Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): November 1, 2023

STAAR Surgical Company

(Exact Name of Registrant as Specified in Charter)


Delaware	0-11634	95-3797439
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

25651 Atlantic Ocean Drive Lake Forest, California		92630
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: 626-303-7902

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


☐	Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 is an emerging growth company as defined in Rule 405 of the Securities Act of 1 933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

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. ☐

Item 2.02 Results of Operations and Financial Condition.

On November 1, 2023, STAAR Surgical Company (the “Company”) published a press release reporting its financial results for the quarter ended September 29, 2023, a copy of which is furnished as Exhibit 99.1 to this report and is incorporated herein by this reference.

This information and the information contained in the press release shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in Item 2.02 of this Current Report, and Exhibit 99.1 are not incorporated by reference into any filings of STAAR made under the Securities Act of 1933, as amended, whether made before or after the date of this Current Report, regardless of any general incorporation language in the filing unless specifically stated so therein.

Item 9.01 Financial Statements and Exhibits


Exhibit No.		Description

99.1		Press release of the Company dated November 1, 2023.

104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

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 hereunto duly authorized.


STAAR Surgical Company

November 1, 2023	By:	/s/ Tom Frinzi
		Thomas G. Frinzi
		President and Chief Executive Officer

Exhibit 99.1

STAAR Surgical Reports Third Quarter 2023 Results

Net Sales of $80.3 Million; ICL Sales of $81.1 Million Up 13% Y/Y

23rd Consecutive Quarter of Double-Digit ICL Sales Growth1

LAKE FOREST, CA, November 1, 2023 --- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of the EVO family of Implantable Collamer® Lenses (ICL) for myopia, astigmatism and presbyopia, today reported financial results for the third quarter ended September 29, 2023.

Third Quarter 2023 Overview

 Net Sales of $80.3 Million Up 6% Y/Y includes a $0.8 Million sales reduction related to Other Products

 ICL Sales of $81.1 Million Up 13% Y/Y

 ICL Units Up 14% Y/Y

 Gross Margin at 79.2% vs. 79.5% in the Prior Year Quarter

 Net Income of $0.10 per Share vs. $0.21 per Share in the Prior Year Quarter

 Cash, Cash Equivalents and Investments Available for Sale Ended the Quarter at $201.7 Million

“Third quarter sales reflect our leadership in lens-based refractive surgery and progress advancing our strategic priorities,” said Tom Frinzi, President and CEO of STAAR Surgical. “Our global ICL sales growth of 13% in the third quarter significantly outperformed industry procedure growth, which was negative in many markets around the world with the exception of China.2 Further, we are mindful of the potential impact the uncertain economic environment globally and world events may have on our surgeon customers and patients. As a result, we now expect fiscal 2023 ICL sales to be at the low end of our previously provided range of $320 million to $325 million.”

Frinzi continued, “We expect our current efforts will deliver our sixth straight year of sales growth and profitability in fiscal 2023 while investing in the initiatives that support development of our surgeon customers and prospects as we drive global adoption of our EVO ICL technology. Over the three-year planning horizon, our focus remains on achieving a 15% to 20% compound annual growth rate in sales as our ICL technology addresses the global myopia epidemic, continuing to take market share and growing the overall market for refractive procedures.”

Financial Overview – Q3 2023

Net sales were $80.3 million for the third quarter of 2023, up 6% compared to $76.1 million reported in the prior year quarter. The sales increase in the third quarter was driven by ICL sales growth of 13% and ICL unit growth of 14%, both as compared to the prior year period. Other Product sales for the third quarter of 2023 were ($0.8) million compared to $4.1 million in the prior year quarter. The $4.9 million change in Other Product sales reflects a $2.4 million reduction in Cataract IOL sales and a $2.4 million reduction in other product sales due to decreased sales of cataract injector parts and increased sales return reserves. ICL sales were $81.1 million for the third quarter of 2023.

