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): | August 1, 2012 |
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 August 1, 2012, STAAR Surgical Company (the “Company”) published a press release reporting its financial results for the quarter ended June 29, 2012, 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.
On August 1, 2012, the Company held a conference call to discuss the financial results for the quarter ended June 29, 2012.
The Company provided slides to accompany its presentation on the August 1, 2012 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 August 1, 2012 | |
99.2 |
Slide presentation dated May 2, 2012 |
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 | ||
August 1, 2012 | By: | /s/ Barry G. Caldwell |
Barry G. Caldwell | ||
President and Chief Executive Officer |
STAAR Surgical Reports Second Quarter 2012 Financial Results
Visian® ICL™ Revenue Increases 4% Year over Year
Gross Margin of 69.3%, 250 Basis Points Above 2Q 2011
$1.7 Million in Cash Generated from Operations; Cash Position Increases to $17.5 Million
MONROVIA, CA, August 1, 2012 -- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today reported that sales of its Visian ICL product in the second quarter ended June 29, 2012 increased 4% to $8.6 million. Total revenue was $15.9 million, down 2% from $16.3 million in the second quarter of 2011. Gross margin of 69.3% was 250 basis points above the 66.8% margin in the second quarter of 2011. The year over year gross margin improvement continues to reflect the increased contribution of Visian ICL sales and margin improvement in IOLs based on increased prices and lower cost.
Net loss, calculated in accordance with GAAP, was $491,000, or $(0.01) per share, compared with net income of $861,000, or $0.02 per diluted share, in the second quarter of 2011. Adjusted net income (excluding manufacturing consolidation expenses, gain (loss) on foreign currency transactions, fair value adjustment of warrants, and share-based compensation expense) for the quarter ended June 29, 2012 was $1.0 million, or $0.03 per diluted share. Adjusted net income for the year ago quarter was $1.4 million, or $0.04 per diluted share. Cash and cash equivalents at June 29, 2012 totaled $17.5 million.
“As we reported earlier in July, our nine consecutive quarters of year over year growth was interrupted during the second quarter due to the unusual combination of three sales limiting dynamics,” said Barry Caldwell, President and CEO. “The shortfall to revenue expectations was about $2 million. One half of that came from China where refractive procedures were flattened due to very negative media focus on the complications of LASIK. China is a market in which we have experienced tremendous growth over the past two and a half years. We’ve seen this dynamic in other markets before and believe recovery trends will become apparent by the end of the year. The second dynamic impacting our growth was the timing of a stocking order from our Korean distributor for their upcoming peak season. The third dynamic was our planned transition to a direct selling model for our Visian ICL in Spain that had a negative impact on our sales, though the now completed transition will provide meaningful revenue upside in Spain during the second half of the year. These three negative dynamics were partially offset by strong Visian ICL revenue increases in Japan, Germany, Italy, India, Latin America, U.S. and Italy,” added Mr. Caldwell.
“We believe that our expanding efforts to build sales of our Visian ICL and IOL products globally will lead to an increased growth rate in the second half of 2012. During the second half of the year, STAAR has several dynamics which should help propel revenue growth, including:
· | Hiring 13 of the budgeted 16 new employees in the sales and marketing area with a particular focus on consumer awareness programs. |
· | ICL revenues in Spain should basically double as compared to the prior year with the shift to recognizing end customer pricing as opposed to distributor pricing in the past. |
· | STAAR will continue to expand penetration of the V4c ICL in the currently approved markets and add additional market approvals. |
· | The KS-SP preloaded single piece acrylic IOL will begin shipping to Japan and Europe during August. |
· | The nanoFLEX Toric IOL will begin shipping in Europe during August as well and both new IOLs will be highlighted at the upcoming ESCRS meeting during September. |
“We continued solid execution on our plan to consolidate manufacturing and recorded approximately $0.7 million in expenses for that effort in the second quarter. The project is on schedule and is expected to help drive our gross margins to nearly 80% and reduce our current tax rate of 50% to 10% beginning in 2014.”
“As a result of these encouraging opportunities, we are well positioned for a significantly improved financial performance in the second half of 2012 and have updated our annual key target metrics for the next six month period that reflect our analysis. Furthermore, we’re introducing today metrics for the second half of the year to illustrate the rebound we are focused on achieving,” concluded Mr. Caldwell.
Second Half 2012 Key Metrics
The Company introduced its key target metrics for the second half of 2012:
1. | Increase in revenues of Solid Double Digit Growth. |
2. | Increase in Visian ICL revenues of 25%. |
3. | Continuous expansion of gross margins to achieve 71% for the full year. |
4. | Achieve profitability in Q3 and Q4. |
5. | Implement manufacturing consolidation with no disruption to customer supply requirements. This metric will be measured by the amount of customer backorders. |
Full Year 2012 Key Metrics
Achieving the second half key metrics would result in the following modification for the full year 2012 Key Metrics:
1. | Revenue growth of high single digits. |
2. | ICL revenue growth of nearly 20%. |
2 |
The final three metrics are unchanged.
