0001144204-11-013079.txt : 20110307 0001144204-11-013079.hdr.sgml : 20110307 20110304192642 ACCESSION NUMBER: 0001144204-11-013079 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20110301 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20110307 DATE AS OF CHANGE: 20110304 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: 11666284 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 v213681_8k.htm Unassociated Document
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 1, 2011

 
STAAR Surgical Company
__________________________________________
(Exact name of registrant as specified in its charter)
 
     
Delaware
0-11634
95-3797439
(State or other jurisdiction
(Commission
(I.R.S. Employer
of incorporation)
File Number)
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:
 
o  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o  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.
 
On March 1, 2011, STAAR Surgical Company (the “Company”) published a press release reporting its financial results for the quarter and fiscal year ended December 31, 2010, a copy of which is furnished as Exhibit 99.1 to this report and is incorporated herein by this reference.
 
Item 7.01 Regulation FD Disclosure.
 
Conference Call Regarding Financial Results.  On March 1, 2011, the Company held a conference call to discuss the financial results for the quarter and fiscal year ended December 31, 2010.  An archive of the webcast of the conference call has been posted on the Company’s website at www.staar.com. A transcript of the conference call is furnished as Exhibit 99.2 to this report and is incorporated herein by this reference.
 
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.
 
March 7, 2011
STAAR Surgical Company
     
  By: /s/ Barry Caldwell
    Barry Caldwell
   
President and Chief Executive Officer

 
Exhibit Index
 
Exhibit No.
Description                                                                                     
 
99.1 
Press release of the Company dated March 1, 2011.
 
99.2 
Conference call of the Company held on March 1, 2011.
EX-99.1 2 v213681_ex99-1.htm Unassociated Document
Exhibit 99.1
 
 
STAAR Surgical Reports Fourth Quarter and Full Year 2010 Financial Results

Core Product Revenue Up 10% in 2010
Company Generates Net Income for Full Year, First Time in 11 Years
Visian ICL Revenue Sets Quarterly Record at $6.5 Million; Units Increase by 20%
Gross Margin for the Quarter Expanded to 64.7%, Highest in 11 Years
Cash Position Increases to $9.5 Million

MONROVIA, CA, March 1, 2011 -- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today reported results for the fourth quarter and full year ended December 31, 2010.  Revenue for the fourth quarter increased 8% to $14.4 million, primarily reflecting growth in core product (IOLs and ICLs) revenue of 7%.  The Company generated cash from operations in the fourth quarter of $213,000 and ended the quarter with cash, cash equivalents, and restricted cash of $9.5 million compared to $8.6 million at October 1, 2010.  The net loss for the recent fourth quarter was $691,000, or $0.02 per share, compared with a net loss of $1.5 million, or $0.04 per share, in the same quarter of the prior year.

For the full year 2010, total revenue increased by 8% to $55.0 million compared with 2009, driven by growth in revenue from core products of 10%, while the defocused product revenue declined by 16%.  Due to the divestiture of Domilens in the first quarter of 2010, the Company reported net income for the full year of $53,000.  The Company reported a loss from continuing operations of $4.1 million, or $0.12 per share, in 2010, a 40% improvement over the $6.9 million, or $0.21 per share, loss from continuing operations reported last year.

“The past year was a pivotal one for STAAR, as we have now moved from playing defense to playing offense,” said Barry G. Caldwell, President and CEO.  “Core product revenue increased 10%, continuing operations are cash flow positive, our balance sheet has been stabilized and we continue to address large markets.  In addition, we reported net income in 2010, the first time the Company has achieved profitability for a full year in 11 years.  This reflected the divestiture of our German distribution business early in the year and improvements in the results from continuing operations.”

“Core product revenue growth in the fourth quarter continued to reflect strength in the sales of the Visian ICL, up 13% from the prior year’s fourth quarter, and 16% growth in nanoFLEX IOL revenue,” continued Mr. Caldwell.  “With our continued focus on core product revenues with higher margins, we achieved a gross profit margin of nearly 65% the highest level in 11 years. Additionally, we were cash flow positive during the fourth quarter and our cash position increased by $900,000, to $9.5 million at year end.  These achievements were accomplished despite the continued challenging economy.”
 
 
 

 

“Overall, though we missed on some opportunities during 2010, we are very pleased with the progress we made,” Mr. Caldwell concluded.  “During 2011 our focus will be on growing the ICL franchise at a higher rate than during 2010 as well as becoming consistently cash flow positive and profitable.”

Other key highlights, outside of financial results, for the year include:

·  
Regulatory approval of the Visian ICL in Japan.
·  
CE Mark for the V4b Visian ICL expanded range in Europe.
·  
Divestiture of the German distribution business.
·  
Settlement of all outstanding litigation.
·  
Retirement of 1.7 million preferred shares.
·  
Elimination of virtually all debt with the exception of a line of credit in Japan.
·  
Initiation of direct-to-consumer viral campaign for the Visian ICL with a more traditional direct-to-consumer program for 2011.

Recent Visian Implantable Collamer® Lens (ICL) Highlights

·  
Fourth quarter Visian ICL sales achieved another record of $6.5 million, 13% above the $5.8 million reported for the fourth quarter of 2009.  The growth was attributable to a 20% increase in total unit volume during the quarter, also a new quarterly high. Toric ICL unit volume grew at a rate of 28% while ICL units grew 17%.  The geographical mix in market pricing resulted in a lower rate of growth in total Visian ICL sales as compared to unit growth.
·  
The Visian Toric ICL, which is available in 45 markets, accounted for 39% of total ICL sales in those markets during the quarter and 43% for the full year 2010.  By comparison Toric ICLs were 36% of total ICL sales during the fourth quarter of 2009 and 39% for the full year 2009.
·  
Shipments of the expanded range Visian V4b ICL began during the fourth quarter.  The roll-out started in key European markets with quite encouraging results.  Ten percent of the sales in those markets were in refractive ranges in which the ICL was not previously approved.
·  
Using data from The Global Refractive Surgery Market published by Market Scope in January of 2011, the Visian ICL grew market share in nine of the top ten targeted markets during 2010.
o  
In the Company’s largest market, Korea, the Visian ICL increased to a 12% to 13% share of the total refractive market.  The table below highlights some of the key growth areas during 2010 and which are expected to  provide major growth opportunities during 2011:

Key Markets
Q4 Unit
Growth
2010 Unit
Growth
2010 Procedure
Growth*
Korea
+8%
+11%
+3%
China
+102%
+104%
+24%
India
+70%
+52%
+5%
Singapore
+49%
+101%
NA
Middle East
+30%
+46%
NA

*The Global Refractive Surgery Market by Market Scope, January 2011
 
 
2

 

·  
The status of the regulatory progress for the Toric ICL submissions in the U.S. and Japan is as follows:
o  
In the U.S. we have responded to all questions regarding the submission and are in discussions with the Post Approval Studies section chief regarding the protocol for those studies.
o  
In Japan we continue to respond to outstanding questions to the PMDA.

Recent Intraocular Lens (IOL) Highlights

·  
Fourth quarter IOL sales increased 2% to $7.1 million from the fourth quarter of 2009.
·  
Average selling prices increased 3% in the fourth quarter; volume was flat.
·  
Sales of the nanoFLEX IOL grew 16% during the quarter.
·  
Preloaded IOL sales grew 9%.
·  
Low margin silicone IOL sales declined 28%.
·  
The Company continues to work with the FDA on its submission for the CAST II clinical protocol and the Preloaded Silicone IOL.  Additionally, the Company is pursuing CE Mark approval for the nanoFLEX IOL.

