8-K

UNITED STATES

SECURITIES AND EXCHANGECOMMISSION

WASHINGTON, DC20549

FORM 8-K

CURRENT REPORT Pursuant to Section13 or15(d) ofthe Securities ExchangeAct of1934

Dateofreport(Dateofearliest event reported): May 1, 2019

STAAR Surgical Company

(ExactNameofRegistrantasSpecifiedinCharter)

Delaware	0-11634	95-3797439
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
1911 Walker Ave., Monrovia, California		91016
(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)

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Item 7.01 Regulation FD Disclosure.

On May 1, 2019, STAAR Surgical Company (the “Company”) published a press release reporting its financial results for the quarter ended March 29, 2019, a copy of which is furnished as Exhibit 99.1 to this report and is incorporated herein by this reference.

On May 1, 2019, the Company also issued a press release announcing that refractive ophthalmic societies in Germany and Japan have increased the diopter range for recommended use of phakic refractive lenses, including the EVO Visian ICL, to -3.0 diopters from -6.0 diopters. A copy of the press release is furnished as Exhibit 99.2 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 May 1, 2019.
99.2	Press release of the Company dated May 1, 2019.

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
May 1, 2019	By:	/s/ Caren Mason
		Caren Mason
		President and Chief Executive Officer

EX-99.1

Exhibit 99.1

STAAR Surgical Reports First Quarter Results

ICL Units Up 39% Resulting in Seventh Consecutive Quarter of Significant Growth  

Earnings per Share of $0.03

Announces U.S. Surgeons Summit

LAKE FOREST, CA, May 1, 2019---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 first quarter ended March 29, 2019.

First Quarter 2019 Overview

• Net Sales of $32.6 Million Up 20% from the Prior Year Quarter

• ICL Sales Up 31% and Units Up 39% from the Prior Year Quarter

• ICL Sales Up 34% and Net Sales Up 23% on a Constant Currency Basis from the Prior Year Quarter

• Gross Margin at 74.2% Up 250 Basis Points from the Prior Year Quarter

• First Quarter Net Income of $0.03 per Share vs. Prior Year Net Income of $0.01 per Share

• Cash, Cash Equivalents and Restricted Cash Ended the Quarter at $102.2 Million

“Our ICL family of lenses continue to grow at rates significantly above reported growth for the Ophthalmic Refractive sector,” said Caren Mason, President and CEO of STAAR Surgical. “Total ICL units grew 39% globally in the first quarter including 86% growth in Japan, 62% in Korea, 56% in China, 27% in Germany and 23% in India as compared to the prior year quarter. As we recognize and appreciate seven quarters of strong double digit ICL sales and unit growth, we anticipate the strong future our product pipeline and market expansion should provide. The U.S. is one of many markets with significant potential for the ICL and we are pleased to announce our inaugural invitation only U.S. Surgeons Summit. This summer weekend summit will bring together key ophthalmic opinion leaders and executives for educational, podium and panel participation and a thoughtful exchange of ideas as we execute our path forward in the U.S. Joining the U.S. contingent will be top surgeons from China, Japan and Germany who will share their clinical pathways, learnings, and business models to a new ICL continuum of visual freedom care and economic expansion. We are delighted to report the initial response to our surgeon outreach has been very strong with U.S. refractive surgeon opinion leaders leading educational sessions and surgeons from the largest refractive markets in the U.S. participating.”  

Financial Overview – Q1 2019

Net sales were $32.6 million for the first quarter of 2019, up 20% compared to $27.1 million reported in the prior year quarter. The sales increase was driven by ICL revenue and unit growth of 31% and 39%, respectively.  Other Product Sales decreased 19% compared to the prior year quarter. Currency, primarily the Euro, negatively impacted Net Sales by approximately $0.7 million in the first quarter. Adjusting for the impact of Currency, Net sales in the first quarter of 2019 were $33.3 million, representing 23% growth over the prior year quarter.