Recent Visian Implantable Collamer® Lens (ICL) Highlights
· | Second quarter Visian ICL sales grew to $8.6 million, a 4% increase from $8.3 million in the second quarter of 2011. |
· | Sales in Europe grew 28% excluding Spain. 56% of total ICL sales to European markets during the second quarter of 2012 were of the Visian V4c ICL. There have been over 5,000 implants of the V4c in Europe with the AquaPORT performing as expected. |
· | During the second quarter of 2012 the Company transitioned the business in Spain from an indirect model to a direct distribution model. That negative impact for comparative purposes was approximately $0.5 million. |
· | ICL sales in North America and the U.S. increased by 5% during the quarter. Sales to private sector accounts increased by 6% while military sales of ICLs during the quarter increased 1% from the prior year. The Company expects to see continued improvement in military ICL sales during the second half of 2012 due both to returning surgeons and the expansion of surgeons using the Visian ICL. |
Recent Intraocular Lens (IOL) Highlights
· | Second quarter IOL sales decreased 4%, or $0.3 million, to $6.8 million compared with $7.1 million in the second quarter of 2011. |
· | Preloaded IOL revenues to China and Japan increased by 11% during the quarter. |
· | In the U.S. and Europe IOL revenues decreased. This was led in the U.S. by declines in silicone IOLs and competitive pricing in which the Company did not participate. In Europe the Company continued to lose pace without the KS-SP IOL which will be available during the third quarter. |
· | IOL gross margins improved by 300 basis points to 60% for the quarter, reflecting an improved gross margin percentage in all five categories of IOLs year over year. |
· | During the third quarter the KS-SP Preloaded Single Piece Acrylic IOL will be available in Japan and Europe. The nanoFLEX Toric IOL will also be available in Europe during the third quarter. Both new IOLs will be available for shipment for the entire fourth quarter. |
Second Quarter Financial Highlights
· | Total net sales in the second quarter decreased 2%, or $0.3 million, to $15.9 million from $16.3 million in the second quarter of 2011. Net sales were also negatively affected by over $0.3 million, or 38%, decline in sales of the “other” product category, primarily legacy products. Core product sales of ICLs and IOLs were flat year over year during the quarter. |
· | Gross margin increased to 69.3% of revenue compared with 66.8% in the prior year’s second quarter. The increase reflected a higher mix of ICL to total sales of 54%, as compared to 51% during the second quarter of 2011, improved average selling prices and a 300 basis point improvement in IOL margins. The decrease in gross margin from the first quarter of 2012 is due to a higher mix of IOL sales during the second quarter. |
· | Total operating expenses were $11.2 million, a 16% increase over $9.7 million in the second quarter of 2011. Marketing and selling expenses increased to $1.2 million due to increased headcount and timing of trade show expenses. There was also a $0.2 million charge associated with the transition from distributor to direct sales model in Spain. This expense will continue through February of 2013, at which time the normal logistics costs of being direct in a market will begin. Manufacturing consolidation expenses totaled $0.7 million during the quarter. Excluding these transitional expenses, operating expenses were $10.3 million, an 8% increase over the 2011 second quarter. The non-cash charge during the quarter for stock-based compensation increased by $0.3 million compared to the second quarter of 2011. |
· | Other income was breakeven versus $160,000 in the prior year period. This was driven by a decrease in gains on foreign currency transactions and lower royalty income offset by a decrease in interest expense and the fair value of outstanding warrants. |
· | GAAP net loss in the second quarter of 2012 was $491,000, or $(0.01) per share, compared with net income in the second quarter last year of $861,000, or $0.02 per diluted share. Adjusted net income was $1.0 million, or $0.03 per diluted share, compared with adjusted net income during the second quarter of 2011 of $1.4 million, or $0.04 per diluted share. |
· | Cash and cash equivalents and restricted cash totaled $17.5 million at June 29, 2012 compared with $16.4 million at March 30, 2012 and $16.7 million at December 30, 2011. The Company generated $1.7 million in cash from operating activities during the second quarter. |
3 |
Conference Call
The Company will host a conference call and video webcast today, August 1, 2012 at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss the Company's second quarter 2012 financial results and recent corporate developments. The dial-in number for the conference call is 800-762-8779 for domestic participants and 480-629-9645 for international participants.
The Company will also be using slides to illustrate its second quarter 2012 results and operational progress. The slides and live webcast of the call can be accessed from the investor relations section of the STAAR website 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. “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, gain or loss on foreign currency transactions, the fair value adjustment of outstanding warrants issued in 2007, and stock-based compensation expenses.
We believe that “Adjusted Net Income” is useful to investors in gauging the outcome of the key drivers of our business performance: our 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 we have control.
