þ
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
o
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
Delaware
|
95-3797439
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
|
(I.R.S.
Employer
Identification
No.)
|
o Large
accelerated filer
|
þ Accelerated
filer
|
o Non-accelerated
filer
(Do
not check if a smaller reporting company)
|
o Smaller
reporting company
|
PAGE
|
|||
NUMBER
|
|||
PART
I – FINANCIAL INFORMATION
|
|||
Item
1.
|
Financial
Statements (Unaudited).
|
||
Condensed
Consolidated Balance Sheets – July 2, 2010 and January
1, 2010.
|
1
|
||
Condensed
Consolidated Statements of Operations – Three and Six Months Ended July 2,
2010 and July 3, 2009.
|
2
|
||
Condensed
Consolidated Statements of Cash Flows – Six Months Ended July 2, 2010 and
July 3, 2009.
|
3
|
||
Notes
to the Condensed Consolidated Financial Statements.
|
4
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations.
|
16
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk.
|
31
|
|
Item
4.
|
Controls
and Procedures.
|
31
|
|
PART
II – OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings.
|
32
|
|
Item
1A.
|
Risk
Factors.
|
32
|
|
Item
6.
|
Exhibits.
|
33
|
|
Signatures
|
34
|
July 2,
2010
|
January 1,
2010
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 7,896 | $ | 6,330 | ||||
Restricted
cash
|
136 | 7,396 | ||||||
Accounts
receivable trade, net
|
6,816 | 9,269 | ||||||
Inventories
|
10,916 | 14,820 | ||||||
Prepaids,
deposits and other current assets
|
1,816 | 2,591 | ||||||
Total
current assets
|
27,580 | 40,406 | ||||||
Property,
plant and equipment, net
|
3,318 | 5,005 | ||||||
Intangible
assets, net
|
3,890 | 4,148 | ||||||
Goodwill
|
1,474 | 7,879 | ||||||
Other
assets
|
1,276 | 1,243 | ||||||
Total
assets
|
$ | 37,538 | $ | 58,681 | ||||
LIABILITIES,
REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’
EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 3,013 | $ | 7,416 | ||||
Line
of credit
|
2,280 | 2,160 | ||||||
Deferred
income taxes
|
360 | 360 | ||||||
Obligations
under capital leases
|
444 | 795 | ||||||
Note
payable, net of discount
|
— | 4,503 | ||||||
Accrued
legal judgments
|
— | 4,000 | ||||||
Other
current liabilities
|
6,196 | 7,706 | ||||||
Total
current liabilities
|
12,293 | 26,940 | ||||||
Obligations
under capital leases
|
687 | 1,098 | ||||||
Deferred
income taxes
|
218 | 653 | ||||||
Pension
obligations
|
2,240 | 2,035 | ||||||
Other
long-term liabilities
|
238 | 101 | ||||||
Total
liabilities
|
15,676 | 30,827 | ||||||
Commitments
and contingencies (Note 13)
|
||||||||
Series
A redeemable convertible preferred stock, $0.01 par value; 10,000 shares
authorized; none and 1,700 shares issued and outstanding at July 2, 2010
and January 1, 2010, respectively. Liquidation value
$6,800.
