STAAR SURGICAL CO - Quarter Report: 2020 July (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
☑ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended: July 3, 2020
Or
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission file number: 0-11634
STAAR SURGICAL COMPANY
(Exact Name of Registrant as Specified in its Charter)
Delaware |
95-3797439 |
(State or Other Jurisdiction of Incorporation or Organization) |
(I.R.S. Employer Identification No.) |
25651 Atlantic Ocean Drive |
92630 |
(Address of Principal Executive Offices) |
(Zip Code) |
(626) 303-7902
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common |
STAA |
NASDAQ |
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. Yes ☑ No ☐
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). Yes ☑ No ☐
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.
Large accelerated filer |
☑ |
|
Accelerated filer |
☐ |
Non-accelerated filer |
☐ |
|
Smaller reporting company |
☐ |
Emerging growth company |
☐ |
|
|
|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☑
The registrant has 45,806,406 shares of common stock, par value $0.01 per share, issued and outstanding as of July 31, 2020.
STAAR SURGICAL COMPANY
INDEX
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PAGE NUMBER |
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1 |
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ITEM 1 |
|
1 |
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ITEM 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
|
19 |
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ITEM 3. |
|
24 |
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ITEM 4. |
|
25 |
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25 |
||
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ITEM 1. |
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25 |
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ITEM 1A. |
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25 |
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ITEM 4. |
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25 |
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ITEM 5. |
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26 |
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ITEM 6. |
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26 |
PART I – FINANCIAL INFORMATION
ITEM 1. |
FINANCIAL STATEMENTS |
STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value amounts)
(Unaudited)
|
|
July 3, 2020 |
|
|
January 3, 2020 |
|
||
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
116,315 |
|
|
$ |
119,968 |
|
Accounts receivable trade, net of allowance of doubtful accounts of $52 and $88, respectively |
|
|
39,469 |
|
|
|
30,996 |
|
Inventories, net |
|
|
17,836 |
|
|
|
17,142 |
|
Prepayments, deposits and other current assets |
|
|
8,897 |
|
|
|
6,560 |
|
Total current assets |
|
|
182,517 |
|
|
|
174,666 |
|
Property, plant and equipment, net |
|
|
21,478 |
|
|
|
17,065 |
|
Finance lease right-of-use assets, net |
|
|
687 |
|
|
|
1,867 |
|
Operating lease right-of-use assets, net |
|
|
5,587 |
|
|
|
6,684 |
|
Intangible assets, net |
|
|
280 |
|
|
|
296 |
|
Goodwill |
|
|
1,785 |
|
|
|
1,786 |
|
Deferred income taxes |
|
|
5,114 |
|
|
|
3,750 |
|
Other assets |
|
|
591 |
|
|
|
751 |
|
Total assets |
|
$ |
218,039 |
|
|
$ |
206,865 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Line of credit |
|
$ |
1,325 |
|
|
$ |
1,827 |
|
Accounts payable |
|
|
8,890 |
|
|
|
8,050 |
|
Obligations under finance leases |
|
|
493 |
|
|
|
560 |
|
Obligations under operating leases |
|
|
2,355 |
|
|
|
2,700 |
|
Allowance for sales returns |
|
|
4,285 |
|
|
|
3,644 |
|
Other current liabilities |
|
|
14,241 |
|
|
|
17,697 |
|
Total current liabilities |
|
|
31,589 |
|
|
|
34,478 |
|
Obligations under finance leases |
|
|
108 |
|
|
|
366 |
|
Obligations under operating leases |
|
|
3,320 |
|
|
|
4,086 |
|
Asset retirement obligations |
|
|
212 |
|
|
|
211 |
|
Pension liability |
|
|
8,136 |
|
|
|
7,840 |
|
Total liabilities |
|
|
43,365 |
|
|
|
46,981 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock, $0.01 par value; 60,000 shares authorized: 45,788 and 44,822 shares issued and outstanding at July 3, 2020 and January 3, 2020, respectively |
|
|
458 |
|
|
|
448 |
|
Additional paid-in capital |
|
|
320,235 |
|
|
|
304,288 |
|
Accumulated other comprehensive loss |
|
|
(2,909 |
) |
|
|
(3,048 |
) |
Accumulated deficit |
|
|
(143,110 |
) |
|
|
(141,804 |
) |
Total stockholders’ equity |
|
|
174,674 |
|
|
|
159,884 |
|
Total liabilities and stockholders’ equity |
|
$ |
218,039 |
|
|
$ |
206,865 |
|
See accompanying notes to the condensed consolidated financial statements.
1
STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
Net sales |
|
$ |
35,194 |
|
|
$ |
39,664 |
|
|
$ |
70,381 |
|
|
$ |
72,247 |
|
Cost of sales |
|
|
10,764 |
|
|
|
9,765 |
|
|
|
21,191 |
|
|
|
18,168 |
|
Gross profit |
|
|
24,430 |
|
|
|
29,899 |
|
|
|
49,190 |
|
|
|
54,079 |
|
Selling, general and administrative expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
7,848 |
|
|
|
7,508 |
|
|
|
15,817 |
|
|
|
14,345 |
|
Marketing and selling |
|
|
10,326 |
|
|
|
11,682 |
|
|
|
21,354 |
|
|
|
21,825 |
|
Research and development |
|
|
7,311 |
|
|
|
6,098 |
|
|
|
14,209 |
|
|
|
11,733 |
|
Total selling, general and administrative expenses |
|
|
25,485 |
|
|
|
25,288 |
|
|
|
51,380 |
|
|
|
47,903 |
|
Operating income (loss) |
|
|
(1,055 |
) |
|
|
4,611 |
|
|
|
(2,190 |
) |
|
|
6,176 |
|
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
20 |
|
|
|
259 |
|
|
|
236 |
|
|
|
530 |
|
Gain (loss) on foreign currency transactions |
|
|
388 |
|
|
|
11 |
|
|
|
(80 |
) |
|
|
(237 |
) |
Royalty income |
|
|
52 |
|
|
|
163 |
|
|
|
146 |
|
|
|
334 |
|
Other income (expense), net |
|
|
(21 |
) |
|
|
1 |
|
|
|
(20 |
) |
|
|
98 |
|
Total other income, net |
|
|
439 |
|
|
|
434 |
|
|
|
282 |
|
|
|
725 |
|
Income (loss) before income taxes |
|
|
(616 |
) |
|
|
5,045 |
|
|
|
(1,908 |
) |
|
|
6,901 |
|
Provision (benefit) for income taxes |
|
|
556 |
|
|
|
1,131 |
|
|
|
(602 |
) |
|
|
1,620 |
|
Net income (loss) |
|
$ |
(1,172 |
) |
|
$ |
3,914 |
|
|
$ |
(1,306 |
) |
|
$ |
5,281 |
|
Net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.03 |
) |
|
$ |
0.09 |
|
|
$ |
(0.03 |
) |
|
$ |
0.12 |
|
Diluted |
|
$ |
(0.03 |
) |
|
$ |
0.08 |
|
|
$ |
(0.03 |
) |
|
$ |
0.11 |
|
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
45,354 |
|
|
|
44,479 |
|
|
|
45,152 |
|
|
|
44,357 |
|
Diluted |
|
|
45,354 |
|
|
|
46,733 |
|
|
|
45,152 |
|
|
|
46,842 |
|
See accompanying notes to the condensed consolidated financial statements.
