STAAR SURGICAL CO - Quarter Report: 2008 June (Form 10-Q)
UNITED
STATES
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: June 27, 2008
|
|
Or
|
|
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
|
For
the transition period
from to
|
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
incorporation
or organization)
|
(I.R.S.
Employer
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 o
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):
o Large
accelerated filer
|
þ Accelerated
filer
|
o Non-accelerated
filer
(Do
not check if a smaller
reporting
company)
|
o 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 29,486,494 shares of common stock, par value $0.01 per share,
issued and outstanding as of August 04, 2008.
STAAR
SURGICAL COMPANY
INDEX
PAGE
|
|||
NUMBER
|
|||
PART
I – FINANCIAL INFORMATION
|
|||
Item
1.
|
Financial
Statements (Unaudited).
|
||
Condensed
Consolidated Balance Sheets – June 27, 2008 and December 28,
2007.
|
1
|
||
Condensed
Consolidated Statements of Operations – Three and Six Months Ended June
27, 2008 and June 29, 2007.
|
2
|
||
Condensed
Consolidated Statements of Cash Flows – Six Months Ended June 27, 2008 and
June 29, 2007.
|
3
|
||
Notes
to the Condensed Consolidated Financial Statements.
|
4
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations.
|
18
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk.
|
34
|
|
Item
4.
|
Controls
and Procedures.
|
34
|
|
PART
II – OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings.
|
34
|
|
|
|||
Item
1A.
|
Risk
Factors.
|
35
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders.
|
36
|
|
Item
6.
|
Exhibits.
|
37
|
|
Signatures
|
38
|
PART
I. FINANCIAL INFORMATION
ITEM
1.
FINANCIAL STATEMENTS
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except par value amounts)
(Unaudited)
June 27,
2008
|
December 28,
2007
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
8,851
|
$
|
10,895
|
|||
Short-term
investments - restricted
|
71
|
150
|
|||||
Accounts
receivable, net
|
10,417
|
6,898
|
|||||
Inventories
|
15,572
|
12,741
|
|||||
Prepaids,
deposits and other current assets
|
2,468
|
1,610
|
|||||
Total
current assets
|
37,379
|
32,294
|
|||||
Property,
plant and equipment, net
|
6,385
|
5,772
|
|||||
Intangible
assets, net
|
6,561
|
3,959
|
|||||
Goodwill
|
7,534
|
7,534
|
|||||
Advance
payment for acquisition of Canon Staar
|
—
|
4,000
|
|||||
Other
assets
|
1,041
|
620
|
|||||
Total
assets
|
$
|
58,900
|
$
|
54,179
|
|||
LIABILITIES,
REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’
EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Line
of credit
|
$
|
1,860
|
$
|
—
|
|||
Accounts
payable
|
7,937
|
4,823
|
|||||
Obligations
under capital leases – current
|
929
|
822
|
|||||
Deferred
income taxes – current
|
105
|
102
|
|||||
Other
current liabilities
|
6,442
|
5,541
|
|||||
Total
current liabilities
|
17,273
|
11,288
|
|||||
Note
payable – long-term, net of discount
|
4,284
|
4,166
|
|||||
Obligations
under capital leases – long-term
|
1,306
|
1,311
|
|||||
Deferred
income taxes – long-term
|
753
|
570
|
|||||
Other
long-term liabilities
|
1,489
|
619
|
|||||
Total
liabilities
|
25,105
|
17,954
|
|||||
Commitments
and contingencies (Note 13)
|
|||||||
Series
A redeemable convertible preferred stock, $0.01 par value; 10,000
shares
authorized, 1,700 and no shares issued and outstanding at June 27,
2008
and December 28, 2007; respectively. Liquidation value $6,800.
|
6,760
|
—
|
|||||
Stockholders’
equity:
|
|||||||
Common
stock, $0.01 par value; 60,000 shares authorized; issued and outstanding
29,486 at June 27, 2008 and 29,488 at December 28, 2007
|
295
|
295
|
|||||
Additional
paid-in capital
|
137,982
|
137,075
|
|||||
Accumulated
other comprehensive income
|
2,939
|
1,551
|
|||||
Accumulated
deficit
|
(114,181
|
)
|
(102,696
|
)
|
|||
Total
stockholders’ equity
|
27,035
|
36,225
|
|||||
Total
liabilities, redeemable convertible preferred stock and stockholders’
equity
|
$
|
58,900
|
$
|
54,179
|
See
accompanying notes to the condensed consolidated financial
statements.
1
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except per share amounts)
(Unaudited)
Three Months Ended
|
Six Months Ended
|
||||||||||||
June
27,
2008
|
June
29,
2007
|
June
27,
2008
|
June
29,
2007
|
||||||||||
Net
sales
|
$
|
20,665
|
$
|
14,932
|
$
|
38,625
|
$
|
29,849
|
|||||
Cost
of sales
|
9,131
|
7,695
|
19,336
|
15,317
|
|||||||||
Gross
profit
|
11,534
|
7,237
|
19,289
|
14,532
|
|||||||||
General
and administrative
|
3,520
|
3,128
|
7,961
|
6,712
|
|||||||||
Marketing
and selling
|
7,646
|
6,147
|
14,113
|
11,449
|
|||||||||
Research
and development
|
2,357
|
1,634
|
4,075
|
3,244
|
|||||||||
Loss
on settlement of pre-existing distribution arrangement
|
—
|
—
|
3,850
|
—
|
|||||||||
Operating
loss
|
(1,989
|
)
|
(3,672
|
)
|
(10,710
|
)
|
(6,873
|
)
|
|||||
Other
income (expense):
|
|||||||||||||
Equity
in operations of joint venture
|
—
|
73
|
—
|
85
|
|||||||||
Interest
income
|
63
|
166
|
91
|
188
|
|||||||||
Interest
expense
|
(222
|
)
|
(213
|
)
|
(423
|
)
|
(317
|
)
|
|||||
Other
income (expense), net
|
(1
|
)
|
(445
|
)
|
211
|
(427
|
)
|
||||||
Other
expense, net
|
(160
|
)
|
(419
|
)
|
(121
|
)
|
(471
|
)
|
|||||
Loss
before provision for income taxes
|
(2,149
|
)
|
(4,091
|
)
|
(10,831
|
)
|
(7,344
|
)
|
|||||
Provision
for income taxes
|
396
|
266
|
654
|
534
|
|||||||||
Net
loss
|
$
|
(2,545
|
)
|
$
|
(4,357
|
)
|
$
|
(11,485
|
)
|
$
|
(7,878
|
)
|
|
Loss
per share – basic and diluted
|
$
|
(0.09
|
)
|
$
|
(0.16
|
)
|
$
|
(.39
|
)
|
$
|
(0.29
|
)
|
|
Weighted
average shares outstanding – basic
and diluted
|
29,488
|
28,041
|
29,488
|
26,845
|
See
accompanying notes to the condensed consolidated financial
statements.