|
— | 6,784 | ||||||
Stockholders’
equity:
|
||||||||
Common
stock, $0.01 par value; 60,000 shares authorized; issued and outstanding
34,806 at July 2, 2010 and 34,747 at January 1, 2010
|
348 | 348 | ||||||
Additional
paid-in capital
|
150,375 | 149,559 | ||||||
Accumulated
other comprehensive income
|
1,328 | 3,254 | ||||||
Accumulated
deficit
|
(130,189 | ) | (132,091 | ) | ||||
Total
stockholders’ equity
|
21,862 | 21,070 | ||||||
Total
liabilities, redeemable convertible preferred stock and stockholders’
equity
|
$ | 37,538 | $ | 58,681 |
Three Months Ended
|
Six Months Ended
|
|||||||||||||||
July 2,
2010
|
July 3,
2009
|
July 2,
2010
|
July 3,
2009
|
|||||||||||||
Net
sales
|
$ | 13,639 | $ | 13,158 | $ | 27,417 | $ | 25,316 | ||||||||
Cost
of sales
|
4,960 | 5,187 | 9,909 | 9,690 | ||||||||||||
Gross
profit
|
8,679 | 7,971 | 17,508 | 15,626 | ||||||||||||
General
and administrative
|
3,268 | 3,820 | 6,657 | 8,101 | ||||||||||||
Marketing
and selling
|
4,134 | 3,727 | 7,965 | 7,552 | ||||||||||||
Research
and development
|
1,376 | 1,441 | 2,909 | 2,853 | ||||||||||||
Other
operating expense
|
700 | — | 700 | — | ||||||||||||
Operating
loss
|
(799 | ) | (1,017 | ) | (723 | ) | (2,880 | ) | ||||||||
Other
income (expense):
|
||||||||||||||||
Interest
income
|
13 | 4 | 14 | 7 | ||||||||||||
Interest
expense
|
(224 | ) | (396 | ) | (630 | ) | (626 | ) | ||||||||
Gain
(loss) on foreign currency transactions
|
(389 | ) | 214 | (439 | ) | 146 | ||||||||||
Loss
on early extinguishment of note payable
|
(267 | ) | — | (267 | ) | — | ||||||||||
Other
income (expense), net
|
(53 | ) | 104 | (12 | ) | 159 | ||||||||||
Other
expense, net
|
(920 | ) | (74 | ) | (1,334 | ) | (314 | ) | ||||||||
Loss
before provision (benefit) for income taxes
|
(1,719 | ) | (1,091 | ) | (2,057 | ) | (3,194 | ) | ||||||||
Provision
(benefit) for income taxes
|
(91 | ) | 278 | 207 | 404 | |||||||||||
Loss
from continuing operations
|
(1,628 | ) | (1,369 | ) | (2,264 | ) | (3,598 | ) | ||||||||
Income
from discontinued operations, net of income taxes
|
— | 281 | 4,166 | 848 | ||||||||||||
Net
income (loss)
|
$ | (1,628 | ) | $ | (1,088 | ) | $ | 1,902 | $ | (2,750 | ) | |||||
Loss
per share from continuing operations – basic and diluted
|
$ | (0.05 | ) | $ | (0.04 | ) | $ | (0.07 | ) | $ | (0.12 | ) | ||||
Income
per share from discontinued operations – basic and diluted
|
$ | — | $ | 0.01 | $ | 0.12 | $ | 0.03 | ||||||||
Net
income (loss) per share
|
$ | (0.05 | ) | (0.04 | ) | $ | 0.05 | $ | (0.09 | ) | ||||||
Weighted
average shares outstanding – basic and diluted
|
34,790 | 30,911 | 34,770 | 30,276 |
Six Months Ended
|
||||||||
July 2,
2010
|
July 3,
2009
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
income (loss)
|
$ | 1,902 | $ | (2,750 | ) | |||
Adjustments
to reconcile net income (loss) to net cash used in operating
activities:
|
||||||||
Income
from discontinued operations
|
(4,166 | ) | (848 | ) | ||||
Depreciation
of property and equipment
|
821 | 1,003 | ||||||
Amortization
of intangibles
|
399 | 390 | ||||||
Amortization
of discount
|
236 | 152 | ||||||
Loss
on early extinguishment of note payable
|
267 | — | ||||||
Fair
value adjustment of warrant
|
137 | 8 | ||||||
Loss
on disposal of property and equipment
|
2 | 37 | ||||||
Change
in net pension liability
|
157 | 106 | ||||||
Stock-based
compensation expense
|
649 | 884 | ||||||
Other
|
112 | 112 | ||||||
Changes
in working capital:
|
||||||||
Accounts
receivable
|
1,040 | (372 | ) | |||||
Inventories
|
777 | 765 | ||||||
Prepaids,
deposits and other current assets
|
272 | 546 | ||||||
Accounts
payable
|
(1,731 | ) | (464 | ) | ||||
