STAAR SURGICAL CO - Quarter Report: 2022 September (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: September 30, 2022

☐	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 Lake Forest, California	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 48,206,299 shares of common stock, par value $0.01 per share, issued and outstanding as of October 28, 2022.

STAAR SURGICAL COMPANY

INDEX

		PAGE NUMBER

PART I – FINANCIAL INFORMATION		1

ITEM 1	FINANCIAL STATEMENTS	1

ITEM 2.	MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	18

ITEM 3.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	24

ITEM 4.	CONTROLS AND PROCEDURES	24

PART II – OTHER INFORMATION		24

ITEM 1.	LEGAL PROCEEDINGS	24

ITEM 1A.	RISK FACTORS	25

ITEM 4.	MINE SAFETY DISCLOSURES	25

ITEM 5.	OTHER INFORMATION	25

ITEM 6.	EXHIBITS	25

PART I – FINANCIAL INFORMATION

ITEM 1.

FINANCIAL STATEMENTS

STAAR SURGICAL COMPANY

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except par value amounts)

(Unaudited)

	September 30, 2022			December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents	$	129,242		$	199,706
Investments available for sale		82,091			—
Accounts receivable trade, net of allowance for credit losses of $103 and $43, respectively		55,429			43,531
Inventories, net		19,930			17,274
Prepayments, deposits and other current assets		10,218			10,900
Total current assets		296,910			271,411
Investments available for sale		13,360			—
Property, plant and equipment, net		48,048			35,912
Finance lease right-of-use assets, net		380			506
Operating lease right-of-use assets, net		29,503			31,310
Intangible assets, net		171			218
Goodwill		1,786			1,786
Deferred income taxes		3,710			3,813
Other assets		808			822
Total assets	$	394,676		$	345,778
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	7,567		$	8,699
Obligations under finance leases		167			127
Obligations under operating leases		3,474			3,283
Allowance for sales returns		5,040			4,816
Other current liabilities		29,072			31,877
Total current liabilities		45,320			48,802
Obligations under finance leases		252			382
Obligations under operating leases		26,032			28,269
Deferred income taxes		1,554			811
Asset retirement obligations		158			198
Pension liability		1,228			8,758
Total liabilities		74,544			87,220
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.01 par value; 60,000 shares authorized: 48,202 and 47,716 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively		482			477
Additional paid-in capital		398,448			373,519
Accumulated other comprehensive loss		(310	)		(4,048	)
Accumulated deficit		(78,488	)		(111,390	)
Total stockholders’ equity		320,132			258,558
Total liabilities and stockholders’ equity	$	394,676		$	345,778

See accompanying notes to the condensed consolidated financial statements.

STAAR SURGICAL COMPANY

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(In thousands, except per share amounts)

(Unaudited)

	Three Months Ended						Nine Months Ended
	September 30, 2022			October 1, 2021			September 30, 2022			October 1, 2021
Net sales	$	76,046		$	58,352		$	220,347		$	171,471
Cost of sales		15,584			13,051			46,749			37,825
Gross profit		60,462			45,301			173,598			133,646
Selling, general and administrative expenses:
General and administrative		14,011			11,018			39,934			32,671
Selling and marketing		23,130			18,175			64,633			50,229
Research and development		9,616			8,271			26,193			24,790
Total selling, general and administrative expenses		46,757			37,464			130,760			107,690
Operating income		13,705			7,837			42,838			25,956
Other expense, net:
Interest income (expense), net		897			(23	)		934			(35	)
Loss on foreign currency transactions		(2,129	)		(610	)		(4,904	)		(2,040	)
Royalty income		77			185			527			496
Other income (expense), net		27			(13	)		178			(47	)
Total other expense, net		(1,128	)		(461	)		(3,265	)		(1,626	)
Income before income taxes		12,577			7,376			39,573			24,330
Provision for income taxes		2,315			1,356			6,671			4,751
Net income	$	10,262		$	6,020		$	32,902		$	19,579
Net income per share:
Basic	$	0.21		$	0.13		$	0.69		$	0.42
Diluted	$	0.21		$	0.12		$	0.67		$	0.40
Weighted average shares outstanding:
Basic		48,102			47,483			47,915			47,064
Diluted		49,549			49,592			49,371			49,448

See accompanying notes to the condensed consolidated financial statements.

STAAR SURGICAL COMPANY

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(In thousands)

(Unaudited)

	Three Months Ended						Nine Months Ended
	September 30, 2022			October 1, 2021			September 30, 2022			October 1, 2021
Net income	$	10,262		$	6,020		$	32,902		$	19,579
Other comprehensive income (loss):
Defined benefit plans:
Net change in plan assets		465			90			7,126			2,717
Reclassification into other income (expense), net		54			121			139			361
Investments available for sale unrealized loss		(432	)		—			(432	)		—
Foreign currency translation gain (loss)		(958	)		29			(3,474	)		(1,198	)
Tax effect		312			(32	)		379			37
Other comprehensive income (loss), net of tax		(559	)		208			3,738			1,917
Comprehensive income	$	9,703		$	6,228		$	36,640		$	21,496

See accompanying notes to the condensed consolidated financial statements.

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 July 1, 2022		48,024	$	480	$	387,328	$	249		$	(88,750	)	$	299,307
Net income		—		—		—		—			10,262			10,262
Other comprehensive loss		—		—		—		(559	)		—			(559	)
Common stock issued upon exercise of options		166		2		5,032		—			—			5,034
Stock-based compensation		—		—		6,088		—			—			6,088
Vested restricted and performance stock		12		—		—		—			—			—
Balance, at September 30, 2022		48,202	$	482	$	398,448	$	(310	)	$	(78,488	)	$	320,132

Balance, at July 2, 2021		47,391	$	474	$	360,316	$	(3,836	)	$	(122,332	)	$	234,622
Net income		—		—		—		—			6,020			6,020
Other comprehensive income		—		—		—		208			—			208
Common stock issued upon exercise of options		183		2		4,210		—			—			4,212
Stock-based compensation		—		—		4,046		—			—			4,046
Vested restricted and performance stock		25		—		—		—			—			—
Balance, at October 1, 2021		47,599	$	476	$	368,572	$	(3,628	)	$	(116,312	)	$	249,108

See accompanying notes to the condensed consolidated financial statements.