2
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
(Unaudited)
|
Six Months Ended
|
||||||
June 27,
2008
|
June 29,
2007
|
||||||
Cash
flows from operating activities:
|
|||||||
Net
loss
|
$
|
(11,485
|
)
|
$
|
(7,878
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
of property, plant and equipment
|
1,340
|
957
|
|||||
Amortization
of intangibles
|
418
|
240
|
|||||
Amortization
of discount
|
118
|
17
|
|||||
Loss
on extinguishment of note payable
|
—
|
233
|
|||||
Fair
value adjustment of warrant
|
2
|
(100
|
)
|
||||
Loss
on disposal of property and equipment
|
84
|
80
|
|||||
Equity
in operations of joint venture
|
—
|
(85
|
)
|
||||
Stock-based
compensation expense
|
825
|
740
|
|||||
Loss
on settlement of pre-existing distribution arrangement
|
3,850
|
—
|
|||||
Other
|
(74
|
)
|
107
|
||||
Changes
in working capital, net of effects from purchase of Canon
Staar:
|
|||||||
Accounts
receivable
|
(2,716
|
)
|
(520
|
)
|
|||
Inventories
|
2,034
|
74
|
|||||
Prepaids,
deposits and other current assets
|
(487
|
)
|
(18
|
)
|
|||
Accounts
payable
|
(753
|
)
|
(542
|
)
|
|||
Other
current liabilities
|
714
|
(269
|
)
|
||||
Net
cash used in operating activities
|
(6,130
|
)
|
(6,964
|
)
|
|||
Cash
flows from investing activities:
|
|||||||
Cash
acquired in acquisition of Canon Staar, net of acquisition
costs
|
2,511
|
—
|
|||||
Acquisition
of property, plant and equipment
|
(415
|
)
|
(242
|
)
|
|||
Proceeds
from sale of property, plant, and equipment
|
89
|
—
|
|||||
Proceeds
from sale of short-term investments – restricted
|
79
|
—
|
|||||
Dividend
received from joint venture
|
—
|
117
|
|||||
Net
change in other assets
|
(63
|
)
|
(16
|
)
|
|||
Net
cash provided by (used in) investing activities
|
2,201
|
(141
|
)
|
||||
Cash
flows from financing activities:
|
|||||||
Borrowings
under notes payable
|
—
|
4,000
|
|||||
Repayment
of notes payable
|
—
|
(4,000
|
)
|
||||
Borrowings
under lines of credit
|
3,800
|
1,812
|
|||||
Repayment
of lines of credit
|
(1,900
|
)
|
(3,610
|
)
|
|||
Repayment
of capital lease lines of credit
|
(419
|
)
|
(310
|
)
|
|||
Net
proceeds from public sale of equity securities
|
—
|
16,810
|
|||||
Proceeds
from the exercise of stock options
|
—
|
584
|
|||||
Net
cash provided by financing activities
|
1,481
|
15,286
|
|||||
Effect
of exchange rate changes on cash and cash equivalents
|
404
|
143
|
|||||
(Decrease)
increase in cash and cash equivalents
|
(2,044
|
)
|
8,324
|
||||
Cash
and cash equivalents, at beginning of the period
|
10,895
|
7,758
|
|||||
Cash
and cash equivalents, at end of the period
|
$
|
8,851
|
$
|
16,082
|
See
accompanying notes to the condensed consolidated financial
statements.
3
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June
27, 2008
(Unaudited)
Note
1 — Basis of Presentation and Significant Accounting
Policies
The
condensed balance sheet as of December 28, 2007 included in this report, which
has been derived from audited financial statements, and the accompanying
unaudited interim condensed consolidated financial statements, have been
prepared in accordance with accounting principles generally accepted in the
U.S.
for interim financial information and with the instructions to Form 10-Q and
Article 10 of Regulation S-X of the Securities Exchange Commission. Accordingly,
they do not include all the information and footnotes required by accounting
principles generally accepted in the U.S. for complete financial statements.
The
condensed consolidated financial statements for the three and six months ended
June 27, 2008 and June 29, 2007, 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. 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 28, 2007.
The
results of operations for the three and six months ended June 27, 2008 and
June
29, 2007 are not necessarily indicative of the results to be expected for any
other interim period or for the entire year.
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.
Prior
Year Reclassifications
Certain
reclassifications have been made to the prior financial statement information
to
conform to current period presentation.
New
Accounting Pronouncements
In
March
2008, the Financial Accounting Standards Board (“FASB”) issued Statement of
Financial Accounting Standards No. 161 (“SFAS No. 161”), “Disclosures about
Derivative Instruments and Hedging Activities-An Amendment of FASB Statement
No.
133.” SFAS No. 161 requires enhanced disclosures about an entity’s derivative
and hedging activities and thereby improves the transparency of financial
reporting. It is effective for financial statements issued for fiscal years
and
interim periods beginning after November 15, 2008, with early application
encouraged. Management does not believe that the provisions of this statement
will have any impact on the Company’s consolidated financial position and
results of operations when they become effective on January 3,
2009.
In
May
2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted
Accounting Principles,” which identifies the sources of accounting principles
and the framework for selecting the principles to be used in the preparation
of
financial statements of nongovernmental entities that are presented in
conformity with generally accepted accounting principles (GAAP) in the United
States (the GAAP hierarchy). The FASB believes that the GAAP hierarchy should
be
directed to entities because it is the entity that is responsible for selecting
accounting principles for financial statements that are presented in conformity
with GAAP. Accordingly, the FASB concluded that the GAAP hierarchy should reside
in the accounting literature established by the FASB and is issuing this
Statement to achieve that result. The FASB does not expect that this Statement
will result in a change in current practice.
Note 2 —
Acquisition of STAAR Japan
On
December 29, 2007 (the “Closing Date”), during STAAR’s 2008 fiscal year, STAAR
acquired the remaining 50% of the shares of Canon Staar Co., Inc. (“Canon
Staar”) that had been owned previously by Canon Inc. and Canon Marketing Japan
Inc. (“Canon Marketing” and, collectively with Canon Inc., the “Canon
companies”). In the transaction (the “Acquisition”), STAAR obtained 100%
ownership of Canon Staar, which was renamed STAAR Japan, Inc. (“STAAR Japan”) as
of the acquisition date. Prior to the Acquisition, Canon Staar was a joint
venture owned 50% by STAAR and 50% by the Canon companies and operating under
a
Joint Venture Agreement since 1988. STAAR accounted for its investment in Canon
Staar as an equity method investor. As of the closing date of the Acquisition,
STAAR Japan became a wholly-owned subsidiary of STAAR, and its financial
information was included in STAAR’s consolidated financial statements as of that
date. The functional currency of STAAR Japan is the local currency, the Japanese
yen. In accordance with SFAS No. 52, “Foreign Currency Translation,” for
purposes of consolidation with the Company, assets and liabilities of STAAR
Japan have been translated at rates of exchange in effect at the end of the
period, except for the acquisition date translation of the assets acquired
and
liabilities assumed, which were translated using the exchange rate in effect
at
the closing date of the Acquisition. Sales and expenses of STAAR Japan
were translated at the weighted average of exchange rates in effect during
the
three and six months ended June 27, 2008. The resulting translation gains
and losses are included in accumulated other comprehensive income on the
condensed consolidated balance sheet as of June 27, 2008.
4
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS –
(Continued)
STAAR
Japan’s business consists of designing, manufacturing and selling IOLs and
injector systems, all of which are sold as integrated Preloaded Injectors.
STAAR
Japan is also currently seeking approval from the Japanese regulatory
authorities to market in Japan STAAR’s Visian ICL, Collamer IOL and the AquaFlow
Device for treatment of glaucoma.
Through
the acquisition STAAR seeks to achieve the following goals:
·
|
to
better exploit the Japanese market for STAAR’s technology and the
worldwide market for the Preloaded Injector technology through greater
control of distribution;
|
·
|
to
re-acquire control of worldwide exclusive rights to STAAR’s technology,
especially the ICL and Collamer IOL, previously licensed to the joint
venture on a worldwide non-exclusive basis;
|
·
|
to
eliminate the risk that Canon Staar could become a competitor of
STAAR,
especially after a change in control of STAAR;
|
·
|
to
increase access to the Preloaded Injector technology; and
|
·
|
to
develop a more effective global R&D strategy by leveraging the
combined technical resources in Japan and the U.S. and taking advantage
of
STAAR Japan’s proven expertise in injector
design.
|
The
aggregate consideration paid for the acquisition to the Canon companies was
as
follows (in thousands):
Fair
value of redeemable, convertible preferred stock issued by STAAR
as
consideration for Canon Staar common shares purchased (see Note
10)
|
$
|
6,800
|
||
Cash
consideration for Canon Staar common shares purchased
|
4,000
|
|||
Transaction
costs
|
1,000
|
|||
Total
acquisition consideration
|
$
|
11,800
|
STAAR
paid approximately 60% of the total consideration by issuing 1.7 million shares
of redeemable, convertible preferred stock on the Closing Date. The fair value
of the convertible preferred stock was determined by a valuation of the
instrument with the assistance of an appraiser (see Note 10). In addition,
STAAR
paid the remaining 40% of the total consideration in cash, which was placed
on
deposit with the Canon companies just prior to the Closing Date and included
in
STAAR’s non-current assets on its consolidated balance sheet as of fiscal year
ended December 28, 2007. Application of the $4.0 million deposit to the purchase
price was subject to numerous closing conditions and the deposit was to be
fully
refunded by the Canon companies if those conditions were not met. Upon
completion of the Acquisition on the Closing Date, the deposited funds were
credited to the Canon companies as part of the total consideration paid by
STAAR. STAAR also incurred approximately $1 million in direct transaction and
related costs, of which $704,000 were paid and $296,000 included in accounts
payable and accrued liabilities as of June 27, 2008.