Other
current liabilities
|
(5,338 | ) | (115 | ) | ||||
Net
cash provided by (used in) operating activities of discontinued
operations
|
(635 | ) | 384 | |||||
Net
cash used in operating activities
|
(5,099 | ) | (162 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Proceeds
from sale of subsidiary, net of transaction costs
|
11,824 | — | ||||||
Decrease
(increase) in restricted cash
|
7,337 | (7,341 | ) | |||||
Deposit
to restricted escrow account
|
(136 | ) | — | |||||
Acquisition
of property and equipment
|
(202 | ) | (232 | ) | ||||
Proceeds
from sale of property and equipment
|
— | 18 | ||||||
Net
change in other assets
|
5 | 5 | ||||||
Net
cash provided by (used in) investing activities of discontinued
operations
|
(50 | ) | 39 | |||||
Net
cash provided by (used in) investing activities
|
18,778 | (7,511 | ) | |||||
Cash
flows from financing activities:
|
||||||||
Repayment
of notes payable
|
(5,000 | ) | — | |||||
Redemption
of Series A preferred stock
|
(6,800 | ) | — | |||||
Net
proceeds from public sale of equity securities
|
— | 8,548 | ||||||
Repayment
of capital lease obligations
|
(495 | ) | (502 | ) | ||||
Borrowings
under line of credit
|
— | 630 | ||||||
Proceeds
from exercise of stock options
|
140 | — | ||||||
Net
cash used in financing activities of discontinued
operations
|
(50 | ) | (57 | ) | ||||
Net
cash provided by (used in) financing activities
|
(12,205 | ) | 8,619 | |||||
Effect
of exchange rate changes on cash and cash equivalents
|
92 | (184 | ) | |||||
Increase
in cash and cash equivalents
|
1,566 | 762 | ||||||
Cash
and cash equivalents, at beginning of the period
|
6,330 | 4,992 | ||||||
Cash
and cash equivalents, at end of the period
|
$ | 7,896 | $ | 5,754 |
·
|
A
rollforward of the allowance for credit losses from the beginning of the
period to the end of the period, by portfolio segment, with the ending
balance further disaggregated based on impairment methodology (e.g.,
individually evaluated for impairment, collectively evaluated for
impairment and loans acquired with deteriorated credit
quality)
|
·
|
Significant
purchases and sales of financing receivables during the
period
|
·
|
At
period end, the amount of nonaccrual financing receivables and those past
due 90 days or more and still
accruing
|
|
·
|
At
period end, the aging of financing receivables past due, as determined by
the entity’s policy
|
|
·
|
At
period end, the amount of impaired financing
receivables
|
|
·
|
At
period end, the recorded investment by credit quality
indicator
|
|
·
|
The
nature and extent of troubled debt restructurings that occurred during the
period and their impact on the allowance for credit
losses
|
|
·
|
The
nature and extent of financing receivables modified as troubled debt
restructurings within the previous 12 months that defaulted during the
period and the effect on the allowance for credit
losses.
|
Fiscal Year
|
Domilens EBIT
|
Earn-Out Payment
|
||
2010
|
€2,500,000
(~ $3.4 million)
|
€200,000
(~$273,000)
|
||
2011
|
€2,900,000
(~ $3.9 million)
|
€225,000
(~$307,000)
|
||
2012
|
€3,500,000
(~ $4.7 million)
|
€250,000
(~$340,000)
|
For the Period
From
January 2, -
March 2,
2010
|
Three Months
Ended
July 3,
2009
|
Six Months
Ended
July 3,
2009
|
||||||||||
Net
sales
|
$ | 3,584 | $ | 5,959 | $ | 12,084 | ||||||
Gross
profit
|
1,544 | 2,694 | 5,378 | |||||||||
Net
gain on disposal, net of $46 of taxes
|
4,118 | — | — | |||||||||
Income
from operations of Domilens before taxes
|
64 | 283 | 1,159 | |||||||||
Provision
for income taxes from operations of Domilens
|
(16 | ) | (2 | ) | (311 | ) | ||||||
Income
from discontinued operations, net of income taxes
