þ
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
|
For
the quarterly period ended: June 27, 2008
|
|
Or
|
|
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
|
For
the transition period
from to
|
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 – June 27, 2008 and December 28,
2007.
|
1
|
||
Condensed
Consolidated Statements of Operations – Three and Six Months Ended June
27, 2008 and June 29, 2007.
|
2
|
||
Condensed
Consolidated Statements of Cash Flows – Six Months Ended June 27, 2008 and
June 29, 2007.
|
3
|
||
Notes
to the Condensed Consolidated Financial Statements.
|
4
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations.
|
18
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk.
|
34
|
|
Item
4.
|
Controls
and Procedures.
|
34
|
|
PART
II – OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings.
|
34
|
|
|
|||
Item
1A.
|
Risk
Factors.
|
35
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders.
|
36
|
|
Item
6.
|
Exhibits.
|
37
|
|
Signatures
|
38
|
June 27,
2008
|
December 28,
2007
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
8,851
|
$
|
10,895
|
|||
Short-term
investments - restricted
|
71
|
150
|
|||||
Accounts
receivable, net
|
10,417
|
6,898
|
|||||
Inventories
|
15,572
|
12,741
|
|||||
Prepaids,
deposits and other current assets
|
2,468
|
1,610
|
|||||
Total
current assets
|
37,379
|
32,294
|
|||||
Property,
plant and equipment, net
|
6,385
|
5,772
|
|||||
Intangible
assets, net
|
6,561
|
3,959
|
|||||
Goodwill
|
7,534
|
7,534
|
|||||
Advance
payment for acquisition of Canon Staar
|
—
|
4,000
|
|||||
Other
assets
|
1,041
|
620
|
|||||
Total
assets
|
$
|
58,900
|
$
|
54,179
|
|||
LIABILITIES,
REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’
EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Line
of credit
|
$
|
1,860
|
$
|
—
|
|||
Accounts
payable
|
7,937
|
4,823
|
|||||
Obligations
under capital leases – current
|
929
|
822
|
|||||
Deferred
income taxes – current
|
105
|
102
|
|||||
Other
current liabilities
|
6,442
|
5,541
|
|||||
Total
current liabilities
|
17,273
|
11,288
|
|||||
Note
payable – long-term, net of discount
|
4,284
|
4,166
|
|||||
Obligations
under capital leases – long-term
|
1,306
|
1,311
|
|||||
Deferred
income taxes – long-term
|
753
|
570
|
|||||
Other
long-term liabilities
|
1,489
|
619
|
|||||
Total
liabilities
|
25,105
|
17,954
|
|||||
Commitments
and contingencies (Note 13)
|
|||||||
Series
A redeemable convertible preferred stock, $0.01 par value; 10,000
shares
authorized, 1,700 and no shares issued and outstanding at June 27,
2008
and December 28, 2007; respectively. Liquidation value $6,800.
