STAA STAAR Surgical Company

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K/A

CURRENT REPORT

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

 

Date of report (Date of earliest event reported): October 30, 2024

 

 

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.)
25510 Commercentre 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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

 

On October 30, 2024, STAAR Surgical Company (the “Company”) reported its financial results for the quarter ended September 27, 2024, and filed a Current Report on Form 8-K (the “Original Form 8-K”), which included the Company’s earnings press release as Exhibit 99.1 and the Company’s slide presentation as Exhibit 99.2. As further discussed below in Item 7.01, the Company is filing this Current Report on Form 8-K/A to amend the Original Form 8-K to correct inconsistencies in the press release and the slide presentation regarding assumptions underlying the Company’s financial outlook for fiscal year 2024 related to APAC regional growth rates.

 

 

Item 7.01 Regulation FD Disclosure.

 

On October 30, 2024, the Company published an updated press release and an updated slide presentation to correctly reflect the Company's assumptions underlying its financial outlook for fiscal year 2024 related to APAC regional growth rates. No other changes were made to the press release or the slide presentation furnished as exhibits to the Original Form 8-K. A copy of the updated press release is furnished herewith as Exhibit 99.1, and a copy of updated slide presentation is furnished herewith as Exhibit 99.2.

 

The Company’s outlook for fiscal year 2024 net sales of $340 million to $345 million, as set forth in the press release and slide presentation, is unchanged. The updated press release and updated slide presentation reflect the following assumptions underlying such outlook: EVO ICL sales growth of 17% in the Americas (prior outlook was 15%) including 20% in the U.S. (prior outlook was 25%); EMEA sales growth of 10% (prior outlook was 6%); and APAC sales growth of 5% (prior outlook was 7%), including approximately 2% growth in China (prior outlook was 10%) and all other APAC countries approximately 10-20% growth (prior outlook was flat).

 

The information contained in this Form 8-K/A and the exhibits hereto shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in this Form 8-K/A, Exhibit 99.1 and Exhibit 99.2 shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Form 8-K/A, regardless of any general incorporation language in the filing.

 

The Company’s financial outlook for fiscal year 2024, including the assumptions underlying such outlook, are forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in the press release and the slide presentation furnished herewith.

 

 

Item 9.01 Financial Statements and Exhibits.

 

Exhibit No.		Description
99.1		Press release of the Company dated October 30, 2024 (updated).
99.2		Slide presentation of the Company dated October 30, 2024 (updated).
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

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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
October 30, 2024	By:	/s/ Tom Frinzi
		Thomas G. Frinzi
		President and Chief Executive Officer

 

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STAAR Surgical Reports Third Quarter 2024 Results

Net Sales Up 10% to $88.6 Million Driven by Growth in All Regions

Americas Up 14%, EMEA Up 12% and APAC Up 9%

Market Building Initiatives Drive EVO ICL™ Uptake and Reinforce Opportunity

 

LAKE FOREST, CA, October 30, 2024 --- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of the EVO family of Implantable Collamer® Lenses (EVO ICL™) for myopia, astigmatism and presbyopia, today reported financial results for the third quarter ended September 27, 2024.

 

Third Quarter 2024 Overview

 

 

"In the third quarter, we achieved double-digit sales growth against a macroeconomic environment that softened in the second half of the quarter, particularly in China," said Tom Frinzi, President and CEO of STAAR Surgical. "STAAR is well positioned to navigate through the current market dynamics, which we believe are transitory. Looking ahead, we are encouraged by the recent shift in fiscal policy and announced stimulus in China and will continue to closely monitor the potential impact on our near to midterm growth outlook.”

Mr. Frinzi concluded, “Our focus on customer engagement and market expansion continues to yield solid results, helping drive industry-leading growth and market share gains. As our surgeon customers perform more EVO procedures, they are increasingly using our technology for moderate myopia, which underscores EVO ICL as the treatment choice for -6D and above and expands our total addressable market.”

Third Quarter 2024 Financial Results

 

Net sales were $88.6 million for the third quarter of 2024, up 10% from $80.3 million reported in the prior year quarter. This sales increase was driven by ICL sales growth of $8.0 million, up 10%, and unit growth of 6% from the prior year period. Other Product sales declined $0.2 million from the prior year period. Changes in currency, primarily the Japanese Yen, negatively impacted reported total net sales by $0.3 million for the third quarter of 2024.

 

Gross profit margin for the third quarter of 2024 was 77.3% of net sales as compared to the prior year quarter of 79.2% of net sales. Gross margin in the third quarter was lower primarily due to reduced unit production that resulted in less absorption of fixed overhead.

 

Operating expenses for the third quarter of 2024 were $62.8 million, up from the prior year quarter of $57.3 million. General and administrative expenses were $21.7 million, up from $19.3 million in the prior year quarter, driven primarily by increased facility costs and compensation-related expenses. Selling and marketing expenses were

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$26.6 million – consistent with the prior year quarter. Research and development expenses were $14.5 million, up from the prior year quarter of $11.5 million, primarily due to purchases of in-process research and development, as well as compensation-related expenses, which were partially offset by lower clinical trial costs.