|
$ | 4,166 | $ | 281 | $ | 848 | ||||||
Income
per share from discontinued operations – basic and diluted
|
$ | 0.12 | $ | 0.01 | $ | 0.03 |
July
2,
|
January
1,
|
|||||||
2010
|
2010(1)
|
|||||||
Raw
materials and purchased parts
|
$ | 2,115 | $ | 1,846 | ||||
Work-in-process
|
2,419 | 2,480 | ||||||
Finished
goods
|
7,278 | 11,736 | ||||||
11,812 | 16,062 | |||||||
Inventory
reserves
|
(896 | ) | (1,242 | ) | ||||
$ | 10,916 | $ | 14,820 |
|
July 2,
2010
|
January 1,
2010(1)
|
||||||
Prepaids
and deposits
|
$ | 1,149 | $ | 1,169 | ||||
Insurance
receivable
|
60 | 438 | ||||||
Other
current assets*
|
607 | 984 | ||||||
|
$ | 1,816 | $ | 2,591 |
July 2, 2010
|
January 1, 2010
|
|||||||||||||||||||||||
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
|
|||||||||||||||||||
Amortized
intangible assets:
|
||||||||||||||||||||||||
Patents
and licenses
|
$ | 10,766 | $ | (8,838 | ) | $ | 1,928 | $ | 10,725 | $ | (8,619 | ) | $ | 2,106 | ||||||||||
Customer
relationships
|
1,788 | (447 | ) | 1,341 | 1,694 | (339 | ) | 1,355 | ||||||||||||||||
Developed
technology
|
1,136 | (515 | ) | 621 | 1,077 | (390 | ) | 687 | ||||||||||||||||
Total
|
$ | 13,690 | $ | (9,800 | ) | $ | 3,890 | $ | 13,496 | $ | (9,348 | ) | $ | 4,148 |
July 2,
2010
|
January 1,
2010(1)
|
|||||||
Accrued
salaries and wages
|
$ | 2,171 | $ | 2,122 | ||||
Accrued
termination benefits
|
700 | — | ||||||
Accrued
audit fees
|
288 | 460 | ||||||
Customer
credit balances
|
598 | 589 | ||||||
Accrued
income taxes
|
892 | 905 | ||||||
Accrued
insurance
|
266 | 386 | ||||||
Accrued
interest on Broadwood Note**
|
— | 499 | ||||||
Accrued
bonuses
|
111 | 530 | ||||||
Other*
|
1,170 | 2,215 | ||||||
$ | 6,196 | $ | 7,706 |
Three Months
Ended
July 2,
2010
|
Three Months
Ended
July 3,
2009
|
Six Months
Ended
July 2,
2010
|
Six Months
Ended
July 3,
2009
|
|||||||||||||
Service
cost
|
$ | 138 | $ | 135 | $ | 277 | $ | 273 | ||||||||
Interest
cost
|
35 | 33 | 68 | 66 | ||||||||||||
Expected
return on plan assets
|
(25 | ) | (24 | ) | (48 | ) | (48 | ) | ||||||||
Amortization
of unrecognized transition obligation or asset
|
— | 6 | — | 12 | ||||||||||||
Amount
of gain recognized due to a settlement or curtailment
|
— | (4 | ) | — | (9 | ) | ||||||||||
Recognized
actuarial loss
|
14 | 8 | 28 | 16 | ||||||||||||
$ | 162 | $ | 154 | $ | 325 | $ | 310 |
As of July 2, 2010
|
|||||||||||||||||||
Schedule
|
Commencement
|
Expiration
|
Original
Required
|
Obligation
|
Available
|
||||||||||||||
Number
|
Date
|
Term
|
Date
|
Commitment
|
Balance
|
Credit
|
|||||||||||||
001
|
April
1, 2007
|
36
Months
|
April
1, 2010
|
$ | 959 | $ | - | $ | - | ||||||||||
002
|
September
1, 2007
|
36
Months
|
September
1, 2010
|
527 | 17 | - | |||||||||||||
003
|
January
1, 2008
|
36
Months
|
January
1, 2011
|
387 | 63 | - | |||||||||||||
004
|
March
1, 2009
|
30
Months
|
September
1, 2011
|
150 | 73 | - | |||||||||||||
005
|
Pending
|
Pending
|
N/A
|
250 | 31 | 219 | |||||||||||||
$ | 2,273 | $ | 184 | $ | 219 |
Three Months Ended
|
Six Months Ended
|
|||||||||||||||
July 2,
2010
|
July 3,
2009
|
July 2,
2010
|
July 3,
2009
|
|||||||||||||
Net
income (loss)
|
$ | (1,628 | ) | $ | (1,088 | ) | $ | 1,902 | $ | (2,750 | ) | |||||
Minimum
pension liability adjustment
|
3 | (1 | ) | 6 | (2 | ) | ||||||||||
Foreign
currency translation adjustment
|
364 | 818 | (1,933 | ) | (225 | ) | ||||||||||
Total
comprehensive loss
|
$ | (1,261 | ) | $ | (271 | ) | $ | (25 | ) | $ | (2,977 | ) |
Three Months Ended
|
Six Months Ended
|
|||||||||||||||
July
2,
|
July
3,
|
July
2,
|
July
3,
|
|||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
United
States