The
Acquisition was accounted for as a “step-acquisition” under EITF Abstracts,
Topic No. D-84, “Accounting for Subsequent Investments in an Investee After
Suspension of Equity Method Loss Recognition When an Investor Increases Its
Ownership Interest from Significant Influence to Control through a Market
Purchase of Voting Securities” (Topic No. D-84) and the provisions of SFAS No.
141, “Business Combinations”. The following table summarizes the estimated fair
values of the assets acquired and liabilities assumed on December 29, 2007
(in
thousands):
December 29,
2007
|
Useful Lives (years)
|
||||||
Cash
|
$
|
3,018
|
|||||
Accounts
receivable
|
500
|
||||||
Inventories
|
4,252
|
||||||
Prepaid
expenses and other current assets
|
464
|
||||||
Property,
plant and equipment
|
728
|
||||||
Intangible
assets:
|
|||||||
Customer
relationships
|
1,389
|
10
|
|||||
Developed
technology
|
882
|
3
- 10
|
|||||
Patents
|
601
|
17
- 21
|
|||||
Total
intangible assets
|
2,872
|
||||||
Deposits
and other long-term assets
|
715
|
||||||
Total
assets acquired
|
|
12,549
|
|||||
Current
liabilities
|
(3,504
|
)
|
|||||
Net
pension liability
|
(771
|
)
|
|||||
Deferred
income taxes
|
(245
|
)
|
|||||
Other
long-term liabilities
|
(79
|
)
|
|||||
Total
liabilities assumed
|
(4,599
|
)
|
|||||
Net
assets acquired
|
7,950
|
||||||
Loss
on settlement of pre-existing distribution arrangement
|
3,850
|
||||||
Total
acquisition consideration
|
$
|
11,800
|
5
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS –
(Continued)
Among
the
assets of Canon Staar acquired in the Acquisition was cash in the amount of
approximately $3 million, which was reduced by $507,000 in transaction costs
paid during the six months ended June 27, 2008. The remaining $2.5 million
of
net cash obtained in the acquisition is included in STAAR’s consolidated
statements of cash flows under investing activities for the six months ended
June 27, 2008.
In
determining the final purchase price allocation, STAAR considered, among other
factors, its intentions for the use of the acquired assets, historical demand
for STAAR Japan’s products, estimates of future demand for those products,
current selling prices of inventories (less estimated costs of completion,
disposal and normal profit), developed technologies incorporated in its
products, customer relationships, the revenue generating potential of patents
and lives of patents. The fair value of intangible assets was primarily
based on the income approach. The rate used to discount the net cash flows
to their present values was a 10.5% weighted average cost of capital for the
business as a whole, and from 12.5% to 14.0% for the individual intangible
assets depending on the risk associated with the assets’ potential
to
generate revenue and its projected remaining useful economic life. The
weighted average cost of capital was determined after consideration of market
rates of return on debt and equity capital of comparable companies, the weighted
average return on invested capital and the risk associated with achieving
forecast sales related to technology and assets acquired from STAAR Japan.
Property, plant and equipment net book value was evaluated at approximate fair
value on the acquisition date due to the nature and relative age of the assets
acquired. The intangible assets and property, plant and equipment are
being amortized and depreciated based on the pattern in which the economic
benefits of these assets are being utilized, using the straight-line
method. There was no goodwill recorded in the Acquisition because the fair
value of the net assets acquired exceeded the price paid in the Acquisition
by
approximately $4 million, net of deferred income taxes. This excess amount
was allocated on a pro rata basis to offset against the initially determined
fair value of intangible assets and property, plant and equipment.
In
connection with the Acquisition, STAAR also assumed the net pension liability
under STAAR Japan’s noncontributory defined benefit pension plan covering
substantially all of the permanent, full-time employees of STAAR Japan (see
Note
8). Other liabilities assumed by STAAR in the Acquisition mainly consisted
of
current trade payables and accrued liabilities and estimated deferred tax
liabilities, representing the differences between the assigned values and the
tax bases of the assets and liabilities recognized in the Acquisition.
In
connection with the Acquisition, the material terms of the Joint Venture
Agreement and other documents governing the joint venture were terminated.
This
included the termination of the distribution arrangement of Canon Staar under
which Canon Marketing had the exclusive right to distribute Canon Staar’s
products in Japan prior to the Acquisition. Under the provisions of EITF
Abstracts Issue No. 04-1 (EITF 04-1), “Accounting for Preexisting Relationships
between the Parties to a Business Combination,” in a business combination
between two parties that had a pre-existing relationship, that relationship
should be evaluated to determine whether a settlement of that relationship
exists. Any such settlement requires accounting separate from the business
combination. As a result of such an assessment under EITF 04-1, STAAR Japan
recorded an approximate $3.9 million loss at the close of the Acquisition,
which
is included in operating loss of STAAR’s consolidated statements of operations
during the six months ended June 27, 2008. This loss represents the portion
of
the consideration paid by STAAR for the Acquisition that was deemed to represent
the settlement amount of the pre-existing relationship between Canon Staar
and
the Canon companies, in particular for the termination of the distribution
arrangement that, when compared to a comparable at-market arrangement as of
the
closing date, was deemed unfavorable to STAAR. The amount of the loss was
determined using the discounted incremental cash flows income method from the
distribution arrangement and a discount rate of 12%.
6
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS –
(Continued)
Because
the Acquisition was completed on the first day of STAAR’s fiscal year 2008, the
results of STAAR Japan are included in the consolidated financial statements
of
STAAR beginning in the first quarter of the fiscal year. The following table
summarizes unaudited pro forma financial information assuming the Acquisition
had occurred on December 30, 2006, in the corresponding period of the fiscal
year immediately preceding the Acquisition, that is, as if the Acquisition
was
completed on STAAR’s first day of fiscal year 2007. This unaudited pro forma
financial information does not necessarily represent what would have occurred
if
the transaction had taken place on December 30, 2006, and should not be taken
as
representative of STAAR’s future consolidated results of operations or financial
position. STAAR also expects to realize operating synergies. These synergies
will come from offering more products across more geographic areas,
consolidating manufacturing at optimal sites, and anticipated reduced costs
in
logistics, marketing, and administration. The pro forma information does not
reflect these potential expenses and synergies.
(In
thousands, except per share amount)
|
Three Months Ended
June 29, 2007
|
Six Months Ended
June 29, 2007
|
||||||||
Net
sales
|
$
|
16,949
|
$
|
33,537
|
||||||
Net
loss
|
$
|
(4,510
|
)
|
$
|
(8,129
|
)
|
||||
Loss
per share – basic and diluted
|
$
|
(0.16
|
)
|
$
|
(0.30
|
)
|
At
the
close of the Acquisition, the Canon companies and STAAR entered into a Current
Employees Secondment Agreement under which Canon Marketing agreed for a term
of
two years to lease certain employees who had served as officers of Canon Staar
to STAAR Japan to serve in the same capacities after the acquisition. STAAR
Japan is required to make monthly payments to Canon Marketing for the services
provided by the seconded employees in an amount equal to the costs of the
employees’ salaries and benefits (“fee”) as calculated by Canon Marketing,
however, the fee may not exceed 69 million Japanese Yen (approximately $641,000
based on the rate of exchange on June 27, 2008) per annum in the aggregate.
Similarly, Canon Marketing and STAAR entered into a New Employees Secondment
Agreement under which Canon Marketing agreed for a term of one year to lease
to
STAAR Japan certain employees who previously conducted the IOL distribution
business of Canon Marketing. STAAR Japan is required to make monthly payments
to
the Canon companies for the services provided by the seconded employees in
an
amount equal to the costs of the employees’ salaries and benefits as calculated
by Canon Marketing, however, the fee may not exceed 190 million Japanese Yen
(approximately $1.8 million based on the rate of exchange on June 27, 2008)
per
annum in the aggregate.