Gross profit margin for the third quarter of 2023 was 79.2% compared to the prior year quarter of 79.5%. Factors impacting gross margin in the third quarter of 2023, as compared to the prior year quarter, include increased sales return reserves and period costs associated with manufacturing projects, partially offset by product and geographic sales mix.

Operating expenses for the third quarter of 2023 were $57.3 million compared to the prior year quarter of $46.8 million. General and administrative expenses were $19.3 million compared to the prior year quarter of $14.0 million. The increase in general and administrative expenses was due to increased compensation related expenses, outside services and facilities costs. Selling and marketing expenses were $26.6 million compared to the prior year quarter of $23.1 million. The increase in selling and marketing expenses is due to increased advertising and promotional expenses and compensation expenses, partially offset by decreased trade show expenses. Research and development expenses were $11.5 million compared to the prior year quarter of $9.6 million. The increase in research and development expenses is due to increased compensation related expenses and clinical trial expenses related to U.S. post-approval studies.

Net income for the third quarter of 2023 was $4.8 million or $0.10 per diluted share compared with net income of $10.3 million or $0.21 per diluted share for the prior year quarter. The year over year decrease in net income is attributable to higher operating expenses partially offset by higher gross profit and other income (expense). Adjusted Net Income for the third quarter of 2023 was $15.0 million or $0.30 per diluted share compared to $18.1 million or $0.37 per diluted share for the prior year quarter. The reconciliation between GAAP and non-GAAP financial information is provided in the financial tables included with this release.

Cash, cash equivalents, and investments available for sale at September 29, 2023, totaled $201.7 million, compared to $225.5 million at end of the fourth quarter of 2022.

1 Excludes Q1 and Q2 2020, which were impacted by the COVID-19 global pandemic.

2 Refractive Surgery Council, RSC Quarterly Statistical Program, Q3 2023 Report, U.S. refractive procedure volumes down 15.1% Y/Y in Q3 2023 and down 13.1% for the first nine months of 2023 and Company estimates using Market Scope 2023 Refractive Procedures Market Trends, October 27, 2023.

Conference Call

The Company will host a conference call and webcast today, Wednesday, November 1 at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and operational progress. To access the conference call (Conference ID 03857916), please dial 888-259-6580 for domestic participants and 206-962-3782 for international participants. The live webcast can be accessed from the investor relations section of the STAAR website at www.staar.com.

A taped replay of the conference call (Replay Code 857916) will be available beginning approximately one hour after the call’s conclusion for seven days. This replay can be accessed by dialing 877-674-7070 for domestic callers and 416-764-8692 for international callers. An archived webcast will also be available at www.staar.com.

Use of Non-GAAP Financial Measures

This press release includes supplemental Non-GAAP financial information, which STAAR believes investors will find helpful in understanding its operating performance. Non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

“Adjusted Net Income” and “Adjusted Net Income for ICL” exclude the following items that are included in “Net Income” as calculated in accordance with U.S. generally accepted accounting principles (“GAAP”): Cataract IOL sales return reserve, Cataract IOL excess inventory reserves, Cataract IOL intangible impairment, and income tax benefit on Cataract IOL Adjusted Net Income also excludes gain or loss on foreign currency transactions, stock-based compensation expenses, and valuation allowance adjustments (if any). Management believes that “Adjusted Net Income” and “Adjusted Net Income for ICL” are useful to investors in gauging the outcome of the key drivers of the business performance: the ability to increase sales revenue and our ability to increase profit margin by improving the mix of high value products while reducing the costs over which management has control.

Management has excluded accounting adjustments related to exiting the Company’s non-core Cataract IOL business. These accounting adjustments include sales return reserve, excess inventory reserves, an intangible impairment charge related to cataract IOLs and the associated tax benefit of these adjustments. The Company has excluded these items in order to focus on its core ICL business as the Company will continue tapering the manufacturing of cataract IOLs, though it will continue to support these products through the end of 2023, as supplies permit. Management believes that disclosing Adjusted Net Income and Adjusted Net Income for ICL excluding these accounting adjustments is useful to investors in gauging the performance of its core ICL business.