2
STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(In thousands)
(Unaudited)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
Net income (loss) |
|
$ |
(1,172 |
) |
|
$ |
3,914 |
|
|
$ |
(1,306 |
) |
|
$ |
5,281 |
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Defined benefit plans: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in plan assets |
|
|
(28 |
) |
|
|
(614 |
) |
|
|
(53 |
) |
|
|
(640 |
) |
Reclassification into other income, net |
|
|
72 |
|
|
|
28 |
|
|
|
142 |
|
|
|
54 |
|
Foreign currency translation loss |
|
|
113 |
|
|
|
382 |
|
|
|
86 |
|
|
|
339 |
|
Tax effect |
|
|
(40 |
) |
|
|
(55 |
) |
|
|
(36 |
) |
|
|
(35 |
) |
Other comprehensive income (loss), net of tax |
|
|
117 |
|
|
|
(259 |
) |
|
|
139 |
|
|
|
(282 |
) |
Comprehensive income (loss) |
|
$ |
(1,055 |
) |
|
$ |
3,655 |
|
|
$ |
(1,167 |
) |
|
$ |
4,999 |
|
See accompanying notes to the condensed consolidated financial statements.
3
STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In thousands)
(Unaudited)
|
|
Three Months Ended |
|
|||||||||||||||||||||
|
|
Common Stock Shares |
|
|
Common Stock Par Value |
|
|
Additional Paid-In Capital |
|
|
Accumulated Other Compre- hensive Income (Loss) |
|
|
Accumulated Deficit |
|
|
Total |
|
||||||
Balance, at April 3, 2020 |
|
|
45,105 |
|
|
$ |
451 |
|
|
$ |
309,480 |
|
|
$ |
(3,026 |
) |
|
$ |
(141,938 |
) |
|
$ |
164,967 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,172 |
) |
|
|
(1,172 |
) |
Other comprehensive income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
117 |
|
|
|
— |
|
|
|
117 |
|
Common stock issued upon exercise of options |
|
|
681 |
|
|
|
7 |
|
|
|
7,546 |
|
|
|
— |
|
|
|
— |
|
|
|
7,553 |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
3,209 |
|
|
|
— |
|
|
|
— |
|
|
|
3,209 |
|
Vested restricted stock |
|
|
2 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Balance, at July 3, 2020 |
|
|
45,788 |
|
|
$ |
458 |
|
|
$ |
320,235 |
|
|
$ |
(2,909 |
) |
|
$ |
(143,110 |
) |
|
$ |
174,674 |
|
Balance, at March 29, 2019 |
|
|
44,447 |
|
|
$ |
444 |
|
|
$ |
292,722 |
|
|
$ |
(1,343 |
) |
|
$ |
(154,485 |
) |
|
$ |
137,338 |
|
Net income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
3,914 |
|
|
|
3,914 |
|
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(259 |
) |
|
|
— |
|
|
|
(259 |
) |
Common stock issued upon exercise of options |
|
|
52 |
|
|
|
1 |
|
|
|
486 |
|
|
|
— |
|
|
|
— |
|
|
|
487 |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
2,855 |
|
|
|
— |
|
|
|
— |
|
|
|
2,855 |
|
Unvested restricted stock |
|
|
11 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Vested restricted stock |
|
|
24 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Balance, at June 28, 2019 |
|
|
44,534 |
|
|
$ |
445 |
|
|
$ |
296,063 |
|
|
$ |
(1,602 |
) |
|
$ |
(150,571 |
) |
|
$ |
144,335 |
|
See accompanying notes to the condensed consolidated financial statements.
4
STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (CONTINUED)
(In thousands)
(Unaudited)
|
|
Six Months Ended |
|
|||||||||||||||||||||
|
|
Common Stock Shares |
|
|
Common Stock Par Value |
|
|
Additional Paid-In Capital |
|
|
Accumulated Other Compre- hensive Income (Loss) |
|
|
Accumulated Deficit |
|
|
Total |
|
||||||
Balance, at January 3, 2020 |
|
|
44,822 |
|
|
$ |
448 |
|
|
$ |
304,288 |
|
|
$ |
(3,048 |
) |
|
$ |
(141,804 |
) |
|
$ |
159,884 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,306 |
) |
|
|
(1,306 |
) |
Other comprehensive income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
139 |
|
|
|
— |
|
|
|
139 |
|
Common stock issued upon exercise of options |
|
|
877 |
|
|
|
9 |
|
|
|
9,548 |
|
|
|
— |
|
|
|
— |
|
|
|
9,557 |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
6,399 |
|
|
|
— |
|
|
|
— |
|
|
|
6,399 |
|
Vested restricted stock |
|
|
89 |
|
|
|
1 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1 |
|
Balance, at July 3, 2020 |
|
|
45,788 |
|
|
$ |
458 |
|
|
$ |
320,235 |
|
|
$ |
(2,909 |
) |
|
$ |
(143,110 |
) |
|
$ |
174,674 |
|
Balance, at December 28, 2018 |
|
|
44,195 |
|
|
$ |
442 |
|
|
$ |
289,584 |
|
|
$ |
(1,320 |
) |
|
$ |
(156,280 |
) |
|
$ |
132,426 |
|
Net income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
5,281 |
|
|
|
5,281 |
|
Impact of the adoption of lease accounting standard |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
113 |
|
|
|
113 |
|
Impact of adoption of nonemployee share-based payment standard |
|
|
— |
|
|
|
— |
|
|
|
(315 |
) |
|
|
— |
|
|
|
315 |
|
|
|
— |
|
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(282 |
) |
|
|
— |
|
|
|
(282 |
) |
Common stock issued upon exercise of options |
|
|
126 |
|
|
|
1 |
|
|
|
1,109 |
|
|
|
— |
|
|
|
— |
|
|
|
1,110 |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
5,685 |
|
|
|
— |
|
|
|
— |
|
|
|
5,685 |
|
Unvested restricted stock |
|
|
11 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Vested restricted stock |
|
|
202 |
|
|
|
2 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2 |
|
Balance, at June 28, 2019 |
|
|
44,534 |
|
|
$ |
445 |
|
|
$ |
296,063 |
|
|
$ |
(1,602 |
) |
|
$ |
(150,571 |
) |
|
$ |
144,335 |
|
See accompanying notes to the condensed consolidated financial statements.
5
STAAR SURGICAL COMPANY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
|
|
Six Months Ended |
|
|||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
(1,306 |
) |
|
$ |
5,281 |
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation of property, plant, and equipment |
|
|
1,518 |
|
|
|
1,983 |
|
Amortization of intangibles |
|
|
17 |
|
|
|
17 |
|
Deferred income taxes |
|
|
(1,369 |
) |
|
|
393 |
|
Change in net pension liability |
|
|
376 |
|
|
|
203 |
|
Loss on disposal of property and equipment |
|
|
3 |
|
|
|
— |
|
Stock-based compensation expense |
|
|
5,839 |
|
|
|
5,220 |
|
Provision for sales returns and bad debts |
|
|
605 |
|
|
|
(32 |
) |
Inventory provision |
|
|
816 |
|
|
|
787 |
|
Changes in working capital: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(8,409 |
) |
|
|
(6,533 |
) |
Inventories |
|
|
(932 |
) |
|
|
106 |
|
Prepayments, deposits, and other current assets |
|
|
(2,172 |
) |
|
|
(1,154 |
) |
Accounts payable |
|
|
297 |
|
|
|
563 |
|
Other current liabilities |
|
|
(3,471 |
) |
|
|
(2,626 |
) |
Net cash provided by (used in) operating activities |
|
|
(8,188 |
) |
|
|
4,208 |
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Acquisition of property and equipment |
|
|
(4,210 |
) |
|
|
(4,601 |
) |
Acquisition of patents and licenses |
|
|
— |
|
|
|
(30 |
) |
Net cash used in investing activities |
|
|
(4,210 |
) |
|
|
(4,631 |
) |
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Repayment of finance lease obligations |
|
|
(346 |
) |
|
|
(681 |
) |
Repayment on line of credit |
|
|
(508 |
) |
|
|
(999 |
) |
Proceeds from the exercise of stock options |
|
|
9,557 |
|
|
|
1,110 |
|
Proceeds from vested restricted stock |
|
|
1 |
|
|
|
2 |
|
Net cash provided by (used in) financing activities |
|
|
8,704 |
|
|
|
(568 |
) |
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
|
41 |
|
|
|
243 |
|
Decrease in cash, cash equivalents and restricted cash |
|
|
(3,653 |
) |
|
|
(748 |
) |
Cash, cash equivalents and restricted cash, at beginning of the period |
|
|
119,968 |
|
|
|
103,999 |
|
Cash, cash equivalents and restricted cash, at end of the period |
|
$ |
116,315 |
|
|
$ |
103,251 |
|
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 six months ended July 3, 2020 and June 28, 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 six months ended July 3, 2020 and June 28, 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 27% of the Company’s consolidated accounts payable as of July 3, 2020. There was one vendor which accounted for over 11% of the Company’s consolidated accounts payable as of January 3, 2020. There were no vendors who accounted for over 10% of the Company’s consolidated purchases for the three months ended July 3, 2020. There were three vendors who accounted for over 43% of the Company’s consolidated purchases for the six months ended July 3, 2020.