|
6,760
|
—
|
|||||
Stockholders’
equity:
|
|||||||
Common
stock, $0.01 par value; 60,000 shares authorized; issued and outstanding
29,486 at June 27, 2008 and 29,488 at December 28, 2007
|
295
|
295
|
|||||
Additional
paid-in capital
|
137,982
|
137,075
|
|||||
Accumulated
other comprehensive income
|
2,939
|
1,551
|
|||||
Accumulated
deficit
|
(114,181
|
)
|
(102,696
|
)
|
|||
Total
stockholders’ equity
|
27,035
|
36,225
|
|||||
Total
liabilities, redeemable convertible preferred stock and stockholders’
equity
|
$
|
58,900
|
$
|
54,179
|
Three Months Ended
|
Six Months Ended
|
||||||||||||
June
27,
2008
|
June
29,
2007
|
June
27,
2008
|
June
29,
2007
|
||||||||||
Net
sales
|
$
|
20,665
|
$
|
14,932
|
$
|
38,625
|
$
|
29,849
|
|||||
Cost
of sales
|
9,131
|
7,695
|
19,336
|
15,317
|
|||||||||
Gross
profit
|
11,534
|
7,237
|
19,289
|
14,532
|
|||||||||
General
and administrative
|
3,520
|
3,128
|
7,961
|
6,712
|
|||||||||
Marketing
and selling
|
7,646
|
6,147
|
14,113
|
11,449
|
|||||||||
Research
and development
|
2,357
|
1,634
|
4,075
|
3,244
|
|||||||||
Loss
on settlement of pre-existing distribution arrangement
|
—
|
—
|
3,850
|
—
|
|||||||||
Operating
loss
|
(1,989
|
)
|
(3,672
|
)
|
(10,710
|
)
|
(6,873
|
)
|
|||||
Other
income (expense):
|
|||||||||||||
Equity
in operations of joint venture
|
—
|
73
|
—
|
85
|
|||||||||
Interest
income
|
63
|
166
|
91
|
188
|
|||||||||
Interest
expense
|
(222
|
)
|
(213
|
)
|
(423
|
)
|
(317
|
)
|
|||||
Other
income (expense), net
|
(1
|
)
|
(445
|
)
|
211
|
(427
|
)
|
||||||
Other
expense, net
|
(160
|
)
|
(419
|
)
|
(121
|
)
|
(471
|
)
|
|||||
Loss
before provision for income taxes
|
(2,149
|
)
|
(4,091
|
)
|
(10,831
|
)
|
(7,344
|
)
|
|||||
Provision
for income taxes
|
396
|
266
|
654
|
534
|
|||||||||
Net
loss
|
$
|
(2,545
|
)
|
$
|
(4,357
|
)
|
$
|
(11,485
|
)
|
$
|
(7,878
|
)
|
|
Loss
per share – basic and diluted
|
$
|
(0.09
|
)
|
$
|
(0.16
|
)
|
$
|
(.39
|
)
|
$
|
(0.29
|
)
|
|
Weighted
average shares outstanding – basic
and diluted
|
29,488
|
28,041
|
29,488
|
26,845
|
|
Six Months Ended
|
||||||
June 27,
2008
|
June 29,
2007
|
||||||
Cash
flows from operating activities:
|
|||||||
Net
loss
|
$
|
(11,485
|
)
|
$
|
(7,878
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
of property, plant and equipment
|
1,340
|
957
|
|||||
Amortization
of intangibles
|
418
|
240
|
|||||
Amortization
of discount
|
118
|
17
|
|||||
Loss
on extinguishment of note payable
|
—
|
233
|
|||||
Fair
value adjustment of warrant
|
2
|
(100
|
)
|
||||
Loss
on disposal of property and equipment
|
84
|
80
|
|||||
Equity
in operations of joint venture
|
—
|
(85
|
)
|
||||
Stock-based
compensation expense
|
825
|
740
|
|||||
Loss
on settlement of pre-existing distribution arrangement
|
3,850
|
—
|
|||||
Other
|
(74
|
)
|
107
|
||||
Changes
in working capital, net of effects from purchase of Canon
Staar:
|
|||||||
Accounts
receivable
|
(2,716
|
)
|
(520
|
)
|
|||
Inventories
|
2,034
|
74
|
|||||
Prepaids,
deposits and other current assets
|
(487
|
)
|
(18
|
)
|
|||
Accounts
payable
|
(753
|
)
|
(542
|
)
|
|||
Other
current liabilities
|
714
|
(269
|
)
|
||||
Net
cash used in operating activities
|
(6,130
|
