8-K
GLAUKOS Corp (GKOS)
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): February 21, 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
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||
|---|---|---|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||
| --- | --- | |||
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||
| --- | --- | |||
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||
| --- | --- | |||
| 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 February 21, 2024, Glaukos Corporation (the “Company”) issued a press release announcing its financial results for the fourth quarter and fiscal year ended December 31, 2023. 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 fourth quarter and fiscal year ended December 31, 2023 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 February 21, 2024 | |
| | | |
| 99.2 | | Quarterly Summary of Glaukos Corporation for the fourth quarter and fiscal year ended December 31, 2023 |
| | | |
| 104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| GLAUKOS CORPORATION<br>(Registrant) | |||
|---|---|---|---|
| | | ||
| By: | /s/ Alex R. Thurman | ||
| Name: | Alex R. Thurman | ||
| Title: | Senior Vice President & Chief Financial Officer |
Date: February 21, 2024
FOR IMMEDIATE RELEASE
Contact:
Chris Lewis
Vice President, Investor Relations & Corporate Affairs
(949) 481-0510
clewis@glaukos.com
Glaukos Announces Fourth Quarter and Full Year 2023 Financial Results
Aliso Viejo, CA – February 21, 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 fourth quarter and full year ended December 31, 2023. Key highlights include:
| ● | Record net sales of $82.4 million in Q4 2023 increased 16% year-over-year on a reported basis and 15% year-over-year on a constant currency basis. |
|---|---|
| ● | Glaucoma net sales of $60.6 million in Q4 2023 increased 15% year-over-year. |
| --- | --- |
| ● | Corneal Health net sales of $21.8 million in Q4 2023 increased 19% year-over-year. |
| --- | --- |
| ● | Gross margin of approximately 77% and non-GAAP gross margin of approximately 84% in Q4 2023. |
| --- | --- |
| ● | Net sales of $314.7 million in FY 2023 increased 11% year-over-year on a reported basis and 12% year-over-year on a constant currency basis. |
| --- | --- |
| ● | Reaffirmed 2024 net sales guidance of $350 million to $360 million. |
| --- | --- |
“Our record fourth quarter results cap off a successful year of global execution and key milestone achievements, leaving us well positioned to execute our strategic plans as we enter into what we believe will be a transformative period for our company over the coming years,” 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.”
Fourth Quarter 2023 Financial Results
Net sales in the fourth quarter of 2023 of $82.4 million increased 16% on a reported basis, or 15% on a constant currency basis, compared to $71.2 million in the same period in 2022.
Gross margin for the fourth quarter of 2023 was approximately 77%, compared to approximately 76% in the same period in 2022. Non-GAAP gross margin for the fourth quarter of 2023 was approximately 84%, compared to approximately 84% in the same period in 2022.
Selling, general and administrative (SG&A) expenses for the fourth quarter of 2023 increased 21% to $63.0 million, compared to $51.9 million in the same period in 2022. Non-GAAP SG&A expenses for the fourth quarter of 2023 increased 22% to $62.3 million, compared to $51.1 million in the same period in 2022.
GAAP and non-GAAP research and development (R&D) expenses for the fourth quarter of 2023 increased 3% to $37.1 million, compared to $35.8 million in the same period in 2022.
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Loss from operations in the fourth quarter of 2023 was $38.6 million, compared to operating loss of $33.7 million in the fourth quarter of 2022. Non-GAAP loss from operations in the fourth quarter of 2023 was $32.4 million, compared to non-GAAP operating loss of $27.4 million in the fourth quarter of 2022.
Net loss in the fourth quarter of 2023 was $36.8 million, or ($0.75) per diluted share, compared to net loss of $31.5 million, or ($0.66) per diluted share, in the fourth quarter of 2022. Non-GAAP net loss in the fourth quarter of 2023 was $30.6 million, or ($0.63) per diluted share, compared to non-GAAP net loss of $25.1 million, or ($0.53) per diluted share, in the fourth quarter of 2022.
Included in non-GAAP loss from operations, non-GAAP net loss and non-GAAP EPS for the fourth quarter of 2023 is an acquired in-process R&D (IPR&D) charge of $2.0 million, which caused the non-GAAP loss per diluted share to have an additional loss of ($0.05) in the fourth quarter of 2023.
Full Year 2023 Financial Results
Net sales in 2023 of $314.7 million increased 11% on a reported basis, or 12% on a constant currency basis, compared to $282.9 million in 2022.
Gross margin for 2023 was approximately 76%, compared to approximately 76% in 2022. Non-GAAP gross margin for 2023 was approximately 83%, compared to approximately 83% in 2022.
SG&A expenses in 2023 increased 16% to $224.1 million, compared to $192.9 million in 2022. Non-GAAP SG&A expenses in 2023 increased 17% to $221.2 million, compared to $189.6 million in 2022.
R&D expenses in 2023 rose 13% to $138.8 million, compared to $123.3 million in 2022. Non-GAAP R&D expenses in 2023 rose 13% to $138.8 million, compared to $123.1 million in 2022.
Loss from operations in 2023 was $128.7 million, compared to operating loss of $82.3 million in 2022. Non-GAAP loss from operations in 2023 was $103.8 million, compared to non-GAAP operating loss of $86.7 million in 2022.
Net loss in 2023 was $134.7 million, or ($2.78) per diluted share, compared to net loss of $99.2 million, or ($2.09) per diluted share, in 2022. Non-GAAP net loss in 2023 was $109.7 million, or ($2.27) per diluted share, compared to non-GAAP net loss of $103.6 million, or ($2.18) per diluted share, in 2022.
During 2022, the company received a $30 million payment related to the company’s settlement of patent litigation with Ivantis, Inc. This receipt was recorded as an offset to GAAP operating expenses in 2022.