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. During the quarter ended July 3, 2020, the Company has experienced some delays in customer payments but 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 as to the impact to customers of COVID-19 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.
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.
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 2018-14, “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):
|
|
July 3, 2020 |
|
|
January 3, 2020 |
|
||
Raw materials and purchased parts |
|
$ |
1,606 |
|
|
$ |
3,334 |
|
Work in process |
|
|
4,997 |
|
|
|
1,870 |
|
Finished goods |
|
|
12,487 |
|
|
|
12,976 |
|
Total inventories, gross |
|
|
19,090 |
|
|
|
18,180 |
|
Less inventory reserves |
|
|
1,254 |
|
|
|
1,038 |
|
Total inventories, net |
|
$ |
17,836 |
|
|
$ |
17,142 |
|
Note 3 — Prepayments, Deposits, and Other Current Assets
Prepayments, deposits, and other current assets consisted of the following (in thousands):
|
|
July 3, 2020 |
|
|
January 3, 2020 |
|
||
Prepayments and deposits |
|
$ |
5,106 |
|
|
$ |
3,031 |
|
Prepaid insurance |
|
|
726 |
|
|
|
1,488 |
|
Consumption tax receivable |
|
|
661 |
|
|
|
875 |
|
Value added tax (VAT) receivable |
|
|
1,313 |
|
|
|
713 |
|
BVG (Swiss Pension) prepayment |
|
|
451 |
|
|
|
— |
|
Other(1) |
|
|
640 |
|
|
|
453 |
|
Total prepayments, deposits and other current assets |
|
$ |
8,897 |
|
|
$ |
6,560 |
|
(1) |
No individual item in “other current assets” exceeds 5% of the total prepayments, deposits and other current assets. |
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):
|
|
July 3, 2020 |
|
|
January 3, 2020 |
|
||
Machinery and equipment |
|
$ |
20,970 |
|
|
$ |
17,173 |
|
Computer equipment and software |
|
|
6,593 |
|
|
|
6,244 |
|
Furniture and fixtures |
|
|
4,561 |
|
|
|
4,169 |
|
Leasehold improvements |
|
|
11,100 |
|
|
|
10,151 |
|
Construction in process |
|
|
8,889 |
|
|
|
8,477 |
|
Total property, plant and equipment, gross |
|
|
52,113 |
|
|
|
46,214 |
|
Less accumulated depreciation |
|
|
30,635 |
|
|
|
29,149 |
|
Total property, plant and equipment, net |
|
$ |
21,478 |
|
|
$ |
17,065 |
|
Note 5 –Intangible Assets
Intangible assets, net consisted of the following (in thousands):
|
|
July 3, 2020 |
|
|
January 3, 2020 |
|
||||||||||||||||||
Long-lived amortized intangible assets |
|
Gross Carrying Amount |
|
|
Accumulated Amortization |
|
|
Net |
|
|
Gross Carrying Amount |
|
|
Accumulated Amortization |
|
|
Net |
|
||||||
Patents and licenses |
|
$ |
9,356 |
|
|
$ |
(9,076 |
) |
|
$ |
280 |
|
|
$ |
9,353 |
|
|
$ |
(9,057 |
) |
|
$ |
296 |
|
Note 6 – Other Current Liabilities
Other current liabilities consisted of the following (in thousands):
|
|
July 3, 2020 |
|
|
January 3, 2020 |
|
||
Accrued salaries and wages |
|
$ |
5,752 |
|
|
$ |
4,400 |
|
Accrued bonuses |
|
|
— |
|
|
|
4,184 |
|
Accrued insurance |
|
|
372 |
|
|
|
1,346 |
|
Income taxes payable |
|
|
2,579 |
|
|
|
2,710 |
|
Accrued consumption tax |
|
|
750 |
|
|
|
1,164 |
|
Accrued professional fees for clinical trials |
|
|
968 |
|
|
|
567 |
|
Marketing obligations |
|
|
838 |
|
|
|
633 |
|
Other(1) |
|
|
2,982 |
|
|
|
2,693 |
|
Total other current liabilities |
|
$ |
14,241 |
|
|
$ |
17,697 |
|
(1) |
No individual item in “Other” exceeds 5% of the other current liabilities. |
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 500,000,000 Yen, at an interest rate equal to the uncollateralized overnight call rate (approximately 0.06% as of July 3, 2020) plus a 0.50% spread, and may be renewed quarterly (the current line expires on August 21, 2020). The credit facility is not collateralized. The Company had 142,500,000 Yen and 197,500,000 Yen outstanding on the line of credit as of July 3, 2020 and January 3, 2020, respectively (approximately $1,325,000 and $1,827,000 based on the foreign exchange rates on July 3, 2020 and January 3, 2020, respectively), which approximates fair value due to the short-term maturity and market interest rates of the line of credit. In case of default, the interest rate will be increased to 14% per annum. There was 357,500,000 Yen and 302,500,000 Yen available for borrowing as of July 3, 2020 and January 3, 2020, respectively (approximately $3,325,000 and $2,798,000 based on the foreign exchange rate on July 3, 2020 and January 3, 2020, respectively). At maturity on August 21, 2020, the Company expects to renew this line of credit for an additional three months, with similar terms.
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 1,000,000 CHF (Swiss Francs) (approximately $1,100,000 and $1,000,000 at the rate of exchange on July 3, 2020 and January 3, 2020 respectively), to be used for working capital purposes. Accrued interest and 0.25% commissions on average outstanding borrowings is payable quarterly and the interest rate will be determined by the Bank based on the then prevailing market conditions at the time of borrowing. The framework agreement is automatically renewed on an annual basis based on the same terms assuming there is no default. The framework agreement may be terminated by either party at any time in accordance with its general terms and conditions. The framework agreement is not collateralized and contains certain conditions such as providing the Bank with audited financial statements annually and notice of significant events or conditions, as defined in the framework agreement. The Bank may also declare all amounts outstanding to be immediately due and payable upon a change of control or a “material qualification” in STAAR Surgical independent auditors’ report, as defined. There were no borrowings outstanding as of July 3, 2020 and January 3, 2020.
