Staar Surgical Co 10-Q for FY2025 Q1
Staar Surgical Co (STAA)
About this 10-Q
Staar Surgical Co filed this 10-Q on May 7, 2025, covering the quarter ended March 28, 2025 (FY2025 Q1).
Headline figures
Quarter ended March 28, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $42.59M
- down 44.9% from $77.36M a year earlier
- Net loss
- $54.21M
- compared with a net loss of $3.34M a year earlier
- Diluted EPS
- -$1.10
- compared with -$0.07 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
(Mark One)
For the quarterly period ended:
Or
Commission file number:
(Exact Name of Registrant as Specified in its Charter)
(State or Other Jurisdiction of Incorporation or Organization) |
(I.R.S. Employer Identification No.) |
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(Address of Principal Executive Offices) |
(Zip Code) |
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(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
The registrant has
STAAR SURGICAL COMPANY
INDEX
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PAGE NUMBER |
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ITEM 1 |
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ITEM 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
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ITEM 3. |
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ITEM 4. |
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ITEM 1. |
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ITEM 1A. |
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ITEM 4. |
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ITEM 5. |
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ITEM 6. |
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PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value amounts)
(Unaudited)
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March 28, 2025 |
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December 27, 2024 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Investments available for sale (amortized cost basis of $ |
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Accounts receivable trade, net of allowance for credit losses of |
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Inventories, net |
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Prepayments, deposits and other current assets |
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Total current assets |
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Property, plant and equipment, net |
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Finance lease right-of-use assets, net |
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Operating lease right-of-use assets, net |
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Goodwill |
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Deferred income taxes |
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Other assets |
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Total assets |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Obligations under finance leases |
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Obligations under operating leases |
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Allowance for sales returns |
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Other current liabilities |
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Total current liabilities |
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Obligations under operating leases |
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Deferred income taxes |
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Asset retirement obligations |
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Pension liability |
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Total liabilities |
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Stockholders’ equity: |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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Accumulated deficit |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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See accompanying notes to the condensed consolidated financial statements.
1
STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
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Three Months Ended |
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March 28, 2025 |
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March 29, 2024 |
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Net sales |
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$ |
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$ |
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Cost of sales |
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Gross profit |
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Selling, general and administrative expenses: |
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General and administrative |
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Selling and marketing |
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Research and development |
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Restructuring, impairment and related charges |
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— |
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Total selling, general and administrative expenses |
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Operating loss |
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Other income (expense), net: |
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Interest income, net |
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Gain (loss) on foreign currency transactions |
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Royalty income |
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— |
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Other income, net |
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Total other income, net |
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Loss before income taxes |
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Provision (benefit) for income taxes |
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Net loss |
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$ |
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$ |
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Net loss per share: |
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Basic |
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$ |
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$ |
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Diluted |
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$ |
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$ |
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Weighted average shares outstanding: |
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Basic |
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Diluted |
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See accompanying notes to the condensed consolidated financial statements.
2
STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In thousands)
(Unaudited)
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Three Months Ended |
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March 28, 2025 |
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March 29, 2024 |
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Net loss |
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$ |
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$ |
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Other comprehensive income (loss): |
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Defined benefit plans: |
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Net change in plan assets |
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Reclassification into other income (expense), net |
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Investments available for sale: |
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Change in unrealized loss |
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Reclassification into other income, net |
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— |
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Foreign currency translation gain (loss) |
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( |
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Tax effect |
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Other comprehensive income (loss), net of tax |
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( |
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Comprehensive loss |
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$ |
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$ |
( |
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See accompanying notes to the condensed consolidated financial statements.
3
STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In thousands)
(Unaudited)
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Three Months Ended |
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Common |
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Common |
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Additional |
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Accumulated |
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Accumulated |
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Total |
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Balance, at December 27, 2024 |
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$ |
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$ |
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$ |
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$ |
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$ |
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Net loss |
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— |
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— |
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— |
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— |
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( |
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( |
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Other comprehensive income |
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— |
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— |
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— |
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— |
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Common stock issued upon exercise of options |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Repurchase of employee common stock for taxes withheld |
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( |
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— |
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( |
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— |
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— |
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( |
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Vested restricted and performance stock units |
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— |
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— |
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— |
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Balance, at March 28, 2025 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Balance at December 29, 2023 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Net loss |
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— |
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— |
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— |
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— |
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( |
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( |
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Other comprehensive loss |
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— |
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— |
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— |
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( |
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— |
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( |
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Common stock issued upon exercise of options |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Repurchase of employee common stock for taxes withheld |
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( |
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— |
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( |
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— |
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— |
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( |
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Forfeited restricted stock |
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( |
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— |
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— |
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— |
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— |
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— |
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Vested restricted and performance stock units |
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— |
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— |
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— |
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Balance at March 29, 2024 |
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$ |
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$ |
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$ |
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$ |
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$ |
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See accompanying notes to the condensed consolidated financial statements.
4
STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
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Three Months Ended |
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March 28, 2025 |
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March 29, 2024 |
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Cash flows from operating activities: |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash provided by (used in) operating activities: |
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Depreciation of property, plant, and equipment |
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Impairment of fixed assets and operating lease right-of-use assets |
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— |
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Accretion/Amortization of investments available for sale |
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( |
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( |
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Deferred income taxes |
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Change in net pension liability |
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Stock-based compensation expense |
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Provision for sales returns and credit losses |
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Inventory provision |
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Changes in working capital: |
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Accounts receivable |
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Inventories |
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( |
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( |
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Prepayments, deposits, and other assets |
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( |
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( |
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Accounts payable |
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Other current liabilities |
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Net cash provided by (used in) operating activities |
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Cash flows from investing activities: |
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Acquisition of property and equipment |
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Purchase of investments available for sale |
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— |
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Proceeds from maturity of investments available for sale |
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Proceeds from sale of investments available for sale |
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Net cash provided by investing activities |
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Cash flows from financing activities: |
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Repayment of finance lease obligations |
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Repurchase of employee common stock for taxes withheld |
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( |
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Proceeds from the exercise of stock options |
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Proceeds from vested restricted and performance stock units |
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Net cash provided by (used in) financing activities |
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( |
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Effect of exchange rate changes on cash and cash equivalents |
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Increase in cash and cash equivalents |
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Cash and cash equivalents, at beginning of the year |
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Cash and cash equivalents, at end of the period |
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$ |
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$ |
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See accompanying notes to the condensed consolidated financial statements.
5
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 1 — Basis of Presentation and Significant Accounting Policies
STAAR Surgical Company, a Delaware corporation, was first incorporated in 1982, and together with its subsidiaries designs, develops, manufactures, and sells implantable lenses for the eye and accessory delivery systems used to deliver the lenses into the eye.
The Condensed Consolidated Financial Statements for the three months ended March 28, 2025 and March 29, 2024, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the Company’s financial condition and results of operations. The results of operations for the three months ended March 28, 2025 and March 29, 2024, are not necessarily indicative of the results to be expected for any other interim period or for the entire year.
Each of the Company’s fiscal reporting periods ends on the Friday nearest to the quarter ending date and generally consists of 13 weeks. Unless the context indicates otherwise “we,” “us,” the “Company,” and “STAAR” refer to STAAR Surgical Company and its consolidated subsidiaries.
Cloud-Based Software
As of March 28, 2025 and December 27, 2024, the Company capitalized $
Vendor Concentration
There was one vendor that accounted for over
Restructuring, Impairment and Related Charges
6
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 1 — Basis of Presentation and Significant Accounting Policies (Continued)
Segment Reporting
The Company’s chief operating decision maker (“CODM”) has been identified as the . The Company’s CODM manages and allocates resources to the operations of the Company on a consolidated basis.
