0001564590-22-000788.txt : 20220110 0001564590-22-000788.hdr.sgml : 20220110 20220110090106 ACCESSION NUMBER: 0001564590-22-000788 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20220110 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220110 DATE AS OF CHANGE: 20220110 FILER: COMPANY DATA: COMPANY CONFORMED NAME: STAAR SURGICAL CO CENTRAL INDEX KEY: 0000718937 STANDARD INDUSTRIAL CLASSIFICATION: OPHTHALMIC GOODS [3851] IRS NUMBER: 953797439 STATE OF INCORPORATION: DE FISCAL YEAR END: 0101 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-11634 FILM NUMBER: 22519957 BUSINESS ADDRESS: STREET 1: 1911 WALKER AVE CITY: MONROVIA STATE: CA ZIP: 91016 BUSINESS PHONE: 6263037902 MAIL ADDRESS: STREET 1: 1911 WALKER AVE CITY: MONROVIA STATE: CA ZIP: 91016 FORMER COMPANY: FORMER CONFORMED NAME: STAAR SURGICAL COMPANY DATE OF NAME CHANGE: 19920703 8-K 1 staa-8k_20220110.htm 8-K staa-8k_20220110.htm
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

FORM 8-K

 

CURRENT REPORT

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

 

Date of report (Date of earliest event reported): January 10, 2022

 

 

STAAR Surgical Company

(Exact Name of Registrant as Specified in Charter)

 

 

Delaware

0-11634

95-3797439

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

 

25651 Atlantic Ocean Drive.,

Lake Forest, California

 

92630

(Address of Principal Executive Offices)

 

(Zip Code)

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

Not Applicable

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

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

 

☐

Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common

STAA

NASDAQ

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

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

Item 2.02 Results of Operations and Financial Condition.

On January 10, 2022, STAAR Surgical Company (the “Company”) published a press release reporting selected preliminary financial results for the quarter and fiscal year ended December 31, 2021, a copy of which is furnished as Exhibit 99.1 to this Report and is incorporated herein by this reference. The financial information is unaudited and subject to adjustment in the final audited financial statements to be filed with the Company’s Annual Report on Form 10-K. The Company expects to report its complete 2021 financial results on its fourth-quarter and full-year earnings call, which it will hold later in the first quarter of 2022.

 

 

The information furnished herewith pursuant to Item 2.02 of this Current Report, including Exhibit 99.1 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 Item 2.02 of this Current Report 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 Current Report, regardless of any general incorporation language in the filing.

 

 

Item 9.01 Financial Statements and Exhibits

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release of the Company dated January 10, 2022.

 

 

 

104

 

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

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

STAAR Surgical Company 

 

January 10, 2022

By:

/s/ Caren Mason

 

 

Caren Mason

 

 

President and Chief Executive Officer

 

 

 

 EX-99.1 2 staa-ex991_7.htm EX-99.1 staa-ex991_7.htm

Exhibit 99.1

STAAR Surgical Announces Preliminary Fourth Quarter and Full Year 2021 Results

Achieves 40% Growth Y/Y with Full Year 2021 Net Sales of Approximately $230 Million

Fourth Quarter Net Sales Approximately $59 Million

 

LAKE FOREST, CA, January 10, 2022--- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, today provided preliminary results for the fourth quarter and fiscal year ended December 31, 2021. The Company expects total net sales for the fourth quarter to be approximately $59 million and full year net sales to be approximately $230 million. GAAP earnings per share is expected to be approximately $0.10 for the fourth quarter and approximately $0.50 for the fiscal year ended December 31, 2021.

 

“STAAR’s preliminary sales results for fiscal 2021 highlight the robust demand for our lenses as our ICLs are elevated within the ophthalmic community. For fiscal 2021 we achieved 40% growth in net sales year over year. ICL units for the fourth quarter of fiscal 2021 were up 36% globally, year over year, including China up 44%, Japan up 45%, South Korea up 35% and India up 74% with growth partially moderated by an increasing number of Covid cases in Europe,” said Caren Mason, President and CEO of STAAR Surgical.

 

“During the second half of 2021, production output was lower than planned due to Covid-related employee absences, modest supply chain challenges and throughput running lower than plan. This resulted in a continuing backlog of over 20,000 lenses in house, mostly made-to-order toric lenses, that usually would have shipped in the prescribed timeframe. We are committed to continuing to push hard to overcome these challenges and are doubling the footprint at our principal manufacturing facility through movement of non-production floor space requirements to other facilities. We are also purchasing and upgrading our tooling and systems to dovetail with the expansion. As we look forward in 2022, we remain focused on advancing our strong growth trajectory for our EVO ICL lenses. In the U.S. our submission of clinical data for STAAR’s EVO ICL family of myopia lenses remains under customary interactive FDA review. For fiscal 2022, we anticipate our net sales will grow to approximately $295 million subject to no unforeseen impact from Covid on our business.”

 

STAAR expects to report complete fourth quarter and fiscal year results on or about February 23 and provided today’s information due to investor meetings taking place January 10-11, 2022. The financial information in this release is unaudited and subject to adjustment in the final audited financial statements to be filed with the Company’s Annual Report on Form 10-K.

 

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 and STAAR markets these lenses in over 75 countries. To learn more about the ICL go to: www.discovericl.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 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 pipeline of ICL products with regulators, including our EVO family of lenses in the U.S., 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 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 January 1, 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. The EVO version of our ICL lens is not yet approved for sale in the United States.

 

 

CONTACT:Investors & Media

Brian Moore

Vice President, Investor, Media Relations and Corporate Development

(626) 303-7902, Ext. 3023

bmoore@staar.com

 

 

 

 

 

 

2

 

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Document And Entity Information
Jan. 10, 2022
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Jan. 10, 2022
Entity Registrant Name STAAR Surgical Co
Entity Central Index Key 0000718937
Entity Emerging Growth Company false
Entity File Number 0-11634
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 95-3797439
Entity Address, Address Line One 25651 Atlantic Ocean Drive
Entity Address, City or Town Lake Forest
Entity Address, State or Province CA
Entity Address, Postal Zip Code 92630
City Area Code 626
Local Phone Number 303-7902
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of each class Common
Trading Symbol(s) STAA
Name of each exchange on which registered NASDAQ
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