Included in non-GAAP loss from operations, non-GAAP net loss and non-GAAP EPS for 2023 and 2022 are acquired IPR&D charges of $5.0 million and $10.0 million, respectively, which caused the non-GAAP loss per diluted share to have an additional loss of ($0.11) and ($0.21) in each of these respective periods.
The company ended the fourth quarter of 2023 with approximately $301 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 $350 million to $360 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
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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, and continues to develop a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases.
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, uncertainties regarding the impact of the COVID-19 pandemic or other future public health crises on our business; the impact of general macroeconomic conditions including foreign currency fluctuations; the reduced physician fee and ASC facility fee reimbursement rate finalized by CMS for 2022 and 2023 for procedures utilizing the Company’s iStent family of products and its impact on our U.S. combo-cataract glaucoma revenue; 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
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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; our ability to properly train, and gain acceptance and trust from ophthalmic surgeons in the use of our products; our ability to compete effectively in the medical device industry and against current and future technologies (including MIGS technologies); our compliance with federal, state and foreign laws and regulations for the approval and sale and marketing of our products and of our manufacturing 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, 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 September 30, 2023, which was filed with the SEC on November 1, 2023, and our Annual Report on Form 10-K for the year ended December 31, 2023, which is expected to be filed with the SEC by February 29, 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. 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). The Company uses the term "Non-GAAP" to exclude 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; 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
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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 | Year Ended | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | | December 31, | | December 31, | | ||||||||
| | | 2023 | **** | 2022 | | 2023 | **** | 2022 | | ||||
| Net sales | | $ | 82,365 | | $ | 71,227 | | $ | 314,711 | | $ | 282,862 | |
| Cost of sales | | | 18,891 | | | 17,222 | | | 75,575 | | | 68,979 | |
| Gross profit | | | 63,474 | | | 54,005 | | | 239,136 | | | 213,883 | |
| Operating expenses: | | | | | | | | | | | | | |
| Selling, general and administrative | | | 63,034 | | | 51,927 | | | 224,068 | | | 192,925 | |
| Research and development | | | 37,062 | | | 35,812 | | | 138,768 | | | 123,271 | |
| Acquired in-process research and development | | | 2,000 | | | — | | | 5,000 | | | 10,000 | |
| Litigation-related settlement | | | — | | | — | | | — | | | (30,000) | |
| Total operating expenses | | | 102,096 | | | 87,739 | | | 367,836 | | | 296,196 | |
| Loss from operations | | | (38,622) | | | (33,734) | | | (128,700) | | | (82,313) | |
| Non-operating income (expense): | | | | | | | | | | | | | |
| Interest income | | | 2,912 | | | 960 | | | 9,164 | | | 2,375 | |
| Interest expense | | | (3,428) | | | (3,409) | | | (13,633) | | | (13,720) | |
| Other income (expense), net | | | 2,420 | | | 5,021 | | | (558) | | | (4,771) | |
| Total non-operating income (expense) | | | 1,904 | | | 2,572 | | | (5,027) | | | (16,116) | |
| Loss before taxes | | | (36,718) | | | (31,162) | | | (133,727) | | | (98,429) | |
| Income tax provision | | | 61 | | | 298 | | | 934 | | | 766 | |
| Net loss | | $ | (36,779) | | $ | (31,460) | | $ | (134,661) | | $ | (99,195) | |
| | | | | | | | | | | | | | |
| Basic and diluted net loss per share | | $ | (0.75) | | $ | (0.66) | | $ | (2.78) | | $ | (2.09) | |
| | | | | | | | | | | | | | |
| Weighted average shares used to compute basic and diluted net loss per share | | | 48,876 | | | 47,738 | | | 48,433 | | | 47,444 | |
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GLAUKOS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except par values)
| | **** | December 31, | **** | December 31, | **** | ||
|---|---|---|---|---|---|---|---|
| | | 2023 | | 2022 | | ||
| | | (unaudited) | | | | ||
| Assets | | | | | | | |
| Current assets: | | | | | | | |
| Cash and cash equivalents | | $ | 93,467 | | $ | 119,525 | |
| Short-term investments | | | 201,964 | | | 233,170 | |
| Accounts receivable, net | | | 39,850 | | | 36,073 | |
| Inventory | | | 41,986 | | | 37,841 | |
| Prepaid expenses and other current assets | | | 18,194 | | | 17,250 | |
| Total current assets | | | 395,461 | | | 443,859 | |
| Restricted cash | | | 5,856 | | | 7,078 | |
| Property and equipment, net | | | 103,212 | | | 94,403 | |
| Operating lease right-of-use asset | | | 27,146 | | | 25,826 | |
| Finance lease right-of-use asset | | | 44,180 | | | 46,601 | |
| Intangible assets, net | | | 282,956 | | | 307,869 | |
| Goodwill | | | 66,134 | | | 66,134 | |
| Deposits and other assets | | | 15,469 | | | 10,613 | |
| Total assets | | $ | 940,414 | | $ | 1,002,383 | |
| | | | | | | | |
| Liabilities and stockholders’ equity | | | | | | | |
| Current liabilities: | | | | | | | |
| Accounts payable | | $ | 13,440 | | $ | 14,403 | |
| Accrued liabilities | | | 60,574 | | | 57,956 | |
| Total current liabilities | | | 74,014 | | | 72,359 | |
| Convertible senior notes | | | 282,773 | | | 281,400 | |
| Operating lease liability | | | 30,427 | | | 28,905 | |