)
|
(6,964
|
)
|
|||
Cash
flows from investing activities:
|
|||||||
Cash
acquired in acquisition of Canon Staar, net of acquisition
costs
|
2,511
|
—
|
|||||
Acquisition
of property, plant and equipment
|
(415
|
)
|
(242
|
)
|
|||
Proceeds
from sale of property, plant, and equipment
|
89
|
—
|
|||||
Proceeds
from sale of short-term investments – restricted
|
79
|
—
|
|||||
Dividend
received from joint venture
|
—
|
117
|
|||||
Net
change in other assets
|
(63
|
)
|
(16
|
)
|
|||
Net
cash provided by (used in) investing activities
|
2,201
|
(141
|
)
|
||||
Cash
flows from financing activities:
|
|||||||
Borrowings
under notes payable
|
—
|
4,000
|
|||||
Repayment
of notes payable
|
—
|
(4,000
|
)
|
||||
Borrowings
under lines of credit
|
3,800
|
1,812
|
|||||
Repayment
of lines of credit
|
(1,900
|
)
|
(3,610
|
)
|
|||
Repayment
of capital lease lines of credit
|
(419
|
)
|
(310
|
)
|
|||
Net
proceeds from public sale of equity securities
|
—
|
16,810
|
|||||
Proceeds
from the exercise of stock options
|
—
|
584
|
|||||
Net
cash provided by financing activities
|
1,481
|
15,286
|
|||||
Effect
of exchange rate changes on cash and cash equivalents
|
404
|
143
|
|||||
(Decrease)
increase in cash and cash equivalents
|
(2,044
|
)
|
8,324
|
||||
Cash
and cash equivalents, at beginning of the period
|
10,895
|
7,758
|
|||||
Cash
and cash equivalents, at end of the period
|
$
|
8,851
|
$
|
16,082
|
·
|
to
better exploit the Japanese market for STAAR’s technology and the
worldwide market for the Preloaded Injector technology through greater
control of distribution;
|
·
|
to
re-acquire control of worldwide exclusive rights to STAAR’s technology,
especially the ICL and Collamer IOL, previously licensed to the joint
venture on a worldwide non-exclusive basis;
|
·
|
to
eliminate the risk that Canon Staar could become a competitor of
STAAR,
especially after a change in control of STAAR;
|
·
|
to
increase access to the Preloaded Injector technology; and
|
·
|
to
develop a more effective global R&D strategy by leveraging the
combined technical resources in Japan and the U.S. and taking advantage
of
STAAR Japan’s proven expertise in injector
design.
|
Fair
value of redeemable, convertible preferred stock issued by STAAR
as
consideration for Canon Staar common shares purchased (see Note
10)
|
$
|
6,800
|
||
Cash
consideration for Canon Staar common shares purchased
|
4,000
|
|||
Transaction
costs
|
1,000
|
|||
Total
acquisition consideration
|
$
|
11,800
|
December 29,
2007
|
Useful Lives (years)
|
||||||
Cash
|
$
|
3,018
|
|||||
Accounts
receivable
|
500
|
||||||
Inventories
|
4,252
|
||||||
Prepaid
expenses and other current assets
|
464
|
||||||
Property,
plant and equipment
|
728
|
||||||
Intangible
assets:
|
|||||||
Customer
relationships
|
1,389
|
10
|
|||||
Developed
technology
|
882
|
3
- 10
|
|||||
Patents
|
601
|
17
- 21
|
|||||
Total
intangible assets
|
2,872
|
||||||
Deposits
and other long-term assets
|
715
|
||||||
Total
assets acquired
|
|
12,549
|
|||||
Current
liabilities
|
(3,504
|
)
|
|||||
Net
pension liability
|
(771
|
)
|
|||||
Deferred
income taxes
|
(245
|
)
|
|||||
Other
long-term liabilities
|
(79
|
)
|
|||||
Total
