Staar Surgical Co 10-Q for FY2022 Q3
Staar Surgical Co (STAA)
About this 10-Q
Staar Surgical Co filed this 10-Q on November 2, 2022, covering the quarter ended September 30, 2022 (FY2022 Q3).
Headline figures
Quarter ended September 30, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $76.05M
- up 30.3% from $58.35M a year earlier
- Net income
- $10.26M
- up 70.5% from net income of $6.02M a year earlier
- Diluted EPS
- $0.21
- up 75.0% from $0.12 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended:
Or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission file number:
(Exact Name of Registrant as Specified in its Charter)
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(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:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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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
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ITEM 1. |
FINANCIAL STATEMENTS |
STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value amounts)
(Unaudited)
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September 30, 2022 |
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December 31, 2021 |
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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 |
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— |
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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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Investments available for sale |
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— |
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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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Intangible 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 finance leases |
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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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Commitments and contingencies |
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Stockholders’ equity: |
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Common stock, $ December 31, 2021, respectively |
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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 INCOME
(In thousands, except per share amounts)
(Unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, 2022 |
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October 1, 2021 |
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September 30, 2022 |
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October 1, 2021 |
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Net sales |
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$ |
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$ |
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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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Total selling, general and administrative expenses |
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Operating income |
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Other expense, net: |
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Interest income (expense), net |
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( |
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( |
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Loss on foreign currency transactions |
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( |
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( |
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Royalty income |
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Other income (expense), net |
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( |
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( |
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Total other expense, net |
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( |
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( |
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Income before income taxes |
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Provision for income taxes |
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Net income |
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$ |
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$ |
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$ |
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$ |
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Net income per share: |
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Basic |
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$ |
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$ |
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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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$ |
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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 INCOME
(In thousands)
(Unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, 2022 |
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October 1, 2021 |
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September 30, 2022 |
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October 1, 2021 |
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Net income |
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$ |
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$ |
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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 unrealized loss |
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( |
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— |
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( |
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— |
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Foreign currency translation gain (loss) |
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( |
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( |
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( |
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Tax effect |
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( |
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Other comprehensive income (loss), net of tax |
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( |
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Comprehensive income |
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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.
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 Stock Shares |
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Common Stock Par Value |
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Additional Paid-In Capital |
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Accumulated Other Compre- hensive Income (Loss) |
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Accumulated Deficit |
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Total |
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Balance, at July 1, 2022 |
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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 income |
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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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Vested restricted and performance 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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Balance, at September 30, 2022 |
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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 July 2, 2021 |
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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 income |
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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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Vested restricted and performance 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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Balance, at October 1, 2021 |
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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 STOCKHOLDERS’ EQUITY
(In thousands)
(Unaudited)
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Nine Months Ended |
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Common Stock Shares |
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Common Stock Par Value |
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Additional Paid-In Capital |
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Accumulated Other Compre- hensive Income (Loss) |
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Accumulated Deficit |
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Total |
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Balance, at December 31, 2021 |
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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 income |
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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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Unvested 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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Vested restricted and performance stock |
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— |
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— |
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— |
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Balance, at September 30, 2022 |
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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 January 1, 2021 |
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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 income |
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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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Unvested restricted stock |
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— |
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— |
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— |
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|
|
— |
|
|
|
— |
|
|
Vested restricted and performance stock |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
Balance, at October 1, 2021 |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
See accompanying notes to the condensed consolidated financial statements.
5
STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
|
|
|
Nine Months Ended |
|
|||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
|
|
|
$ |
|
|
|
Adjustments to reconcile net income to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
|
Depreciation of property, plant, and equipment |
|
|
|
|
|
|
|
|
|
Amortization of intangibles |
|
|
|
|
|
|
|
|
|
Accretion/Amortization of investments available for sale |
|
|
( |
) |
|
|
— |
|
|
Deferred income taxes |
|
|
|
|
|
|
|
|
|
Change in net pension liability |
|
|
|
|
|
|
|
|
|
Loss on disposal of property and equipment |
|
|
— |
|
|
|
|
|
|
Stock-based compensation expense |
|
|
|
|
|
|
|
|
|
Provision for sales returns and bad debts |
|
|
|
|
|
|
|
|
|
Inventory provision |
|
|
|
|
|
|
|
|
|
Changes in working capital: |
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
( |
) |
|
|
( |
) |
|
Inventories |
|
|
( |
) |
|
|
|
|
|
Prepayments, deposits, and other current assets |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
( |
) |
|
|
( |
) |
|
Other current liabilities |
|
|
( |
) |
|
|
|
|
|
Net cash provided by operating activities |
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
Acquisition of property and equipment |
|
|
( |
) |
|
|
( |
) |
|
Purchase of investments available for sale |
|
|
( |
) |
|
|
— |
|
|
Net cash used in investing activities |
|
|
( |
) |
|
|
( |
) |
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
Repayment of finance lease obligations |
|
|
( |
) |
|
|
( |
) |
|
Proceeds from the exercise of stock options |
|
|
|
|
|
|
|
|
|
Proceeds from vested restricted stock |
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
( |
) |
|
|
( |
) |
|
Increase (decrease) in cash and cash equivalents |
|
|
( |
) |
|
|
|
|
|
Cash and cash equivalents, at beginning of the period |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, at end of the period |
|
$ |
|
|
|
$ |
|
|
See accompanying notes to the condensed consolidated financial statements.