 

Operating income for the third quarter of 2024 was $5.7 million or 6.4% of net sales as compared to operating income of $6.3 million or 7.8% of net sales for the third quarter of 2023.

 

Net income for the third quarter of 2024 was $10.0 million or $0.20 income per share, up from $4.8 million or $0.10 income per share for the prior year quarter. The increase in net income was primarily attributable to a gain on foreign currency transactions.

 

As of September 27, 2024, cash, cash equivalents and investments available for sale totaled $236.0 million, up from $232.4 million on December 29, 2023.

 

Outlook

 

The Company maintained its prior outlook for fiscal year 2024 net sales and Adjusted EBITDA.

 

 

The outlook above contemplates EVO ICL sales growth of 17% in the Americas (prior outlook was 15%) including 20% in the U.S. (prior outlook was 25%); EMEA sales growth of 10% (prior outlook was 6%); and APAC sales growth of 5% (prior outlook was 7%), including approximately 2% growth in China (prior outlook was 10%) and all other APAC countries approximately 10-20% growth (prior outlook was flat).

 

Earnings Webcast

The Company will host an earnings webcast today, Wednesday, October 30 at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and operational progress. To access the webcast please use the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=fmU0YbKB

 

The live webcast, earnings webcast presentation and an archived version of the webcast can be accessed from the investor relations section of the STAAR website at www.staar.com.

 

Use of Non-GAAP Financial Measures

 

To supplement the Company’s financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), this press release and the accompanying tables include certain non-GAAP financial measures, including Adjusted EBITDA. Management uses these non-GAAP financial measures in its evaluation of Company operating performance and believes investors will find them useful in evaluating the Company’s operating performance, including cash flow generation, and in analyzing period-to-period financial performance of core business operations and underlying business trends. Non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

EBITDA is a non-GAAP financial measure, which is calculated by adding interest income and expense, net; provision for income taxes; and depreciation and amortization to net income. In calculating Adjusted EBITDA and Adjusted EBITDA per diluted share, the Company further adjusts for stock-based compensation expense. As stock-based compensation is a non-cash expense that can vary significantly based on the timing, size and nature of awards granted,

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the Company believes that the exclusion of stock-based compensation expense can assist investors in comparisons of Company operating results with other peer companies because (i) the amount of such expense in any specific period may not directly correlate to the underlying performance of our business operations and (ii) such expense can vary significantly between periods as a result of the timing of grants of new stock-based awards, including inducement grants in connection with hiring. Additionally, the Company believes that excluding stock-based compensation from Adjusted EBITDA and Adjusted EBITDA per diluted share assists management and investors in making meaningful comparisons between the Company’s operating performance and the operating performance of other companies that may use different forms of employee compensation or different valuation methodologies for their stock-based compensation. Investors should note that stock-based compensation is a key incentive offered to employees whose efforts contributed to the operating results in the periods presented and are expected to contribute to operating results in future periods. Investors should also note that such expenses will recur in the future.

The Company also presents certain financial information on a constant currency basis, which is intended to exclude the effects of foreign currency fluctuations. 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.

In the tables provided below, the Company has included a reconciliation of Adjusted EBITDA and Adjusted EBITDA per diluted share to net income and net income per diluted share, the most directly comparable GAAP financial measure, as well as supplemental financial information with net sales expressed in constant currency. The Company has also provided a reconciliation of forward-looking Adjusted EBITDA and Adjusted EBITDA per diluted share to net income and net income per diluted share. This represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Safe Harbor section of this press release.

 

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 3,000,000 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, anticipated financial results, estimates and outlook (including as to net sales, Adjusted EBITDA, and Adjusted EBITDA per diluted share), plans, strategies, and objectives of management for 2024 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 2024 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 global economic conditions, as well as the factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 29, 2023 under the caption “Risk Factors,” which is on file with the Securities and Exchange

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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 COVID-19; 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 conflicts, 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 & Media
	Brian Moore
	Vice President, Investor Relations and Corporate Development
	626-303-7902, Ext. 3023
	bmoore@staar.com

 

	Investors – Asia
	Niko Liu, CFA
	Director, Investor Relations and Corporate Development – Asia
	+852-6092-5076
	nliu@staar.com

 

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Consolidated Balance Sheets
(in 000's)
Unaudited
ASSETS		September 27, 2024				December 29, 2023
Current assets:
Cash and cash equivalents		$	164,003			$	183,038
Investments available for sale			71,955				37,688
Accounts receivable trade, net			104,510				94,704
Inventories, net			40,361				35,130
Prepayments, deposits, and other current assets			16,277				14,709
Total current assets			397,106				365,269
Investments available for sale			-				11,703
Property, plant, and equipment, net			81,580				66,835
Finance lease right-of-use assets, net			73				183
Operating lease right-of-use assets, net			37,897				34,387
Goodwill			1,786				1,786
Deferred income taxes			5,324				5,190
Other assets			13,824				3,339
Total assets		$	537,590			$	488,692
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable		$	14,694			$	13,557
Obligations under finance leases			84				165
Obligations under operating leases			4,531				4,202
Allowance for sales returns			8,124				6,174
Other current liabilities			38,908				40,938
Total current liabilities			66,341				65,036
Obligations under finance leases			-				42
Obligations under operating leases			35,385				31,425
Deferred income taxes			1,056				1,077
Asset retirement obligations			127				103
Pension liability			6,559				5,055
Total liabilities			109,468				102,738
Stockholders' equity:
Common stock			493				488
Additional paid-in capital			466,579				436,947
Accumulated other comprehensive loss			(5,602	)			(4,113	)
Accumulated deficit			(33,348	)			(47,368	)
Total stockholders' equity			428,122				385,954
Total liabilities and stockholders' equity		$	537,590			$	488,692

