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):   July 31, 2014

 

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:

 

¨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.

 

On July 31, 2014, STAAR Surgical Company (the “Company”) published a press release reporting its financial results for the quarter ended July 4, 2014, a copy of which is furnished as Exhibit 99.1 to this report and is incorporated herein by this reference.

 

 This information and the information contained in the press release shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in Item 2.02 of this Current Report, and Exhibits 99.1 and 99.2 are not incorporated by reference into any filings of STAAR made under the Securities Act of 1933, as amended, whether made before or after the date of this Current Report, regardless of any general incorporation language in the filing unless specifically stated so therein.

 

Item 7.01 Regulation FD Disclosure.

 

On July 31, 2014, the Company held a conference call to discuss the financial results for the quarter ended July 4, 2014.  The Company provided slides to accompany its presentation on the July 31, 2014 conference call, which are available on the Company’s website at www.staar.com.  A copy of the slide presentation is furnished as Exhibit 99.2 to this report and is incorporated herein by this reference.

 

Item 9.01 Financial Statements and Exhibits

 

Exhibit No.   Description
99.1   Press release of the Company dated July 31, 2014
99.2    Slide presentation dated July 31, 2014

 

 

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.

 

STAAR Surgical Company 
 
July 31, 2014 By: /s/ Barry G. Caldwell
    Barry G. Caldwell
    President and Chief Executive Officer

 

 

 

 

 

 


 

Exhibit 99.1

 

 

 

STAAR Surgical Reports 10% Second Quarter Revenue Growth

 

~Total Sales Increased to $20.0M from $18.2M in Q2 2013~

~ Quarterly Visian® ICL™ Sales Increased to $12.2 Million ~

~ IOL Sales Growth of 10% Led by Increased Supply of the KS-IOLs~

~ GAAP Net Income Loss of $0.05 per Share~

 

MONROVIA, CA, July 30, 2014---STAAR Surgical Company (NASDAQ: STAA) a leading developer, manufacturer and marketer of implantable lenses and delivery systems for the eye today reported revenue for the second quarter ended July 4, 2014 of $20.0 million, a 10% increase over $18.2 million reported for the second quarter of 2013. On a constant currency basis, revenues grew 11% during the second quarter of 2014 compared to the second quarter of 2013. The effect of foreign currency exchange reduced sales by $0.1 million during the quarter. The results included quarterly sales of $12.2 million of the Company’s Visian ICL product portfolio, and $6.4 million of its IOL products. Lower margin Other Product sales were $1.4 million, a 39% increase compared to the second quarter of 2013. The GAAP net loss for the second quarter of 2014 was $1.8 million or $0.05 on a per diluted share basis, compared with a net income of $278,000, or $0.01 on a per diluted share basis, in the second quarter of 2013.

 

“Our revenue growth for the first half of 2014 was 11% as reported and 13% in constant currency which was higher than our initial expectations,” said Barry G. Caldwell, President and CEO. “We currently expect our second half growth rate to be even higher given new product releases and increased IOL supply. Visian ICL growth continues to be fueled by the expansion and penetration of the ICL with CentraFLOW® technology, which makes the procedure more convenient and cost effective for both the patient and the surgeon. The CentraFLOW technology drove a revenue increase during the first half of 24% in our EMEA region with deeper penetration in Europe and expansion to our Latin America markets. We also believe the CE Mark approval of the Preloaded ICL should help to drive additional revenue growth starting with full commercialization during the fourth quarter. The Preloaded ICL eliminates multiple steps in the loading and delivery process which many surgeons believe is the most challenging aspect of the procedure. In addition the Preloaded System should reduce the learning curve to the procedure and the overall ICL procedure time. We believe this ICL enhancement will be very important for both our experienced ICL implanters as well as those surgeons wanting to add the ICL to their current refractive offerings. Global ICL revenue growth was 8% in the quarter and procedure growth was 5%. We continue to gain market share globally as LASIK procedures remain under downward pressure.”

 

 
 

 

 

“IOL revenue increased by 10% during the quarter driven by a 17% increase in unit sales. This growth was driven by the expansion of our KS-IOL products in the European and Japanese markets. IOL revenue increased by 117% in Europe while units basically doubled. Increased supply of the KS-IOL products allowed us to rebuild consignment accounts in Japan to where they were a year ago. This allowed our KS-IOL products to generate 28% growth in Japan during the quarter and 83% growth the final eight weeks of the quarter. We now feel more confident about our supply levels for the rest of the year, which should help to drive additional growth during the second half of the year focused in our higher margin markets,” continued Mr. Caldwell.

 

Gross profit margin for the quarter was 68.2% compared to 69.5% in the second quarter of 2013. Three key factors drove a 450 basis point negative impact on the gross margin during the quarter; two of which should improve and one remain negative during the second half. The increased geographical sales mix of KS-IOL products had a negative impact of approximately 230 basis points. This should improve with the increasing growth rate of KS-IOL sales within our higher margin markets. Secondly, the increase of lower margin IOL injectors to a third party drove a negative impact of 80 basis points. This factor should continue to be a headwind during the second half. Finally, the transition of ICL production to the U.S. had a negative impact of 140 basis points. This should improve during the second half, as it did during the first half, with increased manufacturing experience in the U.S. and the transfer of management from Switzerland. An increase of 3% in the average prices on ICLs had a positive impact on gross margin during the second quarter. The Company expects higher average prices for both ICLs and IOLs which should have a positive impact during the second half of the year.

 

Operating expenses for the quarter were $15.1 million, up 26% from $11.9 million in the prior year. This includes a $0.8 million increase in R&D expenses driven by the cost of an increased number of regulatory approvals in process, consultants working with the Company on the actions to address the issues in the FDA Warning Letter and cost associated with the development of the Preloaded ICL and the V6a ICL. Investments in Sales and Marketing increased by $1.4 million which includes cost related to the expansion of the U.S. sales team in anticipation of the potential launch of the TICL and increased promotional spending. General and Administrative expenses increased by $1.4 million primarily due to the increased cost of stock compensation due to a higher stock price in the second quarter of 2014 than in the second quarter of 2013, higher bonus accrual as targets for bonus achievement are on track, and tax consulting expenses.

 

The income tax provision was $0.4 million during the second quarter of 2014 compared to a provision of $0.6 million during the second quarter of 2013. The effective tax rate for the second quarter was 26%, while the rate for the first half was 23%. The effective income tax rates are negative in periods where we have both consolidated pre-tax losses and tax provisions in foreign jurisdictions with pre-tax profits.

