Unassociated Document
SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C.
20549
________________
Form 10-Q
(Mark
One)
þ
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the quarterly period ended: September 30,
2011
o
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the transition period
from to
Commission
file number: 0-11634
STAAR
SURGICAL COMPANY
(Exact
name of registrant as specified in its charter)
Delaware
|
95-3797439
|
(State or other jurisdiction of
|
(I.R.S. Employer
|
incorporation or organization)
|
Identification No.)
|
1911
Walker Avenue
Monrovia,
California 91016
(Address
of principal executive offices)
(626) 303-7902
(Registrant’s
telephone number, including area code))
Indicate
by check mark whether the registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days. Yes þ No ¨
Indicate
by check mark whether the Registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T
(§ 232.405 of this chapter) during the preceding 12 months (or for
such shorter period that the Registrant was required to submit and post such
files). Yes þ No ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check
one):
¨ Large
accelerated filer
|
þ Accelerated
filer
|
¨ Non-accelerated
filer
|
¨ Smaller
reporting company
|
|
|
(Do not check if a smaller
|
|
|
|
reporting company) |
|
Indicate
by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act). Yes o No þ
The
registrant has 36,096,107 shares of common stock, par value $0.01 per share,
issued and outstanding as of October 25, 2011.
STAAR
SURGICAL COMPANY
INDEX
|
|
PAGE
|
|
|
NUMBER
|
|
|
|
PART
I – FINANCIAL INFORMATION
|
|
|
|
|
|
Item
1.
|
Financial
Statements (Unaudited).
|
1
|
|
|
|
|
|
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations.
|
13
|
|
|
|
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk.
|
23
|
|
|
|
|
|
Item
4.
|
Controls
and Procedures.
|
23
|
|
|
|
|
PART
II – OTHER INFORMATION
|
|
|
|
|
|
|
Item
1.
|
Legal
Proceedings.
|
24
|
|
|
|
|
|
Item 1A.
|
Risk
Factors.
|
24
|
|
|
|
|
|
Item
5.
|
Other
Information.
|
25
|
|
|
|
|
|
Item
6.
|
Exhibits.
|
25
|
STAAR
SURGICAL COMPANY
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except par value amounts)
(Unaudited)
|
|
September 30,
2011
|
|
|
December 31,
2010
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
16,755 |
|
|
$ |
9,376 |
|
Restricted
cash
|
|
|
136 |
|
|
|
133 |
|
Accounts
receivable trade, net
|
|
|
6,786 |
|
|
|
8,219 |
|
Inventories,
net
|
|
|
10,612 |
|
|
|
10,543 |
|
Prepaids,
deposits and other current assets
|
|
|
1,498 |
|
|
|
1,715 |
|
Total
current assets
|
|
|
35,787 |
|
|
|
29,986 |
|
Property,
plant and equipment, net
|
|
|
3,710 |
|
|
|
3,732 |
|
Intangible
assets, net
|
|
|
3,210 |
|
|
|
3,672 |
|
Goodwill
|
|
|
1,786 |
|
|
|
1,786 |
|
Deferred
income taxes
|
|
|
202 |
|
|
|
202 |
|
Other
assets
|
|
|
1,202 |
|
|
|
1,207 |
|
Total
assets
|
|
$ |
45,897 |
|
|
$ |
40,585 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
3,586 |
|
|
$ |
3,717 |
|
Line
of credit
|
|
|
2,600 |
|
|
|
2,460 |
|
Deferred
income taxes
|
|
|
326 |
|
|
|
326 |
|
Obligations
under capital leases
|
|
|
590 |
|
|
|
431 |
|
Other
current liabilities
|
|
|
5,722 |
|
|
|
6,513 |
|
Total
current liabilities
|
|
|
12,824 |
|
|
|
13,447 |
|
Obligations
under capital leases
|
|
|
990 |
|
|
|
1,403 |
|
Deferred
income taxes
|
|
|
638 |
|
|
|
488 |
|
Other
long-term liabilities
|
|
|
3,068 |
|
|
|
2,820 |
|
Total
liabilities
|
|
|
17,520 |
|
|
|
18,158 |
|
|
|
|
|
|
|
|
|
|
Commitments
and contingencies (Note 13)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity:
|
|
|
|
|
|
|
|
|
Common
stock, $0.01 par value; 60,000 shares authorized; 35,932 and
35,084 shares issued and outstanding at September 30, 2011 and December
31, 2010
|
|
|
359 |
|
|
|
351 |
|
Additional
paid-in capital
|
|
|
156,429 |
|
|
|
152,014 |
|
Accumulated
other comprehensive income
|
|
|
2,388 |
|
|
|
2,100 |
|
Accumulated
deficit
|
|
|
(130,799
|
) |
|
|
(132,038
|
) |
Total
stockholders’ equity
|
|
|
28,377 |
|
|
|
22,427 |
|
Total
liabilities and stockholders’ equity
|
|
$ |
45,897 |
|
|
$ |
40,585 |
|
See
accompanying notes to the condensed consolidated financial
statements.
STAAR
SURGICAL COMPANY
CONDENSED
CONSOLIDATED STATEMENTS OF INCOME
(In
thousands, except per share amounts)
(Unaudited)
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
2011
|
|
|
October 1,
2010
|
|
|
September 30,
2011
|
|
|
October 1,
2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
sales
|
|
$ |
15,266 |
|
|
$ |
13,152 |
|
|
$ |
46,385 |
|
|
$ |
40,569 |
|
Cost
of sales
|
|
|
4,816 |
|
|
|
4,892 |
|
|
|
15,445 |
|
|
|
14,801 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
profit
|
|
|
10,450 |
|
|
|
8,260 |
|
|
|
30,940 |
|
|
|
25,768 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
3,820 |
|
|
|
3,591 |
|
|
|
11,448 |
|
|
|
10,247 |
|
Marketing
and selling
|
|
|
4,439 |
|
|
|
4,552 |
|
|
|
13,098 |
|
|
|
12,517 |
|
Research
and development
|
|
|
1,454 |
|
|
|
1,309 |
|
|
|
4,279 |
|
|
|
4,218 |
|
Other
general and administrative expenses
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
700 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
income (loss)
|
|
|
737 |
|
|
|
(1,192
|
) |
|
|
2,115 |
|
|
|
(1,914
|
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
7 |
|
|
|
7 |
|
|
|
24 |
|
|
|
22 |
|
Interest
expense
|
|
|
(134
|
) |
|
|
(152
|
) |
|
|
(440
|
) |
|
|
(783
|
) |
Gain
(loss) on foreign currency transactions
|
|
|
(277
|
) |
|
|
446 |
|
|
|
167 |
|
|
|
6 |
|
Loss
on early extinguishment of note payable
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(267
|
) |
Other
(expense) income, net
|
|
|
(42
|
) |
|
|
89 |
|
|
|
358 |
|
|
|
77 |
|
Other
(expense) income, net
|
|
|
(446
|
) |
|
|
390 |
|
|
|
109 |
|
|
|
(945
|
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
(loss) before provision for income taxes
|
|
|
291 |
|
|
|
(802
|
) |
|
|
2,224 |
|
|
|
(2,859
|
) |
Provision
for income taxes
|
|
|
214 |
|
|
|
356 |
|
|
|
985 |
|
|
|
563 |
|
Income
(loss) from continuing operations
|
|
|
77 |
|
|
|
(1,158
|
) |
|
|
1,239 |
|
|
|
(3,422
|
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
from discontinued operations, net of income taxes
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
4,166 |
|
Net
income (loss)
|
|
$ |
77 |
|
|
$ |
(1,158 |
) |
|
$ |
1,239 |
|
|
$ |
744 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) per share from continuing operations – basic
|
|
$ |
0.00 |
|
|
$ |
(0.03 |
) |
|
$ |
0.04 |
|
|
$ |
(0.10 |
) |
Net
income (loss) per share from continuing operations
–diluted
|
|
$ |
0.00 |
|
|
$ |
(0.03 |
) |
|
$ |
0.03 |
|
|
$ |
(0.10 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
per share from discontinued operations – basic and diluted
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
0.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) per share - basic
|
|
$ |
0.00 |
|
|
$ |
(0.03 |
) |
|
$ |
0.04 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) per share - diluted
|
|
$ |
0.00 |
|
|
$ |
(0.03 |
) |
|
$ |
0.03 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding - basic
|
|
|
35,539 |
|
|
|
34,831 |
|
|
|
35,304 |
|
|
|
34,790 |
|
Weighted
average shares outstanding - diluted
|
|
|
36,953 |
|
|
|
34,831 |
|
|
|
36,507 |
|
|
|
34,790 |
|
See
accompanying notes to the condensed consolidated financial
statements.
STAAR
SURGICAL COMPANY
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
(Unaudited)
|
|
Nine Months Ended
|
|
|
|
September 30,
2011
|
|
|
October 1,
2010
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$ |
1,239 |
|
|
$ |
744 |
|
Adjustments
to reconcile net income to net cash provided
byoperating activities:
|
|
|
|
|
|
|
|
|
Income
from discontinued operations
|
|
|
— |
|
|
|
(4,166
|
) |
Depreciation
of property and equipment
|
|
|
890 |
|
|
|
1,191 |
|
Amortization
of intangibles
|
|
|
595 |
|
|
|
607 |
|
Amortization
of discount
|
|
|
— |
|
|
|
236 |
|
Loss
on early extinguishment of note payable
|
|
|
— |
|
|
|
267 |
|
Deferred
income taxes
|
|
|
150 |
|
|
|
— |
|
Fair
value adjustment of warrant
|
|
|
(29
|
) |
|
|
117 |
|
Gain
(loss) on disposal of property and equipment
|
|
|
(14
|
) |
|
|
4 |
|
Change
in net pension liability
|
|
|
147 |
|
|
|
256 |
|
Stock-based
compensation expense
|
|
|
1,330 |
|
|
|
945 |
|
Other
|
|
|
(70
|
) |
|
|
40 |
|
Changes
in working capital:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
1,630 |
|
|
|
862 |
|
Inventories
|
|
|
241 |
|
|
|
1,042 |
|
Prepaids,
deposits and other current assets
|
|
|
331 |
|
|
|
717 |
|
Accounts
payable
|
|
|
(201
|
) |
|
|
(1,395
|
) |
Other
current liabilities
|
|
|
(829
|
) |
|
|
(5,462
|
) |
Net
cash used in operating activities of discontinued
operations
|
|
|
— |
|
|
|
(635
|
) |
Net
cash provided by (used in) operating activities
|
|
|
5,410 |
|
|
|
(4,630
|
) |
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Proceeds
from sale of subsidiary, net of transaction costs
|
|
|
— |
|
|
|
11,824 |
|
Release
of restricted cash
|
|
|
— |
|
|
|
7,396 |
|
Deposit
to restricted escrow account
|
|
|
— |
|
|
|
(136
|
) |
Acquisition
of property and equipment
|
|
|
(722
|
) |
|
|
(247
|
) |
Proceeds
from sale of property and equipment
|
|
|
26 |
|
|
|
— |
|
Net
change in other assets
|
|
|
48 |
|
|
|
10 |
|
Net
cash used in investing activities of discontinued
operations
|
|
|
— |
|
|
|
(50
|
) |
Net
cash (used in) provided by investing activities
|
|
|
(648
|
) |
|
|
18,797 |
|
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Repayment
of notes payable
|
|
|
— |
|
|
|
(5,000
|
) |
Redemption
of Series A preferred stock
|
|
|
— |
|
|
|
(6,800
|
) |
Repayment
of capital lease obligations
|
|
|
(412
|
) |
|
|
(609
|
) |
Proceeds
from exercise of stock options
|
|
|
2,983 |
|
|
|
292 |
|
Net
cash used in financing activities of discontinued
operations
|
|
|
— |
|
|
|
(50
|
) |
Net
cash provided by (used in) financing activities
|
|
|
2,571 |
|
|
|
(12,167
|
) |
|
|
|
|
|
|
|
|
|
Effect
of exchange rate changes on cash and cash equivalents
|
|
|
46 |
|
|
|
158 |
|
|
|
Nine Months Ended
|
|
|
|
September 30,
2011
|
|
|
October 1,
2010
|
|
Increase
in cash and cash equivalents
|
|
|
7,379 |
|
|
|
2,158 |
|
Cash
and cash equivalents, at beginning of the period
|
|
|
9,376 |
|
|
|
6,330 |
|
Cash
and cash equivalents, at end of the period
|
|
$ |
16,755 |
|
|
$ |
8,488 |
|
See
accompanying notes to the condensed consolidated financial
statements.