STAAR SURGICAL COMPANY

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands)

(Unaudited)

	Nine Months Ended
	Common Stock Shares		Common Stock Par Value		Additional Paid-In Capital		Accumulated Other Compre- hensive Income (Loss)			Accumulated Deficit			Total
Balance, at December 31, 2021		47,716	$	477	$	373,519	$	(4,048	)	$	(111,390	)	$	258,558
Net income		—		—		—		—			32,902			32,902
Other comprehensive income		—		—		—		3,738			—			3,738
Common stock issued upon exercise of options		417		4		8,175		—			—			8,179
Stock-based compensation		—		—		16,754		—			—			16,754
Unvested restricted stock		7		—		—		—			—			—
Vested restricted and performance stock		62		1		—		—			—			1
Balance, at September 30, 2022		48,202	$	482	$	398,448	$	(310	)	$	(78,488	)	$	320,132

Balance, at January 1, 2021		46,448	$	464	$	338,194	$	(5,545	)	$	(135,891	)	$	197,222
Net income		—		—		—		—			19,579			19,579
Other comprehensive income		—		—		—		1,917			—			1,917
Common stock issued upon exercise of options		1,089		11		18,311		—			—			18,322
Stock-based compensation		—		—		12,067		—			—			12,067
Unvested restricted stock		3		—		—		—			—			—
Vested restricted and performance stock		59		1		—		—			—			1
Balance, at October 1, 2021		47,599	$	476	$	368,572	$	(3,628	)	$	(116,312	)	$	249,108

See accompanying notes to the condensed consolidated financial statements.

STAAR SURGICAL COMPANY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

	Nine Months Ended
	September 30, 2022			October 1, 2021
Cash flows from operating activities:
Net income	$	32,902		$	19,579
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation of property, plant, and equipment		3,101			2,671
Amortization of intangibles		22			26
Accretion/Amortization of investments available for sale		(307	)		—
Deferred income taxes		23			845
Change in net pension liability		40			91
Loss on disposal of property and equipment		—			2
Stock-based compensation expense		15,375			10,985
Provision for sales returns and bad debts		361			1,069
Inventory provision		2,020			1,097
Changes in working capital:
Accounts receivable		(13,108	)		(7,072	)
Inventories		(4,123	)		1,301
Prepayments, deposits, and other current assets		526			1,288
Accounts payable		(1,834	)		(40	)
Other current liabilities		(2,253	)		3,622
Net cash provided by operating activities		32,745			35,464
Cash flows from investing activities:
Acquisition of property and equipment		(14,083	)		(8,956	)
Purchase of investments available for sale		(95,576	)		—
Net cash used in investing activities		(109,659	)		(8,956	)
Cash flows from financing activities:
Repayment of finance lease obligations		(85	)		(314	)
Proceeds from the exercise of stock options		8,179			18,322
Proceeds from vested restricted stock		1			1
Net cash provided by financing activities		8,095			18,009
Effect of exchange rate changes on cash and cash equivalents		(1,645	)		(724	)
Increase (decrease) in cash and cash equivalents		(70,464	)		43,793
Cash and cash equivalents, at beginning of the period		199,706			152,453
Cash and cash equivalents, at end of the period	$	129,242		$	196,246

See accompanying notes to the condensed consolidated financial statements.

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 1 — Basis of Presentation and Significant Accounting Policies

The Condensed Consolidated Financial Statements of the Company present the financial position, results of operations, and cash flows of STAAR Surgical Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Exchange Commission. In accordance with those rules and regulations certain information and footnote disclosures normally included in the Comprehensive Financial Statements have been condensed or omitted pursuant to such rules and regulations. The Consolidated Balance Sheet as of December 31, 2021 was derived from the audited financial statements at that date, but does not include all the information and footnotes required by GAAP. These financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.

The Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2022 and October 1, 2021, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the Company’s financial condition and results of operations. The results of operations for the three and nine months ended September 30, 2022 and October 1, 2021, are not necessarily indicative of the results to be expected for any other interim period or for the entire year.

Each of the Company’s fiscal reporting periods ends on the Friday nearest to the quarter ending date and generally consists of 13 weeks. Unless the context indicates otherwise “we,” “us,” the “Company,” and “STAAR” refer to STAAR Surgical Company and its consolidated subsidiaries.

Cash and Cash Equivalents

Cash and cash equivalents include cash and balances in deposits and money market accounts held at banks and financial institutions. Such balances generally exceed the federal insurance limits; however, the Company periodically assesses the financial condition of the institutions and believes that the risk of any loss is minimal.

Investments Available for Sale

Investments available for sale (“AFS”) are investments in debt securities for which the Company does not have the positive intent and ability to hold to maturity. The Company’s investment policy primary objective is capital preservation while maximizing its return on investment. Investments may include U.S. government and corporate debt securities, commercial paper, certain certificates of deposit and related security types, that are rated by two nationally recognized statistical rating organizations with minimum investment grade ratings of AAA to A-/A-1+ to A-2, or the equivalent. There are also limits to the amount of credit exposure in any given security type.

Investments AFS are measured at fair value and its unrealized gains and losses reported net of the allowance for credit losses and applicable income taxes, are recognized in accumulated other comprehensive income (loss) on the Consolidated Balance Sheets. The cost of investments AFS is adjusted for amortization of premiums and accretion of discounts to maturity. Interest earned, including amortization of premiums and accretion of discounts recognized, is included in interest income (expense) on the Consolidated Statements of Income. The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method.

The Company recognizes other-than-temporary impairment (“OTTI”) of a debt security for which there has been a decline in fair value below amortized cost if (i) management intends to sell the security, (ii) it is more-likely-than-not that the Company will be required to sell the security before recovery of its amortized cost basis, or (iii) the Company does not expect to recover the entire amortized cost basis of the security. The amount by which amortized cost exceeds the fair value of a debt security that is considered to have OTTI is separated into a component representing the credit loss, which is recognized in other income (expense) on the Consolidated Statements of Income, and a component related to all other factors, which is recognized in accumulated other comprehensive income (loss) on the Consolidated Balance Sheets. The measurement of the credit loss component is equal to the difference between the debt security’s amortized cost basis and the present value of its expected future cash flows discounted at the security’s effective yield.

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 1 — Basis of Presentation and Significant Accounting Policies (Continued)

Vendor Concentration

There were no vendors that accounted for over 10% of the Company’s consolidated accounts payable as of September 30, 2022 and December 31, 2021. There were no vendors that accounted for over 10% of the Company’s consolidated purchases for the three and nine months ended September 30, 2022 and October 1, 2021, respectively.

Note 2 — Investments Available for Sale

In the three months ended September 30, 2022, the Company started to invest its cash in slightly higher yielding securities. Investments AFS and the related fair value measurement consisted of the following (dollars in thousands):

	September 30, 2022
	Amortized Cost		Unrealized Gains		Unrealized Losses			Estimated Fair Value
Level 2 Fair Value Measurements:
Commercial paper	$	35,093	$	1	$	(75	)	$	35,019
Certificates of deposit		14,404		1		(66	)		14,339
U.S. Treasury and agency securities		4,188		—		(1	)		4,187
Corporate debt securities		41,898		5		(297	)		41,606
Accrued interest receivable		300		—		—			300
Total investments AFS	$	95,883	$	7	$	(439	)	$	95,451

The Company obtains the fair value from third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market-based approaches and observable market inputs to determine value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers and other industry and economic events.