The measure of segment assets is reported on the balance sheet as total consolidated assets and the expenditures for additions to long-lived assets, and depreciation and amortization expense is consistent with those presented on the Condensed Statement of Cash Flows.
See “Note 13 – Disaggregation of Revenues, Geographic Sales and Product Sales” and “Note 14 – Geographic Assets” for specific information regarding the Company’s sales and long-lived assets.
Recent Accounting Pronouncements Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740).” ASU 2023-09 improves the transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. It also includes certain other amendments to improve the effectiveness of income tax disclosures regarding (a) income or loss from continuing operations disaggregated between domestic and foreign and (b) income tax expense or benefit from continuing operations disaggregated by federal, state and foreign. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the disclosure requirements and its effect on the Condensed Consolidated Financial Statements.
In November 2024, the FASB issued ASU 2024-03, “Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40).” ASU 2024-03 does not change the expense captions an entity presents on the face of the income statement; rather it requires disaggregation of certain expense captions into specified categories in disclosures within the footnotes to the financial statements. ASU 2024-03 requires footnote disclosure about specific expenses to disaggregate, in a tabular presentation, each relevant expense caption on the face of the income statement that includes any of the following natural expenses: (1) purchases of inventory, (2) employee compensation, (3) depreciation, (4) intangible asset amortization, and (5) depreciation, depletion and amortization recognized as part of oil- and gas-production activities or other types of depletion expenses. The tabular disclosure would also include certain other expenses, when applicable. ASU 2024-03 does not change or remove existing expense disclosure requirements; however, it may affect where that information appears in the footnotes to the financial statements. ASU 2024-03 is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. The requirements will be applied prospectively with the option for retrospective application. Early adoption is permitted. The Company will adopt the annual disclosure requirements of ASU 2024-03 at the beginning of fiscal year 2026 and will adopt the interim disclosure requirement beginning fiscal year 2027. The Company is currently evaluating the disclosure requirements and its effect on the Condensed Consolidated Financial Statements.
7
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 2 — Investments Available for Sale
Investments available for sale (“AFS”) and the related fair value measurement consisted of the following (dollars in thousands):
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March 28, 2025 |
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Fair Value Measurements |
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Amortized Cost |
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Unrealized Gains |
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Unrealized Losses |
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Estimated Fair Value |
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Level 1 |
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Level 2 |
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Commercial paper |
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$ |
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$ |
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$ |
— |
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$ |
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$ |
— |
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$ |
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Certificates of deposit |
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— |
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— |
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U.S. Treasury securities |
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( |
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— |
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Corporate debt securities |
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|
|
( |
) |
|
|
|
|
|
— |
|
|
|
|
||||
Total investments AFS |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
|
December 27, 2024 |
|
|||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements |
|
|||||||||
|
|
Amortized Cost |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Estimated Fair Value |
|
|
Level 1 |
|
|
Level 2 |
|
||||||
Commercial paper |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
— |
|
|
$ |
|
||||
Certificates of deposit |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
U.S. Treasury securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
— |
|
||||
Corporate debt securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
|
||||
Total investments AFS |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
The Company obtains the fair value from third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market-based approaches and observable market inputs to determine value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers and other industry and economic events.
The Company assessed each debt security in a gross unrealized loss position to determine whether the decline in fair value below amortized cost was a result of credit losses or other factors, whether the Company expects to recover the amortized cost of the debt security, the Company’s intent to sell and whether it is more-likely-than-not that the Company will not be required to sell the debt security before the recovery of the amortized cost basis. There has been no allowance for expected credit losses recorded for the three months ended March 28, 2025 and March 29, 2024.
The following table shows the fair value of investments AFS by contractual maturity (dollars in thousands):
|
|
As of March 28, 2025 |
|
||||||||||
|
|
Within one year |
|
|
After one year through five years |
|
|
|
Total |
|
|||
Commercial paper |
|
$ |
|
|
$ |
— |
|
|
|
$ |
|
||
Certificates of deposit |
|
|
|
|
|
— |
|
|
|
|
|
||
U.S. Treasury securities |
|
|
|
|
|
— |
|
|
|
|
|
||
Corporate debt securities |
|
|
|
|
|
— |
|
|
|
|
|
||
Total investments AFS |
|
$ |
|
|
$ |
— |
|
|
|
$ |
|
||
8
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 2 — Investments Available for Sale (Continued)
During the three months ended March 28, 2025, one of the Company’s investments AFS with an aggregate fair value of $
Note 3 — Inventories
Inventories, net are stated at the lower of cost and net realizable value, determined on a first-in, first-out basis and consisted of the following (in thousands):
|
|
March 28, 2025 |
|
|
December 27, 2024 |
|
||
Raw materials and purchased parts |
|
$ |
|
|
$ |
|
||
Work in process |
|
|
|
|
|
|
||
Finished goods |
|
|
|
|
|
|
||
Total inventories, gross |
|
|
|
|
|
|
||
Less inventory reserves |
|
|
( |
) |
|
|
( |
) |
Total inventories, net |
|
$ |
|
|
$ |
|
||
Note 4 — Prepayments, Deposits, and Other Current Assets
Prepayments, deposits, and other current assets consisted of the following (in thousands):
|
|
March 28, 2025 |
|
|
December 27, 2024 |
|
||
Prepayments and deposits |
|
$ |
|
|
$ |
|
||
Prepaid rent |
|
|
|
|
|
|
||
Prepaid insurance |
|
|
|
|
|
|
||
Value added tax (VAT) receivable |
|
|
|
|
|
|
||
BVG (Swiss Pension) prepayment |
|
|
|
|
|
|
||
Other(1) |
|
|
|
|
|
|
||
Total prepayments, deposits and other current assets |
|
$ |
|
|
$ |
|
||
Note 5 — Property, Plant and Equipment
Property, plant and equipment, net consisted of the following (in thousands):
|
|
March 28, 2025 |
|
|
December 27, 2024 |
|
||
Machinery and equipment |
|
$ |
|
|
$ |
|
||
Computer equipment and software |
|
|
|
|
|
|
||
Furniture and fixtures |
|
|
|
|
|
|
||
Leasehold improvements |
|
|
|
|
|
|
||
Construction in process |
|
|
|
|
|
|
||
Total property, plant and equipment, gross |
|
|
|
|
|
|
||
Less accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Total property, plant and equipment, net |
|
$ |
|
|
$ |
|
||
9
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 5 — Property, Plant and Equipment (Continued)
As discussed in Note 1, during the three months ended March 28, 2025, the Company recognized fixed asset impairment expense of $
Construction in process primarily consists of the build out of and validation of machinery and equipment.