6
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 1 — Basis of Presentation and Significant Accounting Policies
The Condensed Consolidated Financial Statements of the Company present the financial position, results of operations, and cash flows of STAAR Surgical Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Exchange Commission. In accordance with those rules and regulations certain information and footnote disclosures normally included in the Comprehensive Financial Statements have been condensed or omitted pursuant to such rules and regulations. The Consolidated Balance Sheet as of December 31, 2021 was derived from the audited financial statements at that date, but does not include all the information and footnotes required by GAAP. These financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.
The Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2022 and October 1, 2021, 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 and nine months ended September 30, 2022 and October 1, 2021, 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.
Cash and Cash Equivalents
Cash and cash equivalents include cash and balances in deposits and money market accounts held at banks and financial institutions. Such balances generally exceed the federal insurance limits; however, the Company periodically assesses the financial condition of the institutions and believes that the risk of any loss is minimal.
Investments Available for Sale
Investments available for sale (“AFS”) are investments in debt securities for which the Company does not have the positive intent and ability to hold to maturity. The Company’s investment policy primary objective is capital preservation while maximizing its return on investment. Investments 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. There are also limits to the amount of credit exposure in any given security type.
Investments AFS are measured at fair value and its unrealized gains and losses reported net of the allowance for credit losses and applicable income taxes, are recognized in accumulated other comprehensive income (loss) on the Consolidated Balance Sheets. The cost of investments AFS is adjusted for amortization of premiums and accretion of discounts to maturity. Interest earned, including amortization of premiums and accretion of discounts recognized, is included in interest income (expense) on the Consolidated Statements of Income. The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method.
The Company recognizes other-than-temporary impairment (“OTTI”) of a debt security for which there has been a decline in fair value below amortized cost if (i) management intends to sell the security, (ii) it is more-likely-than-not that the Company will be required to sell the security before recovery of its amortized cost basis, or (iii) the Company does not expect to recover the entire amortized cost basis of the security. The amount by which amortized cost exceeds the fair value of a debt security that is considered to have OTTI is separated into a component representing the credit loss, which is recognized in other income (expense) on the Consolidated Statements of Income, and a component related to all other factors, which is recognized in accumulated other comprehensive income (loss) on the Consolidated Balance Sheets. The measurement of the credit loss component is equal to the difference between the debt security’s amortized cost basis and the present value of its expected future cash flows discounted at the security’s effective yield.
7
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 1 — Basis of Presentation and Significant Accounting Policies (Continued)
Vendor Concentration
There were no vendors that accounted for over
Note 2 — Investments Available for Sale
In the three months ended September 30, 2022, the Company started to invest its cash in slightly higher yielding securities. Investments AFS and the related fair value measurement consisted of the following (dollars in thousands):
|
|
|
September 30, 2022 |
|
|||||||||||||
|
|
|
Amortized Cost |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Estimated Fair Value |
|
||||
|
Level 2 Fair Value Measurements: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial paper |
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
Certificates of deposit |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
U.S. Treasury and agency securities |
|
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
|
|
|
Corporate debt securities |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
Accrued interest receivable |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
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 with gross unrealized losses for credit impairment. As part of that assessment, the Company concluded that it is more-likely-than-not that the Company will not be required to sell, prior to the recovery of the amortized cost basis. The Company did
The following table shows the fair value of investments AFS by contractual maturity (dollars in thousands):
|
|
|
As of September 30, 2022 |
|
||||||||||
|
|
|
Within one year |
|
|
After one year through five years |
|
|
|
Total |
|
|||
|
Commercial paper |
|
$ |
|
|
|
$ |
— |
|
|
|
$ |
|
|
|
Certificates of deposit |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
U.S. Treasury and agency securities |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
Corporate debt securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued interest receivable |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
Total investments AFS |
|
$ |
|
|
|
$ |
|
|
|
|
$ |
|
|
8
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
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):
|
|
|
September 30, 2022 |
|
|
December 31, 2021 |
|
||
|
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):
|
|
|
September 30, 2022 |
|
|
December 31, 2021 |
|
||
|
Prepayments and deposits |
|
$ |
|
|
|
$ |
|
|
|
Prepaid insurance |
|
|
|
|
|
|
|
|
|
Prepaid marketing |
|
|
|
|
|
|
|
|
|
Consumption tax receivable |
|
|
|
|
|
|
|
|
|
Value added tax (VAT) receivable |
|
|
|
|
|
|
|
|
|
BVG (Swiss Pension) prepayment |
|
|
|
|
|
|
|
|
|
Other(1) |
|
|
|
|
|
|
|
|
|
Total prepayments, deposits and other current assets |
|
$ |
|
|
|
$ |
|
|
|
(1) |
|
Note 5 — Property, Plant and Equipment
Property, plant and equipment, net consisted of the following (in thousands):
|
|
|
September 30, 2022 |
|
|
December 31, 2021 |
|
||
|
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 6 – Intangible Assets
Intangible assets, net consisted of the following (in thousands):
|
|
|
September 30, 2022 |
|
|
December 31, 2021 |
|
||||||||||||||||||
|
Long-lived amortized intangible assets |
|
Gross Carrying Amount |
|
|
Accumulated Amortization |
|
|
Net |
|
|
Gross Carrying Amount |
|
|
Accumulated Amortization |
|
|
Net |
|
||||||
|
Patents and licenses |
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
Note 7 – Other Current Liabilities
Other current liabilities consisted of the following (in thousands):
|
|
|
September 30, 2022 |
|
|
December 31, 2021 |
|
||
|
Accrued salaries and wages |
|
$ |
|
|
|
$ |
|
|
|
Accrued bonuses |
|
|
|
|
|
|
|
|
|