| Finance lease liability | | | 70,538 | | | 72,172 | |
| Deferred tax liability, net | | | 7,144 | | | 7,264 | |
| Other liabilities | | | 13,752 | | | 10,278 | |
| Total liabilities | | | 478,648 | | | 472,378 | |
| | | | | | | | |
| Stockholders’ equity: | | | | | | | |
| Preferred stock, $0.001 par value; 5,000 shares authorized; no shares issued or outstanding as of December 31, 2023 and 2022 | | | — | | | — | |
| Common stock, $0.001 par value; 150,000 shares authorized; 49,148 and 47,782 shares issued and 49,120 and 47,754 shares outstanding at December 31, 2023 and 2022, respectively | | | 49 | | | 48 | |
| Additional paid-in capital | | | 1,059,751 | | | 997,470 | |
| Accumulated other comprehensive income (loss) | | | 1,165 | | | (2,975) | |
| Accumulated deficit | | | (599,067) | | | (464,406) | |
| Less treasury stock (28 shares as of December 31, 2023 and 2022) | | | (132) | | | (132) | |
| Total stockholders’ equity | | | 461,766 | | | 530,005 | |
| Total liabilities and stockholders’ equity | | $ | 940,414 | | $ | 1,002,383 | |
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GLAUKOS CORPORATION
GAAP to Non-GAAP Reconciliations
(in thousands, except per share amounts and percentage data)
(unaudited)
| | **** | Q4 2023 | Q4 2022 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | | GAAP | Adjustments | Non-GAAP | | GAAP | Adjustments | Non-GAAP | | ||||||||||
| Cost of sales | | $ | 18,891 | | $ | (5,523) | (a) | $ | 13,368 | | $ | 17,222 | | $ | (5,533) | (a) | $ | 11,689 | |
| Gross Margin | | | 77.1 | % | | 6.7 | % | | 83.8 | % | | 75.8 | % | | 7.8 | % | | 83.6 | % |
| | | | | | | | | | | | | | | | | | | | |
| Operating expenses: | | | | | | | | | | | | | | | | | | | |
| Selling, general and administrative | | $ | 63,034 | | $ | (705) | (b) | $ | 62,329 | | $ | 51,927 | | $ | (782) | (b) | $ | 51,145 | |
| Loss from operations | | $ | (38,622) | | $ | 6,228 | | $ | (32,394) | | $ | (33,734) | | $ | 6,315 | | $ | (27,419) | |
| Net loss | | $ | (36,779) | | $ | 6,228 | (c) | $ | (30,551) | | $ | (31,460) | | $ | 6,315 | (c) | $ | (25,145) | |
| Basic and diluted net loss per share | | $ | (0.75) | | $ | 0.12 | | $ | (0.63) | | $ | (0.66) | | $ | 0.13 | | $ | (0.53) | |
| (a) | Cost of sales adjustments related to the acquisition of Avedro, Inc. (Avedro), including amortization of developed technology intangible assets of $5.5 million in Q4 2023 and amortization of developed technology intangible assets and stock-based compensation expense related to replacement awards, totaling $5.5 million in Q4 2022. |
|---|---|
| (b) | Avedro acquisition-related expenses, including amortization expense of customer relationship intangible assets of $0.7 million in Q4 2023 and customer relationship intangible assets and stock-based compensation expense related to replacement awards of $0.8 million in Q4 2022. |
| --- | --- |
| (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 2023 and 2022. |
| --- | --- |
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GLAUKOS CORPORATION
GAAP to Non-GAAP Reconciliations
(in thousands, except per share amounts and percentage data)
(unaudited)
| | **** | Full Year 2023 | Full Year 2022 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | | GAAP | Adjustments | Non-GAAP | | GAAP | Adjustments | Non-GAAP | | ||||||||||
| Cost of sales | | $ | 75,575 | | $ | (22,092) | (a) | $ | 53,483 | | $ | 68,979 | | $ | (22,166) | (a) | $ | 46,813 | |
| Gross Margin | | | 76.0 | % | | 7.0 | % | | 83.0 | % | | 75.6 | % | | 7.8 | % | | 83.5 | % |
| | | | | | | | | | | | | | | | | | | | |
| Operating expenses: | | | | | | | | | | | | | | | | | | | |
| Selling, general and administrative | | $ | 224,068 | | $ | (2,820) | (b) | $ | 221,248 | | $ | 192,925 | | $ | (3,315) | (b) | $ | 189,610 | |
| Research and development | | $ | 138,768 | | $ | — | | $ | 138,768 | | $ | 123,271 | | $ | (127) | (c) | $ | 123,144 | |
| Litigation-related settlement | | $ | — | | $ | — | | $ | — | | $ | (30,000) | | $ | 30,000 | (d) | $ | — | |
| Loss from operations | | $ | (128,700) | | $ | 24,912 | | $ | (103,788) | | $ | (82,313) | | $ | (4,392) | | $ | (86,705) | |
| Net loss | | $ | (134,661) | | $ | 24,912 | (e) | $ | (109,749) | | $ | (99,195) | | $ | (4,392) | (e) | $ | (103,587) | |
| Basic and diluted net loss per share | | $ | (2.78) | | $ | 0.51 | | $ | (2.27) | | $ | (2.09) | | $ | (0.09) | | $ | (2.18) | |
| (a) | Cost of sales adjustments related to the acquisition of Avedro, Inc. (Avedro), including amortization of developed technology intangible assets of $22.1 million in 2023 and amortization of developed technology intangible assets and stock-based compensation expense related to replacement awards, totaling $22.2 million in 2022. |
|---|---|
| (b) | Avedro acquisition-related expenses, including amortization expense of customer relationship intangible assets of $2.8 million in 2023 and customer relationship intangible assets and stock-based compensation expense related to replacement awards of $3.3 million in 2022. |
| --- | --- |
| (c) | Stock-based compensation expense related to replacement awards from the acquisition of Avedro. |
| --- | --- |
| (d) | Settlement proceeds received related to the Company’s patent infringement litigation. |
| --- | --- |
| (e) | 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 2023 and 2022. |
| --- | --- |
9
Reported Sales vs. Prior Periods (in thousands)
| | | | | | | | | | | | Year-over-Year Percent Change | | Quarter-over-Quarter Percent Change | | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | **** | 4Q 2023 | **** | 4Q 2022 | **** | 3Q 2023 | **** | Reported | **** | Operations (1) | **** | Currency (2) | **** | Reported | **** | Operations (1) | **** | Currency (2) | **** | |||
| | | | | | | | | | | | | | | | | | | | | | | |