Fourth Quarter Financial Highlights

·  
Total net sales in the fourth quarter increased 8% to $14.4 million from $13.3 million in the fourth quarter of 2009.  Foreign currency changes favorably impacted sales by $359,000. Core product revenue increased 7% in the quarter.
·  
Gross margin increased to 64.7% of revenue from 61.6% of revenue in the fourth quarter of 2009.  The increase is primarily due to decreased inventory provisions, decreased royalty expense, and improved product mix.  These improvements allowed the increase in gross profit dollars to equal the growth in sales of $1.1 million.
·  
Total operating expenses were $10.0 million, an increase of 10.4% over the fourth quarter 2009 total of $9.0 million.  The effect of unfavorable exchange rate changes was approximately $166,000.
-  
General and administrative expenses were essentially unchanged from the prior year’s fourth quarter at $3.8 million.
-  
Sales and marketing expenses were up 18% to $4.7 million as compared to $4.0 million during the fourth quarter of 2009 due to additional headcount in the U.S. direct sales force and increased promotional spending in the U.S. and Japan.
-  
 R&D expenses were basically flat with the fourth quarter of 2009 at $1.5 million.  These expenses increased from the third quarter of 2010 largely due to clinical activities related to the FDA review of the Toric ICL.
·  
Net loss for the fourth quarter of 2010 was $691,000 or $0.02 per share.  For the fourth quarter of 2009, net loss was $1.5 million, or $0.04 per share.
·  
Cash and cash equivalents and restricted cash totaled $9,509,000 compared with $13,726,000 as of January 1, 2010 and $8,624,000 as of October 1, 2010.  STAAR generated cash from operating activities of $213,000 during the fourth quarter of 2010.
 
 
3

 
 
Full Year 2010 Results

·  
Total net sales for 2010 grew 8% to $55.0 million from $51.1 million in 2009.  Core product revenues increased by 10%, while revenue from defocused other products declined by 16%. The effect of foreign exchange on net sales was favorable by approximately $1.2 million.
 
Revenues
2010
% of Total
2009
% of Total
Change
IOLs
$27.6M
50%
$26.3M
52%
+5%
ICLs
$24.3M
44%
$21.0M
41%
+16%
Other
$  3.1M
6%
$  3.7M
7%
(16%)
Total
$55.0M
 
$51.1M
 
+8%

·  
Total Visian ICL units increased 19% compared to 2009.
·  
During 2010, nanoFLEX IOL sales increased 21%.  Preloaded IOL sales grew 10%, reflecting a 28% increase in KS-X Hydrophobic Acrylic Preloaded IOL. Low price silicone IOLs decreased 23% as the Company focuses on more premium IOLs.
·  
Gross margin increased to 63.8% of revenue compared with 61.3% of revenue for 2009.   The increase was primarily due to a decrease in royalty expense and improved product mix.
·  
Total operating expenses were $37.7 million, a 4% increase over 2009 total of $36.2 million.  The unfavorable effect of exchange rate changes was approximately $720,000.
-  
General and administrative expenses decreased by 8% over 2009, primarily reflecting a decline in legal expenses which was partially offset by an increase in compensation and travel.
-  
Sales and marketing expenses were up 12% over 2009 due to higher headcount and travel in the U.S. and Europe and increased promotional activities in the U.S., Europe and Japan.
-  
R&D expense decreased 3% over 2009, reflecting lower legal and depreciation expense.
·  
Other Operating Expenses (Recoveries) of $700,000 were the result of severance costs associated with the non-renewal of an executive employment agreement.
·  
The results for 2010 compared with 2009 are as follows:
-  
Loss from continuing operations was $4.1 million, or $0.12 per share, compared to a loss of $6.9 million, or $0.21 per share, in the prior year.
-  
Income from discontinued operations was $4.2 million, or $0.12 per share, compared to income of $702,000, or $0.02 per share.
-  
Net income of $53,000, or $0.00 per share, compared to a net loss of $6.2 million, or $0.19 per share, last year.
·  
During 2010, the Company used $4.4 million in cash for operating activities which included a $4.0 million litigation settlement payment and $635,000 in cash used by discontinued operations.

All reported results reflect STAAR’s March 2, 2010 divestiture of its German distribution subsidiary, Domilens GmbH.  Operating results reported for both full year 2010 and for the comparative prior year periods include only results from continuing operations and exclude any contribution from Domilens, which the Company has presented in all reported periods as discontinued operations in accordance with U.S. Generally Accepted Accounting Principles (U.S. GAAP).
 
 
4

 

Except where otherwise stated, all financial comparisons in this press release are comparing corresponding periods of 2010 and 2009.

Conference Call

The Company will host a conference call and webcast on Tuesday, March 1, 2011 at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss the Company's fourth quarter and full year financial results, and recent corporate developments. The dial-in number for the conference call is 877-941-6007 for domestic participants and 480-629-9768 for international participants.

A taped replay of the conference call will also be available beginning approximately one hour after the call's conclusion and will be available for seven days. This replay can be accessed by dialing 800-406-7325 for domestic callers and 303-590-3030 for international callers, both using passcode 4411951#. To access the live webcast of the call, go to STAAR's website at www.staar.com. An archived webcast will also be available at www.staar.com.

About STAAR Surgical
 
STAAR, which has been dedicated solely to ophthalmic surgery for over 25 years, designs, develops, manufactures and markets implantable lenses for the eye.  All of these lenses are foldable, which permits the surgeon to insert them through a small incision.  A lens used to replace the natural lens after cataract surgery is called an intraocular lens or “IOL.”  A lens used in refractive surgery as an alternative to LASIK is called an Implantable Collamer® Lens or “ICL.”  Over 200,000 Visian ICLs have been implanted to date; to learn more about the ICL go to: www.visianinfo.com.  STAAR has approximately 300 full time employees and markets lenses in approximately 50 countries.  Headquartered in Monrovia, CA, it manufactures in the following locations: Nidau, Switzerland; Ichikawa City, Japan; Aliso Viejo, CA; and Monrovia, CA.  For more information, please visit the Company’s website at www.staar.com or call 626-303-7902.
 
Collamer® is the registered trademark for STAAR’s proprietary biocompatible collagen copolymer lens material.
 
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: 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 increased Visian ICL sales as a result of the expanded range of correction in certain regions, advertising campaigns or any of our other initiatives; prospects for any product approval, including approval of the Visian Toric ICL in the U.S. or Japan; the outcome of our development and clinical research plans;  statements of belief; and any statements of assumptions underlying any of the foregoing.
 
 
5

 

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: our limited capital resources and limited access to financing; the negative effect of the global recession on sales of products, especially products such as the ICL used in non-reimbursed elective procedures; the risk that our increased expenditure on U.S. sales resources may not yield substantial new revenues; the challenge of managing our foreign subsidiaries; the risk of unfavorable changes in currency exchange rate; the risk that improved sales in our U.S. IOL product line may not be sustainable; the risk that efforts to develop new products, such as accommodating lenses, may not be successful; the broad discretion of regulators in approving medical devices in our major markets; the willingness of surgeons and patients to adopt a new product and procedure; patterns of Visian ICL use that have typically limited our penetration of the refractive surgery market, and a general decline in the demand for refractive surgery, which STAAR believes has resulted from both concerns about the safety and effectiveness of laser procedures and current economic conditions.
 