Income taxes payable |
|
|
|
|
|
|
|
|
|
Marketing obligations |
|
|
|
|
|
|
|
|
|
Other(1) |
|
|
|
|
|
|
|
|
|
Total other current liabilities |
|
$ |
|
|
|
$ |
|
|
|
(1) |
|
Note 8 – Leases
Finance Leases
The Company entered into finance leases primarily related to purchases of equipment used for manufacturing, computer-related equipment or furniture and fixtures. These finance leases are
|
|
|
September 30, 2022 |
|
|
December 31, 2021 |
|
||
|
Machinery and equipment |
|
$ |
|
|
|
$ |
|
|
|
Computer equipment and software |
|
|
|
|
|
|
|
|
|
Furniture and fixtures |
|
|
|
|
|
|
|
|
|
Finance lease right-of-use assets, gross |
|
|
|
|
|
|
|
|
|
Less accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
|
Finance lease right-of-use assets, net |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current finance lease obligations |
|
$ |
|
|
|
$ |
|
|
|
Long-term finance lease obligations |
|
|
|
|
|
|
|
|
|
Total finance lease liability |
|
$ |
|
|
|
$ |
|
|
|
Weighted-average remaining lease term (in years) |
|
|
|
|
|
|
|
|
|
Weighted-average discount rate |
|
|
|
% |
|
|
|
% |
10
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 8 – Leases (Continued)
Finance Leases (Continued)
Supplemental cash flow information related to finance leases consisted of the following (dollars in thousands):
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||||
|
Amortization of finance lease right-of-use asset |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Interest on finance lease liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for amounts included in the measurement of finance lease liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating cash flows |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing cash flows |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
September 30, 2022 |
|
|
December 31, 2021 |
|
||
|
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 |
|
|
|
% |
|
|
|
% |
Supplemental cash flow information related to operating leases was as follows (dollars in thousands):
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||||
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 8 – Leases (Continued)
Maturities of Lease Liabilities
Maturities of lease liabilities under operating and finance leases having initial or remaining non-cancelable lease terms more than one year as of September 30, 2022 is as follows (in thousands):
.
|
As of September 30, 2022 12 Months Ended |
|
Operating Leases |
|
|
Finance Leases |
|
||
|
September 2023 |
|
$ |
|
|
|
$ |
|
|
|
September 2024 |
|
|
|
|
|
|
|
|
|
September 2025 |
|
|
|
|
|
|
|
|
|
September 2026 |
|
|
|
|
|
|
— |
|
|
September 2027 |
|
|
|
|
|
|
— |
|
|
Thereafter |
|
|
|
|
|
|
— |
|
|
Total future minimum lease payments |
|
$ |
|
|
|
$ |
|
|
|
Less amounts representing interest |
|
|
( |
) |
|
|
( |
) |
|
Present value of future minimum lease payments |
|
$ |
|
|
|
$ |
|
|
Note 9 — Income Taxes
The Company recorded an income tax provision as follows (in thousands):
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||||
|
Provision for income taxes |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
The effective tax rates for the three months ended September 30, 2022 and October 1, 2021 was
Note 10 – 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 |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||||
|
Service cost(1) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Interest cost(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected return on plan assets(2) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
Prior service credit(2),(3) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
Actuarial loss recognized in current period(2),(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic pension cost |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
(1) |
|
|
(2) |
|
|
(3) |
|
12
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 10 – Defined Benefit Pension Plans (Continued)
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 |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||||
|
Employer contribution |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Note 11 — Stockholders’ Equity
Stock-Based Compensation
The cost that has been charged against income for stock-based compensation is set forth below (in thousands):
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||||
|
Employee stock options |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Restricted stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Performance stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonemployee stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
The Company recorded stock-based compensation costs in the following categories (in thousands):
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||||
|
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 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Incentive Plan
The Amended and Restated Omnibus Equity Incentive Plan (“the Plan”) provides for various forms of stock-based incentives. To date, of the available forms of awards under the Plan, the Company has granted only stock options, restricted stock, unrestricted share grants, restricted stock units (“RSUs”) and performance stock units (“PSUs”). Options under the Plan are granted at fair market value on the date of grant, become exercisable generally over a period, or as determined by the Board of Directors, and expire over periods not exceeding
13
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 11 — Stockholders’ Equity (Continued)
Assumptions
The fair value of each 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 options granted is derived from the historical exercises and post-vesting cancellations and represents the period of time that options granted are expected to be outstanding. The Company has calculated a
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||||
|
Expected dividend yield |
|
|
|
% |
|
|
|
% |
|
|
|
% |
|
|
|
% |
|
Expected volatility |
|
|
|
% |
|
|
|
% |
|
|
|
% |
|
|
|
% |
|
Risk-free interest rate |
|
|
|
% |
|
|
|
% |
|
|
|
% |
|
|
|
% |
|
Expected term (in years) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Options
A summary of stock option activity under the Plan for nine months ended September 30, 2022 is presented below:
|
|
|
Stock Options (in 000’s) |
|
|
Minimum Exercise Price |
|
|
Maximum Exercise Price |
|
|||
|
Outstanding at December 31, 2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2022 |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
Exercisable at September 30, 2022 |
|
|
|
|
|
|
|
|
|
|
|
|
Restricted Stock, Restricted Stock Units and Performance Stock Units
A summary of restricted stock, RSUs and PSUs activity under the Plan for the nine months ended September 30, 2022 is presented below (shares in thousands):
|
|
|
Restricted Stock |
|
|
RSUs |
|
|
PSUs |
|
|||
|
Unvested at December 31, 2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
Unvested at September 30, 2022 |
|
|
|
|
|
|
|
|
|
|
|
|
14
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 12 - 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. STAAR 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.