The Company recorded depreciation expense in the following categories as follows (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
||
Cost of sales |
|
$ |
|
|
$ |
|
||
General and administrative |
|
|
|
|
|
|
||
Selling and marketing |
|
|
|
|
|
|
||
Research and development |
|
|
|
|
|
|
||
Total depreciation expense |
|
$ |
|
|
$ |
|
||
Note 6 – Other Current Liabilities
Other current liabilities consisted of the following (in thousands):
|
|
March 28, 2025 |
|
|
December 27, 2024 |
|
||
Accrued salaries and wages |
|
$ |
|
|
$ |
|
||
Accrued bonuses |
|
|
|
|
|
|
||
Severance payable(1) |
|
|
|
|
|
|
||
Accrued insurance |
|
|
|
|
|
|
||
Income taxes payable |
|
|
|
|
|
|
||
Marketing obligations |
|
|
|
|
|
|
||
Other(2) |
|
|
|
|
|
|
||
Total other current liabilities |
|
$ |
|
|
$ |
|
||
10
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 7 – Leases
Operating Leases
The Company entered into operating leases primarily related to real property (office, manufacturing and warehouse facilities), automobiles and copiers. These operating leases are two to ten years in length with options to extend. The Company does not include any lease extensions in the initial valuation unless the Company was reasonably certain to extend the lease. Depending on the lease, there are those with fixed payment amounts for the entire length of the contract or payments which increase periodically as noted in the contract or increased at an inflation rate indicator. For operating leases that increase using an inflation rate indicator, the Company used the inflation rate at the time the lease was entered into for the length of the lease term.
|
|
March 28, 2025 |
|
|
December 27, 2024 |
|
||
Machinery and equipment |
|
$ |
|
|
$ |
|
||
Computer equipment and software |
|
|
|
|
|
|
||
Real property |
|
|
|
|
|
|
||
Operating lease right-of-use assets, gross |
|
|
|
|
|
|
||
Less accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Operating lease right-of-use assets, net |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Current operating lease obligations |
|
$ |
|
|
$ |
|
||
Long-term operating lease obligations |
|
|
|
|
|
|
||
Total operating lease liability |
|
$ |
|
|
$ |
|
||
Weighted-average remaining lease term (in years) |
|
|
|
|
|
|
||
Weighted-average discount rate |
|
|
% |
|
|
% |
||
As discussed in Note 1, during the three months ended March 28, 2025, the Company recognized impairment on real property right-of-use assets of $
Supplemental cash flow information related to operating leases was as follows (dollars in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
||
Operating lease cost |
|
$ |
|
|
$ |
|
||
Cash paid for amounts included in the measurement of operating lease liabilities: |
|
|
|
|
|
|
||
Operating cash flows |
|
|
|
|
|
|
||
Right-of-use assets obtained in exchange for new operating lease liabilities |
|
|
|
|
|
|
||
Future Maturities of Lease Liabilities
Estimated future maturities of lease liabilities under operating leases having initial or remaining non-cancelable lease terms more than one year as of March 28, 2025 is as follows (in thousands):
.
As of March 28, 2025 |
|
Operating Leases |
|
|
March 2026 |
|
$ |
|
|
March 2027 |
|
|
|
|
March 2028 |
|
|
|
|
March 2029 |
|
|
|
|
March 2030 |
|
|
|
|
Thereafter |
|
|
|
|
Total future minimum lease payments |
|
$ |
|
|
Less amounts representing interest |
|
|
( |
) |
Total lease liability |
|
$ |
|
|
11
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 8 — Income Taxes
The Company recorded an income tax provision (benefit) as follows (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
||
Provision (benefit) for income taxes |
|
$ |
( |
) |
|
$ |
|
|
The effective tax rates for the three months ended March 28, 2025 and March 29, 2024 were
Note 9 – Defined Benefit Pension Plans
The Company has defined benefit plans covering employees of its Switzerland and Japan operations. The following table summarizes the components of net periodic pension cost recorded for the Company’s defined benefit pension plans (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
||
Service cost(1) |
|
$ |
|
|
$ |
|
||
Interest cost(2) |
|
|
|
|
|
|
||
Expected return on plan assets(2) |
|
|
( |
) |
|
|
( |
) |
Prior service credit(2),(3) |
|
|
( |
) |
|
|
( |
) |
Settlement gain(2),(3) |
|
|
( |
) |
|
|
— |
|
Actuarial loss recognized in current period(2),(3) |
|
|
|
|
|
|
||
Net periodic pension cost |
|
$ |
|
|
$ |
|
||
The Company currently is not required to and does not make contributions to its Japan pension plan. The Company’s contributions to its Swiss pension plan are as follows (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
||
Employer contribution |
|
$ |
|
|
$ |
|
||
Note 10 — Stockholders’ Equity
Incentive Plan
The Company maintains an Amended and Restated Omnibus Equity Incentive Plan, as amended (the “Equity Plan”). The Equity Plan allows for awards of stock options, stock appreciation rights, restricted stock, restricted stock units (“RSUs”) and performance stock units (“PSUs”) and other stock- and cash-based awards, including awards that are subject to service-based and performance-based vesting conditions. As of March 28, 2025, the Company had outstanding grants of stock options, restricted stock awards, RSUs and PSUs.
Stock options granted under the Equity Plan are granted at fair market value on the date of grant, become exercisable generally over a
12
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 10 — Stockholders’ Equity (Continued)
Stock-Based Compensation
The cost that has been charged against income for stock-based compensation is set forth below (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
||
Employee stock options |
|
$ |
|
|
$ |
|
||
Restricted stock |
|
|
|
|
|
|
||
RSUs |
|
|
|
|
|
|
||
PSUs |
|
|
|
|
|
|
||
Nonemployee stock options |
|
|
|
|
|
|
||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
||
The Company recorded stock-based compensation costs in the following categories (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
||
Cost of sales |
|
$ |
|
|
$ |
|
||
General and administrative |
|
|
|
|
|
|
||
Selling and marketing |
|
|
|
|
|
|
||
Research and development |
|
|
|
|
|
|
||
Total stock-based compensation expense, net |
|
|
|
|
|
|
||
Amounts capitalized as part of inventory |
|
|
|
|
|
|
||
Total stock-based compensation expense, gross |
|
$ |
|
|
$ |
|
||
As of March 28, 2025, total unrecognized compensation cost related to non-vested stock-based compensation arrangements were as follows (in thousands):
|
|
March 28, 2025 |
|
|
Stock options |
|
$ |
|
|
Restricted stock, RSUs and PSUs |
|
|
|
|
Total unrecognized stock-based compensation cost |
|
$ |
|
|
The cost is expected to be recognized over a weighted-average period of approximately
Assumptions
The fair value of each stock option award is estimated on the date of grant using a Black-Scholes option valuation model applying the weighted-average assumptions noted in the following table. Expected volatilities are based on historical volatility of the Company’s stock. The expected term of stock options granted is derived from the historical exercises and post-vesting cancellations and represents the period of time that stock options granted are expected to be outstanding. The Company has calculated a
|
|
Three Months Ended |
|
|||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
||
Expected dividend yield |
|
|
% |
|
|
% |
||
Expected volatility |
|
|
% |
|
|
% |
||
Risk-free interest rate |
|
|
% |
|
|
% |
||
Expected term (in years) |
|
|
|
|
|
|
||
13
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 10 — Stockholders’ Equity (Continued)
Stock Options
A summary of stock option activity under the Equity Plan for three months ended March 28, 2025 is presented below:
|
|
Stock |
|
|
Weighted- |
|
|
Weighted- |
|
|
Aggregate |
|
||||
Outstanding at December 27, 2024 |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Forfeited or expired |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding at March 28, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable at March 28, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Restricted Stock, Restricted Stock Units and Performance Stock Units
A summary of restricted stock, RSU and PSU activity under the Equity Plan for the three months ended March 28, 2025 is presented below (shares in thousands):
|
|
Restricted |
|
|
RSUs |
|
|
PSUs |
|
|||
Unvested at December 27, 2024 |
|
|
|
|
|
|
|
|
|
|||
Granted |
|
|
|
|
|
|
|
|
|
|||
Vested |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Forfeited or expired |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Unvested at March 28, 2025 |
|
|
|
|
|
|
|
|
|
|||
Note 11 - Commitments and Contingencies
Litigation and Claims
From time to time, the Company is involved in various legal proceedings and other matters arising in the normal course of business. These legal proceedings and other matters may relate to, among other things, contractual rights and obligations, employment matters, or claims of product liability. The Company maintains insurance coverage for various matters, including product liability and certain securities claims. While the Company does not believe that any of the claims known is likely to have a material adverse effect on the Company’s financial condition or results of operations, new claims or unexpected results of existing claims could lead to significant financial harm.