|
$ | 3,810 | $ | 4,116 | $ | 7,832 | $ | 8,312 | ||||||||
Japan
|
3,940 | 3,857 | 7,972 | 7,556 | ||||||||||||
Korea
|
1,161 | 1,614 | 2,647 | 2,600 | ||||||||||||
Other
|
4,728 | 3,571 | 8,966 | 6,848 | ||||||||||||
Total
|
$ | 13,639 | $ | 13,158 | $ | 27,417 | $ | 25,316 |
Three Months Ended
|
Six Months Ended
|
|||||||||||||||
July
2,
|
July
3,
|
July
2,
|
July
3,
|
|||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
IOLs
|
$ | 7,006 | $ | 6,691 | $ | 13,883 | $ | 12,895 | ||||||||
ICLs
|
5,864 | 5,384 | 11,724 | 10,270 | ||||||||||||
Core
products
|
12,870 | 12,075 | 25,607 | 23,165 | ||||||||||||
Other
Surgical Products
|
769 | 1,083 | 1,810 | 2,151 | ||||||||||||
Total
|
$ | 13,639 | $ | 13,158 | $ | 27,417 | $ | 25,316 |
Three Months Ended
|
Six Months Ended
|
|||||||||||||||
July 2,
2010
|
July 3,
2009
|
July 2,
2010
|
July 3,
2009
|
|||||||||||||
Stock-based
compensation expense
|
$ | 194 | $ | 216 | $ | 442 | $ | 489 | ||||||||
Common
stock issued to employees
|
— | — | — | 278 | ||||||||||||
Restricted
stock expense
|
103 | 53 | 137 | 118 | ||||||||||||
Consultant
compensation
|
41 | 20 | 70 | (1 | ) | |||||||||||
Total
|
$ | 338 | $ | 289 | $ | 649 | $ | 884 |
Three
Months Ended
|
Six
Months Ended
|
|||||||||||||||
July
2,
2010
|
July
3,
2009
|
July
2,
2010
|
July
3,
2009
|
|||||||||||||
Expected
dividend yield
|
0 | % | 0 | % | 0 | % | 0 | % | ||||||||
Expected
volatility
|
81.07 | % | 79.06 | % | 80.61 | % | 73.43 | % | ||||||||
Risk-free
interest rate
|
2.13 | % | 2.66 | % | 2.31 | % | 1.89 | % | ||||||||
Expected
term (in years)
|
5.6 | 5.5 | 5.6 | 5.5 |
Options
|
Shares
(000’s)
|
Weighted-
Average
Exercise
Price
|
Weighted-
Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
(000’s)
|
||||||||||||
Outstanding
at January 1, 2010
|
3,743 | $ | 5.36 | |||||||||||||
Granted
|
356 | 3.92 | ||||||||||||||
Exercised
|
(54 | ) | 2.58 | |||||||||||||
Forfeited
or expired
|
(277 | ) | 7.71 | |||||||||||||
Outstanding
at July 2, 2010
|
3,768 | $ | 5.09 | 5.38 | $ | 5,996 | ||||||||||
Exercisable
at July 2, 2010
|
3,087 | $ | 5.50 | 4.62 | $ | 4,282 |
Nonvested Shares
|
Shares
(000’s)
|
Weighted-
Average
Grant Date
Fair Value
|
||||||
Nonvested
at January 1, 2010
|
759 | $ | 1.84 | |||||
Granted
|
356 | 2.68 | ||||||
Vested
|
(411 | ) | 2.12 | |||||
Forfeited
|
(23 | ) | 2.26 | |||||
Nonvested
at July 2, 2010
|
681 | $ | 2.28 |
July 2,
2010
|
July 3,
2009
|
|||||||
Non-cash
investing and financing activities:
|
||||||||
Assets
obtained by capital lease
|
$ | 31 | $ | 479 | ||||
Issuance
of common stock to attorneys for legal services performed
|
— | 425 | ||||||
Warrants
issued to Broadwood
|
— | 290 |
ITEM
2.
|
MANAGEMENT'S DISCUSSION AND
ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
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The
silicone Toric IOL, used in cataract surgery to treat preexisting
astigmatism. Astigmatism is a condition that causes blurred
vision due to the irregular shape of the cornea which prevents light from
focusing properly on the retina;
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The
Preloaded Injector, a three-piece silicone or acrylic IOL preloaded into a
single-use disposable injector;
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Aspheric IOLs,
available in silicone or Collamer, designed to provide a clearer image
than traditional spherical IOLs, by reducing spherical aberrations and
improving contrast sensitivity;
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The
nanoFLEX IOL, a single-piece Collamer aspheric IOL that can be implanted
through a 2.2 mm incision with the nanoPOINT injector
system.