The Company assessed each debt security with gross unrealized losses for credit impairment. As part of that assessment, the Company concluded that it is more-likely-than-not that the Company will not be required to sell, prior to the recovery of the amortized cost basis. The Company did not recognize impairment for the three and nine months ended September 30, 2022.

The following table shows the fair value of investments AFS by contractual maturity (dollars in thousands):

	As of September 30, 2022
	Within one year		After one year through five years		Total
Commercial paper	$	35,019	$	—	$	35,019
Certificates of deposit		14,339		—		14,339
U.S. Treasury and agency securities		4,187		—		4,187
Corporate debt securities		28,246		13,360		41,606
Accrued interest receivable		300		—		300
Total investments AFS	$	82,091	$	13,360	$	95,451

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 3 — Inventories

Inventories, net are stated at the lower of cost and net realizable value, determined on a first-in, first-out basis and consisted of the following (in thousands):

	September 30, 2022			December 31, 2021
Raw materials and purchased parts	$	5,607		$	3,971
Work in process		4,038			4,031
Finished goods		12,109			10,429
Total inventories, gross		21,754			18,431
Less inventory reserves		(1,824	)		(1,157	)
Total inventories, net	$	19,930		$	17,274

Note 4 — Prepayments, Deposits, and Other Current Assets

Prepayments, deposits, and other current assets consisted of the following (in thousands):

	September 30, 2022		December 31, 2021
Prepayments and deposits	$	3,716	$	4,047
Prepaid insurance		517		2,647
Prepaid marketing		2,590		543
Consumption tax receivable		694		830
Value added tax (VAT) receivable		1,555		2,197
BVG (Swiss Pension) prepayment		722		15
Other⁽¹⁾		424		621
Total prepayments, deposits and other current assets	$	10,218	$	10,900

⁽¹⁾	No individual item in “other current assets” exceeds 5% of the total prepayments, deposits and other current assets.

Note 5 — Property, Plant and Equipment

Property, plant and equipment, net consisted of the following (in thousands):

	September 30, 2022			December 31, 2021
Machinery and equipment	$	27,860		$	24,127
Computer equipment and software		9,243			8,807
Furniture and fixtures		4,453			3,658
Leasehold improvements		12,212			11,821
Construction in process		31,398			21,827
Total property, plant and equipment, gross		85,166			70,240
Less accumulated depreciation		(37,118	)		(34,328	)
Total property, plant and equipment, net	$	48,048		$	35,912

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 6 – Intangible Assets

Intangible assets, net consisted of the following (in thousands):

September 30, 2022

December 31, 2021

Long-lived amortized intangible assets

Gross

Carrying

Amount

Accumulated

Amortization

Net

Gross

Carrying

Amount

Accumulated

Amortization

Net

Patents and licenses

9,194

(9,023

)

171

9,315

(9,097

)

218

Note 7 – Other Current Liabilities

Other current liabilities consisted of the following (in thousands):

	September 30, 2022		December 31, 2021
Accrued salaries and wages	$	9,174	$	12,030
Accrued bonuses		5,356		8,091
Income taxes payable		5,232		2,248
Marketing obligations		2,418		2,243
Other⁽¹⁾		6,892		7,265
Total other current liabilities	$	29,072	$	31,877

⁽¹⁾	No individual item in “Other” exceeds 5% of the other current liabilities.

Note 8 – Leases

Finance Leases

The Company entered into finance leases primarily related to purchases of equipment used for manufacturing, computer-related equipment or furniture and fixtures. These finance leases are 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):

	September 30, 2022			December 31, 2021
Machinery and equipment	$	28		$	35
Computer equipment and software		16			506
Furniture and fixtures		475			475
Finance lease right-of-use assets, gross		519			1,016
Less accumulated depreciation		(139	)		(510	)
Finance lease right-of-use assets, net	$	380		$	506

Current finance lease obligations	$	167		$	127
Long-term finance lease obligations		252			382
Total finance lease liability	$	419		$	509
Weighted-average remaining lease term (in years)		2.5			3.2
Weighted-average discount rate		4.11	%		4.02	%

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 8 – Leases (Continued)

Finance Leases (Continued)

Supplemental cash flow information related to finance leases consisted of the following (dollars in thousands):

	Three Months Ended				Nine Months Ended
	September 30, 2022		October 1, 2021		September 30, 2022		October 1, 2021
Amortization of finance lease right-of-use asset	$	39	$	15	$	121	$	71
Interest on finance lease liabilities		5		1		13		6
Cash paid for amounts included in the measurement of finance lease liabilities:
Operating cash flows		5		1		13		6
Financing cash flows		40		36		85		314

Operating Leases

The Company entered into operating leases primarily related to real property (office, manufacturing and warehouse facilities), automobiles and copiers. These operating leases are two to ten years in length with options to extend. The Company does not include any lease extensions in the initial valuation unless the Company was reasonably certain to extend the lease. Depending on the lease, there are those with fixed payment amounts for the entire length of the contract or payments which increase periodically as noted in the contract or increased at an inflation rate indicator. For operating leases that increase using an inflation rate indicator, the Company used the inflation rate at the time the lease was entered into for the length of the lease term. Supplemental balance sheet information related to operating leases consisted of the following (dollars in thousands):

	September 30, 2022			December 31, 2021
Machinery and equipment	$	762		$	760
Computer equipment and software		446			472
Real property		33,751			34,426
Operating lease right-of-use assets, gross		34,959			35,658
Less accumulated depreciation		(5,456	)		(4,348	)
Operating lease right-of-use assets, net	$	29,503		$	31,310

Current operating lease obligations	$	3,474		$	3,283
Long-term operating lease obligations		26,032			28,269
Total operating lease liability	$	29,506		$	31,552
Weighted-average remaining lease term (in years)		7.6			7.8
Weighted-average discount rate		4.04	%		3.56	%

Supplemental cash flow information related to operating leases was as follows (dollars in thousands):

	Three Months Ended				Nine Months Ended
	September 30, 2022		October 1, 2021		September 30, 2022		October 1, 2021
Operating lease cost	$	1,167	$	931	$	3,471	$	2,571
Cash paid for amounts included in the measurement of operating lease liabilities:
Operating cash flows		1,103		846		3,069		2,432
Right-of-use assets obtained in exchange for new operating lease liabilities		126		15,212		1,166		19,219

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 8 – Leases (Continued)

Maturities of Lease Liabilities

Maturities of lease liabilities under operating and finance leases having initial or remaining non-cancelable lease terms more than one year as of September 30, 2022 is as follows (in thousands):