| International Glaucoma | | $ | 21,857 | | $ | 17,530 | | $ | 20,280 | | 24.7 | % | 22.5 | % | 2.2 | % | 7.8 | % | 9.3 | % | (1.5) | % |
| | | | | | | | | | | | | | | | | | | | | | | |
| Total Net Sales | | $ | 82,365 | | $ | 71,227 | | $ | 78,048 | | 15.6 | % | 15.1 | % | 0.5 | % | 5.5 | % | 5.9 | % | (0.4) | % |
| (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 |
| --- | --- |
Reported Sales vs. Prior Periods (in thousands)
| | | | | | | | | Year-over-Year Percent Change | | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| **** | 2023 | **** | 2022 | **** | Reported | **** | Operations (1) | **** | Currency (2) | **** | |||
| International Glaucoma | | $ | 85,560 | | $ | 69,577 | | 23.0 | % | 24.4 | % | (1.4) | % |
| | | | | | | | | ||||||
| Total Net Sales | | $ | 314,711 | | $ | 282,862 | | 11.3 | % | 11.6 | % | (0.3) | % |
| (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 |
| --- | --- |
10
FEBRUARY 21, 2024
**** ****
GLAUKOS CORPORATION (NYSE: GKOS) **** **** ****
FOURTH QUARTER & FULL YEAR 2023 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: February 21, 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. |
| --- | --- |
1
FEBRUARY 21, 2024
FOURTH QUARTER & FULL YEAR 2023 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 | GlaucomaCorneal HealthRetinal Disease |
| Revenue (Growth) | 4Q 202382.4 million(+16% reported, +15% constant currency vs. 4Q 2022) |
| Gross Margin (Non-GAAP) | 4Q 202383.8%(versus 83.6% in 4Q 2022) |
| Cash & Cash Equivalents, Short-Term Investments, and Restricted Cash | 301.3 million as of December 31, 2023 (versus 306.7 million as of September 30, 2023) |
| FY2024 Sales Guidance | FY 2024 global consolidated revenues of 350 - 360 million expected |
All values are in US Dollars.
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.
2
FEBRUARY 21, 2024
Revenue Performance & Commercial Overview
Global Consolidated Revenue Performance
Glaukos reported record fourth quarter net revenues of $82.4 million that were up 16% on a reported basis or up 15% on a constant currency basis versus 4Q 2022. Our fourth quarter performance reflected continued solid execution across our global Glaucoma and Corneal Health franchises.
For fiscal year 2023, net revenues were approximately $315 million, up 11% on a reported basis, or up 12% on a constant currency basis, compared to net revenues of approximately $283 million in 2022.
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FEBRUARY 21, 2024
Franchise Revenue Performance
U.S. Glaucoma
Our fourth quarter U.S. Glaucoma net revenues were approximately $38.7 million, representing year-over-year growth of 10% versus 4Q 2023.
For fiscal year 2023, U.S. Glaucoma net revenues were approximately $151.5 million, representing year-over-year growth of 5% versus fiscal year 2022.
International Glaucoma
Our fourth quarter International Glaucoma net revenues were approximately $21.9 million, representing year-over-year reported growth of 25%, or 23% on a constant currency basis, versus 4Q 2022. The strong growth internationally during the fourth 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.
For fiscal year 2023, International Glaucoma net revenues were approximately $85.6 million, representing year-over-year reported growth of 23%, or 24% on a constant currency basis, versus fiscal year 2022.
Corneal Health
Our record fourth quarter Corneal Health net revenues were approximately $21.8 million, representing year-over-year growth of 19% versus 4Q 2022, including U.S. Photrexa® record sales of $19.2 million, which increased 26% year-over-year as our key strategic initiatives continue to take hold in support of this important business.
For fiscal year 2023, Corneal Health net revenues were approximately $77.7 million, representing year-over-year reported growth of 13% versus fiscal year 2022. U.S Photrexa sales in 2023 were $66.3 million, an increase of 18% compared to 2022.
We continue to focus on expanding access for keratoconus patients suffering from this rare disease.
4
FEBRUARY 21, 2024
2024 Revenue Guidance Reaffirmed
Glaukos reaffirms full-year 2024 global consolidated net sales of $350 - $360 million. This 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 |
| --- | --- |
| ● | The latest foreign currency exchange spot rates as of our 4Q23 earnings call on February 21, 2024 |
| --- | --- |
| ● | Combo-cataract MIGS competition globally |
| --- | --- |
5
FEBRUARY 21, 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 |
| --- | --- |
6
FEBRUARY 21, 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 $500 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) |
|---|---|
| o | Commenced initial commercial launch activites for iDose TR (1Q 2024) |
| --- | --- |
| ✓ | Commenced PMA pivotal trial for iStent infinite in mild-to-moderate glaucoma patients (4Q 2023) |
| --- | --- |
| ✓ | Commenced first-in-human Retina XR clinical development program for IVT multi-kinase inhibitor in wet AMD patients (GLK-401) (4Q 2023) |
| --- | --- |
| ✓ | Commenced Phase 2a clinical trial for iLution™ Travoprost (4Q 2023) |
| --- | --- |
| ✓ | Progressing towards trial completion in second Phase 3 confirmatory pivotal trial for Epioxa*™ (Epi-on*) |
| --- | --- |
| o | 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-generation iLink therapy |
| --- | --- |
| ✓ | PRESERFLO MicroShunt |
| --- | --- |
| o | U.S. Investigation Device Excemption (IDE) application open – targeting clinical study commencement in 1H 2024 |
| --- | --- |
| o | Ongoing regulatory submissions and approvals in Latin America |
| --- | --- |
| ✓ | Preparing to commence Phase 3 clincial trial for iDose TREX, our next-generation iDose therapy, by the end of 2024 |
| --- | --- |
7
FEBRUARY 21, 2024
Product / Pipeline Chart
8
FEBRUARY 21, 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.