CONTACT: Investors Media
  EVC Group EVC Group
  Jenifer Kirtland, 415-896-6820 Christopher Gale, 646-201-5431
  Douglas Sherk, 415-896-6820  
 
 
6

 
 
STAAR Surgical Company
Condensed Consolidated Statements of Operations
(In 000's except for per share data)
Audited
 
 
    
Three Months Ended
   
Year Ended
 
   
% of
   
December 31,
   
% of
   
January 1,
   
Change
   
% of
   
December 31,
   
% of
   
January 1,
   
Change
 
   
Sales
   
2010
   
Sales
   
2010
   
Amount
   
%
   
Sales
   
2010
   
Sales
   
2010
   
Amount
   
%
 
                                                                         
Net sales
    100.0 %   $ 14,389       100.0 %   $ 13,289     $ 1,100       8.3 %     100.0 %   $ 54,958       100.0 %   $ 51,060     $ 3,898       7.6 %
                                                                                                 
Cost of sales
    35.3 %     5,081       38.4 %     5,104       (23 )     -0.5 %     36.2 %     19,882       38.7 %     19,737       145       0.7 %
                                                                                                 
Gross profit
    64.7 %     9,308       61.6 %     8,185       1,123       13.7 %     63.8 %     35,076       61.3 %     31,323       3,753       12.0 %
                                                                                                 
Selling, general and administrative expenses:
                                                                                         
General and administrative
    26.6 %     3,831       28.9 %     3,843       (12 )     -0.3 %     25.6 %     14,078       29.9 %     15,247       (1,169 )     -7.7 %
Marketing and selling
    32.4 %     4,659       29.7 %     3,950       709       17.9 %     31.3 %     17,176       30.0 %     15,300       1,876       12.3 %
Research and development
    10.5 %     1,506       11.3 %     1,498       8       0.5 %     10.4 %     5,724       11.5 %     5,893       (169 )     -2.9 %
Other general and administrative expenses (recoveries), net
    0.0 %     -       -1.8 %     (238 )     238       0.0 %     1.3 %     700       -0.5 %     (238 )     938       0.0 %
                                                                                                 
Total selling, general and administrative expenses
    69.5 %     9,996       68.1 %     9,053       943       10.4 %     68.6 %     37,678       70.9 %     36,202       1,476       4.1 %
                                                                                                 
Operating loss
    -4.8 %     (688 )     -6.5 %     (868 )     180       -20.7 %     -4.7 %     (2,602 )     -9.6 %     (4,879 )     2,277       -46.7 %
                                                                                                 
Other income (expense):
                                                                                               
Interest income
    0.1 %     21       0.2 %     29       (8 )     -27.6 %     0.1 %     43       0.1 %     67       (24 )     -35.8 %
Interest expense
    -0.8 %     (113 )     -1.1 %     (142 )     29       -20.4 %     -1.6 %     (896 )     -2.6 %     (1,317 )     421       -32.0 %
Gain (loss) on foreign currency transactions
    -0.7 %     (94 )     -0.8 %     (100 )     6       -6.0 %     -0.2 %     (87 )     0.2 %     124       (211 )     -170.2 %
Loss on early extinguishment of note payable
    0.0 %     0       0.0 %     -       -       0.0 %     -0.5 %     (267 )     0.0 %     -       (267 )     0.0 %
Other income, net
    0.4 %     52       1.3 %     168       (116 )     -69.0 %     0.2 %     128       0.5 %     257       (129 )     -50.2 %
Other expense, net
    -0.9 %     (134 )     -0.3 %     (45 )     (89 )     197.8 %     -2.0 %     (1,079 )     -1.7 %     (869 )     (210 )     24.2 %
                                                                                                 
Loss before provision for income taxes
    -5.7 %     (822 )     -6.9 %     (913 )     91       -10.0 %     -6.7 %     (3,681 )     -11.3 %     (5,748 )     2,067       -36.0 %
                                                                                                 
Provision for income taxes
    -0.9 %     (131 )     4.2 %     557       (688 )     -123.5 %     0.8 %     432       2.3 %     1,154       (722 )     -62.6 %
                                                                                                 
Loss from continuing operations
    -4.8 %     (691 )     -11.1 %     (1,470 )     779       -53.0 %     -7.5 %     (4,113 )     -13.5 %     (6,902 )     2,789       -40.4 %
                                                                                                 
Income (loss) from discontinued operations, net of income taxes
    0.0 %     -       -0.1 %     (13 )     13       -100.0 %     7.6 %     4,166       1.4 %     702       3,464       493.4 %
                                                                                                 
Net income (loss)
    -4.8 %   $ (691 )     -11.2 %   $ (1,483 )   $ 792       -53.4 %     0.1 %   $ 53       -12.1 %   $ (6,200 )   $ 6,253       -100.9 %
                                                                                                 
                                                                                                 
Loss per share from continuing operations:
                                                                                         
Basic and diluted
          $ (0.02 )           $ (0.04 )                           $ (0.12 )           $ (0.21 )                
                                                                                                 
Income (loss) per share from discontinued operations:
                                                                                 
Basic and diluted
          $ -             $ -                             $ 0.12             $ 0.02                  
                                                                                                 
Income (loss) per share:
                                                                                               
Basic and diluted
          $ (0.02 )           $ (0.04 )                           $ 0.00             $ (0.19 )                
                                                                                                 
Weighted average shares outstanding:
                                                                                               
Basic and diluted
            34,930               34,729                               34,825               32,498                  
 
**Note: Prior year results of operations have been adjusted to reflect the discontinued operations of
the Company's German subsidiary, Domilens, which was sold on March 2, 2010.
 
 
7

 
 
STAAR Surgical Company
Global Sales
(in 000's)
Audited
 
 
   
Three Months Ended
         
For Year Ended
 
         
December 31,
         
January 1,
   
%
         
December 31,
         
January 1,
   
%
 
Geographic Sales
       
2010
         
2010
   
Change
         
2010
         
2010
   
Change
 
United States
    23.6 %   $ 3,397       28.3 %   $ 3,760       -9.7 %     27.2 %   $ 14,957       31.5 %   $ 16,088       -7.0 %
                                                                                 
Japan
    23.9 %     3,434       22.2 %     2,953       16.3 %     24.8 %     13,605       25.2 %     12,884       5.6 %
China
    8.8 %     1,269       6.4 %     856       48.2 %     7.1 %     3,910       5.6 %     2,855       37.0 %
Korea
    12.0 %     1,724       12.8 %     1,702       1.3 %     11.1 %     6,080       10.5 %     5,366       13.3 %
Spain
    5.4 %     774       6.4 %     854       -9.4 %     4.5 %     2,482       5.0 %     2,548       -2.6 %
Other
    26.3 %     3,791       23.8 %     3,164       19.8 %     25.3 %     13,924       22.2 %     11,319       23.0 %
  Total International Sales
    76.4 %     10,992       71.7 %     9,529       15.4 %     72.8 %     40,001       68.5 %     34,972       14.4 %
                                                                                 
    Total Sales
    100.0 %   $ 14,389       100.0 %   $ 13,289       8.3 %     100.0 %   $ 54,958       100.0 %   $ 51,060       7.6 %
                                                                                 