The Company is in compliance with covenants of its credit facilities and lines of credit as of July 3, 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 two to five years in length and have fixed payment amounts for the term of the contract and have options to purchase the assets at the end of the lease term. Supplemental balance sheet information related to finance leases consisted of the following (dollars in thousands):
|
|
July 3, 2020 |
|
|
January 3, 2020 |
|
||
Machinery and equipment |
|
$ |
568 |
|
|
$ |
1,885 |
|
Computer equipment and software |
|
|
860 |
|
|
|
912 |
|
Furniture and fixtures |
|
|
— |
|
|
|
102 |
|
Leasehold improvements |
|
|
— |
|
|
|
27 |
|
Finance lease right-of-use assets, gross |
|
|
1,428 |
|
|
|
2,926 |
|
Less accumulated depreciation |
|
|
741 |
|
|
|
1,059 |
|
Finance lease right-of-use assets, net |
|
$ |
687 |
|
|
$ |
1,867 |
|
|
|
|
|
|
|
|
|
|
Total finance lease liability |
|
$ |
601 |
|
|
$ |
926 |
|
Weighted-average remaining lease term (in years) |
|
|
|
|
|
|
|
|
Weighted-average discount rate |
|
|
5.40 |
% |
|
|
6.17 |
% |
Supplemental cash flow information related to finance leases consisted of the following (dollars in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
Amortization of finance lease right-of-use asset |
|
$ |
50 |
|
|
$ |
145 |
|
|
$ |
167 |
|
|
$ |
306 |
|
Interest on finance lease liabilities |
|
|
8 |
|
|
|
22 |
|
|
|
18 |
|
|
|
41 |
|
Cash paid for amounts included in the measurement of finance lease liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating cash flows |
|
|
8 |
|
|
|
22 |
|
|
|
18 |
|
|
|
41 |
|
Financing cash flows |
|
|
110 |
|
|
|
316 |
|
|
|
346 |
|
|
|
681 |
|
Right-of-use assets obtained in exchange for new finance lease liabilities |
|
|
22 |
|
|
|
37 |
|
|
|
22 |
|
|
|
679 |
|
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 two to five years in length with options to extend. The Company did not include any lease extensions in the initial valuation unless the Company was reasonably certain to extend the lease. Depending on the lease, there are those with fixed payment amounts for the entire length of the contract or payments which increase periodically as noted in the contract or increased at an inflation rate indicator. For operating leases that increase using an inflation rate indicator, the Company used the inflation rate at the time the lease was entered into for the length of the lease term. Supplemental balance sheet information related to operating leases consisted of the following (dollars in thousands):
|
|
July 3, 2020 |
|
|
January 3, 2020 |
|
||
Machinery and equipment |
|
$ |
837 |
|
|
$ |
765 |
|
Computer equipment and software |
|
|
462 |
|
|
|
462 |
|
Real property |
|
|
11,247 |
|
|
|
11,116 |
|
Operating lease right-of-use assets, gross |
|
|
12,546 |
|
|
|
12,343 |
|
Less accumulated depreciation |
|
|
6,959 |
|
|
|
5,659 |
|
Operating lease right-of-use assets, net |
|
$ |
5,587 |
|
|
$ |
6,684 |
|
|
|
|
|
|
|
|
|
|
Total operating lease liability |
|
$ |
5,675 |
|
|
$ |
6,786 |
|
Weighted-average remaining lease term (in years) |
|
|
|
|
|
|
|
|
Weighted-average discount rate |
|
|
1.75 |
% |
|
|
1.82 |
% |
Supplemental cash flow information related to operating leases was as follows (dollars in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
Operating lease cost |
|
$ |
746 |
|
|
$ |
683 |
|
|
$ |
1,486 |
|
|
$ |
1,294 |
|
Cash paid for amounts included in the measurement of operating lease liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating cash flows |
|
|
763 |
|
|
|
691 |
|
|
|
1,501 |
|
|
|
1,292 |
|
Right-of-use assets obtained in exchange for new operating lease liabilities |
|
|
249 |
|
|
|
1,193 |
|
|
|
318 |
|
|
|
2,657 |
|
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 July 3, 2020 is as follows (in thousands):
As of July 3, 2020 12 Months Ended |
|
Operating Leases |
|
|
Finance Leases |
|
||
June 2021 |
|
$ |
2,473 |
|
|
$ |
510 |
|
June 2022 |
|
|
1,394 |
|
|
|
84 |
|
June 2023 |
|
|
1,216 |
|
|
|
14 |
|
June 2024 |
|
|
665 |
|
|
|
11 |
|
June 2025 |
|
|
171 |
|
|
|
— |
|
Thereafter |
|
|
— |
|
|
|
— |
|
Total minimum lease payments, including interest |
|
$ |
5,919 |
|
|
$ |
619 |
|
Less amounts representing interest |
|
|
244 |
|
|
|
18 |
|
Total minimum lease payments |
|
$ |
5,675 |
|
|
$ |
601 |
|
11
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 9 — Income Taxes
The Company recorded an income tax provision (benefit) as follows (in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
Provision (benefit) for income taxes |
|
$ |
556 |
|
|
$ |
1,131 |
|
|
$ |
(602 |
) |
|
$ |
1,620 |
|
The Company recorded income taxes of $556,000 and $1,131,000 for the three months ended July 3, 2020 and June 28, 2019, respectively, primarily due to pre-tax income generated in certain foreign jurisdictions. Also included in the three months ended June 28, 2019 were withholding taxes on foreign operations. The Company recorded an income tax benefit of $602,000 for the six months ended July 3, 2020 due to the income tax benefit from the release of its U.S. valuation allowance, offset by income tax expense from profits generated from its foreign operations. The Company recorded income taxes of $1,620,000 for the six months ended June 28, 2019, primarily due to pre-tax income generated in certain foreign jurisdictions and withholding taxes on foreign operations. The Company’s quarterly provision for income taxes is determined by estimating an annual effective tax rate. This estimate may fluctuate throughout the year as new information becomes available affecting its underlying assumptions. In the fourth quarter of fiscal year 2019, the Company reversed all previously recorded withholding taxes recorded for 2019, at which time the Company formed STAAR Surgical UK Limited as a holding company for its foreign operations. Based on the current tax treaties between the U.S., United Kingdom and Switzerland, the Company will no longer accrue for Switzerland withholding taxes on foreign earnings after fiscal 2018 (see also Note 10 in its fiscal 2019 Form 10-K for more information). There are no unrecognized tax benefits related to uncertain tax positions taken by the Company. All earnings from the Company’s subsidiaries are not considered to be permanently reinvested.
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 50 percent of GILTI, however this deduction is limited by the Company’s U.S. taxable income. The Company has elected to account for GILTI as a current period expense when incurred.
For the three and six months ended July 3, 2020, the Company included GILTI of $4,137,000 and $5,400,000, respectively, and for the three and six months ended June 28, 2019, included GILTI of $5,635,000 and $7,699,000, respectively, in U.S. gross income, which was fully offset by net operating loss carryforwards. The Company was not able to utilize the deduction of 50 percent of GILTI, as this deduction is limited by the Company’s pre-GILTI U.S. taxable income.
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 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 $3,003,000 and $373,000 against the federal and certain states deferred tax assets, respectively. During the six months ended July 3, 2020, the Company revised its global forecasts as a result of COVID-19, and released an additional $1,369,000 of valuation allowance. As of July 3, 2020, the Company released approximately $4,745,000 of valuation allowance on its deferred tax assets in the U.S. jurisdiction utilizing the incremental cash tax savings approach.
Under the incremental cash tax savings approach, the U.S. valuation allowances of $36,530,000, will remain as the usage of the remaining net operating losses and deferred tax assets will not result in cash tax savings and therefore provide no additional benefit. As of July 3, 2020, the Company had net deferred tax assets in the U.S. of $4,881,000, which consisted of the federal and state valuation allowance release of $4,439,000 and $306,000, respectively, and the refundable alternative minimum tax credit of $136,000.
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).