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United
States. STAAR operates its global administrative headquarters
and a manufacturing facility in Monrovia, California. The
Monrovia manufacturing facility principally makes Collamer and silicone
IOLs and injector systems for IOLs and ICLs. STAAR also manufactures the
Collamer material in a facility in Aliso Viejo,
California.
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Switzerland. STAAR
operates an administrative, manufacturing and distribution facility in
Nidau, Switzerland under its wholly owned subsidiary, STAAR Surgical AG.
The Nidau manufacturing facility makes all of STAAR’s ICLs and TICLs and
also manufactures the AquaFlow Device. STAAR Surgical AG handles
distribution and other administrative affairs for Europe, the Middle East
and Africa.
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Japan. STAAR
operates administrative, manufacturing and distribution facilities in
Japan under its wholly owned subsidiary, STAAR Japan Inc. STAAR
Japan’s administrative and distribution facility is located in
Shin-Urayasu and its manufacturing facility is located in Ichikawa City.
All of STAAR’s preloaded injectors are manufactured at the Ichikawa City
facility. Following its approval by the Japanese Ministry of
Health, Labor and Welfare on February 2, 2010, STAAR Japan began marketing
and distributing the Visian ICL in Japan. STAAR Japan will also
handle distribution and other administrative affairs for the Pacific Asia
region under the re-alignment of STAAR’s global business discussed
below.
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Achievement
of double-digit percentage growth in sales from core ICL and IOL products
as compared to the same quarter in the prior
year;
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Improvement
in gross profit margins to the mid-60% level for the
year;
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Progress
toward profitability throughout the year, with a goal of achieving net
income for the full year;
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Continued
generation of cash flow from operations;
and
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Improvement
in financial condition by retiring obligations and strengthening the
balance sheet.
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Increasing ICL sales as a
percentage of STAAR’s overall product mix. Visian ICLs
and TICLs generally yield an 80% gross profit margin. The
Visian product line is STAAR’s most profitable product family and the
largest contributor to enhanced gross profit margins. During
2010 we expect the launch of ICL sales in Japan, and expanding market
share in existing markets, to improve STAAR’s gross profit
margins.
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Increasing Sales of Higher
Value IOLs in the U.S. In 2007 and 2008 STAAR began converting its
U.S. IOL product offering from lower value legacy products to newer
aspheric designs that are eligible for enhanced Centers for Medicare and
Medicaid Services (“CMS”) reimbursement as NTIOLs. With the
introduction of the nanoFLEX IOL in 2009, STAAR has introduced aspheric
versions for both of its IOL product platforms. As STAAR’s
customers switch to aspheric lenses, U.S. IOL gross profit margins have
increased. In addition, results for the past year marketing
efforts for the nanoFLEX lens suggest that this product has attracted new
customers to STAAR IOLs and may rebuild U.S. IOL market share, further
enhancing gross profit margins.
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Continuing to Implement
Centers of Excellence Program. STAAR believes that it
has an opportunity to reduce costs while continuing its history of
innovation by rationalizing its business among its worldwide operations
through its Centers of Excellence program. During 2009 STAAR
moved the production of silicone IOLs for use in Preloaded Injectors from
Japan to the U.S., centralizing all silicone lens production in the U.S.,
thereby reducing STAAR’s overall IOL costs. During 2010 STAAR
intends to complete the transfer of IOL and ICL injector system
manufacturing and R&D from the U.S. to Japan, which is expected to
lead to cost savings and a greater focus on STAAR Japan’s more advanced
lens injector designs. STAAR also intends to take further
efforts to improve silicone manufacturing efficiency in the U.S., based in
part on the efficiencies of scale made possible by centralized
manufacturing.
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the
U.S. refractive surgery market has been dominated by corneal laser-based
techniques, which continue to be better known than the Visian ICL among
potential refractive patients;
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other
newly introduced surgical products will continue to compete with the
Visian ICL for the attention of surgeons seeking to add new, high value
surgical products, in particular multifocal and accommodating
IOLs;
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concerns
about medical complications and patient dissatisfaction following LASIK
could reduce interest in all refractive surgical procedures;
and
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FDA
approval of the TICL, which STAAR sells in 45 international markets for
treating patients affected by both myopia and astigmatism, has not yet
been realized.