                                                                                 
Product Sales
                                                                               
  Core products
                                                                               
    IOLs
    49.4 %   $ 7,108       52.3 %   $ 6,950       2.3 %     50.1 %   $ 27,550       51.5 %   $ 26,299       4.8 %
    ICLs
    45.5 %     6,543       43.4 %     5,774       13.3 %     44.2 %     24,300       41.2 %     21,046       15.5 %
  Total core products
    94.9 %     13,651       95.7 %     12,724       7.3 %     94.3 %     51,850       92.7 %     47,345       9.5 %
  Non-core products
                                                                               
    Other
    5.1 %     738       4.3 %     565       30.6 %     5.7 %     3,108       7.3 %     3,715       -16.3 %
    Total Sales
    100.0 %   $ 14,389       100.0 %   $ 13,289       8.3 %     100.0 %   $ 54,958       100.0 %   $ 51,060       7.6 %
 
**Note: Prior year results of operations have been adjusted to reflect the discontinued operations of
the Company's German subsidiary, Domilens, which was sold on March 2, 2010.
 
 
8

 
 
STAAR Surgical Company
           
Condensed Consolidated Balance Sheets
           
(in 000's)
           
Audited
           
             
   
December 31,
   
January 1,
 
   
2010
      2010**  
               
Current assets:
             
Cash and cash equivalents
  $ 9,376     $ 6,330  
Restricted cash
    133       7,396  
Accounts receivable trade, net
    8,219       9,269  
Inventories, net
    10,543       14,820  
Prepaids, deposits, and other current assets
    1,715       2,591  
   Total current assets
    29,986       40,406  
Property, plant, and equipment, net
    3,732       5,005  
Intangible assets, net
    3,672       4,148  
Goodwill
    1,786       7,879  
Deferred income taxes
    202       104  
Other assets
    1,207       1,139  
   Total assets
  $ 40,585     $ 58,681  
                 
Current liabilities:
               
Line of credit
  $ 2,460     $ 2,160  
Accounts payable
    3,717       7,416  
Deferred income taxes
    326       360  
Obligations under capital leases
    431       795  
Accrued legal judgments
    -       4,000  
Note payable, net of discount
    -       4,503  
Other current liabilities
    6,513       7,706  
   Total current liabilities
    13,447       26,940  
Obligations under capital leases
    1,403       1,098  
Deferred income taxes
    488       653  
Other long-term liabilities
    2,820       2,136  
Total liabilities
    18,158       30,827  
                 
Series A redeemable convertible preferred stock
    -       6,784  
                 
Stockholders' equity:
               
Common stock
    351       348  
Additional paid-in capital
    152,014       149,559  
Accumulated other comprehensive income
    2,100       3,254  
Accumulated deficit
    (132,038 )     (132,091 )
   Total stockholders' equity
    22,427       21,070  
Total liabilities, redeemable convertible preferred stock and stockholders' equity
  $ 40,585     $ 58,681  
 
**Note: Prior year balance sheet includes the discontinued operations of
the Company's German subsidiary, Domilens, which was sold on March 2, 2010.
 
 
9

 
 
STAAR Surgical Company
                       
Condensed Consolidated Statements of Cash Flows
                       
(in 000's)
                       
Audited
                       
   
Three Months Ended
   
Year Ended
 
   
December 31,
   
January 1,
   
December 31,
   
January 1,
 
   
2010
   
2010
   
2010
   
2010
 
Cash flows from operating activities:
                       
Net income (loss)
  $ (691 )   $ (1,483 )   $ 53     $ (6,200 )
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
         
(Income) loss from discontinued operations
    -       13       (4,166 )     (702 )
Depreciation of property and equipment
    399       447       1,590       1,973  
Amortization of intangibles
    209       817       816       1,402  
Amortization of discount
    -       114       236       379  
Deferred income taxes
    279       220       253       220  
Loss on extinguishment of debt
    -       -       267       -  
Fair value adjustment of warrant
    27       (34 )     144       40  
Loss on disposal of property and equipment
    (6 )     7       (2 )     98  
Stock-based compensation expense
    303       244       1,248       1,428  
Change in net pension liability
    62       115       318       232  
Other
    27       86       93       148  
Changes in working capital:
    -       -                  
Accounts receivable
    (1,069 )     (497 )     (207 )     (604 )
Inventories
    479       314       1,521       1,425  
Prepaids, deposits and other current assets
    63       (211 )     780       (116 )
Accounts payable
    191       667       (1,204 )     595  
Other current liabilities
    (60 )     (950 )     (5,522 )     (554 )
Net cash provided by (used in) operating activities of discontinued operations
    -       1,256       (635 )     1,663  
Net cash provided by (used in) operating activities
    213       1,125       (4,417 )     1,427  
                                 
Cash flows from investing activities:
                               
Proceeds from sale of subsidiary, net of transaction costs
    -       -       11,824       -  
Decrease (increase) in restricted cash, including reinvested interest
    -       (28 )     7,396       (7,396 )
Acquisition of property and equipment
    (73 )     (253 )     (320 )     (553 )
Purchase of short-term investments
    (1 )     (2 )     (219 )     (24 )
Sale of short-term investments
    5       8       87       198  
Proceeds from sale of property and equipment
    29       1       29       23  
Net change in other assets
    14       (15 )     24       (10 )
Net cash provided by (used in) investing activities of discontinued operations
    -       31       (50 )     149  
Net cash provided by (used in) investing activities
    (26 )     (258 )     18,771       (7,613 )
                                 
Cash flows from financing activities:
                               
Repayment of notes payable
    -       -       (5,000 )     -  
Redemption of Series A preferred stock
    -       -       (6,800 )     -  
Net proceeds from private sale of equity securities
    -       (46 )     -       8,502  
Repayment of capital lease lines of credit
    (187 )     (267 )     (796 )     (1,011 )
Borrowings under line of credit
    -       12       -       642  
Repayment under line of credit
    -       (12 )     -       (642 )
Proceeds from exercise of stock options
    832       1       1,124       1  
Net cash used in financing activities of discontinued operations
    -       (28 )     (50 )     (136 )
Net cash provided by (used in) financing activities
    645       (340 )     (11,522 )     7,356  
                                 
Effect of exchange rate changes on cash and cash equivalents
    56       159       214       168  
                                 
Increase in cash and cash equivalents
    888       686       3,046       1,338  
Cash and cash equivalents, at beginning of the period
    8,488       5,644       6,330       4,992  
Cash and cash equivalents, at end of the period
  $ 9,376     $ 6,330     $ 9,376     $ 6,330  
 
 
10

 
 
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Exhibit 99.2
 
STAAR SURGICAL COMPANY
CONFERENCE CALL
March 1, 2011, 4:30 PM ET

Operator:
Ladies and gentlemen, thank you for standing by.  Welcome to the STAAR Surgical Fourth Quarter 2010 Financial Results Conference Call.  During today's presentation, all participants will be in a listen-only mode.  Following the presentation, the conference will be open for questions.  If you have a question, please press the star, followed by the one on your touch tone phone.  If you'd like to withdraw your question, press the star, followed by the two.  If you're using speaker equipment, it will be necessary to lift the handset before making your selection.   Today's conference is being recorded March 1st, 2011.