Employment Agreements
The Company’s Chief Executive Officer entered into an employment agreement with the Company, effective March 1, 2015. She 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 its assets, or termination “without cause or for good reason” as defined in the employment agreements.
Note 13 — Basic and Diluted Net Income Per Share
The following table sets forth the computation of basic and diluted net income per share (in thousands except per share amounts):
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||||
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: Unvested restricted stock |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
Denominator for basic calculation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average effects of potentially diluted common stock: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested restricted stock |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
RSUs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PSUs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for diluted calculation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Diluted |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
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 |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||||
|
Stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted stock, RSUs and PSUs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 14 — 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 following breaks down sales into the following categories (in thousands):
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||||
|
Non-consignment sales |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Consignment sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net sales |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
The Company markets and sells its products in over
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||||
|
Domestic |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Foreign: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
China |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Japan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other(1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total foreign sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net sales |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
(1) |
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||||
|
ICLs |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Other product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cataract IOLs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other surgical products |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other product sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net sales |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
One customer, the Company’s distributor in China, accounted for
16
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 15 — COVID-19 Developments
In December 2019, COVID-19 surfaced and in March 2020, the World Health Organization declared a pandemic related to the rapid spread of COVID-19 around the world. The impact of the COVID-19 outbreak on the businesses and the economy in the U.S. and the rest of the world is, and is expected to continue to be, uncertain and may continue to be significant as COVID-19 variant strains emerge. The Company’s revenues have been adversely impacted, and the Company experienced a substantial slowdown in sales beginning March 20, 2020 in global geographies characterized as “hot spots” for the COVID-19 virus, including parts of Europe, North America, Asia, the Middle East and India. In certain of these markets, sales have paused as elective surgeries are discouraged to support COVID-19 related needs. The Company continues to monitor the commercial and operational impact of new variants of COVID-19.
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, and Section 21E of the Securities Exchange Act of 1934, as amended. Readers can recognize forward-looking statements by the use of words like “anticipate,” “estimate,” “expect,” “intend,” “plan,” “believe,” “will,” “should,” “forecast” and similar expressions in connection with any discussion of future operating or financial performance. In particular, these include statements about any of the following: any projections of or guidance as to earnings, revenue, sales, profit margins, expense rate, cash, effective tax rate, product mix, capital expense or any other financial items; the expected impact of the COVID-19 pandemic and related public health measures (including but not limited to their impact on sales, operations or clinical trials globally), 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 2022 and 2023 business plans; 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, such statements are inherently subject to risks and we can give no assurance that our expectations will prove to be correct. Actual results could differ from those described in this report because of numerous factors, many of which are beyond our control. These factors include, without limitation, those described in in our Annual Report on Form 10-K in “Item 1A. Risk Factors” filed on February 23, 2022. We undertake no obligation to update these forward-looking statements after the date of this report to reflect future events or circumstances or to reflect actual outcomes.
The following discussion should be read in conjunction with the audited consolidated financial statements of STAAR, including the related notes, provided in this report.
Overview
STAAR Surgical Company designs, develops, manufactures, and sells implantable lenses for the eye and companion delivery systems used to deliver the lenses into the eye. We are the world’s leading manufacturer of intraocular lenses for patients seeking refractive vision correction, and we also make lenses for use in surgery to treat cataracts. All the lenses we make are foldable, which allows the surgeon to insert them into the eye through a small incision during minimally invasive surgery. Refractive surgery is performed to treat the type of visual disorders that have traditionally been corrected using eyeglasses or contact lenses. We refer to our lenses used in refractive surgery as “implantable Collamer® lenses” or “ICLs.” The field of refractive surgery includes both lens-based procedures, using products like our ICL family of products, and laser-based procedures like LASIK. Successful refractive surgery can correct common vision disorders such as myopia, hyperopia, and astigmatism. Cataract surgery is a common outpatient procedure where the eye’s natural lens that has become cloudy with age is removed and replaced with an artificial lens called an intraocular lens (“IOL”) to restore the patient’s vision. STAAR employs a commercialization strategy that strives for sustainable profitable growth. 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 position our cataract IOL lenses used in surgery that treats cataracts based on quality and value.