As of September 30, 2022 12 Months Ended	Operating Leases			Finance Leases
September 2023	$	5,179		$	181
September 2024		5,152			176
September 2025		4,224			85
September 2026		3,659			—
September 2027		3,671			—
Thereafter		13,099			—
Total future minimum lease payments	$	34,984		$	442
Less amounts representing interest		(5,478	)		(23	)
Present value of future minimum lease payments	$	29,506		$	419

Note 9 — Income Taxes

The Company recorded an income tax provision as follows (in thousands):

	Three Months Ended				Nine Months Ended
	September 30, 2022		October 1, 2021		September 30, 2022		October 1, 2021
Provision for income taxes	$	2,315	$	1,356	$	6,671	$	4,751

The effective tax rates for the three months ended September 30, 2022 and October 1, 2021 was 18.4% and 18.4%, respectively, and was 16.9% and 19.5%, for the nine months ended September 30, 2022 and October 1, 2021, respectively. The Company’s effective tax rates differ from the U.S. federal statutory rate of 21% for the three and nine months ended September 30, 2022 and October 1, 2021, respectively, primarily due to the income taxes generated in foreign jurisdictions. The differences in the effective tax rate for the three and nine months ended September 30, 2022 compared to the same period in 2021 was primarily due to jurisdictions in which the income is earned.

Note 10 – Defined Benefit Pension Plans

The Company has defined benefit plans covering employees of its Switzerland and Japan operations. The following table summarizes the components of net periodic pension cost recorded for the Company’s defined benefit pension plans (in thousands):

	Three Months Ended						Nine Months Ended
	September 30, 2022			October 1, 2021			September 30, 2022			October 1, 2021
Service cost⁽¹⁾	$	306		$	326		$	941		$	1,003
Interest cost⁽²⁾		22			14			63			42
Expected return on plan assets⁽²⁾		(125	)		(99	)		(366	)		(299	)
Prior service credit⁽^2),(3)		(44	)		(10	)		(135	)		(32	)
Actuarial loss recognized in current period⁽^2),(3)		98			131			274			393
Net periodic pension cost	$	257		$	362		$	777		$	1,107

⁽¹⁾	Recognized in selling general and administrative expenses on the Condensed Consolidated Statements of Income.

⁽²⁾	Recognized in other expense, net on the Condensed Consolidated Statements of Income.

⁽³⁾	Amounts reclassified from accumulated other comprehensive income (loss).

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 10 – Defined Benefit Pension Plans (Continued)

The Company currently is not required to and does not make contributions to its Japan pension plan. The Company’s contributions to its Swiss pension plan are as follows (in thousands):

	Three Months Ended				Nine Months Ended
	September 30, 2022		October 1, 2021		September 30, 2022		October 1, 2021
Employer contribution	$	230	$	204	$	666	$	601

Note 11 — Stockholders’ Equity

Stock-Based Compensation

The cost that has been charged against income for stock-based compensation is set forth below (in thousands):

	Three Months Ended				Nine Months Ended
	September 30, 2022		October 1, 2021		September 30, 2022		October 1, 2021
Employee stock options	$	2,865	$	2,594	$	7,649	$	7,850
Restricted stock		67		109		618		507
Restricted stock units		1,249		700		3,242		2,048
Performance stock units		1,240		124		2,932		325
Nonemployee stock options		306		136		934		255
Total stock-based compensation expense	$	5,727	$	3,663	$	15,375	$	10,985

The Company recorded stock-based compensation costs in the following categories (in thousands):

	Three Months Ended				Nine Months Ended
	September 30, 2022		October 1, 2021		September 30, 2022		October 1, 2021
Cost of sales	$	233	$	61	$	409	$	150
General and administrative		2,584		1,671		7,171		4,925
Selling and marketing		1,335		851		3,548		2,637
Research and development		1,575		1,080		4,247		3,273
Total stock-based compensation expense, net		5,727		3,663		15,375		10,985
Amounts capitalized as part of inventory		361		383		1,379		1,082
Total stock-based compensation expense, gross	$	6,088	$	4,046	$	16,754	$	12,067

Incentive Plan

The Amended and Restated Omnibus Equity Incentive Plan (“the Plan”) provides for various forms of stock-based incentives. To date, of the available forms of awards under the Plan, the Company has granted only stock options, restricted stock, unrestricted share grants, restricted stock units (“RSUs”) and performance stock units (“PSUs”). Options under the Plan are granted at fair market value on the date of grant, become exercisable generally over a three-year 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 and PSUs outstanding under the Plan generally vest based on service, performance, or a combination of both. As of September 30, 2022, there were 2,133,765 shares available for grant under the Plan.

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 11 — Stockholders’ Equity (Continued)

Assumptions

The fair value of each option award is estimated on the date of grant using a Black-Scholes option valuation model applying the weighted-average assumptions noted in the following table. Expected volatilities are based on historical volatility of the Company’s stock. The expected term of options granted is derived from the historical exercises and post-vesting cancellations and represents the period of time that options granted are expected to be outstanding. The Company has calculated a 5% 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						Nine Months Ended
	September 30, 2022			October 1, 2021			September 30, 2022			October 1, 2021
Expected dividend yield		0	%		0	%		0	%		0	%
Expected volatility		54	%		53	%		54	%		53	%
Risk-free interest rate		2.91	%		0.79	%		1.88	%		0.84	%
Expected term (in years)		5.10			5.38			5.10			5.38

Stock Options

A summary of stock option activity under the Plan for nine months ended September 30, 2022 is presented below:

	Stock Options (in 000’s)			Minimum Exercise Price		Maximum Exercise Price
Outstanding at December 31, 2021		2,435
Granted		443
Exercised		(417	)
Forfeited or expired		(23	)
Outstanding at September 30, 2022		2,438		$	5.34	$	154.96
Exercisable at September 30, 2022		1,778

Restricted Stock, Restricted Stock Units and Performance Stock Units

A summary of restricted stock, RSUs and PSUs activity under the Plan for the nine months ended September 30, 2022 is presented below (shares in thousands):

	Restricted Stock			RSUs			PSUs
Unvested at December 31, 2021		3			131			10
Granted		6			116			113
Vested		(5	)		(57	)		(5	)
Unvested at September 30, 2022		4			190			118

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 12 - Commitments and Contingencies

Litigation and Claims

From time to time, the Company is involved in various legal proceedings and other matters arising in the normal course of business. These legal proceedings and other matters may relate to, among other things, contractual rights and obligations, employment matters, or claims of product liability. STAAR maintains insurance coverage for various matters, including product liability and certain securities claims. While the Company does not believe that any of the claims known is likely to have a material adverse effect on the Company’s financial condition or results of operations, new claims or unexpected results of existing claims could lead to significant financial harm.