 
I would now like to turn the conference over to Doug Sherk.  Please go ahead.

Doug Sherk:
Thank you, Operator, and good afternoon everyone.  Thank you for joining us for the STAAR Surgical conference call to review the company's financial results for the fourth quarter of 2010, which ended on December 31, 2010.  The news release announcing the fourth quarter results crossed the wire about a half an hour ago, and is available at STAAR's website at www.staar.com.

 
Additionally, we have arranged for a taped replay of this call, which may be accessed by phone.  A replay will become available approximately one hour after the call's conclusion, and will remain available for seven days.  In addition, today's call is being broadcast live, and along with an archived replay will be available at the STAAR website.

 
Before we get started, during the course of this conference call the company will make forward-looking statements.  We caution you that any statement that is not a statement of historical fact is a forward-looking statement.  This includes any projections of earnings, revenues, sales, cash or other financial statements, any statements about plans, strategies or objectives of management for future operations, any statements concerning proposed new products, governmental approval of new products or other future actions of the FDA or other regulators, any statements regarding expectations for the success of our products in the US and the international markets, the outcome of product research and the development or any clinical study, 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 conference call, and are subject to numerous risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
 
 
Page 1

 
 
 
These risks are described in the Safe Harbor Statement in today's press release, and in the Risk Factor section of our Annual Report on Form 10-K, which we expect to be filed with the Commission later today.  Investors or potential investors should read these risks.  STAAR assumes no obligation to update these forward-looking statements to reflect future events or actual outcomes, and does not intend to do so.

 
Now, I would like to turn the call over to Barry Caldwell, President and Chief Executive Officer of STAAR Surgical.

Barry Caldwell:
Thank you, Doug, and good afternoon everyone.  I'd like thank you for joining us to review the fourth quarter and full year 2010 results.  Deborah Andrews, our CFO, is also with me on the call today.  I'll begin an update of our progress on the five key operating metrics that we'd established at the beginning of 2010, then Deborah will provide additional details on our financial results for the quarter and the year.  Finally, I'll come back to summarize key accomplishments during the year and to present the key metrics we will be monitoring with you during 2011.  Then we will open the call for your questions.

 
First, I'd like to say that I'm very encouraged by the progress we made during 2010.  Overall I think the year was very good for STAAR.  We grew our core, or focused, revenues by 10%.  The balance sheet was greatly improved.  We are cash flow positive.  Our product pipeline is robust and we have momentum.  Because of our superior technology, our international footprint and large markets, our prospects for 2011 and beyond, are very promising.  I am confident we'll take advantage of these opportunities.

 
Now to review the metrics.

 
Our first metric was to generate double-digit growth from our core ICL and IOL product lines.  Core product revenues increased by 7% during the quarter; that was below our target.  For the year, however, we did achieve this metric with core product revenue growth of 10%.  We established another new quarterly record for both revenue and units of the Visian ICL products.  Revenues increased by 13% during the quarter, while unit volume increased 20%, reflecting continued gains in the market share over LASIK.  For the year, ICL revenues increased by 16%, while units increased 19%.

 
Looking at the top ten markets, where we've been focused, we believe we gained share in the refractive surgery segment in nine of those ten markets during 2010.  According to Market Scope, refractive procedures in those top ten markets, procedures increased by only 3% during 2010, collectively, while ICL units in those countries increased by 19%.  During the fourth quarter we began shipping the Visian ICL V4b, that's the expanded range product, to some parts of Europe.  It's also quite encouraging that during the fourth quarter 10% of the sales of the expanded range product were in refractive ranges where the ICL had not been previously approved.  During the first two months of the first quarter of 2011, this rate is now at 14%.  The V4b is currently approved in 25 countries, and to-date nine of those 25 markets have been converted to the expanded range product.
 
 
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Turning now to IOLs. The 2% overall growth for the quarter masked a strong 16% increase in the sales of the nanoFLEX IOL, which continues to grow share in the US market.  In Japan and Europe, preloaded IOL sales grew 9%.  Sales were offset, however, somewhat by our lower price silicon IOLs, which fell 28% in the quarter, reflecting our focus on the higher priced IOL segments.  For the year, our IOL sales increased by 5%, with a 21% increase in the nanoFLEX IOL.  I dare say that most of our competitors would be very pleased with the 5% increase in IOL sales during 2010.

 
Our second metric was to achieve gross profit margins in the mid -- or the low-to-mid -- 60% range.  We were successful on this metric, generating a gross profit margin of 64.7% in the fourth quarter compared to 61.6% in the prior year.  This is the highest gross margin percentage achieved during a quarter since 1999 for the company.  We also achieved our gross profit goal for the full year.  In 2010 our gross profit margin was 23.8%, with -- as compared to 61.3% in 2009.  Deborah will address this topic in more detail, but I will add that I believe we can make further improvements to our gross margin during 2011.

 
Our third metric was to reduce our losses and generate profitability for the year.  We did make progress on this metric, reducing the losses from continuing operations.  For the full year the company generated net income of $53,000.  This was the first profitable year for STAAR Surgical since 1999.  But remember, the 2010 net income reflected the divestiture of our German distribution business in the first quarter of the year.  It also reflects improvements that we made in our continuing operations.  If you exclude the divestiture, I'd have to say this is a metric we which -- which we did not meet, although we are well positioned for profitability during 2011 and we'll discuss that later in the call.

 
We achieved our fourth metric to generate cash from operations.  In the fourth quarter we generated $213,000 in cash from operations.  For the full year 2010, we used 4.4 million; however, included in that amount was 4 million for the litigation settlement and 635,000 in cash used by discontinued operations, both non-repeatable expenses.  As you can see, without these non-recurring expenses we generated cash from operations during the year.
 
 
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Our fifth metric was to improve our balance sheet.  During the year we made significant progress here.  This metric was fully accomplished during the past year.

 
To summarize, we successfully completed four of the five metrics for the continuing operations that we established at the beginning of 2010 and that has positioned us well for enhanced growth and profit achievement in 2011.

 
Now, I'd like to turn the call over to Deborah for an in-depth review of the quarter and full year operational and financial highlights.  Deborah?

Deborah Andrews:
Thanks, Barry.  Good afternoon, everyone.  I'd like to focus my comments today on the key financial results and highlights of the quarter and year.

 
Total revenues for the fourth quarter increased by 8% to 14.4 million, which is higher than the 14.2 million reported in preliminary revenue we announced in early January. The growth reflected a 7% increase in core product revenue.  Core revenue growth was driven by a 13% increase in Visian ICL sales to over $6.5 million, another quarterly record and the fifth consecutive quarter of ICL sales growth, despite the continued challenged economy.  Unit volume of ICLs grew 20% during the quarter.  The increase in ICL sales reflected strength in the Middle East and Asia.  Sales in China grew 88%.  China represents the largest refractive market in the world, according to Market Scope, and we continue to gain share there.  Sales to Singapore increased 64% and sales to India grew 63%.  ICL sales in the Middle East increased by 19%.  In Korea, sales for the quarter grew 3% and units grew 8%.  For the year, sales increased 13%, while units increased 11%, reflecting more growth in Toric ICLs.  Korea remains a strong example of the potential for the ICL in the refractive surgery segment.  Our share of the refractive market there in 2010 was between 12 and 13%, based on the latest Market Scope procedure data released in January.