Note 3 —
Short-Term Investments-Restricted
As
of
June 27, 2008, the Company’s short-term investments consisted of a three-month
Certificate of Deposit with a 3.25% interest rate. The short-term investments
were used to collateralize capital leases funded under a lease line of credit
with Mazuma Capital Corporation (See Note 9). The short-term investments are
classified as held to maturity, carried at amortized cost and approximate fair
value.
Note 4 —
Inventories
Inventories
are stated at the lower of cost, determined on a first-in, first-out basis,
or
market and consisted of the following (in thousands):
June 27,
|
December 28,
|
||||||
2008
|
2007
|
||||||
Raw
materials and purchased parts
|
$
|
1,381
|
$
|
914
|
|||
Work-in-process
|
1,920
|
2,035
|
|||||
Finished
goods
|
12,271
|
9,792
|
|||||
$
|
15,572
|
$
|
12,741
|
7
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS –
(Continued)
Note 5 —
Prepaids, Deposits, and Other Current Assets
Prepaids,
deposits, and other current assets consisted of the following (in
thousands):
|
June
27,
2008
|
December
28,
2007
|
|||||
Prepaids
and deposits
|
$
|
1,788
|
$
|
1,330
|
|||
Other
current assets
|
680
|
280
|
|||||
|
$
|
2,468
|
$
|
1,610
|
Note 6
– Intangible Assets, Net
Intangible
assets consisted of the following (in thousands):
June
27, 2008
|
December
28, 2007
|
||||||||||||||||||
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
|
||||||||||||||
Amortized
intangible assets:
|
|||||||||||||||||||
Patents
and licenses
|
$
|
12,120
|
$
|
(7,788
|
)
|
$
|
4,332
|
$
|
11,489
|
$
|
(7,530
|
)
|
$
|
3,959
|
|||||
Customer
relationships
|
1,459
|
(73
|
)
|
1,386
|
—
|
—
|
—
|
||||||||||||
Developed
technology
|
927
|
(84
|
)
|
843
|
—
|
—
|
—
|
||||||||||||
Total
|
$
|
14,506
|
$
|
(7,945
|
)
|
$
|
6,561
|
$
|
11,489
|
$
|
(7,530
|
)
|
$
|
3,959
|
During
2008, the Company acquired intangible assets through the acquisition of the
remaining interest in STAAR Japan, Inc. (See Note 2). As of June 27, 2008 the
gross carrying amount of the intangible assets acquired through the acquisition
had increased by $145,000 as a result of changes in the exchange
rate.
Note 7
– Other Current Liabilities
Other
current liabilities consisted of the following (in thousands):
June
27,
2008
|
December 28,
2007
|
||||||
Accrued
salaries and wages
|
$
|
2,002
|
$
|
1,910
|
|||
Commissions
due to outside sales representatives
|
487
|
544
|
|||||
Accrued
audit expenses
|
369
|
542
|
|||||
Accounts
receivable credit balances
|
535
|
516
|
|||||
Accrued
income taxes
|
689
|
363
|
|||||
Accrued
insurance
|
243
|
334
|
|||||
Accrued
legal expenses
|
420
|
141
|
|||||
Other*
|
1,697
|
1,191
|
|||||
$
|
6,442
|
$
|
5,541
|
_____________
*
No item
in “other” above exceeds 5% of total current liabilities.
Note 8
– Employee Benefits
The
Company has historically maintained a passive pension plan (the “Swiss Plan”)
covering employees of its Swiss subsidiary. This plan was previously classified
and accounted for as a defined contribution plan. Based on new guidance obtained
in the fourth quarter of fiscal 2007 from the Swiss Auditing Chamber’s Auditing
Practice Committee and its Accounting Practice Committee with respect to a
change in Swiss pension law, the Company concluded that the features of the
Swiss Plan now conform to the features of a defined benefit plan. As a result,
the Company adopted the recognition and disclosure requirements of Statement
of
Financial Accounting Standards (“SFAS”) No. 158, “Employers’ Accounting for
Defined Benefit Pension and Other Postretirement Plans,” an amendment of SFAS
Nos. 87, 88, 106 and 132R (“SFAS 158”) on October 1, 2007.
8
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS –
(Continued)
In
connection with the Company’s acquisition of the remaining interest in STAAR
Japan, Inc., STAAR assumed the net pension liability under STAAR Japan’s
noncontributory defined benefit pension plan substantially covering all of
the
employees of STAAR Japan. STAAR Japan adopted the recognition and disclosure
requirements of Statement of Financial Accounting Standards (“SFAS”) No. 158,
“Employers’ Accounting for Defined Benefit Pension and Other Postretirement
Plans,” an amendment of SFAS Nos. 87, 88, 106 and 132R (“SFAS 158”) on December
29, 2007.
The
following table summarizes the components of net periodic pension cost recorded
for the Company’s defined benefit plans (in thousands):
Three Months
Ended
|
Six Months
Ended
|
||||||
June
27,
2008
|
June
27,
2008
|
||||||
Service
cost
|
$
|
104
|
$
|
201
|
|||
Interest
cost
|
38
|
71
|
|||||
Expected
return on plan assets
|
(34
|
)
|
(61
|
)
|
|||
Amortization
of unrecognized transition obligation or asset
|
5
|
11
|
|||||
Amount
of gain recognized due to a settlement or curtailment
|
(3
|
)
|
(7
|
)
|
|||
Recognized
actuarial loss
|
7
|
12
|
|||||
|
$
|
117
|
$
|
227
|
During
the six months ended June 27, 2008, the Company made cash contributions totaling
approximately $228,000 to its defined benefit pension plans. The Company expects
to make additional cash contributions totaling approximately $82,000 to its
defined benefit pension plans during 2008.
Note 9 —
Credit Facilities
Broadwood
Loan Notes
On
December 14, 2007, the Company borrowed $5 million from Broadwood Partners,
L.P.
(“Broadwood”), a stockholder in the Company, pursuant to a Senior Promissory
Note (the “Note”) between the Company and Broadwood. The borrowed funds were
used to finance the cash consideration and related transaction costs in the
Company’s purchase of the remaining interests of the Canon companies in its
Canon Staar Co., Inc. joint venture. The Note has a term of three years and
bears interest at a rate of 7% per annum, increasing to 20% per annum if there
is a default. The Note is not secured by any collateral, may be pre-paid by
the
Company at any time without penalty, and is not subject to covenants based
on
financial performance or financial condition (except for insolvency). The Note
provides that, with certain exceptions, the Company will not incur indebtedness
senior to or at parity with its indebtedness under the Note without the consent
of Broadwood. Based on representations made by Broadwood in the Promissory
Note,
on the date of the transaction Broadwood beneficially owned 4,396,231 shares
of
the Company’s common stock, comprising 15% of the Company’s common stock as of
December 14, 2007. Based on publicly available information filed by Broadwood,
Neal Bradsher, President of Broadwood Partners, L.P., may have been deemed
to
beneficially own all of the 4,396,231 shares. As additional consideration for
the loan, the Company also entered into a Warrant Agreement with Broadwood
(See
Note 14). In accordance with Accounting Principles Board (“APB”) Opinion No. 14,
“Accounting for Convertible Debt and Debt Issued with Stock Purchase Warrants,”
the total $5 million proceeds were allocated to the December 2007 Warrant and
Note based on their relative fair values, approximating $842,000 and $4.2
million on the issuance date, respectively. The $842,000 was treated as an
additional discount on the loan and is being amortized using the effective
interest method over the life of the loan (See Note 14).
9
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS –
(Continued)
Capital
Lease Agreements
The
Company’s lease agreement with Farnam Street Financial, Inc. (“Farnam”), as
amended on October 9, 2006, provides for purchases of up to $1,500,000 of
property, plant and equipment. In accordance with the requirements of SFAS
13
“Accounting for Leases,” purchases under this facility are accounted for as
capital leases and have a three-year term. Under the agreement, the Company
has
the option to purchase any item of the leased property at the end of that item’s
lease term, at a mutually agreed fair value. On April 1, 2007, the Company
signed an additional leasing schedule with Farnam, which provides for additional
purchases of $800,000 during fiscal year 2008. The terms of this new schedule
conform to the amended agreement dated October 9, 2006. Approximately $327,000
borrowings related to future purchases are available under this facility as
of
June 27, 2008.