 

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Consolidated Statements of Income
(in 000's except for per share data)
Unaudited
		Three Months Ended																								Year to Date
		% of Sales				September 27, 2024				% of Sales				September 29, 2023				Fav (Unfav) Amount				%				% of Sales				September 27, 2024				% of Sales				September 29, 2023				Fav (Unfav) Amount				%
Net sales			100.0	%		$	88,590				100.0	%		$	80,308			$	8,282				10.3	%			100.0	%		$	264,951				100.0	%		$	246,142			$	18,809				7.6	%
Cost of sales			22.7	%			20,103				20.8	%			16,670				(3,433	)			(20.6	)%			21.5	%			57,017				22.0	%			54,216				(2,801	)			(5.2	)%
Gross profit			77.3	%			68,487				79.2	%			63,638				4,849				7.6	%			78.5	%			207,934				78.0	%			191,926				16,008				8.3	%
Selling, general and administrative expenses:
General and administrative			24.4	%			21,685				24.0	%			19,266				(2,419	)			(12.6	)%			25.9	%			68,554				22.6	%			55,461				(13,093	)			(23.6	)%
Selling and marketing			30.1	%			26,623				33.1	%			26,607				(16	)			(0.1	)%			31.0	%			82,150				34.6	%			85,238				3,088				3.6	%
Research and development			16.4	%			14,497				14.3	%			11,470				(3,027	)			(26.4	)%			15.8	%			41,931				13.6	%			33,535				(8,396	)			(25.0	)%
Total selling, general, and administrative expenses			70.9	%			62,805				71.4	%			57,343				(5,462	)			(9.5	)%			72.7	%			192,635				70.8	%			174,234				(18,401	)			(10.6	)%
Operating income			6.4	%			5,682				7.8	%			6,295				(613	)			(9.7	)%			5.8	%			15,299				7.2	%			17,692				(2,393	)			(13.5	)%
Other income (expense):
Interest income, net			1.6	%			1,407				2.1	%			1,690				(283	)			(16.7	)%			1.6	%			4,358				2.1	%			5,287				(929	)			(17.6	)%
Gain (loss) on foreign currency transactions			6.7	%			5,931				-1.7	%			(1,384	)			7,315				528.5	%			0.2	%			585				-1.3	%			(3,240	)			3,825				118.1	%
Royalty income			0.0	%			-				0.1	%			74				(74	)			(100.0	)%			0.2	%			508				0.0	%			74				434				586.5	%
Other income, net			0.2	%			139				0.1	%			71				68				95.8	%			0.2	%			532				0.1	%			144				388				269.4	%
Total other income, net			8.5	%			7,477				0.6	%			451				7,026				1557.9	%			2.2	%			5,983				0.9	%			2,265				3,718				164.2	%
Income before provision for income taxes			14.9	%			13,159				8.4	%			6,746				6,413				95.1	%			8.0	%			21,282				8.1	%			19,957				1,325				6.6	%
Provision for income taxes			3.6	%			3,179				2.4	%			1,929				(1,250	)			(64.8	)%			2.7	%			7,262				2.6	%			6,366				(896	)			(14.1	)%
Net income			11.3	%			9,980				6.0	%			4,817				5,163				107.2	%			5.3	%			14,020				5.5	%			13,591				429				3.2	%
Net income per share - basic							0.20								0.10																0.29								0.28
Net income per share - diluted							0.20								0.10																0.28								0.27
Weighted average shares outstanding - basic							49,199								48,613																49,078								48,426
Weighted average shares outstanding - diluted							49,731								49,370																49,614								49,494

 