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2011
(Unaudited)
Note
1 — Basis of Presentation and Significant Accounting Policies
The
consolidated financial statements of the Company present the financial position,
results of operations, and cash flows of STAAR Surgical Company and its wholly
owned subsidiaries. All significant intercompany accounts and
transactions have been eliminated. The accompanying unaudited
condensed consolidated financial statements, have been prepared in accordance
with accounting principles generally accepted in the United States (“GAAP”) for
interim financial information and with the instructions to Form 10-Q and Article
10 of Regulation S-X of the Securities Exchange Commission. In
accordance with those rules and regulations certain information and footnote
disclosures normally included in comprehensive financial statements have been
condensed or omitted pursuant to such rules and regulations. The
consolidated balance sheet as of December 31, 2010 derives from the audited
financial statements at that date, but does not include all the information and
footnotes required by GAAP. These financial statements should be read
in conjunction with the audited financial statements and notes thereto included
in the Company’s Annual Report on Form 10-K for the year ended December 31,
2010.
The
condensed consolidated financial statements for the three and nine months ended
September 30, 2011 and October 1, 2010, in the opinion of management, include
all adjustments, consisting only of normal recurring adjustments, necessary for
a fair presentation of the Company’s financial condition and results of
operations. The results of operations for the three and nine months
ended September 30, 2011 and October 1, 2010 are not necessarily indicative of
the results to be expected for any other interim period or for the entire
year. As discussed in Note 2, on March 2, 2010, the Company disposed
of all of its interests in a subsidiary, Domilens GmbH (“Domilens”), and in
accordance with GAAP reported the income received from Domilens prior to the
disposition as “income from discontinued operations.” Income from
continuing operations does not include the results of operations
of Domilens.
Each of the Company's
reporting periods ends on the Friday nearest to the quarter ending date and
generally consists of 13 weeks. Unless the context indicates
otherwise “we,” “us,” the “Company,” and “STAAR” refer to STAAR Surgical Company
and its consolidated subsidiaries.
Note 2 —
Disposal of Domilens Subsidiary
On March 2, 2010 (the
“Closing Date”), STAAR Surgical Company completed the divestiture (the
“Transaction”) of all of its interest in its German distribution subsidiary,
Domilens GmbH (“Domilens”), through a management buyout led by funds managed by
Hamburg-based Small Cap Buyout Specialist BPE Unternehmensbeteiligungen GmbH
(“BPE”).
See Note
3, Disposal of Domilens
Subsidiary, to the consolidated
financial statements accompanying the 2010 Annual Report on Form 10-K for
additional information regarding the sale of Domilens.
Note
3 — Restricted Cash
On
March 2, 2010, as part of the disposition of Domilens, the Company deposited
$136,000 into a restricted escrow account to provide for the potential payment
of unaccrued taxes assessed for periods prior to December 31,
2009. The balance of funds remaining, if any, after the payment of
such taxes, will be distributed to STAAR from the escrow account, no
later than December 31, 2011. As of September 30, 2011, restricted
cash was $136,000, an increase of $3,000 from December 31, 2010, due to the
effect of foreign currency translation.
Note 4 —
Inventories
Inventories,
net are stated at the lower of cost, determined on a first-in, first-out basis,
or market and consisted of the following (in thousands):
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2011
|
|
|
2010
|
|
Raw
materials and purchased parts
|
|
$ |
1,986 |
|
|
$ |
1,920 |
|
Work-in-process
|
|
|
2,108 |
|
|
|
2,255 |
|
Finished
goods
|
|
|
7,295 |
|
|
|
7,349 |
|
|
|
|
11,389 |
|
|
|
11,524 |
|
Inventory
reserves
|
|
|
(777
|
) |
|
|
(981
|
) |
|
|
$ |
10,612 |
|
|
$ |
10,543 |
|
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2011
(Unaudited)
Note 5 —
Prepaids, Deposits, and Other Current Assets
Prepaids,
deposits, and other current assets consisted of the following (in
thousands):
|
|
September 30,
2011
|
|
|
December 31,
2010
|
|
Prepaids
and deposits
|
|
$ |
816 |
|
|
$ |
1,219 |
|
Other
current assets
|
|
|
682 |
|
|
|
496 |
|
|
|
$ |
1,498 |
|
|
$ |
1,715 |
|
Note 6
– Amortizable Intangible Assets
Amortizable
intangible assets consisted of the following (in thousands):
|
|
September 30, 2011
|
|
|
December 31, 2010
|
|
|
|
|
Gross Carrying
Amount
|
|
|
Accumulated
Amortization
|
|
|
Net
|
|
|
Gross
Carrying
Amount
|
|
|
Accumulated
Amortization
|
|
|
Net
|
Amortized
intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents
and licenses
|
|
$ |
10,875 |
|
|
$ |
(
9, 400 |
) |
|
$ |
1,475 |
|
|
$ |
10,827 |
|
|
$ |
(9,064 |
) |
|
$ |
1,763 |
|
Customer
relationships
|
|
|
2,039 |
|
|
|
(
765 |
) |
|
|
1,274 |
|
|
|
1,929 |
|
|
|
(579 |
) |
|
|
1,350 |
|
Developed
technology
|
|
|
1,296 |
|
|
|
( 835 |
) |
|
|
461 |
|
|
|
1,226 |
|
|
|
(667 |
) |
|
|
559 |
|
Total
|
|
$ |
14,210 |
|
|
$ |
(11,000 |
) |
|
$ |
3,210 |
|
|
$ |
13,982 |
|
|
$ |
(10,310 |
) |
|
$ |
3,672 |
|
As of
September 30, 2011 the gross carrying amount of amortizable intangible assets
increased by $228,000
due to changes in the foreign exchange rate.
Note 7
– Other Current Liabilities
Other
current liabilities consisted of the following (in thousands):
|
|
September 30,
2011
|
|
|
December 31,
2010
|
|
Accrued
salaries and wages
|
|
$ |
1,853 |
|
|
$ |
2,121 |
|
Accrued
audit fees
|
|
|
408 |
|
|
|
417 |
|
Customer
credit balances
|
|
|
572 |
|
|
|
566 |
|
Accrued
bonuses
|
|
|
1,070 |
|
|
|
751 |
|
Accrued
income taxes
|
|
|
165 |
|
|
|
147 |
|
Accrued
insurance
|
|
|
120 |
|
|
|
422 |
|
Accrued
severance
|
|
|
104 |
|
|
|
570 |
|
Other
|
|
|
1,430 |
|
|
|
1,519 |
|
|
|
$ |
5,722 |
|
|
$ |
6,513 |
|
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2011
(Unaudited)
Note 8
– Pension Plans
The following table summarizes the
components of net periodic pension cost recorded for the Company’s defined
benefit pension plans (in thousands):
|
|
Three Months
Ended
September 30,
2011
|
|
|
Three Months
Ended
October 1,
2010
|
|
|
Nine Months
Ended
September 30,
2011
|
|
|
Nine Months
Ended
October 1,
2010
|
|
Service
cost
|
|
$ |
161 |
|
|
$ |
144 |
|
|
$ |
423 |
|
|
$ |
421 |
|
Interest
cost
|
|
|
42 |
|
|
|
35 |
|
|
|
104 |
|
|
|
103 |
|
Expected
return on plan assets
|
|
|
(34 |
) |
|
|
(25 |
) |
|
|
(83 |
) |
|
|
(73 |
) |
Amortization
of unrecognized transition obligation
|
|
|
4 |
|
|
|
— |
|
|
|
12 |
|
|
|
— |
|
Amortization
of prior service cost
|
|
|
(1 |
) |
|
|
— |
|
|
|
(1 |
) |
|
|
— |
|
Recognized
actuarial (gain) loss
|
|
|
(2 |
) |
|
|
13 |
|
|
|
(18 |
) |
|
|
41 |
|
|
|
$ |
170 |
|
|
$ |
167 |
|
|
$ |
437 |
|
|
$ |
492 |
|
During the nine months ended
September 30, 2011 and October 1, 2010, the Company made cash contributions
totaling approximately $203,000 and $183,000 to its Swiss defined benefit
pension plan. The Company expects to make additional cash
contributions totaling approximately $68,000 during the remainder of
2011. The Company is not required to and does not make contributions
to its Japan pension plan. Benefits are paid from operating cash
flows and were not material during the quarter ended September 30,
2011.
Note 9 —
Lines of Credit and Capital Lease Obligations
The Company’s Japanese
subsidiary, STAAR Japan, has an agreement, as amended on June 30, 2009, with
Mizuho Bank, which provides for borrowings of up to 300,000,000 Yen
(approximately $3.9 million based on the rate of exchange on September 30,
2011), at an interest rate equal to the Tokyo short-term prime interest rate
(approximately 1.475% as of September 30, 2011) plus 1.125%. The
agreement may be renewed annually (the current line expires on April 2,
2012). The credit facility is not collateralized. The
Company had 200,000,000 Yen outstanding on the line of credit as of September
30, 2011 and December 31, 2010, (approximately $2.6 million and $2.5 million
based on the foreign exchange rates on September 30, 2011 and December 31, 2010)
which approximates fair value due to the short-term maturity and market interest
rates of the line of credit. In case of default, the interest rate
will increase to 14% per annum. As of September 30, 2011, 100,000,000 Yen
(approximately $1.3 million based on the rate of exchange on September 30, 2011)
of the line was available for borrowing.
In August 2010, the Company’s
wholly-owned Swiss subsidiary, STAAR Surgical AG, entered into a credit
agreement with Credit Suisse (the “Bank”). The credit agreement provides for
borrowings of up to 1,000,000 Swiss Francs ($1,114,000 at the rate of exchange
on September 30, 2011), to be used for working capital
purposes. Accrued interest and 0.25% commissions on average
outstanding borrowings is payable quarterly and the interest rate will be
determined by the Bank based on the then prevailing market conditions at the
time of borrowing. The credit agreement renews automatically on an
annual basis based on the same terms, assuming there is no
default. The credit agreement may be terminated by either party at
any time in accordance with its general terms and conditions. The
credit facility is not collateralized and contains customary conditions such as
providing the Bank with audited financial statements annually and notice of
significant events or conditions as defined in the credit
agreement. The Bank may also declare all amounts outstanding to be
immediately due and payable upon a change of control or a “material
qualification” in STAAR Surgical AG’s independent auditors’
report. There were no borrowings outstanding as of September 30, 2011
and the full amount of the line was available for borrowing.
Capital Lease
Obligations
The
Company leases certain property, plant, and equipment under non-cancelable
capital lease agreements. These leases vary in amount, duration, and
rates.