Gross profit margin for the first quarter of 2019, was 74.2% compared to the prior year period of 71.7%.  The 250 basis point increase in gross profit margin for the quarter is due to favorable product mix resulting from increased sales of ICLs and decreased sales of injector parts and lower unit costs, partially offset by the effect of lower average selling prices (ASPs) for lower diopter ICLs and large volume commitment strategic partners.

1

Exhibit 99.1

Operating expenses for the quarter were $22.6 million compared to the prior year quarter of $18.6 million.  General and administrative expenses were $6.8 million compared to the prior year quarter of $5.8 million.  The increase in general and administrative expenses was due to increased headcount and salary-related expenses including stock-based compensation and increased facility costs.  Marketing and selling expenses were $10.1 million compared to the prior year quarter of $7.5 million.  The increase in marketing and selling expenses was due to increased headcount and salary-related expenses including stock-based compensation, increased travel expenses and continued investments in digital, strategic, and consumer marketing.  Research and development expenses were $5.6 million compared to the prior year quarter of $5.4 million.  

Net income for the first quarter of 2019 was $1.4 million or approximately $0.03 per share compared with net income of $0.6 million or $0.01 per share for the prior year quarter.  Non-GAAP Adjusted Net Income for the first quarter of 2019 was $4.3 million or $0.09 per share compared to $2.0 million or $0.05 per 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 restricted cash at March 29, 2019 totaled $102.2 million, compared to $104.0 million at the end of the fourth quarter of 2018.  The Company generated $0.7 million in cash from operations in the first quarter.

Conference Call

The Company will host a conference call and webcast today, Wednesday, May 1, 2019 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 2299537), please dial 855-765-5684 for domestic participants and 262-912-6252 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 (Conference ID 2299537) will be available beginning approximately one hour after the call’s conclusion for seven days. This replay can be accessed by dialing 855-859-2056 for domestic callers and 404-537-3406 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” and “Adjusted Net Income Per Share” exclude 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 and stock-based compensation expenses.  Management believes that “Adjusted Net Income” and “Adjusted Net Income Per Share” 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 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.  In calculating Adjusted Net Income and Adjusted Net Income Per Share, STAAR excludes these expenses because they are non-cash expenses and because of the complexity and 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.

About STAAR Surgical

STAAR, which has been dedicated solely to ophthalmic surgery for over 30 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 Visian ICL™ product line. More than 1,000,000 Visian ICLs have been implanted to date. To learn more about the ICL go to: www.discovericl.com.  STAAR markets lenses in over 75 countries and had approximately 475 full-time equivalent employees at December

2

Exhibit 99.1

28, 2018. Headquartered in Lake Forest, CA, the company operates manufacturing facilities in Aliso Viejo, CA and Monrovia, CA. For more information, please visit the Company’s website at www.staar.com.

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: any financial projections, including those relating to the plans, strategies, and objectives of management for 2019 or prospects for achieving such plans, expectations for sales, revenue, or earnings, product safety or effectiveness, and any statements of assumptions underlying any of the foregoing, including those relating to our product pipeline and market expansion activities. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in the Company’s Annual Report on Form 10-K for the year ended December 28, 2018 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 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; potential international trade disputes; and the willingness of surgeons and patients to adopt a new or improved product and procedure. The Visian ICL with CentraFLOW, now known as EVO Visian ICL, is not yet approved for sale in the United States.