4 |
We have excluded manufacturing consolidation expenses because these are non-recurring expenses and their inclusion may mask underlying trends in our business performance.
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 Statement of Financial Accounting
Standards (“SFAS”) No. 123R. 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. 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.” Over 300,000 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: any projections of earnings, revenue, sales, profit margins, cash or any other financial items; the plans, strategies, and objectives of management for future operations or prospects for achieving such plans; statements regarding new products, including but not limited to, expectations for success of the new ICL or other products in the U.S. or international markets or government approval of new products, the outcome of product research or development of future economic conditions or performance, size of market opportunities, expected savings from business consolidation plans and the timetable for those 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 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 as we prepare for our manufacturing facility consolidation; the risk of unfavorable changes in currency exchange rate; the discretion of regulatory agencies to approve or reject new products, or to require additional actions before approval; 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 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 particularly in the U.S. and China, 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 V4c are not yet approved for sale in the United States.
CONTACT: | Investors | Media |
EVC Group | EVC Group | |
Jenifer Kirtland, 415-568-9349 | Christopher Gale, 646-201-5431 | |
Douglas Sherk, 415-652-9100 |
6 |
STAAR Surgical Company | ||||||||
Condensed Consolidated Balance Sheets | ||||||||
(in 000's) | ||||||||
June 29, | December 30, | |||||||
2012 | 2011 | |||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 17,544 | $ | 16,582 | ||||
Restricted cash | - | 129 | ||||||
Accounts receivable trade, net | 8,628 | 9,089 | ||||||
Inventories, net | 11,258 | 10,933 | ||||||
Prepaids, deposits, and other current assets | 2,059 | 1,921 | ||||||
Total current assets | 39,489 | 38,654 | ||||||
Property, plant, and equipment, net | 4,651 | 4,222 | ||||||
Intangible assets, net | 2,585 | 2,989 | ||||||
Goodwill | 1,786 | 1,786 | ||||||
Deferred income taxes | 150 | 152 | ||||||
Other assets | 1,184 | 1,203 | ||||||
Total assets | $ | 49,845 | $ | 49,006 | ||||
Current liabilities: | ||||||||
Line of credit | $ | 2,520 | $ | 2,580 | ||||
Accounts payable | 3,139 | 4,261 | ||||||
Deferred income taxes | 472 | 472 | ||||||
Obligations under capital leases | 872 | 597 | ||||||
Other current liabilities | 6,241 | 6,106 | ||||||
Total current liabilities | 13,244 | 14,016 | ||||||
Obligations under capital leases | 712 | 1,124 | ||||||
Deferred income taxes | 791 | 708 | ||||||
Other long-term liabilities | 719 | 940 | ||||||
Pension obligations | 2,892 | 2,760 | ||||||
Total liabilities | 18,358 | 19,548 | ||||||
Stockholders' equity: | ||||||||
Common stock | 363 | 360 | ||||||
Additional paid-in capital | 159,880 | 157,383 | ||||||
Accumulated other comprehensive income | 2,193 | 2,405 | ||||||
Accumulated deficit | (130,949 | ) | (130,690 | ) | ||||
Total stockholders' equity | 31,487 | 29,458 | ||||||
Total liabilities and stockholders' equity | $ | 49,845 | $ | 49,006 |
7 |
STAAR Surgical Company | ||||||||||||||||||||||||||||||||||||||||||||||||
Condensed Consolidated Statements of Operations | ||||||||||||||||||||||||||||||||||||||||||||||||
(In 000's except for per share data) | ||||||||||||||||||||||||||||||||||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||
% of | June 29, | % of | July 1, | Change | % of | June 29, | % of | July 1, | Change | |||||||||||||||||||||||||||||||||||||||
Sales | 2012 | Sales | 2011 | Amount | % | Sales | 2012 | Sales | 2011 | Amount | % | |||||||||||||||||||||||||||||||||||||
