ICL Units Up 40% Y/Y; Constant Currency Net Sales of $80.0 Million

STAAR Surgical Company (NASDAQ:STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, today reported financial results for the third quarter ended September 30, 2022.

Third Quarter 2022 Overview

Net Sales of $76.0 Million Up 30% and Constant Currency Net Sales of $80.0 Million Up 37% from the Prior Year Quarter
ICL Sales of $72.0 Million Up 33% and Constant Currency ICL Sales of $75.2 Million Up 39% from the Prior Year Quarter
ICL Units Up 40% from the Prior Year Quarter
Gross Margin at 79.5% vs. 77.6% in the Prior Year Quarter
Net Income of $0.21 per Share vs. $0.12 per Share in the Prior Year Quarter
Cash, Cash Equivalents and Investments Available for Sale Ended the Quarter at $224.7 Million

"STAAR achieved 30% net sales growth in the third quarter which reflects strong EVO ICL unit growth in APAC and strong accelerating growth in the U.S., despite constant currency challenges and, in Europe, macroeconomic headwinds," said Caren Mason, President and CEO of STAAR Surgical. "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, highlighted by media campaigns with global entertainment celebrity Joe Jonas and NBA player Max Strus, 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. Despite stringent COVID policies in China we achieved strong results in the third quarter and expect our EVO lenses to capture more than 25% of China's estimated 1.2 million annual refractive procedures by the end of 2022. However, 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, which represents $300 million adjusted for constant currency. Our fiscal 2022 outlook includes ICL sales of approximately $272 million, representing approximately 28% year over year growth, and Other Products sales of approximately $13 million."

Ms. Mason continued, "Today it is vital that STAAR focus on the significant growth opportunities we have with our premium EVO products. At the same time, 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, despite the aforementioned challenges, 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 see significant growth potential for our EVO family of lenses globally and look forward to continuing our focus, efforts and resources on especially large growth opportunities in the U.S. and Asia in 2023."

Financial Overview – Q3 2022

Net sales were $76.0 million for the third quarter of 2022, up 30% compared to $58.4 million reported in the prior year quarter. The sales increase was driven by ICL sales and unit growth of 33% and 40%, respectively, as compared to the prior year period. Other Product sales decreased 3% compared to the prior year quarter. ICL sales were 95% of total net sales for the third quarter of 2022. Changes in currency, primarily in the Japanese Yen as well as the Euro, negatively impacted reported total net sales by $4.0 million for the third quarter of 2022.

Gross profit margin for the third quarter of 2022 was 79.5% compared to the prior year quarter of 77.6%. Factors impacting gross margin in the third quarter of 2022, as compared to the prior year quarter, due mainly to product and geographic mix, partially offset by increased period costs associated with manufacturing projects.

Operating expenses for the third quarter of 2022 were $46.8 million compared to the prior year quarter of $37.5 million. General and administrative expenses were $14.0 million compared to the prior year quarter of $11.0 million. The increase in general and administrative expenses was due to compensation related expenses, increased facilities costs and outside services. Selling and marketing expenses were $23.1 million compared to the prior year quarter of $18.2 million. The increase in selling and marketing expenses is due to increased trade shows and sales meetings, advertising and promotional activities, travel expenses and compensation related expenses. Research and development expenses were $9.6 million compared to the prior year quarter of $8.3 million due to increased compensation related expenses.

Net income for the third quarter of 2022 was $10.3 million or $0.21 per diluted share compared with net income of $6.0 million or $0.12 per diluted share for the prior year quarter. The year over year increase is attributable to higher sales and gross profit and, as a percentage of sales, lower operating expenses. Adjusted Net Income for the third quarter of 2022 was $18.1 million or $0.37 per diluted share compared to $10.3 million or $0.21 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 30, 2022 totaled $224.7 million compared to $199.7 million at December 31, 2021.

Conference Call

The Company will host a conference call and webcast today, Wednesday, November 2 at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and operational progress. To access the conference call (Access Code 976076), please dial 844-200-6205 for domestic participants and 929-526-1599 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 710361) will be available beginning approximately one hour after the call's conclusion for seven days. This replay can be accessed by dialing 866-813-9403 for domestic callers and 929-458-6194 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. "Adjusted Net Income" excludes the following items that are included in "Net Income" as calculated in accordance with U.S. generally accepted accounting principles ("GAAP"): gain or loss on foreign currency transactions, stock-based compensation expenses, and valuation allowance adjustments. Management believes that "Adjusted Net Income" is 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 also excluded 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 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 with companion delivery systems. 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 2,000,000 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 (including sales), plans, strategies, and objectives of management for 2022, 2023, or prospects for achieving such plans, expectations for sales, revenue, margin, expenses or earnings, the expected impact of the COVID-19 pandemic and related public health measures (including but not limited to its impact on sales, operations or clinical trials globally), product safety or effectiveness, the status of our current and pipeline of ICL products with regulators, and any statements of assumptions underlying any of the foregoing, including those relating to our current and pipeline of ICL products and market expansion activities. 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 31, 2021 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 approval, or to take enforcement action; international trade disputes; and the willingness of surgeons and patients to adopt a new or improved product and procedure.