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Consolidated Statements of Cash Flows
(in 000's)
Unaudited
		Three Months Ended								Year to Date
		September 27, 2024				September 29, 2023				September 27, 2024				September 29, 2023
Cash flows from operating activities:
Net income		$	9,980			$	4,817			$	14,020			$	13,591
Adjustments to reconcile net income to net cash provided by (used in) operating activities:
Depreciation of property and equipment			1,757				1,345				4,516				3,743
Amortization of long-lived intangibles			-				(2	)			-				169
Accretion/Amortization of investments available for sale			(124	)			(348	)			(410	)			(2,172	)
Deferred income taxes			(13	)			(10	)			47				65
Change in net pension liability			(16	)			(139	)			(162	)			(766	)
Stock-based compensation expense			7,160				8,846				22,541				23,334
Change in asset retirement obligation			4				3				24				(104	)
Loss on disposal of property and equipment			1,642				17				1,668				41
Provision for sales returns and bad debts			868				921				1,947				1,925
Inventory provision			849				460				1,873				4,090
Changes in working capital:
Accounts receivable			(10,139	)			(18,092	)			(9,703	)			(50,436	)
Inventories			(1,091	)			(5,593	)			(5,962	)			(9,975	)
Prepayments, deposits and other assets			(5,152	)			(919	)			(12,237	)			(3,584	)
Accounts payable			(5,649	)			(1,819	)			(2,031	)			(3,266	)
Other current liabilities			3,740				4,538				(1,048	)			5,970
Net cash provided by (used in) operating activities			3,816				(5,975	)			15,083				(17,375	)
Cash flows from investing activities:
Acquisition of property and equipment			(6,231	)			(9,185	)			(17,669	)			(15,100	)
Purchase of investments available for sale			(40,945	)			(9,712	)			(61,194	)			(52,314	)
Proceeds from sale or maturity of investments available for sale			11,935				50,737				39,141				119,359
Net provided by (used in) investing activities			(35,241	)			31,840				(39,722	)			51,945
Cash flows from financing activities:
Repayment of finance lease obligations			(42	)			(39	)			(124	)			(121	)
Repurchase of employee common stock for taxes withheld			-				(112	)			(1,396	)			(2,096	)
Proceeds from vested restricted stock and exercise of stock options			1,657				7,258				7,354				9,265
Net cash provided by financing activities			1,615				7,107				5,834				7,048
Effect of exchange rate changes on cash and cash equivalents			1,037				(235	)			(230	)			(666	)
Increase (decrease) in cash and cash equivalents			(28,773	)			32,737				(19,035	)			40,952
Cash and cash equivalents, at beginning of the period			192,776				94,695				183,038				86,480
Cash and cash equivalents, at end of the period		$	164,003			$	127,432			$	164,003			$	127,432

 

 

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Reconciliation of Non-GAAP Financial Measure
Net Income to Adjusted EBITDA
(in 000's except for per share data)
Unaudited
		2021				Q1-22				Q2-22				Q3-22				Q4-22				2022				Q1-23				Q2-23				Q3-23				Q4-23				2023				Q1-24				Q2-24				Q3-24				2024 Outlook(2)
Net income (loss) - (as reported)		$	27,511			$	9,602			$	13,038			$	10,262			$	6,763			$	39,665			$	2,710			$	6,064			$	4,817			$	7,756			$	21,347			$	(3,339	)		$	7,379			$	9,980			$	3,800
Provision (benefit) for income taxes			3,793				1,925				2,431				2,315				(784	)			5,887				2,009				2,428				1,929				5,983				12,349				1,128				2,955				3,179				7,600
Other (income) expense, net			2,035				586				1,551				1,128				(5,015	)			(1,750	)			(1,919	)			105				(451	)			(3,334	)			(5,599	)			(70	)			1,564				(7,477	)			(7,500	)
Depreciation			3,608				994				1,030				1,077				1,380				4,481				1,113				1,285				1,345				1,368				5,111				1,237				1,522				1,757				6,000
(Gain) loss on disposal of property plant and equipment(3)			2				-				-				-				65				65				-				24				17				32				73				-				26				1,642				1,700
Amortization of intangible assets			34				8				7				7				6				28				7				10				(2	)			(2	)			13				-				-				-				-
Stock-based compensation			14,605				3,894				5,754				5,727				4,996				20,371				6,065				8,423				8,846				182				23,516				6,339				9,042				7,160				30,200
Adjusted EBITDA		$	51,588			$	17,009			$	23,811			$	20,516			$	7,411			$	68,747			$	9,985			$	18,339			$	16,501			$	11,985			$	56,810			$	5,295			$	22,488			$	16,241			$	41,800
Adjusted EBITDA as a % of Revenue			22.4	%			26.9	%			29.4	%			27.0	%			11.6	%			24.2	%			13.6	%			19.9	%			20.6	%			15.7	%			17.6	%			6.8	%			22.7	%			18.3	%			12.2	%
Net income (loss) per share, diluted - (as reported)		$	0.56			$	0.19			$	0.26			$	0.21			$	0.14			$	0.80			$	0.05			$	0.12			$	0.10			$	0.16			$	0.43			$	(0.07	)		$	0.15			$	0.20			$	0.07
Provision (benefit) for income taxes			0.08				0.04				0.05				0.05				(0.02	)			0.12				0.04				0.05				0.04				0.12				0.25				0.02				0.06				0.06				0.15
Other (income) expense, net			0.04				0.01				0.03				0.02				(0.10	)			(0.04	)			(0.04	)			-				(0.01	)			(0.07	)			(0.11	)			-				0.03				(0.15	)			(0.14	)
Depreciation			0.07				0.02				0.02				0.02				0.03				0.09				0.02				0.03				0.03				0.03				0.10				0.03				0.03				0.04				0.12
(Gain) loss on disposal of property plant and equipment			-				-				-				-				-				-				-				-				-				-				-				-				-				0.03				0.03
Amortization of intangible assets			-				-				-				-				-				-				-				-				-				-				-				-				-				-				-
Stock-based compensation			0.30				0.08				0.12				0.12				0.10				0.41				0.12				0.17				0.18				-				0.48				0.13				0.18				0.14				0.58
Adjusted EBITDA per share, diluted(1)		$	1.04			$	0.35			$	0.48			$	0.41			$	0.15			$	1.39			$	0.20			$	0.37			$	0.33			$	0.24			$	1.15			$	0.11			$	0.45			$	0.33			$	0.80
Weighted average shares outstanding - Diluted			49,456				49,288				49,223				49,549				49,389				49,380				49,500				49,516				49,370				49,242				49,427				48,907				49,811				49,731				52,000
(1)  Adjusted EBITDA per diluted share may not add due to rounding
(2) 2024 Adjusted EBITDA Outlook line items are all approximations and assumes breakeven Net Income
(3) The Q3-2024 non cash write-off of $1.6M was related to the former EVO Experience Center