Recent Developments
STAAR achieved 30% net sales growth in the third quarter despite constant currency challenges and, in Europe, macroeconomic headwinds. In the third quarter global ICL unit growth was up 40% year over year, highlighted by unit growth in China up 52%, the U.S. up 63%, Japan up 40%, South Korea up 49% and Asia Pacific distributor markets up 47%. We advanced our patient awareness, engagement and market building initiatives for EVO in the U.S. during and subsequent to the third quarter, and introduced our presbyopia lens, EVO Viva™, to surgeons at our Experts Meeting preceding the annual congress of the European Society of Cataract and Refractive Surgeons. In China, we expect to exceed a 25% share of refractive surgery market units by year end. Due to tighter COVID restrictions in China resulting in expected delayed demand in the fourth quarter, ongoing headwinds in Europe, weakness in the Yen and Euro, and lower Other Products sales, we now anticipate total net sales will be approximately $285 million for fiscal 2022. Our fiscal 2022 outlook includes ICL sales of approximately $272 million, representing 28% year over year growth, and Other Products sales of approximately $13 million.”
Our low margin Other Products business, which represents approximately 5% of sales and consists of cataract IOLs, IOL injectors and injector parts, has faced increasing supply chain challenges. As a result of third-party materials and supply chain
18
challenges that only affect our Other Products business, we will no longer be able to support Other Products as we have historically. We will continue to support customers of Other Products through the end of 2023. As we look to fiscal 2023, we expect to achieve approximately 30% ICL sales growth, year over year, to approximately $355 million in total company net sales which contemplates limited sales from Other Products. We do not expect contribution from Other Products thereafter. We continue to see significant growth potential for our EVO family of lenses globally.
Critical Accounting Estimates
This Management’s Discussion and Analysis of Financial Condition and Results of Income 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 nine months ended September 30, 2022 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 31, 2021.
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 |
|
|
Percentage of Net Sales for Nine Months |
|
||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||||
|
Net sales |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
Cost of sales |
|
|
20.5 |
% |
|
|
22.4 |
% |
|
|
21.2 |
% |
|
|
22.1 |
% |
|
Gross profit |
|
|
79.5 |
% |
|
|
77.6 |
% |
|
|
78.8 |
% |
|
|
77.9 |
% |
|
General and administrative |
|
|
18.4 |
% |
|
|
18.9 |
% |
|
|
18.1 |
% |
|
|
19.0 |
% |
|
Selling and marketing |
|
|
30.4 |
% |
|
|
31.1 |
% |
|
|
29.3 |
% |
|
|
29.3 |
% |
|
Research and development |
|
|
12.7 |
% |
|
|
14.2 |
% |
|
|
12.0 |
% |
|
|
14.5 |
% |
|
Total selling, general and administrative |
|
|
61.5 |
% |
|
|
64.2 |
% |
|
|
59.4 |
% |
|
|
62.8 |
% |
|
Operating income |
|
|
18.0 |
% |
|
|
13.4 |
% |
|
|
19.4 |
% |
|
|
15.1 |
% |
|
Total other expense, net |
|
|
(1.5 |
)% |
|
|
(0.8 |
)% |
|
|
(1.5 |
)% |
|
|
(0.9 |
)% |
|
Income before income taxes |
|
|
16.5 |
% |
|
|
12.6 |
% |
|
|
17.9 |
% |
|
|
14.2 |
% |
|
Provision for income taxes |
|
|
3.0 |
% |
|
|
2.3 |
% |
|
|
3.0 |
% |
|
|
2.8 |
% |
|
Net income |
|
|
13.5 |
% |
|
|
10.3 |
% |
|
|
14.9 |
% |
|
|
11.4 |
% |
19
Net Sales
The following table presents our net sales, by product (dollars in thousands):
|
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Nine Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
2022 vs. 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
2022 vs. 2021 |
|
||||||
|
ICLs |
|
$ |
71,953 |
|
|
$ |
54,153 |
|
|
|
32.9 |
% |
|
$ |
208,550 |
|
|
$ |
159,889 |
|
|
|
30.4 |
% |
|
Other product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cataract IOLs |
|
|
2,191 |
|
|
|
2,525 |
|
|
|
(13.2 |
)% |
|
|
7,640 |
|
|
|
9,324 |
|
|
|
(18.1 |
)% |
|
Other surgical products |
|
|
1,902 |
|
|
|
1,674 |
|
|
|
13.6 |
% |
|
|
4,157 |
|
|
|
2,258 |
|
|
|
84.1 |
% |
|
Total other product sales |
|
|
4,093 |
|
|
|
4,199 |
|
|
|
(2.5 |
)% |
|
|
11,797 |
|
|
|
11,582 |
|
|
|
1.9 |
% |
|
Net sales |
|
$ |
76,046 |
|
|
$ |
58,352 |
|
|
|
30.3 |
% |
|
$ |
220,347 |
|
|
$ |
171,471 |
|
|
|
28.5 |
% |
Net sales for the three months ended September 30, 2022 increased 30% from the same period of 2021. The increase in net sales was due to increased ICL sales of $17.8 million. Changes in foreign currency unfavorably impacted net sales by $4.0 million.