Employment Agreements

The Company’s Chief Executive Officer entered into an employment agreement with the Company, effective March 1, 2015. She and certain officers have as provisions of their agreements certain rights, including continuance of cash compensation and benefits, upon a “change in control,” which may include an acquisition of substantially all its assets, or termination “without cause or for good reason” as defined in the employment agreements.

Note 13 — Basic and Diluted Net Income Per Share

The following table sets forth the computation of basic and diluted net income per share (in thousands except per share amounts):

	Three Months Ended						Nine Months Ended
	September 30, 2022			October 1, 2021			September 30, 2022			October 1, 2021
Numerator:
Net income	$	10,262		$	6,020		$	32,902		$	19,579
Denominator:
Weighted average common shares:
Common shares outstanding		48,106			47,486			47,919			47,067
Less: Unvested restricted stock		(4	)		(3	)		(4	)		(3	)
Denominator for basic calculation		48,102			47,483			47,915			47,064
Weighted average effects of potentially diluted common stock:
Stock options		1,336			2,013			1,378			2,277
Unvested restricted stock		2			—			2			6
RSUs		64			86			55			90
PSUs		45			10			21			11
Denominator for diluted calculation		49,549			49,592			49,371			49,448
Net income per share:
Basic	$	0.21		$	0.13		$	0.69		$	0.42
Diluted	$	0.21		$	0.12		$	0.67		$	0.40

The following table sets forth (in thousands) the weighted average number of options to purchase shares of common stock, restricted stock, RSUs and PSUs with either exercise prices or unrecognized compensation cost per share greater than the average market price per share of the Company’s common stock, which were not included in the calculation of diluted per share amounts because the effects would be anti-dilutive.

	Three Months Ended				Nine Months Ended
	September 30, 2022		October 1, 2021		September 30, 2022		October 1, 2021
Stock options		864		33		865		201
Restricted stock, RSUs and PSUs		2		6		20		3
Total		866		39		885		204

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 14 — Disaggregation of Sales, Geographic Sales and Product Sales

In the following tables, sales are disaggregated by category, sales by geographic market and sales by product data. The following breaks down sales into the following categories (in thousands):

	Three Months Ended				Nine Months Ended
	September 30, 2022		October 1, 2021		September 30, 2022		October 1, 2021
Non-consignment sales	$	71,223	$	53,819	$	205,236	$	156,604
Consignment sales		4,823		4,533		15,111		14,867
Total net sales	$	76,046	$	58,352	$	220,347	$	171,471

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				Nine Months Ended
	September 30, 2022		October 1, 2021		September 30, 2022		October 1, 2021
Domestic	$	3,873	$	2,385	$	10,375	$	7,429
Foreign:
China		42,246		28,411		116,635		80,984
Japan		10,546		10,488		32,481		29,374
Other⁽¹⁾		19,381		17,068		60,856		53,684
Total foreign sales		72,173		55,967		209,972		164,042
Total net sales	$	76,046	$	58,352	$	220,347	$	171,471

⁽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				Nine Months Ended
	September 30, 2022		October 1, 2021		September 30, 2022		October 1, 2021
ICLs	$	71,953	$	54,153	$	208,550	$	159,889
Other product sales:
Cataract IOLs		2,191		2,525		7,640		9,324
Other surgical products		1,902		1,674		4,157		2,258
Total other product sales		4,093		4,199		11,797		11,582
Total net sales	$	76,046	$	58,352	$	220,347	$	171,471

One customer, the Company’s distributor in China, accounted for 56% and 49% of net sales for the three months ended September 30, 2022 and October 1, 2021, respectively, and the same customer accounted for 53% and 47% for the nine months ended September 30, 2022 and October 1, 2021, respectively. As of September 30, 2022 and December 31, 2021, respectively, one customer, the Company’s distributor in China, accounted for 57% and 47% of consolidated trade receivables.

STAAR SURGICAL COMPANY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONTINUED)

Note 15 — COVID-19 Developments

In December 2019, COVID-19 surfaced and in March 2020, the World Health Organization declared a pandemic related to the rapid spread of COVID-19 around the world. The impact of the COVID-19 outbreak on the businesses and the economy in the U.S. and the rest of the world is, and is expected to continue to be, uncertain and may continue to be significant as COVID-19 variant strains emerge. The Company’s revenues have been adversely impacted, and the Company experienced a substantial slowdown in sales beginning March 20, 2020 in global geographies characterized as “hot spots” for the COVID-19 virus, including parts of Europe, North America, Asia, the Middle East and India. In certain of these markets, sales have paused as elective surgeries are discouraged to support COVID-19 related needs. The Company continues to monitor the commercial and operational impact of new variants of COVID-19.

ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The matters addressed in this Item 2 that are not historical information constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Readers can recognize forward-looking statements by the use of words like “anticipate,” “estimate,” “expect,” “intend,” “plan,” “believe,” “will,” “should,” “forecast” and similar expressions in connection with any discussion of future operating or financial performance. In particular, these include statements about any of the following: any projections of or guidance as to earnings, revenue, sales, profit margins, expense rate, cash, effective tax rate, product mix, capital expense or any other financial items; the expected impact of the COVID-19 pandemic and related public health measures (including but not limited to their impact on sales, operations or clinical trials globally), the plans, strategies, and objectives of management for future operations or prospects for achieving such plans; statements regarding new, existing, or improved products, including but not limited to, expectations for success of new, existing, and improved products in the U.S. or international markets or government approval of a new or improved products; commercialization of new or improved products; future economic conditions or size of market opportunities; expected costs of operations; statements of belief, including as to achieving 2022 and 2023 business plans; expected regulatory activities and approvals, product launches, and any statements of assumptions underlying any of the foregoing.

Although we believe that the expectations reflected in these forward-looking statements are reasonable, such statements are inherently subject to risks and we can give no assurance that our expectations will prove to be correct. Actual results could differ from those described in this report because of numerous factors, many of which are beyond our control. These factors include, without limitation, those described in in our Annual Report on Form 10-K in “Item 1A. Risk Factors” filed on February 23, 2022. We undertake no obligation to update these forward-looking statements after the date of this report to reflect future events or circumstances or to reflect actual outcomes.

The following discussion should be read in conjunction with the audited consolidated financial statements of STAAR, including the related notes, provided in this report.