Consolidated Balance Sheets
(in 000's)
Unaudited

	September 30, 2022			December 31, 2021
ASSETS	September 30, 2022			December 31, 2021
Current assets:
Cash and cash equivalents	$	129,242		$	199,706
Investments available for sale		82,091			-
Accounts receivable trade, net		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



Stockholders' equity:
Common stock		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

Consolidated Statements of Income
(In 000's except for per share data)
Unaudited


	Three Months Ended															Nine Months Ended
	% of		September 30, 2022			% of		October 1, 2021			Fav (Unfav)					% of		September 30, 2022			% of		October 1, 2021			Fav (Unfav)
	Sales		September 30, 2022			Sales		October 1, 2021			Amount			%		Sales		September 30, 2022			Sales		October 1, 2021			Amount			%
Net sales	100.0	%	$	76,046		100.0	%	$	58,352		$	17,694		30.3	%	100.0	%	$	220,347		100.0	%	$	171,471		$	48,876		28.5	%

Cost of sales	20.5	%		15,584		22.4	%		13,051			(2,533	)	-19.4	%	21.2	%		46,749		22.1	%		37,825			(8,924	)	-23.6	%

Gross profit	79.5	%		60,462		77.6	%		45,301			15,161		33.5	%	78.8	%		173,598		77.9	%		133,646			39,952		29.9	%

Selling, general and administrative expenses:
General and administrative	18.4	%		14,011		18.9	%		11,018			(2,993	)	-27.2	%	18.1	%		39,934		19.0	%		32,671			(7,263	)	-22.2	%
Selling and marketing	30.4	%		23,130		31.1	%		18,175			(4,955	)	-27.3	%	29.3	%		64,633		29.3	%		50,229			(14,404	)	-28.7	%
Research and development	12.7	%		9,616		14.2	%		8,271			(1,345	)	-16.3	%	12.0	%		26,193		14.5	%		24,790			(1,403	)	-5.7	%
Total selling, general, and administrative expenses	61.5	%		46,757		64.2	%		37,464			(9,293	)	-24.8	%	59.4	%		130,760		62.8	%		107,690			(23,070	)	-21.4	%

Operating income	18.0	%		13,705		13.4	%		7,837			5,868		74.9	%	19.4	%		42,838		15.1	%		25,956			16,882		65.0	%

Other expense, net:
Interest income (expense), net	1.2	%		897		0.0	%		(23	)		920		4000.0	%	0.4	%		934		0.0	%		(35	)		969		2768.6	%
Loss on foreign currency transactions	-2.8	%		(2,129	)	-1.1	%		(610	)		(1,519	)	-249.0	%	-2.2	%		(4,904	)	-1.2	%		(2,040	)		(2,864	)	-140.4	%
Royalty income	0.1	%		77		0.3	%		185			(108	)	-58.4	%	0.2	%		527		0.3	%		496			31		6.3	%
Other income (expense), net	0.0	%		27		0.0	%		(13	)		40		307.7	%	0.1	%		178		0.0	%		(47	)		225		478.7	%
Total other expense, net	-1.5	%		(1,128	)	-0.8	%		(461	)		(667	)	-144.7	%	-1.5	%		(3,265	)	-0.9	%		(1,626	)		(1,639	)	-100.8	%

Income before provision for income taxes	16.5	%		12,577		12.6	%		7,376			5,201		70.5	%	17.9	%		39,573		14.2	%		24,330			15,243		62.7	%

Provision for income taxes	3.0	%		2,315		2.3	%		1,356			(959	)	-70.7	%	3.0	%		6,671		2.8	%		4,751			(1,920	)	-40.4	%

Net income	13.5	%	$	10,262		10.3	%	$	6,020		$	4,242		70.5	%	14.9	%	$	32,902		11.4	%	$	19,579		$	13,323		68.0	%


Net income per share - basic			$	0.21				$	0.13									$	0.69				$	0.42
Net income per share - diluted			$	0.21				$	0.12									$	0.67				$	0.40

Weighted average shares outstanding - basic				48,102					47,483										47,915					47,064
Weighted average shares outstanding - diluted				49,549					49,592										49,371					49,448

Consolidated Statements of Cash Flows
(in 000's)
Unaudited

		Three Months Ended						Nine Months Ended
		September 30, 2022			October 1, 2021			September 30, 2022			October 1, 2021
		September 30, 2022			October 1, 2021			September 30, 2022			October 1, 2021
Cash flows from operating activities:
Net income		$	10,262		$	6,020		$	32,902		$	19,579
Adjustments to reconcile net income to net cash provided by operating activities:
	Depreciation of property and equipment		1,077			917			3,101			2,671
	Amortization of long-lived intangibles		7			9			22			26
	Accretion/Amortization of investments available for sale		(307	)		-			(307	)		-
	Deferred income taxes		23			-			23			845
	Change in net pension liability		(12	)		118			40			91
	Stock-based compensation expense		5,727			3,663			15,375			10,985
	Loss on disposal of property and equipment		-			-			-			2
	Provision for sales returns and bad debts		(439	)		137			361			1,069
	Inventory provision		592			400			2,020			1,097
Changes in working capital:
	Accounts receivable		7,029			6,725			(13,108	)		(7,072	)
	Inventories		(2,298	)		(937	)		(4,123	)		1,301
	Prepayments, deposits and other current assets		2,786			1,595			526			1,288
	Accounts payable		(5,077	)		228			(1,834	)		(40	)
	Other current liabilities		4,739			3,441			(2,253	)		3,622
	Net cash provided by operating activities		24,109			22,316			32,745			35,464