 

 

 
 

 

Adjusted net income (excluding manufacturing consolidation expenses, distribution transition expenses in Spain, gain (loss) on foreign currency transactions, fair value adjustment of warrants, stock-based compensation expense and Toric ICL FDA panel expenses) for the quarter ended July 4, 2014 was $0.3 million, or $0.01 per share versus adjusted net income for the year ago quarter of $1.8 million, or $0.05 per diluted share.

 

The GAAP net loss for the first half of 2014 was $3.1 million or $0.08 on a per diluted share basis, compared with a net income of $0.7 million, or $0.02 on a per diluted share basis, in the first half of 2013. Adjusted net income (excluding manufacturing consolidation expenses, distribution transition expenses in Spain, gain (loss) on foreign currency transactions, fair value adjustment of warrants, stock-based compensation expense and Toric ICL FDA panel expenses) for the first half of 2014 was $1.9 million, or $0.05 per share versus adjusted net income for the year ago first half of 2013 at $5.0 million, or $0.13 per diluted share.

 

Cash and cash equivalents at July 4, 2014 totaled $19.2 million. During the quarter, the Company used $1.5 million in cash for operating activities including: $1.0 million to build inventory to support the potential U.S. launch of the TICL and the Preloaded ICL for EU launch.

 

Recent Visian Implantable Collamer® Lens (ICL) Highlights.

 

·Sales grew 8% globally during the second quarter and were driven by an increase of 9% in the Company’s target markets. Average selling price increased 3% driven by mix and new product introductions.

 

·Procedures grew globally 5% in the second quarter, the same rate of growth in the target markets.

 

·In the more than 60 markets where the TICL is available, second quarter sales of TICL represented 49% of total ICL revenue and 39% of the units. TICL sales grew 19% during the quarter globally while the ICL grew 1%.

 

·Visian ICLs with CentraFLOW technology represented approximately 63% of all ICL procedures during the quarter. Over 70,000 Visian ICLs with the CentraFLOW technology have been successfully implanted since introduction.

 

·During the first half of 2014, ICL sales grew 12% with procedure growth at 9% and a 2% increase in average selling price.

 

Regional ICL Updates

 

Europe, Middle East, Africa (EMEA)

 

·In the second quarter, Visian ICL revenues grew by 22% while procedures increased 16% and average selling price increased 5%.

 

·Revenues in Europe during the quarter increased 23% and ICL procedures grew 17%. 2014 results reflect the second full year that Europe has had the CentraFLOW technology.

 

 
 

 

·France increased revenue by 47% and procedures 38%.

 

·Germany increased revenue by 21% and procedures 17%.

 

·Spain increased revenue by 26% and procedures 19%.

 

·The Middle East, where the Visian ICL with CentraFLOW was introduced last year, grew 37% in revenues and 33% in procedures.

 

·Latin America declined 4% in revenue and 9% in procedures after a 58% rate of revenue growth during the first quarter.

 

·During the first half, EMEA ICL revenue grew 24% with procedure growth at 20% and a 4% increase in average selling price.

 

Asia Pacific (APAC)

 

·APAC grew 2% in revenue while ICL procedures increased 1% and average selling price increased 1%. ICL revenue declined 4% while TICL revenue grew 12% during the quarter.

 

·Korea ICL revenue grew 6% during the quarter while procedures were flat. The average selling price increased by 7%.

 

·China ICL revenue grew 9% during the quarter while procedures increased 9%. The average selling price was flat.

 

·ICL revenue increased 9% in India driven by the ICL with CentraFLOW technology as procedures were flat.

 

·ICL revenue in Japan declined 32% as refractive procedures in this market continued to experience strong downward pressure.

 

·During the first half, APAC ICL revenue grew 9% with procedures growth at 8% and a 1% increase in average selling price.

 

North America (NA)

 

·NA ICL revenue decreased 1% while units decreased 7%. Average selling price grew 6% during the quarter.

 

·During the first half, NA ICL revenue declined 8% with procedures declining at 13% and a 6% increase in average selling price.

 

Quarterly Intraocular Lens (IOL) Highlights

 

·Second quarter IOL sales were $6.4 million, a 10% increase from $5.9 million in the second quarter of 2013 while units increased 17%. This was driven by increased supply of the KS-IOL Preloaded Acrylic product.

 

·Sales in Japan represented 46% of the Company’s total IOL sales. Sales declined by 10% during the quarter. IOL unit sales decreased by 11% during the quarter.

 

 
 

 

·IOL sales in EMEA, which represented 28% of total IOL sales, increased by 117% and 99% in units during the quarter due to the increased supply of the Preloaded Acrylic KS-IOLs.

 

·IOL sales in China increased by 65% despite the fact that supply of the KS-IOL has not yet been restored. Supply to this market was suspended during the second quarter of 2013. Sales in the U.S. market declined by 11% during the quarter.

 

·The Company ended the quarter with approximately $0.2 million in backorders of its preloaded acrylic for Europe, approximately one-half of the first quarter ending backorder level.

 

·During the first half of 2014 global IOL sales increased 7% and units increased 17%.

 

Other Operational Highlights during the Quarter

 

·The Visian ICL Preloaded System received CE Mark Approval in late June. The Preloaded ICL reduces overall procedure time, shortens the learning curve for new surgeons to perform ICL procedures and enables more consistent ICL lens delivery in the eye. New intellectual property developed by the STAAR R&D team has been incorporated into the Preloaded Injector design. Additional intellectual property includes a new hydrophilic coating technology, nanoCOAT™, which allows for the smooth transition of the ICL through the injector system into the small incision for the ICL procedure.

 

·On July 1, 2014 the FDA posted on its website a Warning Letter issued to the Company which followed a GMP inspection at the Monrovia facility. The Company takes this letter very seriously and is diligently working to resolve the observations cited in the letter. The areas under review by the Company to address fall generally within the following four categories:

 

oDesign Control Documentation.

 

oValidation of software for an on-line calculator.

 

oData collection and trending of ICL vault complaints.

 

oShelf life data on the ICL product.

 

·The Company successfully completed the manufacturing consolidation project at the end of June. This project has taken nearly four years at a cost of approximately $6.3 million. The Company is experiencing partial tax benefits from the project in 2014 with greater realization expected in 2015.

 

·On May 15th the Company completed an Experts Panel Meeting in China on the Visian ICL with CentraFLOW. The CFDA has asked some post panel questions to which the Company has prepared responses and the Company expects to receive a decision within the next 105 working days.

 

·During the quarter the Company provided additional information in response to communications with the FDA regarding the TICL submission. The TICL received a favorable panel recommendation from the Advisory Committee on March 14, 2014.

