Staar Surgical Co 10-Q for FY2020 Q3
Staar Surgical Co (STAA)
About this 10-Q
Staar Surgical Co filed this 10-Q on November 4, 2020, covering the quarter ended October 2, 2020 (FY2020 Q3).
Headline figures
Quarter ended October 2, 2020, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $47.08M
- up 20.6% from $39.06M a year earlier
- Net income
- $3.89M
- up 63.0% from net income of $2.39M a year earlier
- Diluted EPS
- $0.08
- up 60.0% from $0.05 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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October 2, 2020 |
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January 3, 2020 |
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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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Accounts receivable trade, net of allowance of doubtful accounts of $ |
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Inventories, net |
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Prepayments, deposits and other current assets |
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Total current assets |
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Property, plant and equipment, net |
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Finance lease right-of-use assets, net |
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Operating lease right-of-use assets, net |
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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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Line of credit |
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$ |
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$ |
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Accounts payable |
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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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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, $ January 3, 2020, 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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October 2, 2020 |
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September 27, 2019 |
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October 2, 2020 |
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September 27, 2019 |
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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 income (expense), net: |
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Interest income, net |
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Gain (loss) on foreign currency transactions |
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( |
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Royalty income |
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Other income (expense), net |
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Total other income (expense), net |
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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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October 2, 2020 |
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September 27, 2019 |
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October 2, 2020 |
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September 27, 2019 |
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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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( |
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( |
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( |
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( |
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Reclassification into other income, net |
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Foreign currency translation loss |
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( |
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Tax effect |
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( |
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( |
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Other comprehensive income (loss), net of tax |
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( |
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( |
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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 3, 2020 |
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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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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 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 2, 2020 |
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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 June 28, 2019 |
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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 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 27, 2019 |
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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 (CONTINUED)
(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 January 3, 2020 |
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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 stock |
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— |
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— |
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— |
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Balance, at October 2, 2020 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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Balance, at December 28, 2018 |
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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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Impact of the adoption of lease accounting standard |
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— |
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— |
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— |
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— |
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Impact of adoption of nonemployee share-based payment standard |
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— |
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— |
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( |
) |
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— |
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— |
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Other comprehensive loss |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Common stock issued upon exercise of options |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Unvested restricted stock |
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|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Vested restricted stock |
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
Balance, at September 27, 2019 |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
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 |
|
|||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
||
|
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 |
|
|
|
|
|
|
|
|
|
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 |
|
|
( |
) |
|
|
( |
) |
|
Acquisition of patents and licenses |
|
|
— |
|
|
|
( |
) |
|
Net cash used in investing activities |
|
|
( |
) |
|
|
( |
) |
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
Repayment of finance lease obligations |
|
|
( |
) |
|
|
( |
) |
|
Repayment on line of credit |
|
|
( |
) |
|
|
( |
) |
|
Proceeds from the exercise of stock options |
|
|
|
|
|
|
|
|
|
Proceeds from vested restricted stock |
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities |
|
|
|
|
|
|
( |
) |
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
|
|
|
|
|
|
|
|
Increase in cash, cash equivalents and restricted cash |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and restricted cash, at beginning of the period |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and restricted cash, 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 January 3, 2020 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 January 3, 2020.
The Condensed Consolidated Financial Statements for the three and nine months ended October 2, 2020 and September 27, 2019, 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 October 2, 2020 and September 27, 2019, 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.
Vendor Concentration
There were two vendors which accounted for over
Use of Estimates
During the COVID-19 pandemic, the Company believes it has used reasonable estimates and assumptions in determining valuation allowances for uncollectible trade receivables, sales returns reserves, obsolete and excess inventory reserves, deferred income taxes, and tax reserves, including valuation allowances for deferred tax assets, pension liabilities, evaluation of asset impairment, in determining the useful life of depreciable and definite-lived intangible assets, and in the variables and assumptions used to calculate and record stock-based compensation. Throughout the COVID-19 pandemic the Company offered extended payment terms to assist its surgeon customers and their clinics as they resumed business. During the quarter ended October 2, 2020, the Company has experienced improvements in customer payments and is unaware of any material impairment of customer receivables. The Company’s sales representatives throughout the world remain engaged with customers conducting online training and other educational courses which have been very well attended. This activity has given the Company insight into COVID-19’s impact on customers and potential impairment of receivables.
Recently Adopted Accounting Pronouncements and Recent Accounting Pronouncements Not Yet Adopted
On January 4, 2020 (beginning of fiscal year 2020), the Company adopted Accounting Standards Update (“ASU”) 2016‑13, “Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,” which (i) significantly changes the impairment model for most financial assets that are measured at amortized cost and certain other instruments from an incurred loss model to an expected loss model; and (ii) provides for recording credit losses on available-for-sale debt securities through an allowance account. ASU 2016-13 also requires certain incremental disclosures. Subsequently, the FASB issued ASU 2018-19, ASU 2019-04, ASU 2019-05, ASU 2020-02 and ASU 2020-03 to clarify and improve ASU 2016-13. The adoption of ASU 2016-13 did not have a material impact on the Condensed Consolidated Financial Statements.
7
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 1 — Basis of Presentation and Significant Accounting Policies (Continued)
Recently Adopted Accounting Pronouncements and Recent Accounting Pronouncements Not Yet Adopted (Continued)
On January 4, 2020 (beginning of fiscal year 2020), the Company adopted ASU 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement,” which modifies certain disclosures requirements for reporting fair value measurements. The adoption of ASU 2018-13 did not have a material impact on the Condensed Consolidated Financial Statements.