Net sales | 100.0 | % | $ | 15,942 | 100.0 | % | $ | 16,269 | $ | (327 | ) | -2.0 | % | 100.0 | % | $ | 31,451 | 100.0 | % | $ | 31,118 | $ | 333 | 1.1 | % | |||||||||||||||||||||||
Cost of sales | 30.7 | % | 4,897 | 33.2 | % | 5,408 | 511 | -9.4 | % | 30.2 | % | 9,504 | 34.2 | % | 10,628 | 1,124 | -10.6 | % | ||||||||||||||||||||||||||||||
Gross profit | 69.3 | % | 11,045 | 66.8 | % | 10,861 | 184 | 1.7 | % | 69.8 | % | 21,947 | 65.8 | % | 20,490 | 1,457 | 7.1 | % | ||||||||||||||||||||||||||||||
Selling, general and administrative expenses: | ||||||||||||||||||||||||||||||||||||||||||||||||
General and administrative | 22.7 | % | 3,633 | 24.0 | % | 3,905 | (272 | ) | -7.0 | % | 23.7 | % | 7,493 | 23.5 | % | 7,303 | 190 | 2.6 | % | |||||||||||||||||||||||||||||
Marketing and selling | 33.7 | % | 5,366 | 25.8 | % | 4,200 | 1,166 | 27.8 | % | 31.9 | % | 10,029 | 27.8 | % | 8,659 | 1,370 | 15.8 | % | ||||||||||||||||||||||||||||||
Research and development | 9.5 | % | 1,513 | 8.6 | % | 1,393 | 120 | 8.6 | % | 9.7 | % | 3,059 | 9.1 | % | 2,825 | 234 | 8.3 | % | ||||||||||||||||||||||||||||||
Selling, general, and administrative expenses | 65.9 | % | 10,512 | 58.4 | % | 9,498 | 1,014 | 10.7 | % | 65.4 | % | 20,581 | 60.4 | % | 18,787 | 1,794 | 9.5 | % | ||||||||||||||||||||||||||||||
Other general and administrative expenses | 4.4 | % | 697 | 1.2 | % | 193 | 504 | 261.1 | % | 4.0 | % | 1,252 | 1.0 | % | 325 | 927 | 285.2 | % | ||||||||||||||||||||||||||||||
Total selling, general and administrative expenses | 70.3 | % | 11,209 | 59.6 | % | 9,691 | 1,518 | 15.7 | % | 69.4 | % | 21,833 | 61.4 | % | 19,112 | 2,721 | 14.2 | % | ||||||||||||||||||||||||||||||
Operating (loss) income | -1.0 | % | (164 | ) | 7.2 | % | 1,170 | (1,334 | ) | -114.0 | % | 0.4 | % | 114 | 4.4 | % | 1,378 | (1,264 | ) | -91.7 | % | |||||||||||||||||||||||||||
Other income (expense): | ||||||||||||||||||||||||||||||||||||||||||||||||
Interest income | 0.0 | % | 7 | 0.0 | % | 5 | 2 | 40.0 | % | 0.0 | % | 7 | 0.1 | % | 18 | (11 | ) | -61.1 | % | |||||||||||||||||||||||||||||
Interest expense | -0.4 | % | (67 | ) | -0.9 | % | (153 | ) | 86 | -56.2 | % | -0.5 | % | (162 | ) | -1.0 | % | (306 | ) | 144 | -47.1 | % | ||||||||||||||||||||||||||
(Loss) Gain on foreign currency transactions | -1.6 | % | (249 | ) | 0.4 | % | 72 | (321 | ) | -445.8 | % | -0.6 | % | (182 | ) | 1.4 | % | 444 | (626 | ) | -141.0 | % | ||||||||||||||||||||||||||
Other income, net | 1.9 | % | 309 | 1.5 | % | 236 | 73 | 30.9 | % | 1.7 | % | 523 | 1.3 | % | 399 | 124 | 31.1 | % | ||||||||||||||||||||||||||||||
Total other income | 0.0 | % | 0 | 1.0 | % | 160 | (160 | ) | -100.0 | % | 0.6 | % | 186 | 1.8 | % | 555 | (369 | ) | -66.5 | % | ||||||||||||||||||||||||||||
(Loss) income before provision for income taxes | -1.0 | % | (164 | ) | 8.2 | % | 1,330 | (1,494 | ) | -112.3 | % | 1.0 | % | 300 | 6.2 | % | 1,933 | (1,633 | ) | -84.5 | % | |||||||||||||||||||||||||||
Provision for income taxes | 2.1 | % | 327 | 3.0 | % | 469 | (142 | ) | -30.3 | % | 1.8 | % | 559 | 2.6 | % | 772 | (213 | ) | -27.6 | % | ||||||||||||||||||||||||||||
Net (loss) income | -3.1 | % | $ | (491 | ) | 5.3 | % | $ | 861 | $ | (1,352 | ) | -157.0 | % | -0.8 | % | $ | (259 | ) | 3.7 | % | $ | 1,161 | $ | (1,420 | ) | -122.3 | % | ||||||||||||||||||||
Net (loss) Income per share-basic | $ | (0.01 | ) | $ | 0.02 | $ | (0.01 | ) | $ | 0.03 | ||||||||||||||||||||||||||||||||||||||
Net (loss) Income per share-diluted | $ | (0.01 | ) | $ | 0.02 | $ | (0.01 | ) | $ | 0.03 | ||||||||||||||||||||||||||||||||||||||
Weighted average shares outstanding - basic | 36,257 | 35,443 | 36,164 | 35,316 | ||||||||||||||||||||||||||||||||||||||||||||
Weighted average shares outstanding - diluted | 36,257 | 36,439 | 36,164 | 36,389 |
8 |
STAAR Surgical Company | ||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||
(in 000's) | ||||||||
Six Months Ended | ||||||||
June 29, | July 1, | |||||||
2012 | 2011 | |||||||
Cash flows from operating activities: | ||||||||
Net (loss) income | $ | (259 | ) | $ | 1,161 | |||