 
IOL sales grew 2% during the quarter to 7.1 million, driven by a 17% increase in nanoFLEX sales in the US, and a 9% increase in preloaded IOL sales in international markets.  The increase in higher margin IOL sales was partially offset by a decrease in low margin silicone IOL sales.  IOL unit volume was flat, while average selling prices increased by 3%, resulting in the fourth quarter increase.   Foreign currency exchange had a favorable impact on revenue in the quarter of about $359,000.

 
Gross margin for the quarter increased to 64.7 million -- or 64.7% from 61.6% in Q4 2009.  The increase was primarily due to a decrease in royalty expense and a shift to higher margin product sales.  The increase in cost of goods of 1.1 million matched the sales growth in the quarter.
 
 
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SG&A expense increased 10% over the year ago period.  G&A expenses, while essentially flat with the fourth quarter last year, represented an increase from the earlier quarters of 2010.  This was due to additional bonus accruals as well as expenses associated with the cost of a third party study on future improvements in our manufacturing cost.  G&A expenses by quarter in 2011 should approximate Q1 and Q2 levels.

 
R&D expense was also flat with the 2009 fourth quarter, but up compared with the third quarter, primarily due to clinical activities associated with the regulatory approval process for the Toric ICL in the US and Japan.

 
Marketing and selling expense rose 18%, the result of increasing headcount in the US direct sales force and additional promotional spending in both the US and Japan.

 
For the full year, SG&A expense rose 4%, driven by a 12% increase in sales and marketing expense, partially offset by declines in G&A and R&D from 2009.   Loss from continuing operations was 691,000 for the quarter, which represents a 53% improvement over the fourth quarter of last year, and 4.1 million for the year, which represents a 40% improvement over 2009.   Fourth quarter net loss per share was $0.02 compared with $0.04 per share last year.  For the full year, loss from continuing operations per share was $0.12 compared with $0.21 per share last year.  For the full year, we reported a net income of 53,000, as Barry mentioned, the company's first profitable year since 1999.

 
Finally, we generated cash in the fourth quarter and ended the year with 9.5 million in cash on the balance sheet.

 
Now, I'll turn the call back over to Barry for additional comments.

Barry Caldwell:
Thank you, Deborah.

 
As I'd mentioned earlier, we made excellent progress during 2010 to position the company for growth.  Major accomplishments during the year include: regulatory approvals of the Visian ICL in Japan and the CE mark for the V4b ICL expanded range product; divestiture of our German distribution business; settlement of outstanding litigations; retirement of the 1.7 million preferred shares which were on the balance sheet; elimination of virtually all debt, with the exception of a outstanding line of credit in Japan; initiation of a direct-to-consumer viral campaign for the Visian ICL; and increased and enhanced brokerage firm analyst coverage.  There are a few important items which do slide into 2011, including some key regulatory approvals and the expansion of the direct-to-consumer campaign for the Visian ICL.

 
First on the regulatory side in the US, we have responded to all questions from the FDA regarding the Toric ICL submission.  Separately, we are in conversations with the Post Approval Studies section chief on that requirement.  We're told this does not impact the timing nor the decision on the submission.  As we'd said before, there are three things that can happen to the submission: it can be approved; it can not be approved or it could be sent to the ophthalmic advisory panel for recommendation.  With the preloaded silicon IOL in the US, we received what we believe to be their final question in early January.  It took us about 48 hours in which to respond.  It's been about -- that's been about six weeks ago, and we've not received any additional direction from the agency at this time.  In Japan, we continue to respond to questions from PMDA on our Toric ICL submission there.
 
 
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Now to the direct-to-consumer campaign.  We began Phase 1 of that campaign during the fourth quarter, which consisted of the seven videos highlighting the benefits of the Visian ICL over glasses, contact lenses and LASIK.  These appeared on several web formats.  Phase 2 consists of five 30 second commercial spots which focus on the ICL as the latest in refractive surgery and the advantages of the Visian ICL over contact lenses and glasses.  These will appear both on cable television and in movie theatres in some test markets.  You'll hear more about that during the next week.

 
Let's now turn to 2011.

 
Building on our achievements in 2010, we've established the following key metrics upon which we will report each quarter.

 
One, increase total revenue by double-digits.  Yes, this will primarily be driven by our core revenues, but total revenues will be easier to track during the year, and our metric is to increase our total revenue by double-digits.

 
Number two, grow Visian ICL sales by 25%.  Yes, this is a stretch.  We grew Visian ICL sales by 16% in dollars during 2010, but we see the opportunities in several key markets to further expand our market share there during 2011.

 
Number three, continuously expand gross profit margin each quarter so as to finish the year at 66%.  A key component of this will be the increased sales of the Visian ICL and the Visian Toric ICL and continued improvements in the selling price points for our IOLs.

 
Metric number four, and the last one, achieve profitability in at least three of four -- out of the four quarters and for all of 2011.  We anticipate that the first quarter will be our most difficult quarter in terms of being profitable, which reflects the normal expenses which hit during first quarter that do not repeat for the remainder of the year.  It is our goal to be profitable for the quarter, but it will be a close call during the first quarter.  After Q1, however, we would expect to generate solid profit in every quarter of 2011.
 
 
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In closing, I'd like to first thank our employees for their tireless efforts during the past few years, and everyone on the call for your support of the company.  To use a sports term, during 2010, we moved from playing defense to playing offense.  We're now focused on scoring.  We're very optimistic about 2011.  Growth in sales, which is our highest priority, must be accomplished by reaching profitability from continuing operations.  Our clear goal for 2011 is profitable growth.

 
With that, I think we're ready for questions.  Operator, could you please open the line.

Operator:
Thank you, sir.  Ladies and gentlemen, we will now begin the question-and-answer session.  As a reminder, if you have a question, please press the star, followed by the one on your touch tone phone.  If you need to withdraw your question, press the star, followed by the two.  If you're using speaker equipment, it will be necessary to lift the handset before making your selection.

 
Our first question comes from the line of Joanne Wuensch with BMO.  Please go ahead.

Joanne Wuensch:
Happy afternoon.  A couple of quick questions.  You talked about a gross margin exiting the year at 66%, so I'm going to assume that's a fourth quarter call.  Would you like to give a full year number?

Barry Caldwell:
No, the 66 -- you're talking about the metric, Joanne, for 2011?

Joanne Wuensch:
Yes.

Barry Caldwell:
Had a 66% for the year.  We exited fourth quarter at about 65%.

Joanne Wuensch:
Okay, that's why I just wanted to clarify.

Deborah Andrews:
And it should be increasing by quarter.

Barry Caldwell:
Yes.

Joanne Wuensch:
Increasing each quarter.

Deborah Andrews:
Mm-hmm.  Yes.

Joanne Wuensch:
And when you talk -- you gave 2011 metrics -- by the way, thank you very much for those - for R&D and G&A but you didn't do one for marketing and selling, unless I missed it.
 
 
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Barry Caldwell:
No, I don't think Deborah did.

Deborah Andrews:
I threw you a carrot there.

Joanne Wuensch:
Okay.  Any chance you'd like to share or should I just have a go at it?

Barry Caldwell:
I think it would be fair, Joanne, to say, you know, we have ramped up our spending in sales and marketing last year in anticipation of launching the Toric ICL in the US.  We also ramped up some expenses in Japan anticipating getting the ICL up and going and Toric approval shortly there.  So, I don't see them expanding beyond what they've been third and fourth quarter.