Fourth quarter 2023 financial performance summary:
| <br><br><br><br><br><br> | 2022: 84%<br><br>∆: +20 bps<br><br> | <br><br> |
|---|---|---|
 <br>Gross Margin<br><br>(Non-GAAP)<br><br><br><br><br><br><br><br> |
4Q 2023: 84%<br><br>4Q 2022: 84%<br><br>YoY ∆: +20 bps | ●<br><br>Please note that our non-GAAP adjustments to cost of goods sold include substantial amounts related to Avedro acquisition accounting<br><br> |
 <br>SG&A<br><br>(Non-GAAP)<br><br> |
4Q 2023: $62.3M<br><br>4Q 2022: $51.1M<br><br>YoY ∆: +22% | ●<br><br>16% sequential increase vs $53.5M in 3Q 2023<br><br>●<br><br>YoY and QoQ increases primarily reflect various one-time expenses in the quarter, including non-cash stock comp associated with certain performance award target achievements, samples expense, and commercial and G&A investments globally and new product launch activities |
 <br>R&D<br><br>(Non-GAAP)<br><br><br><br> |
4Q 2023: $37.1M<br><br>4Q 2022: $35.8M<br><br>YoY ∆: +3% | ●<br><br>11% sequential increase vs $33.3M in 3Q 2023<br><br>●<br><br>YoY and QoQ increases reflect continued investment in and advancement of R&D programs<br><br> |
 <br>SG&A + R&D<br><br>(Non-GAAP)<br><br><br><br> |
4Q 2023: $99.4M<br><br>4Q 2022: $87.0M<br><br>YoY ∆: +14% | ●<br><br>14% sequential increase vs $86.8M in 3Q 2023 |
 <br>Earnings<br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br> |
Op Loss (Non-GAAP)<br><br>4Q 2023: ($32.4M)<br><br>4Q 2022: ($27.4M)<br><br><br><br>Net Loss (Non-GAAP)<br><br>4Q 2023: ($30.6M)<br><br>4Q 2022: ($25.1M)<br><br><br><br>Diluted EPS (Non-GAAP)<br><br>4Q 2023: ($0.63)<br><br>4Q 2022: ($0.53) | |
 CapEx<br><br><br><br> |
4Q 2023: $4.2M<br><br>4Q 2022: 8.2M<br><br>YoY ∆: (-$4.0M)<br><br> | ●<br><br>Capital expenditures moderating to levels more consistent with historical norms, a trend expected to continue throughout 2024<br><br>●<br><br>YoY decrease reflects the substantial completion of Aliso Viejo, CA and Burlington, MA facilities |
 Cash<br><br><br><br><br><br> |
4Q 2023: $301.3M<br><br>3Q 2023: $306.7M<br><br>QoQ ∆: (-$5.4M) | ●<br><br>Operating expenses and capital investments<br><br><br><br><br><br><br><br> |
9
FEBRUARY 21, 2024
Annual Supplement
Provided annually in conjunction with the fourth quarter earnings call
10
FEBRUARY 21, 2024
Pipeline: 2023 Achievements & 2024 Milestone Targets
2023 was an important year for Glaukos as we successfully executed on our core business key strategic objectives while achieving notable pipeline advancements and milestones that leave us well-positioned as we enter into what should be a transformative period for our company in the years ahead.
Our achievements in 2023 leave us excited about our prospects and well-positioned for the next phase of our pioneering journey. In 2024, we aim to accomplish the following pipeline milestones:
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FEBRUARY 21, 2024
Delivering the Portfolio for Long-Term Growth & Value Creation
While we execute commercially, we continue to successfully invest in and advance our robust pipeline of novel, promising platform technologies that we believe can significantly expand our addressable markets and leverage our commercial platform to fundamentally transform our company over time.
We believe the strong financial profile and capital position we’ve built provides a solid foundation that has allowed us to remain on offense when it comes to successfully investing for our future, leaving us well-positioned for the next phase of our pioneering journey as we target clinical, regulatory, and commercial milestones this year and the years ahead.
Our mission is to disrupt conventional treatment paradigms to advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide suffering from sight-threatening chronic eye diseases. We believe our platforms and product candidates have the ability to generate a robust cadence of new product introductions over the coming years that can generate layers of future growth.
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FEBRUARY 21, 2024
Key Technology Platforms / Products / Product Candidates
| | ||
|---|---|---|
| Our platforms embody ambitious, big ideas aimed at addressing large and chronically underserved eye diseases, including for glaucoma, corneal disorders, and retinal diseases. Over the years the number of disclosed pipeline programs associated with these platforms has expanded significantly to 14 entering into 2024.<br><br><br><br>iStent Micro-Scale Surgical Devices<br><br> |  |
|
 |
Our foundational iStent micro-surgical device platform primarily involves the insertion of a micro-scale device designed to reduce | |
| IOP by restoring the natural aqueous humor outflow pathways for patients suffering from glaucoma. We believe our iStent portfolio is the industry’s most comprehensive offering of minimally-invasive, tissue-sparing glaucoma solutions, supporting our goal to provide a full range of options to fit | ||
| surgeons’ individual glaucoma treatment algorithms that offer the best short- and long-term benefit-to-risk calculus at every stage of disease progression, from ocular hypertension through refractory disease, and in both combo-cataract and standalone procedures. We are proud to be the corporate pioneer and global market leader in MIGS, with our family of iStent technologies supported by approximately 300 peer-reviewed publications, 20+ years of clinical and commercial experience, and 1+ million iStent devices implanted worldwide since our inception. |
iDose Sustained-Release Procedural Pharmaceuticals
Our iDose sustained-release procedural pharmaceutical platform consists of a targeted, minimally-invasive, injectable implant designed to deliver therapeutic levels of medication from within the eye for extended periods of time. Designed to address ubiquitous patient non-adherence and chronic side effects associated with topical medications by providing 24/7, long-duration, robust efficacy with minimal side effects. Given our development success to date with iDose TR, we continue to invest resources to expand our pharmaceutical development capabilities and develop future iDose solutions.