liabilities assumed
|
(4,599
|
)
|
|||||
Net
assets acquired
|
7,950
|
||||||
Loss
on settlement of pre-existing distribution arrangement
|
3,850
|
||||||
Total
acquisition consideration
|
$
|
11,800
|
(In
thousands, except per share amount)
|
Three Months Ended
June 29, 2007
|
Six Months Ended
June 29, 2007
|
||||||||
Net
sales
|
$
|
16,949
|
$
|
33,537
|
||||||
Net
loss
|
$
|
(4,510
|
)
|
$
|
(8,129
|
)
|
||||
Loss
per share – basic and diluted
|
$
|
(0.16
|
)
|
$
|
(0.30
|
)
|
June 27,
|
December 28,
|
||||||
2008
|
2007
|
||||||
Raw
materials and purchased parts
|
$
|
1,381
|
$
|
914
|
|||
Work-in-process
|
1,920
|
2,035
|
|||||
Finished
goods
|
12,271
|
9,792
|
|||||
$
|
15,572
|
$
|
12,741
|
|
June
27,
2008
|
December
28,
2007
|
|||||
Prepaids
and deposits
|
$
|
1,788
|
$
|
1,330
|
|||
Other
current assets
|
680
|
280
|
|||||
|
$
|
2,468
|
$
|
1,610
|
June
27, 2008
|
December
28, 2007
|
||||||||||||||||||
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
|
||||||||||||||
Amortized
intangible assets:
|
|||||||||||||||||||
Patents
and licenses
|
$
|
12,120
|
$
|
(7,788
|
)
|
$
|
4,332
|
$
|
11,489
|
$
|
(7,530
|
)
|
$
|
3,959
|
|||||
Customer
relationships
|
1,459
|
(73
|
)
|
1,386
|
—
|
—
|
—
|
||||||||||||
Developed
technology
|
927
|
(84
|
)
|
843
|
—
|
—
|
—
|
||||||||||||
Total
|
$
|
14,506
|
$
|
(7,945
|
)
|
$
|
6,561
|
$
|
11,489
|
$
|
(7,530
|
)
|
$
|
3,959
|
June
27,
2008
|
December 28,
2007
|
||||||
Accrued
salaries and wages
|
$
|
2,002
|
$
|
1,910
|
|||
Commissions
due to outside sales representatives
|
487
|
544
|
|||||
Accrued
audit expenses
|
369
|
542
|
|||||
Accounts
receivable credit balances
|
535
|
516
|
|||||
Accrued
income taxes
|
689
|
363
|
|||||
Accrued
insurance
|
243
|
334
|
|||||
Accrued
legal expenses
|
420
|
141
|
|||||
Other*
|
1,697
|
1,191
|
|||||
$
|
6,442
|
$
|
5,541
|
Three Months
Ended
|
Six Months
Ended
|
||||||
June
27,
2008
|
June
27,
2008
|
||||||
Service
cost
|
$
|
104
|
$
|
201
|
|||
Interest
cost
|
38
|
71
|
|||||
Expected
return on plan assets
|
(34
|
)
|
(61
|
)
|
|||
Amortization
of unrecognized transition obligation or asset
|
5
|
11
|
|||||
Amount
of gain recognized due to a settlement or curtailment
|
(3
|
)
|
(7
|
)
|
|||
Recognized
actuarial loss
|
7
|
12
|
|||||
|
$
|
117
|
$
|
227
|
Average
common stock price*
|
$
|
3.12
|
||
Expected
volatility
|
67.4
|
%
|
||
Expected
dividend yield
|
0
|
%
|
||
Risk-free
interest rate
|
3.43
|
%
|
||
Issuer’s
call price per share
|
$
|
4.00
|
||
Redemption
price per share
|
$
|
4.00
|
Three
Months Ended
|
Six
Months Ended
|
||||||||||||
June
27,
2008
|
June
29,
2007
|
June
27,
2008
|
June
29,
2007
|
||||||||||
Net
loss
|
$
|
(2,545
|
)
|
$
|
(4,357
|
)
|
$
|
(11,485
|
)
|
$
|
(7,878
|
)
|
|
Minimum
pension liability adjustment
|
(9
|
)
|
—
|
(7
|
)
|
—
|
|||||||
Foreign
currency translation adjustment
|
(528
|
)
|
81
|
1,395
|
143
|
||||||||
Total
comprehensive loss
|
$
|
(3,082
|
)
|
$
|
(4,276
|
)
|
$
|
(10,097
|
)
|
$
|
(7,735
|
)
|
Three
Months Ended
|
Six
Months Ended
|
||||||||||||
June
27,
|
June
29,
|
June
27,
|
June
29,
|
||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
United
States
|
$
|
5,198
|
$
|
5,158
|
$
|