 

 
 

 

 

·The recruitment of patients for the V6a ICL technology has begun in anticipation of the start of initial confirmatory study during the third quarter. The V6a ICL is designed to add a near-vision enhancement capability which would further differentiate the ICL from LASIK for myopic patients nearing the age of 40. The goal of the V6a ICL would be to delay the need for reading glasses in that population. This technology would combine the proven ICL platform with known optic designs and new intellectual property developed by the Company.

 

2014 Annual Objectives

 

The Company’s annual 2014 annual objectives were established at beginning of the year and the Company will continue to report progress each quarter on those objectives. Those annual objectives are:

 

•Revenue growth of 8% to 10%.
•ICL revenue growth of 20%.
•Gross Margin expansion of 300 bps, 72.7%.
•Profitable on a GAAP basis.
•Successfully complete manufacturing consolidation project by mid-year.

 

Conference Call

 

The Company will host a conference call and webcast today 5:00 p.m. Eastern / 2:00 p.m. Pacific to discuss these results and recent corporate developments. The dial-in number for the conference call is 866-515-2907 for domestic participants and 617-399-5121 for international participants, both using the passcode 24164533. The Company will also be using slides to illustrate its second quarter results and operational progress. The webcast with accompanying slides can be accessed from the investor relations section of the STAAR website at www.staar.com.

 

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 888-286-8010 for domestic callers and 617-801-6888 for international callers, both using passcode 54025734. An archived audio webcast will also be available at www.staar.com.

 

Use of Non-GAAP Financial Measures

 

This press release includes supplemental non-GAAP financial information, which STAAR believes investors will find helpful in understanding its operating performance.

The Company conducts a significant part of its activities outside the U.S. It receives sales revenue and pays expenses principally in U.S. dollars, Swiss francs, Japanese yen and Euros. The exchange rates between dollars and non-U.S. currencies can fluctuate greatly and can have a significant effect on our results when reported in U.S. dollars. When preparing its financial statements in conformity with GAAP, the Company translates foreign currency sales and expenses denominated in Japanese yen to dollars at the weighted average of exchange rates in effect during the period. As a result, the Company's reported performance may be significantly affected by currency fluctuations. In order to compare the Company's performance from period to period without the effect of currency, the Company will apply the same average exchange rate applicable in the prior period, or the "constant currency" rate to sales or expenses in the current period as well. Because changes in currency are outside of the control of the Company and its managers, management finds this non-GAAP measure useful in determining the long term progress of its initiatives and determining whether its managers are achieving their performance goals. The Company believes that the non-GAAP constant-currency sales results measures provided in this press release are similarly useful to investors to give insight on long term trends in the Company's performance without the external effect of changes in relative currency values. The table below shows sales results calculated in accordance with GAAP, the effect of currency, and the resulting non-GAAP measure expressed in constant currency.

 

 
 

  

“Adjusted Net Income” excludes the following items that are included in “Net Income” as calculated in accordance with U.S. generally accepted accounting principles (“GAAP”): manufacturing consolidation expenses, Spain distribution transition expenses, gain or loss on foreign currency transactions, the fair value adjustment of outstanding warrants issued in 2007, stock-based compensation expenses, and FDA TICL Panel expense.

 

Management believes that “Adjusted Net Income” is useful to investors in gauging the outcome of the key drivers of the business performance: the ability to increase sales revenue and our ability to increase profit margin by improving the mix of high value products while reducing the costs over which management has control.

 

We have excluded manufacturing consolidation, Spain distribution transition expenses, and FDA Toric ICL panel expenses because these are non-recurring expenses and their inclusion may mask underlying trends in our business performance. Expenses associated with the Company’s plans to consolidate its manufacturing operations to the U.S. are largely expected to have been completed by the middle of 2014 and the Spain distribution transition expenses were completed at the end of the first quarter of 2013.

We have excluded gains and losses on foreign currency transactions and the fair value adjustment of warrants because of the significant fluctuations that can result from period to period as a result of market driven factors.

 

Stock-based compensation expenses consist of expenses for stock options and restricted stock under the Financial Accounting Standards Board’s Accounting Standards Codification (ASC) 718. In calculating Adjusted Net Income STAAR excludes these expenses and the fair value adjustment of outstanding warrants because they are non-cash expenses and because of the complexity and considerable judgment involved in calculating their values. In addition, these expenses tend to be driven by fluctuations in the price of our stock and not by the same factors that generally affect our other business expenses.

 

 
 

 

 

We have provided below a detailed reconciliation table, which is useful to investors in providing the context to understand our Adjusted Net Income and how it differs from Net Income calculated in accordance with GAAP.

 

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 and delivery systems therefor. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR's lens used in refractive surgery as an alternative to LASIK is called an Implantable Collamer® Lens or "ICL." A lens used to replace the natural lens after cataract surgery is called an intraocular lens or "IOL." More than 450,000 Visian ICLs have been implanted to date; to learn more about the ICL go to: www.visianinfo.com. STAAR has approximately 335 full time employees and markets lenses in over 60 countries. Headquartered in Monrovia, CA, it manufactures in the following locations: Nidau, Switzerland; Aliso Viejo, CA; and Monrovia, CA. For more information, please visit the Company's website at www.staar.com.

 

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: any projections of earnings, revenue, sales, profit margins, cash, effective tax rate or any other financial items; the plans, strategies, and objectives of management for future operations or prospects for achieving such plans; metrics for 2014; statements regarding new or improved products, including but not limited to, expectations for success of new or improved products in the U.S. or international markets or government approval of new or improved products (including the Toric ICL in the U.S.); the nature, timing and likelihood of resolving issues sited in the FDA’s Warning Letter; future economic conditions or size of market opportunities; expected IOL backorder position; expected costs of Monrovia facility expansion; expected costs and savings from business consolidation plans and the timetable for those plans; statements of belief, including as to achieving 2014 growth plans or metrics; expected regulatory activities and approvals, product launches, and any statements of assumptions underlying any of the foregoing. Important additional factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in the company’s Annual Report on Form 10-K for the year ended January 3, 2014, 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.”

 

 

 
 

 

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 unstable global economic conditions on sales of products, especially products such as the ICL used in non-reimbursed elective procedures; the challenge of managing our foreign subsidiaries; backlog or supply delays as we fully integrate our manufacturing facility consolidation; the risk of unfavorable changes in currency exchange rate; the discretion of regulatory agencies to approve or reject new or improved products, or to require additional actions before approval (including but not limited to FDA requirements regarding the TICL and/or actions related to the FDA Warning Letter); unexpected costs or delays that could reduce or eliminate the expected benefits of our consolidation plans; the risk that research and development efforts will not be successful or may be delayed in delivering for launch; the purchasing patterns of our distributors carrying inventory in the market; the willingness of surgeons and patients to adopt a new or improved product and procedure; patterns of Visian ICL use that have typically limited our penetration of the refractive procedure market, and a general decline in the demand for refractive surgery particularly in the U.S. and the Asia Pacific region, which STAAR believes has resulted from both concerns about the safety and effectiveness of laser procedures and current economic conditions. The Visian Toric ICL and the Visian ICL with CentraFLOW are not yet approved for sale in the United States.