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Marketing
ICLs in the expanded diopter power range recently approved outside the
United States so that patients with lower refractive error can be treated
with the ICL;
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Making
other modifications to improve the performance of the ICL:
and
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Extending
the shelf life of Collamer products (both IOLs and
ICLs).
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the
introduction of STAAR’s aspheric three-piece Collamer IOL in April
2007;
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the
introduction of STAAR’s aspheric three-piece silicone IOL November
2007;
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the
April 2008 introduction of the nanoPOINT injector, which delivers STAAR’s
single-piece Collamer IOL, through a 2.2 mm
incision;
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the
grant of New Technology IOL (“NTIOL”) status for the aspheric three-piece
Collamer IOL in March 2008;
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the
grant of NTIOL status for the nanoFLEX aspheric single-piece Collamer IOL
and the aspheric three-piece silicone IOL in July
2008;
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the
introduction of the nanoFLEX aspheric single-piece Collamer IOL in the
second quarter of 2009, which brings advanced aspheric optics to the
micro-incision nanoPOINT platform;
and
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the
launch of the Epiphany injector for the Collamer three-piece lens in the
third quarter of 2009 which brings smoother and more controlled delivery
to one of STAAR’s most advanced lenses and paves the way for U.S.
introduction of the silicone preloaded
injector.
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Introducing
a preloaded injector with a single piece acrylic IOL in addition to the
current three-piece acrylic
offering;
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Extending
the shelf life of Collamer products (both IOLs and
ICLs);
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Completing
the development of the Collamer Toric IOL to complement our pioneering
silicone Toric IOL and better compete with the Alcon acrylic Toric IOL.
The Collamer Toric IOL should provide a product with advanced optic
materials and rotational stability to provide superior outcomes for
cataract patients with astigmatism;
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Gaining
approval for a preloaded silicone IOL injector system in the U.S. in
2010;
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Developing
a preloaded injector system for our Collamer
IOLs;
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Initiating
a formal post-market clinical evaluation to support a possible submission
to the FDA of claims that the lens offers patients less spectacle
dependence or accommodation; and
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Initiating
a clinical study of a new IOL we have designed to enhance the near and
intermediate visual results with
Collamer.
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A
rollforward of the allowance for credit losses from the beginning of the
period to the end of the period, by portfolio segment, with the ending
balance further disaggregated based on impairment methodology (e.g.,
individually evaluated for impairment, collectively evaluated for
impairment and loans acquired with deteriorated credit
quality)
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Significant
purchases and sales of financing receivables during the
period
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At
period end, the amount of nonaccrual financing receivables and those past
due 90 days or more and still
accruing
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At
period end, the aging of financing receivables past due, as determined by
the entity’s policy
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At
period end, the amount of impaired financing
receivables
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At
period end, the recorded investment by credit quality
indicator
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The
nature and extent of troubled debt restructurings that occurred during the
period and their impact on the allowance for credit
losses
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The
nature and extent of financing receivables modified as troubled debt
restructurings within the previous 12 months that defaulted during the
period and the effect on the allowance for credit
losses.