The
Company’s lease agreement with Mazuma Capital Corporation (“Mazuma”), as amended
on August 16, 2006, provides for purchases of up to $301,000 of property, plant
and equipment. In accordance with the requirements of SFAS 13 “Accounting for
Leases,” purchases under this facility are accounted for as capital leases and
have a two-year term. The Company was required to open a certificate of deposit
as collateral in STAAR Surgical Company’s name at the underwriting bank for 50%
of the assets funded by Mazuma. As of June 27, 2008, the Company had a
certificate of deposit for approximately $71,000 recorded as “short-term
investment - restricted” with a three-month term at a fixed interest
rate of 3.25%. The agreement also provides that the Company may elect to
purchase any item of the leased property at the end of its lease term for $1.
No
borrowings were available under this facility as of June 27, 2008.
Lines
of Credit
The
Company’s German subsidiary, Domilens, entered into a credit agreement on August
30, 2005. The credit agreement provides for borrowings of up to 100,000 EUR
($157,000 at the rate of exchange on June 27, 2008), at a rate of 8.5% per
annum
and does not have a termination date. The credit agreement is automatically
renewed on an annual basis based on the same terms. The credit agreement may
be
terminated by the lender in accordance with its general terms and conditions.
The credit facility is not collateralized. There were no borrowings outstanding
as of June 27, 2008 and December 28, 2007 and the full amount of the line was
available for borrowing as of June 27, 2008.
The
Company’s Japanese subsidiary, STAAR Japan, has an agreement with Mizuho Bank
providing borrowings of up to 400,000,000 Japanese Yen (approximately $3.7
million based on the rate of exchange on June 27, 2008), at an interest rate
equal to the Tokyo short-term prime interest rate (approximately 1.875% as
of
June 27, 2008) and terminates on April 20, 2009, but may be renewed annually.
The credit facility is not collateralized. As of June 27, 2008 the Company
had
200,000,000 Japanese Yen outstanding on the line of credit (approximately $1.86
million based on the rate of exchange on June 27, 2008).
Covenant
Compliance
The
Company was in compliance with the covenants of these credit facilities as
of
June
27,
2008.
Note
10 — Redeemable, Convertible Preferred Stock
Under
its
Certificate of Incorporation the Company has had 10,000,000 shares of “blank
check” preferred stock, which the Board of Directors is authorized to issue with
such rights, preferences and privileges as the Board may determine. On October
22, 2007, the Board approved the designation of 1,700,000 shares of the
preferred stock as Series A Redeemable Convertible Preferred Stock (“Preferred
Stock”) to be issued in connection with the acquisition of the 50% interest in
Canon Staar Co., Inc. which was consummated on December 29, 2007 (see Note
2).
On December 29, 2007, the Company issued the 1,700,000 shares of Preferred
Stock to the Canon companies as partial consideration for their shares of Canon
Staar Co., Inc. at an estimated fair value of $4.00 per share, or $6.8 million
in the aggregate.
The
Preferred Stock is redeemable by the Company at any time on or after the first
anniversary of the issuance date at a price of $4.00 per share plus any accrued
or declared but unpaid dividends (“Redemption Price”). The holders of the
Preferred Stock have a right, exercisable at any time on or after the third
anniversary of the issuance date by a majority vote of the Preferred Stock
holders, to require the Company to redeem the Preferred Stock at the Redemption
Price.
The
Preferred Stock is convertible into shares of the Company’s common stock at any
time after the issuance date at a one-to-one conversion ratio that is adjustable
only for stock splits, combinations, subdivisions, dividends or
recapitalizations (“Conversion Ratio”). On the fifth anniversary of the issuance
date, the Preferred Stock expires and each share of Preferred Stock will be
automatically converted to common stock of the Company at the Conversion
Ratio.
10
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS –
(Continued)
The
fair
value of the Preferred Stock was determined on the issuance date by the Company
with the assistance of a valuation specialist using the Binomial Tree option
valuation model. This model considers the Preferred Stock to be a derivative
asset of the Company’s common stock where the preferred stockholder has options
to choose certain payoffs that maximize returns and therefore maximize the
value
of the preferred stock. The payoff available to the preferred stockholder is
contingent on the future market value of the Company’s common stock. Therefore
the model, based on certain significant management assumptions, analyzes various
payoff patterns for different possible paths that might be followed by the
common stock price over the life of the Preferred Stock until the automatic
conversion on the fifth anniversary of the issuance date.
The
significant assumptions used in the valuation were as follows:
Average
common stock price*
|
$
|
3.12
|
||
Expected
volatility
|
67.4
|
%
|
||
Expected
dividend yield
|
0
|
%
|
||
Risk-free
interest rate
|
3.43
|
%
|
||
Issuer’s
call price per share
|
$
|
4.00
|
||
Redemption
price per share
|
$
|
4.00
|
______________
*
Average
common stock price used in the valuation represents the average closing market
price per share of the Company’s common stock a few days before and after the
announcement date of the Canon Staar acquisition.
The
Company filed and secured effectiveness of a registration statement with the
SEC
for the public resale of the common stock issuable upon conversion of the
Preferred Stock and must maintain effectiveness for the remainder of the
two-year period following issuance, subject to permitted suspensions of thirty
days up to twice a year under specified circumstances. Other than such permitted
suspensions, if the Company fails to keep the registration statement effective
for the two-year period, as the holders’ sole remedy the Company will be
obligated to issue an additional 30,000 shares of common stock to the holders
for each calendar month that the Company does not meet this effectiveness
requirement (“Penalty Shares”). The Company does not consider the issuance of
any Penalty Shares to be likely.
The
rights, preferences and privileges of the Preferred Stock are specified in
a
Certificate of Designation that the Company filed with the Delaware Secretary
of
State on December 24, 2007. The Preferred Stock does not have voting rights
in the election of directors or any other matter, except as may be required
under the Delaware General Corporation. However, the Company cannot, without
the
consent of at least two-thirds of the holders of the Preferred Stock, authorize
or issue any other equity security senior to or at parity with the Preferred
Stock as to dividend, conversion or redemption rights or liquidation
preferences.
The
Preferred Stock has the right to participate equally, on an as-converted basis,
in any dividend or distribution paid to the common stockholders.
On
or
prior to the effective date of certain change in control or liquidation events
of the Company specified in the Certificate of Designation, the Preferred Stock
is redeemable at the option of the holder at the Redemption Price; however,
the
holder will continue to have the right to convert the Preferred Stock into
common stock of the Company until the close of the second business day prior
to
the effective date of such an event.
In
the
event of a liquidation of the Company, as defined in the Certificate of
Designation, the Preferred Stockholders have a right to receive a distribution
equal to the Redemption Price prior to the distribution of any funds to the
common stockholders. After payment of the Redemption Price the Preferred
Stockholders do not participate in the distribution of the remaining proceeds
of
the liquidation, which will be distributed to the common stockholders. However,
until the effective date of any such liquidation, each Preferred Stockholder
may
convert its shares to common stock of the Company and participate in the
proceeds of the liquidation to be paid to common stockholders in lieu of the
Redemption Price.
On
a
liquidation or change in control of the Company, if a Preferred Stockholder
does
not make a timely election to either receive the Redemption Price or convert
the
Preferred shares to common stock, the Certificate of Designation provides that
the Preferred Stockholder will be deemed to have elected the higher in value
of
the two alternatives, to be calculated as provided in the Certificate of
Designation.
11
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS –
(Continued)
Because
after the third anniversary of issuance the Preferred Stock is redeemable at
the
option of the holders, which is not within the control of the Company, the
Company has presented the Preferred Stock in the mezzanine section of the
consolidated balance sheet in accordance with the provisions of EITF Abstracts,
Topic No. D-98 (“Topic D-98”), “Classification and Measurement of Redeemable
Securities.” Because the Preferred Stock fair value recorded on the issuance
date approximates the redemption price, no further accretion will be required
by
the Company to redemption value and no subsequent revaluation will be necessary
so long as the Preferred Stock is still considered a temporary equity
instrument. However, issuance and registration costs of approximately $48,000
were incurred related to the Preferred Stock, which were offset against the
fair
value of the Preferred Stock on the issuance date and are being accreted to
the
redemption value using the interest method with a corresponding charge to
Additional Paid-In Capital over a three-year period.