  

 

CONTACT:  Investors  Media
    EVC Group  EVC Group
    Doug Sherk, 415-652-9100  Nicole Kruse, 212-850-6025

 

 

 
 

 

 

STAAR Surgical Company        
Condensed Consolidated Balance Sheets        
(in 000's)        
Unaudited        
         
   July 4,   January 3, 
   2014   2014 
ASSETS        
Current assets:          
Cash and cash equivalents  $19,186   $22,954 
Accounts receivable trade, net   12,700    10,731 
Inventories, net   14,932    12,514 
Prepaids, deposits, and other current assets   3,539    3,503 
Deferred income taxes   384    373 
   Total current assets   50,741    50,075 
Property, plant, and equipment, net   9,320    7,405 
Intangible assets, net   1,206    1,380 
Goodwill   1,786    1,786 
Deferred income taxes   647    626 
Other assets   672    659 
   Total assets  $64,372   $61,931 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
Current liabilities:          
Line of credit  $4,900   $4,750 
Accounts payable   5,269    6,263 
Deferred income taxes   738    739 
Obligations under capital leases   445    288 
Other current liabilities   5,833    6,372 
   Total current liabilities   17,185    18,412 
Obligations under capital leases   629    141 
Deferred income taxes   1,735    1,654 
Asset retirement obligations   134    157 
Pension liability   2,858    2,715 
   Total liabilities   22,541    23,079 
           
           
           
Stockholders' equity:          
Common stock   384    379 
Additional paid-in capital   176,204    170,246 
Accumulated other comprehensive income   446    282 
Accumulated deficit   (135,203)   (132,055)
   Total stockholders' equity   41,831    38,852 
   Total liabilities and stockholders' equity  $64,372   $61,931 

 

 

 
 

 

 

STAAR Surgical Company

Condensed Consolidated Statements of Operations

(In 000's except for per share data)

Unaudited                                        

 

   Three Months Ended   Six Months Ended 
   % of   July 4,   % of   June 28,   Fav (Unfav)   % of   July 4,   % of   June 28,   Fav (Unfav) 
   Sales   2014   Sales   2013   Amount   %   Sales   2014   Sales   2013   Amount   % 
                                                 
Net sales   100.0%  $20,048    100.0%  $18,164   $1,884    10.4%   100.0%  $40,226    100.0%  $36,165   $4,061    11.2%
                                                             
Cost of sales   31.8%   6,381    30.5%   5,544    (837)   -15.1%   31.5%   12,675    30.1%   10,891    (1,784)   -16.4%
                                                             
Gross profit   68.2%   13,667    69.5%   12,620    1,047    8.3%   68.5%   27,551    69.9%   25,274    2,277    9.0%
                                                             
Selling, general and administrative expenses:                                                            
  General and administrative   26.5%   5,321    21.6%   3,923    (1,398)   -35.6%   26.6%   10,717    21.8%   7,881    (2,836)   -36.0%
  Marketing and selling   35.0%   7,026    31.2%   5,659    (1,367)   -24.2%   32.7%   13,164    30.3%   10,945    (2,219)   -20.3%
  Research and development   12.5%   2,498    9.3%   1,686    (812)   -48.2%   14.9%   5,981    8.4%   3,052    (2,929)   -96.0%
  Medical device excise tax   0.3%   47    0.2%   45    (2)   -100.0%   0.3%   87    0.3%   104    17    -100.0%
     Selling, general, and administrative expenses   74.3%   14,892    62.3%   11,313    (3,579)   -31.6%   74.5%   29,949    60.8%   21,982    (7,967)   -36.2%
  Other general and administrative expenses   0.8%   165    3.4%   613    448    73.1%   0.8%   334    4.2%   1,514    1,180    77.9%
                                                             
     Total selling, general and administrative expenses   75.1%   15,057    65.7%   11,926    (3,131)   -26.3%   75.3%   30,283    65.0%   23,496    (6,787)   -28.9%
                                                             
Operating income (loss)   -6.9%   (1,390)   3.8%   694    (2,084)   300.3%   -6.8%   (2,732)   4.9%   1,778    (4,510)   -253.7%
                                                             
Other income (expense):                                                            
  Interest income   0.0%   10    0.0%   8    2    25.0%   0.0%   18    0.0%   15    3    20.0%
  Interest expense   -0.2%   (34)   -0.2%   (41)   7    17.1%   -0.2%   (67)   -0.2%   (96)   29    30.2%
  Gain (loss) on foreign currency transactions   -0.7%   (134)   0.4%   77    (211)   274.0%   -0.2%   (68)   -0.7%   (264)   196    74.2%
  Other income, net   0.6%   126    0.8%   139    (13)   -9.4%   0.7%   287    0.6%   230    57    24.8%
    Total other income (expense), net   -0.2%   (32)   1.0%   183    (215)   100.0%   0.4%   170    -0.3%   (115)   285    -247.8%
                                                             
Income (loss) before provision for income taxes   -7.1%   (1,422)   4.8%   877    (2,299)   262.1%   -6.4%   (2,562)   4.6%   1,663    (4,225)   254.1%
                                                             
Provision for income taxes   1.8%   367    3.3%   599    232    38.7%   1.4%   586    2.5%   914    328    35.9%
                                                             
Net income (loss)   -8.9%  $(1,789)   1.5%  $278   $(2,067)   743.5%   -7.8%  $(3,148)   2.1%  $749   $(3,897)   520.3%
                                                             
                                                             
                                                             
Net income (loss) per share - basic       $(0.05)       $0.01                  $(0.08)       $0.02           
Net income (loss) per share - diluted       $(0.05)       $0.01                  $(0.08)       $0.02           
                                                             
Weighted average shares outstanding - basic        38,168         36,496                   37,970         36,461           
Weighted average shares outstanding - diluted        38,168         38,342                   37,970         37,887           

 

 

 

 
 

 

 

STAAR Surgical Company

Condensed Consolidated Statements of Cash Flows

(in 000's)

Unaudited            

 