Estimated
future minimum payments under capital lease obligations are as follows (in
thousands):
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2011
(Unaudited)
Fiscal Year
|
|
September 30,
2011
|
|
|
December 31,
2010
|
|
2011
|
|
$ |
187 |
|
|
$ |
938 |
|
2012
|
|
|
844 |
|
|
|
763 |
|
2013
|
|
|
595 |
|
|
|
627 |
|
2014
|
|
|
75 |
|
|
|
68 |
|
2015
|
|
|
— |
|
|
|
36 |
|
Thereafter
|
|
|
— |
|
|
|
— |
|
Total
minimum lease payments
|
|
$ |
1,701 |
|
|
$ |
2,432 |
|
Less:
interest
|
|
|
(121
|
) |
|
|
(598
|
) |
Total
lease obligation
|
|
$ |
1,580 |
|
|
$ |
1,834 |
|
|
|
|
|
|
|
|
|
|
Current
|
|
$ |
590 |
|
|
$ |
431 |
|
Long-term
|
|
$ |
990 |
|
|
$ |
1,403 |
|
Borrowings available under
the Company’s lease lines of credit with Farnam Street Financial are
approximately $238,350. See Note 10, Notes Payable, to the consolidated
financial statements accompanying the 2010 Annual Report Form 10-K for
additional information regarding the Company’s capital lease
agreements.
Covenant
Compliance
The
Company is in compliance with the covenants of its credit facilities as of the
date of this report.
Note 10 —
Basic and Diluted Income Per Share
The
following table sets forth the computation of basic and diluted net income per
share (in thousands except per share amounts):
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
2011
|
|
|
October 1,
2010
|
|
|
September 30,
2011
|
|
|
October 1,
2010
(Note A)
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Income (loss)
|
|
$ |
77 |
|
|
$ |
(1,158
|
) |
|
$ |
1,239 |
|
|
$ |
744 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares and denominator for basic
calculation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding
|
|
|
35,695 |
|
|
|
34,945 |
|
|
|
35,442 |
|
|
|
34,879 |
|
Less:
Unvested restricted stock
|
|
|
(156
|
) |
|
|
(114
|
) |
|
|
(138
|
) |
|
|
(89
|
) |
Denominator
for basic calculation
|
|
|
35,539 |
|
|
|
34,831 |
|
|
|
35,304 |
|
|
|
34,790 |
|
Weighted
average effects of dilutive equity-based compensation
awards:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee
stock options
|
|
|
846 |
|
|
|
— |
|
|
|
751 |
|
|
|
— |
|
Warrants
|
|
|
568 |
|
|
|
— |
|
|
|
452 |
|
|
|
— |
|
Denominator
for diluted calculation
|
|
|
36,953 |
|
|
|
34,831 |
|
|
|
36,507 |
|
|
|
34,790 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) per share – basic
|
|
$ |
0.00 |
|
|
$ |
(0.03 |
) |
|
$ |
0.04 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) per share - diluted
|
|
$ |
0.00 |
|
|
$ |
(0.03 |
) |
|
$ |
0.03 |
|
|
$ |
0.02 |
|
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2011
(Unaudited)
Note
A: For 2010, although the Company reported net income as a result of
the gain on sale of Domilens, it used the net loss from continuing operations as
the control number in determining whether including potential common shares in
the diluted income per share calculation would be dilutive or
anti-dilutive.
The
following table sets forth (in thousands) the weighted average number of options
and warrants to purchase shares of common stock, restricted stock and preferred
stock which were not included in the calculation of diluted per share amounts
because the effects would be anti-dilutive.
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
2011
|
|
|
October 1,
2010
|
|
|
September 30,
2011
|
|
|
October 1,
2010
|
|
Options
and restricted stock
|
|
|
1,405 |
|
|
|
3,929 |
|
|
|
1,279 |
|
|
|
3,900 |
|
Warrants
|
|
|
70 |
|
|
|
1,470 |
|
|
|
70 |
|
|
|
1,470 |
|
Preferred
Stock
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
897 |
|
Total
|
|
|
1,475 |
|
|
|
5,399 |
|
|
|
1,349 |
|
|
|
6,267 |
|
Note 11 —
Comprehensive Income
The
components of comprehensive income (loss) are as follows (in
thousands):
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
2011
|
|
|
October 1,
2010
|
|
|
September 30,
2011
|
|
|
October 1, 2010
|
|
Net
income (loss)
|
|
$ |
77 |
|
|
$ |
(1,158 |
) |
|
$ |
1,239 |
|
|
$ |
744 |
|
Other
comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Minimum
pension liability adjustment
|
|
|
19 |
|
|
|
3 |
|
|
|
(22 |
) |
|
|
9 |
|
Foreign
currency translation adjustment
|
|
|
407 |
|
|
|
519 |
|
|
|
310 |
|
|
|
(1,414 |
)(1) |
Comprehensive
income (loss)
|
|
|
426 |
|
|
|
522 |
|
|
|
288 |
|
|
|
(1,405 |
) |
Total
comprehensive income (loss)
|
|
$ |
503 |
|
|
$ |
(636 |
) |
|
$ |
1,527 |
|
|
$ |
(661 |
) |
|
(1)
|
Includes
$2,256 related to the sale of
Domilens.
|
Note
12 — Geographic and Product Data
The Company markets and sells
its products in more than 50 countries and has manufacturing sites in the United
States, Switzerland and Japan. Other than the United States, Japan, Korea, and
China, the Company does not conduct business in any country in which its sales
exceed 5% of consolidated sales. Sales are attributed to countries based on
location of customers. The composition of the Company’s net sales to
unaffiliated customers is set forth below (in thousands):
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
September 30,
|
|
|
October 1,
|
|
|
September 30,
|
|
|
October 1,
|
|
|
2011
|
|
|
2010
|
|
|
2011
|
|
|
2010
|
United
States
|
|
$ |
3,211 |
|
|
$ |
3,727 |
|
|
$ |
10,448 |
|
|
$ |
11,560 |
|
Japan
|
|
|
4,037 |
|
|
|
3,283 |
|
|
|
11,772 |
|
|
|
10,170 |
|
Korea
|
|
|
2,069 |
|
|
|
1,710 |
|
|
|
5,463 |
|
|
|
4,356 |
|
China
|
|
|
1,825 |
|
|
|
785 |
|
|
|
4,832 |
|
|
|
2,641 |
|
Other
|
|
|
4,124 |
|
|
|
3,647 |
|
|
|
13,870 |
|
|
|
11,842 |
|
Total
|
|
$ |
15,266 |
|
|
$ |
13,152 |
|
|
$ |
46,385 |
|
|
$ |
40,569 |
|
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2011
(Unaudited)
100% of the Company’s sales are generated
from the ophthalmic surgical product segment and therefore the Company operates
as one operating segment for financial reporting purposes. The Company’s
principal products are implantable Collamer lenses (“ICLs”) used in refractive
surgery and intraocular lenses (“IOLs”) used in cataract surgery. The
composition of the Company’s net sales by product line is as follows (in
thousands):
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
|
|
|
October 1,
|
|
|
September 30,
|
|
|
October 1,
|
|
|
|
2011
|
|
|
2010
|
|
|
2011
|
|
|
2010
|
|
ICLs
|
|
$ |
7,902 |
|
|
$ |
6,034 |
|
|
$ |
23,093 |
|
|
$ |
17,757 |
|
IOLs
|
|
|
6,571 |
|
|
|
6,559 |
|
|
|
20,767 |
|
|
|
20,442 |
|
Core
products
|
|
|
14,473 |
|
|
|
12,593 |
|
|
|
43,860 |
|
|
|
38,199 |
|
Other
Surgical Products
|
|
|
793 |
|
|
|
559 |
|
|
|
2,525 |
|
|
|
2,370 |
|
Total
|
|
$ |
15,266 |
|
|
$ |
13,152 |
|
|
$ |
46,385 |
|
|
$ |
40,569 |
|
The
Company sells its products internationally, which subjects the Company to
several potential risks, including fluctuating foreign currency exchange rates
(to the extent the Company’s transactions are not in U.S. dollar), regulation of
fund transfers by foreign governments, United States and foreign export and
import duties and tariffs, and political instability.
Note
13— Commitments and Contingencies
On May
24, 2010, the Company accrued $700,000 in executive termination benefit costs in
connection with the notice of non-renewal given under an executive employment
agreement. This accrual represented the Company’s best estimate of the
contractual termination benefits due to the former executive. The actual amount
ultimately paid to the former executive may be different than the amount
estimated. As of September 30, 2011,
accrued unpaid severance was approximately $104,000.
Note
14 — Stock-Based Compensation
The cost that has been
charged against income for stock-based compensation is set forth below (in
thousands):
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
2011
|
|
|
October 1,
2010
|
|
|
September 30,
2011
|
|
|
October 1,
2010
|
|
SFAS
123R expense
|
|
$ |
363 |
|
|
$ |
200 |
|
|
$ |
978 |
|
|
$ |
642 |
|
Restricted
stock expense
|
|
|
115 |
|
|
|
77 |
|
|
|
320 |
|
|
|
214 |
|
Consultant
compensation
|
|
|
45 |
|
|
|
19 |
|
|
|
32 |
|
|
|
89 |
|
Total
|
|
$ |
523 |
|
|
$ |
296 |
|
|
$ |
1,330 |
|
|
$ |
945 |
|
The
Company recognized no net income tax benefit in its income statement for
share-based compensation arrangements because the Company fully offsets net
deferred tax assets with a valuation allowance. In addition, the
Company capitalized $33,000 and $109,000 of stock compensation to inventory for
the three and nine months ended September 30, 2011, and $22,000 and $65,000,
respectively, for the three and nine months ended October 1, 2010. It recognizes
those amounts as expense in Cost of Sales as the inventory is sold.
Stock
Option Plans
In fiscal year 2003, the
Board of Directors approved the 2003 Omnibus Equity Incentive Plan (the “2003
Plan”) authorizing awards of equity compensation, including options to purchase
common stock and restricted shares of common stock. The 2003 Plan amends,
restates and replaces the 1991 Stock Option Plan, the 1995 Consultant Stock
Plan, the 1996 Non-Qualified Stock Plan, and the 1998 Stock Option Plan (the
“Restated Plans”). On May 19, 2010, the stockholders of STAAR
approved the Restated 2003 Omnibus Plan, which increased the number of shares
available for grants under the plan by 2,000,000 shares and extended the term of
the plan to May 18, 2020. As of September 30, 2011, there were
1,755,697 shares authorized and available for grants under the Restated 2003
Omnibus Plan. The 2003 Plan provides for various forms of stock-based
incentives. To date, of the available forms of awards under the 2003
Plan, the Company has granted only stock options, restricted stock and
unrestricted share grants. Options under the plan are granted at fair market
value on the date of grant, become exercisable over a three or four-year period,
or as determined by the Board of Directors, and expire over periods not
exceeding 10 years from the date of grant. Certain option and share awards
provide for accelerated vesting if there is a change in control (as defined in
the 2003 Plan). Pursuant to the plan, options for 3,121,972 shares were
outstanding at September 30, 2011 with exercise prices ranging between $0.95 and
$8.12 per share. Restricted stock grants under the 2003 Plan
generally vest over a period of one, three or four years. There were
155,500 shares of restricted stock outstanding at September 30, 2011.
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2011
(Unaudited)
In fiscal year 1998, the
Board of Directors approved the 1998 Stock Option Plan, authorizing the granting
of options to purchase common stock or awards of common stock. Pursuant to the
plan, options for 7,000 shares were outstanding at September 30, 2011 with an
exercise price of $3.60 per share. No further awards may be made under this
plan.
Assumptions
The
fair value of each option award is estimated on the date of grant using a
Black-Scholes option valuation model applying the assumptions noted in the
following table. Expected volatilities are based on historical
volatility of the Company’s stock. The Company uses historical data to estimate
option exercise and employee termination behavior. The expected term of options
granted is derived from the historical exercise activity over the past 15 years,
and represents the period of time that options granted are expected to be
outstanding. Options granted with a three-year vesting life during
the nine months ended September 30, 2011 and October 1, 2010 had an expected
term of 5.49 and 5.60 years, respectively, and were derived from historical
exercise and termination activity. The Company has calculated a
10.05% estimated forfeiture rate used in the model for fiscal year 2011 option
grants based on historical forfeiture experience. The risk-free rate
for periods within the contractual life of the option is based on the U.S.