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | ||||||||
Depreciation of property and equipment | 627 | 598 | ||||||
Amortization of intangibles | 350 | 394 | ||||||
Deferred income taxes | 82 | 118 | ||||||
Fair value adjustment of warrant | (207 | ) | (182 | ) | ||||
Loss (gain) on disposal of property and equipment | 31 | (14 | ) | |||||
Stock-based compensation expense | 1,481 | 807 | ||||||
Change in net pension liability | 136 | 62 | ||||||
Other | 71 | (32 | ) | |||||
Changes in working capital: | ||||||||
Accounts receivable | 334 | 263 | ||||||
Inventories | (344 | ) | 779 | |||||
Prepaids, deposits and other current assets | (138 | ) | 23 | |||||
Accounts payable | (1,089 | ) | (273 | ) | ||||
Other current liabilities | 153 | (793 | ) | |||||
Net cash provided by operating activities | 1,228 | 2,911 | ||||||
Cash flows from investing activities: | ||||||||
Acquisition of property and equipment | (833 | ) | (207 | ) | ||||
Release of restricted cash | 129 | - | ||||||
Proceeds from sale of property and equipment | - | 26 | ||||||
Net change in other assets | - | 47 | ||||||
Net cash used in investing activities | (704 | ) | (134 | ) | ||||
Cash flows from financing activities: | ||||||||
Repayment of capital lease lines of credit | (438 | ) | (228 | ) | ||||
Proceeds from exercise of stock options | 950 | 1,216 | ||||||
Net cash provided by financing activities | 512 | 988 | ||||||
Effect of exchange rate changes on cash and cash equivalents | (74 | ) | (141 | ) | ||||
Increase in cash and cash equivalents | 962 | 3,624 | ||||||
Cash and cash equivalents, at beginning of the period | 16,582 | 9,376 | ||||||
Cash and cash equivalents, at end of the period | $ | 17,544 | $ | 13,000 |
9 |
STAAR Surgical Company | ||||||||||||||||||||||||||||||||||||||||
Global Sales | ||||||||||||||||||||||||||||||||||||||||
(in 000's) | ||||||||||||||||||||||||||||||||||||||||
Three Months Ended | Year Ended | |||||||||||||||||||||||||||||||||||||||
June 29, | July 1, | % | June 29, | July 1, | % | |||||||||||||||||||||||||||||||||||
Geographic Sales | 2012 | 2011 | Change | 2012 | 2011 | Change | ||||||||||||||||||||||||||||||||||
United States | 20.2 | % | $ | 3,216 | 22.8 | % | $ | 3,705 | -13.2 | % | 20.3 | % | $ | 6,390 | 23.3 | % | $ | 7,238 | -11.7 | % | ||||||||||||||||||||
Japan | 25.7 | % | 4,094 | 23.9 | % | 3,890 | 5.2 | % | 25.3 | % | 7,951 | 24.9 | % | 7,734 | 2.8 | % | ||||||||||||||||||||||||
Korea | 10.8 | % | 1,721 | 12.3 | % | 2,009 | -14.3 | % | 11.5 | % | 3,624 | 10.9 | % | 3,394 | 6.8 | % | ||||||||||||||||||||||||
China | 13.4 | % | 2,141 | 11.1 | % | 1,803 | 18.7 | % | 13.5 | % | 4,247 | 9.7 | % | 3,007 | 41.2 | % | ||||||||||||||||||||||||
Other | 29.9 | % | 4,770 | 29.9 | % | 4,862 | -1.9 | % | 29.4 | % | 9,239 | 31.3 | % | 9,745 | -5.2 | % | ||||||||||||||||||||||||
Total International Sales | 79.8 | % | 12,726 | 77.2 | % | 12,564 | 1.3 | % | 79.7 | % | 25,061 | 76.7 | % | 23,880 | 4.9 | % | ||||||||||||||||||||||||
Total Sales | 100.0 | % | $ | 15,942 | 100.0 | % | $ | 16,269 | -2.0 | % | 100.0 | % | $ | 31,451 | 100.0 | % | $ | 31,118 | 1.1 | % | ||||||||||||||||||||
Product Sales | ||||||||||||||||||||||||||||||||||||||||
Core products | ||||||||||||||||||||||||||||||||||||||||
ICLs | 54.0 | % | $ | 8,606 | 51.0 | % | $ | 8,293 | 3.8 | % | 54.7 | % | $ | 17,211 | 48.8 | % | $ | 15,191 | 13.3 | % | ||||||||||||||||||||
IOLs | 42.5 | % | 6,774 | 43.5 | % | 7,076 | -4.3 | % | 41.8 | % | 13,132 | 45.6 | % | 14,205 | -7.6 | % | ||||||||||||||||||||||||
Total core products | 96.5 | % | 15,380 | 94.5 | % | 15,369 | 0.1 | % | 96.5 | % | 30,343 | 94.5 | % | 29,396 | 3.2 | % | ||||||||||||||||||||||||
Non-core products | ||||||||||||||||||||||||||||||||||||||||
Other | 3.5 | % | 562 | 5.5 | % | 900 | -37.6 | % | 3.5 | % | 1,108 | 5.5 | % | 1,722 | -35.7 | % | ||||||||||||||||||||||||
Total Sales | 100.0 | % | $ | 15,942 | 100.0 | % | $ | 16,269 | -2.0 | % | 100.0 | % | $ | 31,451 | 100.0 | % | $ | 31,118 | 1.1 | % |
10 |
STAAR Surgical Company | ||||||||||||||||
