarter reported revenues.  

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. In the interim, we expect the trialing of new competitive products in our major international markets may become an increasing headwind as we enter 2025.

Corneal Health

Our third quarter Corneal Health net revenues were approximately $20.6 million, representing year-over-year growth of 5% versus 3Q 2023, including U.S. Photrexa® net sales of $17.9 million. As discussed last quarter, these third quarter results reflect the impact to Photrexa realized revenues as a result of our entry as a company into MDRP.

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

4


Graphic

NOVEMBER 4, 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 third quarter of 2024
oInterventional glaucoma education efforts and improved facility economics driving increased access for and utilization of iStent infinite in standalone procedures for patients that have failed prior medical and surgical therapy
oFocused on key market access initiatives to support consistent and dependable professional fee payment, with six of the seven MACs now including CPT code 0671T on their latest fee schedules
oFive of the seven MACs have issued final LCD reconsiderations that provide coverage for iStent infinite consistent with FDA approval and based upon our coverage reconsideration requests (scheduled to become effective November 2024)
Advanced initial commercial launch activities for iDose TR
oExpanded access of iDose TR to all of our sales field personnel helped support a growing number of trained surgeons and expanding utilization
oUnique, permanent J-code for iDose TR, J7355, became effective on July 1, 2024; this J-code is expected to increase patient access 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 entering 2025
oJ7355 was included in CMS’s latest HOPD and ASC quarterly update addendums, appropriately establishing pricing of J7355 at ASP +6%, effective as of October 1
oAdvanced efforts to secure professional fee coverage and payment with MACs, as well as establish commercial and Medicare Advantage coverage now that the permanent J-code is effective
oExpanded set of peer-reviewed literature, now consisting of 8 different peer-reviewed publications highlighting iDose TR as a transformative new treatment alternative for patients suffering with glaucoma and ocular hypertension
Secured several international regulatory approvals, including for iStent inject W in China and standalone usage indication for iStent inject W in Japan, alongside the approvals of both iStent infinite and PRESERFLO in Brazil earlier this year

5


Graphic

NOVEMBER 4, 2024

CMS’s Final Rules for Calendar Year 2025 – Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Facility Fee Schedule updates:
oAPC assignment for standalone trabecular bypass procedures, CPT 0671T, finalized to remain in APC 5493 (unchanged versus CY 2024)
oAPC assignment for combined cataract plus trabecular bypass procedures, CPT 66989 and CPT 66991, finalized to remain in APC 5493 (unchanged versus CY 2024)
oAPC assignment for iDose TR procedural pharmaceutical, CPT 0660T and 0661T, finalized to remain in APC 5492
oThese rules will go into effect on January 1, 2025

6


Graphic

NOVEMBER 4, 2024

2024 Revenue Guidance Raised to Reflect Strong Continued Momentum

Glaukos now expects full-year 2024 global consolidated net sales of $377 - $379 million, up from its previous guidance of $370 - $376 million. This upwardly revised guidance attempts to take into consideration:

Potential expanding contributions from iDose TR as reimbursement confidence is established
Potential growing contributions from iStent infinite as broader IG initiatives take hold
Potential impact of finalized 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
Potential headwinds within our U.S. Corneal Health franchise associated with our entry as a company into the MDRP
The latest anticipated foreign currency exchange impact based on the spot rates as of our 3Q 2024 earnings call on November 4, 2024
Combo-cataract MIGS competition globally

7


Graphic

NOVEMBER 4, 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-erodible sustained-release pharmaceuticals

Graphic

8


Graphic

NOVEMBER 4, 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 more than $600 million of investment into our R&D programs since 2018 alone. Recent updates in our pipeline include:

Announced positive topline outcomes in the second Phase 3 confirmatory pivotal trial for Epioxa™ (Epi-on)
oCompleted successful clinical pre-NDA meeting with the FDA, in which the Agency agreed that our clinical data package is sufficient to support an NDA submission and review
oResults from this second Phase 3 confirmatory pivotal trial together with the already-completed first Phase 3 pivotal trial are expected to support our anticipated NDA submission for Epioxa by the end of 2024
Preparing to commence Phase 3 clinical trial for iDose TREX, our next-generation iDose therapy, by the end of 2024
Advancing dialogue with the FDA regarding the re-administration of iDose TR
Completed patient enrollment in Phase 2a clinical trial for iLution™ Travoprost
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)
Completed patient enrollment in two Phase 2 trials for third-generation iLink therapy
PRESERFLO MicroShunt
oU.S. Investigation Device Exemption (IDE) application open; targeting clinical study commencement in 1H 2025
oOngoing regulatory submissions and approvals in Latin America

9


Graphic

NOVEMBER 4, 2024

Product / Pipeline Chart

Graphic

10


Graphic

NOVEMBER 4, 2024

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.  

Third quarter 2024 financial performance summary:

2023: 83%

∆: -100 bps

Graphic

Gross Margin

(Non-GAAP)

3Q 2024: 82%

3Q 2023: 83%

YoY ∆: -100 bps

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

Graphic

SG&A

(Non-GAAP)

3Q 2024: $63.3M

3Q 2023: $53.5M

YoY ∆: +18%

(3%) sequential decrease vs $65.5M in 2Q 2024
YoY increase primarily reflects commercial and G&A investments globally and new product launch activities

Graphic

R&D

(Non-GAAP)

3Q 2024: $34.7M

3Q 2023: $33.3M

YoY ∆: +4%

+1% sequential increase vs $34.4M in 2Q 2024
YoY and QoQ increases primarily reflect continued investment in and advancement of R&D programs

Graphic

SG&A + R&D

(Non-GAAP)

3Q 2024: $98.0M

3Q 2023: $86.8M

YoY ∆: +13%

(2%) sequential decrease vs $99.9M in 2Q 2024
Graphic

Earnings

Op Loss (Non-GAAP)

3Q 2024 ($18.4M)

3Q 2023: ($21.8M)

Net Loss (Non-GAAP)

3Q 2024: ($15.2M)

3Q 2023: ($24.2M)

Diluted EPS (Non-GAAP)

3Q 2024: ($0.28)

3Q 2023: ($0.50)

Graphic

CapEx

3Q 2024: $1.4M

3Q 2023: $3.4M

YoY ∆: (-$1.9M)

Capital expenditures moderating to levels more consistent with historical norms, a trend expected to continue throughout 2024
YoY decrease reflects the substantial completion of Aliso Viejo, CA and Burlington, MA facilities
Graphic

Cash

3Q 2024: $267.2M

2Q 2024: $266.4M

QoQ ∆: +$0.8M

Operating expenses, capital expenditures and changes in working capital

11


Graphic

NOVEMBER 4, 2024

Other Important Updates

ØOn October 4, 2024, we issued a notice of redemption for the remaining $57.5 million in principal amount outstanding of our convertible senior notes due 2027. Pursuant to the notice, we anticipate these notes to convert to common stock before the redemption date of December 16, 2024, helping to further solidify our already strong capital position through a de-leveraging and de-risking of our balance sheet as well as a significant reduction in future cash interest expense. See associated 8-K filing (here) for additional information.

12


Graphic

NOVEMBER 4, 2024

Additional Information

Graphic

13


Graphic

NOVEMBER 4, 2024

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, 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, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, which we expect to file on or before November 12, 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 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.

14


Graphic

NOVEMBER 4, 2024

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; 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. 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.