12
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 9 — Income Taxes (Continued)
On July 20, 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. As the regulations were finalized on July 20, 2020, after the current reporting period, the impact if any on the financial statements will be reported in the third quarter. Management is currently evaluating the effect if any this election would have on their financial statements.
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 |
|
|
Six Months Ended |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
Service cost(1) |
|
$ |
320 |
|
|
$ |
248 |
|
|
$ |
639 |
|
|
$ |
480 |
|
Interest cost(2) |
|
|
11 |
|
|
|
20 |
|
|
|
22 |
|
|
|
40 |
|
Expected return on plan assets(2) |
|
|
(46 |
) |
|
|
(34 |
) |
|
|
(89 |
) |
|
|
(67 |
) |
Prior service credit(2),(3) |
|
|
(8 |
) |
|
|
(5 |
) |
|
|
(17 |
) |
|
|
(11 |
) |
Actuarial loss recognized in current period(2),(3) |
|
|
80 |
|
|
|
33 |
|
|
|
159 |
|
|
|
65 |
|
Net periodic pension cost |
|
$ |
357 |
|
|
$ |
262 |
|
|
$ |
714 |
|
|
$ |
507 |
|
(1) |
Recognized in selling general and administrative expenses on the Condensed Consolidated Statements of Income. |
(2) |
Recognized in other income (expense), net on the Condensed Consolidated Statements of Income. |
(3) |
Amounts reclassified from accumulated other comprehensive income (loss). |
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 |
|
|
Six Months Ended |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
Employer contribution |
|
$ |
155 |
|
|
$ |
137 |
|
|
$ |
330 |
|
|
$ |
263 |
|
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 |
|
|
Six Months Ended |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
Employee stock options |
|
$ |
2,505 |
|
|
$ |
2,162 |
|
|
$ |
4,737 |
|
|
$ |
3,592 |
|
Restricted stock |
|
|
76 |
|
|
|
77 |
|
|
|
154 |
|
|
|
159 |
|
Restricted stock units |
|
|
274 |
|
|
|
311 |
|
|
|
823 |
|
|
|
1,415 |
|
Nonemployee stock options |
|
|
63 |
|
|
|
29 |
|
|
|
125 |
|
|
|
54 |
|
Total stock-based compensation expense |
|
$ |
2,918 |
|
|
$ |
2,579 |
|
|
$ |
5,839 |
|
|
$ |
5,220 |
|
The Company recorded stock-based compensation costs in the following categories (in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
Cost of sales |
|
$ |
30 |
|
|
$ |
22 |
|
|
$ |
52 |
|
|
$ |
36 |
|
General and administrative |
|
|
1,209 |
|
|
|
1,018 |
|
|
|
2,294 |
|
|
|
1,796 |
|
Marketing and selling |
|
|
812 |
|
|
|
690 |
|
|
|
1,867 |
|
|
|
1,861 |
|
Research and development |
|
|
867 |
|
|
|
849 |
|
|
|
1,626 |
|
|
|
1,527 |
|
Total stock-based compensation expense, net |
|
|
2,918 |
|
|
|
2,579 |
|
|
|
5,839 |
|
|
|
5,220 |
|
Amounts capitalized as part of inventory |
|
|
291 |
|
|
|
276 |
|
|
|
560 |
|
|
|
465 |
|
Total stock-based compensation expense, gross |
|
$ |
3,209 |
|
|
$ |
2,855 |
|
|
$ |
6,399 |
|
|
$ |
5,685 |
|
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, and restricted stock units (“RSUs”). 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 10 years from the date of grant. Certain option and share awards provide for accelerated vesting if there is a change in control and pre-established financial metrics are met (as defined in the Plan). Grants of restricted stock outstanding under the Plan generally vest over periods of one to three years. Grants of RSUs outstanding under the Plan generally vest based on service, performance, or a combination of both. As of July 3, 2020, there were 842,975 shares available for grant under the PlanAssumptions
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 6% estimated forfeiture rate based on historical forfeiture experience. The risk-free rate is based on the U.S. Treasury yield curve corresponding to the expected term at the time of the grant.
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
Expected volatility |
|
|
53 |
% |
|
|
53 |
% |
|
|
53 |
% |
|
|
53 |
% |
Risk-free interest rate |
|
|
0.31 |
% |
|
|
2.05 |
% |
|
|
0.53 |
% |
|
|
2.41 |
% |
Expected term (in years) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 11 — Stockholders’ Equity (Continued)
Stock Options
A summary of stock option activity under the Plan for the six months ended July 3, 2020 is presented below:
|
|
Stock Options (in 000’s) |
|
|
Minimum Exercise Price |
|
|
Maximum Exercise Price |
|
|||
Outstanding at January 3, 2020 |
|
|
4,326 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
609 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(876 |
) |
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(12 |
) |
|
|
|
|
|
|
|
|
Outstanding at July 3, 2020 |
|
|
4,047 |
|
|
$ |
5.05 |
|
|
$ |
43.84 |
|
Exercisable at July 3, 2020 |
|
|
2,717 |
|
|
|
|
|
|
|
|
|
Restricted Stock and Restricted Stock Units
A summary of restricted stock and RSU activity under the Plan for the six months ended July 3, 2020 is presented below:
|
|
Restricted Stock (in 000’s) |
|
|
Restricted Stock Units (in 000’s) |
|
||
Unvested at January 3, 2020 |
|
|
11 |
|
|
|
104 |
|
Granted |
|
|
— |
|
|
|
97 |
|
Vested |
|
|
(11 |
) |
|
|
(89 |
) |
Forfeited or expired |
|
|
— |
|
|
|
(1 |
) |
Unvested at July 3, 2020 |
|
|
— |
|
|
|
111 |
|
Note 12 - Commitments and Contingencies
Litigation and Claims
From time to time, the Company is involved in various legal proceedings and other matters arising in the normal course of business. These legal proceedings and other matters may relate to, among other things, contractual rights and obligations, employment matters, or claims of product liability. STAAR maintains insurance coverage for various matters, including product liability and certain securities claims. While the Company does not believe that any of the claims known is likely to have a material adverse effect on the Company’s financial condition or results of operations, new claims or unexpected results of existing claims could lead to significant financial harm.
Employment Agreements
The Company’s Chief Executive Officer entered into an employment agreement with the Company, effective March 1, 2015. She and certain officers have as provisions of their agreements certain rights, including continuance of cash compensation and benefits, upon a “change in control,” which may include an acquisition of substantially all its assets, or termination “without cause or for good reason” as defined in the employment agreements.