9,722
|
$
|
10,252
|
|||||
Germany
|
6,976
|
5,683
|
13,416
|
11,729
|
|||||||||
Japan
|
3,529
|
104
|
6,481
|
179
|
|||||||||
Korea
|
890
|
750
|
1,640
|
1,529
|
|||||||||
Other
|
4,072
|
3,237
|
7,366
|
6,160
|
|||||||||
Total
|
$
|
20,665
|
$
|
14,932
|
$
|
38,625
|
$
|
29,849
|
Three
Months Ended
|
Six
Months Ended
|
||||||||||||
June
27,
|
June
29,
|
June
27,
|
June
29,
|
||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Cataract
|
$
|
14,945
|
$
|
10,833
|
$
|
28,357
|
$
|
21,856
|
|||||
Refractive
|
5,534
|
3,943
|
9,909
|
7,663
|
|||||||||
Glaucoma
|
186
|
156
|
359
|
330
|
|||||||||
Total
|
$
|
20,665
|
$
|
14,932
|
$
|
38,625
|
$
|
29,849
|
Three
Months Ended
|
Six
Months Ended
|
||||||||||||
June
27,
2008
|
June
29,
2007
|
June
27,
2008
|
June
29,
2007
|
||||||||||
SFAS
123R expense
|
$
|
308
|
$
|
332
|
$
|
672
|
$
|
684
|
|||||
Restricted
stock expense
|
59
|
17
|
133
|
41
|
|||||||||
Consultant
compensation
|
20
|
2
|
20
|
15
|
|||||||||
Total
|
$
|
387
|
$
|
351
|
$
|
825
|
$
|
740
|
Three
Months Ended
|
Six
Months Ended
|
||||||||||||
|
June
27,
2008
|
June
29,
2007
|
June
27,
2008
|
June
29,
2007
|
|||||||||
Expected
dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
0
|
%
|
|||||
Expected
volatility
|
60.87
|
%
|
70.17
|
%
|
61.82
|
%
|
70.17
|
%
|
|||||
Risk-free
interest rate
|
3.07
|
%
|
4.56
|
%
|
2.94
|
%
|
4.56
|
%
|
|||||
Expected
term (in years)
|
5.5
|
5.4
& 5.5
|
5.5
|
5.4
& 5.5
|
Options
|
Shares
(000’s)
|
Weighted-
Average
Exercise
Price
|
Weighted-
Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
(000’s)
|
|||||||||
Outstanding
at December 28, 2007
|
3,717
|
$
|
6.70
|
||||||||||
Granted
|
631
|
2.45
|
|||||||||||
Exercised
|
—
|
—
|
|||||||||||
Forfeited
or expired
|
(580
|
)
|
6.55
|
||||||||||
Outstanding
at June 27, 2008
|
3,768
|
$
|
6.01
|
6.22
|
$
|
487
|
|||||||
Exercisable
at June 27, 2008
|
2,547
|
$
|
7.05
|
4.87
|
$
|
70
|
Nonvested
Shares
|
Shares
(000’s)
|
Weighted-
Average
Grant
Date
Fair
Value
|
|||||
Nonvested
at December 28, 2007
|
1,055
|
$
|
5.18
|
||||
Granted
|
631
|
1.44
|
|||||
Vested
|
(422
|
)
|
3.16
|
||||
Forfeited
|
(43
|
)
|
2.85
|
||||
Nonvested
at June 27, 2008
|
1,221
|
$
|
2.37
|
As
of
June 27, 2008
|
As
of
December 28, 2007
|
||||||
Expected
dividends
|
0
|
%
|
0
|
%
|
|||
Expected
volatility
|
55.2
|
%
|
62.5
|
%
|
|||
Risk-free
rate
|
3.36
|
%
|
3.77
|
%
|
|||
Remaining
life (in years)
|
4.75
|
5.25
|
As
of
December 14, 2007
|
||||
Expected
dividends
|
0
|
%
|
||
Expected
volatility
|
67.3
|
%
|
||
Risk-free
rate
|
3.88
|
%
|
||
Remaining
life (in years)
|
6.0
|
June
27,
2008
|
June
29,
2007
|
||||||
Interest
paid
|
$
|
115
|
$
|
316
|
|||
Income
taxes paid, net of refunds
|
630
|
68
|
|
June
27,
2008
|
June
29,
2007
|
|||||
Non-cash
investing and financing activities:
|
|||||||
Acquisition
of Canon Staar
|
$
|
7,147
|
$
|
—
|
|||
Applied
2007 advance payment on acquisition of Canon Staar
|
(4,000
|
)
|
—
|
||||
Applied
2007 deferred acquisition costs
|
(197
|
)
|
—
|
||||
Acquisition
costs in accounts payable and accrued liabilities
|
296
|
—
|
|||||
Purchase
of property and equipment on terms
|
—
|
884
|
|||||
Assets
obtained by capital lease
