UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 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): April 10,
2010
STAAR Surgical
Company
(Exact
name of registrant as specified in its charter)
|
Delaware
|
|
0-11634
|
|
95-3797439
|
|
(State or other jurisdiction
|
|
(Commission File Number)
|
|
(I.R.S. Employer
|
|
of incorporation)
|
|
|
|
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 below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
¨ Written
communications 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
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item
2.02 Results of Operations and Financial Condition.
In
connection with the annual conference of the American Society of Cataract and
Refractive Surgery, being held in Boston, Massachusetts, the President and
Chief Executive Officer of STAAR Surgical Company ("STAAR"), Barry Caldwell, conducted a breakfast meeting with
investors and potential investors in STAAR on April 10, 2010. A copy
of a slide presentation (the "Slide Presentation") used by Mr. Caldwell in these discussions, which
includes selected preliminary financial information for the quarter ended
April 2, 2010, is attached to this Report as Exhibit 99.1 and is
incorporated herein by this reference.
On
April 12, 2010, STAAR published a press
release (the "Press Release") that includes selected preliminary financial information for the quarter
ended April 2, 2010, a copy of which is attached to this Report as Exhibit
99.1 and is incorporated herein by this reference.
Item
7.01 Regulation FD Disclosure.
The
information contained in the Slide Presentation and the Press Release is also
being furnished in this Report pursuant to Regulation FD.
Safe
Harbor
The
financial information furnished in this Report for the quarter ended April 2,
2010 is preliminary and remains subject to review by STAAR’s independent
registered public accountants. Final financial information for the quarter,
which STAAR will report in its Quarterly Report on Form 10-Q, may
differ.
All
statements in this Report that are not statements of historical fact are
forward-looking statements, including statements about any of the following:
STAAR’s possible achievement of profitability, projections of earnings; revenue;
sales; cash or any other financial items; the plans, strategies, and objectives
of management for future operations or prospects for achieving such plans;
prospects for any product approval, including approval of the Visian Toric ICL
in the U.S.; the outcome of plans to develop accommodating lenses or other
products; the financial effect of the Domilens divestiture; statements of
belief; and any statements of assumptions underlying any of the
foregoing.
These
statements are based on expectations and assumptions as of the date of this
Report 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: our history of
losses, the negative effect of the global recession on sales of products,
especially products such as the ICL used in non-reimbursed elective procedures;
the challenge of managing our foreign subsidiaries; the risk that sales of our
newly introduced products may not restore profitability to our U.S. IOL product
line; the risk that clinical research into the accommodating power of the
nanoFLEX lens may not confirm early results and we may be unable to add a new
claim to our labeling, the discretion of the FDA and other regulators in
approving new products and the risk that they will not approve our new products,
our ability to overcome negative publicity resulting from warning letters and
other correspondence from the FDA Office of Compliance and to demonstrate to the
agency that its past concerns have been resolved; the willingness of surgeons
and patients to adopt a new product and procedure; and the potential effect of
recent negative publicity about LASIK on the demand for refractive surgery in
general in the U.S. STAAR assumes no obligation to update its forward-looking
statements to reflect future events or actual outcomes and does not intend to do
so.
SIGNATURES
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.
|
April 12,
2010
|
STAAR
Surgical Company
|
|
|
|
|
|
|
By:
|
/s/
Barry Caldwell
|
|
|
|
Barry
Caldwell
|
|
|
|
President
and Chief Executive Officer
|
Exhibit Index
|
Exhibit
No.
|
|
Description
|
|
99.1
|
|
Slide
Presentation dated April 10, 2010.
|
|
99.2
|
|
Press
release dated April 12,
2010.
|