On January 4, 2020 (beginning of fiscal year 2020), the Company adopted ASU 2018-14, “Compensation – Retirement Benefits – Defined Benefit Plans – General (Subtopic 715-20); Disclosure Framework – Changes in the Disclosure Requirement for Defined Benefit Plans,” which modifies disclosure requirements for employers that sponsor defined benefit pension or other post retirement plans. The adoption of ASU 2018-14 did not have a material impact on the Condensed Consolidated Financial Statements.
In December 2019, the FASB issued ASU 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes.” ASU 2019-12 removes the following exceptions: exception to the incremental approach for intra period tax allocation; exception to accounting for basis differences when there are ownership changes in foreign investments; and exception to interim period tax accounting for year to date losses that exceed anticipated losses. ASU 2019-12 also improves financial reporting for franchise taxes that are partially based on income; transactions with a government that result in a step up in the tax basis of goodwill; separate financial statements of legal entities that are not subject to tax; and enacted changes in tax laws in interim periods. ASU 2019-12 is effective for fiscal years beginning after December 15, 2020 and interim periods within those fiscal years. Early adoption is permitted. The Company will adopt this standard as of January 2, 2021 (beginning of fiscal year 2021) and is currently evaluating the disclosure requirements and its effect on the Condensed Consolidated Financial Statements.
Note 2 — 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):
|
|
|
October 2, 2020 |
|
|
January 3, 2020 |
|
||
|
Raw materials and purchased parts |
|
$ |
|
|
|
$ |
|
|
|
Work in process |
|
|
|
|
|
|
|
|
|
Finished goods |
|
|
|
|
|
|
|
|
|
Total inventories, gross |
|
|
|
|
|
|
|
|
|
Less inventory reserves |
|
|
|
|
|
|
|
|
|
Total inventories, net |
|
$ |
|
|
|
$ |
|
|
Note 3 — Prepayments, Deposits, and Other Current Assets
Prepayments, deposits, and other current assets consisted of the following (in thousands):
|
|
|
October 2, 2020 |
|
|
January 3, 2020 |
|
||
|
Prepayments and deposits |
|
$ |
|
|
|
$ |
|
|
|
Prepaid insurance |
|
|
|
|
|
|
|
|
|
Consumption tax receivable |
|
|
|
|
|
|
|
|
|
Value added tax (VAT) receivable |
|
|
|
|
|
|
|
|
|
Other(1) |
|
|
|
|
|
|
|
|
|
Total prepayments, deposits and other current assets |
|
$ |
|
|
|
$ |
|
|
|
(1) |
|
8
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 4 — Property, Plant and Equipment
Property, plant and equipment, net consisted of the following (in thousands):
|
|
|
October 2, 2020 |
|
|
January 3, 2020 |
|
||
|
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 |
|
$ |
|
|
|
$ |
|
|
Note 5 –Intangible Assets
Intangible assets, net consisted of the following (in thousands):
|
|
|
October 2, 2020 |
|
|
January 3, 2020 |
|
||||||||||||||||||
|
Long-lived amortized intangible assets |
|
Gross Carrying Amount |
|
|
Accumulated Amortization |
|
|
Net |
|
|
Gross Carrying Amount |
|
|
Accumulated Amortization |
|
|
Net |
|
||||||
|
Patents and licenses |
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
Note 6 – Other Current Liabilities
Other current liabilities consisted of the following (in thousands):
|
|
|
October 2, 2020 |
|
|
January 3, 2020 |
|
||
|
Accrued salaries and wages |
|
$ |
|
|
|
$ |
|
|
|
Accrued bonuses |
|
|
|
|
|
|
|
|
|
Accrued insurance |
|
|
|
|
|
|
|
|
|
Income taxes payable |
|
|
|
|
|
|
|
|
|
Accrued consumption tax |
|
|
|
|
|
|
|
|
|
Accrued professional fees for clinical trials |
|
|
|
|
|
|
|
|
|
Marketing obligations |
|
|
|
|
|
|
|
|
|
Other(1) |
|
|
|
|
|
|
|
|
|
Total other current liabilities |
|
$ |
|
|
|
$ |
|
|
|
(1) |
|
Note 7 – Lines of Credit
Since 1998, the Company’s wholly owned Japanese subsidiary, STAAR Japan, has had an agreement with Mizuho Bank which provides for borrowings of up to
9
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 7 – Lines of Credit (Continued)
In September 2013, the Company’s wholly owned Swiss subsidiary, STAAR Surgical AG, entered into a framework agreement for loans (“framework agreement”) with Credit Suisse (the “Bank”). The framework agreement provides for borrowings of up to
The Company is in compliance with covenants of its credit facilities and lines of credit as of October 2, 2020.