14
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 12 — Basic and Diluted Net Loss Per Share
The following table sets forth the computation of basic and diluted net loss per share (in thousands except per share amounts):
|
|
Three Months Ended |
|
|||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
||
Numerator: |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Denominator: |
|
|
|
|
|
|
||
Weighted average common shares: |
|
|
|
|
|
|
||
Common shares outstanding |
|
|
|
|
|
|
||
Denominator for basic calculation |
|
|
|
|
|
|
||
Weighted average effects of potentially diluted common stock: |
|
|
|
|
|
|
||
Stock options |
|
|
|
|
|
— |
|
|
Unvested restricted stock |
|
|
|
|
|
— |
|
|
RSUs |
|
|
|
|
|
— |
|
|
PSUs |
|
|
|
|
|
— |
|
|
Denominator for diluted calculation |
|
|
|
|
|
|
||
Net loss per share: |
|
|
|
|
|
|
||
Basic |
|
$ |
( |
) |
|
$ |
( |
) |
Diluted |
|
$ |
( |
) |
|
$ |
( |
) |
Because the Company had a net loss for the three months ended March 28, 2025 and March 29, 2024, the number of diluted shares is equal to the number of basic shares. The following table sets forth (in thousands) the weighted average number of options to purchase shares of common stock, restricted stock, RSUs and PSUs with either exercise prices or unrecognized compensation cost per share greater than the average market price per share of the Company’s common stock, which were not included in the calculation of diluted per share amounts because the effects would be anti-dilutive.
|
|
Three Months Ended |
|
|||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
||
Stock options |
|
|
|
|
|
|
||
Restricted stock, RSUs and PSUs |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
15
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 13 — Disaggregation of Sales, Geographic Sales and Product Sales
In the following tables, sales are disaggregated by category, sales by geographic market and sales by product data.
The Company maintains finished goods inventory at different sites in the United States, Switzerland and Japan, and from time to time, consigns or ships finished goods inventory to surgeons, hospitals, and distributors in advance of anticipated demand. The Company maintains title and risk of loss on consigned inventory and generally does not recognize revenue for consignment inventory until the Company is notified that the lenses have been implanted.
|
|
Three Months Ended |
|
|||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
||
Non-consignment sales |
|
$ |
|
|
$ |
|
||
Consignment sales |
|
|
|
|
|
|
||
Total net sales |
|
$ |
|
|
$ |
|
||
In April 2025, in order to mitigate potential financial exposure from tariffs imposed by China, the Company negotiated and implemented consignment agreements with its
The Company markets and sells its products in over
|
|
Three Months Ended |
|
|||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
||
Domestic |
|
$ |
|
|
$ |
|
||
Foreign: |
|
|
|
|
|
|
||
China |
|
|
|
|
|
|
||
Japan |
|
|
|
|
|
|
||
Korea |
|
|
|
|
|
|
||
Other(1) |
|
|
|
|
|
|
||
Total foreign sales |
|
|
|
|
|
|
||
Total net sales |
|
$ |
|
|
$ |
|
||
The Company’s principal products are implantable Collamer lenses (“ICLs”) used in refractive surgery. Historically the Company marketed and sold cataract intraocular lenses (“IOLs”) and related injectors and injector parts. The Company phased out sales of such products in fiscal 2023, and did not sell any such products in fiscal 2024 and it does not expect such sales in the future.
|
|
Three Months Ended |
|
|||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
||
ICLs |
|
$ |
|
|
$ |
|
||
Other surgical products(1) |
|
|
|
|
|
|
||
Total net sales |
|
$ |
|
|
$ |
|
||
(1)
The Company’s Korea distributor accounted for
16
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 14 — Geographic Assets
The Company’s long-lived assets are located in the following geographical locations in which the Company operates. Other than the U.S. and Switzerland, no other geographic location exceeds
|
|
March 28, 2025 |
|
|||||||||||||
|
|
U.S. |
|
|
Switzerland |
|
|
Other(1) |
|
|
Total |
|
||||
Property, plant and equipment, net |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Operating lease ROU assets, net |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
December 27, 2024 |
|
|||||||||||||
|
|
U.S. |
|
|
Switzerland |
|
|
Other(1) |
|
|
Total |
|
||||
Property, plant and equipment, net |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Finance lease ROU assets, net |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Operating lease ROU assets, net |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
17
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The matters addressed in this Item 2 that are not historical information constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and the Private Securities Litigation Reform Act of 1995, and is subject to the safe harbor created therein. In some cases readers can recognize forward-looking statements by the use of words like “anticipate,” “estimate,” “expect,” “project,” “intend,” “may,” “plan,” “believe,” “will,” “should,” “could,” “forecast,” “potential,” “continue,” “ongoing” (or the negative of those words and similar words or expressions), although not all forward-looking statements contain these words. Forward-looking statements include, without limitation, statements regarding the intent, belief or current expectations of the Company and its management regarding any of the following: demand for our implantable Collamer® lenses (“ICLs”); the benefits of our leadership realignment and related efforts; China macroeconomic conditions, procedure volumes, demand, and inventory levels; any projections of or guidance as to future earnings, revenue, sales, profit margins, expense rate, cash, effective tax rate, product mix, capital expense or any other financial items; the plans, strategies, and objectives of management for future operations or prospects for achieving such plans; statements regarding new, existing, or improved products, including but not limited to, expectations for success of new, existing, and improved products in the U.S. or international markets or government approval of a new or improved products; commercialization of new or improved products; future economic conditions or size of market opportunities; expected costs of operations; statements of belief, including as to achieving business plans for 2025 and beyond; expected regulatory activities and approvals, product launches, and any statements of assumptions underlying any of the foregoing.
Although we believe that the expectations reflected in these forward-looking statements are reasonable, we caution investors and prospective investors that any such forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other factors, which if they do not materialize or prove correct, could cause actual results to differ materially from those expressed or implied by such forward-looking statements. We caution you not to place undue reliance on these forward-looking statements and to note they speak only as of the date hereof. Factors that could cause actual results to differ materially from those set forth in the forward-looking statements include, without limitation, those described in our Annual Report on Form 10-K in “Item 1A. Risk Factors” filed on February 27, 2024. We disclaim any intention or obligation to update or review these financial projections or forward-looking statements due to new information or other events except as required by law.
The following discussion should be read in conjunction with the Company’s unaudited Condensed Consolidated Financial Statements, including the related notes, provided in this report.
We intend to use our website as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Such disclosures will be included on our website in the ‘Investor Relations’ sections. Accordingly, investors should monitor such portions of our website, in addition to following our press releases, SEC filings and public conference calls and webcasts.
Overview
STAAR Surgical Company designs, develops, manufactures, and sells implantable lenses for the eye and accessory delivery systems used to deliver the lenses into the eye. We are the leading manufacturer of phakic implantable lenses used worldwide in corrective or “refractive” surgery. We have been dedicated solely to ophthalmic surgery for over 40 years. Our goal is to position our refractive lenses throughout the world as primary and premium solutions for patients seeking visual freedom from wearing eyeglasses or contact lenses while achieving excellent visual acuity through refractive vision correction. We generate worldwide revenue almost exclusively from sales of our implantable Collamer® lenses, or “ICLs.” Our ICLs are made from Collamer, which is a proprietary collagen copolymer material created and exclusively used by STAAR to make our lenses soft, flexible and biocompatible with the eye. Our ICLs are phakic lenses, meaning that they are implanted into the eye without removing the eye’s natural crystalline lens. This distinguishes an ICL procedure from other refractive procedures, as it does not involve the removal of corneal eye tissue. All of our ICLs are foldable, which allows the surgeon to insert them into the eye through a small incision during minimally invasive surgery. Further, while ICLs are intended to be permanent, our ICLs are reversible lens implants, meaning they can be removed by a doctor if desired.
