Full Press Release Details
STAAR Surgical Reports Continued Momentum
During Third Quarter
~Total Sales of $17.1 Million Increased
8% from Q3 2012 / 14% Increase in Constant Currency~
~Visian ICL Sales Grew
18%; Visian ICL with CentraFLOW Technology Driving Growth~
Revised Revenue Growth Metric of
13% to 14% is at Upper End of Range
GAAP Net Income of $0.01 per share;
Non-GAAP Net Income of $0.04 per share
Cash Position Increases to $23.4
MONROVIA, CA, October 30, 2013 -- STAAR Surgical Company
(NASDAQ: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today reported revenue
for the third quarter ended September 27, 2013 of $17.1 million, which represented 8% growth compared to $15.9 million reported
for the third quarter of 2012. The results included sales of $10.7 million of the Company's Visian ICL product portfolio
and $5.3 million of its IOL products. Low margin Other Product sales increased to $1.1 million, a 51% increase over the prior
year and 73% in constant currency. The effect of foreign currency exchange during the third quarter versus the same quarter in
the prior year reduced total sales by $1.0 million. On a constant currency basis, revenues grew 14% during the third quarter of
2013 compared to the third quarter of 2012.
"Visian ICL sales continued to show strong growth during
the quarter while LASIK continues to be under downward pressure," said Barry Caldwell, President and CEO. "ICLs with
CentraFLOW technology continue to be the key growth driver for us in markets where it is available. Key markets with CentraFLOW
like Europe and the Middle East grew 42% and 39% respectively. In Europe, Spain grew 23% year over year, reflecting the first
quarter with a true direct to direct distribution model comparison. We are still in the early days of adoption of the technology
in Korea, India and Argentina. Approximately 33,000 Visian ICLs with CentraFLOW have been successfully implanted since the introduction
of the technology. The CentraFLOW technology makes the procedure more convenient and cost effective for both the surgeon and the
patient. As a result of the momentum generated in the marketplace by our rapid cadence of new product developments, the Visian
ICL continues to gain market share in the global refractive surgical market.
"The recent ESCRS meeting in Amsterdam was an exceptionally
successful and productive event for STAAR. During the week there were 111 presentations on our Visian ICL technology, with the
Visian ICL Experts Meeting prior to ESCRS drawing 160 surgeons for the two day symposium. Throughout the week, we maintained a
strong presence, with the largest and most active booth in the Company's history and an evening ICL Symposium on the Visian
ICL technology that drew over 200 attendees. We also introduced the Visian ICL Preloaded System, which includes an enhanced optic
design with the CentraFLOW technology," added Caldwell. "This technology is designed to reduce the procedure time,
increase the useful optical zone for patients with larger pupils, as well as make the delivery of the ICL even more consistent.
We expect to gain CE Mark approval in Q4 and begin a full launch of commercialization during the first quarter of next year. As
we continue the rapid cadence of new products utilizing our ICL platform, the focus within our Research and Development group
turns to the V6 ICL. This product will both expand into a new market segment of presbyopia correction as well as make the ICL
more competitive to LASIK in the myopic age group nearing their 40's."
Gross profit margin for the quarter was 70.5% compared to 70.4
% in the third quarter of 2012. The manufacturing of the preloaded silicone IOL in the U.S. now has a higher cost structure in
Japan due to the weaker value of the yen as compared to 2012 which negatively impacts gross margin dollars. Increased IOL injector
sales sold at low margins to the Company's KS-IOL lens supplier negatively impacted gross margin as well. Combined these
two factors negatively impacted gross margin percent for the quarter by 270 basis points. Without the impact of these factors,
gross margins would have been 73.2%. As long as the value of the yen compared to the dollar is weak, the Company's gross
margin expansion will continue to be negatively impacted.