Note 8 – Leases
Finance Leases
The Company entered into finance leases primarily related to purchases of equipment used for manufacturing or computer-related equipment. These finance leases are
|
|
|
October 2, 2020 |
|
|
January 3, 2020 |
|
||
|
Machinery and equipment |
|
$ |
|
|
|
$ |
|
|
|
Computer equipment and software |
|
|
|
|
|
|
|
|
|
Furniture and fixtures |
|
|
— |
|
|
|
|
|
|
Leasehold improvements |
|
|
— |
|
|
|
|
|
|
Finance lease right-of-use assets, gross |
|
|
|
|
|
|
|
|
|
Less accumulated depreciation |
|
|
|
|
|
|
|
|
|
Finance lease right-of-use assets, net |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total finance lease liability |
|
$ |
|
|
|
$ |
|
|
|
Weighted-average remaining lease term (in years) |
|
|
|
|
|
|
|
|
|
Weighted-average discount rate |
|
|
|
% |
|
|
|
% |
Supplemental cash flow information related to finance leases consisted of the following (dollars in thousands):
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
||||
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Right-of-use assets obtained in exchange for new finance lease liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 8 – Leases (Continued)
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
|
|
|
October 2, 2020 |
|
|
January 3, 2020 |
|
||
|
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 |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
||||
|
Operating lease cost |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Cash paid for amounts included in the measurement of operating lease liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating cash flows |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Right-of-use assets obtained in exchange for new operating lease liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Future Minimum Lease Commitments
Estimated future minimum lease payments under operating and finance leases having initial or remaining non-cancelable lease terms more than one year as of October 2, 2020 is as follows (in thousands):
|
As of October 2, 2020 12 Months Ended |
|
Operating Leases |
|
|
Finance Leases |
|
||
|
September 2021 |
|
$ |
|
|
|
$ |
|
|
|
September 2022 |
|
|
|
|
|
|
|
|
|
September 2023 |
|
|
|
|
|
|
|
|
|
September 2024 |
|
|
|
|
|
|
|
|
|
September 2025 |
|
|
|
|
|
|
— |
|
|
Thereafter |
|
|
|
|
|
|
— |
|
|
Total minimum lease payments, including interest |
|
$ |
|
|
|
$ |
|
|
|
Less amounts representing interest |
|
|
|
|
|
|
|
|
|
Total minimum lease payments |
|
$ |
|
|
|
$ |
|
|
11
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 9 — Income Taxes
The Company recorded an income tax provision as follows (in thousands):
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
||||
|
Provision for income taxes |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
The Company recorded income taxes of $
The 2017 Tax Act subjects a U.S. shareholder to tax on Global Intangible Low Tax Income (“GILTI”) earned by certain foreign subsidiaries. In general, GILTI is the excess of a U.S. shareholder’s total net foreign income over a deemed return on tangible assets. The provision further allows a deduction of
On July 20, 2020 the U.S. Treasury issued final regulations for addressing the treatment of foreign income that is subject to a high rate of foreign tax (the GILTI high-tax exclusion). The final regulations allow companies to exclude certain high-taxed income from their GILTI calculation. The GILTI high-tax exclusion applies if the effective foreign tax rate is 90% or more of the rate that would apply if the income were subject to the maximum US rate of tax specified in section 11 (currently 18.9%, based on a maximum rate of 21%). The final regulations also provide that the GILTI high-tax exclusion is an annual election made each year and is retroactive to years beginning after December 31, 2017. The Company has made the election to exclude certain high-taxed income from its GILTI calculation for 2019 and the three and nine months ended October 2, 2020.
The ultimate realization of deferred tax assets is dependent upon future generation of income during the periods in which temporary differences representing net future deductible amounts become deductible. Management considers the projected future income and tax planning strategies in making this assessment. As of fiscal year end 2019, the Company had three years of accumulated profits for federal and various state income tax purposes as a result of GILTI. However, the three-year income position is not solely determinative and, accordingly, management considers all other available positive and negative evidence in its analysis. This includes existing profits in foreign jurisdiction as well as projected future profits. As further described in Notes 1 and 10 of the Company’s fiscal 2019 Form 10-K, under the “incremental cash tax savings approach,” the Company recorded a valuation allowance release of $
12
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 9 — Income Taxes (Continued)
Under the incremental cash tax savings approach, the U.S. valuation allowances of $
On March 27, 2020, the Coronavirus Aid, Relief and Economic Security (“CARES”) Act was enacted and signed into law. The Company reviewed the provisions of the CARES Act, but does not expect it to have a material impact to its tax provision (also see note 15).
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 |
|
||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
||||
|
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) |
|
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 |
|
||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
||||
|
Employer contribution |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
13
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
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 |
|
||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
||||
|
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 |
|
||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
||||
|
Cost of sales |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketing and selling |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
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 an
14
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 11 — Stockholders’ Equity (Continued)
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
||||
|
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 the nine months ended October 2, 2020 is presented below:
|
|
|
Stock Options (in 000’s) |
|
|
Minimum Exercise Price |
|
|
Maximum Exercise Price |
|
|||
|
Outstanding at January 3, 2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
Outstanding at October 2, 2020 |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
Exercisable at October 2, 2020 |
|
|
|
|
|
|
|
|
|
|
|
|
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 October 2, 2020 is presented below:
|
|
|
Restricted Stock (in 000’s) |
|
|
Restricted Stock Units (in 000’s) |
|
|
Performance Stock Units (in 000’s) |
|
|||
|
Unvested at January 3, 2020 |
|
|
|
|
|
|
|
|
|
|
— |
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
|
Forfeited or expired |
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
Unvested at October 2, 2020 |
|
|
|
|
|
|
|
|
|
|
|
|
Note 12 - Commitments and Contingencies
Litigation and Claims
On August 19, 2020, a putative federal securities class action, Alwazaan v. STAAR Surgical Co., et al., was filed against the Company and certain of its executives in the U.S. District Court for the Central District of California. On September 1, 2020, a substantially similar federal securities class action, Zhang v. STAAR Surgical Co., et al., was filed against the Company and the same executives in the U.S. District Court for the Central District of California. On September 11, 2020, the court consolidated the two actions under the caption In re STAAR Surgical Co. Securities Litigation. The plaintiffs in the lawsuit allege that the Company made material misstatements regarding its sales in China, its marketing spend, and its R&D expenses. Plaintiffs seek compensatory and punitive damages as well as attorneys’ fees. Although the ultimate outcome of this action cannot be determined with certainty, the Company denies any wrongdoing and will vigorously defend itself against these claims.