   Six Months Ended 
   July 4,   June 28, 
   2014   2013 
Cash flows from operating activities:          
   Net income (loss)  $(3,148)  $749 
   Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:          
Depreciation of property and equipment   981    840 
Amortization of intangibles   213    225 
Deferred income taxes   57    129 
Fair value adjustment of warrant   -    (27)
Loss on disposal of property and equipment   -    59 
Stock-based compensation expense   3,183    2,019 
Change in net pension liability   83    57 
Accretion of asset retirement obligation   2    7 
Provision for sales returns and bad debts   1    111 
   Changes in working capital:          
Accounts receivable trade, net   (1,895)   (2,229)
Inventories   (2,093)   71 
Prepaids, deposits and other current assets   (20)   (507)
Accounts payable   (874)   (1,123)
Other current liabilities   (554)   (25)
      Net cash provided by (used in) operating activities   (4,064)   356 
           
Cash flows from investing activities:          
Acquisition of property and equipment   (2,269)   (2,017)
Cash proceeds from sale of property and equipment   68    - 
      Net cash used in investing activities   (2,201)   (2,017)
           
Cash flows from financing activities:          
Repayment of capital lease lines of credit   (251)   (478)
Proceeds from exercise of stock options   2,632    952 
      Net cash provided by financing activities   2,381    474 
           
Effect of exchange rate changes on cash and cash equivalents   116    (763)
           
Decrease in cash and cash equivalents   (3,768)   (1,950)
Cash and cash equivalents, at beginning of the period   22,954    21,675 
Cash and cash equivalents, at end of the period  $19,186   $19,725 

 

 
 

 

STAAR Surgical Company

Global Sales

(in 000's)

Unaudited

                           

 

                                         
   Three Months Ended   Six Months Ended 
       July 4,       June 28,   % Change       July 4,       June 28,   % Change 
Geographic Sales      2014       2013   Fav (Unfav)       2014       2013   Fav (Unfav) 
United States   14.6%  $2,926    17.4%  $3,154    -7.2%   14.4%  $5,801    17.7%  $6,394    -9.3%
                                                   
Japan   22.7%   4,549    25.6%   4,648    -2.1%   23.8%   9,557    26.0%   9,387    1.8%
Korea   9.7%   1,952    10.1%   1,834    6.4%   11.4%   4,573    10.7%   3,869    18.2%
China   12.6%   2,535    12.3%   2,230    13.7%   11.8%   4,759    11.9%   4,301    10.6%
Spain   7.4%   1,474    6.4%   1,163    26.7%   7.7%   3,092    6.8%   2,454    26.0%
France   5.9%   1,190    3.3%   595    100.0%   5.3%   2,136    3.1%   1,127    89.5%
Germany   5.1%   1,015    3.4%   611    66.1%   4.8%   1,912    3.1%   1,126    69.8%
Other   22.0%   4,407    21.6%   3,929    12.2%   20.8%   8,396    20.8%   7,507    11.8%
  Total International Sales   85.4%   17,122    82.6%   15,010    14.1%   85.6%   34,425    82.3%   29,771    15.6%
                                                   
    Total Sales   100.0%  $20,048    100.0%  $18,164    10.4%   100.0%  $40,226    100.0%  $36,165    11.2%
                                                   
                                                   
Product Sales                                                  
  Core products                                                  
    ICLs   60.7%  $12,172    62.0%  $11,261    8.1%   60.7%  $24,413    60.5%  $21,892    11.5%
    IOLs   32.1%   6,428    32.3%   5,863    9.6%   32.4%   13,041    33.8%   12,211    6.8%
  Total core products   92.8%   18,600    94.3%   17,124    8.6%   93.1%   37,454    94.3%   34,103    9.8%
  Non-core products                                                  
    Other   7.2%   1,448    5.7%   1,040    39.2%   6.9%   2,772    5.7%   2,062    34.4%
    Total Sales   100.0%  $20,048    100.0%  $18,164    10.4%   100.0%  $40,226    100.0%  $36,165    11.2%

 

 
 

 

 

STAAR Surgical Company            
Reconciliation of Non-GAAP Financial Measure            
(in 000's)            

Unaudited  Three Months Ended   Six Months Ended 
   July 4,   June 28,   July 4,   June 28, 
   2014   2013   2014   2013 
Net income (loss) - (as reported)  $(1,789)  $278   $(3,148)  $749 
Less:                    
  Manufacturing consolidation expenses   165    613    334   $1,514 
  Spain distribution transition cost   -    -    -   $442 
  Foreign currency impact   134    (77)   68   $264 
  Fair value adjustment of warrants   -    -    -   $(27)
  Stock-based compensation expense   1,683    985    3,183   $2,019 
  FDA panel expense - Toric ICL   98    -    1,492   $- 
Net income - (adjusted)  $291   $1,799   $1,929   $4,961 
                     
Net income (loss) per share, basic - (as reported)  $(0.05)  $0.01   $(0.08)  $0.02 
  Manufacturing consolidation expenses   0.00    0.02    0.01    0.04 
  Spain distribution transition cost   -    -    -    0.01 
  Foreign currency impact   0.00    (0.00)   0.00    0.01 
  Fair value adjustment of warrants   -    -    -    (0.00)
  Stock-based compensation expense   0.04    0.03    0.08    0.06 
  FDA panel expense - Toric ICL   0.00    -    0.04    - 
Net income per share, basic - (adjusted)  $0.01   $0.05   $0.05   $0.14 
                     
Net income (loss) per share, diluted - (as reported)  $(0.04)  $0.01   $(0.08)  $0.02 
  Manufacturing consolidation expenses   0.00    0.02    0.01    0.04 
  Spain distribution transition cost   -    -    -    0.01 
  Foreign currency impact   0.00    (0.00)   0.00    0.01 
  Fair value adjustment of warrants   -    -    -    (0.00)
  Stock-based compensation expense   0.04    0.03    0.08    0.05 
  FDA panel expense - Toric ICL   0.00    -    0.04    - 
Net income per share, diluted - (adjusted)  $0.01   $0.05   $0.05   $0.13 
                     
Weighted average shares outstanding - Basic   38,168    36,496    37,970    36,461 
Weighted average shares outstanding - Diluted   40,557    38,342    40,514    37,887 

 

Note:  Net income per share (adjusted), basic and diluted, may not add up due to rounding    

 

 

 
 

 

 

STAAR Surgical Company                    
Reconciliation of Non-GAAP Financial Measure                
Constant Currency Sales                    
(in 000's)                      
Unaudited                      

 

   Three Months Ended 
   GAAP Sales                             
   July 4,   Effect of   Constant   June 28,   As Reported   Constant Currency 
   2014   Currency   Currency   2013   $ Change   % Change   $ Change   % Change 
 ICL  $12,172   $19   $12,191   $11,261   $911    8%  $930    8%
 IOL  $6,428    44    6,472    5,863    565    10%   609    10%
 Other   1,448    27    1,475    1,040    408    39%   435    42%
 Total Sales  $20,048   $90   $20,138   $18,164   $1,884    10%  $1,974    11%
                                         