STAAR employs a commercialization strategy that strives for sustainable profitable growth. Our growth strategy includes making our complete ICL product line available in our existing geographic markets and expanding into attractive markets where we do not sell our products today. In addition, we are focused on driving awareness of the ICL procedure and the clinical benefits of our ICLs, and providing surgeon training, support and education, particularly in our newer markets.
18
Business Environment and Factors Affecting Comparability
For the three months ended March 28, 2025, we reported $42.6 million of net sales, a decrease of 45% compared to $77.4 million of net sales for the three months ended March 29, 2024. This significant decrease is primarily due to dynamics within our business in China. Net sales to our two distributors in China were $0.4 million for the three months ended March 28, 2025, compared to net sales of $38.5 million for the three months ended March 29, 2024. During the three months ended March 28, 2025, our distributors in China purchased fewer ICLs, as they were able to satisfy procedural demand largely from their existing inventory. Our distributors in China have historically purchased products from us in bulk shipments in advance of anticipated demand, which they use to satisfy orders from hospital customers based on scheduled surgeries. During fiscal 2024, our distributors in China purchased lenses above contracted minimums in anticipation of higher procedural volumes during what is typically a summer “high season” in China. Due to dynamic macroeconomic conditions and other factors, the number of ICL procedures performed during the high season and the second half of 2024 overall was lower than expected. Accordingly, our distributors in China held, as of December 27, 2024, elevated levels of ICL product inventory. While the level of inventory owned by our distributors in China has decreased substantially since December 27, 2024, we believe their ICL inventory is likely sufficient to meet currently expected procedure volumes for at least the first half of fiscal 2025. We therefore anticipate we will report minimal China ICL sales in the first half of fiscal 2025. As China in-country inventory is reduced during the first half of fiscal 2025, we would expect our China revenue to normalize. However, our ability to successfully address these challenges will depend on a number of factors, including the risk of a prolonged slowdown or disruption in China and the status of trade tariffs both globally and between the United States and China.
In April 2025, in response to the announcement of tariffs by the United States on Chinese goods, China announced retaliatory tariffs on U.S.-origin goods. In order to mitigate potential financial exposure from such tariffs, we negotiated and implemented consignment agreements with our two distributors in China, and we delivered consigned inventory to China in advance of the implementation of tariffs. While the tariff situation is evolving, we believe that these efforts to increase the amount of ICLs in China reduce the Company’s tariff risk in China in the near-term. In addition, we are rapidly ramping up our production capabilities in Switzerland to supplement our manufacturing capacity in the United States to provide optionality under multiple tariff scenarios.
Given that we now maintain consigned inventory in China, we believe that purchases by our distributors will largely be satisfied from our consigned inventory in-country in the near-term, rather than through bulk purchases. As a result, we expect our distributors will likely make more frequent purchases of ICLs in smaller quantities that are more closely aligned to actual procedural volumes as opposed to anticipated demand. We believe this will reduce the risk of elevated inventory buildup by our distributors, while at the same time maintaining sufficient ICL inventory in China to support quick and efficient delivery and fulfillment for surgical procedures.
Critical Accounting Estimates
This Management’s Discussion and Analysis of Financial Condition and Results of Operations discusses and analyzes data in our unaudited Condensed Consolidated Financial Statements provided in this report, which we have prepared in accordance with U.S. generally accepted accounting principles. Preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. Management bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Senior management has discussed the development, selection and disclosure of these estimates with the Audit Committee of our Board of Directors. Actual conditions may differ from our assumptions and actual results may differ from our estimates.
Management believes that there have been no significant changes during the three months ended March 28, 2025 to the items that we disclosed as our critical accounting estimates in Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the fiscal year ended December 27, 2024.
19
Results of Operations
The following table shows the percentage of our total sales represented by certain items reflected in our Condensed Consolidated Statements of Income for the periods indicated.
|
|
Percentage of Net Sales for |
|
|||||
|
|
Three Months Ended |
|
|||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
||
Net sales |
|
|
100.0 |
% |
|
|
100.0 |
% |
Cost of sales |
|
|
34.2 |
% |
|
|
21.1 |
% |
Gross profit |
|
|
65.8 |
% |
|
|
78.9 |
% |
General and administrative |
|
|
57.4 |
% |
|
|
30.0 |
% |
Selling and marketing |
|
|
57.8 |
% |
|
|
34.5 |
% |
Research and development |
|
|
32.1 |
% |
|
|
17.3 |
% |
Restructuring, impairment and related charges |
|
|
53.2 |
% |
|
|
0.0 |
% |
Total selling, general and administrative |
|
|
200.5 |
% |
|
|
81.8 |
% |
Operating loss |
|
|
(134.7 |
)% |
|
|
(2.9 |
)% |
Total other income, net |
|
|
6.8 |
% |
|
|
0.1 |
% |
Loss before income taxes |
|
|
(127.9 |
)% |
|
|
(2.8 |
)% |
Provision (benefit) for income taxes |
|
|
(0.6 |
)% |
|
|
1.5 |
% |
Net loss |
|
|
(127.3 |
)% |
|
|
(4.3 |
)% |
Net Sales
The following table presents our net sales, by product (dollars in thousands):
|
|
Three Months Ended |
|
|
Percentage |
|
||||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
|
2025 vs. 2024 |
|
|||
ICLs |
|
$ |
41,498 |
|
|
$ |
77,151 |
|
|
|
(46.2 |
)% |
Other surgical products |
|
|
1,091 |
|
|
|
205 |
|
|
|
— |
* |
Net sales |
|
$ |
42,589 |
|
|
$ |
77,356 |
|
|
|
(44.9 |
)% |
* Denotes change is greater than +100%.
Net sales for the three months ended March 28, 2025 decreased 45% from the same period of 2024, primarily due to decreased China sales, partially offset by increased other product sales. The sales decrease was driven by the APAC region, which decreased by 61%, with ICL unit decrease of 62%. The decrease in the APAC region was driven by decreased sales in China, partially offset by sales growth in Korea and Japan. The Company expects China sales to return to normalized levels beginning in the third quarter of 2025. The EMEA region sales increased 10% with ICL unit growth up 10%, due to sales growth in our distributor and direct markets. The Americas region sales increased 9%, with ICL unit growth up 3%, primarily due to sales growth in the U.S. and our Latin America distributor markets. Changes in foreign currency unfavorably impacted net sales by $0.5 million.
Other product sales includes delivery systems and normal recurring sales adjustments such as sales return allowances.
20
Gross Profit
The following table presents our gross profit and gross profit margin (dollars in thousands):
|
|
Three Months Ended |
|
|
Percentage |
|
||||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
|
2025 vs. 2024 |
|
|||
Gross profit |
|
$ |
28,005 |
|
|
$ |
61,035 |
|
|
|
(54.1 |
)% |
Gross margin |
|
|
65.8 |
% |
|
|
78.9 |
% |
|
|
|
|
Gross profit for the three months ended March 28, 2025 decreased 54.1%, from the same period of 2024. Gross profit margin decreased to 65.8% of revenue for the three months ended March 28, 2025 compared to 78.9% of revenue for the three months ended March 29, 2024, due primarily to higher manufacturing costs per unit due to lower production volume, increased excess and obsolete inventory reserves and period costs associated with the expansion of the Company’s manufacturing capabilities in its Nidau, Switzerland facility.