Reconciliation of Non-GAAP Financial Measure | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 29, | July 1, | June 29, | July 1, | |||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||
Net income (loss) - (as reported) | $ | (491 | ) | $ | 861 | $ | (259 | ) | $ | 1,161 | ||||||
Less: | ||||||||||||||||
Manufacturing consolidation expenses | 697 | 193 | 1,252 | $ | 326 | |||||||||||
Loss (gain) on foreign currency | 249 | (72 | ) | 182 | $ | (444 | ) | |||||||||
Fair value adjustment of warrants | (222 | ) | (79 | ) | (207 | ) | $ | (182 | ) | |||||||
Stock-based compensation expense | 794 | 452 | 1,481 | $ | 807 | |||||||||||
Net income - (adjusted) | $ | 1,027 | $ | 1,355 | $ | 2,449 | $ | 1,668 | ||||||||
Net income (loss) per share, basic - (as reported) | $ | (0.01 | ) | $ | 0.02 | $ | (0.01 | ) | $ | 0.03 | ||||||
Manufacturing consolidation expenses | $ | 0.02 | $ | 0.01 | $ | 0.03 | $ | 0.01 | ||||||||
Loss (gain) on foreign currency | $ | 0.01 | $ | (0.00 | ) | $ | 0.01 | $ | (0.01 | ) | ||||||
Fair value adjustment of warrants | $ | (0.01 | ) | $ | (0.00 | ) | $ | (0.01 | ) | $ | (0.01 | ) | ||||
Stock-based compensation expense | $ | 0.02 | $ | 0.01 | $ | 0.04 | $ | 0.02 | ||||||||
Net income per share, basic - (adjusted) | $ | 0.03 | $ | 0.04 | $ | 0.07 | $ | 0.05 | ||||||||
Net income (loss) per share, diluted - (as reported) | $ | (0.01 | ) | $ | 0.02 | $ | (0.01 | ) | $ | 0.03 | ||||||
Manufacturing consolidation expenses | $ | 0.02 | $ | 0.01 | $ | 0.03 | $ | 0.01 | ||||||||
Loss (gain) on foreign currency | $ | 0.01 | $ | (0.00 | ) | $ | 0.00 | $ | (0.01 | ) | ||||||
Fair value adjustment of warrants | $ | (0.01 | ) | $ | (0.00 | ) | $ | (0.01 | ) | $ | (0.01 | ) | ||||
Stock-based compensation expense | $ | 0.02 | $ | 0.01 | $ | 0.04 | $ | 0.02 | ||||||||
Net income per share, diluted - (adjusted) | $ | 0.03 | $ | 0.04 | $ | 0.06 | $ | 0.05 | ||||||||
Weighted average shares outstanding - Basic | 36,257 | 35,443 | 36,164 | 35,316 | ||||||||||||
Weighted average shares outstanding - Diluted | 38,369 | 36,439 | 38,406 | 36,389 |
Note: Net income per share (adjusted), basic and diluted, may not add up due to rounding
11 |
Q2 2012 RESULTS Investor Presentation August 1, 2012
SAFE HARBOR All statements in this presentation that are not statements of historical fact are forward - looking statements, including any projections of earnings, revenue , sales, profit margins, cash or other financial items, any statements of the plans, strategies, and objectives of management for future operations , or prospects for achieving such plans, including but not limited to, expectations for success of the ICL or other products in U.S. or international markets, any statements concerning proposed new products and government approval of new products or developments, or other future actions of the FDA or other regulators, the outcome of product research and development or any clinical study, any statements regarding future economic conditions or performance, the size of market opportunities 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 presentation 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 our limited capital resources and limited access to financing, the broad discretion of the FDA and other regulators in approving any medical device and the inherent uncertainty that new devices will be approved, the likelihood of administrative delays, the risk that our global consolidation plans will not yield the expected savings in taxes or cost of goods or expose us to supply interruptions, the negative effect of global economic conditions on sales of products, especially products like the ICL used in non - reimbursed elective procedures, the challenge of managing our foreign subsidiaries, the risk that research and development efforts will not be successful or may be delayed in delivering for launch, the willingness of surgeons and patients to adopt a new product and procedure, and the potential effect of negative publicity about LASIK on the demand for refractive surgery in general in the U.S., and the other factors discussed under the heading “Risk Factors” in our Annual Report on Form 10 - K filed with the SEC on March 8, 2012 and in today’s press release. STAAR assumes no obligation to update its forward - looking statements to reflect future events or actual outcomes and does not intend to do so. ®