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.
15
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
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 |
|
||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
||||
|
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 |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Performance stock units |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
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 |
|
||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
||||
|
Stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted stock, restricted stock units and performance stock units |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
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 |
|
||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
||||
|
Non-consignment sales |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Consignment sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net sales |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
The Company markets and sells its products in over
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
||||
|
Domestic |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Foreign: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
China |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Japan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other(1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total foreign sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net sales |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
(1) |
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
||||
|
ICLs |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Other product sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IOLs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other surgical products |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other product sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net sales |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
One customer, the Company’s distributor in China, accounted for
17
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 15 — COVID-19 and CARES Act 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 be significant. Accordingly, the Company cannot predict the extent to which its financial condition and results of operation will be affected. On March 17, 2020, the Company suspended most of its production and non-essential business locations where employees can work from home. A very limited number of manufacturing personnel remained at work for critical late staged processes, until the end of March 2020. Manufacturing resumed on April 27, 2020. The Company’s revenues have been adversely impacted, as customers in China were not able to carry out procedures during the month of February 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, 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 expects decreases in sales in certain geographies to continue through the remainder of 2020 and into 2021 as different geographies resume business activities on differing timelines.
The CARES Act, among other things, includes provisions relating to refundable payroll tax credits, deferment of employer side social security payments, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations, increased limitations on qualified charitable contributions, and technical corrections to tax depreciation methods for qualified improvement property. The Company did not apply for or require financing available under the CARES Act and does not expect to do so given the strength of our balance sheet. The Company will continue to monitor the impact that the CARES Act may have on its business, financial condition, results of operations, or liquidity.
18
|
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, 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 (including the EVO family of lenses in the U.S. and the EVO Viva family of lenses for presbyopia internationally); 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 2020 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, risks and uncertainties related to the COVID-19 pandemic and related public health measures, and those described in in our Annual Report on Form 10-K in “Item 1A. Risk Factors” filed on February 26, 2020, as well as the updated risk factor disclosed in our Quarterly Report on Form 10-Q in “Item 1A. Risk Factors” filed on May 16, 2020. 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 IOL lenses used in surgery that treats cataracts based on quality and value.
Recent Developments
For the third quarter of 2020 STAAR’s net sales increased 21% over the prior year driven by 25% global ICL unit growth as markets more fully reopened following COVID-19 related shutdowns. Notable markets for ICL unit growth in the third quarter of 2020 included China, Japan, South Korea, Spain, Germany, European distributor markets, and rest of APAC. India and the Middle East were the two markets that remained most challenged by COVID-19 during the third quarter. During the third quarter we completed patient enrollment in our U.S. EVO clinical trial and by October 30, 2020 all primary patients in the trial were implanted with the lens. Primary study analysis will be conducted when 300 primary eyes complete six months of follow-up, which is anticipated early in the second quarter of 2021 with submission of the study results to the FDA shortly thereafter. Considering the subsequent six-month patient follow-up and time to prepare our data submission to the FDA, we believe we are on track for potential marketing approval and commercialization of EVO in the U.S. in the second half of 2021. Also, on November 4, 2020, we announced the first EVO Viva lens patient who was implanted in Belgium. We are embarking upon the phased rollout of that presbyopia-correcting lens in Europe.
19
While COVID-19 hotspots and government public health mandates may reoccur moving forward, we anticipate less business interruption and continued interest in our EVO ICL lens-based refractive solutions in the fourth quarter of 2020. We also continue to believe that we will achieve a 20% share of the refractive procedure market in China by the end of the year. Assuming significant COVID-19 hotspots and government public health mandates do not reoccur and global economic improvement progresses, our outlook for the fourth quarter of 2020 currently anticipates revenue in the range of $42 to $44 million with the caveat of increased spending to support a developing strong outlook for 2021.
Critical Accounting Policies
This Management’s Discussion and Analysis of Financial Condition and Results of Operations discusses and analyzes data in our unaudited Condensed Consolidated Financial Statements provided in this report, which we have prepared in accordance with U.S. generally accepted accounting principles. Preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. Management bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Senior management has discussed the development, selection and disclosure of these estimates with the Audit Committee of our Board of Directors. Actual conditions may differ from our assumptions and actual results may differ from our estimates.
An accounting policy is deemed critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, if different estimates reasonably could have been used, or if changes in the estimate that are reasonably likely to occur could materially impact the financial statements. Management believes that there have been no significant changes during the nine months ended October 2, 2020 to the items that we disclosed as our critical accounting policies and 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 January 3, 2020.
Results of Operations
The following table shows the percentage of our total sales represented by certain items reflected in our Condensed Consolidated Statements of Operations for the periods indicated.