15
STAAR SURGICAL COMPANY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)
Note 13 — Basic and Diluted Net Income (Loss) Per Share
The following table sets forth the computation of basic and diluted net income (loss) per share (in thousands except per share amounts):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
(1,172 |
) |
|
$ |
3,914 |
|
|
$ |
(1,306 |
) |
|
$ |
5,281 |
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common shares outstanding |
|
|
45,354 |
|
|
|
44,489 |
|
|
|
45,152 |
|
|
|
44,368 |
|
Less: Unvested restricted stock |
|
|
— |
|
|
|
(10 |
) |
|
|
— |
|
|
|
(11 |
) |
Denominator for basic calculation |
|
|
45,354 |
|
|
|
44,479 |
|
|
|
45,152 |
|
|
|
44,357 |
|
Weighted average effects of potentially diluted common stock: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
— |
|
|
|
2,149 |
|
|
|
— |
|
|
|
2,292 |
|
Unvested restricted stock |
|
|
— |
|
|
|
97 |
|
|
|
— |
|
|
|
185 |
|
Restricted stock units |
|
|
— |
|
|
|
8 |
|
|
|
— |
|
|
|
8 |
|
Denominator for diluted calculation |
|
|
45,354 |
|
|
|
46,733 |
|
|
|
45,152 |
|
|
|
46,842 |
|
Net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.03 |
) |
|
$ |
0.09 |
|
|
$ |
(0.03 |
) |
|
$ |
0.12 |
|
Diluted |
|
$ |
(0.03 |
) |
|
$ |
0.08 |
|
|
$ |
(0.03 |
) |
|
$ |
0.11 |
|
Because the Company had a net loss for the three and six months ended July 3, 2020, the number of diluted shares is equal to the number of basic shares. The following table sets forth (in thousands) the weighted average number of options to purchase shares of common stock, restricted stock, and restricted stock units 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 |
|
|
Six Months Ended |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
Stock options |
|
|
3,082 |
|
|
|
1,991 |
|
|
|
3,502 |
|
|
|
1,256 |
|
Restricted stock and restricted stock units |
|
|
59 |
|
|
|
1 |
|
|
|
72 |
|
|
|
— |
|
Total |
|
|
3,141 |
|
|
|
1,992 |
|
|
|
3,574 |
|
|
|
1,256 |
|
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 |
|
|
Six Months Ended |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
Non-consignment sales |
|
$ |
23,446 |
|
|
$ |
35,556 |
|
|
$ |
53,846 |
|
|
$ |
63,822 |
|
Consignment sales |
|
|
11,748 |
|
|
|
4,108 |
|
|
|
16,535 |
|
|
|
8,425 |
|
Total net sales |
|
$ |
35,194 |
|
|
$ |
39,664 |
|
|
$ |
70,381 |
|
|
$ |
72,247 |
|
The Company markets and sells its products in over 75 countries and conducts its manufacturing in the United States. Other than China and Japan, the Company does not conduct business in any country in which its sales exceed 10% of worldwide consolidated net sales. Sales are attributed to countries based on location of customers. The composition of the Company’s net sales to unaffiliated customers was as follows (in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
Domestic |
|
$ |
882 |
|
|
$ |
2,114 |
|
|
$ |
2,621 |
|
|
$ |
4,066 |
|
Foreign: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
China |
|
|
18,603 |
|
|
|
19,394 |
|
|
|
30,318 |
|
|
|
31,165 |
|
Japan |
|
|
7,463 |
|
|
|
6,275 |
|
|
|
15,765 |
|
|
|
11,794 |
|
Other(1) |
|
|
8,246 |
|
|
|
11,881 |
|
|
|
21,677 |
|
|
|
25,222 |
|
Total foreign sales |
|
|
34,312 |
|
|
|
37,550 |
|
|
|
67,760 |
|
|
|
68,181 |
|
Total net sales |
|
$ |
35,194 |
|
|
$ |
39,664 |
|
|
$ |
70,381 |
|
|
$ |
72,247 |
|
(1) |
No other location individually exceeds 10% of the total sales. |
100% of the Company’s sales are generated from the ophthalmic surgical product segment and the chief operating decision maker makes operating decisions and allocates resources based upon the consolidated operating results, and therefore the Company operates as one operating segment for financial reporting purposes. The Company’s principal products are implantable Collamer lenses (“ICLs”) used in refractive surgery and intraocular lenses (“IOLs”) used in cataract surgery. The composition of the Company’s net sales by product line was as follows (in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
ICLs |
|
$ |
30,728 |
|
|
$ |
34,432 |
|
|
$ |
60,068 |
|
|
$ |
62,218 |
|
Other product sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IOLs |
|
|
2,561 |
|
|
|
3,874 |
|
|
|
6,555 |
|
|
|
7,891 |
|
Other surgical products |
|
|
1,905 |
|
|
|
1,358 |
|
|
|
3,758 |
|
|
|
2,138 |
|
Total other product sales |
|
|
4,466 |
|
|
|
5,232 |
|
|
|
10,313 |
|
|
|
10,029 |
|
Total net sales |
|
$ |
35,194 |
|
|
$ |
39,664 |
|
|
$ |
70,381 |
|
|
$ |
72,247 |
|
One customer, the Company’s distributor in China, accounted for 53% and 43% of net sales for the three and six months ended July 3, 2020, respectively, and the same customer, accounted for 49% and 43% of net sales for the three and six months ended June 28, 2019, respectively. As of July 3, 2020 and January 3, 2020, respectively, one customer, the Company’s distributor in China, accounted for 57% and 43% of consolidated trade receivables.
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 and North America. 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 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 EDOF ICL 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 herein. 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
While refractive procedures were down significantly or came to a halt in April and May in much of North America, Europe, Latin America, India and the Middle East, continuing recovery and growth were recorded in Japan, Korea and China. The positive trending continued in July with China experiencing stronger than anticipated demand as the peak season began in earnest. While COVID-19 hotspots and government public health mandates may reoccur moving forward, we anticipate less business interruption and continued increased interest in our EVO ICL lens-based refractive solutions in the third and 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 third quarter of 2020 currently anticipates a sequential revenue increase of over 20% from our second quarter of 2020 results which would then result in year-over-year double digit growth. Also, we currently expect fourth quarter of 2020 revenue will be similar to third quarter of 2020.
19
We resumed production at our California manufacturing facilities on April 27, 2020 and anticipate that we will be able to meet the demand for both our Spheric and Toric EVO lenses through the remainder of 2020. We are moving forward with our plans to restart manufacturing in our Nidau, Switzerland facility in 2021. With respect to our U.S. clinical trial for our EVO family of myopia lenses, assuming no material change in the current operating environment we anticipate that we will complete enrollment in the trial by the end of September. 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.
As previously disclosed, we received on July 2, 2020, CE Mark approval for our extended depth of focus or EDOF presbyopia lens, EVO Viva, that is designed to correct near, intermediate and distance vision. We will commence a phased-rollout beginning in Spain, Belgium and Germany. We anticipate the first implants will occur in September following physician training and certification.
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 six months ended July 3, 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 Six Months |
|
||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
||||
Net sales |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
Cost of sales |
|
|
30.6 |
% |
|
|
24.6 |
% |
|
|
30.1 |
% |
|
|
25.1 |
% |
Gross profit |
|
|
69.4 |
% |
|
|
75.4 |
% |
|
|
69.9 |
% |
|
|
74.9 |
% |
General and administrative |
|
|
22.3 |
% |
|
|
18.9 |
% |
|
|
22.5 |
% |
|
|
19.9 |
% |
Marketing and selling |
|
|
29.3 |
% |
|
|
29.5 |
% |
|
|
30.3 |
% |
|
|
30.2 |
% |
Research and development |
|
|
20.8 |
% |
|
|
15.4 |
% |
|
|
20.2 |
% |
|
|
16.3 |
% |
Total selling, general and administrative |
|
|
72.4 |
% |
|
|
63.8 |
% |
|
|
73.0 |
% |
|
|
66.4 |
% |
Operating income (loss) |
|
|
(3.0 |
)% |
|
|
11.6 |
% |
|
|
(3.1 |
)% |
|
|
8.5 |
% |
Total other income (expense), net |
|
|
1.2 |
% |
|
|
1.1 |
% |
|
|
0.4 |
% |
|
|
1.0 |
% |
Income (loss) before income taxes |
|
|
(1.8 |
)% |
|
|
12.7 |
% |
|
|
(2.7 |
)% |
|
|
9.5 |
% |
Provision (benefit) for income taxes |
|
|
1.5 |
% |
|
|
2.9 |
% |
|
|
(0.8 |
)% |
|
|
2.2 |
% |
Net income (loss) |
|
|
(3.3 |
)% |
|
|
9.8 |
% |
|
|
(1.9 |
)% |
|
|
7.3 |
% |
20
Net Sales
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Six Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
2020 vs. 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
2020 vs. 2019 |
|
||||||
ICLs |
|
$ |
30,728 |
|
|
$ |
34,432 |
|
|
|
(10.8 |
)% |
|
$ |
60,068 |
|
|
$ |
62,218 |
|
|
|
(3.5 |
)% |
Other product sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IOLs |
|
|
2,561 |
|
|
|
3,874 |
|
|
|
(33.9 |
)% |
|
|
6,555 |
|
|
|
7,891 |
|
|
|
(16.9 |
)% |
Other surgical products |
|
|
1,905 |
|
|
|
1,358 |
|
|
|
40.3 |
% |
|
|
3,758 |
|
|
|
2,138 |
|
|
|
75.8 |
% |
Total other product sales |
|
|
4,466 |
|
|
|
5,232 |
|
|
|
(14.6 |
)% |
|
|
10,313 |
|
|
|
10,029 |
|
|
|
2.8 |
% |
Net sales |
|
$ |
35,194 |
|
|
$ |
39,664 |
|
|
|
(11.3 |
)% |
|
$ |
70,381 |
|
|
$ |
72,247 |
|
|
|
(2.6 |
)% |
Net sales for the three months ended July 3, 2020 were $35.2 million, a decrease of 11% from $39.7 million reported during the same period of 2019. The decrease in net sales was due to decreases in ICL sales of $3.7 million and other product sales of $0.8 million.
