false STAAR SURGICAL CO 0000718937 0000718937 2020-01-13 2020-01-13

UNITED STATES

SECU RITI ES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pu rsuant to S e ction 13 or 15(d) of t he S ec u rities Exchange Act of 1934

Date of re port (Date of earli est e v e nt r e porte d): January 13, 2020

STAAR Surgical Company

(Exact Na me of Registrant as Specified in Charter)

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)

Check the appropriate box bel ow if the Fo rm 8-K fili ng is i ntended to simultaneously satis fy the filing obligation of the registrant under any of the f ollo w i ng provisions (s ee General Instruction A.2. belo w):

☐ | 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 w h ether the registra nt is an e merg ing gro w th co mpany as defined in Rule 405 of the Sec urities Act of 1 933 (17 CFR §230.405) or Rule 12 b-2 of the Sec urities E x change Act of 1934 (17 CFR §240.12 b-2).

Emer g i ng g row th co m pany ☐

If an e merg ing gro wth co mpany, i ndicate by check mark if t he registrant has elected not to use t he exte nded transition period for compl y i ng w ith any n ew or revised fin a ncial accounting sta ndards provided pursuant to Section 13(a) of the Exch ange Act. ☐

Item 7.01 Regulation FD Disclosure.

On January 13, 2020, STAAR Surgical Company (the “Company”) published a press release reporting selected preliminary financial results for the quarter and fiscal year ended January 3, 2020, 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 2019 financial results on its fourth-quarter and full-year earnings call, which it will hold later in the first quarter of 2020.

On January 13, 2020, the Company issued a press release announcing CE Mark approval from its European Notified Body, DEKRA, expanding the indications of use for the EVO/EVO+ and Visian implantable Collamer lenses (ICL) for myopia and hyperopia, and EVO/EVO+ and Visian toric implantable Collamer lenses for myopia and hyperopia with astigmatism as a supplemental lens in post-cataract IOL (intraocular lens) surgery patients. A copy of the press release is furnished as Exhibit 99.2 to this Report and is incorporated herein by this reference.

Representatives of the Company will give presentations to investors commencing on January 13, 2020. A copy of the slide presentation they will use in their presentations is furnished as Exhibit 99.3 to this Report and is incorporated herein by this reference.

The information furnished herewith pursuant to Item 7.01 of this Current Report, including Exhibits 99.1, 99.2 and 99.3 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 7.01 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 99.2 99.3 |  | Press release of the Company dated January 13, 2020. Press release of the Company dated January 13, 2020. Slide presentation dated January 13, 2020.
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 13, 2020 | By: | /s/ Caren Mason
|  | Caren Mason
|  | President and Chief Executive Officer