Treasury yield curve in effect at the time of grant.
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
2011
|
|
|
October 1,
2010
|
|
|
September 30,
2011
|
|
|
October 1,
2010
|
|
Expected
dividend yield
|
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
Expected
volatility
|
|
|
76.99 |
% |
|
|
80.17 |
% |
|
|
76.93 |
% |
|
|
80.53 |
% |
Risk-free
interest rate
|
|
|
1.12 |
% |
|
|
1.40 |
% |
|
|
1.94 |
% |
|
|
2.15 |
% |
Expected
term (in years)
|
|
|
5.49 |
|
|
|
5.6 |
|
|
|
5.49 |
|
|
|
5.6 |
|
A summary
of option activity under the Plans as of September 30, 2011 is presented
below:
Options
|
|
Shares
(000’s)
|
|
|
Weighted-
Average
Exercise
Price
|
|
|
Weighted-
Average
Remaining
Contractual
Term
|
|
|
Aggregate
Intrinsic
Value
(000’s)
|
|
Outstanding
at December 31, 2010
|
|
|
3,331 |
|
|
$ |
4.35 |
|
|
|
— |
|
|
$ |
— |
|
Granted
|
|
|
629 |
|
|
|
5.59 |
|
|
|
— |
|
|
|
— |
|
Exercised
|
|
|
(742
|
) |
|
|
4.02 |
|
|
|
— |
|
|
|
— |
|
Forfeited
or expired
|
|
|
(88
|
) |
|
|
5.41 |
|
|
|
— |
|
|
|
— |
|
Outstanding
at September 30, 2011
|
|
|
3,130 |
|
|
$ |
4.65 |
|
|
|
6.69 |
|
|
|
3,245 |
|
Exercisable
at September 30, 2011
|
|
|
1,996 |
|
|
$ |
4.37 |
|
|
|
5.30 |
|
|
$ |
2,784 |
|
The
weighted-average grant-date fair value of options granted during the nine months
ended September 30, 2011 and October 1, 2010 was $3.63 and $2.84 per
option. The total fair value of options vested during the nine months
ended September 30, 2011 and October 1, 2010 was $806,000 and $995,000,
respectively. There were 742,264 and 84,732 options exercised with an
intrinsic value of $1,823,000 and $152,000
during the nine months ended September 30, 2011 and October 1,
2010.
A summary of the status of the
Company’s non-vested shares as of September 30, 2011 and changes during the
period is presented below:
Nonvested Shares
|
|
Shares
(000’s)
|
|
|
Weighted-
Average
Grant Date
Fair Value
|
|
Nonvested
at December 31, 2010
|
|
|
885 |
|
|
$ |
2.89 |
|
Granted
|
|
|
629 |
|
|
|
3.63 |
|
Vested
|
|
|
(330
|
) |
|
|
2.45 |
|
Forfeited
|
|
|
(65
|
) |
|
|
3.73 |
|
Nonvested
at September 30, 2011
|
|
|
1,119 |
|
|
$ |
3.67 |
|
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2011
(Unaudited)
As of September 30, 2011, the Company
had $2.9 million
of total unrecognized compensation cost related to non-vested share-based
compensation arrangements granted under the Plans. That cost is expected to be
recognized over a weighted-average period of 1.80 years.
Note 15 —
Supplemental Disclosure of Cash Flow Information
Interest paid was $374,000 and $930,000
for the nine months ended September 30, 2011 and October 1, 2010, respectively.
Income taxes paid amounted to approximately $648,000 and
$1,081,000 for the nine months ended September 30, 2011 and October 1, 2010,
respectively.
The Company’s non-cash investing and
financing activities were as follows (in thousands):
|
|
September 30,
2011
|
|
|
October 1,
2010
|
|
Non-cash
investing and financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets
obtained by capital lease
|
|
$ |
79 |
|
|
$ |
776 |
|
Note 16 — New Accounting
Pronouncements
In June
2011, the Financial Accounting Standards Board (FASB) issued Accounting
Standards Update (ASU No. 2011-05) “Comprehensive Income (Topic 220) —
Presentation of Comprehensive Income.” ASU 2011-05 requires that all
nonowner changes in stockholders’ equity be presented either in a single
continuous statement of comprehensive income or in two separate but consecutive
statements. In both choices, an entity is required to present each
component of net income along with total net income, each component of other
comprehensive income along with a total for other comprehensive income, and a
total amount for comprehensive income. ASU 2011-05 is effective
retrospectively for fiscal years, and interim periods within those years,
beginning after December 15, 2011. We are assessing the impact of ASU
2011-05 on our comprehensive income presentation.
In
May 2011, the FASB issued ASU No. 2011-04 “Fair Value Measurement (Topic 820)
- Amendments to Achieve Common Fair Value Measurement and Disclosure
Requirements in U.S. GAAP and IFRSs.” ASU 2011-04 changes the
wording used to describe many of the requirements in U.S. GAAP for measuring
fair value and for disclosing information about fair value measurements.
Consequently, the amendments in this update result in common fair value
measurement and disclosure requirements in U.S. GAAP and IFRSs (International
Financial Reporting Standards). ASU 2011-04 is effective prospectively
during interim and annual periods beginning on or after December 15,
2011. We are assessing the impact of ASU 2011-04 on our fair value
disclosures.
ITEM 2.
|
MANAGEMENT'S DISCUSSION AND
ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
The matters addressed in this Item 2 that
are not historical information constitute “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as
amended. Although we believe that the expectations reflected in these
forward-looking statements are reasonable, such statements are inherently
subject to risks and STAAR can give no assurances that its expectations will
prove to be correct. Actual results could differ materially from
those described in this report because of numerous factors, many of which are
beyond the control of STAAR. These factors include, without
limitation, those described in our Annual Report on Form 10-K for the fiscal
year ended December 31, 2010 and in this Quarterly Report under the heading
“
Risk Factors.” STAAR
undertakes no obligation to update these forward-looking statements that may be
made to reflect events or circumstances after the date of this report or to
reflect actual outcomes.
The following discussion
should be read in conjunction with STAAR’s interim condensed financial
statements and the related notes provided under “Item 1—
Financial Statements”
above.
Overview
STAAR Surgical Company
designs, develops, manufactures and sells implantable lenses for the
eye. We are the world’s leading manufacturer of intraocular lenses
used in corrective or “refractive” surgery, and we also make lenses for use in
surgery that treats cataracts. All of the lenses we make are
foldable, which allows the surgeon to insert them into the eye through a small
incision during minimally invasive surgery. Cataract surgery is a relatively
common outpatient procedure where the eye’s natural lens that has become cloudy
with age is removed and replaced with an artificial lens called an intraocular
lens (IOL) to restore the patient’s vision. Refractive surgery is
performed to treat the type of visual disorders that have traditionally been
corrected using eyeglasses or contact lenses. We refer to our lenses
used in refractive surgery as “implantable Collamer® lenses” or “ICLs” and
market them under the Visian® brand name. The field of refractive surgery
includes both lens-based procedures, using products like the Visian ICL, and
laser-based procedures like LASIK. Successful refractive surgery can
correct common vision disorders such as myopia, hyperopia and astigmatism.
Originally incorporated in
California in 1982, STAAR Surgical Company reincorporated in Delaware in
1986. Unless the context indicates otherwise, “we,” “us,” the
“Company,” and “STAAR” refer to STAAR Surgical Company and its consolidated
subsidiaries.
STAAR
Surgical Company, Visian®, Collamer®, STAARVISC®, Elastimide®, nanoFLEX™,
nanoPOINT™, CentraFLOW™, AquaPORT™, Epiphany™ and AquaFlow™ are
trademarks or registered trademarks of STAAR in the U.S. and other
countries.
Collamer® is the brand name
for STAAR’s proprietary collagen copolymer lens material.
Background Regarding Our
Business
A detailed description of
STAAR’s business appears in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2010, along with a glossary explaining many of the
specialized terms used in describing our products and our
business. We recommend that readers unfamiliar with STAAR refer to
that description.
Visian
Implantable Collamer Lenses. Sales of
refractive lenses make up approximately half of our total sales. Made
from our proprietary biocompatible Collamer material, STAAR’s VISIAN ICL and
VISIAN Toric ICL, or TICL™, treat refractive disorders such as myopia
(near-sightedness), hyperopia (far-sightedness) and astigmatism. The
surgeon implants the foldable Visian lens through a tiny incision, generally
under topical anesthesia. STAAR began selling the Visian ICL outside
the U.S. in 1996 and inside the U.S. in 2006. STAAR began selling the
Visian TICL outside the U.S. in 2002. STAAR’s goal is to position the
ICL and TICL throughout the world as primary choices for refractive
surgery.
Sales of ICLs during the
three months and nine months ended September 30, 2011 were $7.9 million and
$23.1 million, compared to $6.0 million and $17.8 million for the same periods
in the prior year. Having surpassed our sales of IOLs for the first
time in the second quarter of 2011, ICL sales represented approximately 52% of
total net sales in the three-month period and 50% in the nine-month
period.
IOLs -
Intraocular Lenses for Cataract Surgery. Sales of foldable
IOLs used in minimally invasive cataract surgery made up approximately 43% of
our total sales in the third quarter. Our range of IOLs includes the
following:
|
·
|
Aspheric IOLs,
available in silicone and in Collamer®, STAAR’s proprietary biocompatible
collagen copolymer lens material. Aspheric IOLs are designed to improve
the patient’s quality of vision when compared to earlier spherical IOL
designs.
|
|
·
|
The nanoFLEX IOL, a
single-piece Collamer aspheric IOL that can be implanted through a 2.2 mm
incision with the nanoPOINT injector system is available in the U.S
and other territories that accept the CE Mark.
|
|
·
|
The Preloaded Injector,
a three-piece silicone or acrylic IOL preloaded into a single-use
disposable injector and currently available outside the
U.S. The acrylic Preloaded Injector uses an acrylic lens
sourced from another
manufacturer.
|
|
·
|
The silicone Toric IOL,
used in cataract surgery to treat preexisting astigmatism which is
currently available in the U.S. Astigmatism is a condition that
causes blurred vision when an irregular shape of the cornea prevents light
from focusing properly on the
retina.
|
Because most cataract
patients are elderly, government agencies or government sponsored entities
generally pay the cost of IOLs in our major markets, including the
U.S. As a result, IOL revenues will likely remain relatively stable
even under adverse conditions in the general economy. However,
changes in reimbursement policy under these agencies and entities can reduce our
selling prices or reduce the volume of cataract procedures.
Sales of IOLs during the
three months and nine months ended September 30, 2011 were $6.6 million and
$20.8 million, compared to $6.6 million and $20.4 million for the same periods
in the prior year. IOL sales represented approximately 43% of total
net sales in the three-month period and 45% in the nine-month
period.
Other
Surgical Products. We also sell other
instruments, devices, and equipment used in cataract or refractive surgery,
which we either manufacture or have manufactured for us. However, we
have been deemphasizing these products since 2009 because of their lower overall
gross profit margins. We also make the AquaFlow Collagen Glaucoma
Drainage Device, an implantable device used for surgical treatment of
glaucoma.
Sales of other surgical
products during the three months and nine months ended September 30, 2011 were
$0.8 million and $2.5 million, compared to $0.6 million and $2.4 million for the
same periods in the prior year, representing approximately 5% of total net sales
in both the three-month and nine-month periods.