For the reasons referenced above in connection with calculating Adjusted Net Income and Adjusted Net Income for ICL, management also supplements the Company’s GAAP consolidated financial statements and GAAP financial measures with other Non-GAAP financial measures, comprising of Adjusted Net Sales, Adjusted Cost of Sales, Adjusted Gross Profit Margin, Adjusted Operating Expenses, Adjusted Income Tax Provision, which in each case exclude the impact of any accounting adjustments related to the exiting of the Company’s non-core Cataract IOL business. The Company believes that these Non-GAAP financial measures provide additional insight into the ongoing financial results of its business which investors find useful to gauge the performance of its core ICL business.

Management has also excluded from the calculation of Adjusted Net Income gains and losses on foreign currency transactions because of the significant fluctuations that can result from period to period as a result of market driven factors. Stock-based compensation expenses consist of expenses for stock options and restricted stock under the Financial Accounting Standards Board’s Accounting Standards Codification (ASC) 718. Valuation allowance adjustments can occur from time to time based on forecasted changes in operating results until all net operating loss carryforwards are fully utilized. In calculating Adjusted Net Income, STAAR excludes stock-based compensation expenses and valuation allowance adjustments (if any) because they are non-cash expenses and because of the considerable judgment involved in calculating their values. In addition, these expenses tend to be driven by fluctuations in the price of our stock and not by the same factors that generally affect our other business expenses.

The Company also uses Constant Currency as a Non-GAAP financial measure to exclude the effects of currency fluctuations on net sales. The Company conducts a significant part of its activities outside the U.S. It receives sales revenue and pays expenses principally in U.S. dollars, Swiss francs, Japanese yen and euros. The exchange rates between dollars and non-U.S. currencies can fluctuate greatly and can have a significant effect on the Company’s results when reported in U.S. dollars. In order to compare the Company's performance from period to period without the effect of currency, the Company will apply the same average exchange rate applicable in the prior period, or the "constant currency" rate to sales or expenses in the current period as well. Because changes in currency are outside of the control of the Company and its managers, management finds this Non-GAAP measure useful in determining the long-term progress of its initiatives and determining whether its managers are achieving their performance goals. The Company believes that the Non-GAAP constant-currency sales results measures provided in this press release are similarly useful to investors to give insight on long term trends in the Company's performance without the external effect of changes in relative currency values. The table provided in this press release shows sales results calculated in accordance with GAAP, the effect of currency, and the resulting Non-GAAP measure expressed in constant currency.

About STAAR Surgical

STAAR, which has been dedicated solely to ophthalmic surgery for over 40 years, designs, develops, manufactures and markets implantable lenses for the eye. These lenses are intended to provide visual freedom for patients, lessening or eliminating the reliance on glasses or contact lenses. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR’s lens used in refractive surgery is called an Implantable Collamer® Lens or “ICL,” which includes the EVO ICL™ product line. More than 2,500,000 ICLs have been sold to date and STAAR markets these lenses in over 75 countries. To learn more about the ICL go to: EVOICL.com. Headquartered

in Lake Forest, CA, the company operates manufacturing and packaging facilities in Aliso Viejo, CA, Monrovia, CA and Nidau, Switzerland. For more information, please visit the Company’s website at www.staar.com.

Safe Harbor

All statements that are not statements of historical fact are forward-looking statements, including statements about any of the following: any financial projections (including sales), plans, strategies, and objectives of management for 2023 and beyond or prospects for achieving such plans, expectations for sales, revenue, margin, expenses or earnings, and any statements of assumptions underlying any of the foregoing, including those relating to financial performance in the upcoming quarter, fiscal year 2023 and beyond. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include risks and uncertainties related to the COVID-19 pandemic and related public health measures, as well as the factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 30, 2022 under the caption “Risk Factors,” which is on file with the Securities and Exchange Commission and available in the “Investor Information” section of the company’s website under the heading “SEC Filings.” We disclaim any intention or obligation to update or revise any financial projections or forward-looking statement due to new information or events. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties include the following: global economic conditions; the impact of the COVID-19 pandemic on markets; the discretion of regulatory agencies to approve or reject existing, new or improved products, or to require additional actions before or after approval, or to take enforcement action; international trade disputes and substantial dependence on demand from Asia; and the willingness of surgeons and patients to adopt a new or improved product and procedure.