|
460
|
—
|
|||||
Issuance
of preferred stock
|
6,800
|
—
|
|||||
Issuance
and registration costs of preferred stock included in accounts payable
and
accrued liabilities
|
(48
|
)
|
—
|
ITEM 2. |
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
•
|
Aspheric
Collamer and silicone IOLs, designed to provide a clearer image than
traditional spherical designs;
|
•
|
The
silicone Toric IOL, used in cataract surgery to reduce preexisting
astigmatism;
|
•
|
The
Preloaded Injector, a three-piece silicone or acrylic IOL preloaded
into a
single-use disposable injector;
|
•
|
STAARVISCTM
II, a viscoelastic material which is used as a tissue protective
lubricant
and to maintain the shape of the eye during surgery;
|
•
|
Cruise
Control, a disposable filter that allows for a faster, cleaner
phacoemulsification procedure and is compatible with all
phacoemulsification equipment utilizing Venturi and peristaltic pump
technologies.
|
•
|
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 the U.S.
|
•
|
Switzerland.
STAAR operates an administrative and manufacturing 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 Collamer IOLs and the AquaFlow™ Collagen Glaucoma Drainage
Device. STAAR Surgical AG handles distribution and other administrative
affairs for Europe and other territories outside North America and
Japan.
|
•
|
Japan.
STAAR completed the acquisition of the remaining 50% interest in
its joint
venture Canon Staar, Co., Inc. during the first quarter of 2008,
following
which the entity’s name was changed to STAAR Japan, Inc. (“STAAR Japan”).
Through this new wholly owned subsidiary STAAR operates an administrative
facility in Tokyo, Japan and a manufacturing facility in Ichikawa
City.
All of STAAR’s preloaded injectors are manufactured at the Ichikawa City
facility. STAAR Japan is also currently seeking approval from the
Japanese
regulatory authorities to market in Japan STAAR’s Visian ICL, Collamer IOL
and AquaFlow Device.
|
•
|
Germany.
Domilens, a wholly owned subsidiary of STAAR Surgical AG, operates
its
distribution business at facilities in Hamburg, Germany.
|
•
|
improving
cash flow;
|
•
|
increasing
U.S. sales by reversing the decline in cataract sales and improving
the
growth of refractive sales;
|
•
|
successfully
integrating STAAR Japan; and
|
•
|
maintaining
and expanding international growth rates.
|
·
|
increasing
use of the ICL by a number of surgeons among STAAR’s established U.S.
customers as they have gained experience with the product and become
more
skilled at identifying, attracting and supporting those patients
most
likely to benefit from the ICL;
|
·
|
increased
patient awareness of the ICL as a result of favorable mass media
exposure
for the ICL;
|
·
|
a
change in marketing focus as STAAR, in its third year of ICL marketing
in
the U.S., has shifted from increasing its overall customer base to
devoting more attention to identifying and supporting those surgical
practices that show potential for significant repeat business through
a
professional commitment to the ICL technology; and
|
·
|
greater
stability and focus in STAAR’s refractive sales force following its
reorganization in the second half of 2007.