STAAR has significant
operations both within and outside the U.S. Sales from activities
outside the U.S. accounted for approximately 79% of our total sales for the
quarter ended September 30, 2011. STAAR operates its global
administrative headquarters and a manufacturing facility in Monrovia,
California. STAAR operates an administrative, manufacturing and
distribution facility in Nidau, Switzerland under its wholly owned subsidiary,
STAAR Surgical AG. STAAR operates administrative, manufacturing and
distribution facilities in Chiba Prefecture, Japan under its wholly owned
subsidiary, STAAR Japan Inc. We also have a manufacturing facility in Aliso
Viejo, California.
The global nature of STAAR’s
business operations subjects it to risks, including the effect of changes in
currency exchange rates, differences in laws, including laws protecting
intellectual property and regulating medical devices, political risks and the
challenge of managing foreign subsidiaries.
STAAR has
developed a plan to methodically consolidate its manufacturing in a single site
at its Monrovia, California location by the end of 2013, which is expected
subsequently to yield significant savings in cost of goods and to lower our
global administrative and regulatory costs. This plan, which is
subject to significant risks, is described in greater detail in Management’s
Discussion and Analysis of Financial Condition under the caption “Manufacturing Consolidation Project
and Tax Strategy.”
Strategy and Key Operational
Metrics
STAAR’s strategy is to be
valued as a leading global provider of innovative intraocular lens system
technologies. STAAR will employ a focused commercialization strategy
that enables sustainable profitable growth.
STAAR’s
key operational metrics in 2011 are guided by two principal strategic
goals: to achieve and maintain profitability and to lay the
groundwork for further growth. In pursuit of these goals, STAAR has
aligned its business initiatives during 2011 along four key operational metrics
it uses to gauge its success during the year. Based on performance in
excess of targets during the second quarter, STAAR increased the targets for
three of the four metrics, and they are currently established as follows:
|
·
|
Increase total revenue
by double digits.
|
|
·
|
Grow Visian ICL and
TICL sales by 30%.
|
|
·
|
Continuously
increase gross profit margin each quarter to achieve a level of 66.5% for
the full year.
|
|
·
|
Achieve
profitability in all four quarters of
2011.
|
STAAR satisfied all four of
the metrics, including the three increased metrics, during the third quarter of
2011.
Increase
total revenue by double digits. As STAAR
continues to place less emphasis on its less profitable non-core products and
experiences increasing revenue in its higher value core products, it has set a
target of double digit growth in total revenue during 2011. In the
third quarter of 2011, STAAR achieved year-over-year total revenue growth of
16%, and for the nine-month period it achieved growth of 14% in total
revenue.
Grow
Visian ICL and TICL sales by 30%. STAAR achieved a growth rate
of 31% in the third quarter, and 30% growth for the first nine months of the
year. We have been pursuing the goal of increased ICL and TICL sales
by identifying the top ten markets and concentrating our sales and marketing
efforts on increasing our market share in those regions. Growth rates in the top
ten markets on which we currently focus were 33% during the third quarter, and
32% for the first nine months of the year. STAAR launched its new
Visian V4c with CentraFLOW™ technology in the countries covered by the CE Mark
in the third week of September 2011, which is expected to positively affect
sales growth in Europe in the fourth quarter. U.S. ICL sales have continued a
trend of relatively slow growth seen over the last two years, and experienced a
decline of 7% for the third quarter and declined 2% for the first nine months of
2011. Our goal had originally been to increase Visian ICL and TICL
sales by 25%; we increased the goal after exceeding the target level in the
second quarter. Because Visian products are used in elective surgery,
the rate of sales growth depends on continued improvement in global economic
conditions. We discuss recent trends in Visian sales in greater
detail below under the heading Visian
ICL and TICL sales.
Continuously
expand gross profit margin each quarter to achieve a level of 66.5% for the full
year. STAAR’s gross profit margin
was 68.5% for the third quarter and 66.7% for the first nine months of 2011.
While cost savings have contributed to improving margins, the biggest factor has
been the change in our product mix. Visian products yield a significantly higher
profit margin than IOLs. Among IOLs, STAAR has increased average
selling prices by emphasizing sales of its higher value IOLs, such as nanoFLEX
and our Toric IOL. Preloaded IOL sales in some territories,
especially Japan, have historically yielded good profit margins and their sales
increased during the first half of 2011. Since 2009 STAAR has
de-emphasized lower margin sales of non-IOL, non-ICL products. Based
on performance in the first half of 2011, STAAR raised this target to 66.5% for
the full year from an initial target of 66%.
Achieve
profitability in all four quarters of 2011. In the third quarter STAAR
achieved net earnings of $0.08 million, or $0.00 per share. STAAR’s
achievement of net earnings of $0.3 million in the first quarter of 2011 was the
first quarter since 1999 during which the company reported net income from
continuing operations. Based on this performance STAAR increased this
metric from an original target of profitability in three of four
quarters. We caution that STAAR has just crossed the threshold of
profitability, and sustained profitability remains vulnerable to the competitive
nature of our industry and to the risk factors described in our Annual Report on
Form 10-K.
Global Visian ICL and TICL
Sales
STAAR continues to focus its
Visian marketing and sales efforts in the key territories where it has
established significant market share, based on the success of this strategy in
2009 and 2010. The key territories in which STAAR is currently
seeking to enhance Visian sales are the U.S., Japan, Korea, China, India, Spain,
Middle East, Germany, U.K., and Latin America.
Since 2009, STAAR has
experienced a breakthrough in market penetration in Korea, where it believes
implants of Visian products have reached approximately 15% of the total volume
of refractive surgery procedures. Revenues from sales of Visian ICL
products in Korea increased 22% in the third quarter and 26% in the first nine
months of 2011. Because of the rapid growth of Visian ICL sales and
market share in Korea, STAAR is using Korea as a model of best practices for
marketing that may serve to significantly increase market share in other key
territories. Other territories where Visian products have experienced
significant growth in the first nine months of 2011 over prior year were China,
Japan, Germany, the Middle East and India.
In September 2011, STAAR
launched the V4c model of the Visian ICL with CentraFLOW technology in countries
that recognize the CE Mark. The CentraFLOW technology uses a
proprietary port in the center of the ICL optic of a size determined to optimize
the flow of fluid within the eye, and eliminates the need for the surgeon to
perform a YAG peripheral iridotomy procedure days before the ICL implant or a
surgical iridotomy at time of implant. By simplifying the
procedure and increasing patient comfort, the V4c makes the superior visual
outcomes of the Visian ICL available through a surgical implantation
experience closer to LASIK, which should attract new surgeons and patients to
the product. STAAR believes that a number of presentations by surgeons at the
September 2011 Congress of the European Society of Cataract and Refractive
Surgery demonstrated keen interest in V4c among surgeons. Based on
these clinical presentations and early ordering activity for the V4c, STAAR
believes the product has the potential to further increase the rate of global
Visian sales growth. Availability of the V4c will begin to affect
sales in the fourth quarter of 2011, so it is too early to determine whether and
to what degree the product will actually affect
sales.
The launch of V4c follows
the September 2010 introduction of the V4b model, which offers an expanded range
of correction, in territories that recognize the CE Mark. The
expanded range includes ICLs with lower levels of myopia correction in
quarter-diopter increments, Toric hyperopic ICLs to treat astigmatism and
far-sightedness, and Toric ICLs in the low to zero range of myopia to treat
patients primarily affected by astigmatism. These product line
extensions more than double the number of patients who could benefit from Visian
products in Europe and other territories that accept the CE Mark. In the first
nine months of 2011, approximately 7 % of the V4b sales in the markets in which
it is available were in the new expanded treatment range.
STAAR believes that, where
available, the V4c and V4b models have significantly improved the
competitiveness of the Visian product line and have moved STAAR closer to its
goal of positioning the ICL and TICL throughout the world as primary choices for
refractive surgery. Visian products now address all degrees of
refractive error that can be treated with laser eye surgery, as well as moderate
and severe errors beyond the effective range of laser eye
surgery.
In some key markets of the
Asia Pacific region where STAAR has not yet introduced the V4b, STAAR plans to
seek approval of the V4c and to move directly to that model.
STAAR is currently seeking
approval of the TICL in the U.S. and Japan.
STAAR’s ability to maintain
or accelerate the rate of growth in Visian ICL sales will partly depend on
continued improvement in worldwide economic conditions and progress with
regulatory agencies. ICL surgery is a relatively expensive elective
procedure and is seldom reimbursed by insurers or government
agencies. STAAR believes that the global recession reduced overall
demand for refractive surgery particularly in the U.S., and it has been reported
that consumer spending and consumer confidence has not returned to pre-recession
levels.
In May 2011 STAAR received
approval to market the Visian model V4 ICL in Brazil. This approval
helped to drive STAAR’s decision to target the Latin American market for Visian
ICL growth, and it intends to add sales and marketing resources in the region to
capitalize on the new opportunity. In addition, STAAR is working to
expand regulatory approvals in the market.
We consider Visian ICL sales
growth in the U.S. market important because of the size of the U.S. refractive
surgery market and the perceived worldwide leadership of the U.S. in adopting
innovative medical technologies. The Visian ICL was approved by the
FDA for treatment of myopia on December 22, 2005.
U.S. sales of ICLs decreased
by 7% in the third quarter and 2% for the first nine months of 2011, compared to
prior year. Sales in the private sector continued to increase by 1% in the
quarter and were up 13% for the nine months. Sales to the military declined 15%
in the quarter bringing the year to date decline to 37%. This percentage decline
has decreased on a sequential quarterly basis, the first quarter and second
quarter declines were 57% and 34% respectively, and we anticipate this trend
will continue and that military sales will return to growth in 2012.
Military sales accounted for 16% of total US ICL sales in the first nine
months, compared to 25% in the same period last year. The increase in private
sector sales, which STAAR believes resulted from its efforts to drive greater
adoption and increased usage of the lower diopter range among its existing
customer base. If the economy continues to improve, and overall refractive
procedures volume increases, STAAR could see further growth in private sector
ICL sales in the U.S.
STAAR believes that the FDA’s
scrutiny of patient satisfaction levels following laser refractive surgery,
which began in 2008, has affected the overall U.S. market for refractive
surgery. The negative publicity generated by that regulatory activity
continued in 2010 after a former FDA official publicly petitioned FDA to revoke
its approval of LASIK. Patient concerns about LASIK could increase
interest in the Visian ICL as an alternative for patients who have a greater
risk of complications from LASIK. The fact that the Visian ICL is
removable may also be appealing to some patients with new concerns about risks
of refractive surgery. However, STAAR believes in the short term the
negative publicity concerning LASIK has decreased patient interest in all
refractive surgery, including Visian ICL. Because nearly all
candidates for refractive surgery can achieve acceptable vision through the use
of spectacles or contact lenses, for most patients the decision to have
refractive surgery is a lifestyle choice that depends on high confidence in
achieving a satisfactory outcome.
In addition to poor
conditions in the general economy, in particular the refractive surgery market,
and negative publicity concerning LASIK, other challenges to resumed growth in
U.S. Visian ICL sales include the following:
|
·
|
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;
|
|
·
|
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;
|
|
·
|
the
fact that the FDA has not granted approval to sell the TICL, which STAAR
sells in over 50 international markets for treating patients affected by
both myopia and astigmatism;
and.
|
|
·
|
FDA
approval of the V4c is expected to be significantly more time consuming
than regulatory approval in most international
markets.
|
Beginning the fourth quarter
of 2010 STAAR has been testing direct-to-consumer advertising initiatives online
and has used conventional DTC media to test a campaign in selected markets. This
activity seeks to increase potential refractive patient visits and to encourage
patients to inquire specifically about the Visian ICL by distinguishing it from
other refractive treatments. The current materials for the campaign are a
series of humorous videos contrasting the Visian ICL with LASIK, eyeglasses and
contact lenses. The videos highlight certain benefits of the ICL over
other treatments, including clarity of vision, absence of surgically induced dry
eye, removability and ultraviolet protection. STAAR is assessing the data
obtained to date to determine whether, and in what form, to launch a broader
direct-to-consumer campaign
Additionally,
STAAR has begun efforts to increase the visibility of the Visian ICL technology
on social network sites. The Facebook Visian ICL Contest was just
completed which saw the fan base for the Visian ICL more than double in
size. Contestants developed videos in which they were trying to convince
voters why they needed a free Visian ICL procedure. STAAR worked with nine
ophthalmic practices across the U.S. and five winners were determined based upon
consumer voting on the network. The Visian ICL procedures are now being
arranged along with a focus to drive local media around the event. During
the recent American Academy of Ophthalmology meeting STAAR offered online
marketing consulting for key practices to support their viral efforts around the
Visian ICL technology. STAAR has decided to expand its social networking
department in 2012 in order to more effectively drive consumer testimonials and
respond to consumer questions.