We intend to use our website as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Such disclosures will be included on our website in the ‘Investor Relations’ sections. Accordingly, investors should monitor such portions of our website, in addition to following our press releases, SEC filings and public conference calls and webcasts.

CONTACT: Investors and Media

Brian Moore

Vice President, Investor Relations and Corporate Development

(626) 303-7902, Ext. 3023

bmoore@staar.com

Consolidated Balance Sheets

(in 000's)

Unaudited


ASSETS	September 29, 2023			December 30, 2022
Current assets:
Cash and cash equivalents	$	127,432		$	86,480
Investments available for sale		60,681			125,159
Accounts receivable trade, net		112,367			62,447
Inventories, net		31,061			24,161
Prepayments, deposits, and other current assets		15,527			13,476
Total current assets		347,068			311,723
Investments available for sale		13,627			13,902
Property, plant, and equipment, net		62,886			50,921
Finance lease right-of-use assets, net		220			342
Operating lease right-of-use assets, net		34,992			30,270
Intangible assets, net		-			173
Goodwill		1,786			1,786
Deferred income taxes		8,560			8,744
Other assets		2,382			957
Total assets	$	471,521		$	418,818

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	8,786		$	11,576
Obligations under finance leases		164			169
Obligations under operating leases		4,003			3,524
Allowance for sales returns		7,557			5,706
Other current liabilities		36,265			30,741
Total current liabilities		56,775			51,716
Obligations under finance leases		84			210
Obligations under operating leases		31,643			27,136
Deferred income taxes		1,295			1,489
Asset retirement obligations		98			220
Pension liability		3,031			1,935
Total liabilities		92,926			82,706

Stockholders' equity:
Common stock		488			482
Additional paid-in capital		436,117			404,189
Accumulated other comprehensive income (loss)		(2,886	)		156
Accumulated deficit		(55,124	)		(68,715	)
Total stockholders' equity		378,595			336,112
Total liabilities and stockholders' equity	$	471,521		$	418,818

Consolidated Statements of Income

(In 000's except for per share data)

Unaudited


	Three Months Ended																		Nine Months Ended
	% of						% of						Fav (Unfav)						% of						% of						Fav (Unfav)
	Sales			September 29, 2023			Sales			September 30, 2022			Amount			%			Sales			September 29, 2023			Sales			September 30, 2022			Amount			%
Net sales		100.0	%	$	80,308			100.0	%	$	76,046		$	4,262			5.6	%		100.0	%	$	246,142			100.0	%	$	220,347		$	25,795			11.7	%

Cost of sales		20.8	%		16,670			20.5	%		15,584			(1,086	)		-7.0	%		22.0	%		54,216			21.2	%		46,749			(7,467	)		-16.0	%

Gross profit		79.2	%		63,638			79.5	%		60,462			3,176			5.3	%		78.0	%		191,926			78.8	%		173,598			18,328			10.6	%

Selling, general and administrative expenses:
General and administrative		24.0	%		19,266			18.4	%		14,011			(5,255	)		-37.5	%		22.6	%		55,461			18.1	%		39,934			(15,527	)		-38.9	%
Selling and marketing		33.1	%		26,607			30.4	%		23,130			(3,477	)		-15.0	%		34.6	%		85,238			29.3	%		64,633			(20,605	)		-31.9	%
Research and development		14.3	%		11,470			12.7	%		9,616			(1,854	)		-19.3	%		13.6	%		33,535			12.0	%		26,193			(7,342	)		-28.0	%
Total selling, general, and administrative expenses		71.4	%		57,343			61.5	%		46,757			(10,586	)		-22.6	%		70.8	%		174,234			59.4	%		130,760			(43,474	)		-33.2	%