Cash flows from investing activities:
	Acquisition of property and equipment		(6,273	)		(3,273	)		(14,083	)		(8,956	)
	Purchase of investments available for sale		(95,576	)		-			(95,576	)		-
	Net cash used in investing activities		(101,849	)		(3,273	)		(109,659	)		(8,956	)

Cash flows from financing activities:
	Repayment of finance lease obligations		(40	)		(36	)		(85	)		(314	)
	Proceeds from vested restricted stock and exercise of stock options		5,034			4,212			8,180			18,323
	Net cash provided by financing activities		4,994			4,176			8,095			18,009

Effect of exchange rate changes on cash and cash equivalents			(502	)		(56	)		(1,645	)		(724	)

Increase (decrease) in cash and cash equivalents			(73,248	)		23,163			(70,464	)		43,793
Cash and cash equivalents, at beginning of the period			202,490			173,083			199,706			152,453
Cash and cash equivalents, at end of the period		$	129,242		$	196,246		$	129,242		$	196,246

Reconciliation of Non-GAAP Financial Measure
Adjusted Net Income and Net Income Per Share
(in 000's)
Unaudited	Three Months Ended				Nine Months Ended
	September 30, 2022		October 1, 2021		September 30, 2022		October 1, 2021
	September 30, 2022		October 1, 2021		September 30, 2022		October 1, 2021
Net income (as reported)	$	10,262	$	6,020	$	32,902	$	19,579
Less:
Foreign currency impact		2,129		610		4,904		2,040
Stock-based compensation expense		5,727		3,663		15,375		10,985
Valuation allowance adjustment		-		-		-		845
Net income (adjusted)	$	18,118	$	10,293	$	53,181	$	33,449

Net income per share, basic (as reported)	$	0.21	$	0.13	$	0.69	$	0.42
Foreign currency impact		0.05		0.01		0.10		0.04
Stock-based compensation expense		0.12		0.08		0.32		0.23
Valuation allowance adjustment		-		-		-		0.02
Net income per share, basic (adjusted)	$	0.38	$	0.22	$	1.11	$	0.71

Net income per share, diluted (as reported)	$	0.21	$	0.12	$	0.67	$	0.40
Foreign currency impact		0.04		0.01		0.10		0.04
Stock-based compensation expense		0.12		0.08		0.31		0.22
Valuation allowance adjustment		-		-		-		0.02
Net income per share, diluted (adjusted)	$	0.37	$	0.21	$	1.08	$	0.68

Weighted average shares outstanding - Basic		48,102		47,483		47,915		47,064
Weighted average shares outstanding - Diluted		49,549		49,592		49,371		49,448

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

STAAR Surgical Company
Reconciliation of Non-GAAP Financial Measure
Constant Currency Sales
(in 000's)
Unaudited

	Three Months Ended
	September 30, 2022		Effect of Currency		Constant Currency		October 1, 2021		As Reported					Constant Currency
Sales	September 30, 2022		Effect of Currency		Constant Currency		October 1, 2021		$ Change			% Change		$ Change			% Change
ICL	$	71,953	$	3,210	$	75,163	$	54,153	$	17,800		32.9	%	$	21,010		38.8	%

Cataract IOL		2,191		484		2,675		2,525		(334	)	-13.2	%		150		5.9	%
Other		1,902		284		2,186		1,674		228		13.6	%		512		30.6	%
Other Products		4,093		768		4,861		4,199		(106	)	-2.5	%		662		15.8	%

Total Sales	$	76,046	$	3,978	$	80,024	$	58,352	$	17,694		30.3	%	$	21,672		37.1	%

	Nine Months Ended
	September 30, 2022		Effect of Currency		Constant Currency		October 1, 2021		As Reported					Constant Currency
Sales	September 30, 2022		Effect of Currency		Constant Currency		October 1, 2021		$ Change			% Change		$ Change			% Change
ICL	$	208,550	$	7,166	$	215,716	$	159,889	$	48,661		30.4	%	$	55,827		34.9	%

Cataract IOL		7,640		1,137		8,777		9,324		(1,684	)	-18.1	%		(547	)	-5.9	%
Other		4,157		721		4,878		2,258		1,899		84.1	%		2,620		116.0	%
Other Products		11,797		1,858		13,655		11,582		215		1.9	%		2,073		17.9	%

Total Sales	$	220,347	$	9,024	$	229,371	$	171,471	$	48,876		28.5	%	$	57,900		33.8	%

View source version on businesswire.com: https://www.businesswire.com/news/home/20221102005910/en/

STAAR Surgical Reports Third Quarter Net Sales of $76 Million Up 30% Y/Y