STAAR
pioneered the development of folding lenses for use in cataract surgery, and
IOLs continue to represent approximately 45% of STAAR’s
business. Sales of IOLs during the three months and nine months ended
September 30, 2011 were $6.6 million and $20.8 million, compared to $6.6 million
and $20.4 million for the same periods in the prior year.
In September 2011, STAAR
launched its nanoFLEX Collamer Single Piece IOL which can be injected through a
2.2 mm incision with the nanoPOINT™ Injector System, in the territories that the
recognize the CE Mark. This follows the April 2011 CE Mark approval
of the product. nanoFLEX has been STAAR’s fastest growing IOL product
in U.S. markets and STAAR believes the lens can receive broad commercial
acceptance outside the U.S. STAAR hopes that the biocompatibility and
outstanding optical properties of Collamer, with which surgeons have become
acquainted through the ICL, will build interest in the nanoFLEX IOL
worldwide. STAAR’s Collamer Accommodating Study Team (CAST) used the
nanoFLEX lens in its 2009 clinical observations and reported promising
assessments regarding initial intermediate and near vision
results. These properties of nanoFLEX may also spur interest in the
lens in new markets, especially among surgeons seeking an IOL for monovision
treatment.
Among STAAR’s initiatives to
grow its IOL business are the following:
|
·
|
we
plan to seek further approvals for the nanoFLEX in an effort to build a
global product franchise for Collamer
IOLs;
|
|
·
|
we
are seeking approval to introduce the silicone Preloaded Injector in the
U.S. market to enhance our U.S. IOL offering and help STAAR maintain or
increase its market share in the hospital based
segment;
|
|
·
|
a
new version of the hydrophobic acrylic Preloaded Injector, featuring the
popular single-piece IOL format, received CE Mark approval in May 2011,
and STAAR plans to introduce it into international markets in
the2012;
|
|
·
|
we
plan to introduce a preloaded injector for the
nanoFLEX;
|
|
·
|
we are developing a
Collamer Toric IOL on the nanoFLEX platform to complement our pioneering
silicone Toric IOL and better compete with other Toric
IOL;
|
|
·
|
we
have recently seen renewed interest in our silicone Toric IOL among U.S.
surgeons and are ramping up marketing efforts for the lens;
and
|
|
·
|
we
are researching accommodating and/or multifocal designs that exploit the
unique optical properties of the Collamer
material.
|
STAAR cautions that the
successful development and introduction of new products is subject to risks and
uncertainties, including the risk of unexpected delays and, in some cases,
approval of regulatory authorities.
STAAR’s efforts to increase
U.S. IOL sales face a number of short and long-term challenges, including
successfully meeting its objectives to develop new and enhanced products and
marketing them with limited resources. The U.S. IOL market has
recently become more fragmented with the entry of new competitors, resulting in
greater competition for market share. We cannot assure that our
efforts will ultimately be successful.
Manufacturing
Consolidation Project and Tax Strategy. During 2011 STAAR
has devoted significant resources to two initiatives: a project to
consolidate global manufacturing, and development of a strategy to optimize our
global organization for tax purposes. The goal of both of these
strategies is to continue our improvement in gross profit margin by reducing
costs and to position the company for future growth.
STAAR currently manufactures
its products in four facilities worldwide. It has developed a plan to
methodically consolidate its manufacturing in a single site at its Monrovia,
California location by the end of 2013, which is expected subsequently to yield
significant savings in cost of goods and to lower our global administrative and
regulatory costs.
In addition, as STAAR’s
profitability grows, its liability for income taxes in various jurisdictions has
also increased. STAAR has developed a strategy to minimize its future
tax liabilities as its business grows. Among other things, STAAR
seeks to utilize the approximately $125 million in net operating losses that it
has accumulated in the U.S.
In connection with its
Centers of Excellence project in 2009 and 2010, STAAR successfully transferred
manufacturing of some of its products; STAAR believes this experience will be
helpful in undertaking the more ambitious transfers involved in the
manufacturing consolidation project.
STAAR expects these
initiatives to cost approximately $6 million over a three-year period, of which
it has spent approximately $0.5 million for the nine months ended September 30,
2011 and expects to spend approximately $150,000 in the fourth quarter of 2011.
Expenditures to date have largely consisted of professional fees to advisors and
consultants. We expect approximately $1 million in additional capital
expenditures to consolidate our manufacturing. STAAR anticipates that
the two initiatives could yield savings of $100 million over the period 2014 to
2020, and could result in profit margin in the 75% range.
We cannot assure that we will
achieve the expected benefits of these initiatives. Among other things, costs
could exceed current estimates, product manufacturing transfers can result in
delays or supply interruptions, changes in tax laws could reduce or eliminate
expected benefits of some or our tax strategies, and future profit margins can
be affected by a variety of factors unrelated to our level of manufacturing
efficiency.
Effect of
Earthquake on Japan Operations. On March 11,
2011, a 9.0 magnitude earthquake struck northeastern Japan, followed by a
tsunami that devastated the region’s coastal
communities. STAAR Japan’s staff and their immediate
families suffered no serious injuries. STAAR’s manufacturing
facilities in Ichikawa City, Chiba Prefecture, suffered only minor damage and
resumed operations on Wednesday, March 16, 2011. Despite the
disaster, STAAR Japan’s revenues and its domestic IOL and ICL business have
continued to grow; revenues in the third quarter were 32% higher than prior year
and revenues in the first nine months of 2011 were 21% higher than prior
year. Nevertheless, widespread disruptions in the Japanese economy
and infrastructure may have slowed the rate of growth in STAAR Japan’s recently
launched ICL business, and that effect may continue until recovery is
complete.
Backlog. The ICL is manufactured
to precisely address refractive prescriptions across a broad range of
correction, resulting in a large number of Stock Keeping Units (SKUs)
.. The challenge of maintaining inventory in all models, combined with
rapidly increasing global demand for the ICL, can result in a backlog in
customer orders. While the dollar amount of backlog orders is not
currently significant in relation to our total annual sales, unexpectedly large
orders for ICLs could increase our backlog. STAAR believes it
has sufficient capacity to ramp up production levels to meet demand and that any
backlogs will be temporary. However, delays in filling orders can
result in lost sales if alternative refractive treatments are available to the
patient. Because Toric ICLs treat an even greater variety of refractive errors
and at times must be custom made for the patient, customers are accustomed to a
special order procedure and do not expect immediate delivery of Toric ICLs from
inventory.
Status of
U.S. TICL Submission. STAAR submitted a
Pre-Market Approval Application (PMA) supplement for the TICL to the FDA on
April 28, 2006, which the agency has designated as a panel-track
supplement. In August 2007, following negative inspectional
observations and a Warning Letter from FDA’s Division of Bioresearch Monitoring
(“BIMO”), the FDA Office of Device Evaluation placed an integrity hold on
STAAR’s TICL application. Over a two-year period STAAR took a number
of corrective actions to address BIMO’s concerns and to remove the integrity
hold, including engaging an independent third party to conduct a 100% audit of
patient records in the TICL clinical study, along with an audit of clinical
systems to ensure accuracy and completeness of data before resubmitting the
application. On July 21, 2009, the FDA notified STAAR that as a
result of STAAR’s corrective actions the FDA had removed the integrity hold on
our application for approval of the TICL, and would resume its consideration of
the application. During August and September 2009, the agency and
STAAR resolved a number of questions related to the TICL supplement in an
interactive process. On February 3, 2010, STAAR received a letter of
deficiency from the FDA outlining additional questions. On August 2,
2010 we responded to the FDA’s deficiency letter. Since that
response, STAAR has been in dialogue with the agency, working interactively to
resolve a series of follow-up questions. On April 22, 2011, STAAR
responded to the most recent questions from the agency, which concerned the
basis for an increase in the number of reported patient follow-up visits
following the independent third party audit of the clinical data, and has
responded to additional follow-up questions after that date. STAAR
cannot predict when, or if, the FDA may grant approval of the Visian Toric
ICL.
Status of Japan TICL Submission. On February,
2, 2010, Japan’s Ministry of Health, Labor and Welfare (MHLW) approved the sale
of the Visian ICL. STAAR submitted a partial change application for
approval of the Visian Toric ICL to the Pharmaceuticals and Medical Device
Agency (PMDA) on April 9, 2010. PMDA conducted an audit of clinical
practices related to the application during August 2011, and subsequent to
quarter end the Company received notice from the PMDA that the TICL
application will not need to go before the Approval Committee. In addition the
PMDA and MHLW have permitted STAAR to add the clinical data collection on the
Toric ICL Post Market Studies (PMS) to the current PMS protocols underway for
the Visian ICL. Final regulatory approval in Japan will require that the
DFU (Directions for Use) be finalized, the Post Market Study protocol for the
Toric ICL be completed, and the GCP (Good Clinical Practices) audit of the U.S.
clinical trial data be finalized. We believe that these items can be
completed within the fourth quarter and final approval should be announced
shortly after their completion.
Critical
Accounting Policies
This
Management's Discussion and Analysis of Financial Condition and Results of
Operations discusses and analyzes data in our unaudited Condensed Consolidated
Financial Statements, which we have prepared in accordance with U.S. generally
accepted accounting principles. Preparation of these financial
statements requires management to make estimates and assumptions that affect the
reported amounts of assets, liabilities, revenue and expenses, and related
disclosure of contingent assets and liabilities. Management bases its estimates
on historical experience and on various other assumptions that it believes to be
reasonable under the circumstances, the results of which form the basis for
making judgments about the carrying values of assets and liabilities that are
not readily apparent from other sources. Senior management has
discussed the development, selection and disclosure of these estimates with the
Audit Committee of our Board of Directors. Actual conditions may differ from our
assumptions and actual results may differ from our estimates.
An
accounting policy is deemed critical if it requires an accounting estimate to be
made based on assumptions about matters that are highly uncertain at the time
the estimate is made, if different estimates reasonably could have been used, or
if changes in the estimate that are reasonably likely to occur could materially
impact the financial statements. Management believes that there have been no
significant changes during the nine months ended September 30, 2011 to the items
that we disclosed as our critical accounting policies and estimates in
Management's Discussion and Analysis of Financial Condition and Results of
Operations in our Annual Report on Form 10-K for the fiscal year ended December
31, 2010.