Operating income		7.8	%		6,295			18.0	%		13,705			(7,410	)		-54.1	%		7.2	%		17,692			19.4	%		42,838			(25,146	)		-58.7	%

Other income (expense), net:
Interest income, net		2.1	%		1,690			1.2	%		897			793			88.4	%		2.1	%		5,287			0.4	%		934			4,353			466.1	%
Loss on foreign currency transactions		-1.7	%		(1,384	)		-2.8	%		(2,129	)		745			35.0	%		-1.3	%		(3,240	)		-2.2	%		(4,904	)		1,664			33.9	%
Royalty income		0.1	%		74			0.1	%		77			(3	)		-3.9	%		0.0	%		74			0.2	%		527			(453	)		-86.0	%
Other income, net		0.1	%		71			0.0	%		27			44			163.0	%		0.1	%		144			0.1	%		178			(34	)		-19.1	%
Total other income (expense), net		0.6	%		451			-1.5	%		(1,128	)		1,579			140.0	%		0.9	%		2,265			-1.5	%		(3,265	)		5,530			169.4	%

Income before provision for income taxes		8.4	%		6,746			16.5	%		12,577			(5,831	)		-46.4	%		8.1	%		19,957			17.9	%		39,573			(19,616	)		-49.6	%

Provision for income taxes		2.4	%		1,929			3.0	%		2,315			386			16.7	%		2.6	%		6,366			3.0	%		6,671			305			4.6	%

Net income		6.0	%	$	4,817			13.5	%	$	10,262		$	(5,445	)		-53.1	%		5.5	%	$	13,591			14.9	%	$	32,902		$	(19,311	)		-58.7	%


Net income per share - basic				$	0.10					$	0.21											$	0.28					$	0.69
Net income per share - diluted				$	0.10					$	0.21											$	0.27					$	0.67

Weighted average shares outstanding - basic					48,613						48,102												48,426						47,915
Weighted average shares outstanding - diluted					49,370						49,549												49,494						49,371

Consolidated Statements of Cash Flows

(in 000's)

Unaudited


		Three Months Ended						Nine Months Ended
		September 29, 2023			September 30, 2022			September 29, 2023			September 30, 2022
Cash flows from operating activities:
Net income		$	4,817		$	10,262		$	13,591		$	32,902
Adjustments to reconcile net income to net cash provided by (used in) operating activities:
	Depreciation of property and equipment		1,345			1,077			3,743			3,101
	Amortization/Impairment of long-lived intangibles		(2	)		7			169			22
	Accretion/Amortization of investments available for sale		(348	)		(307	)		(2,172	)		(307	)
	Deferred income taxes		(10	)		23			65			23
	Change in net pension liability		(139	)		(12	)		(766	)		40
	Stock-based compensation expense		8,846			5,727			23,334			15,375
	Change in asset retirement obligation		3			-			(104	)		-
	Loss on disposal of property and equipment		17			-			41			-
	Provision for sales returns and bad debts		921			(439	)		1,925			361
	Inventory provision		460			592			4,090			2,020
Changes in working capital:
	Accounts receivable		(18,092	)		7,029			(50,436	)		(13,108	)
	Inventories		(5,593	)		(2,298	)		(9,975	)		(4,123	)
	Prepayments, deposits and other current assets		(919	)		2,786			(3,584	)		526
	Accounts payable		(1,819	)		(5,077	)		(3,266	)		(1,834	)
	Other current liabilities		4,538			4,739			5,970			(2,253	)
	Net cash provided by (used in) operating activities		(5,975	)		24,109			(17,375	)		32,745