|
|
|
Percentage of Net Sales for Three Months |
|
|
Percentage of Net Sales for Nine Months |
|
||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
||||
|
Net sales |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
Cost of sales |
|
|
25.9 |
% |
|
|
25.6 |
% |
|
|
28.4 |
% |
|
|
25.3 |
% |
|
Gross profit |
|
|
74.1 |
% |
|
|
74.4 |
% |
|
|
71.6 |
% |
|
|
74.7 |
% |
|
General and administrative |
|
|
18.2 |
% |
|
|
18.2 |
% |
|
|
20.8 |
% |
|
|
19.3 |
% |
|
Selling and marketing |
|
|
26.9 |
% |
|
|
31.9 |
% |
|
|
29.0 |
% |
|
|
30.8 |
% |
|
Research and development |
|
|
18.6 |
% |
|
|
15.8 |
% |
|
|
19.5 |
% |
|
|
16.1 |
% |
|
Total selling, general and administrative |
|
|
63.7 |
% |
|
|
65.9 |
% |
|
|
69.3 |
% |
|
|
66.2 |
% |
|
Operating income |
|
|
10.4 |
% |
|
|
8.5 |
% |
|
|
2.3 |
% |
|
|
8.5 |
% |
|
Total other income (expense), net |
|
|
1.1 |
% |
|
|
(0.5 |
)% |
|
|
0.7 |
% |
|
|
0.5 |
% |
|
Income before income taxes |
|
|
11.5 |
% |
|
|
8.0 |
% |
|
|
3.0 |
% |
|
|
9.0 |
% |
|
Provision for income taxes |
|
|
3.2 |
% |
|
|
1.9 |
% |
|
|
0.8 |
% |
|
|
2.1 |
% |
|
Net income |
|
|
8.3 |
% |
|
|
6.1 |
% |
|
|
2.2 |
% |
|
|
6.9 |
% |
20
Net Sales
|
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Nine Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
2020 vs. 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
2020 vs. 2019 |
|
||||||
|
ICLs |
|
$ |
41,493 |
|
|
$ |
33,815 |
|
|
|
22.7 |
% |
|
$ |
101,561 |
|
|
$ |
96,033 |
|
|
|
5.8 |
% |
|
Other product sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IOLs |
|
|
3,325 |
|
|
|
4,093 |
|
|
|
(18.8 |
)% |
|
|
9,880 |
|
|
|
11,984 |
|
|
|
(17.6 |
)% |
|
Other surgical products |
|
|
2,263 |
|
|
|
1,147 |
|
|
|
97.3 |
% |
|
|
6,021 |
|
|
|
3,285 |
|
|
|
83.3 |
% |
|
Total other product sales |
|
|
5,588 |
|
|
|
5,240 |
|
|
|
6.6 |
% |
|
|
15,901 |
|
|
|
15,269 |
|
|
|
4.1 |
% |
|
Net sales |
|
$ |
47,081 |
|
|
$ |
39,055 |
|
|
|
20.6 |
% |
|
$ |
117,462 |
|
|
$ |
111,302 |
|
|
|
5.5 |
% |
Net sales for the three months ended October 2, 2020 were $47.1 million, an increase of 21% from $39.1 million reported during the same period of 2019. The increase in net sales was due to increased ICL sales of $7.7 million and other product sales of $0.3 million. Changes in foreign currency favorably impacted net sales by $0.4 million.
Net sales for the nine months ended October 2, 2020 were $117.5 million, an increase of 6% from $111.3 million reported during the same period of 2019. The increase in net sales was due to increased ICL sales of $5.5 million and other product sales of $0.6 million. Changes in foreign currency favorably impacted net sales by $0.5 million.
Total ICL sales for the three months ended October 2, 2020 were $41.5 million, an increase of 23% from $33.8 million reported for the same period of 2019, with unit increase of 25%. The APAC region sales increased by 29%, with unit growth up 31% due to unit growth in Japan up 67%, other APAC Distributors up 67%, China up 33%, and Korea up 21%. The Europe, Middle East, Africa and Latin America region sales increased 7% with unit decrease of 2% due to a decrease in units in the Middle East and Africa of 54%, offset by unit growth in the UK up 44%, Spain up 24%, Distributor Operations up 17%, Germany up 13% and Latin America up 12%. The North America region sales decreased 3%, with unit decrease of 1%, due to a decrease in units of 8% in the U.S., offset by unit growth in Canada of 31%. ICL sales represented 88.1% and 86.6% of our total sales for the three months ended October 2, 2020 and September 27, 2019, respectively.
Total ICL sales for the nine months ended October 2, 2020 were $101.6 million, a 6% increase from $96.0 million reported for the same period of 2019, with unit growth up 10%. The APAC region sales increased by 13%, with unit growth up 17% due to unit growth in Japan up 62%, Korea up 17%, China up 16% and other APAC Distributors up 30%. The Europe, Middle East, Africa and Latin America region sales decreased 9% and units decreased 12%. The North America region sales and units decreased 22%. The decrease in both these regions were impacted by the COVID-19 pandemic in the first half of 2020; most markets started to reopen in mid-May/early June. ICL sales represented 86.5% and 86.3% of our total sales for the nine months ended October 2, 2020 and September 27, 2019, respectively.
Other product sales, including IOLs were $5.6 million for the three months ended October 2, 2020, an increase of 7% from $5.2 million reported for the same period of 2019. Other product sales were $15.9 million for the nine months ended October 2, 2020, an increase of 4% from $15.3 million reported for the same period of 2019. The increase in both periods was due to increased preloaded injector part sales to a third-party manufacturer for product they sell to their customers, offset by decreased IOL sales. Other product sales represented 11.9% and 13.4% of our total sales for the three months ended October 2, 2020 and September 27, 2019, respectively, and represented 13.5% and 13.7% of our total sales for the nine months ended October 2, 2020 and September 27, 2019, respectively.