|
· |
the
U.S. refractive surgery market has been dominated by corneal laser-based
techniques, which unlike the Visian ICL are already well known to
potential refractive patients;
|
· |
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;
|
· |
an
economic downturn in the U.S. that has impacted LASIK volumes and
could
reduce demand for the Visian ICL;
|
· |
negative
publicity about complications of LASIK could reduce interest in all
refractive surgical procedures; and
|
· |
FDA
approval of the TICL, which STAAR sells in international markets
for
treating patients severely affected by both myopia and astigmatism,
has
been delayed.
|
· |
The
introduction of STAAR’s aspheric three-piece Collamer IOL in April
2007;
|
· |
The
introduction of STAAR’s aspheric three-piece silicone IOL November
2007;
|
· |
The
April 2008 introduction of the nanoPOINT™ injector, which delivers STAAR’s
single piece Collamer IOL through a 2.2 mm
incision;
|
· |
The
grant of New Technology IOL (“NTIOL”) status for the aspheric three-piece
Collamer IOL in March, 2008;
|
· |
The
introduction of an aspheric single-piece Collamer IOL in 2008, which
brings advanced aspheric optics to the micro-incision nanoPOINT platform;
and
|
· |
The
grant of NTIOL status for the aspheric single-piece Collamer IOL
and the
aspheric three-piece silicone IOL in July,
2008.
|
· |
developing
a Collamer Toric IOL to complement our pioneering silicone Toric
IOL and
better compete with the Alcon acrylic Toric
IOL;
|
· |
developing
an all new injector system for the three-piece Collamer IOL; and
|
· |
Adapting
our proprietary Preloaded Injector system for our new silicone aspheric
IOLs.
|
·
|
to
better exploit the Japanese market for STAAR’s technology and the
worldwide market for the Preloaded Injector technology through greater
control of distribution;
|
·
|
to
re-acquire control of world-wide exclusive rights to STAAR’s technology,
especially the ICL and Collamer IOL, previously licensed to the joint
venture;
|
·
|
to
eliminate the risk that Canon Staar could become a competitor of
STAAR,
especially after a change in control of STAAR;
|
·
|
to
increase access to the Preloaded Injector technology; and
|
·
|
to
develop a more effective global R&D strategy by leveraging the
combined technical resources in Japan and the U.S. and taking advantage
of
STAAR Japan’s proven expertise in injector
design.
|
·
|
the
risk that STAAR may not successfully integrate the former Canon Staar
business or its employees into its overall business,
|
·
|
the
risk that key employees of STAAR Japan may leave,
|
·
|
the
risk that removal of the Canon name from STAAR Japan and its products
may
reduce its goodwill or the acceptance of its products,
|
·
|
the
risk that STAAR Japan may not sustain current or prior sales levels
or
achieve projected levels,
|
·
|
the
risk that STAAR's limited access to information has limited its ability
to
accurately assess the projections of management of STAAR Japan,
|
·
|
the
risk that Japanese regulators may not approve the sale of the ICL
or
Collamer IOLs,
|
·
|
the
risk of operating a foreign subsidiary with limited direct
oversight,
|
·
|
the
risk that applying U.S. accounting standards and controls and procedures
over financial reporting may be more difficult, more expensive or
more
time-consuming than anticipated,
|
·
|
the
risk that STAAR’s need to rely on the completeness and accuracy of
information provided by the sellers during STAAR’s investigation of the
STAAR Japan business prevented discovery of material problems, and
|
·
|
the
risk that STAAR Japan may find financing for its operations or for
additional working capital purposes difficult to maintain on reasonable
terms, if at all.
|
Percentage of Net Sales for
Three
Months
|
Percentage
Change for
Three
Months
|
Percentage of Net Sales for
Six
Months
|
Percentage
Change for
Six
Months
|
||||||||||||||||
June
27.
2008
|
June
29,
2007
|
2008
vs. 2007
|
June
27.