 

   Six Months Ended 
   GAAP Sales                             
   July 4,   Effect of   Constant   June 28,   As Reported   Constant Currency 
   2014   Currency   Currency   2013   $ Change   % Change   $ Change   % Change 
 ICL  $24,413   $34   $24,447   $21,892   $2,521    12%  $2,555    12%
 IOL   13,041    526    13,567    12,211    830    7%   1,356    11%
 Other   2,772    121    2,893    2,062    710    34%   831    40%
 Total Sales  $40,226   $681   $40,907   $36,165   $4,061    11%  $4,742    13%

 

 

 


Exhibit 99.2

 

1 NASDAQ: STAA Q2 2014 Results – Investor Presentation July 31, 2014

 
 

Forward - Looking Statements All statements in this press release that are not statements of historical fact are forward - looking statements, including statements about any of the following: any projections of earnings, revenue, sales, profit margins, cash, effective tax rate or any other financial items; the plans, strategies, and o bje ctives of management for future operations or prospects for achieving such plans; metrics for 2014; statements regarding new or improved products, including but not limite d t o, expectations for success of new or improved products in the U.S. or international markets or government approval of new or improved products (including the Toric ICL in the U.S.); the nature, timing and likelihood of resolving issues sited in the FDA’s Warning Letter; future economic conditions or size of market opportunities; expected IOL bac korder position; expected costs of Monrovia facility expansion; expected costs and savings from business consolidation plans and the timetable for those plans; statement s o f belief, including as to achieving 2014 growth plans or metrics; expected regulatory activities and approvals, product launches, and any statements of assumptions underlyin g a ny of the foregoing. Important additional factors that could cause actual results to differ materially from those indicated by such forward - looking statements are set forth in th e company’s Annual Report on Form 10 - K for the year ended January 3, 2014, under the caption “Risk Factors,” and also in the company’s Quarterly Report on Form 10 - Q for the qu arter ended July 4, 2014, under the caption “Risk Factors,” both of which are on file with the Securities and Exchange Commission and available in the “Investor Informat ion ” section of the company’s website under the heading “SEC Filings . These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous r isk s 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 unstable global economic con dit ions on sales of products, especially products such as the ICL used in non - reimbursed elective procedures; the challenge of managing our foreign subsidiaries; backlog or supply del ays as we fully integrate our manufacturing facility consolidation; the risk of unfavorable changes in currency exchange rate; the discretion of regulatory agencies to a ppr ove or reject new or improved products, or to require additional actions before approval (including but not limited to FDA requirements regarding the TICL and/or actions related t o t he FDA Warning Letter); unexpected costs or delays that could reduce or eliminate the expected benefits of our consolidation plans; the risk that research and developmen t e fforts will not be successful or may be delayed in delivering for launch; the purchasing patterns of our distributors carrying inventory in the market; the willingness of surge ons and patients to adopt a new or improved product and procedure; patterns of Visian ICL use that have typically limited our penetration of the refractive procedure market, and a g ene ral decline in the demand for refractive surgery particularly in the U.S. and the Asia Pacific region, which STAAR believes has resulted from both concerns about the safety a nd effectiveness of laser procedures and current economic conditions. The Visian Toric ICL and the Visian ICL with CentraFLOW are not yet approved for sale in the United States . In addition, to supplement the GAAP numbers, this presentation includes supplemental non - GAAP financial information, which STAAR believes investors will find helpful in understanding its operating performance. “Adjusted Net Income” excludes the following items that are included in “Net Income (L oss)” as calculated in accordance with U.S. generally accepted accounting principles (“GAAP”): manufacturing consolidation expenses, gain or loss on foreign currency tran sactions, Spain distribution transition cost, the fair value adjustment of outstanding warrants issued in 2007, stock - based compensation expenses and FDA TICL Panel expenses. A table reconciling the GAAP information to the non - GAAP information is included in our financial release which can be found in our Form 8 - K filed on April 28, 2014 and also available on our website. 2

 
 

Agenda 2014 Annual Objectives Barry G. Caldwell Chief Executive Officer Q2 & YTD Key Financial Results Steve Brown Chief Financial Officer Operational Updates Barry G. Caldwell Chief Executive Officer 3 Q&A Session Your Questions

 
 

Key Operating Metrics for 2014 Annual Objectives • Annual Key Operating Metrics established at the beginning of 2014 are Annual Objectives to Which We Report Our Progress Quarterly – Revenue Growth of 8% to 10% – ICL Revenue Growth of 20% – Gross Margin Expansion of 300 bps – GAAP Profitable Full Year – Successfully Complete Manufacturing Consolidation by Mid - Year 4

 
 

2014 Annual Objectives Report Revenue Growth • Q2 Revenue Growth of 10% to $20.0M – $20.1M in Constant Currency (CC )/+11% – Value in Q2 2013 was 99.4 yen to USD/Q2 2014 was 101.9 • Visian ICL Revenue 60.7% of Total vs. 62.0%, IOL 32.1% vs. 32.3% • Other Low Margin Sales increased 39% • 7.2% of Revenue vs. 5.7% • H1 Revenue Growth of 11% to $40.2M/13% Growth in CC • See Opportunity for Expansion of Growth in H2 5

 
 

2014 Annual Objectives Report Revenue Growth (IOL Growth) • Q2 Sales Were $ 6.4M, Increase of $0.6M or 10% – Driven by 117% Increase in Europe, 65% Increase in China • IOL Units Increased 17% during the Quarter – Driven by 99% Unit Increase in Europe, 70% in China • Approximately $ 0.2M Backorders Remain for Europe – Backorders reduced by one half during Quarter • Supply of KS - IOLs Looks Even More Promising for H2 – Seeing the Results from Japan Q1 Investments in Consigned Accounts – Initiated KS - IOL Sales to one New Market in Europe, Plan Another in H2 6

 
 

Japan EMEA U.S. China Total Revenue in CC +$609k with Unit Increase of 17% 2014 Annual Objectives Report Q2 IOL Revenue and Unit Growth - 10% / - 9% - 11% +117% +65% +10% - 11% +99% - 12% +70% +17% Japan EMEA U.S. China Total Q2 14 Q2 13 Revenue Growth of 10% Unit Growth of 17%

 
 

Visian ICL Revenue & Procedures Increase in 9 of 12 Key Markets 2014 Annual Objectives Report Q2 ICL Growth (Continue to Gain Share Globally) APAC EMEA NA Total APAC EMEA NA Total Q2 14 Q2 13 Revenue Growth of 8% APAC +2% EMEA +22% NA (1%) Procedure Growth of 5% APAC +1% EMEA +16% NA (7%)