Gross Profit
|
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Nine Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
2020 vs. 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
2020 vs. 2019 |
|
||||||
|
Gross profit |
|
$ |
34,871 |
|
|
$ |
29,051 |
|
|
|
20.0 |
% |
|
$ |
84,061 |
|
|
$ |
83,130 |
|
|
|
1.1 |
% |
|
Gross margin |
|
|
74.1 |
% |
|
|
74.4 |
% |
|
|
|
|
|
|
71.6 |
% |
|
|
74.7 |
% |
|
|
|
|
Gross profit for the three months ended October 2, 2020 was $34.9 million, a 20.0% increase compared to the $29.1 million reported for the same period of 2019. Gross profit margin decreased to 74.1% of revenue for the three months ended October 2, 2020 compared to 74.4% of revenue for the three months ended September 27, 2019, due to geographic sales mix, period costs associated with the manufacturing expansion projects, and increased mix of injector part sales which carry a lower margin.
21
Gross profit for the nine months ended October 2, 2020 was $84.1 million, a 1.1% increase compared to the $83.1 million reported for the same period of 2019. Gross profit margin decreased to 71.6% of revenue for the nine months ended October 2, 2020 compared to 74.7% of revenue for the three months ended September 27, 2019, due primarily to geographic sales mix, $1.2 million in expenses related to the COVID-19 manufacturing pause from March 17 through April 27, 2020, period costs associated with the manufacturing expansion projects and increased mix of injector part sales which carry a lower margin.
General and Administrative Expense
|
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Nine Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
2020 vs. 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
2020 vs. 2019 |
|
||||||
|
General and administrative expense |
|
$ |
8,589 |
|
|
$ |
7,098 |
|
|
|
21.0 |
% |
|
$ |
24,406 |
|
|
$ |
21,443 |
|
|
|
13.8 |
% |
|
Percentage of sales |
|
|
18.2 |
% |
|
|
18.2 |
% |
|
|
|
|
|
|
20.8 |
% |
|
|
19.3 |
% |
|
|
|
|
General and administrative expenses for the three months ended October 2, 2020 were $8.6 million, a 21.0% increase compared to the $7.1 million reported for the same period of 2019, due to increased salary-related expenses, variable compensation and facility costs. General and administrative expenses for the nine months ended October 2, 2020 were $24.4 million, a 13.8% increase compared to the $21.4 million reported for the same period of 2019, due to increased salary-related expenses, variable compensation, tax consulting, facility costs and corporate insurance, partially offset by decreased travel expenses.
Selling and Marketing Expense
|
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Nine Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
2020 vs. 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
2020 vs. 2019 |
|
||||||
|
Selling and marketing expense |
|
$ |
12,649 |
|
|
$ |
12,463 |
|
|
|
1.5 |
% |
|
$ |
34,003 |
|
|
$ |
34,288 |
|
|
|
(0.8 |
)% |
|
Percentage of sales |
|
|
26.9 |
% |
|
|
31.9 |
% |
|
|
|
|
|
|
29.0 |
% |
|
|
30.8 |
% |
|
|
|
|
Selling and marketing expenses for the three months ended October 2, 2020 were $12.6 million, a 1.5% increase compared to the $12.5 million reported for the same period of 2019, due to increased salary-related expenses, advertising and promotional activities and variable compensation, offset by decreased trade show and travel expenses. Marketing and selling expenses for the nine months ended October 2, 2020 were $34.0 million, an 0.8% decrease compared to the $34.3 million reported for the same period of 2019, due to decreased trade show and travel expenses, offset by increased advertising and promotional activities, salary-related expenses and variable compensation.
Research and Development Expense
|
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Nine Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
2020 vs. 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
2020 vs. 2019 |
|
||||||
|
Research and development expense |
|
$ |
8,751 |
|
|
$ |
6,156 |
|
|
|
42.2 |
% |
|
$ |
22,960 |
|
|
$ |
17,889 |
|
|
|
28.3 |
% |
|
Percentage of sales |
|
|
18.6 |
% |
|
|
15.8 |
% |
|
|
|
|
|
|
19.5 |
% |
|
|
16.1 |
% |
|
|
|
|
Research and development expenses for the three months ended October 2, 2020 were $8.8 million, a 42.2% increase compared to the $6.2 million reported for the same period of 2019, primarily due to increased clinical expenses associated with our EVO clinical trial in the U.S., variable compensation and salary-related expenses. Research and development expenses for the nine months ended October 2, 2020 were $23.0 million, a 28.3% increase compared to the $17.9 million reported for the same period of 2019, primarily due to increased clinical expenses associated with our EVO clinical trial in the U.S., and increased salary-related expenses, partially offset by travel expense.
22
Other Income (Expense), Net
|
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Nine Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
2020 vs. 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
2020 vs. 2019 |
|
||||||
|
Other income (expense), net |
|
$ |
499 |
|
|
$ |
(186 |
) |
|
|
—* |
|
|
$ |
781 |
|
|
$ |
539 |
|
|
|
44.9 |
% |
|
Percentage of sales |
|
|
1.1 |
% |
|
|
(0.5 |
)% |
|
|
|
|
|
|
0.7 |
% |
|
|
0.5 |
% |
|
|
|
|
|
* |
Denotes change is greater than +100%. |
Other income, net for the three months ended October 2, 2020 was $0.5 million, compared to other expense, net of $0.2 million reported for the same period of 2019. The change in other income (expense), net for the three months was due increased foreign exchange gains (primarily euro), partially offset by a decrease interest income, net, as a result of lower interest rates. Other income, net for the nine months ended October 2, 2020 was $0.8 million, a 44.9% increase compared to $0.5 million reported for the same period of 2019. The increase in other income, net for the nine months was due to increased foreign exchange gains (primarily the euro), offset by decreases in interest income, as a result of lower interest rates, and royalty income, which was impacted by COVID-19 pandemic.