Net sales for the nine months ended September 30, 2022 increased 29% from same period of 2021. The increase in net sales was due to increased ICL sales of $48.7 million. Changes in foreign currency unfavorably impacted net sales by $9.0 million.
Total ICL sales for the three months ended September 30, 2022 increased 33% from the same period of 2021, with unit increase of 40%. The APAC region sales increased by 40%, with unit growth up 47%, due to sales growth in Korea up 50%, China up 49%, other APAC regions up 49% and Japan up 12%. The Europe, Middle East, Africa and Latin America region sales decreased 9% with unit decrease of 2%, due to sales decreases in in our direct markets down 12% and distributor markets down 4%. The North America region sales increased 66%, with unit growth up 56%, primarily due to sales growth in the U.S. up 75%. In late March 2022, the U.S. started to sell EVO ICLs. Changes in foreign currency unfavorably impacted ICL sales by $3.2 million for the three months ended September 30, 2022, which impacted our Japan and Europe, Middle East and Africa markets. ICL sales represented 94.6% and 92.8% of our total sales for the three months ended September 30, 2022 and October 1, 2021, respectively.
Total ICL sales for the nine months ended September 30, 2022 increased 30% from the same period of 2021, with unit increase of 38%. The APAC region sales increased by 38%, with unit growth up 43%, due to sales growth in other APAC regions up 59%, India up 44%, China up 44%, Korea up 25% and Japan up 16%. The Europe, Middle East, Africa and Latin America region sales decreased 1% with unit growth up 12%, due to sales decreases in our direct markets down 8%, offset by sales growth in distributor markets up 8%. The North America region sales increased 43%, with unit growth up 35%, primarily due to sales growth in the U.S. up 47%. In late March 2022, the U.S. started to sell EVO ICLs. Changes in foreign currency unfavorably impacted ICL sales by $7.2 million for the nine months ended September 30, 2022, which impacted our Japan and Europe, Middle East and Africa markets. ICL sales represented 94.6% and 93.2% of our total sales for the nine months ended September 30, 2022 and October 1, 2021, respectively.
Other product sales, including cataract IOLs for the three months ended September 30, 2022, decreased 3% from the same period of 2021, due to decreased sales of cataract IOLs, partially offset by other surgical products. Other product sales for the nine months ended September 30, 2022, increased 2% due to other surgical products, offset by decreased sales of cataract IOLs. Included in other product sales are sales of preloaded injector parts. In the first half of 2021, we experienced product yield issues requiring rework related to preloaded injector parts manufactured on our behalf by a third-party vendor then sold by us to a third-party manufacturer for product they sell to their customers. Changes in foreign currency unfavorably impacted other product sales by $0.8 million and $1.8 million for the three and nine months September 30, 2022, respectively. Other product sales represented 5.4% and 7.2% of our total sales for the three months ended September 30, 2022 and October 1, 2021, respectively, and represented 5.4% and 6.8% of our total sales for the nine months ended September 30, 2022 and October 1, 2021, respectively.
20
Gross Profit
The following table presents our gross profit and gross profit margin (dollars in thousands):
|
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Nine Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
2022 vs. 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
2022 vs. 2021 |
|
||||||
|
Gross profit |
|
$ |
60,462 |
|
|
$ |
45,301 |
|
|
|
33.5 |
% |
|
$ |
173,598 |
|
|
$ |
133,646 |
|
|
|
29.9 |
% |
|
Gross margin |
|
|
79.5 |
% |
|
|
77.6 |
% |
|
|
|
|
|
|
78.8 |
% |
|
|
77.9 |
% |
|
|
|
|
Gross profit for the three months ended September 30, 2022 increased 33.5% from the same period of 2021. Gross profit margin increased to 79.5% of revenue for the three months ended September 30, 2022 compared to 77.6% of revenue for the three months ended October 1, 2021, due mainly to product and geographic sales mix, partially offset by increased period costs associated with manufacturing projects.
Gross profit for the nine months ended September 30, 2022 increased 29.9% from the same period of 2021. Gross profit margin increased to 78.8% of revenue for the nine months ended September 30, 2022 compared to 77.9% of revenue for the nine months ended October 1, 2021, due mainly to product and geographic sales mix, partially offset by inventory reserves recognized as a result of discontinuance of our older generation Visian ICL in the U.S. and increased period costs associated with manufacturing projects.