2008
|
June
29,
2007
|
2008
vs. 2007
|
||||||||||||||
Net
sales
|
100.0
|
%
|
100.0
|
%
|
38.4
|
%
|
100.0
|
%
|
100.0
|
%
|
29.4
|
%
|
|||||||
Cost
of sales
|
44.2
|
51.5
|
18.7
|
50.1
|
51.3
|
26.2
|
|||||||||||||
Gross
profit
|
55.8
|
48.5
|
59.4
|
49.9
|
48.7
|
32.7
|
|||||||||||||
General
and administrative
|
17.0
|
20.9
|
12.5
|
20.5
|
22.4
|
18.6
|
|||||||||||||
Marketing
and selling
|
37.0
|
41.2
|
24.4
|
36.5
|
38.4
|
23.3
|
|||||||||||||
Research
and development
|
11.4
|
11.0
|
44.2
|
10.6
|
10.9
|
25.6
|
|||||||||||||
Loss
on settlement of pre-existing distribution arrangement
|
—
|
—
|
—
|
10.0
|
—
|
—*
|
|||||||||||||
65.4
|
73.1
|
24.0
|
77.6
|
71.7
|
40.1
|
||||||||||||||
Operating
loss
|
(9.6
|
)
|
(24.6
|
)
|
(45.8
|
)
|
(27.7
|
)
|
(23.0
|
)
|
55.8
|
||||||||
Other
expense, net
|
(0.8
|
)
|
(2.8
|
)
|
(61.8
|
)
|
(0.3
|
)
|
(1.6
|
)
|
(74.3
|
)
|
|||||||
Loss
before provision for income
taxes
|
(10.4
|
)
|
(27.4
|
)
|
(47.5
|
)
|
(28.0
|
)
|
(24.6
|
)
|
47.5
|
||||||||
Provision
for income taxes
|
1.9
|
1.8
|
48.9
|
1.7
|
1.8
|
22.5
|
|||||||||||||
Net
loss
|
(12.3
|
)%
|
(29.2
|
)%
|
(41.6
|
)
|
(29.7
|
)%
|
(26.4
|
)%
|
45.8
|
|
Number of Shares
|
||||||
|
For
|
Withheld
|
|||||
|
|
|
|||||
Mr.
Don Bailey
|
23,714,693
|
698,705
|
|||||
Mr.
David Bailey
|
19,600,177
|
4,813,221
|
|||||
Mr.
Barry Caldwell
|
23,862,937
|
550,461
|
|||||
Mr.
Donald Duffy
|
20,241,214
|
4,172,184
|
|||||
Mr.
John C. Moore
|
23,836,837
|
574,561
|
|||||
Mr.
David Morrison
|
20,537,078
|
3,876,320
|
3.1
|
Certificate
of Incorporation, as amended to date.(1)
|
|
3.2
|
By-laws,
as amended to date.(2)
|
|
4.1
|
Certificate
of Designation of Series A Convertible Preferred
Stock.(1)
|
|
4.2
|
1991
Stock Option Plan of STAAR Surgical Company(3)
|
|
4.3
|
1998
STAAR Surgical Company Stock Plan, adopted April 17,
1998(4)
|
|
4.4
|
Form
of Certificate for Common Stock, par value $0.01 per
share(5)
|
|
4.5
|
2003
Omnibus Equity Incentive Plan and form of Option Grant and Stock
Option
Agreement(6)
|
|
31.1
|
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.(*)
|
|
31.2
|
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.(*)
|
|
Certification
Pursuant to 18 U.S.C. Section 1350, Adopted Pursuant to Section
906 of the
Sarbanes-Oxley Act of
2002.(*)
|
(1)
|
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.
|
(2)
|
Incorporated
by reference to the Company’s Current Report on Form 8-K filed with the
Commission on May 23, 2006.
|
(3)
|
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.
|
(4)
|
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.
|
(5)
|
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.
|
(6)
|
Incorporated
by reference to the Company’s Proxy Statement for its Annual Meeting of
Stockholders held on June 18, 2003, as filed with the Commission on
May 19, 2003.
|
(*) | Filed herewith. |
STAAR
SURGICAL COMPANY
|
|||
Date:
August 6, 2008
|
By:
|
/s/
DEBORAH ANDREWS
|
|
Deborah
Andrews
|
|||
Chief
Financial Officer
|
|||
(on
behalf of the Registrant and as its
|
|||
principal
financial officer)
|