-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, EUQJ7RHlA9L1+R3emqoRuacDmav2XQyZ19NVh8uxwPXgve/BxiCckht7BQ78HODX LQW+Q1vpSEwhwHvyV4kIig== 0001141218-04-000033.txt : 20040401 0001141218-04-000033.hdr.sgml : 20040401 20040401144646 ACCESSION NUMBER: 0001141218-04-000033 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040303 ITEM INFORMATION: ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040401 FILER: COMPANY DATA: COMPANY CONFORMED NAME: STAAR SURGICAL COMPANY 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: 04709164 BUSINESS ADDRESS: STREET 1: 1911 WALKER AVE CITY: MONROVIA STATE: CA ZIP: 91016 BUSINESS PHONE: 8183037902 MAIL ADDRESS: STREET 1: 1911 WALKER AVE CITY: MONROVIA STATE: CA ZIP: 91016 8-K 1 staar0331048k.htm CURRENT REPORT Form 8-K

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):  March 31, 2004

STAAR SURGICAL COMPANY
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of incorporation)

0-11634
(Commission File Number)

95-3797439
(IRS Employer Identification No.)

1911 Walker Avenue
Monrovia, California 91016
(Address of principal executive offices)   (Zip Code)

Registrant's telephone number, including area code:  (626) 303-7902

_____________________________________________________
(Former name or former address, if changed since last report)













Item 7.  Financial Statements and Exhibits.

(c)  Exhibits

Exhibit Number Description
99.1 Press Release dated March 31, 2004.



Item 12.  Results of Operations and Financial Condition.

On March 31, 2004, STAAR Surgical Company issued a press release announcing preliminary estimates of revenue for the first fiscal quarter of 2004. A copy is attached as Exhibit 99.1 to this Report and is incorporated herein by this reference.

The information in this Current Report on Form 8-K, including the exhibit, will not be treated as "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section. This information will not be incorporated by reference into a filing under the Securities Act of 1933, or into another filing under the Exchange Act, unless that filing expressly refers to specific information in this report.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.

Date:  April 1, 2004 STAAR SURGICAL COMPANY
  By:   /s/ John Bily               
        John Bily
        Chief Financial Officer

 

EXHIBIT INDEX

Exhibit Number Description
99.1 Press Release dated March 31, 2004.
EX-99 3 staar0331048kex991.htm PRESS RELEASE SEC EDGAR Document

Exhibit 99.1

 

STAAR Surgical Provides Preliminary First Quarter Revenue Outlook of $13.3 Million to $13.5

Million International Visian(TM) ICL Sales Expected to Grow
Approximately 30% Year-Over-Year

FDA Deems Plan to Address Warning Letter Issues 'Adequate'

STAAR Completes Internal Audit in Preparation for Requesting Re-Audit by FDA

Cash Burn Reduced Significantly

MONROVIA, Calif., March 31 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced preliminary revenue results for the first quarter ending April 2, 2004.

The Company currently expects total revenue for the first quarter to range between $13.3 million and $13.5 million, up four to five percent from the $12.77 million reported in the first quarter of 2003. International sales of the Company's implantable contact lens (ICL), marketed under the Visian brand, are also expected to increase approximately 30% compared with sales during the first quarter of 2003.

"During the quarter we continued to execute well on our plan to grow sales of our innovative ICL, resulting in both sequential and year-over-year revenue growth," said David Bailey, President and CEO of STAAR Surgical. "We believe that the ICL is continuing to take market share in Europe from competing technology. In addition, we have significantly reduced our cash burn in February and March. This reduction and stabilization of our spending should have a positive impact on our cash position this year," Mr. Bailey said.

The Company also announced it has received a formal response from the U.S. Food and Drug Administration (FDA) regarding the Warning Letter received by STAAR on December 29, 2003. In the response, the FDA deemed STAAR's plans to address the issues raised in the letter as "adequate." This plan was developed internally by STAAR and presented to the FDA on January 14, 2003. In an effort to ensure that the Company's response to the FDA's Warning Letter would be as comprehensive as possible, STAAR engaged the services of two outside consulting firms to perform audits on the Company's facilities in Nidau, Switzerland and Monrovia, California. Both of these audits were completed during the first quarter and STAAR is actively pursuing a plan to implement the auditors' suggestions. To assist the Company in completing this process, STAAR has engaged the services of Quintiles Consulting, a firm with in-depth experience in regulatory support, including submissions and communications with Global agencies. This engagement is effective April 1, 2004 and will remain in place through the entire re-audit process to help ensure STAAR's full compliance with the FDA's requirements on a broader basis.

"We have completed a thorough internal audit and believe we are well on the way to fully correct the issues raised by the FDA in the Warning Letter," Mr. Bailey continued. "In addition, with Quintiles' help we are proactively addressing other issues identified in the audits, which go well beyond the boundaries of the FDA's Warning Letter. We believe these issues are correctible over the short term and will issue a press release when we are ready to request a re-audit by the FDA of our Monrovia facility. We will provide a comprehensive update on all of this activity, including our expected timeline for audit of our Swiss facility, during our quarterly conference call to discuss our final first quarter results on April 29, 2004," concluded Mr. Bailey.

About STAAR Surgical

STAAR Surgical is a leader in the development, manufacture and marketing of minimally invasive ophthalmic products employing proprietary technologies. STAAR's products are used by ophthalmic surgeons and include the revolutionary VISIAN ICL(TM) as well as innovative products designed to improve patient outcomes for cataracts and glaucoma. STAAR's ICL has received CE Marking, is approved for sale in 37 countries and has been implanted in more than 35,000 eyes worldwide.

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including any projections of earnings, revenue, or other financial items, any statements of the plans, strategies, and objectives of management for future operations, any statements concerning proposed new products and government approval of new products, services or developments, any statements regarding future economic conditions or performance, 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 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 results of our response to an FDA warning letter, the need to obtain regulatory approval for new products, acceptance of new products by medical practitioners and consumers, the rapid pace of technological change in the ophthalmic industry, general domestic and international economic conditions, access to financing and other factors beyond the control of STAAR Surgical Company, including those detailed from time to time in STAAR Surgical Company's reports filed with the Securities and Exchange Commission. STAAR Surgical Company assumes no obligation to update these forward-looking statements and does not intend to do so.

CONTACT: investors, Douglas Sherk, +1-415-896-6820, or Jennifer Beugelmans,
+1-415-896-6820, or media, Sheryl Seapy, +1-415-272-3323, all of EVC Group, for STAAR Surgical.

SOURCE STAAR Surgical Company Web
Site: http://www.staar.com

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