General and Administrative Expense
The following table presents our general and administrative expenses (dollars in thousands):
|
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Nine Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
2022 vs. 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
2022 vs. 2021 |
|
||||||
|
General and administrative expense |
|
$ |
14,011 |
|
|
$ |
11,018 |
|
|
|
27.2 |
% |
|
$ |
39,934 |
|
|
$ |
32,671 |
|
|
|
22.2 |
% |
|
Percentage of sales |
|
|
18.4 |
% |
|
|
18.9 |
% |
|
|
|
|
|
|
18.1 |
% |
|
|
19.0 |
% |
|
|
|
|
General and administrative expenses for the three months ended September 30, 2022 increased 27.2% from the same period of 2021 due to increased stock-based compensation expenses, facility costs and outside services. General and administrative expenses for the nine months ended September 30, 2022 increased 22.2% from the same period of 2021 due to increased facility costs, stock-based compensation expenses and outside services.
Selling and Marketing Expense
The following table presents our selling and marketing expenses (dollars in thousands):
|
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Nine Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
2022 vs. 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
2022 vs. 2021 |
|
||||||
|
Selling and marketing expense |
|
$ |
23,130 |
|
|
$ |
18,175 |
|
|
|
27.3 |
% |
|
$ |
64,633 |
|
|
$ |
50,229 |
|
|
|
28.7 |
% |
|
Percentage of sales |
|
|
30.4 |
% |
|
|
31.1 |
% |
|
|
|
|
|
|
29.3 |
% |
|
|
29.3 |
% |
|
|
|
|
Selling and marketing expenses for the three months ended September 30, 2022 increased 27.3% from the same period of 2021 due to increased trade shows and sales meetings, advertising and promotional activities, travel expenses and stock-based compensation expenses. Selling and marketing expenses for the nine months ended September 30, 2022 increased 28.7% from the same period of 2021 due to increased advertising and promotional activities, trade shows and sales meetings, travel expenses and stock-based compensation expenses.
21
Research and Development Expense
The following table presents our research and development expenses (dollars in thousands):
|
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Nine Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
2022 vs. 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
2022 vs. 2021 |
|
||||||
|
Research and development expense |
|
$ |
9,616 |
|
|
$ |
8,271 |
|
|
|
16.3 |
% |
|
$ |
26,193 |
|
|
$ |
24,790 |
|
|
|
5.7 |
% |
|
Percentage of sales |
|
|
12.7 |
% |
|
|
14.2 |
% |
|
|
|
|
|
|
12.0 |
% |
|
|
14.5 |
% |
|
|
|
|
Research and development expenses for the three months ended September 30, 2022 increased 16.3% from the same period of 2021 due mainly to increased salary-related and payroll tax expenses. Research and development expenses for the nine months ended September 30, 2022 increased 5.7% from the same period of 2021 due mainly to increased salary-related and payroll tax expenses and stock-based compensation expenses, partially offset by decreased clinical expenses associated with our clinical trials.
Other Expense, Net
The following table presents our other expenses, net (dollars in thousands):
|
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Nine Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
2022 vs. 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
2022 vs. 2021 |
|
||||||
|
Other expense, net |
|
$ |
(1,128 |
) |
|
$ |
(461 |
) |
|
|
—* |
|
|
$ |
(3,265 |
) |
|
$ |
(1,626 |
) |
|
|
—* |
|
|
Percentage of sales |
|
|
(1.5 |
)% |
|
|
(0.8 |
)% |
|
|
|
|
|
|
(1.5 |
)% |
|
|
(0.9 |
)% |
|
|
|
|
|
* |
Denotes change is greater than +100%. |
The change in other expense, net for the three and nine months ended September 30, 2022 and October 1, 2021, respectively, was due primarily to foreign exchange losses (primarily euro), and for the three and nine months ended September 30, 2022, partially offset by increased interest income mainly due to our investments held available for sale.
Income Taxes
The following table presents our income tax provision (dollars in thousands):
|
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Nine Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
2022 vs. 2021 |
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
|
2022 vs. 2021 |
|
||||||
|
Income tax provision |
|
$ |
2,315 |
|
|
$ |
1,356 |
|
|
|
70.7 |
% |
|
$ |
6,671 |
|
|
$ |
4,751 |
|
|
|
40.4 |
% |
The effective tax rates for the three months ended September 30, 2022 and October 1, 2021 was 18.4% and 18.4%, respectively, and was 16.9% and 19.5%, for the nine months ended September 30, 2022 and October 1, 2021, respectively. Our effective tax rates differ from the U.S. federal statutory rate of 21% for the three and nine months ended September 30, 2022 and October 1, 2021, respectively, primarily due to the income taxes generated in foreign jurisdictions. The differences in the effective tax rate for the three and nine months ended September 30, 2022 compared to the same period in 2021 was primarily due to jurisdictions in which the income is earned.