General and Administrative Expense
The following table presents our general and administrative expenses (dollars in thousands):
|
|
Three Months Ended |
|
|
Percentage |
|
||||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
|
2025 vs. 2024 |
|
|||
General and administrative expense |
|
$ |
24,458 |
|
|
$ |
23,228 |
|
|
|
5.3 |
% |
Percentage of sales |
|
|
57.4 |
% |
|
|
30.0 |
% |
|
|
|
|
General and administrative expenses for the three months ended March 28, 2025 increased 5.3% from the same period of 2024 due to increased salary-related and payroll tax expenses.
Selling and Marketing Expense
The following table presents our selling and marketing expenses (dollars in thousands):
|
|
Three Months Ended |
|
|
Percentage |
|
||||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
|
2025 vs. 2024 |
|
|||
Selling and marketing expense |
|
$ |
24,621 |
|
|
$ |
26,708 |
|
|
|
(7.8 |
)% |
Percentage of sales |
|
|
57.8 |
% |
|
|
34.5 |
% |
|
|
|
|
Selling and marketing expenses for the three months ended March 28, 2025 decreased 7.8% from the same period of 2024 due to decreased advertising and promotional activities.
Research and Development Expense
The following table presents our research and development expenses (dollars in thousands):
|
|
Three Months Ended |
|
|
Percentage |
|
||||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
|
2025 vs. 2024 |
|
|||
Research and development expense |
|
$ |
13,663 |
|
|
$ |
13,380 |
|
|
|
2.1 |
% |
Percentage of sales |
|
|
32.1 |
% |
|
|
17.3 |
% |
|
|
|
|
Research and development expenses for the three months ended March 28, 2025 increased 2.1% from the same period of 2024, due mainly to increased salary-related and payroll tax expenses, partially offset by decreased clinical expenses.
21
Restructuring, Impairment and Related Charges
The following table presents our restructuring, impairment and related charges (dollars in thousands):
|
|
Three Months Ended |
|
|
Percentage |
|
||||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
|
2025 vs. 2024 |
|
|||
Restructuring, impairment and related charges |
|
$ |
22,664 |
|
|
$ |
— |
|
|
|
— |
* |
Percentage of sales |
|
|
53.2 |
% |
|
|
0.0 |
% |
|
|
|
|
* Denotes change is greater than +100%.
In the first quarter of 2025, we took a number of steps to change our leadership team, realign our leadership structure to better address market needs, reduce costs and discretionary spending and better position the Company to return to sustainable growth. As part of the leadership realignment and related efforts, during the three months ended March 28, 2025, we recognized costs related to severance, reduction in workforce, and consulting expenses of $9,447,000; impairment expenses on leasehold improvements and machinery and equipment of $7,059,000 as we will no longer be using these assets; and impairment on real property right-of-use assets of $3,407,000, as we are actively pursuing subleasing opportunities for two of our leased properties. In addition, we also recognized impairment of $2,751,000 for internally developed software that we will no longer be using as we will transition to a cloud-based software solution.
Other Income, Net
The following table presents our other income, net (dollars in thousands):
|
|
Three Months Ended |
|
|
Percentage |
|
||||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
|
2025 vs. 2024 |
|
|||
Other income, net |
|
$ |
2,915 |
|
|
$ |
70 |
|
|
|
— |
* |
Percentage of sales |
|
|
6.8 |
% |
|
|
0.1 |
% |
|
|
|
|
* Denotes change is greater than +100%.
The increase in other income, net for the three months ended March 28, 2025, was due mainly to higher foreign exchange gains for the three months ended March 28, 2025.
Income Taxes
The following table presents our income tax provision (benefit) (dollars in thousands):
|
|
Three Months Ended |
|
|
Percentage |
|
||||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
|
2025 vs. 2024 |
|
|||
Income (benefit) tax provision |
|
$ |
(275 |
) |
|
$ |
1,128 |
|
|
|
— |
* |
* Denotes change is greater than +100%.
The effective tax rates for the three months ended March 28, 2025 and March 29, 2024 were 0.5% and (51.0)%, respectively. Our effective tax rates differ from the U.S. federal statutory rate of 21%, primarily due to the income tax expense generated in foreign jurisdictions.
Our future effective income tax rate depends on various factors, such as changes in tax laws, regulations, accounting principles, or interpretations thereof, and the geographic composition of our pre-tax income. We carefully monitor these factors and adjust our effective income tax rate accordingly.
22
Liquidity and Capital Resources
Our principal sources of liquidity are cash, cash equivalents, investments available for sale (“AFS”) and cash flow from operating activities. We believe these sources of liquidity will be sufficient to meet our anticipated cash needs, including working capital needs, capital expenditures and contractual obligations for at least 12 months from the issuance date of the financial statements. We expect that cash flow from operating activities may fluctuate in future periods as a result of a number of factors, including fluctuations in our operating results, working capital needs, capital expenditures, and capital deployment decisions. In addition, future capital requirements will depend on many factors including our growth rate in net sales, the timing and extent of spending to support our growth strategy, the expansion of selling and marketing activities, the timing of introductions of new products, as well as global macroeconomic factors. If our anticipated future cash flow from operating activities is insufficient to satisfy our future capital requirements in the long-term, we may need to seek additional capital. Our financial condition at March 28, 2025 and December 27, 2024 included the following (in thousands):
|
|
March 28, 2025 |
|
|
December 27, 2024 |
|
|
2025 vs. 2024 |
|
|||
Cash and cash equivalents |
|
$ |
173,114 |
|
|
$ |
144,159 |
|
|
$ |
28,955 |
|
Investments available for sale |
|
|
49,647 |
|
|
|
86,335 |
|
|
|
(36,688 |
) |
Total |
|
$ |
222,761 |
|
|
$ |
230,494 |
|
|
$ |
(7,733 |
) |
|
|
|
|
|
|
|
|
|
|
|||
Current assets |
|
$ |
326,498 |
|
|
$ |
367,940 |
|
|
$ |
(41,442 |
) |
Current liabilities |
|
|
68,356 |
|
|
|
70,306 |
|
|
|
(1,950 |
) |
Working capital |
|
$ |
258,142 |
|
|
$ |
297,634 |
|
|
$ |
(39,492 |
) |
Cash and cash equivalents include cash and balances in deposits and money market accounts held at banks and financial institutions. Our investment policy’s primary objective is capital preservation while maximizing our return on investment. Investments available for sale may include U.S. government and corporate debt securities, commercial paper, certain certificates of deposit and related security types, that are rated by two nationally recognized statistical rating organizations with minimum investment grade ratings of AAA to A-/A-1+ to A-2, or the equivalent. The maturity of individual investments may not extend 24 months from the date of purchase. There are also limits to the amount of credit exposure in any given security type. We do not have any off-balance sheet arrangements.
A summary of cash flows for the three months ended March 28, 2025 and March 29, 2024 was as follows (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
March 28, 2025 |
|
|
March 29, 2024 |
|
||
Cash flows from: |
|
|
|
|
|
|
||
Operating activities |
|
$ |
(5,734 |
) |
|
$ |
21,680 |
|
Investing activities |
|
|
35,351 |
|
|
|
16,187 |
|
Financing activities |
|
|
(948 |
) |
|
|
4,056 |
|
Effect of exchange rate changes |
|
|
286 |
|
|
|
(937 |
) |
Net increase in cash and cash equivalents |
|
|
28,955 |
|
|
|
40,986 |
|
Cash and cash equivalents, at beginning of year |
|
|
144,159 |
|
|
|
183,038 |
|
Cash and cash equivalents, at end of period |
|
$ |
173,114 |
|
|
$ |
224,024 |
|
For the three months ended March 28, 2025, net cash used in operating activities consisted of $54.2 million in net loss; partially offset by $29.4 million in working-capital changes primarily rated to changes in accounts receivable, partially offset by changes in inventory, and $19.1 million in non-cash items primarily related to impairment on fixed assets and operating leases and stock-based compensation. For the three months ended March 29, 2024 net cash provided by operating activities consisted of $16.8 million in working-capital changes primarily related to changes in accounts receivable and cloud-based software, partially offset by changes in other liabilities and inventories; and $8.2 million in non-cash items primarily related to stock based compensation expenses, partially offset by a net loss of $3.3 million.