Overview

STAAR Surgical Company designs, develops, manufactures, and sells implantable lenses for the eye and companion delivery systems used to deliver the lenses into the eye. We are the world’s leading manufacturer of intraocular lenses for patients seeking refractive vision correction, and we also make lenses for use in surgery to treat cataracts. All the lenses we make are foldable, which allows the surgeon to insert them into the eye through a small incision during minimally invasive surgery. Refractive surgery is performed to treat the type of visual disorders that have traditionally been corrected using eyeglasses or contact lenses. We refer to our lenses used in refractive surgery as “implantable Collamer® lenses” or “ICLs.” The field of refractive surgery includes both lens-based procedures, using products like our ICL family of products, and laser-based procedures like LASIK. Successful refractive surgery can correct common vision disorders such as myopia, hyperopia, and astigmatism. Cataract surgery is a common outpatient procedure where the eye’s natural lens that has become cloudy with age is removed and replaced with an artificial lens called an intraocular lens (“IOL”) to restore the patient’s vision. STAAR employs a commercialization strategy that strives for sustainable profitable growth. Our goal is to position our refractive lenses throughout the world as primary and premium solutions for patients seeking visual freedom from wearing eyeglasses or contact lenses while achieving excellent visual acuity through refractive vision correction. We position our cataract IOL lenses used in surgery that treats cataracts based on quality and value.

Recent Developments

STAAR achieved 30% net sales growth in the third quarter despite constant currency challenges and, in Europe, macroeconomic headwinds. In the third quarter global ICL unit growth was up 40% year over year, highlighted by unit growth in China up 52%, the U.S. up 63%, Japan up 40%, South Korea up 49% and Asia Pacific distributor markets up 47%. We advanced our patient awareness, engagement and market building initiatives for EVO in the U.S. during and subsequent to the third quarter, and introduced our presbyopia lens, EVO Viva™, to surgeons at our Experts Meeting preceding the annual congress of the European Society of Cataract and Refractive Surgeons. In China, we expect to exceed a 25% share of refractive surgery market units by year end. Due to tighter COVID restrictions in China resulting in expected delayed demand in the fourth quarter, ongoing headwinds in Europe, weakness in the Yen and Euro, and lower Other Products sales, we now anticipate total net sales will be approximately $285 million for fiscal 2022. Our fiscal 2022 outlook includes ICL sales of approximately $272 million, representing 28% year over year growth, and Other Products sales of approximately $13 million.”

Our low margin Other Products business, which represents approximately 5% of sales and consists of cataract IOLs, IOL injectors and injector parts, has faced increasing supply chain challenges. As a result of third-party materials and supply chain

challenges that only affect our Other Products business, we will no longer be able to support Other Products as we have historically. We will continue to support customers of Other Products through the end of 2023. As we look to fiscal 2023, we expect to achieve approximately 30% ICL sales growth, year over year, to approximately $355 million in total company net sales which contemplates limited sales from Other Products. We do not expect contribution from Other Products thereafter. We continue to see significant growth potential for our EVO family of lenses globally.

Critical Accounting Estimates

This Management’s Discussion and Analysis of Financial Condition and Results of Income discusses and analyzes data in our unaudited Condensed Consolidated Financial Statements provided in this report, which we have prepared in accordance with U.S. generally accepted accounting principles. Preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. Management bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Senior management has discussed the development, selection and disclosure of these estimates with the Audit Committee of our Board of Directors. Actual conditions may differ from our assumptions and actual results may differ from our estimates.

Management believes that there have been no significant changes during the nine months ended September 30, 2022 to the items that we disclosed as our critical accounting estimates in Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021.

Results of Operations

The following table shows the percentage of our total sales represented by certain items reflected in our Condensed Consolidated Statements of Income for the periods indicated.

	Percentage of Net Sales for Three Months						Percentage of Net Sales for Nine Months
	September 30, 2022			October 1, 2021			September 30, 2022			October 1, 2021
Net sales		100.0	%		100.0	%		100.0	%		100.0	%
Cost of sales		20.5	%		22.4	%		21.2	%		22.1	%
Gross profit		79.5	%		77.6	%		78.8	%		77.9	%
General and administrative		18.4	%		18.9	%		18.1	%		19.0	%
Selling and marketing		30.4	%		31.1	%		29.3	%		29.3	%
Research and development		12.7	%		14.2	%		12.0	%		14.5	%
Total selling, general and administrative		61.5	%		64.2	%		59.4	%		62.8	%
Operating income		18.0	%		13.4	%		19.4	%		15.1	%
Total other expense, net		(1.5	)%		(0.8	)%		(1.5	)%		(0.9	)%
Income before income taxes		16.5	%		12.6	%		17.9	%		14.2	%
Provision for income taxes		3.0	%		2.3	%		3.0	%		2.8	%
Net income		13.5	%		10.3	%		14.9	%		11.4	%

Net Sales

The following table presents our net sales, by product (dollars in thousands):

	Three Months Ended				Percentage Change			Nine Months Ended				Percentage Change
	September 30, 2022		October 1, 2021		2022 vs. 2021			September 30, 2022		October 1, 2021		2022 vs. 2021
ICLs	$	71,953	$	54,153		32.9	%	$	208,550	$	159,889		30.4	%
Other product sales:
Cataract IOLs		2,191		2,525		(13.2	)%		7,640		9,324		(18.1	)%
Other surgical products		1,902		1,674		13.6	%		4,157		2,258		84.1	%
Total other product sales		4,093		4,199		(2.5	)%		11,797		11,582		1.9	%
Net sales	$	76,046	$	58,352		30.3	%	$	220,347	$	171,471		28.5	%

Net sales for the three months ended September 30, 2022 increased 30% from the same period of 2021. The increase in net sales was due to increased ICL sales of $17.8 million. Changes in foreign currency unfavorably impacted net sales by $4.0 million.

Net sales for the nine months ended September 30, 2022 increased 29% from same period of 2021. The increase in net sales was due to increased ICL sales of $48.7 million. Changes in foreign currency unfavorably impacted net sales by $9.0 million.

Total ICL sales for the three months ended September 30, 2022 increased 33% from the same period of 2021, with unit increase of 40%. The APAC region sales increased by 40%, with unit growth up 47%, due to sales growth in Korea up 50%, China up 49%, other APAC regions up 49% and Japan up 12%. The Europe, Middle East, Africa and Latin America region sales decreased 9% with unit decrease of 2%, due to sales decreases in in our direct markets down 12% and distributor markets down 4%. The North America region sales increased 66%, with unit growth up 56%, primarily due to sales growth in the U.S. up 75%. In late March 2022, the U.S. started to sell EVO ICLs. Changes in foreign currency unfavorably impacted ICL sales by $3.2 million for the three months ended September 30, 2022, which impacted our Japan and Europe, Middle East and Africa markets. ICL sales represented 94.6% and 92.8% of our total sales for the three months ended September 30, 2022 and October 1, 2021, respectively.