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
We believe that current cash and cash equivalents, investments available for sale and future cash flow from operating activities 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 included in this quarterly report. Our financial condition at September 30, 2022 and December 31, 2021 included the following (in thousands):
|
|
|
September 30, 2022 |
|
|
December 31, 2021 |
|
|
2022 vs. 2021 |
|
|||
|
Cash and cash equivalents |
|
$ |
129,242 |
|
|
$ |
199,706 |
|
|
$ |
(70,464 |
) |
|
Investments available for sale |
|
|
95,451 |
|
|
|
— |
|
|
|
95,451 |
|
|
Total |
|
$ |
224,693 |
|
|
$ |
199,706 |
|
|
$ |
24,987 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets |
|
$ |
296,910 |
|
|
$ |
271,411 |
|
|
$ |
25,499 |
|
|
Current liabilities |
|
|
45,320 |
|
|
|
48,802 |
|
|
|
(3,482 |
) |
|
Working capital |
|
$ |
251,590 |
|
|
$ |
222,609 |
|
|
$ |
28,981 |
|
Cash and cash equivalents include cash and balances in deposits and money market accounts held at banks and financial institutions. Our investment policy 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 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. 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 nine months ended September 30, 2022 and October 1, 2021 was as follows (in thousands):
|
|
|
Nine Months Ended |
|
|||||
|
|
|
September 30, 2022 |
|
|
October 1, 2021 |
|
||
|
Cash flows from: |
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
32,745 |
|
|
$ |
35,464 |
|
|
Investing activities |
|
|
(109,659 |
) |
|
|
(8,956 |
) |
|
Financing activities |
|
|
8,095 |
|
|
|
18,009 |
|
|
Effect of exchange rate changes |
|
|
(1,645 |
) |
|
|
(724 |
) |
|
Net increase (decrease) in cash and cash equivalents |
|
|
(70,464 |
) |
|
|
43,793 |
|
|
Cash and cash equivalents, at beginning of year |
|
|
199,706 |
|
|
|
152,453 |
|
|
Cash and cash equivalents, at end of year |
|
$ |
129,242 |
|
|
$ |
196,246 |
|
For the nine months ended September 30, 2022, net cash used by operating activities consisted of $32.9 million in net income, $20.6 million in non-cash items, offset by $20.8 million in working-capital changes.
In the three months ended September 30, 2022, we decided to invest our cash in slightly higher yielding securities. For the nine months ended September 30, 2022, net cash used in investment activities was $109.7 million which consisted of $95.6 million in purchases of investments available for sale and $14.1 million in purchases of property, plant and equipment. The increase in investments of property, plant and equipment of $5.1 million for the nine months ended September 30, 2022 relative to the same period of 2021, was due to increased investments in manufacturing facilities.
Net cash provided by financing activities for the nine months ended September 30, 2022 consisted of $8.2 million of proceeds from the exercise of stock options. For the nine months ended October 1, 2021, net cash provided by financing activities consisted of $18.3 million of proceeds from the exercise of stock options, partially offset by $0.3 million repayment of finance lease obligations.
23
Commitments
Employment Agreements
The Company’s Chief Executive Officer entered into an employment agreement with the Company, effective March 1, 2015. She 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 nine months ended September 30, 2022, 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 31, 2021.
|
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 September 30, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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. STAAR 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.
24
|
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 31, 2021. 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 |
None.
|
ITEM 6. |
EXHIBITS |
|
3.1 |
|
|
|
|
|
3.2 |
|
|
|
|
|
4.1 |
Form of Certificate for Common Stock, par value $0.01 per share.(3) |
|
|
|
|
†4.2 |
|
|
|
|
|
31.1 |
|
|
|
|
|
31.2 |
|
|
|
|
|
32.1 |
|
|
|
|
|
101 |
Financial statements from the quarterly report on Form 10-Q of STAAR Surgical Company for the quarter ended September 30, 2022 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.* |
|
|
|
|
104 |
The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, has been formatted in Inline XBRL with applicable taxonomy extension information contained in Exhibit 101. |
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(1) |
Incorporated by reference to Appendix 2 of the Company’s Proxy Statement on Form DEF 14A as filed with the Commission on April 13, 2018. |
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(2) |
Incorporated by reference to Appendix 3 of the Company’s Proxy Statement on Form DEF 14A as filed with the Commission on April 13, 2018. |
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(3) |
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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(4) |
Incorporated by reference to Exhibit 4.2 to the Company’s Quarterly Report on Form 10-Q, for the period ended July 3, 2020, as filed with the Commission on August 5, 2020. |
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* |
Filed herewith. |
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** |
Furnished herewith. |
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† |
Management contract or compensatory plan. |
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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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November 2, 2022 |
By: |
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/s/ PATRICK F. WILLIAMS |
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Patrick F. Williams |
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Chief Financial Officer |
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(on behalf of the Registrant and as its principal financial officer) |
26
Exhibit 31.1
Certifications
I, Caren Mason, 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.
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November 2, 2022 |
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/s/ CAREN MASON |
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Caren Mason |
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President, Chief Executive Officer, and Director |
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(principal executive officer) |
Exhibit 31.2
Certifications
I, Patrick F. Williams, 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.
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Dated: |
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November 2, 2022 |
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/s/ PATRICK F. WILLIAMS |
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Patrick F. Williams |
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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 September 30, 2022 (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.
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Dated: |
November 2, 2022 |
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/s/ CAREN MASON |
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Caren Mason |
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President, Chief Executive Officer, |
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and Director (principal executive officer) |
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Dated: |
November 2, 2022 |
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/s/ PATRICK F. WILLIAMS |
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Patrick F. Williams |
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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.