Joanne Wuensch:
Right.

Barry Caldwell:
And I think that would be kind of the run rate I would look at.

Joanne Wuensch:
Yes.  Okay.  And, last question.  How much or are you assuming Toric ICL in the US in your double-digit revenue guidance?

Barry Caldwell:
That's really a good question.  The answer is no.  We certainly would like to have and anticipate we will -- could have Toric approval in the US during 2011 but with the opportunities we see in some key markets, particularly in Asia-Pacific, led by China, India, now Japan, also in Europe, in Spain and a couple of -- the Middle East, you know, we believe by stretching our marketing efforts a little bit more effectively that we should be able to achieve that kind of growth rate during the year even if we don't get approval in the US.

Joanne Wuensch:
Okay, wonderful.  Thank you.

Barry Caldwell:
Thank you.

Operator:
Thank you.  Our next question comes from the line of Chris Cooley with Stephens.  Please go ahead.

Chris Cooley:
Thank you and thank you for taking the question.  If I could, two questions, Barry.  First, when you just think about the domestic cataract marketplace, and I realize it's early at this juncture, but any early read on just what you're seeing from a practitioner perspective as a result of the NTIOL expirations?  And I have a follow-up.  Thank you.

Barry Caldwell:
Yes, thank you, Chris, and good talking to you.  That's a really good question.  As most of you know, the NTIOL for aspheric lenses, which is an additional $50 reimbursement, just ended here in the last few days in the US market.  Robin Hughes, our Global VP of Marketing, was in my office last week, Wednesday or Thursday, and it was funny, we were talking about this.  We haven't gotten one call about NTIOL going away.  And I think that, you know, as we've spoken, Chris, and we've also talked about this openly in presentations, that the prices of our lenses even with our nanoFLEX, which is our superior technology, is still below the old reimbursement rate of 150 versus 200, and that we didn't expect to see a lot of impact and we've certainly not seen that at least as of yet.
 
 
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Chris Cooley:
Okay, super.  And then just as a follow-on.  If you think about the ICL and the growth that you are seeing during the quarter, you know, very strong in China, Singapore and India, but Korea seems to have tapered a bit there.  Was there any change in terms of the marketing approach?  Was there some pull-through do you think in the prior quarter?  Just trying to get kind of a better understanding of kind of a more established ICL growth market versus some of these more emerging growth markets outside of the US.  Thank you.

Barry Caldwell:
A very, very fair question.  I'm glad you asked it.  And that's why Deborah said we believe our market share was 12 to 13% last year in Korea, that would have been up from 11%, and the reason we did 12 to 13 is because we know that our distributor there shipped more from their inventory to customers rather than what they purchased from us and the way we've historically measured our market share by country is to take the data exactly as Market Scope prints it and then -- and that would be the denominator, and making the numerator the units that we sold to our distributor.  So we think it probably -- and that number comes out to 12.3% for the year, by the way, but we think it's probably a little bit higher than that because our distributor did ship more from their own inventories.

 
Now I was just a few weeks ago in Europe at a meeting with our Korean distributor.  They presented their plans for 2011 and their plans are to invest in marketing alone in Korea, 8 to $900,000 of their own money.  They've established a new direct-to-consumer campaign which they'll introduce during the second quarter.  It's a different approach than what we've taken in some of the other markets and with which you'll see next week in these new five, thirty second commercials.  But they are a very committed distributor and as I've said before, you know, they want to get their share of the 20%, not the 12 to 13%.  So overall, you know, we're very pleased with what our distributor in Korea has done for the year and since they've had the product line.

Chris Cooley:
May I squeeze one more in then I'll get back in queue?

Barry Caldwell:
Yes.

Chris Cooley:
Since Joanne fleshed out the marketing and selling line, maybe I can help as well.  Any guidance there that you want to provide just when you think about FX and the ubiquitous other line?  Thanks so much.

Deborah Andrews:
Okay.
 
 
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Chris Cooley:
We'll have them modeled up by that point.

Deborah Andrews:
If you want to give me guidance on FX I'll take it.

Chris Cooley:
Thanks much.

Operator:
Thank you.  Our next question comes from the line of Raymond Myers with the Benchmark Company.  Please go ahead.

Raymond Myers:
Yes, thank you.

Deborah Andrews:
Hi, Ray.

Barry Caldwell:
Yes?

Deborah Andrews:
Hello.  Ray?

Operator:
Mr. Myers, your line is open.

Raymond Myers:
Can you hear me?

Deborah Andrews:
Yes.

Raymond Myers:
Hello?  Okay, great.  I want to ask you to describe the progress you've had in leveraging the Collamer IOL for cataract surgery and update us on the CAST follow-up study and next generation IOL products.

Barry Caldwell:
Okay.  So, first, your question is tying the -- actually, the nanoFLEX which is our primary focused IOL with the ICL in terms of accounts.  It is a very nice, obviously, selling story in terms of the material because the material does make such a difference, and we have been focused in accounts that have adopted the ICL and helping them understand that the same material of the ICL that provides the clarity of vision is also available in an IOL.  And we've had several very good success stories in terms of that transition.  I can't give you a number overall in terms of where the increase came during the year from customers who did cross both paths, but it is clearly a selling tactic and a marketing tactic that we're using in those accounts and the nanoFLEX for the year grew 20% in the US market.  So clearly we're doing a few things right there.

Raymond Myers:
I guess what I'm asking also about is the, there was a CAST study and then there was a follow-up study to CAST that was planned - where does that stand?

Barry Caldwell:
Yes, we do have a protocol in to the FDA on what we've referred to as our CASTII study.  We're still waiting for guidance on that protocol.  I think as we'd said earlier, when we first gave them the protocol they misinterpreted that we were asking for an accommodating claim but instead we were looking for a protocol which could establish a claim on perhaps intermediate vision or near vision as it compares to other IOLs that are on the market.  So we've got to get that protocol approved by the FDA before we can start it.  But also, as you know, we've got the blended vision approach which we're also using with physicians.  We did a webinar with surgeons just three weeks ago on the nanoFLEX with blended vision, and that seems to also be going very well.  There seems to be a real movement, maybe even stronger than it was a year ago, towards finding ways to get to these premium procedures with good results, and, you know, a lot of surgeons in the US have moved to premium procedures but then didn't find the results, the refractive visual results with patients.  So the blended vision is something that we're using from a selling and marketing perspective until we can get the CAST II up and going.
 
 
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Raymond Myers:
Okay, good.  And then what is the status of the silicon IOL FDA submission?

Barry Caldwell:
That's the preloaded silicon - we did get what we believe is their final question.  You might recall that just prior to the Academy they told us they had one more question.  We got that in early January.  It was on ETO residuals from sterilization, which they had told us it was -- that was the topic of the question.  It took us about 48 hours to respond and we're awaiting further direction from that, from them, but as of today we're not aware of any additional questions they may have.

Raymond Myers:
Okay, that's great.  And let's talk some more about sales and marketing, drilling down more into that.  You've projected a very nice 25% growth in Visian ICL sales, how much of that is driven by increased sales and marketing and how much is that, of that is the rapid growth rate in foreign markets?

Barry Caldwell:
How much of it is expand -- the expansion of our sales team in terms of increased volume versus -- the last part I didn't hear, Ray.