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FEBRUARY 21, 2024
iLink Bio-Activated Pharmaceuticals
Our iLink bio-activated pharmaceutical platform consists of novel single-use drug formulations that are bio-activated by our proprietary systems through the delivery of ultraviolet light to the cornea to induce a biochemical reaction called corneal cross-linking designed to strengthen, stabilize, and reshape the cornea. Even though keratoconus is a serious sight-threatening disease and the leading cause of full thickness corneal transplants in the U.S., we believe it remains vastly undertreated. This undertreatment is due primarily to under-diagnosis and the historical lack of an effective solution. In order to maximize the availability of this important Photrexa therapy for patients, we have made substantial investments and executed upon a number of strategies designed to expand our commercial organization, lower the barriers for adoption by practices, increase awareness of keratoconus across the optometric and ophthalmic community, streamline the referral patterns, and train corneal health professionals on our iLink procedure.
iLution Transdermal Pharmaceuticals
Our iLution transdermal pharmaceutical platform, which consists of patented cream-based drug formulations, are applied to the outer surface of the eyelid for dropless transdermal delivery of pharmaceutically active compounds for the treatment of eye disorders. We believe iLution’s differentiated delivery approach on the eyelid may offer significant advantages over traditional topical delivery, including the potential for easier administration, faster onset of action, and fewer side effects, such as reduced preservative induced corneal and conjunctival sequalae, all of which can help contribute to better compliance and improved patient outcomes.
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FEBRUARY 21, 2024
Retina XR Bio-Erodible Sustained-Release Pharmaceuticals
Our bio-erodible sustained release pharmaceutical platform, known as Retina XR, is designed to treat retinal diseases, the largest market in ophthalmology today. The goal of these investigational programs is to provide retinal specialists and their patients with novel sustained pharmaceutical treatment options that offer a meaningfully longer duration-of-effect than the current standard of care dominated by short-lasting biological injections that often impose tremendous treatment burdens on patients because of the high-frequency of required treatments.
Our Other Novel Complimentary Ophthalmic Technologies
Radius XR™: The Radius XR platform is a novel portable vision diagnostic and patient engagement system designed to enable more efficient detection of eye disease and better management and treatment of sight-threatening conditions. It combines medical-grade diagnostics, business management tools and patient education resources within a wearable spatial computing device. This comprehensive hardware and software system provides the tools for medical professionals to diagnose patients accurately, enhance patient engagement and reduce staff workload. It enables patients to perform self-guided vision tests with minimal supervision, aiding in eye care practices' flow, efficiency and patient experience. In July 2023, Glaukos entered into a collaboration and marketing agreement with Radius XR, Inc., whereby Glaukos became the exclusive sales agent to market, promote and solicit orders for the Radius XR system within the United States.
Developed by Glaukos in partnership with ophthalmic surgeons, iAccess is a precision blade designed to cut trabecular meshwork tissue, thereby allowing aqueous to flow directly into Schlemm’s canal. Goniotomy with iAccess is designed to provide the surgeon versatility in surgical technique, allowing the surgeon to determine what is best suited for the patient, whether it be multiple small incisions spanning over several clock hours that preserve up to 95% more anatomy, or an extensive opening to Schlemm’s canal.
iPRIME is a novel, truly minimally-invasive viscoelastic delivery system that further supports the needs of physicians and patients by providing the delivery of viscoelastic during ophthalmic surgery. This technology further expands Glaukos’ broad portfolio of innovative ophthalmic solutions and is consistent with our longstanding position on the value of minimally-invasive therapies. We believe iPRIME will be another important tool that supports the needs of physicians and patients.
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FEBRUARY 21, 2024
Additional Information
16
FEBRUARY 21, 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, uncertainties regarding the impact of the COVID-19 pandemic or other public health crises on our business; the impact of general macroeconomic conditions including foreign currency fluctuations; the reduced physician fee and ASC facility fee reimbursement rate finalized by CMS for 2022 and 2023 for procedures utilizing the Company’s iStent family of products and its impact on our U.S. combo-cataract glaucoma revenue; 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; our ability to properly train, and gain acceptance and trust from ophthalmic surgeons in the use of our products; our ability to compete effectively in the medical device industry and against current and future technologies (including MIGS technologies); our compliance with federal, state and foreign laws and regulations for the approval and sale and marketing of our products and of our manufacturing 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, 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 September 30, 2023, which was filed with the SEC on November 1, 2023, and our Annual Report on Form 10-K for the year ended December 31, 2023, which is expected to be filed with the SEC by February 29, 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
17
FEBRUARY 21, 2024
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. 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). The Company uses the term "Non-GAAP" to exclude 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; 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.