Results
of Operations
The
following table shows the percentage of our total sales represented by the
specific items listed in our statements of operations for the periods indicated,
and the percentage by which these items increased or decreased over the prior
period.
|
|
Percentage of Net Sales for
Three Months
|
|
|
Percentage
Change for
Three
Months
|
|
|
Percentage of Net Sales for
Nine Months
|
|
|
Percentage
Change
for Nine
Months
|
|
|
|
September 30,
2011
|
|
|
October 1,
2010
|
|
|
2011
vs. 2010
|
|
|
September
30, 2011
|
|
|
October 1,
2010
|
|
|
2011
vs. 2010
|
|
Net sales
|
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
16.1 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
14.3 |
% |
Cost
of sales
|
|
|
31.5 |
|
|
|
37.2 |
|
|
|
(1.6 |
) |
|
|
33.3 |
|
|
|
36.5 |
|
|
|
4.4 |
|
Gross
profit
|
|
|
68.5 |
|
|
|
62.8 |
|
|
|
26.5 |
|
|
|
66.7 |
|
|
|
63.5 |
|
|
|
20.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
|
25.0 |
|
|
|
27.3 |
|
|
|
6.4 |
|
|
|
24.7 |
|
|
|
25.3 |
|
|
|
11.7 |
|
Marketing
and selling
|
|
|
29.1 |
|
|
|
34.6 |
|
|
|
(2.5 |
) |
|
|
28.2 |
|
|
|
30.9 |
|
|
|
4.6 |
|
Research
and development
|
|
|
9.5 |
|
|
|
10.0 |
|
|
|
11.1 |
|
|
|
9.2 |
|
|
|
10.4 |
|
|
|
1.4 |
|
Other
general and administrative expenses
|
|
|
— |
|
|
|
— |
|
|
|
— |
* |
|
|
— |
|
|
|
1.7 |
|
|
|
(100.0 |
) |
|
|
|
63.6 |
|
|
|
71.9 |
|
|
|
2.8 |
|
|
|
62.1 |
|
|
|
68.2 |
|
|
|
4.1 |
|
Operating
income (loss)
|
|
|
4.8 |
|
|
|
(9.1 |
) |
|
|
— |
* |
|
|
4.6 |
|
|
|
(4.7 |
) |
|
|
— |
* |
Other
expense, net
|
|
|
(2.9 |
) |
|
|
3.0 |
|
|
|
— |
* |
|
|
0.2 |
|
|
|
(2.3 |
) |
|
|
— |
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
(loss) before provision for income taxes
|
|
|
1.9 |
|
|
|
(6.1 |
) |
|
|
— |
* |
|
|
4.8 |
|
|
|
(7.0 |
) |
|
|
— |
* |
Provision
for income taxes
|
|
|
1.4 |
|
|
|
2.7 |
|
|
|
(39.9 |
) |
|
|
2.1 |
|
|
|
1.4 |
|
|
|
75.0 |
|
Income
(loss) from continuing operations
|
|
|
0.5 |
|
|
|
(8.8 |
) |
|
|
— |
* |
|
|
2.7 |
|
|
|
(8.4 |
) |
|
|
— |
* |
Income
from discontinued operations, net of taxes
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
10.3 |
|
|
|
(100.0 |
) |
Net
income (loss)
|
|
|
0.5 |
% |
|
|
(8.8 |
)
% |
|
|
— |
* |
|
|
2.7 |
% |
|
|
1.8 |
% |
|
|
66.5 |
% |
* Denotes change is greater than
+100%.
Net
Sales
Net sales
for the three and nine months ended September 30, 2011 were $15.3 million and
$46.4 million, an increase of approximately 16.1% and 14.3%, respectively,
compared with $13.2 million and $40.6 million for the three and nine months
ended October 1, 2010. The increase in net sales was due primarily to
increased sales of ICLs. Changes in currency had a $0.4 million and
$1.4 million favorable impact on net sales, respectively for the three and nine
months ended September 30, 2011.
Total ICL
sales for the three and nine months ended September 30, 2011 were $7.9 million
and $23.1 million, an increase of 31% and 30% respectively, compared with $6.0
million and $17.8 million for the comparable periods in 2010. The
increase in ICL sales primarily resulted from a 33% increase in our top ten
refractive markets during the third quarter. ICL sales represented
52% and 50%, respectively, of our total sales for the three and nine months
ended September 30, 2011.
Total IOL
sales for the three and nine months ended September 30, 2011 were $6.6 million
and $20.8 million, an increase of 0.2% and 1.6%
respectively, compared with $6.6 million and $20.4 million for the
three and nine months ended October 1, 2010. The increase in IOL
sales is due to the favorable effect of currency. IOL sales represent 43.0% and
44.8% of the sales for the three and nine months ended September 30,
2011.
Gross
Profit
Gross
profit for the third quarter was $10.5 million, or 68.5% of revenue, compared
with $8.3 million, or 62.8% of revenue, in the prior year
period. During the nine months of 2011, gross profit was $30.9
million, or 66.7% of revenue, compared with $25.8 million, or 63.5% of revenue,
in the prior year period. The increase in gross profit and gross
profit margin was largely attributable to a higher mix of ICL sales and improved
margins on IOL sales.
General
and Administrative
General
and administrative expenses increased by 6.4% to $3.8 million in the third
quarter of 2011 from the $3.6 million reported in the third quarter of
2010. General and administrative expenses for the nine months ended
September 30, 2011 were $11.4 million, an increase of 11.7% when compared with
$10.2 million reported last year. The increase in both periods was
primarily due to increased bonus accruals and professional fees incurred in
evaluating future manufacturing and tax strategies.
Marketing
and Selling
Marketing
and selling expenses decreased by 2.5% to $4.4 million in the third quarter of
2011, compared with $4.6 million in the third quarter of
2010. Marketing and selling expenses for the nine months ended
September 30, 2011 were $13.1 million, an increase of 4.6% when compared with
$12.5 million reported last year. The decrease for the third quarter
resulted from transition of the Company’s Australia business to a distribution
model. For the nine month period the increase in expense was
primarily due to increased salaries and promotional activities.
Research
and Development
Research
and development expenses increased by 11.1% to $1.5 million in the third quarter
of 2011, compared with $1.3 million in the third quarter of
2010. Research and development expenses for the nine months ended
September 30, 2011 were $4.3 million, an increase of 1.4% when compared with
$4.2 million reported last year. The increases for both periods
resulted from increased payroll and patent related cost.
Other
General and Administrative Expenses
Other
general and administrative expenses in 2010 reflected a $700,000 charge for
executive termination benefits cost recorded in connection with the non-renewal
of an executive employment agreement. There was no corresponding
expense in 2011.
Other
Income (Expense), net
Other
expenses total $0.4 million, compared with other income in the third quarter of
2010 of $0.4 million. This $0.8 million swing is due primarily to foreign
exchange losses of $0.3 million recorded during the quarter compared with $0.4
in exchange gain which was recorded in the third quarter of 2010. In
addition, other expense increased approximately $0.2 million as a result of the
fair value adjustment of outstanding warrants. For the nine months of 2011,
other income was $0.1 million, compared with other expense of $0.9 million for
the nine months of 2010. This swing is due to reduced interest and other expense
resulting from the repayment of the Broadwood note in 2010, foreign exchange
gains, increased royalty income, and income from the fair value adjustment of
outstanding warrants.
Liquidity
and Capital Resources
STAAR’s
liquidity requirements arise from the funding of our working capital needs,
primarily inventory and accounts receivable. Our primary sources for
working capital and capital expenditures are cash flows from operating
activities, proceeds from the exercise of stock options, and borrowings under
our credit facilities. Our liquidity also depends, in part, on
customers paying within credit terms, and any extended delays in payments or
changes in credit terms given to major customers may have an impact on STAAR’s
cash flow. In addition, any abnormal product returns or pricing
adjustments may also affect our short-term funding.
STAAR
believes its current cash balances, coupled with cash flow from operating
activities will be sufficient to meet its working capital requirements for the
foreseeable future, including the estimated $6 million cost associated with the
manufacturing consolidation plan. STAAR’s need for working capital,
and the terms on which financing may be available, will depend in part on its
degree of success in maintaining positive cash flow and earnings through the
strategies described above under the caption “Strategy.” If the need for
financing arises, STAAR cannot assure that it will be available on
acceptable terms, if at all.
STAAR’s
cash balances have steadily increased over the last two years. To the
extent STAAR’s cash balances exceed levels needed for working capital and as a
cushion for unforeseen demands, STAAR intends to invest its cash in expanding
and improving its business. It does not anticipate paying dividends
from its earnings for the foreseeable future.
Overview of Changes in Cash and Cash
Equivalents and Other Working Capital Accounts.
As of
September 30, 2011 and December 31, 2010, STAAR had $16.9 million and $9.5
million, respectively, of cash and cash equivalents and restricted
cash.
Net cash
provided by operating activities was $5.4 million for the nine months ended
September 30, 2011, compared to $4.6 million in net cash used by operating
activities for the nine months ended October 1, 2010. For the nine
months ended September 30, 2011, net cash provided by operating activities
consisted of net income of $1.2 million, $3.0 million in non-cash activities and
$1.2 million generated from working capital. For the nine months ended October
1, 2010, net cash provided by investing activities was due to the $11.8 million
net cash proceeds from the sale of our German subsidiary in March 2010 and the
release of the $7.4 million restricted deposit, including interest, by the
Court, offset by $0.2 million of acquisitions of property, plant and
equipment.
Net
cash used in investing activities was $0.6 million for the nine months ended
September 30, 2011, compared with cash provided by investing activities of $18.8
million for the nine months ended October 1, 2010. Net cash used in
investing activities was mainly due to $0.7 million in acquisitions of property,
plant and equipment. For the nine months ended October 1, 2010, net cash
provided by investing activities was mainly due to $11.8 million of net cash
proceeds from sale of our German subsidiary in March 2010 and the release of the
$7.3 million restricted deposit by the Court in June 2010, offset by $0.3
million of acquisitions of property, plant and equipment.
Net cash
provided by financing activities was $2.6 million for the nine months ended
September 30, 2011, compared to net cash used in financing activities of $12.2
million for the nine months ended October 1, 2010. Net cash provided
by financing activities consisted of $3.0 million in proceeds from the exercise
of stock options, partially offset by $0.4 million in capital lease
repayments. For the nine months ended October 1, 2010, net cash used
in financing activities was due to the $5 million payment of the Broadwood note,
the $6.8 million cash redemption of the Series A preferred shares and repayment
of our capital lease obligations of $0.6 million, partially offset by $0.2
million in proceeds from stock option exercises.
Credit
Facilities, Contractual Obligations and Commitments
Accrued
Termination Benefits for Executive
On May 24, 2010, STAAR accrued $700,000
in executive termination benefit costs in connection with the notice of
non-renewal given under an executive employment agreement. This
accrual represented STAAR’s estimate of the contractual termination benefits due
to the former executive. The actual amount ultimately paid to the
former executive may be different than the amount estimated. The
balance of accrued unpaid severance at September 30, 2011 was approximately
$104,000.
The
Company’s Japanese subsidiary, STAAR Japan, has an agreement, as amended on June
30, 2009, with Mizuho Bank, which provides for borrowings of up to 300,000,000
Yen (approximately $3.9 million based on the rate of exchange on September 30,
2011), at an interest rate equal to the Tokyo short-term prime interest rate
(approximately 1.475% as of September 30, 2011) plus 1.125%. The
agreement may be renewed annually (the current line expires on April 2,
2012). The credit facility is not collateralized. The
Company had 200,000,000 Yen outstanding on the line of credit as of September
30, 2011 and December 31, 2010, (approximately $2.6 million and $2.5 million
based on the foreign exchange rates on September 30, 2011 and December 31, 2010)
which approximates fair value due to the short-term maturity and market interest
rates of the line of credit. In case of default, the interest rate
will increase to 14% per annum. As of September 30, 2011, 100,000,000 Yen
(approximately $1.3 million based on the rate of exchange on September 30, 2011)
of the line was available for borrowing.