Cash flows from investing activities:
	Acquisition of property and equipment		(9,185	)		(6,273	)		(15,100	)		(14,083	)
	Purchase of investments available for sale		(9,712	)		(95,576	)		(52,314	)		(95,576	)
	Proceeds from sale or maturity of investments available for sale		50,737			-			119,359			-
	Net cash provided by (used in) investing activities		31,840			(101,849	)		51,945			(109,659	)

Cash flows from financing activities:
	Repayment of finance lease obligations		(39	)		(40	)		(121	)		(85	)
	Repurchase of employee common stock for taxes withheld		(112	)		-			(2,096	)		-
	Proceeds from vested restricted stock and exercise of stock options		7,258			5,034			9,265			8,180
	Net cash provided by financing activities		7,107			4,994			7,048			8,095

Effect of exchange rate changes on cash and cash equivalents			(235	)		(502	)		(666	)		(1,645	)

Increase (decrease) in cash and cash equivalents			32,737			(73,248	)		40,952			(70,464	)
Cash and cash equivalents, at beginning of the period			94,695			202,490			86,480			199,706
Cash and cash equivalents, at end of the period		$	127,432		$	129,242		$	127,432		$	129,242


Check - ending cash		$	-		$	-

Reconciliation of Non-GAAP Financial Measure

Financial Metrics Excluding Other Product Cataract IOL Adjustmenrts

(in 000's)

Unaudited


	Three Months Ended																Nine Months Ended
											Fav (Unfav)																	Fav (Unfav)
	% of Sales			September 29, 2023		% of Sales			September 30, 2022		Amount			%			% of Sales			September 29, 2023			% of Sales			September 30, 2022		Amount			%
Net sales:
Net sales, GAAP		100.0	%	$	80,308		100.0	%	$	76,046	$	4,262			5.6	%		100.0	%	$	246,142			100.0	%	$	220,347	$	25,795			11.7	%
Add: Cataract IOL sales return reserve					-					-		-									742						-		742
Adjusted Net sales, Non-GAAP		100.0	%	$	80,308		100.0	%	$	76,046	$	4,262			5.6	%		100.0	%	$	246,884			100.0	%	$	220,347	$	26,537			12.0	%

Cost of sales:
Cost of sales, GAAP		20.8	%	$	16,670		20.5	%	$	15,584	$	(1,086	)		-7.0	%		22.0	%	$	54,216			21.2	%	$	46,749	$	(7,467	)		-16.0	%
Less: Cataract IOL inventory reserve					-					-		-									(2,800	)					-		2,800
Adjusted Cost of sales, Non-GAAP		20.8	%	$	16,670		20.5	%	$	15,584	$	(1,086	)		-7.0	%		20.8	%	$	51,416			21.2	%	$	46,749	$	(4,667	)		-10.0	%

Gross profit and gross profit margin:
Gross profit and gross profit margin, GAAP		79.2	%	$	63,638		79.5	%	$	60,462	$	3,176			5.3	%		78.0	%	$	191,926			78.8	%	$	173,598	$	18,328			10.6	%
Add: Cataract IOL sales return reserve					-					-		-									742						-		742
Add: Cataract IOL inventory reserve					-					-		-									2,800						-		2,800
Adjusted Gross profit and gross profit margin, Non-GAAP		79.2	%	$	63,638		79.5	%	$	60,462	$	3,176			5.3	%		79.2	%	$	195,468			78.8	%	$	173,598	$	21,870			12.6	%

Operating expenses:
Operating expenses, GAAP		71.4	%	$	57,343		61.5	%	$	46,757	$	(10,586	)		-22.6	%		70.8	%	$	174,234			59.3	%	$	130,760	$	(43,474	)		-33.2	%
Less: Cataract IOL intangible impairment					-					-		-									(154	)					-		154
Adjusted Operating expenses, Non-GAAP		71.4	%	$	57,343		61.5	%	$	46,757	$	(10,586	)		-22.6	%		70.5	%	$	174,080			59.3	%	$	130,760	$	(43,320	)		-33.1	%