Total ICL sales for the nine months ended September 30, 2022 increased 30% from the same period of 2021, with unit increase of 38%. The APAC region sales increased by 38%, with unit growth up 43%, due to sales growth in other APAC regions up 59%, India up 44%, China up 44%, Korea up 25% and Japan up 16%. The Europe, Middle East, Africa and Latin America region sales decreased 1% with unit growth up 12%, due to sales decreases in our direct markets down 8%, offset by sales growth in distributor markets up 8%. The North America region sales increased 43%, with unit growth up 35%, primarily due to sales growth in the U.S. up 47%. In late March 2022, the U.S. started to sell EVO ICLs. Changes in foreign currency unfavorably impacted ICL sales by $7.2 million for the nine months ended September 30, 2022, which impacted our Japan and Europe, Middle East and Africa markets. ICL sales represented 94.6% and 93.2% of our total sales for the nine months ended September 30, 2022 and October 1, 2021, respectively.

Other product sales, including cataract IOLs for the three months ended September 30, 2022, decreased 3% from the same period of 2021, due to decreased sales of cataract IOLs, partially offset by other surgical products. Other product sales for the nine months ended September 30, 2022, increased 2% due to other surgical products, offset by decreased sales of cataract IOLs. Included in other product sales are sales of preloaded injector parts. In the first half of 2021, we experienced product yield issues requiring rework related to preloaded injector parts manufactured on our behalf by a third-party vendor then sold by us to a third-party manufacturer for product they sell to their customers. Changes in foreign currency unfavorably impacted other product sales by $0.8 million and $1.8 million for the three and nine months September 30, 2022, respectively. Other product sales represented 5.4% and 7.2% of our total sales for the three months ended September 30, 2022 and October 1, 2021, respectively, and represented 5.4% and 6.8% of our total sales for the nine months ended September 30, 2022 and October 1, 2021, respectively.

Gross Profit

The following table presents our gross profit and gross profit margin (dollars in thousands):

	Three Months Ended						Percentage Change			Nine Months Ended						Percentage Change
	September 30, 2022			October 1, 2021			2022 vs. 2021			September 30, 2022			October 1, 2021			2022 vs. 2021
Gross profit	$	60,462		$	45,301			33.5	%	$	173,598		$	133,646			29.9	%
Gross margin		79.5	%		77.6	%					78.8	%		77.9	%

Gross profit for the three months ended September 30, 2022 increased 33.5% from the same period of 2021. Gross profit margin increased to 79.5% of revenue for the three months ended September 30, 2022 compared to 77.6% of revenue for the three months ended October 1, 2021, due mainly to product and geographic sales mix, partially offset by increased period costs associated with manufacturing projects.

Gross profit for the nine months ended September 30, 2022 increased 29.9% from the same period of 2021. Gross profit margin increased to 78.8% of revenue for the nine months ended September 30, 2022 compared to 77.9% of revenue for the nine months ended October 1, 2021, due mainly to product and geographic sales mix, partially offset by inventory reserves recognized as a result of discontinuance of our older generation Visian ICL in the U.S. and increased period costs associated with manufacturing projects.

General and Administrative Expense

The following table presents our general and administrative expenses (dollars in thousands):

	Three Months Ended						Percentage Change			Nine Months Ended						Percentage Change
	September 30, 2022			October 1, 2021			2022 vs. 2021			September 30, 2022			October 1, 2021			2022 vs. 2021
General and administrative expense	$	14,011		$	11,018			27.2	%	$	39,934		$	32,671			22.2	%
Percentage of sales		18.4	%		18.9	%					18.1	%		19.0	%

General and administrative expenses for the three months ended September 30, 2022 increased 27.2% from the same period of 2021 due to increased stock-based compensation expenses, facility costs and outside services. General and administrative expenses for the nine months ended September 30, 2022 increased 22.2% from the same period of 2021 due to increased facility costs, stock-based compensation expenses and outside services.

Selling and Marketing Expense

The following table presents our selling and marketing expenses (dollars in thousands):

	Three Months Ended						Percentage Change			Nine Months Ended						Percentage Change
	September 30, 2022			October 1, 2021			2022 vs. 2021			September 30, 2022			October 1, 2021			2022 vs. 2021
Selling and marketing expense	$	23,130		$	18,175			27.3	%	$	64,633		$	50,229			28.7	%
Percentage of sales		30.4	%		31.1	%					29.3	%		29.3	%

Selling and marketing expenses for the three months ended September 30, 2022 increased 27.3% from the same period of 2021 due to increased trade shows and sales meetings, advertising and promotional activities, travel expenses and stock-based compensation expenses. Selling and marketing expenses for the nine months ended September 30, 2022 increased 28.7% from the same period of 2021 due to increased advertising and promotional activities, trade shows and sales meetings, travel expenses and stock-based compensation expenses.

Research and Development Expense

The following table presents our research and development expenses (dollars in thousands):

	Three Months Ended						Percentage Change			Nine Months Ended						Percentage Change
	September 30, 2022			October 1, 2021			2022 vs. 2021			September 30, 2022			October 1, 2021			2022 vs. 2021
Research and development expense	$	9,616		$	8,271			16.3	%	$	26,193		$	24,790			5.7	%
Percentage of sales		12.7	%		14.2	%					12.0	%		14.5	%

Research and development expenses for the three months ended September 30, 2022 increased 16.3% from the same period of 2021 due mainly to increased salary-related and payroll tax expenses. Research and development expenses for the nine months ended September 30, 2022 increased 5.7% from the same period of 2021 due mainly to increased salary-related and payroll tax expenses and stock-based compensation expenses, partially offset by decreased clinical expenses associated with our clinical trials.

Other Expense, Net

The following table presents our other expenses, net (dollars in thousands):

	Three Months Ended						Percentage Change		Nine Months Ended						Percentage Change
	September 30, 2022			October 1, 2021			2022 vs. 2021		September 30, 2022			October 1, 2021			2022 vs. 2021
Other expense, net	$	(1,128	)	$	(461	)		—*	$	(3,265	)	$	(1,626	)		—*
Percentage of sales		(1.5	)%		(0.8	)%				(1.5	)%		(0.9	)%

*	Denotes change is greater than +100%.

The change in other expense, net for the three and nine months ended September 30, 2022 and October 1, 2021, respectively, was due primarily to foreign exchange losses (primarily euro), and for the three and nine months ended September 30, 2022, partially offset by increased interest income mainly due to our investments held available for sale.

Income Taxes

The following table presents our income tax provision (dollars in thousands):

Three Months Ended

Percentage

Change

Nine Months Ended

Percentage

Change

September 30, 2022

October 1, 2021

2022 vs. 2021

September 30, 2022

October 1, 2021

2022 vs. 2021

Income tax provision

2,315

1,356

70.7

6,671

4,751

40.4

The effective tax rates for the three months ended September 30, 2022 and October 1, 2021 was 18.4% and 18.4%, respectively, and was 16.9% and 19.5%, for the nine months ended September 30, 2022 and October 1, 2021, respectively. Our effective tax rates differ from the U.S. federal statutory rate of 21% for the three and nine months ended September 30, 2022 and October 1, 2021, respectively, primarily due to the income taxes generated in foreign jurisdictions. The differences in the effective tax rate for the three and nine months ended September 30, 2022 compared to the same period in 2021 was primarily due to jurisdictions in which the income is earned.