 
 

Visian ICL Revenue & Procedures Increase in 10 of 12 Key Markets 2014 Annual Objectives Report H1 ICL Growth (Continue to Gain Share Globally) APAC EMEA NA Total APAC EMEA NA Total Q2 14 Q2 13 Revenue Growth of 12% APAC +9% EMEA +24% NA (8%) Procedure Growth of 9% APAC +8% EMEA +20% NA (13%)

 
 

2014 Annual Objectives Report Gross Margin Expansion of 300 bps for Full Year • Headwinds Continue in Three Areas: • Geographic Mix of IOL Sales • Start up Costs for ICL in U.S. Higher • Increased Sales of Lower Margin IOL Injectors • Do Not Expect to Make up H1 Shortfalls in Gross Margin unless Something currently Not in our Projections were to Occur • Will Continue to Strive to Expand Gross Margin H2, but Not Likely to Achieve 300 bps for Full Year 10

 
 

2014 Annual Objectives Report GAAP Profitable for Full Year • Not Profitable in Q2 or H1 • Investment Spending in R&D and Sales and Marketing • Higher Expenses in General and Administrative • H2 Expect Higher Sales with Lower Operating Expenses due mainly to FDA Panel Expenses H1 offset to Some Degree by Other Expenses • Profitability of the Year Remains the Objective 11

 
 

2014 Annual Objectives Report Manufacturing Consolidation • Approximately 77% of ICLs Manufactured during Q2 Manufactured in U.S. – Excluding the over 6,500 TICLs Manufactured for U.S. in Switzerland • Last Production in Switzerland was Completed before the end of June • ICL Inventory 33% higher than end of 2013, +90% from end of Q2 2013 • Space and Equipment Remain if the Need were to Arise to Manufacture Additional ICLs in Switzerland • Our former Employees in Japan and Switzerland Deserve a Salute for their Total D edication to the Completion of this Project – Since beginning of 2012: 130 Employees Hired & 96 Employees Released 12

 
 

Q2 Adds to Solid Start to 2 014 Puts and Takes for H2 • Revenue Growth Exceeded Expectations for the Q2 & H1 – See Opportunities to Expand During H2 – KS - IOL Supply Appears to be Getting Stronger • Enhanced ICL Growth to be Driven by Penetration of New ICL Products • Expect to See Gross Margin Improvement from Completion of Consolidation though Continued Headwinds from Higher IOL Injector sales • Target Profitable H2 despite some Increased Spending Not Previously Planned 13

 
 

Q2 Key Financial Results Topics to Discuss • GAAP and non - GAAP P&L • Gross Margin Expansion Plan • Operating Expenses • Tax Provisions for the Year 14

 
 

Q2 Key Financial Results 15 Q2 2014 Q2 2013 Change Revenue $20,048 $18,164 +$1,884/+10% Gross Profit $13,667 $12,620 +$1,047/+8% Gross Profit Margin 68.2% 69.5% (130bps) Operating Expenses $15,057 $11,926 +$3,131/+26% Income Before Taxes $(1,422) $ 877 $(2,299) Income Taxes $ 367 $ 599 $ 232 Net Income $ ( 1,789) $ 278 $(2,067) Net Income per Diluted Share $(0.05) $0.01 $(0.06) 2014 GAAP ($ 000’s, except per share)

 
 

Q2 Key Financial Results 2014 Non - GAAP Measures ($ 000’s, except per share ) 16 Measure Q2 2014 Q2 2013 GAAP Net Income (loss) $(1,789) $278 Mfg. Consolidation Expenses $165 $613 Spain Distribution Transition Cost ---- ---- Foreign Currency Impact $134 $(77) Adjustment of Warrant Value ---- ----- Stock - based Compensation Expense $1,683 $985 FDA TICL Panel Expenses $ 98 ---- Adjusted Net Income $ 291 $1,799 Adjusted Net Income Per Share $0.01 $0.05

 
 

H1 Key Financial Results 17 H1 2014 H1 2013 Change Revenue $40,226 $36,165 +$4,061/+11% Gross Profit $27,551 $25,274 +$2,277/+9% Gross Profit Margin 68.5% 69.9% (140bps) Operating Expenses $30,283 $23,496 +$6,787/+29% Income Before Taxes $(2,532) $ 1,663 $(4,225) Income Taxes $ 586 $ 914 $ 328 Net Income $ ( 3,148) $ 749 $(3,897) Net Income per Diluted Share $(0.08) $0.02 $(0.10) 2014 GAAP ($ 000’s, except per share )

 
 

H1 Key Financial Results 2014 Non - GAAP Measures ($000’s, except per share ) 18 Measure H1 2014 H1 2013 GAAP Net Income (loss) $(3,148) $749 Mfg. Consolidation Expenses $334 $1,514 Spain Distribution Transition Cost ---- $442 Foreign Currency Impact $68 $264 Adjustment of Warrant Value ---- $ (27) Stock - based Compensation Expense $3,183 $2,019 FDA TICL Panel Expenses $1,492 ---- Adjusted Net Income $1,929 $4,961 Adjusted Net Income Per Share $0.05 $0.13

 
 

Gross Margin Expansion Opportunities and Headwinds • Three Headwinds to Gross Margin Totaled Negative Impact of 450 BPS • The Geographic Mix of Increased KS - IOL Sales • Negative Impact of 230 bps during Q2, Expect to Improve H2 • Increase of Lower Gross Margin IOL Injectors • Negative Impact of 8 0 bps during Q2, Headwind will Continue H2 • Start Up Costs of Manufacturing ICL in U.S. (Learning Curve) • Negative Impact of 140 bps during Q2, Expect to Improve H2 • Expect to see Enhanced ICL Growth with Increased ASP on New Products H2 • ICL Selling Price Increased by 3% in Q2 • Expect to Improve Gross Margin in H2 • Do not Expect to Be Able to Offset for H1 Headwinds in H2 unless New Opportunities appear Not Currently in our Planning 19

 
 

Operating Expenses Q2 Expenses • R&D Increased by $0.8M • Consultant expenses for Regulatory Approvals and Response to FDA Warning Letter • C osts to complete the Preloaded ICL & get V6a ICL to initial Clinical Evaluations • Sales and Marketing Increased by $1.4M • Some of Increase Related to Anticipated Launch of TICL in U.S . • Increased Presence at Ophthalmic Shows during the Quarter • G&A Increased by $1.4M • Increased Stock Compensation Expense of $700k Due to Higher Stock Price • Accrual Higher for Bonus Plan based upon Target Objectives Tracking Closely to Plan 20