15


Graphic

NOVEMBER 4, 2024

GAAP Income Statement

GLAUKOS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except per share amounts)

Three Months Ended

Nine Months Ended

September 30,

September 30,

    

2024

    

2023

    

2024

    

2023

Net sales

$

96,670

$

78,048

$

277,982

$

232,346

Cost of sales

22,584

18,510

65,392

56,684

Gross profit

74,086

59,538

212,590

175,662

Operating expenses:

Selling, general and administrative

64,000

54,247

192,163

161,034

Research and development

34,746

33,301

99,898

101,706

Acquired in-process research and development

14,229

3,000

Total operating expenses

98,746

87,548

306,290

265,740

Loss from operations

(24,660)

(28,010)

(93,700)

(90,078)

Non-operating income (expense):

Interest income

2,700

2,710

8,611

6,252

Interest expense

(1,663)

(3,398)

(8,468)

(10,205)

Charges associated with convertible senior notes

(18,012)

Other income (expense), net

2,391

(1,709)

(338)

(2,978)

Total non-operating income (expense)

3,428

(2,397)

(18,207)

(6,931)

Loss before taxes

(21,232)

(30,407)

(111,907)

(97,009)

Income tax provision

177

37

885

873

Net loss

$

(21,409)

$

(30,444)

$

(112,792)

$

(97,882)

Basic and diluted net loss per share

$

(0.39)

$

(0.63)

$

(2.18)

$

(2.03)

Weighted average shares used to compute

basic and diluted net loss per share

55,037

48,675

51,804

48,284

16


Graphic

NOVEMBER 4, 2024

GAAP Balance Sheet

GLAUKOS CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except par values)

    

September 30,

    

December 31,

2024

2023

(unaudited)

Assets

Current assets:

Cash and cash equivalents

$

100,143

$

93,467

Short-term investments

162,330

201,964

Accounts receivable, net

56,408

39,850

Inventory

59,895

41,986

Prepaid expenses and other current assets

18,506

18,194

Total current assets

397,282

395,461

Restricted cash

4,733

5,856

Property and equipment, net

98,581

103,212

Operating lease right-of-use assets

27,321

27,146

Finance lease right-of-use asset

42,365

44,180

Intangible assets, net

269,418

282,956

Goodwill

66,134

66,134

Deposits and other assets

20,709

15,469

Total assets

$

926,543

$

940,414

Liabilities and stockholders' equity

Current liabilities:

Accounts payable

$

11,103

$

13,440

Accrued liabilities

60,581

60,574

Total current liabilities

71,684

74,014

Convertible senior notes

56,759

282,773

Operating lease liability

30,656

30,427

Finance lease liability

69,712

70,538

Deferred tax liability, net

7,143

7,144

Other liabilities

22,080

13,752

Total liabilities

258,034

478,648

Stockholders' equity:

Preferred stock, $0.001 par value; 5,000 shares authorized; no shares issued or outstanding

Common stock, $0.001 par value; 150,000 shares authorized; 55,122 and 49,148 shares issued and 55,094 and 49,120 shares outstanding as of September 30, 2024 and December 31, 2023, respectively

55

49

Additional paid-in capital

1,377,825

1,059,751

Accumulated other comprehensive income

2,620

1,165

Accumulated deficit

(711,859)

(599,067)

Less treasury stock (28 shares as of September 30, 2024 and December 31, 2023)

(132)

(132)

Total stockholders' equity

668,509

461,766

Total liabilities and stockholders' equity

$

926,543

$

940,414

17


Graphic

NOVEMBER 4, 2024

Primary GAAP to Non-GAAP Reconciliations

GLAUKOS CORPORATION

GAAP to Non-GAAP Reconciliations

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

(unaudited)

Q3 2024

Q3 2023

    

GAAP

    

Adjustments

    

Non-GAAP

    

GAAP

    

Adjustments

    

Non-GAAP

Cost of sales

$

22,584

$

(5,523)

(a)

$

17,061

$

18,510

$

(5,523)

(a)

$

12,987

 

Gross Margin

76.6

%  

5.8

%

82.4

%  

76.3

%  

7.1

%

83.4

%

Operating expenses:

Selling, general and administrative

$

64,000

$

(705)

(b)

$

63,295

$

54,247

$

(705)

(b)

$

53,542

Loss from operations

$

(24,660)

$

6,228

$

(18,432)

$

(28,010)

$

6,228

$

(21,782)

Net loss

$

(21,409)

$

6,228

(c)

$

(15,181)

$

(30,444)

$

6,228

(c)

$

(24,216)

Basic and diluted net loss per share

$

(0.39)

$

0.11

$

(0.28)

$

(0.63)

$

0.13

$

(0.50)


(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.