Note 11 —
Stockholders’ Equity
The
consolidated interim condensed financial statements include “basic” and
“diluted” per share information. Basic per share information is calculated by
dividing net loss by the weighted average number of shares outstanding. Diluted
per share information is calculated by also considering the impact of potential
issuances of common stock on both net income and the weighted number of shares
outstanding. Potential issuances of common stock include outstanding stock
options, warrants issued to Broadwood and 1,700,000 shares issuable on
conversion of the Series A Preferred Stock. Because the Company was in a loss
position, potential common shares of 6,121,511 and 6,164,266 for the three
and
six months ended June 27, 2008, respectively, and 3,323,414 and 3,177,583 for
the three and six months ended June 29, 2007, respectively, were excluded from
the computation as the shares would have had an anti-dilutive
effect.
Comprehensive
loss
The
components of comprehensive loss are as follows (in thousands):
Three
Months Ended
|
Six
Months Ended
|
||||||||||||
June
27,
2008
|
June
29,
2007
|
June
27,
2008
|
June
29,
2007
|
||||||||||
Net
loss
|
$
|
(2,545
|
)
|
$
|
(4,357
|
)
|
$
|
(11,485
|
)
|
$
|
(7,878
|
)
|
|
Minimum
pension liability adjustment
|
(9
|
)
|
—
|
(7
|
)
|
—
|
|||||||
Foreign
currency translation adjustment
|
(528
|
)
|
81
|
1,395
|
143
|
||||||||
Total
comprehensive loss
|
$
|
(3,082
|
)
|
$
|
(4,276
|
)
|
$
|
(10,097
|
)
|
$
|
(7,735
|
)
|
Note
12 — Geographic and Product Data
The
Company reports segment information in accordance with SFAS No. 131,
“Disclosures about Segments of an Enterprise and Related Information” (“SFAS
131”). Under SFAS 131 all publicly traded companies are required to report
certain information about the operating segments, products, services and
geographical areas in which they operate and their major customers.
The
Company markets and sells its products in approximately 50 countries and has
manufacturing sites in the United States, Japan and Switzerland. Other than
the
United States, Germany, Japan, and Korea, 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 between those in the United
States, Germany, and other locations for each year, is set forth below (in
thousands):
Three
Months Ended
|
Six
Months Ended
|
||||||||||||
June
27,
|
June
29,
|
June
27,
|
June
29,
|
||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
United
States
|
$
|
5,198
|
$
|
5,158
|
$
|
9,722
|
$
|
10,252
|
|||||
Germany
|
6,976
|
5,683
|
13,416
|
11,729
|
|||||||||
Japan
|
3,529
|
104
|
6,481
|
179
|
|||||||||
Korea
|
890
|
750
|
1,640
|
1,529
|
|||||||||
Other
|
4,072
|
3,237
|
7,366
|
6,160
|
|||||||||
Total
|
$
|
20,665
|
$
|
14,932
|
$
|
38,625
|
$
|
29,849
|
12
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS –
(Continued)
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 intraocular lenses
(“IOLs”) and ancillary products used in cataract and refractive surgery. The
composition of the Company’s net sales by surgical line is as follows (in
thousands):
Three
Months Ended
|
Six
Months Ended
|
||||||||||||
June
27,
|
June
29,
|
June
27,
|
June
29,
|
||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Cataract
|
$
|
14,945
|
$
|
10,833
|
$
|
28,357
|
$
|
21,856
|
|||||
Refractive
|
5,534
|
3,943
|
9,909
|
7,663
|
|||||||||
Glaucoma
|
186
|
156
|
359
|
330
|
|||||||||
Total
|
$
|
20,665
|
$
|
14,932
|
$
|
38,625
|
$
|
29,849
|
The
Company sells its products internationally, which subjects the Company to
several potential risks, including fluctuating exchange rates (to the extent
the
Company’s transactions are not in U.S. dollars), 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
Litigation
On
December 7, 2007 STAAR filed a general denial of the Parallax and Moody claims
along with cross-complaints against Parallax and Moody for breach of contract
and for misappropriation of trade secrets. STAAR believes that the Parallax
and
Moody claims are without merit. It also believes that its cross complaints
are
well founded. Nevertheless, the outcome of litigation is never certain and
the
possibility that the plaintiffs will recover under their claims, or that STAAR
will not recover on its cross-complaints, cannot be eliminated at this time.
If
STAAR does not succeed in obtaining dismissal of all of the plaintiffs’ claims
through motions for summary adjudication, remaining issues of fact are likely
to
be determined by a jury, which adds additional uncertainty as to the outcome
and
the potential for damages. STAAR has not reserved funds against a negative
outcome in the lawsuits. Costs of defending these lawsuits will be substantial,
and even if STAAR prevails, legal fees are likely to be unrecoverable. An
unexpected negative outcome in these cases or litigation costs that are greater
than anticipated could result in material harm to STAAR’s business.
In
addition to the lawsuits discussed above, STAAR is from time to time subject
to
various claims and legal proceedings arising out of the normal course of its
business. These claims and legal proceedings relate to contractual rights and
obligations, employment matters, and 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.
13
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS –
(Continued)
Note
14 — Stock-Based Compensation
The
Company has adopted Statement of Financial Accounting Standards No. 123
(revised) “Share
Based Payment”, (“SFAS 123R”) effective December 31, 2005. The Company
previously applied APB Opinion No. 25 “Accounting for Stock Issued to Employees”
(“Opinion”) in accounting for stock option plans and in accordance with the
Opinion, no compensation cost has been recognized for employee option grants
for
these plans in the prior period financial statements because there was no
difference between the exercise price and the market price on the date of grant.
The Company has elected to apply the Modified Prospective Application (“MPA”) in
its implementation of SFAS No. 123R and its subsequent amendments and
clarifications. Under this method, the Company has recognized stock -based
compensation expense only for awards newly made or modified on or after the
effective date and for the portion of the outstanding awards for which requisite
service will be performed on or after the effective date. Expenses for awards
previously granted and earned have not been restated.
As
of
June 27, 2008, the Company has multiple share-based compensation plans, which
are described below. The Company issues new shares upon option exercise once
the
optionee remits payment for the exercise price. The compensation cost that
has
been charged against income for the 2003 Omnibus Plan and the 1998 Stock Option
Plan is set forth below (in thousands):
Three
Months Ended
|
Six
Months Ended
|
||||||||||||
June
27,
2008
|
June
29,
2007
|
June
27,
2008
|
June
29,
2007
|
||||||||||
SFAS
123R expense
|
$
|
308
|
$
|
332
|
$
|
672
|
$
|
684
|
|||||
Restricted
stock expense
|
59
|
17
|
133
|
41
|
|||||||||
Consultant
compensation
|
20
|
2
|
20
|
15
|
|||||||||
Total
|
$
|
387
|
$
|
351
|
$
|
825
|
$
|
740
|
There
was
no net income tax benefit recognized in the income statement for share-based
compensation arrangements as the Company fully offsets net deferred tax assets
with a valuation allowance. In addition, the Company capitalized $39,000 and
$88,000 of SFAS No. 123R compensation to inventory for the three and six months
ended June 27, 2008, and $43,000 and $79,000, respectively for the three and
six
months ended June 29, 2007, and recognizes those amounts as expense through
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”). Under provisions of the 2003 Plan, all of
the unissued shares in the Restated Plans are reserved for issuance in the
2003
Plan. Each year the number of shares reserved for issuance under the 2003 Plan
has been increased as necessary to provide that 2% of the total shares of common
stock outstanding on the immediately preceding December 31 would be reserved
for
issuance, up to a maximum of 1,586,371 additional shares, and a maximum total
of
6,500,000 shares issuable under the 2003 Plan and all of the Restated Plans
incorporated in it. The 6,500,000 maximum shares were reached on January 1,
2007, and no additional shares will be available for issuance as incentives
to
employees without stockholder approval. Shares subject to grants under the
2003
Omnibus Plan that lapse or terminate in accordance with their terms become
available for new grants under the 2003 Omnibus Plan. As of June 27, 2008,
762,548 shares were authorized and available for grants under the 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 2,704,000 shares were outstanding at June 27, 2008 with
exercise prices ranging between $2.21 and $10.99 per share. Restricted stock
grants under the 2003 Plan generally vest over a period of one, three or four
years. There were 52,000 shares of restricted stock grants outstanding at June
27, 2008.