 
 

Tax Provisions for 2014 How the Year Has Progressed • Income Tax Provision of $367k for Q2 2014 vs. $599k for Q2 2013 • Effective Tax Rate of 26% for Q2 • H1 Tax Provision of $586k vs. $914k in PY H1 • Effective Tax Rate of 23% for H1 • Profitability in Certain Regions Generate a Tax Liability though not Profitable in Total • Effective Tax Rate could be somewhat Higher or Lower in Q3 and Q4 • Expect Improved Tax Rate in H2 as we work through Inventory of Swiss Manufactured ICLs and Transition to U.S. Manufactured ICLs • Partial Tax Benefits from Consolidation in H1 with Greater Realization in 2015 21

 
 

2014 Key Financial Results Outlook • Gross Margin Expected to Show Recovery • H2 Should provide Expansion due to Consolidation • Increased Supply of the KS IOLs should Drive Sales into Higher Gross Margin Markets • Gross Margins should Benefit from the Commercialization of New Product Approvals • Lower Gross Margin Injector Sales will Continue to be a Drag • Operating Expenses • G&A Increases Expected to be Minimized • Continue to Invest in Sales and Marketing for Revenue Growth • Costs Associated with Warning Letter cost expected to be approximately $500k during H2 • Tax Provision for the Year • May be Some Potential Upside 22

 
 

Operational Updates Opportunities and Challenges H2 • Warning Letter • Preloaded ICL Approval in Europe and Launch Plans • V6a ICL Plans for H2 • Regulatory Approvals in Process • ESCRS Plans 23

 
 

Operational Updates FDA GMP Inspections Past 8 Years at STAAR Facilities Year Monrovia Nidau Aliso Viejo 2006 August ( No Observations ) Sept. ( No Observations ) August ( No Observations ) 2007 2008 2009 Feb. (3 Observations) June (2 Observations) 2010 Nov. ( No Observations ) 2011 2012 Jan. ( No Observations ) April ( No Observations ) 2013 August (3 Observations) 24

 
 

2/10 Inspection 3/21 483 Issued 4/11 Initial Response to 483 5/12 1 st Monthly Update 5/27 WL Received 6/13 2 nd Update, 483 & WL Data 7/18 3 rd Update + 483 & WL Data Operational Updates Inspection February 10 to March 21 Resulted in Warning Letter • We Take this Seriously and Diligently Working to Resolve – A Total of Four Responses to the Agency with Data – Three Proactive Monthly Progress Reports with Two Including Additional Data • Four Key Categories Under Review – Design Control Documents from Nidau – Validation of Software for On - Line Calculator – Data Collection and Trending on ICL Vault Complaints – Shelf Life Data on the ICL Product 25

 
 

® Operational Updates Preloaded ICL Eliminates Multiple Steps during Procedure

 
 

Operational Updates Preloaded ICL Launch Plan in European Markets 27 • Preloaded ICL with Enhanced Optics – Saves Procedure Time – Learning Curve Shortened – More Consistent Delivery – Enhanced Optic Design Increases Useful Optical Zone to Benefit Patients with Larger Pupils • New IP around Product – Design and new nanoCOAT™ Technology to Assure Integrity of ICL Delivery • CE Market Approval end of June – Initial Focus on Key Surgeon Evaluations – Full Launch at ESCRS meeting in London during September – Q4 Commercialization in Approved Markets

 
 

Operational Updates V6a ICL Plans for H2 28 • Differentiates ICL for Myopic Patients Nearing Age 40 Who Will Need Near & Intermediate Adds • Goal To Add Near - Vision Enhancement Capability – Treats the Early Onset and Progression of Presbyopia – Adds ≈2.0 Diopters of Near While Providing Good Intermediate • V6a ICLs currently being manufactured for Initial Confirmatory Study • Patients currently being Recruited • Hope to have some Initial Data to Present at ICL Users Meeting Pre - ESCRS – If not, Data will be Presented at AAO • Expect Approval and Launch in CE Markets H1 of 2015

 
 

Operational Updates Regulatory Approvals in Process 29 • ICL with CentraFLOW in China – Positive Experts Panel Meeting on May 15 th – Response Prepared for Follow up Questions from CFDA – Decision Expected within 105 Working Days • TICL in U.S. – Have Provided Data to Agency since Favorable Advisory Panel Vote upon Request • Data in Regard to the Sensitivity Analysis on Protocol Deviations • ICL Calculator Software for U.S. Market – Questions from Agency in July requiring Additional Data

 
 

Operational Updates ESCRS Plans (Visian ICL Experts Meeting) 30 • Goal is for 300 Attending ICL Surgeons – Nearly Double of Attendance in 2013 – Over 240 currently Confirmed Attendance • Key Topics for Meeting – Success of ICL with CentraFLOW – Surgeon Experience with the Preloaded ICL – Plan for some Initial Data on the V6a ICL • Plan for a Dedicated Session for Chinese Surgeons on CentraFLOW

 
 

Operational Updates ESCRS Plans 31 • Largest Exhibit Presence in our History at ESCRS • Focused Products will be Preloaded ICL and nanoFLEX Toric IOL • Planned Booth Presentations – Featuring Preloaded ICL Experience, CentraFLOW Experience and Early Experience with the V6a ICL • Lunch Symposium on ICL Planned for 250+ Surgeons

 
 

• Expanded ICL with CentraFLOW approvals to Key Markets – Japan March 3 rd Approval – China May Experts Panel Meeting May 15 th Positive • CE Mark Approval of Preloaded ICL at End of June, Launch at ESCRS Meeting • Have Provided Additional Information, as Requested, to FDA after Favorable Vote at FDA Panel Meeting March 14 th • P&L Contributions from Consolidation Benefits H2 14 • Increased Supply of Preloaded Acrylic IOLs in H2 14 • Confirmatory Study of V6a to Start Q3 32 Key Drivers for Growth Upcoming STAAR Catalysts

 
 

Upcoming Investor Meetings • August 12 th at Wedbush Healthcare Conference in New York City • August 13 th at Canaccord Genuity Conference in Boston • Planned Investor Road Show August 19 th & 20 th • ICL Experts Meeting in London September 11 th & 12 th Pre - ESCRS • Investor Breakfast at AAO on Saturday October 18 th in Chicago – Expect to Share Clinical Experiences with Preloaded & Data on V6a ICL • We Expect to Report our Q3 Results on October 29 th 33

 
 

Thank You YOUR QUESTIONS PLEASE 34

 
 

35 NASDAQ: STAA Q2 2014 Results – Investor Presentation July 31, 2014