For the three months ended March 28, 2025, net cash provided by investment activities was $35.4 million which consisted of $51.1 million of proceeds from the maturity of investments AFS, partially offset by $14.7 million in purchases of investments AFS. For the three months ended March 29, 2024, net cash provided by investment activity was $16.2 million which consisted of $20.5 million of proceeds from the maturity of investments AFS, partially offset by $5.2 million in purchases of property, plant and equipment.
23
Net cash used by financing activities for the three months ended March 28, 2025 was $0.9 million which primarily consisted of $1.3 million to repurchase employee common stock for taxes withheld. For the three months ended March 29, 2024, net cash provided by financing activities was $4.1 million which consisted of $5.3 million of proceeds from the exercise of stock options, partially offset by $1.2 million to repurchase employee common stock for taxes withheld.
Commitments
Employment Agreements
The Company’s Chief Executive Officer entered into an employment agreement with the Company, effective February 26, 2025. He and certain officers have as provisions of their agreements certain rights, including continuance of cash compensation and benefits, upon a “change in control,” which may include an acquisition of substantially all of its assets, or termination “without cause or for good reason” as defined in the employment agreements.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
During the three months ended March 28, 2025, there have been no material changes in the Company’s qualitative and quantitative market risk since the disclosure in the Company’s Annual Report on Form 10-K for the year ended December 27, 2024.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our management, including our CEO and CFO, of the effectiveness of the design and operation of the disclosure controls and procedures of the Company. Based on that evaluation, our CEO and CFO concluded, as of the end of the period covered by this quarterly report on Form 10-Q, that our disclosure controls and procedures were effective. For purposes of this statement, the term “disclosure controls and procedures” means controls and other procedures of the Company that are designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act (15 U.S.C. 78a et seq.) is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Our management, including the CEO and the CFO, do not expect that our disclosure controls and procedures or our internal control over financial reporting will necessarily prevent all fraud or material errors. An internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations on all internal control systems, our internal control system can provide only reasonable assurance of achieving its objectives and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of internal control is also based in part upon certain assumptions about the likelihood of future events, and can provide only reasonable, not absolute, assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in circumstances, or the degree of compliance with the policies and procedures may deteriorate.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the quarter ended March 28, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
24
PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
From time to time, the Company is involved in various legal proceedings and other matters arising in the normal course of business. These legal proceedings and other matters may relate to, among other things, contractual rights and obligations, employment matters, or claims of product liability. The Company maintains insurance coverage for various matters, including product liability and certain securities claims. While the Company does not believe that any of the claims known is likely to have a material adverse effect on the Company’s financial condition or results of operations, new claims or unexpected results of existing claims could lead to significant financial harm.
ITEM 1A. RISK FACTORS
Our short and long-term success is subject to many factors that are beyond our control. Investors and prospective investors should consider carefully information contained in this report and the risks and uncertainties described in “Part I—Item 1A—Risk Factors” of the Company’s Form 10-K for the fiscal year ended December 27, 2024. Such risks and uncertainties could materially adversely affect our business, financial condition or operating results.
ITEM 4. MINE SAFETY DISCLOSURES
Not Applicable.
ITEM 5. OTHER INFORMATION
During the quarter ended March 28, 2025, no director or officer
25
ITEM 6. EXHIBITS
Exhibit Number |
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Description |
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3.1 |
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Amended and Restated Certificate of Incorporation (incorporated by reference to Appendix 2 of the Company’s Proxy Statement on Form DEF 14A as filed with the Commission on April 26, 2018). |
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3.2 |
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Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K as filed with the Commission on March 17, 2025). |
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4.1 |
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Form of Certificate for Common Stock, par value $0.01 per share (incorporated by reference to Exhibit 4.1 to Amendment No. 1 to the Company’s Registration Statement on Form 8 A/A as filed with the Commission on April 18, 2003). |
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10.1 |
# |
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Employment Agreement, effective February 26, 2025, by and between the Company and Stephen C. Farrell (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K as filed with the Commission on February 26, 2025). |
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10.2 |
# |
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Consulting Agreement, effective February 26, 2025, by and between the Company and Thomas G. Frinzi (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K as filed with the Commission on February 26, 2025). |
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10.3 |
*# |
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31.1 |
* |
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31.2 |
* |
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32.1 |
** |
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101 |
* |
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Financial statements from the quarterly report on Form 10-Q of STAAR Surgical Company for the quarter ended March 28, 2025 formatted in Inline Extensible Business Reporting Language (iXBRL), are filed herewith and include: (i) the Condensed Consolidated Balance Sheets, (ii) the Condensed Consolidated Statements of Income, (iii) the Condensed Consolidated Statements of Comprehensive Income, (iv) the Condensed Consolidated Statements of Stockholders’ Equity, (v) the Condensed Consolidated Statements of Cash Flows, and (vi) the Notes to Condensed Consolidated Financial Statements tagged as blocks of text. |
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104 |
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The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 28, 2025, has been formatted in Inline XBRL with applicable taxonomy extension information contained in Exhibit 101. |
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# |
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Management contract or compensatory plan, contract or arrangement |
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* |
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Filed herewith. |
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** |
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Certification furnished herewith solely to accompany this annual report pursuant to 18 U.S.C. Section 1350. Certification is not deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section. Such certification is not deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act except to the extent that the registrant specifically incorporates it by reference. |
26
SIGNATURES
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 thereunto duly authorized.
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STAAR SURGICAL COMPANY |
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Dated: |
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May 7, 2025 |
By: |
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/s/ DEBORAH ANDREWS |
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Deborah Andrews |
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Interim Chief Financial Officer |
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(on behalf of the Registrant and as its principal financial officer) |
27
Exhibit 10.3
||||
STAAR Surgical Company
PERFORMANCE STOCK UNIT AWARD GRANT NOTICE
STAAR Surgical Company, a Delaware corporation, (the “Company”), has granted to the participant identified below (the “Participant”) an award (the “Award”) of the number of performance stock units (“Performance Stock Units” or “PSUs”) specified below in this Performance Stock Unit Award Grant Notice (the “Grant Notice”). This Award is granted pursuant to the Company’s Amended and Restated Omnibus Equity Incentive Plan, as amended from time to time (the “Plan”). This Award is subject to all of the terms and conditions set forth in this Grant Notice and the Performance Stock Unit Award Agreement attached hereto as Exhibit A (together with this Grant Notice, the “Agreement”) and the Plan, each of which is incorporated herein by reference. Unless otherwise defined herein, capitalized terms shall have the same meanings assigned to such terms in the Plan or the Agreement, as appropriate.