 

 

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ICL Sales by Geography
(in 000's)
Unaudited
		Fiscal Year												Three Months Ended
ICL Sales by Region(5)		2021				2022				2023				June 30, 2023				September 29, 2023				December 29, 2023				March 29, 2024				June 28, 2024				September 27, 2024
Americas(1)		$	14,054			$	20,114			$	22,233			$	5,954			$	5,449			$	5,264			$	6,260			$	6,794			$	6,187
EMEA(2)			37,343				36,715				39,318				9,782				9,253				10,103				11,299				10,727				10,333
APAC(3)			161,508				212,883				257,876				77,376				66,367				59,254				59,592				81,844				72,581
Global ICL Sales		$	212,905			$	269,712			$	319,427			$	93,112			$	81,069			$	74,621			$	77,151			$	99,365			$	89,101
Global ICL Sales Growth			51	%			27	%			18	%			19	%			13	%			22	%			9	%			7	%			10	%
Americas ICL Sales Growth			59	%			43	%			11	%			12	%			5	%			(8	)%			12	%			14	%			14	%
EMEA ICL Sales Growth			45	%			(2	)%			7	%			(11	)%			14	%			18	%			11	%			10	%			12	%
APAC ICL Sales Growth			51	%			32	%			21	%			26	%			13	%			26	%			9	%			6	%			9	%
Global ICL Unit Growth			48	%			33	%			19	%			21	%			14	%			19	%			2	%			3	%			6	%
		Fiscal Year												Three Months Ended
ICL Sales by Country(4)(5)		2021				2022				2023				June 30, 2023				September 29, 2023				December 29, 2023				March 29, 2024				June 28, 2024				September 27, 2024
China		$	107,130			$	147,967			$	185,404			$	61,288			$	48,262			$	40,813			$	38,460			$	63,345			$	51,719
Growth			50	%			38	%			25	%			33	%			14	%			30	%			10	%			3	%			7	%
Japan		$	28,688			$	32,623			$	36,352			$	8,563			$	9,091			$	9,495			$	10,227			$	9,735			$	10,490
Growth			56	%			14	%			11	%			13	%			12	%			16	%			11	%			14	%			15	%
South Korea		$	15,173			$	17,940			$	19,853			$	3,316			$	4,886			$	4,996			$	6,725			$	3,973			$	5,434
Growth			36	%			18	%			11	%			(15	)%			1	%			39	%			1	%			20	%			11	%
United States		$	9,478			$	15,070			$	17,168			$	4,446			$	4,162			$	4,164			$	5,039			$	5,541			$	4,823
Growth			58	%			59	%			14	%			10	%			6	%			(8	)%			15	%			25	%			16	%
Notes:
(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

 

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Reconciliation of Non-GAAP Financial Measure
Constant Currency Sales
(in 000's)
Unaudited
		Three Months Ended																As Reported								Constant Currency
Sales		September 27, 2024				Effect of Currency				Constant Currency				September 29, 2023				$ Change				% Change				$ Change				% Change
ICL		$	89,101			$	300			$	89,401			$	81,069			$	8,032				9.9	%		$	8,332				10.3	%
Cataract IOL			-				-				-				(221	)			221				(100.0	)%			221				(100.0	)%
Other			(511	)			(2	)			(513	)			(540	)			29				(5.4	)%			27				(5.0	)%
Total Sales		$	88,590			$	298			$	88,888			$	80,308			$	8,282				10.3	%		$	8,580				10.7	%
		Year to Date																As Reported								Constant Currency
Sales		September 27, 2024				Effect of Currency				Constant Currency				September 29, 2023				$ Change				% Change				$ Change				% Change
ICL		$	265,617			$	2,515			$	268,132			$	244,806			$	20,811				8.5	%		$	23,326				9.5	%
Cataract IOL			-				-				-				1,295				(1,295	)			(100.0	)%			(1,295	)			(100.0	)%
Other			(666	)			111				(555	)			41				(707	)			(1724.4	)%			(596	)			(1453.7	)%
Total Sales		$	264,951			$	2,626			$	267,577			$	246,142			$	18,809				7.6	%		$	21,435				8.7	%

 

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NASDAQ: STAA Third Quarter 2024
Earnings Presentation OCTOBER 30, 2024 Exhibit 99.2