Raymond Myers:
Well, I guess, how much of your anticipated 25% ICL growth rate is driven by increased marketing push versus the inherent rapid growth rate of certain markets, such as China and India, Korea?

Barry Caldwell:
Well I think it's a combination of both.  You know, in the rapid growing markets, as you mentioned, like China, and according to Market Scope, China grew procedures 24% last year.  In that market we currently don't anticipate any additional investments in terms of sales and marketing but in some of the other markets, like Japan, which was down 12% last year in terms of procedures, Spain was only up 5%, India was only up 5%, the Korean market was only up 3%.  We do anticipate, you know, additional marketing efforts in those countries to expand our growth rate during 2011 over what we experienced in 2010.
 
 
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Operator:
Thank you.  Our next question comes from the line of Bruce Jackson with Morgan Joseph TriArtisan.  Please go ahead.

Bruce Jackson:
Good afternoon.

Barry Caldwell:
Hi, Bruce.

Bruce Jackson:
With regards to the sale of the new V4b lens in Europe, you mentioned in the press release it was 10% of revenue in the markets where it had been launched.  Do you have a number as to what percentage of total European revenue it represents now?

Barry Caldwell:
Well I do have a number, Bruce, that at least as of now, two months into the first quarter of 2011, it has represented about 25% of our sales outside the US.

Bruce Jackson:
Okay.

Barry Caldwell:
Than V4bs.   And again, from the opening statement, we've converted nine of the 25 countries in which they accept the CE mark approval on the V4b.

Bruce Jackson:
Okay, great.  And then with regards to the CAST II study, so you're talking to the FDA right now about the protocol, if all goes well, just do you have a rough idea of when you might be able to start that study?

Barry Caldwell:
Well, you know, we have -- we've gotten the doctors lined up and I would anticipate that, you know, once we get the go-ahead on the protocol that we can be up and running in 45 to 60 days.  Now if we continue to not get a better understanding of the protocol, we can continue to do some marketing clinicals with more surgeons to add on to the original CAST data that we've accumulated.

Bruce Jackson:
Okay, great.  Thank you.

Barry Caldwell:
Thank you.

Operator:
Thank you.  Our next question comes from the line of Joe Munda with Sidoti & Company.  Please go ahead.

Joseph Munda:
Good afternoon, guys.

Barry Caldwell:
Hey, Joe.

Joseph Munda:
Hey, Barry.  Thanks for taking my call.  You had mentioned in your comments you expect profitability three out of four quarters, I'm guessing it's going to be the second, third and fourth quarter, just by your comments about the first quarter.  What cost, is it going to be manufacturing or operating cost, is going to lead to, you know, possibly not being profitable in Q1?
 
 
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Barry Caldwell:
Right, I'll let Deborah comment on the additional first quarter charges that are not recurring during the rest of the year.

Deborah Andrews:
Yes, those are operating costs generally, general and administrative expenses.

Barry Caldwell:
Audit fees.

Deborah Andrews:
Audit fees, SOX fees, things like that.

Joseph Munda:
Okay.  And I just had one follow-up question.  I think somebody had asked about Visian ICL - with the growth you expect of 25%, what can we expect the numbers for inventory to look like going forward in 2011?  Are we going to see in the 15 million range?

Barry Caldwell:
The impact of the expanded sales of ICL on inventory should be minimal.  Now, remember, Joe, as we're moving to the V4b we are eliminating a lot of the categories of lenses we have to carry - that is one of the advantages of moving to the V4b.  So I think the growth will offset to a large degree -- the growth in sales will offset to a large degree the inventory needed because of the smaller number of SKUs.  I forget the overall impact but it's quite dramatic.

Barry Caldwell:
Yes, we don't anticipate a significant increase in inventory.

Joseph Munda:
Okay.  Thanks, guys.

Barry Caldwell:
Thank you.

Operator:
Thank you.  Ladies and gentlemen, as a reminder, if there are any additional questions, please press star, one on your touch tone phone at this time.  If you are using speaker equipment today, it will be necessary to lift your handset before making your selection.

 
Our next question comes from the line of Larry Haimovitch with Haimovitch Medical Technology Consultants.  Please go ahead.

Larry Haimovitch:
Good afternoon.

Barry Caldwell:
Hi, Larry.

Larry Haimovitch:
Barry, when you look back at the last season -- I mean, year, what would you say are the one or two achievements or successes of the company that you're most proud about and what would you say would be one or two things you would have hoped would have occurred that didn't?
 
 
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Barry Caldwell:
Wow, the first one is tough because there's so many.  You know, I think first of all I'm just -- I'm really proud of our employees who have hung in there.  You know, many of our employees have been through some tough years, here at STAAR.

Larry Haimovitch:
Yes.

Barry Caldwell:
And years in which they've questioned whether the company was going to be viable in the future.

Larry Haimovitch:
Mm-hmm.

Barry Caldwell:
And, you know, at least, I believe, globally, our employee base now understands that we're a viable growing company with clear opportunities before us.  So that overshadows, I think, all of the other ones that I think I mentioned on the call in terms of key accomplishments for the year.

Larry Haimovitch:
Yes.

Barry Caldwell:
It's also easy for me to go the other side because we did miss opportunities during 2010.  My biggest disappointment in 2010 is Japan.  You know, I believe we've got tremendous opportunity with the ICL in Japan.  We've got a lot more work to do there.  You know, I'm very glad we've got a seasoned manager like Don Todd managing Japan right now.  I think we've got things turned around and headed in the right direction to really give us an opportunity to take advantage of the ICL in Japan.  You know, I think overall it's also disappointing, though, somewhat out of our control, that we didn't get approval for the Toric ICL during 2010.  That's a disappointment but I'm not sure we could have done anything differently.

Larry Haimovitch:
Yes.

Barry Caldwell:
A lot of work was done by employees, our regulatory staff and many other disciplines to make major responses.  And, you know, I feel like we've made a lot of progress but we don't have the token at the end of the day to show for it.

Larry Haimovitch:
Right.  Great.  Yes.  Okay, very good.  Well I think overall it was a very good year and I think -- I was just thinking back to a year ago when you were in the midst of some very scary litigation, and isn't it nice that that's all behind you now.

Barry Caldwell:
Well, absolutely.  Yes, if you go back to a year ago from this point, you know, the table only had three legs on it or maybe two and a half.

Larry Haimovitch:
Right, right.  Well, congrats on all the progress, Barry.
 
 
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Barry Caldwell:
Thank you, Larry.

Operator:
Thank you.  Our next question comes from the line of Mark Malcolm, Private Investor.  Please go ahead.

Barry Caldwell:
Hi, Mark.

Operator:
Mr. Malcolm, your line is open.

 
And it appears that Mr. Malcolm has stepped away from the line.  I'd like to turn the conference back to management at this time for closing remarks.

Barry Caldwell:
Great.  Again, I'd like to thank everyone for being on the call today.  If you have any additional questions or need clarification, please feel free to call Deborah or myself.  And I hope you have a great evening and thank you very much.  Good-night.

Operator:
Ladies and gentlemen, this concludes the STAAR Surgical Fourth Quarter 2010 Financial Results conference call.  If you'd like to listen to a replay of today's conference, please dial 1-800-406-7325 or 303-590-3030, and enter the access code of 4411951, followed by the pound sign.  Thank you for your participation.  You may now disconnect.

END
 
 
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