In
fiscal
year 2000, the Board of Directors approved the Stock Option Plan and Agreement
for the Company’s Chief Executive Officer (now President of International)
authorizing the granting of options to purchase common stock or awards of common
stock. The options under the plan were granted at fair market value on the
date
of grant, become exercisable over a three-year period, and expire 10 years
from
the date of grant. Pursuant to this plan, options for 500,000 were outstanding
at June 27, 2008, with an exercise price of $11.125.
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. Under the provisions of the plan, 1.0 million shares were reserved for
issuance; however, the maximum number of shares authorized may be increased
provided such action is in compliance with Article IV of the plan. During fiscal
year 2001, pursuant to Article IV of the plan, the stockholders of the Company
authorized an additional 1.5 million shares. Generally, options under the plan
are granted at fair market value at the date of the grant, become exercisable
over a three-year period, or as determined by the Board of Directors, and expire
over periods not exceeding 10 years from the date of grant. Pursuant to the
plan, options for 404,000 were outstanding at June 27, 2008 with exercise prices
ranging between $3.350 and $13.625 per share. No further awards may be made
under this plan.
14
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS –
(Continued)
In
fiscal
year 1995, the Company adopted the 1995 Consultant Stock Plan, authorizing
the
granting of options to purchase common stock or awards of common stock.
Generally, options under the plan were granted at fair market value at the
date
of the grant, become exercisable on the date of grant and expire 10 years from
the date of grant. Pursuant to this plan, options for 45,000 shares were
outstanding at June 27, 2008 with an exercise price of $1.70 per share. No
further awards may be made under this plan.
Under
provisions of the Company’s 1991 Stock Option Plan, 2.0 million shares were
reserved for issuance. Generally, options under this plan were granted at fair
market value at the date of the grant, become exercisable over a three-year
period, or as determined by the Board of Directors, and expire over periods
not
exceeding 10 years from the date of grant. Pursuant to this plan, options for
60,000 shares were outstanding at June 27, 2008 with exercise prices ranging
from $9.56 to $10.18 per share. No further awards may be made under this
plan.
During
fiscal years 1999 and 2000, the Company issued non-qualified options to purchase
shares of its common stock to employees and consultants. Pursuant to these
agreements, options for 55,000 shares were outstanding at June 27, 2008 with
exercise prices ranging between $9.375 and $10.63.
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 three
and
six months ended June 27, 2008 had an expected term of 5.5 years derived from
historical exercise and termination activity. The Company has calculated a
9.73%
estimated forfeiture rate used in the model for fiscal year 2008 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
|
Six
Months Ended
|
||||||||||||
|
June
27,
2008
|
June
29,
2007
|
June
27,
2008
|
June
29,
2007
|
|||||||||
Expected
dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
0
|
%
|
|||||
Expected
volatility
|
60.87
|
%
|
70.17
|
%
|
61.82
|
%
|
70.17
|
%
|
|||||
Risk-free
interest rate
|
3.07
|
%
|
4.56
|
%
|
2.94
|
%
|
4.56
|
%
|
|||||
Expected
term (in years)
|
5.5
|
5.4
& 5.5
|
5.5
|
5.4
& 5.5
|
A
summary
of option activity under the Plans as of June 27, 2008 is presented
below:
Options
|
Shares
(000’s)
|
Weighted-
Average
Exercise
Price
|
Weighted-
Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
(000’s)
|
|||||||||
Outstanding
at December 28, 2007
|
3,717
|
$
|
6.70
|
||||||||||
Granted
|
631
|
2.45
|
|||||||||||
Exercised
|
—
|
—
|
|||||||||||
Forfeited
or expired
|
(580
|
)
|
6.55
|
||||||||||
Outstanding
at June 27, 2008
|
3,768
|
$
|
6.01
|
6.22
|
$
|
487
|
|||||||
Exercisable
at June 27, 2008
|
2,547
|
$
|
7.05
|
4.87
|
$
|
70
|
The
weighted-average grant-date fair value of options granted during the six months
ended June 27, 2008 was $1.44. The total fair value of options vested during
six
months ended June 27, 2008 and June 29, 2007 was $1,330,000 and $1,074,000,
respectively. The total intrinsic value of options exercised during the six
months ended June 29, 2007 was $62,000. During the six months ended June 27,
2008, no options were exercised.
15
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS –
(Continued)
A
summary
of the status of the Company’s non-vested shares as of June 27, 2008 and changes
during the period is presented below:
Nonvested
Shares
|
Shares
(000’s)
|
Weighted-
Average
Grant
Date
Fair
Value
|
|||||
Nonvested
at December 28, 2007
|
1,055
|
$
|
5.18
|
||||
Granted
|
631
|
1.44
|
|||||
Vested
|
(422
|
)
|
3.16
|
||||
Forfeited
|
(43
|
)
|
2.85
|
||||
Nonvested
at June 27, 2008
|
1,221
|
$
|
2.37
|
As
of
June 27, 2008, there was $2.2 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 1.72 years.
Broadwood
Warrant
On
March
21, 2007, STAAR entered into a loan arrangement with Broadwood Partners, L.P.
(“Broadwood”), a stockholder in the Company. Pursuant to a Promissory Note (the
“March 2007 Note”) between STAAR and Broadwood, STAAR borrowed $4 million from
Broadwood. The loan was subsequently repaid on June 27, 2007.
As
additional consideration for the loan, STAAR also entered into a Warrant
Agreement (the “March 2007 Warrant Agreement”) with Broadwood granting the right
to purchase up to 70,000 shares of STAAR’s common stock at an exercise price of
$6.00 per share, exercisable for a period of six years, with additional warrants
issuable quarterly to Broadwood if the March 2007 Note remained outstanding
after June 30, 2007. Due to the repayment of the March 2007 Note on June 27,
2007, no additional warrants are issuable to Broadwood by STAAR under that
note.
The warrant agreement also provides that STAAR will register the shares issuable
on exercise of the warrant for resale with the SEC. On May 1, 2008, the
registration statement for the warrant shares was declared effective, but STAAR
is required to maintain its effectiveness. Accordingly, in accordance with
the
provisions of Emerging Issues Task Force 00-19, “Accounting for Derivative
Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own
Stock” (“EITF 00-19”), the warrant instrument is accounted for as a liability
because the Company is required to assume that a warrant exercised when
registration requirements have not been satisfied may be settled in cash. The
warrant instrument liability must be revalued at each reporting period with
changes in fair value being reflected in the condensed consolidated statements
of operations. STAAR used the Black-Scholes valuation model to estimate the
warrant’s fair value as of and subsequent to the issuance date. As of March 21,
2007 the fair value of the warrant liability approximated $250,000 with the
residual amount of the total $4 million in proceeds, or $3.75 million being
allocated to the March 2007 Note. The $250,000 was treated as an additional
discount on the loan and the unamortized balance of $215,000 was written off
and
included in other expenses, net, when the loan was paid off in June 2007. The
fair value of the warrant approximated $70,000 as of June 27, 2008 and $68,000
as of December 28, 2007 with the change in value of $2,000 recorded in other
income for the six months ended June 27, 2008.
The
Company estimated the fair value of the warrant on June 27, 2008 and December
28, 2007 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 common stock. The expected life of the warrant is
determined by the amount of time remaining on the original six-year term of
the
agreement as of the valuation date. The risk-free rate for periods within the
contractual life of the warrant is based on the U.S. Treasury yield curve in
effect at each reporting period.