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02 STAAR Surgical Earnings Webcast Third Quarter 2024 Today’s Speakers Investor Relations PATRICK WILLIAMS TOM FRINZI Chair of the Board, President and CEO Chief Financial Officer http://investors.staar.com Brian Moore VP, Investor Relations and Corporate Development Connie Johnson Director, Investor Relations  and High-Performance Management Niko Liu, CFA Director, Investor Relations and Corporate Development – Asia +1 626.303.7902 investorrelations@staar.com

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All statements that are not statements of historical fact are forward-looking statements, including statements about any of the following: any financial projections, anticipated financial results, estimates and outlook (including as to net sales, Adjusted EBITDA, and Adjusted EBITDA per diluted share), plans, strategies, and objectives of management for 2024 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 2024 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 global economic conditions, as well as the factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 29, 2023 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, www.staar.com, 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 presentation 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 COVID-19; 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 conflicts, 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 presentations, SEC filings and public conference calls and webcasts. Forward Looking Statements 03

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Non-GAAP Financial Information To supplement the Company’s financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), this presentation and the accompanying tables include certain non-GAAP financial measures, including Adjusted EBITDA. Management uses these non- GAAP financial measures in its evaluation of Company operating performance and believes investors will find them useful in evaluating the Company’s operating performance, including cash flow generation, and in analyzing period-to-period financial performance of core business operations and underlying business trends. Non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. EBITDA is a non-GAAP financial measure, which is calculated by adding interest income and expense, net; provision for income taxes; and depreciation and amortization to net income. In calculating Adjusted EBITDA and Adjusted EBITDA per diluted share, the Company further adjusts for stock-based compensation expense. As stock-based compensation is a non-cash expense that can vary significantly based on the timing, size and nature of awards granted, the Company believes that the exclusion of stock-based compensation expense can assist investors in comparisons of Company operating results with other peer companies because (i) the amount of such expense in any specific period may not directly correlate to the underlying performance of our business operations and (ii) such expense can vary significantly between periods as a result of the timing of grants of new stock- based awards, including inducement grants in connection with hiring. Additionally, the Company believes that excluding stock-based compensation from Adjusted EBITDA and Adjusted EBITDA per diluted share assists management and investors in making meaningful comparisons between the Company’s operating performance and the operating performance of other companies that may use different forms of employee compensation or different valuation methodologies for their stock-based compensation. Investors should note that stock-based compensation is a key incentive offered to employees whose efforts contributed to the operating results in the periods presented and are expected to contribute to operating results in future periods. Investors should also note that such expenses will recur in the future. The Company also presents certain financial information on a constant currency basis, which is intended to exclude the effects of foreign currency fluctuations. 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. In the appendix to this presentation, the Company has included a reconciliation of Adjusted EBITDA and Adjusted EBITDA per diluted share to net income and net income per diluted share, the most directly comparable GAAP financial measure. The Company has also provided a reconciliation of forward-looking Adjusted EBITDA and Adjusted EBITDA per diluted share to net income and net income per diluted share. This represents forward- looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward Looking Statements section of this presentation. 04

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STAAR Surgical + EVO ICL Around the World THIRD QUARTER 2024 EARNINGS PRESENTATION 05

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Enhanced commercial focus and investments are driving growth In the third quarter, we achieved double-digit sales growth against a macroeconomic environment that softened in the second half of the quarter, particularly in China. STAAR is well positioned to navigate through the current market dynamics, which we believe are transitory. Looking ahead, we are encouraged by the recent shift in fiscal policy and announced stimulus in China and will continue to closely monitor the potential impact on our near to midterm growth outlook. Our focus on customer engagement and market expansion continues to yield solid results, helping drive industry-leading growth and market share gains. As our surgeon customers perform more EVO procedures, they are increasingly using our technology for moderate myopia, which underscores EVO ICL as the treatment choice for -6D and above and expands our total addressable market.” – Tom Frinzi Chair of the Board, President and CEO 06 STAAR / Q3 Results Reflect Continued Market Adoption & Share Gains Third Quarter 2024 Q3’24 GAAP Net Sales $340M - $345M Fiscal 2024 Net Sales Outlook Prior Outlook Maintained* Cash and Cash Equivalents as of Sep. 27, 2024 10% Q3'24 Global ICL Sales Growth 12% EMEA APAC 9% Surgeon Confidence Movement Down Diopter Curve Innovation 14% Americas $236.0M Our recent investments in customer education, innovative tools and comprehensive practice support, coupled with the advancement of our lower diopter strategies, are also expanding our total addressable market. * Prior outlook on August 7, 2024, was for net sales of $340M to $345M and Adjusted EBITDA of approximately $42M or $0.80 per diluted share. $88.6M

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07 STAAR / Surgeon and HCP Professional Education Activities Third Quarter 2024 EVO ICL Experience Center Lake Forest, CASeptember 2024 ESCRS 42nd Annual Congress of the European Society of Cataract and Refractive Surgeons Barcelona, SpainSeptember 2024 >80 ICL Papers Presentations EVO ICL as the choice for -6D and above.