Our future effective income tax rate depends on various factors, such as changes in tax laws, regulations, accounting principles, or interpretations thereof, and the geographic composition of our pre-tax income. We carefully monitor these factors and adjust our effective income tax rate accordingly.

Liquidity and Capital Resources

We believe that current cash and cash equivalents, investments available for sale and future cash flow from operating activities will be sufficient to meet our anticipated cash needs, including working capital needs, capital expenditures and contractual obligations for at least 12 months from the issuance date of the financial statements included in this quarterly report. Our financial condition at September 30, 2022 and December 31, 2021 included the following (in thousands):

	September 30, 2022		December 31, 2021		2022 vs. 2021
Cash and cash equivalents	$	129,242	$	199,706	$	(70,464	)
Investments available for sale		95,451		—		95,451
Total	$	224,693	$	199,706	$	24,987

Current assets	$	296,910	$	271,411	$	25,499
Current liabilities		45,320		48,802		(3,482	)
Working capital	$	251,590	$	222,609	$	28,981

Cash and cash equivalents include cash and balances in deposits and money market accounts held at banks and financial institutions. Our investment policy primary objective is capital preservation while maximizing our return on investment. Investments available for sale may include U.S. government and corporate debt securities, commercial paper, certain certificates deposit and related security types, that are rated by two nationally recognized statistical rating organizations with minimum investment grade ratings of AAA to A-/A-1+ to A-2, or the equivalent. There are also limits to the amount of credit exposure in any given security type. We do not have any off-balance sheet arrangements.

A summary of cash flows for the nine months ended September 30, 2022 and October 1, 2021 was as follows (in thousands):

	Nine Months Ended
	September 30, 2022			October 1, 2021
Cash flows from:
Operating activities	$	32,745		$	35,464
Investing activities		(109,659	)		(8,956	)
Financing activities		8,095			18,009
Effect of exchange rate changes		(1,645	)		(724	)
Net increase (decrease) in cash and cash equivalents		(70,464	)		43,793
Cash and cash equivalents, at beginning of year		199,706			152,453
Cash and cash equivalents, at end of year	$	129,242		$	196,246

For the nine months ended September 30, 2022, net cash used by operating activities consisted of $32.9 million in net income, $20.6 million in non-cash items, offset by $20.8 million in working-capital changes.

In the three months ended September 30, 2022, we decided to invest our cash in slightly higher yielding securities. For the nine months ended September 30, 2022, net cash used in investment activities was $109.7 million which consisted of $95.6 million in purchases of investments available for sale and $14.1 million in purchases of property, plant and equipment. The increase in investments of property, plant and equipment of $5.1 million for the nine months ended September 30, 2022 relative to the same period of 2021, was due to increased investments in manufacturing facilities.

Net cash provided by financing activities for the nine months ended September 30, 2022 consisted of $8.2 million of proceeds from the exercise of stock options. For the nine months ended October 1, 2021, net cash provided by financing activities consisted of $18.3 million of proceeds from the exercise of stock options, partially offset by $0.3 million repayment of finance lease obligations.

Commitments

Employment Agreements

The Company’s Chief Executive Officer entered into an employment agreement with the Company, effective March 1, 2015. She and certain officers have as provisions of their agreements certain rights, including continuance of cash compensation and benefits, upon a “change in control,” which may include an acquisition of substantially all of its assets, or termination “without cause or for good reason” as defined in the employment agreements.

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

During the nine months ended September 30, 2022, there have been no material changes in the Company’s qualitative and quantitative market risk since the disclosure in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.

ITEM 4.

CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our management, including our CEO and CFO, of the effectiveness of the design and operation of the disclosure controls and procedures of the Company. Based on that evaluation, our CEO and CFO concluded, as of the end of the period covered by this quarterly report on Form 10-Q, that our disclosure controls and procedures were effective. For purposes of this statement, the term “disclosure controls and procedures” means controls and other procedures of the Company that are designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act (15 U.S.C. 78a et seq.) is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

Our management, including the CEO and the CFO, do not expect that our disclosure controls and procedures or our internal control over financial reporting will necessarily prevent all fraud or material errors. An internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations on all internal control systems, our internal control system can provide only reasonable assurance of achieving its objectives and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of internal control is also based in part upon certain assumptions about the likelihood of future events, and can provide only reasonable, not absolute, assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in circumstances, or the degree of compliance with the policies and procedures may deteriorate.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the quarter ended September 30, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II – OTHER INFORMATION

ITEM 1.

LEGAL PROCEEDINGS

ITEM 1A.

RISK FACTORS

Our short and long-term success is subject to many factors that are beyond our control. Investors and prospective investors should consider carefully information contained in this report and the risks and uncertainties described in “Part I—Item 1A—Risk Factors” of the Company’s Form 10-K for the fiscal year ended December 31, 2021. Such risks and uncertainties could materially adversely affect our business, financial condition or operating results.

ITEM 4.

MINE SAFETY DISCLOSURES

Not Applicable.

ITEM 5.

OTHER INFORMATION

None.

ITEM 6.

EXHIBITS

3.1	Amended and Restated Certificate of Incorporation.(1)

3.2	Amended and Restated Bylaws.(2)

4.1	Form of Certificate for Common Stock, par value $0.01 per share.(3)

†4.2	Amended and Restated Omnibus Equity Incentive Plan.(4)

31.1	Certifications Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*

31.2	Certifications Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*

32.1	Certification Pursuant to 18 U.S.C. Section 1350, Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. **

101	Financial statements from the quarterly report on Form 10-Q of STAAR Surgical Company for the quarter ended September 30, 2022 formatted in Inline Extensible Business Reporting Language (iXBRL), are filed herewith and include: (i) the Condensed Consolidated Balance Sheets, (ii) the Condensed Consolidated Statements of Income, (iii) the Condensed Consolidated Statements of Comprehensive Income, (iv) the Condensed Consolidated Statements of Stockholders’ Equity, (v) the Condensed Consolidated Statements of Cash Flows, and (vi) the Notes to Condensed Consolidated Financial Statements tagged as blocks of text.*

104	The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, has been formatted in Inline XBRL with applicable taxonomy extension information contained in Exhibit 101.

(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.

(4)	Incorporated by reference to Exhibit 4.2 to the Company’s Quarterly Report on Form 10-Q, for the period ended July 3, 2020, as filed with the Commission on August 5, 2020.

*	Filed herewith.

**	Furnished herewith.

†	Management contract or compensatory plan.

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:	November 2, 2022	By:	/s/ PATRICK F. WILLIAMS
			Patrick F. Williams
			Chief Financial Officer
			(on behalf of the Registrant and as its principal financial officer)