AGENDA Q2 Revenue Results Barry G. Caldwell 2012 Key Metric Review Chief Executive Officer Financial Review Deborah Andrews Project Comet Update Chief Financial Officer Growth Drivers Barry G. Caldwell Second Half Expectations Chief Executive Officer Q&A Session Your Questions ® Also present on the call will be: Hans Blickensdoerfer, President of EMEA Don Fagen, VP of Sales for North America Don Todd, President of APAC
2012 Q2 REVENUES COMPARISON TO Q2 2011 ($000’S) Q2 2012 Q2 2011 Improvement ICL Sales $ 8,606 $ 8,293 +$ 313 /+4% IOL Sales $ 6,774 $ 7,076 ($302)/ - 4% Core Product Sales $15,380 $15,369 +$11/Flat Other $ 562 $ 900 ($338)/ - 38% Total Sales $15,942 $16,269 ($327)/ - 2% ®
VISIAN ICL REVENUE GAINS INCREASE OF 13% YTD 0 1 2 3 4 5 6 7 8 9 10 Q305 Q405 Q106 Q206 Q306 Q406 Q107 Q207 Q307 Q407 Q108 Q208 Q308 Q408 Q109 Q209 Q309 Q409 Q110 Q210 Q310 Q410 Q111 Q211 Q311 Q411 Q112 Q212 Milli ons $ ®
CHINA ICL YOY REVENUE GROWTH RATE 0% 20% 40% 60% 80% 100% 120% 140% 160% Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Average 95% Growth Rate YOY since Q1 2010 % ICL Growth 2010 2011 2012
CHINA MEDIA IMPACT ON REFRACTIVE SURGERY LASIK pioneer advocates education, caution The China Post 3/5/2012 The warning on the FDA's official website states that for some groups of people side effects of LASIK surgery are certain , and a patient should evaluate the risks and the benefits of LASIK surgery by themselves . LifeAfterLasik.com, another website mentioned by Tsai, was also set up by victims of LASIK complications. On its front page the website provides alarming statistics that one - fifth of people who receive LASIK surgery will suffer from complications . Taiwan's Ophthalmological Society stands by LASIK surgical procedure The China Post Publication Date : 16 - 02 - 2012
KEY ICL GROWTH MARKETS 2012 Q2 RESULTS Q2 2011 Q2 2012 Flat - 14% +74% +83% ® +22% +5% +28% +111% - 28%
EMEA AND NA ICL Q2 RESULTS EMEA growth was at 5% (19% growth excluding Spain) Overall ICL sales in Europe increased by 3%, but excluding Spain impact the growth rate for Europe was 28%. We are starting to see the impact of new Sales Directors brought on late last year in Latin America and Italy. 56 % of all ICLs were V4c during the quarter in Europe. 61% conversion to V4c where approved. Over 5,000 implanted and AquaPORT technology worked as expected. NA growth was 5% U.S. civilian sales increased by 6% while military sales returned to an increase of 1%. Military was 11% of total U.S. ICL sales. We anticipate the military sales will continue to increase the second half of this year and we have already seen a strengthening of military ICL sales during the month of July. ®
2012 KEY METRIC REPORT CARD Q1 Q2 Q3 Q4 2012 Increase revenues by 15% Exceed 2011 Visian ICL sales growth of 32% Continuous expansion of GM % to achieve 71% for the full year Profitable each quarter and full year Successfully implement Comet without disruption of product supply ®
Deborah Andrews Chief Financial Officer FINANCIAL REVIEW MANUFACTURING CONSOLIDATION UPDATE ®
2012 Q2 GAAP RESULTS COMPARISON TO Q2 2011 ($000’S) Q2 2012 Q2 2011 Improvement Revenue $15,942 $16,269 ($327)/ - 2.0% Gross Profit Dollars $11,045 $ 10,861 +$184/+1.7% Gross Profit Margin 69.3% 66.8% +250 bps Operating Exps ex Comet $10,512 $ 9,498 +$1,014/+10.7% Operating Expenses $11,209 $ 9,691 +$1,518/+15.7% Operating Income ($ 164) $1,170 ($1,334)/ - 114% Other Income $ 0 $ 160 ($ 160) Income Taxes $ 327 $ 469 ($ 142) Net Income ($ 491) $ 861 ($ 1,352 ) ®
EXPANDING GROSS MARGINS WITH ICL PRODUCT MIX GAINS 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% 80.0% 2007 2008 2009 2010 2011 Q1 2012 Q2 2012 GM% IOL Mix ICL Mix Gross margins have expanded from 49.0% to 69.3%. Q2 Mix: ICLs at 54.0% and IOLs at 42.5%. ®