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08 STAAR / Accelerating ICL Sales Growth in Third Quarter Third Quarter 2024 Notes:
(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 do not include IOL, injector or other sales. Americas EMEA APAC GLOBAL ($ Millions) UNAUDITED U.S. ICL sales up 16% in Q3’24, significantly outpacing the market Signed three additional “Fast Lane” Highway 93 agreements; the eight Fast Lane customers with at least one full quarter of sales delivered 61% ICL sales growth in Q3’24 U.S. refractive procedures, predominantly laser vision correction, declined 18% in Q3’24.5 Growth driven primarily by the Middle East and European distributor markets
Energized by the outperformance of our EMEA region this year; continue to benefit from our investments in this important market EMEA laser vision correction procedures were flat to down 5% in Q3’24.6 ICL Sales Growth Y/Y +14% +12% +9% +10% China ICL sales up 7% in Q3’24; unit growth was positive; early quarter momentum tapered
Japan ICL sales up 15%; consistent double-digit unit growth in 32 of last 35 quarters
South Korea ICL sales up 11% bolstered by country’s first ICL-only clinic China laser vision correction procedures declined 10-15% in Q3’24.6 10% global ICL sales growth reflects pricing power and 6% global ICL unit growth. Consistent with our August 7, 2024, commentary, we continue to expect the benefit from price to be approximately +3 points for FY24, i.e., sales growth to be 3 points higher than unit growth. Achieved double-digit sales growth against a softening macroeconomic environment in the second half of the quarter, particularly in China, which compares to generally down refractive procedures for the overall market in Q3’24 and YTD, globally. (5) Refractive Surgery Council(6) Company estimates

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09 STAAR / Income Statement Third Quarter 2024 PATRICK WILLIAMS Chief Financial Officer Q3’24 net sales of $88.6M
Net sales increased $8.3M or 10%; ICL sales increased $8.0M
Constant Currency net sales of $88.9M increased 10% Q3’24 Gross profit of $68.5M or 77.3% of net sales
Gross profit margin declined 190 bps Y/Y
Y/Y gross margin change primarily due to higher CPUs Gross profit margin now expected to be ~79% for fiscal 2024 Dollars in millions Dollars in millions Net Sales Gross Profit

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10 STAAR / Income Statement Operating Expenses For Q4’24, we continue to expect G&A expense to be approximately $24M For Q4’24, we now expect Selling and Marketing expense to be approximately $32M Third Quarter 2024 Research & Development $26.6M Yr Ago
$28.8M Q2’24 Selling & Marketing $19.3M Yr Ago
$23.6M Q2’24 $14.5M 71% General & Administrative $62.8M $26.6M $21.7M vs. $11.5M Yr Ago
$14.1M Q2’24 vs. vs. Q3’24 Total Operating Expenses For Q4’24 we continue to expect R&D expense to be approximately $15M

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Dollars in millions, except per share amounts GAAP Net Income Continued net income growth in the quarter Per share - Diluted Dollars in millions, except per share amounts Adjusted EBITDA 11 STAAR / Income Statement Continued cash generation in the quarter Per share - Diluted Third Quarter 2024

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STAAR / Strong Balance Sheet and Cash Flows $236.0M Cash, Cash Equivalents & Investments as of September 27, 2024 ~ $30M FY 2024 CapEx Outlook ~ $42M FY 2024 Adjusted EBITDA Outlook No Debt as of September 27, 2024 12

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STAAR / Sales Outlook Outlook Fiscal 2024 EVO ICL Sales Outlook and Global Diversity 13 $340M -$345M Fiscal 2024 Net Sales Outlook Maintained NEW PRIOR APAC China approx. 2% GrowthAll Other Countries approx. 10-20% Growth 5% EMEA 10% AMERICAS U.S. Growth of 20% for Fiscal 2024 17% APAC China approx. 10% GrowthAll Other Countries Flat 7% EMEA 6% AMERICAS U.S. Growth of 25% for Fiscal 2024 15% Chair of the Board, President and CEO TOM FRINZI

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STAAR / Executing Against Our Strategic Priorities Strategic Priorities Growth Accelerators Pace of EVO ICL Adoption Down Diopter Curve is Accelerating Surgeon Confidence in Measurement and Lens Size Selection Own -6D and Above Refractive Vision Correction New Product Innovation 14 AI-Based Protocols for Measurement and Size Selection 01 01 U.S. Head-to-Head Study Harmonizing Label Indications 02 02 03 03 -20D -19D -18D -17D -16D -15D -14D -13D -12D -11D -10D -9D -8D -7D -6D -5D -4D -3D A diopter is a unit of measurement of the refractive power of a lens. 8.9 FISCAL 2022 8.7 FISCAL 2023 8.2 FISCAL 2024 YTD