In
August 2010, our wholly owned Swiss subsidiary, STAAR Surgical AG, entered into
a credit agreement with Credit Suisse (the “Bank”). The credit agreement
provides for borrowings of up to 1,000,000 Swiss Francs ($1,114,000 at the rate
of exchange on September 30, 2011), to be used for working capital
purposes. Accrued interest and 0.25% commissions on average
outstanding borrowings is payable quarterly and the interest rate will be
determined by the Bank based on the then prevailing market conditions at the
time of borrowing. The credit agreement is automatically renewed on
an annual basis based on the same terms assuming there is no
default. The credit agreement may be terminated by either party at
any time in accordance with its general terms and conditions. The
credit facility is not collateralized and contains certain conditions such as
providing the Bank with audited financial statements annually and notice of
significant events or conditions as defined in the credit
agreement. The Bank may also declare all amounts outstanding to be
immediately due and payable upon a change of control or a “material
qualification” in STAAR Surgical AG’s independent auditors’
report. There were no borrowings outstanding as of September 30, 2011
and the full amount of the line was available for borrowing.
Capital Lease
Obligations
STAAR
leases certain property, plant, and equipment under non-cancelable capital lease
agreements. These leases vary in amount, duration, and
rates.
Estimated
future minimum payments under capital lease obligations were as follows (in
thousands):
Fiscal
Year
|
|
September 30,
2011
|
|
|
December 31,
2010
|
|
2011
|
|
$ |
187 |
|
|
$ |
938 |
|
2012
|
|
|
844 |
|
|
|
763 |
|
2013
|
|
|
595 |
|
|
|
627 |
|
2014
|
|
|
75 |
|
|
|
68 |
|
2015
|
|
|
— |
|
|
|
36 |
|
Thereafter
|
|
|
— |
|
|
|
— |
|
Total
minimum lease payments
|
|
$ |
1,701 |
|
|
$ |
2,432 |
|
Less:
interest
|
|
|
(121 |
) |
|
|
(598 |
) |
Total
lease obligation
|
|
$ |
1,580 |
|
|
$ |
1,834 |
|
|
|
|
|
|
|
|
|
|
Current
|
|
$ |
590 |
|
|
$ |
431 |
|
Long-term
|
|
$ |
990 |
|
|
$ |
1,403 |
|
Borrowings available under
our lease lines of credit with Farnam Street Financial are approximately
$238,350. See Note 10, Notes Payable, to the consolidated
financial statements accompanying the 2010 Form 10-K for additional information
regarding STAAR’s Company’s capital lease agreements.
Covenant
Compliance
The
Company is in compliance with the covenants of its credit facilities as of the
date of this report.
Off-Balance
Sheet Arrangements
We
do not have any off-balance sheet arrangements, as that term is defined in the
rules of the SEC, that have or are reasonably likely to have a current or future
effect on our financial condition, changes in financial condition, revenues or
expenses, results of operations, liquidity, capital expenditures or capital
resources that are material to investors.
ITEM
3. QUANTITATIVE AND
QUALITATIVE DISCLOSURES ABOUT MARKET RISK
There have been no material changes in
the Company’s qualitative and quantitative market risk since the disclosure in
the Company’s Annual Report on Form 10-K for the year ended December 31,
2010.
ITEM
4. CONTROLS AND
PROCEDURES
Disclosure
Controls and Procedures
As of the end of the period
covered by this report, we carried out an evaluation, under the supervision and
with the participation of our management, including our CEO and CFO, of the
effectiveness of the design and operation of the disclosure controls and
procedures of STAAR Surgical Company and its subsidiaries (the
“Company”). Based on that evaluation, our CEO and CFO concluded, as
of the end of the period covered by this quarterly report on Form 10-Q, that our
disclosure controls and procedures were effective. For purposes of
this statement, the term “disclosure controls and procedures” means controls and
other procedures of the Company that are designed to ensure that information
required to be disclosed by the Company in the reports that it files or submits
under the Securities Exchange Act (15 U.S.C. 78a et seq.) is recorded,
processed, summarized and reported, within the time periods specified in the
Commission's rules and forms. Disclosure controls and procedures include,
without limitation, controls and procedures designed to ensure that information
required to be disclosed by an issuer in the reports that it files or submits
under the Act is accumulated and communicated to the issuer's management,
including its principal executive and principal financial officers, or persons
performing similar functions, as appropriate to allow timely decisions regarding
required disclosure.
Our
management, including the CEO and the CFO, do not expect that our disclosure
controls and procedures or our internal control over financial reporting will
necessarily prevent all fraud or material errors. An internal control system, no
matter how well conceived and operated, can provide only reasonable, not
absolute, assurance that the objectives of the control system are met. Further,
the design of a control system must reflect the fact that there are resource
constraints, and the benefits of controls must be considered relative to their
costs. Because of the inherent limitations on all internal control systems, our
internal control system can provide only reasonable assurance of achieving its
objectives and no evaluation of controls can provide absolute assurance that all
control issues and instances of fraud, if any, within our Company have been
detected. These inherent limitations include the realities that judgments in
decision-making can be faulty, and that breakdowns can occur because of simple
error or mistake. Additionally, controls can be circumvented by the individual
acts of some persons, by collusion of two or more people, or by management
override of the control. The design of any system of internal control is also
based in part upon certain assumptions about the likelihood of future events,
and can provide only reasonable, not absolute, assurance that any design will
succeed in achieving its stated goals under all potential future conditions.
Over time, controls may become inadequate because of changes in circumstances,
or the degree of compliance with the policies and procedures may
deteriorate.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting during the
quarter ended September 30, 2011 that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
PART
II – OTHER INFORMATION
ITEM
1.
|
LEGAL
PROCEEDINGS
|
From time to time the Company
may be subject to various claims and legal proceedings arising out of the normal
course of our business. These claims and legal proceedings may relate
to contractual rights and obligations, employment matters, or claims of product
liability. STAAR maintains insurance coverage for product liability
claims. While the Company does not believe that any of the claims
known is likely to have a material adverse effect on its financial condition or
results of operations, new claims or unexpected results of existing claims could
lead to significant financial harm.
Our short
and long-term success is subject to many factors that are beyond our control.
Investors and prospective investors should consider carefully the following risk
factors, in addition to other information contained in this report and the risks
and uncertainties described in “Part I—Item 1A—Risk Factors” of the
Company’s Form 10-K for the fiscal year ended December 31, 2010.. Such risks and
uncertainties could materially adversely affect our business, financial
condition or operating results.
We may not
realize the expected benefits of our manufacturing consolidation project and tax
strategies. Beginning in 2011 STAAR has invested
significant resources in a manufacturing consolidation project and a tax
strategy initiative, and it expects to invest several million dollars to
complete the projects. The goal of these projects is to increase
profit margins by improving manufacturing efficiency, simplifying administrative
and regulatory functions, and reducing tax liabilities. We cannot
assure that we will achieve the expected benefits of these
initiatives. Among other things, costs could exceed current
estimates, product manufacturing transfers can be affected by delays or cause
supply interruptions, changes in tax laws could reduce or eliminate expected
benefits of some of our tax strategies, and future profit margins can be
affected by a variety of factors unrelated to our level of manufacturing
efficiency.
We may experience
backlog in ICL orders due to rapid increases in demand. The challenge of
maintaining inventory across the large number of ICL models, combined with
rapidly increasing global demand for the ICL, has from time to time resulted in
a backlog in customer orders. While the dollar amount of backlog
orders is not currently significant in relation to our total annual sales,
unexpectedly large orders for ICLs could increase our backlog to levels that are
financially significant. In addition, delays in filling orders can
result in lost sales if alternative refractive treatments are available to the
patient. If we are unable to ramp up production to meet growing demand we may
not achieve our growth targets.
ITEM
5.
|
OTHER
INFORMATION
|
a.
|
Departure
of Directors or Certain Officers; Election of Directors; Appointment of
Certain Officers; Compensatory Arrangements of Certain
Officers.
|
The
following information is provided pursuant to Item 5.02(e) of Form
8-K:
Compensatory
Arrangements of Certain Officers
On
November 2, 2011, STAAR entered into an Executive Severance Agreement and
Executive Change in Control Agreement with each of the following Named Executive
Officers: Deborah Andrews (Chief Financial Officer) and Robin Hughes
(Vice President, Global Marketing).
In each
case the Executive Severance Agreement and Executive Change in Control Agreement
replaces and supersedes any other prior agreements, arrangements and
understandings between the officer and STAAR with respect to rights upon
severance or a change in control, except rights expressly provided under option
agreements and other equity compensation agreements. Stock options
and other equity compensation awards will continue to be governed by the
original agreements in place with respect to the awards.
A summary
of the terms and conditions of the agreements is provided below.
Severance
Agreement. If the officer is terminated without cause or
resigns for good reason (except in connection with a change in control of
STAAR), the officer will receive the following, subject to the officer entering
into a release of claims with STAAR:
|
·
|
Six
months’ base salary at the rate applicable at the time of termination;
and
|
|
·
|
Six
months’ continuation of group health and dental
benefits.
|
Change in Control
Agreement. If the officer is terminated within 12 months after
a change in control of STAAR, or resigns for good reason within 15 months after
a change in control of STAAR, the officer will receive the following, subject to
the officer entering into a release of claims with the employer:
|
·
|
One
year’s base salary at the greater of the rate applicable at the time of
termination or the rate applicable immediately prior to the announcement
of the change in control;
|
|
·
|
One
year’s target cash bonus amount, plus the greater of the amount of any
bonus earned in the year of termination and the provided amount of the
previous year’s
bonus;
|
|
·
|
One
year’s continuation of group health and dental benefits;
and
|
|
·
|
Limited
roll-backs or deferrals in compensation if necessary to reduce liability
for excise taxes under Section 280G of the Internal Revenue Code, but no
provision of any kind for the gross-up of payments for taxes or for any
other purpose
|
Under
both forms of agreement, resignation “for good reason” generally means that an
employer has adversely changed the officer’s salary, location or other terms and
conditions of employment to such a degree that the executive is entitled to
voluntarily resign and to receive severance benefits.
The
foregoing summary of the terms of the Executive Severance Agreements and
Executive Change in Control Agreement is qualified in its entirety by reference
to the full text of the forms of the agreements, copies of which are attached to
this Report as Exhibit 10.88 and Exhibit 10.89, and which are incorporated into
this Report by this reference.
3.1
|
Certificate
of Incorporation, as amended to date.(1)
|
3.2
|
By-laws,
as amended to date.(2)
|
†4.2
|
1991
Stock Option Plan of STAAR Surgical Company.(4)
|
†4.3
|
1998
STAAR Surgical Company Stock Plan, adopted April 17,
1998.(5)
|
4.4
|
Form
of Certificate for Common Stock, par value $0.01 per
share.(6)
|
†4.5
|
Amended
and Restated 2003 Omnibus Equity Incentive Plan, and form of Option Grant
and Stock Option Agreement.(3)
|
†10.88
|
Form
of Executive Severance Agreement. *
|
†10.89
|
Form
of Executive Change in Control Agreement.
*
|
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.
*
|
32.1
|
Certification
Pursuant to 18 U.S.C. Section 1350, Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. *
|
101
|
Financial
statements from the quarterly report on Form 10-Q of STAAR Surgical
Company for the quarter ended July 1, 2011, formatted in XBRL, are filed
herewith and include: (i) the Condensed Consolidated Balance Sheets, (ii)
the Condensed Consolidated Statements of Income, (iii) the Condensed
Consolidated Statements of Cash Flows, and (iv) the Notes to Condensed
Consolidated Financial Statements tagged as blocks of
text.
|
(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 Quarterly Report on Form 10-Q for quarter
ended July 2, 2010, filed with the Commission on August 11,
2010.
|
(4)
|
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.
|
(5)
|
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.
|
(6)
|
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.
|
†
|
Management
contract or compensatory plan or
arrangement
|
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 thereunto
duly authorized.
|
STAAR
SURGICAL COMPANY
|
|
|
Date: November
2, 2011
|
By:
|
/s/ DEBORAH ANDREWS
|
|
Deborah
Andrews
|
|
|
|
Chief
Financial Officer
|
|
(on
behalf of the Registrant and as its
|
|
principal
financial officer)
|