Income Taxes
|
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Nine Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
2020 vs. 2019 |
|
|
October 2, 2020 |
|
|
September 27, 2019 |
|
|
2020 vs. 2019 |
|
||||||
|
Income tax provision (benefit) |
|
$ |
1,489 |
|
|
$ |
760 |
|
|
|
95.9 |
% |
|
$ |
887 |
|
|
$ |
2,380 |
|
|
|
(62.7 |
)% |
We recorded income taxes of $1.5 million for the three months ended October 2, 2020 due to pre-tax income generated in certain foreign jurisdictions, partially offset by a reversal of $0.2 million of our U.S. valuation allowance, as a result of an increase in foreign income and changes in the usage and release of our deferred tax assets. We recorded income taxes of $0.8 million for the three months ended September 27, 2019 due to pre-tax income generated in certain foreign jurisdictions and withholding taxes on foreign operations. We recorded income taxes of $0.9 million for the nine months ended October 2, 2020 due to income tax expense from profits generated by our foreign operations, partially offset by the release of our U.S. valuation allowances. We recorded income taxes of $2.4 million for the nine months ended September 27, 2019 primarily due to pre-tax income generated in certain foreign jurisdictions and withholding taxes on foreign operations. In the fourth quarter of fiscal year 2019, we reversed all previously recorded withholding taxes recorded for 2019, at which time we formed STAAR Surgical UK Limited as a holding company for our foreign operations. Based on the current tax treaties between the U.S., United Kingdom and Switzerland, we will no longer accrue for Switzerland withholding taxes on foreign earnings after fiscal 2018 (see also Note 10 in our fiscal 2019 Form 10-K for more information). We have no unrecognized tax benefits pertaining to any uncertain tax positions as of any period presented.
ASC 740 requires that a valuation allowance be established when it is more likely than not that all or a portion of a deferred tax asset may not be realizable. As further described in Notes 1 and 10 of our fiscal 2019 Form 10-K, under the “incremental cash tax savings approach,” we recorded a valuation release of $3.0 million and $0.4 million against federal and certain states deferred tax assets, respectively. During the nine months ended October 2, 2020, we revised our global forecasts as a result of COVID-19, and due to changes in the usage and release of certain deferred tax assets, we released an additional $1.2 million of valuation allowance. As of October 2, 2020, we released approximately $4.6 million of valuation allowance on our deferred tax assets in the U.S. jurisdiction utilizing the incremental cash tax savings approach. The ultimate realization of deferred tax assets is dependent upon future generation of income during the periods in which temporary differences representing net future deductible amounts become deductible. We considered the projected future income, tax planning strategies and all other available evidence both positive and negative, as well as results of recent operations in making this assessment. In applying the incremental cash tax savings approach, we will continue to maintain a valuation allowance on the balance of the Company’s net U.S. deferred tax assets of $35.7 million.
Liquidity and Capital Resources
We believe that current cash, cash equivalents 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. Although we have experienced some delays in payments on accounts receivable as a result of the COVID-19 pandemic in the first half of 2020, this has improved during the third quarter of 2020 as our customers resume elective refractive surgery. However, at this time we are
23
unaware of any impairment of assets resulting from the COVID-19 pandemic. The Company did not apply for or require financing available under the Coronavirus Aid, Relief, and Economic Security “CARES” Act and does not expect to do so given the strength of our balance sheet. Our financial condition at October 2, 2020 and January 3, 2020 included the following (in millions):
|
|
|
October 2, 2020 |
|
|
January 3, 2020 |
|
|
2020 vs. 2019 |
|
|||
|
Cash and cash equivalents |
|
$ |
128.3 |
|
|
$ |
120.0 |
|
|
$ |
8.3 |
|
|
Current assets |
|
$ |
196.0 |
|
|
$ |
174.7 |
|
|
$ |
21.3 |
|
|
Current liabilities |
|
|
33.9 |
|
|
|
34.5 |
|
|
|
(0.6 |
) |
|
Working capital |
|
$ |
162.1 |
|
|
$ |
140.2 |
|
|
$ |
21.9 |
|
We invest the net proceeds in short-term interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government. Additionally, at October 2, 2020, we have a line of credit with a Japanese lender, in the amount of $1.3 million, with $3.4 million of availability and a line of credit with a Swiss lender, in the amount of $1.1 million, which is fully available for borrowing.
Net cash provided by operating activities was $1.4 million for the nine months ended October 2, 2020 compared to net cash provided by operating activities of $16.0 million for the nine months ended September 27, 2019. Net cash provided by operating activities for the nine months ended October 2, 2020, consisted of $12.6 in non-cash items and $2.6 million in net income, offset by $13.8 million in working-capital changes. The decrease in net cash provided by operating activities during the nine months ended October 2, 2020 was due to decreases in net working capital of $9.1 million, net income of $5.1 million and non-cash items of $0.4 million.
Net cash used in investing activities was $6.3 million and $7.2 million for the nine months ended October 2, 2020 and September 27, 2019, respectively, and relate primarily to the acquisition of property, plant, and equipment.
Net cash provided by financing activities was $13.0 million for the nine months ended October 2, 2020 compared to net cash used in financing activities of $0.7 million for the nine months ended September 27, 2019. Net cash provided by financing activities for the nine months ended October 2, 2020 consisted of $14.0 million of proceeds from the exercise of stock options, partially offset by $0.5 million repayment on the Japan line of credit and $0.5 million repayment of finance lease obligations.
Credit Facilities and Commitments
Lines of Credit and Leases
See Notes 7 and 8 of the accompanying Condensed Consolidated Financial Statements.