CONTACT:Investors & Media

Brian Moore

Sr. Director, Investor, Media Relations and Corporate Development

(626) 303-7902, Ext. 3023

bmoore@staar.com

3

Exhibit 99.1

Consolidated Balance Sheets
(in 000's)
Unaudited
ASSETS	March 29, 2019			December 28, 2018
Current assets:
Cash and cash equivalents	$	102,111		$	103,877
Accounts receivable trade, net		26,601			25,946
Inventories, net		16,439			16,704
Prepayments, deposits, and other current assets		7,534			5,045
Total current assets		152,685			151,572
Property, plant, and equipment, net		11,300			11,451
Finance lease right-of-use assets, net		2,445			-
Operating lease right-of-use assets, net		6,629			-
Intangible assets, net		263			243
Goodwill		1,786			1,786
Deferred income taxes		1,275			1,278
Other assets		836			1,009
Total assets	$	177,219		$	167,339
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Line of credit	$	3,272		$	3,780
Accounts payable		7,018			6,524
Obligations under finance leases		1,158			1,098
Obligations under operating leases		2,495			-
Allowance for sales returns		2,971			2,895
Other current liabilities		11,317			13,431
Total current liabilities		28,231			27,728
Obligations under finance leases		656			459
Obligations under operating leases		4,270			-
Deferred income taxes		1,100			1,022
Asset retirement obligations		206			206
Deferred rent		-			188
Pension liability		5,418			5,310
Total liabilities		39,881			34,913
Stockholders' equity:
Common stock		444			442
Additional paid-in capital		292,722			289,584
Accumulated other comprehensive loss		(1,343	)		(1,320	)
Accumulated deficit		(154,485	)		(156,280	)
Total stockholders' equity		137,338			132,426
Total liabilities and stockholders' equity	$	177,219		$	167,339

4

Exhibit 99.1

Consolidated Statements of Income
(In 000's except for per share data)
Unaudited
	Three Months Ended
	% of			March 29, 2019			% of			March 30, 2018			Fav (Unfav)
	Sales						Sales						Amount			%
Net sales		100.0	%	$	32,583			100.0	%	$	27,093		$	5,490			20.3	%
Cost of sales		25.8	%		8,403			28.3	%		7,662			(741	)		-9.7	%
Gross profit		74.2	%		24,180			71.7	%		19,431			4,749			24.4	%
Selling, general and administrative expenses:
General and administrative		21.0	%		6,837			21.3	%		5,771			(1,066	)		-18.5	%
Marketing and selling		31.1	%		10,143			27.5	%		7,454			(2,689	)		-36.1	%
Research and development		17.3	%		5,635			20.0	%		5,407			(228	)		-4.2	%
Total selling, general, and administrative expenses		69.4	%		22,615			68.8	%		18,632			(3,983	)		-21.4	%
Operating income		4.8	%		1,565			2.9	%		799			766			95.9	%
Other income (expense):
Interest Income (expense), net		0.8	%		271			0.0	%		(12	)		283			2358.3	%
Loss on foreign currency transactions		-0.7	%		(248	)		-0.3	%		(77	)		(171	)		-222.1	%
Royalty income		0.5	%		171			0.6	%		157			14			8.9	%
Other income, net		0.3	%		97			0.1	%		17			80			470.6	%
Total other income, net		0.9	%		291			0.4	%		85			206			242.4	%
Income before provision for income taxes		5.7	%		1,856			3.3	%		884			972			110.0	%
Provision for income taxes		1.5	%		489			1.1	%		301			(188	)		-62.5	%
Net income		4.2	%	$	1,367			2.2	%	$	583		$	784			134.5	%
Net income per share - basic				$	0.03					$	0.01
Net income per share - diluted				$	0.03					$	0.01
Weighted average shares outstanding - basic					44,235						41,410
Weighted average shares outstanding - diluted					46,913						43,087