Provision for income taxes:
Provision for income taxes, GAAP		2.4	%	$	1,929		3.0	%	$	2,315	$	386			16.7	%		2.6	%	$	6,366			3.0	%	$	6,671	$	305			4.6	%
Add: Income tax benefit on Cataract IOL					-					-		-									405						-		(405	)
Adjusted Provision for income taxes, Non-GAAP		2.4	%	$	1,929		3.0	%	$	2,315	$	386			16.7	%		2.7	%	$	6,771			3.0	%	$	6,671	$	(100	)		-1.5	%

Reconciliation of Non-GAAP Financial Measure

Adjusted Net Income and Net Income Per Share

(in 000's)

Unaudited


Unaudited	Three Months Ended				Nine Months Ended
	September 29, 2023		September 30, 2022		September 29, 2023			September 30, 2022
	$	4,817	$	10,262	$	13,591		$	32,902
Net income (as reported)
Less		-		-		742			-
Cataract IOL sales return reserve		-		-		2,800			-
Cataract IOL inventory reserve		-		-		154			-
Cataract IOL intangible impairment		-		-		(405	)		-
Income tax benefit on Cataract IOL		4,817		10,262		16,882			32,902
Adjusted net income for ICL
Less:		1,384		2,129		3,240			4,904
Foreign currency impact		8,846		5,727		23,334			15,375
Valuation allowance adjustment	$	15,047	$	18,118	$	43,456		$	53,181
Net income (adjusted)
	$	0.10	$	0.21	$	0.28		$	0.69
Net income per share, basic (as reported)		-		-		0.02			-
Cataract IOL sales return reserve		-		-		0.06			-
Cataract IOL inventory reserve		-		-		-			-
Cataract IOL intangible impairment		-		-		(0.01	)		-
Income tax benefit on Cataract IOL		0.10		0.21		0.35			0.69
Adjusted net income for ICL per share, basic		0.03		0.05		0.07			0.10
Foreign currency impact		0.18		0.12		0.48			0.32
Valuation allowance adjustment	$	0.31	$	0.38	$	0.90		$	1.11
Net income per share, basic (adjusted)
	$	0.10	$	0.21	$	0.27		$	0.67
Net income per share, diluted (as reported)		-		-		0.01			-
Cataract IOL sales return reserve		-		-		0.06			-
Cataract IOL inventory reserve		-		-		-			-
Cataract IOL intangible impairment		-		-		(0.01	)		-
Income tax benefit on Cataract IOL		0.10		0.21		0.34			0.67
Adjusted net income for ICL per share, diluted		0.03		0.04		0.07			0.10
Foreign currency impact		0.18		0.12		0.47			0.31
Valuation allowance adjustment	$	0.30	$	0.37	$	0.88		$	1.08
Net income per share, diluted (adjusted)
		48,613		48,102		48,426			47,915
Weighted average shares outstanding - Basic		49,370		49,549		49,494			49,371

Note: Net income per share (adjusted), basic and diluted, may not add due to rounding

STAAR Surgical Company

ICL Sales by Geography

(in 000's)

Unaudited


	Fiscal Year																					Three Months Ended
ICL Sales by Region	2016			2017			2018			2019			2020			2021			2022			September 29, 2023			September 30, 2022

Americas(1)	$	8,663		$	8,581		$	9,112		$	10,250		$	8,834		$	14,054		$	20,114		$	5,449		$	5,168

EMEA(2)		19,330			21,334			25,626			26,398			25,748			37,343			36,715			9,253			8,111

APAC(3)		31,118			38,410			66,343			92,673			106,825			161,508			212,883			66,367			58,674

Global ICL Sales	$	59,111		$	68,325		$	101,081		$	129,321		$	141,407		$	212,905		$	269,712		$	81,069		$	71,953

Global ICL Sales Growth		15	%		16	%		48	%		28	%		9	%		51	%		27	%		13	%		33	%

Global ICL Unit Growth		11	%		17	%		54	%		33	%		11	%		48	%		33	%		14	%		40	%

	Fiscal Year																					Three Months Ended
ICL Sales by Country(4)(5)	2016			2017			2018			2019			2020			2021			2022			September 29, 2023			September 30, 2022