Operating expenses for the third quarter of 2013 were $11.9
million, up 5% from the $11.3 million prior year period reflecting $490,000 in charges associated with the Company's manufacturing
consolidation project. General and Administrative expenses in the third quarter were $4.1 million, a 20% increase over the third
quarter of 2012. This increase was due mainly to an increased accrual as compared to Q3 2012 for the performance based employee
bonus plan and incremental cost associated with the expanded facility in Monrovia. These costs totaled approximately $560,000
additional expense compared to the third quarter of 2012. Sales and Marketing expenses were $5.5 million, essentially flat to
the same quarter in the prior year. The costs of increased headcount were offset by decreased trade show expenses due to the timing
of the ESCRS meeting which fell in the fourth quarter this year as compared to in the third quarter of 2012. Research and Development
expenses were $1.7 million, a 6% increase over Q3 2012 of $1.6 million. This increase was driven by investments in R&D related
new product development and increased regulatory cost associated with key product approvals. The cost of the manufacturing consolidation
project which is recorded as Other Expense was $238,000 lower than the third quarter of 2012. The effect of foreign currency exchange
on overall operating expenses provided a positive impact of $624,000.
"During the quarter we began to see the first tax advantages
from the manufacturing consolidation project as the Company recorded an income tax benefit of $433,000," added Steve Brown,
Chief Financial Officer. "Since we are no longer manufacturing in Japan we are able to release the valuation allowance against
its tax assets." Income taxes provided an overall net benefit of $25,000 during the third quarter of 2013 compared to a
$219,000 tax provision during the third quarter of 2012. Excluding the tax benefit from the Japan restructuring the effective
tax rate for the quarter was approximately 82%.
GAAP net income for the third quarter of 2013 was $525,000,
or $0.01 on a per diluted share basis, compared with net loss of $90,000, or $0.00 on a per diluted share basis, in the third
quarter of 2012. Adjusted net income (excluding manufacturing consolidation expenses, Spain distribution transition costs, gain
(loss) on foreign currency transactions, fair value adjustment of warrants, and stock-based compensation expense) for the quarter
ended September 27, 2013 was $1.7 million or $0.04 per diluted share versus adjusted net income for the year ago quarter of $1.7
million or $0.05 per diluted share. The reconciliation between GAAP and non-GAAP financial matters is provided with financial
tables included with this release.
Cash and cash equivalents on September 27, 2013 reached a record
high of $23.4 million, compared to $19.7 million at the end of the second quarter of 2013 and $21.7 million at the end of fiscal
2012. Cash generation from operations during the quarter was $3.1 million, which includes the use of $0.5 million for the manufacturing
consolidation project. The Company also used $1.0 million for the purchase of property and equipment and generated $1.8 million
in proceeds from stock option exercises.
Recent Visian Implantable Collamer Lens (ICL)
Regional ICL Updates
Europe, Middle East, Africa (EMEA)
Recent Intraocular Lens (IOL) Highlights
Project Comet Update
During the quarter the Company continued to make progress toward
completing the manufacturing consolidation project by mid-2014. At the end of the second quarter the Company had approximately
7,500 ICLs in finished goods inventory. At the end of the third quarter the Company has approximately 11,400 ICLs in inventory
held in both Europe and the U.S. This represents a 50% increase of ICLs in finished goods inventory during the quarter while shipping
15% more units from stock compared to the third quarter of 2012. This inventory build is consistent with management's plan
to assure adequate supply and quality of product throughout this consolidation project. Manufacturing yields of the ICL in the
U.S. continue to increase.
Nine Month YTD Results
For the nine month period ended September 27, 2013, sales increased
to $53.3 million versus $47.3 million during the first nine months of 2012, a 13% increase in U.S. dollars and 18% increase in
constant currency. Gross profit increased by 13% as gross margin percentage reached 70.1%. Gross margin percentage was negatively
impacted by the value of the yen and increased injector sales by 260 basis points. The nine month gross margin would have been
72.7% if not for these two factors. Operating expenses increased $2.3 million or 6.9% and were positively impacted by
the effect of currency exchange by $1,447,000. Key investment spending included of $2.0 million for the manufacturing consolidation
project during the nine month period, approximately $731,000 for the facility improvements in the expanded U.S. facility and $442,000
for the transition to a direct distribution model in Spain. Income taxes increased $109,000 and the new medical device tax was
$149,000. Net Income on a GAAP basis was $1.3 million or $0.03 per diluted share as compared to a loss of $0.3 million or $0.01
per diluted share during the first nine months of 2012. The non-GAAP adjusted net income increased to $6.7 million or $0.17 per
diluted share basis compared to $4.3 million or $0.12 per diluted share basis during the first nine months of 2012. For the first