5

Exhibit 99.1

Consolidated Statements of Cash Flows
(in 000's)
Unaudited
	Three Months Ended
	March 29, 2019			March 30, 2018
Cash flows from operating activities:
Net income	$	1,367		$	583
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation of property and equipment		1,222			549
Amortization of long-lived intangibles		8			9
Deferred income taxes		79			92
Change in net pension liability		119			87
Stock-based compensation expense		2,641			1,301
Loss on disposal of property and equipment		-			6
Provision for sales returns and bad debts		(34	)		514
Inventory provision		455			506
Changes in working capital:
Accounts receivable		(554	)		(2,755	)
Inventories		(7	)		(396	)
Prepayments, deposits and other current assets		(2,317	)		(730	)
Accounts payable		(185	)		2,038
Other current liabilities		(2,063	)		726
Net cash provided by operating activities		731			2,530
Cash flows from investing activities:
Acquisition of property and equipment		(2,203	)		(965	)
Increase in patents and licenses		(30	)		-
Net cash used in investing activities		(2,233	)		(965	)
Cash flows from financing activities:
Repayment on line of credit		(499	)		-
Repayment of finance lease obligations		(365	)		(380	)
Proceeds from vested resricted stock and exercise of stock options		624			454
Net cash provided by (used in) financing activities		(240	)		74
Effect of exchange rate changes on cash, cash equivalents and restricted cash		(24	)		612
(Decrease) increase in cash, cash equivalents and restricted cash		(1,766	)		2,251
Cash, cash equivalents and restricted cash, at beginning of the period		103,999			18,641
Cash, cash equivalents and restricted cash, at end of the period	$	102,233		$	20,892

6

Exhibit 99.1

Global Sales
(in 000's)
Unaudited
	Three Months Ended
				March 29, 2019				March 30, 2018		% Change
Sales by Region										Fav (Unfav)
North America		6.7	%	$	2,198	7.7	%	$	2,079		5.7	%
Europe		21.6	%		7,027	25.8	%		6,990		0.5	%
Middle East, Africa, Latin America		3.8	%		1,238	5.6	%		1,519		-18.5	%
Asia Pacific		67.9	%		22,120	60.9	%		16,505		34.0	%
Total Sales		100.0	%	$	32,583	100.0	%	$	27,093		20.3	%
Core Product Sales
ICLs		85.3	%	$	27,786	78.1	%	$	21,158		31.3	%
Other Product Sales
IOLs		12.3	%		4,017	15.0	%		4,058		-1.0	%
Injector Parts and Other		2.4	%		780	6.9	%		1,877		-58.4	%
Total Other Sales		14.7	%		4,797	21.9	%		5,935		-19.2	%
Total Sales		100.0	%	$	32,583	100.0	%	$	27,093		20.3	%

7

Exhibit 99.1

Reconciliation of Non-GAAP Financial Measure
(in 000's)
Unaudited	Three Months Ended
	March 29, 2019		March 30, 2018
Net income (as reported)	$	1,367	$	583
Less:
Foreign currency impact		248		77
Stock-based compensation expense		2,641		1,301
Net income (adjusted)	$	4,256	$	1,961
Net income per share, basic (as reported)	$	0.03	$	0.01
Foreign currency impact		0.01		-
Stock-based compensation expense		0.06		0.03
Net income per share, basic (adjusted)	$	0.10	$	0.05
Net income per share, diluted (as reported)	$	0.03	$	0.01
Foreign currency impact		0.01		-
Stock-based compensation expense		0.06		0.03
Net income per share, diluted (adjusted)	$	0.09	$	0.05
Weighted average shares outstanding - Basic		44,235		41,410
Weighted average shares outstanding - Diluted		46,913		43,087
Note:  Net income per share (adjusted), basic and diluted, may not add due to rounding

8

EX-99.2

Exhibit 99.2

STAAR Surgical Announces Expanded Recommended Diopter Range for EVO Visian ICL by Refractive Societies in Germany and Japan

LAKE FOREST, CA, May 1, 2019---STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, today announced the leading refractive ophthalmic societies in Germany and Japan have increased the diopter range for recommended use of phakic refractive lenses, including the EVO Visian ICL, to -3.0 diopters from -6.0 diopters. A diopter is a unit of measure of the refractive power of a lens and correlates with the patient’s level of nearsightedness (myopia/distance vision needs).