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FEBRUARY 21, 2024
GAAP Income Statement
GLAUKOS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share amounts)
| | **** | Three Months Ended | Year Ended | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | | December 31, | | December 31, | | ||||||||
| | | 2023 | **** | 2022 | | 2023 | **** | 2022 | | ||||
| Net sales | | $ | 82,365 | | $ | 71,227 | | $ | 314,711 | | $ | 282,862 | |
| Cost of sales | | | 18,891 | | | 17,222 | | | 75,575 | | | 68,979 | |
| Gross profit | | | 63,474 | | | 54,005 | | | 239,136 | | | 213,883 | |
| Operating expenses: | | | | | | | | | | | | | |
| Selling, general and administrative | | | 63,034 | | | 51,927 | | | 224,068 | | | 192,925 | |
| Research and development | | | 37,062 | | | 35,812 | | | 138,768 | | | 123,271 | |
| Acquired in-process research and development | | | 2,000 | | | — | | | 5,000 | | | 10,000 | |
| Litigation-related settlement | | | — | | | — | | | — | | | (30,000) | |
| Total operating expenses | | | 102,096 | | | 87,739 | | | 367,836 | | | 296,196 | |
| Loss from operations | | | (38,622) | | | (33,734) | | | (128,700) | | | (82,313) | |
| Non-operating income (expense): | | | | | | | | | | | | | |
| Interest income | | | 2,912 | | | 960 | | | 9,164 | | | 2,375 | |
| Interest expense | | | (3,428) | | | (3,409) | | | (13,633) | | | (13,720) | |
| Other income (expense), net | | | 2,420 | | | 5,021 | | | (558) | | | (4,771) | |
| Total non-operating income (expense) | | | 1,904 | | | 2,572 | | | (5,027) | | | (16,116) | |
| Loss before taxes | | | (36,718) | | | (31,162) | | | (133,727) | | | (98,429) | |
| Income tax provision | | | 61 | | | 298 | | | 934 | | | 766 | |
| Net loss | | $ | (36,779) | | $ | (31,460) | | $ | (134,661) | | $ | (99,195) | |
| | | | | | | | | | | | | | |
| Basic and diluted net loss per share | | $ | (0.75) | | $ | (0.66) | | $ | (2.78) | | $ | (2.09) | |
| | | | | | | | | | | | | | |
| Weighted average shares used to compute basic and diluted net loss per share | | | 48,876 | | | 47,738 | | | 48,433 | | | 47,444 | |
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FEBRUARY 21, 2024
GAAP Balance Sheet
GLAUKOS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except par values)
| | **** | December 31, | **** | December 31, | **** | ||
|---|---|---|---|---|---|---|---|
| | | 2023 | | 2022 | | ||
| | | (unaudited) | | | | ||
| Assets | | | | | | | |
| Current assets: | | | | | | | |
| Cash and cash equivalents | | $ | 93,467 | | $ | 119,525 | |
| Short-term investments | | | 201,964 | | | 233,170 | |
| Accounts receivable, net | | | 39,850 | | | 36,073 | |
| Inventory | | | 41,986 | | | 37,841 | |
| Prepaid expenses and other current assets | | | 18,194 | | | 17,250 | |
| Total current assets | | | 395,461 | | | 443,859 | |
| Restricted cash | | | 5,856 | | | 7,078 | |
| Property and equipment, net | | | 103,212 | | | 94,403 | |
| Operating lease right-of-use asset | | | 27,146 | | | 25,826 | |
| Finance lease right-of-use asset | | | 44,180 | | | 46,601 | |
| Intangible assets, net | | | 282,956 | | | 307,869 | |
| Goodwill | | | 66,134 | | | 66,134 | |
| Deposits and other assets | | | 15,469 | | | 10,613 | |
| Total assets | | $ | 940,414 | | $ | 1,002,383 | |
| | | | | | | | |
| Liabilities and stockholders’ equity | | | | | | | |
| Current liabilities: | | | | | | | |
| Accounts payable | | $ | 13,440 | | $ | 14,403 | |
| Accrued liabilities | | | 60,574 | | | 57,956 | |
| Total current liabilities | | | 74,014 | | | 72,359 | |
| Convertible senior notes | | | 282,773 | | | 281,400 | |
| Operating lease liability | | | 30,427 | | | 28,905 | |
| Finance lease liability | | | 70,538 | | | 72,172 | |
| Deferred tax liability, net | | | 7,144 | | | 7,264 | |
| Other liabilities | | | 13,752 | | | 10,278 | |
| Total liabilities | | | 478,648 | | | 472,378 | |
| | | | | | | | |
| Stockholders’ equity: | | | | | | | |
| Preferred stock, $0.001 par value; 5,000 shares authorized; no shares issued or outstanding as of December 31, 2023 and 2022 | | | — | | | — | |
| Common stock, $0.001 par value; 150,000 shares authorized; 49,148 and 47,782 shares issued and 49,120 and 47,754 shares outstanding at December 31, 2023 and 2022, respectively | | | 49 | | | 48 | |
| Additional paid-in capital | | | 1,059,751 | | | 997,470 | |
| Accumulated other comprehensive income (loss) | | | 1,165 | | | (2,975) | |
| Accumulated deficit | | | (599,067) | | | (464,406) | |
| Less treasury stock (28 shares as of December 31, 2023 and 2022) | | | (132) | | | (132) | |
| Total stockholders’ equity | | | 461,766 | | | 530,005 | |
| Total liabilities and stockholders' equity | | $ | 940,414 | | $ | 1,002,383 | |
20
FEBRUARY 21, 2024
Primary GAAP to Non-GAAP Reconciliations
GLAUKOS CORPORATION
GAAP to Non-GAAP Reconciliations
(in thousands, except per share amounts and percentage data)
(unaudited)
| | **** | Q4 2023 | Q4 2022 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | | GAAP | Adjustments | Non-GAAP | | GAAP | Adjustments | Non-GAAP | | ||||||||||
| Cost of sales | | $ | 18,891 | | $ | (5,523) | (a) | $ | 13,368 | | $ | 17,222 | | $ | (5,533) | (a) | $ | 11,689 | |
| Gross Margin | | | 77.1 | % | | 6.7 | % | | 83.8 | % | | 75.8 | % | | 7.8 | % | | 83.6 | % |