Net sales for the six months ended July 3, 2020 were $70.4 million, a decrease of 3% from $72.2 million reported during the same period of 2019. The decrease in net sales was due to a decrease in ICL sales of $2.2 million, partially offset by an increase in other product sales of $0.3 million.
Total ICL sales for the three months ended July 3, 2020 were $30.7 million, a decrease of 11% from $34.4 million reported for the same period of 2019, with unit decrease of 3%. The Europe, Middle East, Africa and Latin America region sales decreased 30% with unit decrease of 31%. The North America region sales decreased 55%, with unit decrease of 56%. The decrease in both these regions were impacted by the COVID-19 pandemic when markets started to reopen in mid-May/early June. The APAC region sales decreased by 2%, with unit growth up 5% due to unit growth in Japan up 39%, Korea up 16% and China up 6%. ICL sales represented 87.3% and 86.8% of our total sales for the three months ended July 3, 2020 and June 28, 2019, respectively.
Total ICL sales for the six months ended July 3, 2020 were $60.1 million, a 4% decrease from $62.2 million reported for the same period of 2019, with unit growth up 2%. The Europe, Middle East, Africa and Latin America region sales and units decreased 17%. The North America region sales and units decreased 32%. The decrease in both these regions were impacted by the COVID-19 pandemic when markets started to reopen in mid-May/early June. The APAC region sales increased by 3%, with unit growth up 8% due to unit growth in Japan up 58%, Korea up 15% and China up 7%. ICL sales represented 85.3% and 86.1% of our total sales for the six months ended July 3, 2020 and June 28, 2019, respectively.
Other product sales, including IOLs were $4.5 million for the three months ended July 3, 2020, a decrease of 15% from $5.2 million reported for the same period of 2019. The decrease is due to a decrease in IOL sales, partially offset by an increase in preloaded injector part sales to a third-party manufacturer for product they sell to their customers. Other product sales were $10.3 million for the six months ended July 3, 2020, an increase of 3% from $10.0 million reported for the same period of 2019. The increase is due to an increase in preloaded injector part sales to a third-party manufacturer for product they sell to their customers, offset by a decrease in IOL sales. Other product sales represented 12.7% and 13.2% of our total sales for the three months ended July 3, 2020 and June 28, 2019, respectively, and represented 14.7% and 13.9% of our total sales for the six months ended July 3, 2020 and June 28, 2019, respectively.
Gross Profit
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Six Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
2020 vs. 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
2020 vs. 2019 |
|
||||||
Gross profit |
|
$ |
24,430 |
|
|
$ |
29,899 |
|
|
|
(18.3 |
)% |
|
$ |
49,190 |
|
|
$ |
54,079 |
|
|
|
(9.0 |
)% |
Gross margin |
|
|
69.4 |
% |
|
|
75.4 |
% |
|
|
|
|
|
|
69.9 |
% |
|
|
74.9 |
% |
|
|
|
|
Gross profit for the three months ended July 3, 2020 was $24.4 million, an 18.3% decrease compared to the $29.9 million reported for the same period of 2019. Gross profit margin decreased to 69.4% of revenue for the three months ended July 3, 2020 compared to 75.4% of revenue for the three months ended June 28, 2019, due to geographic sales mix, $1.0 million in expenses related to the COVID-19 manufacturing pause from April 4 through April 27, 2020, 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 six months ended July 3, 2020 was $49.2 million, a 9.0% decrease compared to the $54.1 million reported for the same period of 2019. Gross profit margin decreased to 69.9% of revenue for the six months ended July 3, 2020 compared to 74.9% of revenue for the three months ended June 28, 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 |
|
|
Six Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
2020 vs. 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
2020 vs. 2019 |
|
||||||
General and administrative expense |
|
$ |
7,848 |
|
|
$ |
7,508 |
|
|
|
4.5 |
% |
|
$ |
15,817 |
|
|
$ |
14,345 |
|
|
|
10.3 |
% |
Percentage of sales |
|
|
22.3 |
% |
|
|
18.9 |
% |
|
|
|
|
|
|
22.5 |
% |
|
|
19.9 |
% |
|
|
|
|
General and administrative expenses for the three months ended July 3, 2020 were $7.8 million, a 4.5% increase compared to the $7.5 million reported for the same period of 2019. General and administrative expenses for the six months ended July 3, 2020 were $15.8 million, a 10.3% increase compared to the $14.3 million reported for the same period of 2019. The increase in general and administrative expenses for both periods was due to an increase in headcount and salary-related expenses, partially offset by a decrease in variable compensation and travel expenses, and for the six months also due to increased tax consulting and facilities costs.
Marketing and Selling Expense
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Six Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
2020 vs. 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
2020 vs. 2019 |
|
||||||
Marketing and selling expense |
|
$ |
10,326 |
|
|
$ |
11,682 |
|
|
|
(11.6 |
)% |
|
$ |
21,354 |
|
|
$ |
21,825 |
|
|
|
(2.2 |
)% |
Percentage of sales |
|
|
29.3 |
% |
|
|
29.5 |
% |
|
|
|
|
|
|
30.3 |
% |
|
|
30.2 |
% |
|
|
|
|
Marketing and selling expenses for the three months ended July 3, 2020 were $10.3 million, a 11.6% decrease compared to the $11.7 million reported for the same period of 2019. The decrease in marketing and selling expenses was due to decreased trade show expenses and travel expenses, partially offset by increased advertising and promotional activities.
Marketing and selling expenses for the six months ended July 3, 2020 were $21.4 million, a 2.2% decrease compared to the $21.8 million reported for the same period of 2019. The decrease in marketing and selling expenses was due to decreased trade show expenses and travel expenses, partially offset by increased advertising, promotional activities and salary-related expenses.
Research and Development Expense
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Six Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
2020 vs. 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
2020 vs. 2019 |
|
||||||
Research and development expense |
|
$ |
7,311 |
|
|
$ |
6,098 |
|
|
|
19.9 |
% |
|
$ |
14,209 |
|
|
$ |
11,733 |
|
|
|
21.1 |
% |
Percentage of sales |
|
|
20.8 |
% |
|
|
15.4 |
% |
|
|
|
|
|
|
20.2 |
% |
|
|
16.3 |
% |
|
|
|
|
Research and development expenses for the three months ended July 3, 2020 were $7.3 million, a 19.9% increase compared to the $6.1 million reported for the same period of 2019. Research and development expenses for the six months ended July 3, 2020 were $14.2 million, a 21.1% increase compared to the $11.7 million reported for the same period of 2019. The increase in research and development expenses for both periods was primarily due to an increase in expenses related to clinical expenses associated with our EVO clinical trial in the U.S., and increased headcount and salary-related expenses, partially offset by variable compensation and travel expense.