Participant: |
[NAME] |
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Grant Date: |
[DATE OF GRANT] |
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Target Number of PSUs: |
This Award is for a target of [NUMBER] PSUs, subject to adjustment as set forth in the Agreement. |
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Payment: |
This Award will be payable in shares of the Company’s Common Stock (“Shares”) with each PSU representing the right to receive one Share. The number of PSUs that may be earned under this Award (and the number Shares payable pursuant to this Award) will range from 0% - 200% of the Target Number of PSUs set forth in this Grant Notice, based on the Company’s performance relative to the performance targets set forth herein. |
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Performance Metric: |
The performance metric for this Award is reported revenue under U.S. GAAP for the Company’s trailing four consecutive financial quarters (“Trailing Revenue”), determined as of the end of the financial quarter ending [END OF YEAR1], and each financial quarter thereafter, through and including the financial quarter ending [END OF YEAR3]. |
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Performance Period: |
The performance period for this award is the period beginning [START OF YEAR1] and ending [END OF YEAR3] (the “Performance Period”). |
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Performance Targets: |
The Company will determine Trailing Revenue quarterly during the Performance Period beginning with the quarter ending [END OF YEAR1]. The number of PSUs earned under this Award will be calculated based on such Trailing Revenue relative to the following five revenue performance targets (the “Revenue Performance Targets”), each of which align to five vesting tranches (“Vesting Tranches”) as set forth in the following table: |
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Vesting Tranche |
Revenue Performance Target (Trailing Revenue) |
Percent of Target Number |
1 |
$[THRESHOLD] million |
50% |
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2 |
$[TRANCHE 2] million |
Additional 25% |
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3 |
$[TARGET] million |
Additional 25% |
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4 |
$[TRANCHE 3] million |
Additional 50% |
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5 |
$[MAXIMUM] million |
Additional 50% |
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If at the end of the Performance Period, the Company has failed to achieve Trailing Revenue of at least $[THRESHOLD] million as of the end of any financial quarter during the Performance Period, no portion of the Award will vest and the Award will be forfeited by the Participant without payment of any consideration therefor as of the last day of the Performance Period. For the avoidance of doubt, the maximum number of PSUs that may be earned under this Award is 200% of the Target Number of PSUs. |
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Vesting Tranches: |
This Award will vest in up to five Vesting Tranches. On a quarterly basis beginning with the quarter ending [END OF YEAR1], the Company will assess whether the Trailing Revenue as of the end of a financial quarter has met or exceeded one or more of the Revenue Performance Targets. If so, the Percent of the Target Number of PSUs associated with such Revenue Performance Target and the corresponding Vesting Tranche (the “Earned PSUs”) will be earned on the 15th calendar day of either (i) the second month following the end of such financial quarter, if such quarter is the first, second or third financial quarter of a fiscal year, as applicable, or (ii) the third month following the end of the fourth financial quarter of a fiscal year (each such date, a “Vesting Date”). If the Company achieves two or more Revenue Performance Targets as of the end of a financial quarter during the Performance Period, the Participant may earn multiple Vesting Tranches of PSUs on a Vesting Date. If, as of the end of the Performance Period, the Company has not achieved Trailing Revenue of $[MAXIMUM] million, the Participant shall earn a pro-rated number of Earned PSUs corresponding to the Company’s Trailing Revenue as of [END OF YEAR3]. The Company shall calculate a pro-rated number of Earned PSUs corresponding to such Trailing Revenue based on interpolation between the two Performance Revenue Targets immediately below and above such Trailing Revenue. Based on such interpolation, the Company will determine the percentage achievement of the Revenue Performance Target immediately above such Trailing Revenue and calculate the pro-rated number of Earned PSUs corresponding thereto as a final Vesting Tranche. In no event shall Earned PSUs for achieving a Revenue Performance Target be earned more than once; once a Revenue Performance Target has been achieved for a corresponding Vesting Tranche, and Earned PSUs have been earned for such Vesting Tranche, no additional Earned PSUs shall be earned for achieving such Revenue Performance Target. In addition, any PSUs that do not become Earned PSUs based upon the achievement of the applicable Revenue Performance Targets prior to the end of the Performance Period will be deemed forfeited by the Participant without payment of any consideration therefor as of the last day of the Performance Period. |
Vesting of Earned PSUs: |
The Earned PSUs shall vest subject to the Participant’s continued Service with the Company in two installments, with 50% of the Earned PSUs vesting on the applicable Vesting Date and 50% of the Earned PSUs vesting on the one-year anniversary of the applicable Vesting Date (each such date, an “Anniversary Date”); provided, however, that all Earned PSUs, to the extent not previously vested, shall become vested on March 15, [YEAR], subject to the Participant’s continued Service with the Company through such date. |
Termination: |
If the Participant experiences a Termination of Service prior to the applicable Vesting Date or Anniversary Date, all PSUs that have not become vested on or prior to the date of such Termination of Service (after taking into consideration any vesting that may occur in connection with such Termination of Service, if any) will thereupon be automatically forfeited by the Participant without payment of any consideration therefor. |
By electronically accepting this Award according to the instructions in the Participant’s E*Trade account (pursuant to which the Participant received this Grant Notice), the Participant agrees to be bound by the terms and conditions of the Plan, this Grant Notice, and the Performance Stock Unit Agreement. The Participant acknowledges that copies of the Plan, this Grant Notice, the Performance Stock Unit Agreement, and the prospectus for the Plan are available via the Participant’s E*Trade account.
The Participant represents that the Participant has reviewed the Plan, this Grant Notice, and the Performance Stock Unit Agreement in their entirety, has had an opportunity to obtain the advice of counsel prior to accepting this Award, and fully understands all terms and conditions of this Award. The Participant hereby accepts this Award subject to such terms and conditions and agrees to accept as binding, conclusive and final all decisions or interpretations made by the Compensation Committee of the Company’s Board of Directors upon any questions arising under the Plan, this Grant Notice or the Performance Stock Unit Award Agreement.
2
EXHIBIT A
TO PERFORMANCE STOCK UNIT AWARD GRANT NOTICE
PERFORMANCE STOCK UNIT AWARD AGREEMENT
Pursuant to the Performance Stock Unit Award Grant Notice (the “Grant Notice”) to which this Performance Stock Unit Award Agreement (this “Agreement”) is attached, STAAR Surgical Company, a Delaware corporation (the “Company”), has granted to the Participant an award of performance stock units (“Performance Stock Units” or “PSUs”) under the Company’s Amended and Restated Omnibus Equity Incentive Plan, as amended from time to time (the “Plan”). Unless otherwise defined herein, capitalized terms shall have the same meanings assigned to such terms in the Plan or the Grant Notice, as appropriate.
GENERAL
GRANT OF PERFORMANCE STOCK UNITS
issuance of shares; delivery
1
OTHER PROVISIONS
2
3
4
Exhibit 31.1
Certifications
I, Stephen C. Farrell, certify that:
1. I have reviewed this quarterly report on Form 10-Q of STAAR Surgical Company;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Dated: |
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May 7, 2025 |
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/s/ STEPHEN C. FARRELL |
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Stephen C. Farrell |
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Chief Executive Officer |
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(principal executive officer) |
Exhibit 31.2
Certifications
I, Deborah Andrews, certify that:
1. I have reviewed this quarterly report on Form 10-Q of STAAR Surgical Company;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Dated: |
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May 7, 2025 |
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/s/ DEBORAH ANDREWS |
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Deborah Andrews |
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Interim Chief Financial Officer |
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(principal financial officer) |
Exhibit 32.1
Certification pursuant to 18 U.S.C. Section 1350,
As adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the filing of the Quarterly Report on Form 10-Q for the period ended March 28, 2025 (the “Report”) by STAAR Surgical Company (“Registrant”), each of the undersigned hereby certifies that:
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Registrant as of and for the periods presented in the Report.
Dated: |
May 7, 2025 |
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/s/ STEPHEN C. FARRELL |
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Stephen C. Farrell |
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Chief Executive Officer |
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(principal executive officer) |
Dated: |
May 7, 2025 |
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/s/ DEBORAH ANDREWS |
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Deborah Andrews |
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Interim Chief Financial Officer |
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(principal financial officer) |
A signed original of this written statement required by 18 U.S.C. Section 1350 has been provided to STAAR Surgical Company and will be furnished to the Securities and Exchange Commission or its staff upon request.