RECONCILIATION OF NON - GAAP MEASURE Measure Q2 2012 Q2 2011 GAAP net income (loss) ($ 491) $ 861 Mfg consolidation expenses $ 697 $ 193 Foreign currency impact $ 249 ($ 72) Adjustment of warrant value ($ 222) ($ 79) Stock - based compensation expense $ 794 $ 452 Adjusted net income $1,027 $1,355 Adjusted income per share $ 0.03 $ 0.04 ®
CASH YTD Q2 2012 Q2 2011 Net income (Loss) ($ 259) $1,161 Non - cash $ 2,571 $ 1,751 Working capital ($ 1,084) ($ 1) Cash provided by operations $ 1,228 $2,911 Cash used in investing activities ($ 704) ($ 134) Cash provided by financing activities $ 512 $ 988 Exchange ($ 74) ($ 141) Increase in cash $ 962 $3,624 Cash, at beginning of period $16,582 $ 9,376 Cash, at end of period $17,544 $13,000 ®
PROJECT COMET UPDATE MANUFACTURING CONSOLIDATION Expenses for the quarter were $697k, $1.3M YTD. Total expense for the year approximately $ 2.3M . The shipping of silicone Preloaded IOLs to Japan from U.S. begins this week. All Silicone Preloaded IOLs for Japan to ship from the U.S. beginning in October. Expect to be shipping first Visian ICLs OUS from U.S. during the first quarter of 2013. Project on schedule. ®
STAAR VIEW OF 2014 RESULTS ® Revenue Over $100M Gross Margin %/$ At or near 80% / $80M Operating Expenses Hog wild to $50M Earning before Tax $30M Tax 10% or $3M Net Income $27M
Barry G. Caldwell Chief Executive Officer EXPECTATIONS FOR SECOND HALF Q3 KEY DRIVERS ®
SECOND HALF EXPECTATIONS Grow total revenues by Solid Double Digits Results in high single digit growth for the year Grow ICL revenues by 25% A ssumes little rebound in China Nearly 20% growth for the year Expect to achieve other 3 key metrics: 71% gross margin for the year Profitability Q3, Q4 and for the year Success with manufacturing consolidation
2012 KEY METRIC REPORT CARD Q1 Q2 Q3 Q4 2012 Increase revenues by 15%/ Solid double digit growth 2 nd H &high single digit for year Visian ICL sales growth of 32%/ 25% growth 2 nd H & nearly 20% for year Continuous expansion of GM % to achieve 71% for the full year Profitable each quarter and full year Successfully implement Comet without disruption of product supply ®
Q3 GROWTH DRIVERS North American Visian Excellence Group (NAVEG) August 18 and 19 th in Salt Lake City About 70 surgeons registered ICL User’s Meeting, September 6 and 7 th (Milano) Over 100 surgeons registered European Society of Cataract and Refractive Surgeons Meeting, September 8 th to 12 th (Milano) ICL Symposium Monday September 10 Spanish Society of Ophthalmologists Annual Meeting September 26 th to 28 th (Barcelona) Launch Symposium of our direct presence in the market Introduction of two new IOLs in August KS - SP in Japan and Europe nanoFLEX Toric IOL in Europe More flexible pricing points for nanoFLEX in U.S. ®
NEW HIRES DURING THE FIRST HALF 14 OF PLANNED 16 NOW HIRED EMEA Sales in Italy, Latin America, Western Europe Consumer Awareness Position in Middle East Add two more in Spain by September 1 APAC Consumer awareness marketing in China and India Consumer awareness in Japan (hired, begins August) Still to add Clinical Marketing Position U.S. Four new sales representatives (fully trained) Two Global Online Marketing Specialists ®
CONSUMER AWARENESS ACTIVITIES Online Marketing Objectives ICL Awareness ICL Adoption ICL Evangelism Online Advertising Acquire traffic and interested patients New ICL website www.visianinfo.com Direct interest to ICL surgeons Practice development ICL in office displays Staff online training ®
ICLS TO RAP WITH BLACK EYED PEAS Allen Pindea Lindo, Jr., better know as apl.de.ap recently had Visian ICLs implanted Link to Good Morning America program from July 26 th where his procedure was highlighted: http ://abcnews.go.com/blogs/entertainment/2012/07/ black - eyed - peas - apl - de - ap - gets - vision - back - with - life - changing - surgery/ Link to Visian ICL blog: http://visianinfo.com/black - eyed - peas - apl - de - ap - gets - the - visian - icl/
THANK YOU! YOUR QUESTIONS PLEASE ®
L:KITMM%86YR5:$&DO<:+