22
Other Income (Expense), Net
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Six Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
2020 vs. 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
2020 vs. 2019 |
|
||||||
Other income, net |
|
$ |
439 |
|
|
$ |
434 |
|
|
|
1.2 |
% |
|
$ |
282 |
|
|
$ |
725 |
|
|
|
(61.1 |
)% |
Percentage of sales |
|
|
1.2 |
% |
|
|
1.1 |
% |
|
|
|
|
|
|
0.4 |
% |
|
|
1.0 |
% |
|
|
|
|
* |
Denotes change is greater than +100%. |
Other income, net for the three months ended July 3, 2020 was $0.4 million, comparable to that reported for the same period of 2019. Other income, net for the six months ended July 3, 2020 was $0.3 million compared to other income of $0.7 million reported for the same period of 2019. The decrease in other income, net for the six months was due to decreases in interest income, as a result of lower interest rates, and royalty income, which was impacted by COVID-19 pandemic, partially offset by a decrease in foreign exchange losses (primarily the euro).
Income Taxes
|
|
Three Months Ended |
|
|
Percentage Change |
|
|
Six Months Ended |
|
|
Percentage Change |
|
||||||||||||
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
2020 vs. 2019 |
|
|
July 3, 2020 |
|
|
June 28, 2019 |
|
|
2020 vs. 2019 |
|
||||||
Income tax provision (benefit) |
|
$ |
556 |
|
|
$ |
1,131 |
|
|
|
(50.8 |
)% |
|
$ |
(602 |
) |
|
$ |
1,620 |
|
|
|
—* |
|
* |
Denotes change is greater than +100%. |
We recorded income taxes of $0.6 million and $1.1 million for the three months ended July 3, 2020 and June 28, 2019, respectively, primarily due to pre-tax income generated in certain foreign jurisdictions. Also for the three months ended June 28, 2019 withholding taxes on foreign operations. We recorded an income tax benefit of $0.6 million for the six months ended July 3, 2020 due to the income tax benefit from the release of our U.S. valuation allowances, offset by income tax expense from profits generated by our foreign operations. We recorded income taxes of $1.6 million for the six months ended June 28, 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 six months ended July 3, 2020, we revised our global forecasts as a result of COVID-19, and released an additional $1.4 million of valuation allowance. As of July 3, 2020, we released approximately $4.9 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 $36.5 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. We have experienced some delays in payments on accounts receivable as a result of the COVID-19 pandemic but expect this to improve during the third quarter of 2020 as our customers resume elective refractive surgery. This has had a temporary impact on our working capital. However, at this time we are unaware of any impairment of assets resulting from the COVID19 pandemic. The Company did not apply for or require financing available under the Coronavirus Aid, Relief, and Economic Security “CARES” Act and
23
does not expect to do so given the strength of our balance sheet. Our financial condition at July 3, 2020 and January 3, 2020 included the following (in millions):
|
|
July 3, 2020 |
|
|
January 3, 2020 |
|
|
2020 vs. 2019 |
|
|||
Cash and cash equivalents |
|
$ |
116.3 |
|
|
$ |
120.0 |
|
|
$ |
(3.7 |
) |
Current assets |
|
$ |
182.5 |
|
|
$ |
174.7 |
|
|
$ |
7.8 |
|
Current liabilities |
|
|
31.6 |
|
|
|
34.5 |
|
|
|
(2.9 |
) |
Working capital |
|
$ |
150.9 |
|
|
$ |
140.2 |
|
|
$ |
10.7 |
|
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 July 3, 2020, we have a line of credit with a Japanese lender, in the amount of $1.3 million, with $3.3 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 used in operating activities was $8.2 million for the six months ended July 3, 2020 compared to net cash provided by operating activities of $4.2 million for the six months ended June 28, 2019. Net cash used in operating activities for the six months ended July 3, 2020, consisted of $14.7 million in working-capital changes and a $1.3 million net loss, offset by $7.8 in non-cash items. The change in net cash used in operating activities during the six months ended July 3, 2020 was due to a decrease in net working capital of $5.0 million, a decrease of $0.8 million in non-cash items and the net loss of $1.3 million during the six months ended July 3, 2020 compared to net income of $5.3 million during the six months ended June 28, 2019.
Net cash used in investing activities was $4.2 million and $4.6 million for the six months ended July 3, 2020 and June 28, 2019, respectively, and relate primarily to the acquisition of property, plant, and equipment.
Net cash provided by financing activities was $8.7 million for the six months ended July 3, 2020 compared to net cash used in financing activities of $0.6 million for the six months ended June 28, 2019. Net cash provided by financing activities for the six months ended July 3, 2020 consisted of $9.6 million of proceeds from the exercise of stock options, offset by $0.5 million repayment on the Japan line of credit and $0.3 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 July 3, 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 six months ended July 3, 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.
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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 July 3, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II – OTHER INFORMATION
ITEM 1. |
LEGAL PROCEEDINGS |
From time to time, the Company is involved in various legal proceedings and other matters arising in the normal course of business. These legal proceedings and other matters may relate to, among other things, contractual rights and obligations, employment matters, or claims of product liability. STAAR maintains insurance coverage for various matters, including product liability and certain securities claims. While we do not believe that any of the claims known is likely to have a material adverse effect on our financial condition or results of operations, new claims or unexpected results of existing claims could lead to significant financial harm.
ITEM 1A. |
RISK FACTORS |
Our short and long-term success is subject to many factors that are beyond our control. Investors and prospective investors should consider carefully information contained in this report and the risks and uncertainties described in “Part I—Item 1A—Risk Factors” of the Company’s Form 10-K for the fiscal year ended 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.
ITEM 4. |
MINE SAFETY DISCLOSURES |
Not Applicable.
25
ITEM 5. |
OTHER INFORMATION |
Effective May 1, 2020, the Compensation Committee of the Board of Directors, as Administrator of STAAR’s Equity Incentive Plan, approved an amendment to Section 12.5 of STAAR’s Amended and Restated Omnibus Equity Incentive Plan to permit discretionary acceleration of vesting of equity awards granted to a non-employee director in the event of a Termination of Service, as defined by the Plan, after serving a minimum of at least one-half of the relevant term under any Award Agreement, as defined by the Plan.
ITEM 6. |
EXHIBITS |
3.1 |
|
|
|
3.2 |
|
|
|
4.1 |
Form of Certificate for Common Stock, par value $0.01 per share.(3) |
|
|
†4.2 |
|
|
|
†10.38 |
|
|
|
31.1 |
|
|
|
31.2 |
|
|
|
32.1 |
|
|
|
101 |
Financial statements from the quarterly report on Form 10-Q of STAAR Surgical Company for the quarter ended July 3, 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.* |
|
|
104 |
The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended July 3, 2020, has been formatted in Inline XBRL with applicable taxonomy extension information contained in Exhibit 101. |
(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 |
(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. |
(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. |
* |
Filed herewith. |
** |
Furnished herewith. |
† |
Management contract or compensatory plan. |
26
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
STAAR SURGICAL COMPANY |
||
|
|
|
|
|
|
Dated: |
|
August 5, 2020 |
By: |
|
/s/ PATRICK F. WILLIAMS |
|
|
|
|
|
Patrick F. Williams |
|
|
|
|
|
Chief Financial Officer |
|
|
|
|
|
(on behalf of the Registrant and as its principal financial officer) |
27