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Q&A STAAR SURGICAL
THIRD QUARTER 2024 EARNINGS WEBCAST 15

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Reconciliation of Non-GAAP Financial Measures STAAR Surgical 16 Additional 2024 Outlook Details Net Income to Adjusted EBITDA (in 000's except for per share data) Unaudited Provision for Income Tax is expected to be $0.3M in 4Q’24 Depreciation of approximately $1.5M in 4Q’24 Expect Other Income to be approximately $1.5M in 4Q’24 Expect stock-based compensation to be approximately $8M in 4Q’24 In order to reconcile Adjusted EBITDA from Net Income for our fiscal 2024 profitability Outlook, we are providing the following line item details as of October 30, 2024: (1) Adjusted EBITDA per diluted share may not add due to rounding.
(2) 2024 Outlook lines items are all approximations and assumes breakeven Net Income. Q1-23 Q2-23 Q3-23 Q4-23 2023 Q1-24 Q2-24 Q3-24 2024 Outlook (2) Net income (as reported) $2,710 $6,064 $4,817 $7,756 $21,347 $(3,339) $7,379 $9,980 $3,800 Provision (benefit) for income taxes $2,009 $2,428 $1,929 $5,983 $12,349 $1,128 $2,955 $3,179 $7,600 Other (income) expense, net $(1,919) $105 $(451) $(3,334) $(5,599) $(70) $1,564 $(7,477) $(7,500) Depreciation $1,113 $1,285 $1,345 $1,368 $5,111 $1,237 $1,522 $1,757 $6,000 Other $7 $34 $15 $30 $86 - $26 $1,642 $1,700 Stock-based compensation $6,065 $8,423 $8,846 $182 $23,516 $6,339 $9,042 $7,160 $30,200 Adjusted EBITDA $9,985 $18,339 $16,501 $11,985 $56,810 $5,295 $22,488 $16,241 $41,800 Adjusted EBITDA as a % of Revenue 13.6% 19.9% 20.6% 15.7% 17.6% 6.8% 22.7% 18.3% 12.2% Net income per share, diluted- (as reported) $0.05 $0.12 $0.10 $0.16 $0.43 $(0.07) $0.15 $0.20 $0.07 Provision (benefit) for income taxes $0.04 $0.05 $0.04 $0.12 $0.25 $0.02 $0.06 $0.06 $0.15 Other (income) expense, net $(0.04) - $(0.01) $(0.07) $(0.11) - $0.03 $(0.15) $(0.14) Depreciation $0.02 $0.03 $0.03 $0.03 $0.10 $0.03 $0.03 $0.04 $0.12 Other - - - - - - - $0.03 $0.03 Stock-based compensation $0.12 $0.17 $0.18 - $0.48 $0.13 $0.18 $0.14 $0.58 Adjusted EBITDA per share, diluted(1) $0.20 $0.37 $0.33 $0.24 $1.15 $ 0.11 $ 0.45 $ 0.33 $0.80 Weighted average shares outstanding - Diluted 49,500 49,516 49,370 49,242 49,427 48,907 49,811 49,737 52,000 Other $1.6M non-cash write off related to former EVO Experience Center

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ICL Sales by Geography Notes:
(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. (IN 000’S) UNAUDITED ICL Sales by Region(5) ICL Sales by Country(4,5) 2021 2021 2022 2022 2023 2023 Sep 27, 2024 Sep 27, 2024 Jun 30, 2023 Jun 30, 2023 Sep 29, 2023 Sep 29, 2023 Dec 29, 2023 Dec 29, 2023 Mar 29, 2024 Mar 29, 2024 Jun 28, 2024 Jun 28, 2024 Americas(1)
EMEA(2)
APAC (3)
Global ICL Sales
Global ICL Sales Growth
Americas ICL Sales Growth
EMEA ICL Sales Growth
APAC ICL Sales Growth
Global ICL Unit Growth China
Growth $14,054
$37,343
$161,508
$212,905
51%
59%
45%
51%
48% $107,130
50%
$28,688
56%
$15,173
36%
$9,478
58% $20,114
$36,715
$212,883
$269,712
27%
43%
(2%)
32%
33% $147,967
38%
$32,623
14%
$17,940
18%
$15,070
59% $22,233
$39,318
$257,876
$319,427
18%
11%
7%
21%
19% $185,404
25%
$36,352
11%
$19,853
11%
$17,168
14% $6,187
$10,333 $72,581
$89,101
10%
14%
12%
9%
6% $51,719
7%
$10,490
15%
$5,434
11%
$4,823
16% $5,954
$9,782
$77,376
$93,112
19%
12%
(11%)
26%
21% $61,288
33%
$8,563
13%
$3,316
(15)%
$4,446
10% $5,449
$9,253
$66,367
$81,069
13%
5%
14%
13%
14% $48,262
14%
$9,091
12%
$4,886
1%
$4,162
6% $6,260
$11,299
$59,592
$77,151
9%
12%
11%
9%
2% $38,460
10%
$10,227
11%
$6,725
1%
$5,039
15% $5,264
$10,103
$59,254
$74,621
22%
(8%)
18%
26%
19% $40,813
30%
$9,495
16%
$4,996
39%
$4,164
(8)% $6,794
$10,727
$81,844
$99,365
7%
14%
10%
6%
3% $63,345
3%
$9,735
14%
$3,973
20%
$5,541
25% FISCAL YEAR FISCAL YEAR THREE MONTHS ENDED THREE MONTHS ENDED Japan
Growth South Korea
Growth United States
Growth 17

v3.24.3

Document And Entity Information	Oct. 30, 2024
Cover [Abstract]
Document Type	8-K/A
Amendment Flag	false
Document Period End Date	Oct. 30, 2024
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	25510 Commercentre 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

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