China	$	16,238		$	24,088		$	45,915		$	64,770		$	71,600		$	107,130		$	147,967		$	48,262		$	42,246
Growth		35	%		48	%		91	%		41	%		11	%		50	%		38	%		14	%		49	%

Japan	$	2,746		$	3,695		$	7,037		$	11,774		$	18,366		$	28,688		$	32,623		$	9,091		$	8,134
Growth		51	%		35	%		90	%		67	%		56	%		56	%		14	%		12	%		12	%

South Korea	$	7,453		$	5,540		$	7,564		$	9,517		$	11,119		$	15,173		$	17,940		$	4,886		$	4,857
Growth		-7	%		-26	%		37	%		26	%		17	%		36	%		18	%		1	%		50	%

United States	$	6,055		$	5,744		$	5,792		$	7,210		$	6,003		$	9,478		$	15,070		$	4,162		$	3,920
Growth		7	%		-5	%		1	%		24	%		-17	%		58	%		59	%		6	%		75	%

(1)

Americas includes the United States, Canada and Latin American countries

(2)

EMEA includes Spain, Germany, United Kingdom, European, Middle East and Africa Distributors

(3)

APAC includes China, Japan, South Korea, India and the rest of Asia Pacific distributors

(4)

ICL Sales by country includes countries representing more than 5% of total ICL sales in the most recently completed fiscal year

(5)

ICL sales do not include IOL, injector or other sales.

STAAR Surgical Company

Reconciliation of Non-GAAP Financial Measure

Constant Currency Sales

(in 000's)

Unaudited


	Three Months Ended
				Effect of			Constant					As Reported						Constant Currency
Sales	September 29, 2023			Currency			Currency			September 30, 2022		$ Change			% Change			$ Change			% Change
ICL	$	81,069		$	(112	)	$	80,957		$	71,953	$	9,116			12.7	%	$	9,004			12.5	%

Cataract IOL		(221	)		13			(208	)		2,191		(2,412	)		-110.1	%		(2,399	)		-109.5	%
Other		(540	)		(8	)		(548	)		1,902		(2,442	)		-128.4	%		(2,450	)		-128.8	%
Other Products		(761	)		5			(756	)		4,093		(4,854	)		-118.6	%		(4,849	)		-118.5	%

Total Sales	$	80,308		$	(107	)	$	80,201		$	76,046	$	4,262			5.6	%	$	4,155			5.5	%

	Nine Months Ended
				Effect of			Constant					As Reported						Constant Currency
Sales	September 29, 2023			Currency			Currency			September 30, 2022		$ Change			% Change			$ Change			% Change
ICL	$	244,806		$	2,004		$	246,810		$	208,550	$	36,256			17.4	%	$	38,260			18.3	%

Cataract IOL		1,295			172			1,467			7,640		(6,345	)		-83.0	%		(6,173	)		-80.8	%
Other		41			104			145			4,157		(4,116	)		-99.0	%		(4,012	)		-96.5	%
Other Products		1,336			276			1,612			11,797		(10,461	)		-88.7	%		(10,185	)		-86.3	%

Total Sales	$	246,142		$	2,280		$	248,422		$	220,347	$	25,795			11.7	%	$	28,075			12.7	%

Document And Entity Information	Nov. 01, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 01, 2023
Entity Registrant Name	STAAR SURGICAL CO
Entity Central Index Key	0000718937
Entity Emerging Growth Company	false
Entity File Number	0-11634
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	95-3797439
Entity Address, Address Line One	25651 Atlantic Ocean Drive
Entity Address, City or Town	Lake Forest
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92630
City Area Code	626
Local Phone Number	303-7902
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of each class	Common
Trading Symbol(s)	STAA
Name of each exchange on which registered	NASDAQ