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Percentage of Net Sales
for
Three Months
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Percentage
Change
for
Three
Months
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Percentage of Net Sales for
Six Months
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Percentage
Change
for
Six
Months
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|||||||||||||||||||||
July 2,
2010
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July 3,
2009
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2010
vs. 2009
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July 2,
2010
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July 3,
2009
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2010
vs. 2009
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|||||||||||||||||||
Net
sales
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100.0 | % | 100.0 | % | 3.7 | % | 100.0 | % | 100.0 | % | 8.3 | % | ||||||||||||
Cost
of sales
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36.4 | 39.4 | (4.4 | ) | 36.1 | 38.3 | 2.3 | |||||||||||||||||
Gross
profit
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63.6 | 60.6 | 8.9 | 63.9 | 61.7 | 12.0 | ||||||||||||||||||
General
and administrative
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24.0 | 29.0 | (14.5 | ) | 24.3 | 32.0 | (17.8 | ) | ||||||||||||||||
Marketing
and selling
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30.3 | 28.3 | 10.9 | 29.1 | 29.8 | 5.5 | ||||||||||||||||||
Research
and development
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10.1 | 11.0 | (4.5 | ) | 10.6 | 11.3 | 2.0 | |||||||||||||||||
Other
operating expense
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5.1 | — | — | * | 2.5 | — | — | * | ||||||||||||||||
69.5 | 68.3 | 5.5 | 66.5 | 73.1 | (1.5 | ) | ||||||||||||||||||
Operating
loss
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(5.9 | ) | (7.7 | ) | (21.4 | ) | (2.6 | ) | (11.4 | ) | (74.9 | ) | ||||||||||||
Other
expense, net
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(6.7 | ) | (0.6 | ) | — | * | (4.9 | ) | (1.2 | ) | — | * | ||||||||||||
Loss
before provision (benefit) for income taxes
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(12.6 | ) | (8.3 | ) | 57.6 | (7.5 | ) | (12.6 | ) | (35.6 | ) | |||||||||||||
Provision
(benefit) for income taxes
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(0.7 | ) | 2.1 | — | * | 0.8 | 1.6 | (48.8 | ) | |||||||||||||||
Loss
from continuing operations
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(11.9 | ) | (10.4 | ) | 18.9 | (8.3 | ) | (14.2 | ) | (37.1 | ) | |||||||||||||
Income
from discontinued operations, net of taxes
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— | 2.1 | (100.0 | ) | 15.2 | 3.3 | — | * | ||||||||||||||||
Net
income (loss)
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(11.9 | )% | (8.3 | )% | 49.6 | 6.9 | % | (10.9 | )% | — | * |
As of July 2, 2010
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Schedule
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Commencement
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Expiration
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Original
Required
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Obligation
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Available
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Number
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Date
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Term
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Date
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Commitment
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Balance
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Credit
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|||||||||||||
001
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April
1, 2007
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36
Months
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April
1, 2010
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$ | 959 | $ | - | $ | - | ||||||||||
002
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September
1, 2007
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36
Months
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September
1, 2010
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527 | 17 | - | |||||||||||||
003
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January
1, 2008
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36
Months
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January
1, 2011
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387 | 63 | - | |||||||||||||
004
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March
1, 2009
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30
Months
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September
1, 2011
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150 | 73 | - | |||||||||||||
005
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Pending
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Pending
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N/A
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250 | 31 | 219 | |||||||||||||
$ | 2,273 | $ | 184 | $ | 219 |
3.1
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Certificate
of Incorporation, as amended to date.(1)
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3.2
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By-laws,
as amended to date.(2)
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4.1
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Certificate
of Elimination of Series A Convertible Preferred
Stock.(*)
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4.2
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1991
Stock Option Plan of STAAR Surgical Company.(3)
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4.3
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1998
STAAR Surgical Company Stock Plan, adopted April 17,
1998.(4)
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4.4
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Form
of Certificate for Common Stock, par value $0.01 per
share.(5)
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4.5
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Amended
and Restated 2003 Omnibus Equity Incentive Plan, and form of Option Grant
and Stock Option Agreement.*
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31.1
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Certification
Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, Adopted
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*
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31.2
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Certification
Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, Adopted
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*
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32.1
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Certification
Pursuant to 18 U.S.C. Section 1350, Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. *
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(1)
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Incorporated
by reference to the Company’s Annual Report on Form 10-K for the fiscal
year ended December 28, 2007, as filed with the Commission on March
12, 2008.
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(2)
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Incorporated
by reference to the Company’s Current Report on Form 8-K filed with the
Commission on May 23, 2006.
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(3)
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Incorporated
by reference to the Company’s Registration Statement on Form S-8, File No.
033-76404, as filed with the Commission on March 11,
1994.
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(4)
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Incorporated
by reference to the Company’s Proxy Statement for its Annual Meeting of
Stockholders held on May 29, 1998, filed with the Commission on
May 1, 1998.
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(5)
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Incorporated
by reference to Exhibit 4.1 to Amendment No. 1 to the Company’s
Registration Statement on Form 8-A/A, as filed with the Commission on
April 18, 2003.
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*
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Filed
herewith.
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STAAR
SURGICAL COMPANY
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Date: August
11, 2010
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By: /s/ DEBORAH ANDREWS
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Deborah
Andrews
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Chief
Financial Officer
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(on
behalf of the Registrant and as its
|
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principal
financial officer)
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