(b)

Avedro acquisition-related amortization expense of customer relationship intangible assets of $0.7 million.

(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 2024 and 2023.

18


Graphic

NOVEMBER 4, 2024

Primary GAAP to Non-GAAP Reconciliations

GLAUKOS CORPORATION

GAAP to Non-GAAP Reconciliations

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

(unaudited)

Year-to-Date Q3 2024

Year-to-Date Q3 2023

    

GAAP

    

Adjustments

    

Non-GAAP

    

GAAP

    

Adjustments

    

Non-GAAP

Cost of sales

$

65,392

$

(16,569)

(a)

$

48,823

$

56,684

$

(16,569)

(a)

$

40,115

 

Gross Margin

76.5

%  

5.9

%  

82.4

%  

75.6

%  

7.1

%  

82.7

%

Operating expenses:

Selling, general and administrative

$

192,163

$

(2,115)

(b)

$

190,048

$

161,034

$

(2,115)

(b)

$

158,919

Loss from operations

$

(93,700)

$

18,684

$

(75,016)

$

(90,078)

$

18,684

$

(71,394)

Non-operating income (expense):

Charges associated with convertible senior notes

$

(18,012)

$

18,012

(c)

$

$

$

$

Net loss

$

(112,792)

$

36,696

(d)

$

(76,096)

$

(97,882)

$

18,684

(d)

$

(79,198)

Basic and diluted net loss per share

$

(2.18)

$

0.71

$

(1.47)

$

(2.03)

$

0.39

$

(1.64)


(a)Cost of sales adjustment related to amortization of developed technology intangible assets associated with the acquisition of Avedro, Inc. (Avedro) of $16.6 million.
(b)Avedro acquisition-related amortization expense of customer relationship intangible assets of $2.1 million.
(c)Expenses associated with the exchange of convertible senior notes, consisting of a non-cash inducement charge of $17.4 million and direct transaction costs of $0.6 million.
(d)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 2024 and 2023.

19


Graphic

NOVEMBER 4, 2024

Additional GAAP to Non-GAAP Reconciliations

Reported Sales vs. Prior Periods (in thousands)

    

    

    

    

Year-over-Year Percent Change

    

Quarter-over-Quarter Percent Change

3Q 2024

3Q 2023

2Q 2024

Reported

Operations (1)

Currency (2)

Reported

Operations (1)

Currency (2)

International Glaucoma

  

$

24,467

  

$

20,280

  

$

26,131

  

20.6

%  

20.9

%  

(0.2%)

  

(6.4%)

(8.2%)

1.8

%

Total Net Sales

$

96,670

$

78,048

$

95,690

23.9

%  

23.9

%  

(0.0%)

  

1.0%

0.5%

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.

20


v3.24.3
Document and Entity Information
Nov. 04, 2024
Document and Entity Information  
Document Type 8-K
Document Period End Date Nov. 04, 2024
Entity Registrant Name Glaukos Corporation
Entity File Number 001-37463
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 33-0945406
Entity Address, Address Line One One Glaukos Way
Entity Address, City or Town Aliso Viejo
Entity Address, State or Province CA
Entity Address, Postal Zip Code 92656
City Area Code 949
Local Phone Number 367-9600
Title of 12(b) Security Common Stock
Trading Symbol GKOS
Security Exchange Name NYSE
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company false
Entity Central Index Key 0001192448
Amendment Flag false

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