| | | | | | | | | | | | | | | | | | | | |
| Operating expenses: | | | | | | | | | | | | | | | | | | | |
| Selling, general and administrative | | $ | 63,034 | | $ | (705) | (b) | $ | 62,329 | | $ | 51,927 | | $ | (782) | (b) | $ | 51,145 | |
| Loss from operations | | $ | (38,622) | | $ | 6,228 | | $ | (32,394) | | $ | (33,734) | | $ | 6,315 | | $ | (27,419) | |
| Net loss | | $ | (36,779) | | $ | 6,228 | (c) | $ | (30,551) | | $ | (31,460) | | $ | 6,315 | (c) | $ | (25,145) | |
| Basic and diluted net loss per share | | $ | (0.75) | | $ | 0.12 | | $ | (0.63) | | $ | (0.66) | | $ | 0.13 | | $ | (0.53) | |
| (a) | Cost of sales adjustments related to the acquisition of Avedro, Inc. (Avedro), including amortization of developed technology intangible assets of $5.5 million in Q4 2023 and amortization of developed technology intangible assets and stock-based compensation expense related to replacement awards, totaling $5.5 million in Q4 2022. |
|---|---|
| (b) | Avedro acquisition-related expenses, including amortization expense of customer relationship intangible assets of $0.7 million in Q4 2023 and customer relationship intangible assets and stock-based compensation expense related to replacement awards of $0.8 million in Q4 2022. |
| --- | --- |
| (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 2023 and 2022. |
| --- | --- |
21
FEBRUARY 21, 2024
Primary GAAP to Non-GAAP Reconciliations
GLAUKOS CORPORATION
GAAP to Non-GAAP Reconciliations
(in thousands, except per share amounts and percentage data)
(unaudited)
| | **** | Full Year 2023 | Full Year 2022 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | | GAAP | Adjustments | Non-GAAP | | GAAP | Adjustments | Non-GAAP | | ||||||||||
| Cost of sales | | $ | 75,575 | | $ | (22,092) | (a) | $ | 53,483 | | $ | 68,979 | | $ | (22,166) | (a) | $ | 46,813 | |
| Gross Margin | | | 76.0 | % | | 7.0 | % | | 83.0 | % | | 75.6 | % | | 7.8 | % | | 83.5 | % |
| | | | | | | | | | | | | | | | | | | | |
| Operating expenses: | | | | | | | | | | | | | | | | | | | |
| Selling, general and administrative | | $ | 224,068 | | $ | (2,820) | (b) | $ | 221,248 | | $ | 192,925 | | $ | (3,315) | (b) | $ | 189,610 | |
| Research and development | | $ | 138,768 | | $ | — | | $ | 138,768 | | $ | 123,271 | | $ | (127) | (c) | $ | 123,144 | |
| Litigation-related settlement | | $ | — | | $ | — | | $ | — | | $ | (30,000) | | $ | 30,000 | (d) | $ | — | |
| Loss from operations | | $ | (128,700) | | $ | 24,912 | | $ | (103,788) | | $ | (82,313) | | $ | (4,392) | | $ | (86,705) | |
| Net loss | | $ | (134,661) | | $ | 24,912 | (e) | $ | (109,749) | | $ | (99,195) | | $ | (4,392) | (e) | $ | (103,587) | |
| Basic and diluted net loss per share | | $ | (2.78) | | $ | 0.51 | | $ | (2.27) | | $ | (2.09) | | $ | (0.09) | | $ | (2.18) | |
| (a) | Cost of sales adjustments related to the acquisition of Avedro, Inc. (Avedro), including amortization of developed technology intangible assets of $22.1 million in 2023 and amortization of developed technology intangible assets and stock-based compensation expense related to replacement awards, totaling $22.2 million in 2022. |
|---|---|
| (b) | Avedro acquisition-related expenses, including amortization expense of customer relationship intangible assets of $2.8 million in 2023 and customer relationship intangible assets and stock-based compensation expense related to replacement awards of $3.3 million in 2022. |
| --- | --- |
| (c) | Stock-based compensation expense related to replacement awards from the acquisition of Avedro. |
| --- | --- |
| (d) | Settlement proceeds received related to the Company’s patent infringement litigation. |
| --- | --- |
| (e) | 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 2023 and 2022. |
| --- | --- |
22
FEBRUARY 21, 2024
Additional GAAP to Non-GAAP Reconciliations
| Reported Sales vs. Prior Periods (in thousands) | | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | | | | | | | | | | | Year-over-Year Percent Change | | Quarter-over-Quarter Percent Change | | ||||||||
| | **** | 4Q 2023 | **** | 4Q 2022 | **** | 3Q 2023 | **** | Reported | **** | Operations (1) | **** | Currency (2) | **** | Reported | **** | Operations (1) | **** | Currency (2) | **** | |||
| | | | | | | | | | | | | | | | | | | | | | | |
| International Glaucoma | | $ | 21,857 | | $ | 17,530 | | $ | 20,280 | | 24.7 | % | 22.5 | % | 2.2 | % | 7.8 | % | 9.3 | % | (1.5) | % |
| | | | | | | | | | | | | | | | | | | | | | | |
| Total Net Sales | | $ | 82,365 | | $ | 71,227 | | $ | 78,048 | | 15.6 | % | 15.1 | % | 0.5 | % | 5.5 | % | 5.9 | % | (0.4) | % |
| (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 | ||||||||||||
| --- | --- | ||||||||||||
| Reported Sales vs. Prior Periods (in thousands) | | ||||||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | | | Year-over-Year Percent Change | | ||||
| **** | 2023 | **** | 2022 | **** | Reported | **** | Operations (1) | **** | Currency (2) | **** | |||
| | | | | | | | | ||||||
| International Glaucoma | | $ | 85,560 | | $ | 69,577 | | 23.0 | % | 24.4 | % | (1.4) | % |
| | | | | | | | | | | | | | |
| Total Net Sales | | $ | 314,711 | | $ | 282,862 | | 11.3 | % | 11.6 | % | (0.3) | % |
| (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.
23