The German society, the Kommission Refraktive Chirurgie (KRC), meaning Commission of Refractive Surgery, which is a joint commission of two leading German ophthalmic societies, the BVA (Berufsverband der Augenärzte Deutschlands) and the DOG (Deutsche Ophthalmologische Gesellschaft), (i) expanded the recommended range for use of phakic refractive lenses, including the EVO Visian ICL, from -6.0 diopters (KRC’s prior recommendation) to -3.0 diopters, and (ii) expanded the ‘border’ recommended range for use from -3.0 diopters (KRC’s prior recommendation) to -1.0 diopters.  Separately, the Japanese Ophthalmological Society modified its surgical indication criteria for recommended use of phakic intraocular lenses, such as the EVO Visian ICL, from -6.0 diopters to -3.0 diopters.  

Caren Mason, President and CEO of STAAR Surgical, stated, “Germany and Japan are two highly-respected countries known for their high regulatory standards, precision and quality.  Historically, phakic intraocular lenses were reserved for patients with high levels of myopia (greater than or equal to -6.0 diopters) or those patients who did not qualify for corneal refractive procedures such as PRK or LASIK.  We are delighted that these esteemed medical societies have updated their guidelines to reflect their review of contemporary clinical evidence of safety and effectiveness of phakic refractive lenses, including the EVO Visian ICL family of lenses and support its use in patients with moderate levels of myopia, which previously was reserved primarily for corneal refractive procedures.  These recent decisions are consistent with a growing number of ophthalmic refractive surgeons who are selecting EVO lenses as a premium and primary solution for suitable patients with low, moderate or high myopia seeking visual freedom from spectacles and contact lenses.”

“We are pleased with the modified KRC recommendations and see ample growth opportunities in the lower diopter segment of refractive vision correction for the EVO Visian ICL.” said the EVO Visian ICL Expert Group based in Germany.  The group consists of Drs. Martin Bechmann, Johannes Gonnermann, Laszlo Kiraly, Gero Krommes, Tobias Neuhann, and Amir Parasta. “The modifications of KRC recommendations are in line with international practice for the EVO Visian ICL where low diopters are a focus of refractive growth.” said Dr. Alonso Juarez of Spain. "I am pleased that after reviewing the clinical data, the Japanese Ophthalmological Society modified its guideline for use of the EVO Visian ICL to include lower diopters in the -3D to -6D range.  We believe that EVO is an important and useful addition to the refractive options available for these patients in Japan," said Dr. Kazutaka Kamiya of Japan.

These decisions do not change the approved labeling of use in either country; rather, they reflect the contemporary positioning of phakic refractive lenses, such as the EVO Visian ICL family of lenses, for patients with low to moderate myopia (distance vision correction needs).  EVO is the latest version of STAAR Surgical Company’s implantable

1

Collamer® lens (ICL) that works with the patient’s natural eye to correct vision and provide patients visual freedom from spectacles and contact lenses.

About STAAR Surgical

STAAR, which has been dedicated solely to ophthalmic surgery for over 30 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 Visian ICL™ product line. More than 1,000,000 Visian ICLs have been implanted to date. To learn more about the ICL go to: www.discovericl.com.  STAAR markets lenses in over 75 countries and had approximately 475 full-time equivalent employees at December 28, 2018. Headquartered in Lake Forest, CA, the company operates manufacturing facilities in Aliso Viejo, CA and Monrovia, CA. For more information, please visit the Company’s website at www.staar.com.

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: any financial projections, including those relating to growth opportunities, expectations for sales, revenue, or earnings relating to updated recommendations from ophthalmic societies in Germany or Japan, and any statements of assumptions underlying any of the foregoing. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in the Company’s Annual Report on Form 10-K for the year ended December 28, 2018 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 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; potential international trade disputes; and the willingness of surgeons and patients to adopt a new or improved product and procedure. The Visian ICL with CentraFLOW, now known as EVO Visian ICL, is not yet approved for sale in the United States.

CONTACT:Brian Moore

Sr. Director, Investor, Media Relations and Corporate Development

(626) 303-7902, Ext. 3023

bmoore@staar.com