Covenant Compliance
The Company is in compliance with the covenants of its credit facilities as of October 2, 2020.
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.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements, as that term is defined in the rules of the SEC, that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
|
ITEM 3. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
During the nine months ended October 2, 2020, 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 January 3, 2020.
24
|
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 October 2, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II – OTHER INFORMATION
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ITEM 1. |
LEGAL PROCEEDINGS |
On August 19, 2020, a putative federal securities class action, Alwazaan v. STAAR Surgical Co., et al., was filed against the Company and certain of its executives in the U.S. District Court for the Central District of California. On September 1, 2020, a substantially similar federal securities class action, Zhang v. STAAR Surgical Co., et al., was filed against the Company and the same executives in the U.S. District Court for the Central District of California. On September 11, 2020, the court consolidated the two actions under the caption In re STAAR Surgical Co. Securities Litigation. The plaintiffs in the lawsuit allege that the Company made material misstatements regarding its sales in China, its marketing spend, and its R&D expenses. Plaintiffs seek compensatory and punitive damages as well as attorneys’ fees. Although the ultimate outcome of this action cannot be determined with certainty, the Company denies any wrongdoing and will vigorously defend itself against these claims.
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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 January 3, 2020 and in “Part II—Item 1A—Risk Factors” of the Company’s Form 10-Q for the three months ended April 3, 2020. Such risks and uncertainties could materially adversely affect our business, financial condition or operating results.
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ITEM 4. |
MINE SAFETY DISCLOSURES |
Not Applicable.
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ITEM 5. |
OTHER INFORMATION |
On or about October 30, 2020, STAAR Surgical Company entered into a lease amendment (the “Lease Amendment”) with 2000 Gold L.P. (its Landlord), exercising its renewal option of a total of approximately 45,000 square feet of leased, industrial use real property located at 1911 Walker Avenue and 1900 Myrtle Avenue, Monrovia, California (“Premises”). The Lease Amendment expires October 31, 2023. The Company has conducted office and manufacturing related operations at the Premises since 2012.
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ITEM 6. |
EXHIBITS |
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3.1 |
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3.2 |
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4.1 |
Form of Certificate for Common Stock, par value $0.01 per share.(3) |
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†4.2 |
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10.39 |
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10.40 |
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10.41 |
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31.1 |
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31.2 |
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32.1 |
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101 |
Financial statements from the quarterly report on Form 10-Q of STAAR Surgical Company for the quarter ended October 2, 2020 formatted in Inline Extensible Business Reporting Language (iXBRL), are filed herewith and include: (i) the Condensed Consolidated Balance Sheets, (ii) the Condensed Consolidated Statements of Income, (iii) the Condensed Consolidated Statements of Comprehensive Income, (iv) the Condensed Consolidated Statements of Stockholders’ Equity, (v) the Condensed Consolidated Statements of Cash Flows, and (vi) the Notes to Condensed Consolidated Financial Statements tagged as blocks of text.* |
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104 |
The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended October 2, 2020, 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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(5) |
Incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission on September 14, 2020. |
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(6) |
Incorporated by reference to the Company’s Current Report on Form 8-K as filed with the Commission on October 8, 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 4, 2020 |
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) |
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Exhibit 10.41
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2000 Gold Limited Partnership 2530 Corporate Pl Suite A210 Monterey Park, CA 97145 |
Telephone: 323 406 2388 Fax: 323 406 2391 |
AMENDMENT NO. 1 TO LEASE
THIS AMENDMENT No. 1 TO LEASE (“Amendment”) is entered into as of October 30, 2020 by and between 2000 Gold L.P., a California Limited Partnership (“Lessor”) and STAAR SURGICAL COMPANY, a Delaware Corporation (“Lessee”), with reference to the following:
R E C I T A L S
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A. |
Lessor and Lessee entered into that certain Industrial/Commercial Single-Tenant Lease Agreement dated August 10, 2017 (“the Agreement”), for the premises consisting of entire buildings comprised approximately 44,550 sqft located at 1911 Walker St & 1900 Myrtle Ave, Monrovia, California and more particularly described in the Agreement. Capitalized terms used herein and not defined have the meanings given them in the Agreement. |
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B. |
The lease has a “Term” of 34 months, commencing January 1, 2018 and ending October 31, 2020 with an option to extend the term of the Agreement for one (1), additional three (3) year period. |
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C. |
Lessor received a written notice dated March 10, 2020 from Lessee for exercising Lessee’s option to extend the term of the Agreement for an additional three (3) years. |
Now THEREFORE, for receipt of good and valuable consideration the sufficiency of which us hereby acknowledge, Lessor and Lessee hereby agree as follows:
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1. |
Lease Term: The current Term of the Lease, as set forth in the Agreement, is hereby extended for a period of three (3) years, commencing November 1, 2020 and ending October 31, 2023. |
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2. |
Counterparts: This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. |
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3. |
Full Force: Except as expressly set forth herein, the Agreement shall remain unmodified and in full force and effect. |
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INITIALS INITIALS
Exhibit 10.41
IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed as of the day and the year first written above.
LESSOR: LESSEE:
2000 Gold L.P. STAAR SURGICAL COMPANY
By: /s/ Michael Tang By: /s/ Graydon C. Hansen
Michael Tang, General Partner Name: Graydon C. Hansen
Its: Chief Manufacturing Officer
_________ __________
INITIALS INITIALS
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 4, 2020 |
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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 4, 2020 |
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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 October 2, 2020 (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 4, 2020 |
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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 4, 2020 |
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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.