Attached files
| file | filename |
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| 8-K - STAAR SURGICAL CO | v207810_8k.htm |
| EX-99.2 - STAAR SURGICAL CO | v207810_ex99-2.htm |
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CONTACT:
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Investors
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Media
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EVC
Group
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EVC
Group
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Douglas
Sherk, 415-896-6820
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Chris
Gale
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Jenifer
Kirtland, 415-896-2005
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646-201-5431
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STAAR
SURGICAL ANNOUNCES FOURTH QUARTER 2010 REVENUE EXPECTED TO EXCEED $14.2
MILLION
Record
Quarter for ICLs with Estimated13% Increase in Revenues and 20% Increase in
Units
Company
Receives Approval for KS-X2 Preloaded Single Piece Acrylic Injector
Delivery System in Japan
MONROVIA,
CA, January 11, 2011 -- STAAR Surgical Company (NASDAQ: STAA), a leading
developer, manufacturer and marketer of minimally invasive ophthalmic products,
today announced that it expects
revenue for the fourth quarter ended December 31, 2010 to exceed $14.2 million.
Revenues for the full year were approximately $55 million, a 7% increase over
2009 revenues, driven by an increase of approximately 10% in revenues from the
core ICL and IOL product lines. The Company expects to announce its
fourth quarter and full year 2010 results on March 1, 2011.
“Our
estimated fourth quarter revenues were driven by strong growth in the Visian ICL
product lines, which achieved a record in both revenues and units,” said Barry
G. Caldwell, president and CEO of STAAR Surgical. “Expected ICL
revenues were up approximately 13% from the prior year’s fourth quarter and 8%
from the previous third quarter 2010 record. Unit volume grew
approximately 20% from the fourth quarter last year. During the
quarter, approximately 10% of our ICL sales in our recently introduced expanded
range Visian ICL models were in segments where we have not previously
participated, specifically low myopes and toric hyperopes. This
demonstrates the demand and opportunity for the expanded treatment range, which
received CE Mark approval during late third quarter. The strong
growth for the Visian ICL continued in China, India and the Middle East during
the quarter, and revenues in Japan began to reflect our extremely positive
efforts in that market.”
STAAR also announced that it has
received approval from the Japanese Ministry of Health, Labor and Welfare
(MHLW) to market its KS-X2 Preloaded Single Piece Hydrophobic Acrylic Injector
System in Japan. STAAR has been offering the three-piece KS-X system
in Japan for two years and in selective CE Mark countries for the past
year. The Company expects pre-market launch of the new product in
Japan during the first quarter of 2011 with full release during the second
quarter.
“The
approval of our single piece injector system is an important achievement and
expands the products that we can offer to ophthalmologists in Japan,” Mr.
Caldwell continued. “Approval of the KS-X2 allows us to compete in
the single piece hydrophobic acrylic space, the largest segment of the IOL
market, according to Market Scope, and certainly the most lucrative segment
globally.We anticipate CE Mark approval of the product during the third quarter
of this year, with launch shortly thereafter. This product once again
illustrates STAAR’s core competency in preloaded delivery systems.”
The
single and three-piece preloaded delivery systems are manufactured by STAAR
Japan from hydrophobic lenses that are independently sourced. The
STAAR system delivers the lens into the eye through a 2.8 millimeter incision
and is compatible with the most commonly used small incision cataract extraction
procedures.
“We have
made significant progress during 2010 from both a product delivery and financial
standpoint. During 2011, we remain focused on continuing our efforts
to gain regulatory approvals for the Visian Toric ICL in both Japan and the
United States, expanding our direct-to-consumer marketing campaign and driving
revenue growth and profitability. We look forward to sharing
additional details when we announce our financial results for 2010,” Mr.
Caldwell concluded.
About STAAR
Surgical
STAAR,
which has been dedicated solely to ophthalmic surgery for over 25 years,
designs, develops, manufactures and markets implantable lenses for the
eye. All of these lenses are foldable, which permits the surgeon to
insert them through a small incision. A lens used to replace the
natural lens after cataract surgery is called an intraocular lens or
“IOL.” A lens used in refractive surgery as an alternative to LASIK
is called an Implantable Collamer® Lens or “ICL.” Over 200,000 Visian
ICLs have been implanted to date; to learn more about the ICL go to:
www.visianinfo.com. STAAR has approximately 300 full time employees
and markets lenses in approximately 50 countries. Headquartered in
Monrovia, CA, it manufactures in the following locations: Nidau, Switzerland;
Ichikawa City, Japan; Aliso Viejo, CA; and Monrovia, CA. For more
information, please visit the Company’s website at www.staar.com
or call 626-303-7902.
Safe
Harbor
The
financial information presented in this press release for the quarter ended
December 31, 2010 is preliminary and remains subject to review by STAAR's
independent registered public accountants. Statements of results for the fourth
quarter and full year are estimates. Final financial information for the
quarter, which STAAR will report in its Annual Report on Form 10-K, may
differ.
All
statements in this press release that are not statements of historical fact are
forward-looking statements, including statements about any of the following:
future revenue, sales or any other financial items; the plans, strategies, and
objectives of management for future operations or prospects for achieving such
plans; anticipated product approvals, prospects for approval of the Visian Toric
ICL in the U.S. or Japan; statements of belief; and any statements of
assumptions underlying any of the foregoing.
These
statements are based on expectations and assumptions as of the date of this
press release and are subject to numerous risks and uncertainties, which could
cause actual results to differ materially from those described in the
forward-looking statements. The risks and uncertainties include the following:
our limited capital resources and limited access to financing; the negative
effect of the global recession on sales of products, especially products such as
the ICL used in non-reimbursed elective procedures; the challenge of managing
our foreign subsidiaries; the risk of unfavorable changes in currency exchange
rates; the broad discretion of regulators in approving medical devices in our
major markets; uncertainty as to the effectiveness of newly initiated direct to
consumer advertising campaigns, the willingness of surgeons and patients to
adopt a new product and procedure; patterns of Visian ICL use that have
typically limited our penetration of the refractive surgery market, and a
general decline in the demand for refractive surgery, which STAAR believes has
resulted both from concerns about the safety and effectiveness of laser
procedures and from general economic conditions.