As
of
June 27, 2008
|
As
of
December 28, 2007
|
||||||
Expected
dividends
|
0
|
%
|
0
|
%
|
|||
Expected
volatility
|
55.2
|
%
|
62.5
|
%
|
|||
Risk-free
rate
|
3.36
|
%
|
3.77
|
%
|
|||
Remaining
life (in years)
|
4.75
|
5.25
|
16
STAAR
SURGICAL COMPANY AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS –
(Continued)
On
December 14, 2007 STAAR entered into a new loan arrangement with Broadwood,
which as noted above is a stockholder of the Company. Pursuant to a Senior
Promissory Note (the “December 2007 Note”) between STAAR and Broadwood, STAAR
borrowed $5 million from Broadwood (See Note 9). As additional consideration
for
the loan, the Company also entered into a Warrant Agreement with Broadwood
(the
“December 2007 Warrant Agreement”) granting Broadwood the right to purchase up
to 700,000 shares of common stock at an exercise price of $4.00 per share,
exercisable for a period of six years. The December 2007 Note also provides
that
if any indebtedness remains outstanding under the Note on June 29, 2009, the
Company will issue additional warrants on the same terms as set forth in the
December 2007 Warrant Agreement in a number equal to 700,000 times the
percentage of the original $5 million principal that remains outstanding. The
December 2007 Warrant Agreement also provides that the Company will register
for
resale with the Securities Exchange Commission (“SEC”) the 700,000 shares
issuable on exercise of the December 2007 Warrant, and the up to 700,000 shares
that may be issuable under additional warrants if indebtedness remains
outstanding on the Note on June 29, 2009. The Company filed and secured
effectiveness of a registration statement covering resale of the shares. If
the
registration statement is not kept effective by the Company and the lapse
exceeds permitted suspensions, the Company is obligated to issue additional
30,000 warrants per month for each month that the Company remains non-compliant
with the registration requirement through the term of the warrants as the sole
remedy to the warrant holder. The Company does not believe there is any
liability incurred associated with not complying with the registration
requirement and therefore no liability was accrued as of June 27, 2008 and
December 28, 2007. The December 2007 Warrant Agreement has been accounted for
as
an equity instrument in accordance with the provisions of EITF 00-19.
The
fair
value of the warrant was estimated on the December 14, 2007 issuance date using
a Black-Scholes option valuation model applying the assumptions noted in the
following table.
As
of
December 14, 2007
|
||||
Expected
dividends
|
0
|
%
|
||
Expected
volatility
|
67.3
|
%
|
||
Risk-free
rate
|
3.88
|
%
|
||
Remaining
life (in years)
|
6.0
|
Note 15 —
Supplemental Disclosure of Cash Flow Information
Interest
and income taxes paid for the six months ended were as follows:
June
27,
2008
|
June
29,
2007
|
||||||
Interest
paid
|
$
|
115
|
$
|
316
|
|||
Income
taxes paid, net of refunds
|
630
|
68
|
The
Company’s non-cash investing and financing activities for the six months ended
were as follows (in thousands):
|
June
27,
2008
|
June
29,
2007
|
|||||
Non-cash
investing and financing activities:
|
|||||||
Acquisition
of Canon Staar
|
$
|
7,147
|
$
|
—
|
|||
Applied
2007 advance payment on acquisition of Canon Staar
|
(4,000
|
)
|
—
|
||||
Applied
2007 deferred acquisition costs
|
(197
|
)
|
—
|
||||
Acquisition
costs in accounts payable and accrued liabilities
|
296
|
—
|
|||||
Purchase
of property and equipment on terms
|
—
|
884
|
|||||
Assets
obtained by capital lease
|
460
|
—
|
|||||
Issuance
of preferred stock
|
6,800
|
—
|
|||||
Issuance
and registration costs of preferred stock included in accounts payable
and
accrued liabilities
|
(48
|
)
|
—
|
17
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 the Company believes that the expectations reflected in
these forward-looking statements are reasonable, such statements are inherently
subject to risks and the Company 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 the Company. These factors include, without limitation, those
described in this report and in our Annual Report on Form 10-K for the fiscal
year ended December 28, 2007 under the heading "Risk Factors." The Company
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 the Company’s interim
condensed financial statements and the related notes provided under “Item 1—
Financial Statements” above.
Overview
STAAR
Surgical Company develops, manufactures and sells visual implants and other
innovative ophthalmic products to improve or correct the vision of patients
with
cataracts and refractive conditions. We manufacture products in the U.S.,
Switzerland and Japan and distribute our products worldwide.
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®, SonicWAVE™ 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.
Principal
Products
STAAR’s
products generally fall into two categories within the ophthalmic surgical
product segment: products designed for cataract surgery and our Visian ICL™ line
of products designed to surgically correct refractive conditions such as myopia
(nearsightedness), hyperopia (farsightedness) and astigmatism.
Intraocular
Lenses (IOLs) and Related Cataract Treatment Products.
The
majority of our revenue is generated by manufacturing and selling foldable
intraocular lenses, known as IOLs, and related products for cataract surgery.
A
foldable IOL is a prosthetic lens used to replace a cataract patient’s natural
lens after it has been extracted in minimally invasive small incision cataract
surgery. STAAR makes IOLs out of silicone and out of Collamer®, STAAR’s
proprietary biocompatible collagen copolymer lens material. STAAR’s IOLs are
available in both three-piece and one-piece designs. Over the years, we have
expanded our range of products for use in cataract surgery to include the
following:
•
|
Aspheric
Collamer and silicone IOLs, designed to provide a clearer image than
traditional spherical designs;
|
•
|
The
silicone Toric IOL, used in cataract surgery to reduce preexisting
astigmatism;
|
•
|
The
Preloaded Injector, a three-piece silicone or acrylic IOL preloaded
into a
single-use disposable injector;
|
•
|
STAARVISCTM
II, a viscoelastic material which is used as a tissue protective
lubricant
and to maintain the shape of the eye during surgery;
|
•
|
Cruise
Control, a disposable filter that allows for a faster, cleaner
phacoemulsification procedure and is compatible with all
phacoemulsification equipment utilizing Venturi and peristaltic pump
technologies.
|
We
also
sell other instruments, devices and equipment that we manufacture or that are
manufactured by others in the ophthalmic industry. In general, these products
complement STAAR’s proprietary product range and allow us to compete more
effectively.
18
Refractive
Surgery.
Manufacturing and selling lenses for refractive surgery is an increasingly
important source of revenue for STAAR. We have used our proprietary
biocompatible Collamer material to develop and manufacture the Implantable
Collamer Lens, or ICL. STAAR’s VISIANTM
ICL and
VISIANTM
Toric
ICL, or TICLTM,
treat
refractive disorders such as myopia (near-sightedness), hyperopia
(far-sightedness) and astigmatism. These disorders of vision affect a large
proportion of the population. Unlike the IOL, which replaces a cataract
patient’s cloudy lens, these products are designed to work with the patient’s
natural lens to correct refractive disorders. The surgeon implants the foldable
Visian lens through a tiny incision, generally under local 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. These
products are sold in more than 40 countries. STAAR’s goal is to establish the
position of the ICL and TICL throughout the world as one of the primary choices
for refractive surgery.
Distribution.
STAAR’s
wholly owned subsidiary, Domilens Vertrieb fuer medizinische Produkte GmbH
(“Domilens”) is a leading distributor of ophthalmic products in Germany.
Products sold by Domilens include implantable lenses, related surgical
equipment, consumables and other supplies. Domilens sells custom surgical kits
that incorporate a surgeon’s preferred supplies and consumables in a single
ready-to-use package, and services phacoemulsification and other surgical
equipment. In addition to distributing and servicing products of third party
manufacturers, Domilens distributes STAAR’s Visian ICL and TICL, IOLs, and
Preloaded Injectors.
Operations
STAAR
has
significant operations both within and outside the U.S. Revenue from activities
outside the U.S. accounted for 75% of our total revenues in the first half
of
2008 and 66% of our total revenues in the first half of 2007. Most of the
increase in the share of our revenue derived from outside the U.S. results
from
the acquisition of the remaining interests in our Japanese joint venture in
early fiscal 2008. Prior to that time none of the Japanese Company’s revenues
was included in our consolidated financial statements. STAAR’s principal
business units and their operations are as follows:
•
|
United
States.
STAAR operates its global administrative headquarters and a manufacturing
facility in Monrovia, California. The Monrovia manufacturing facility
principally makes Collamer and silicone IOLs and injector systems
for IOLs
and ICLs. STAAR also manufactures the Collamer material in the U.S.
|
•
|
Switzerland.
STAAR operates an administrative and manufacturing facility in Nidau,
Switzerland under its wholly owned subsidiary, STAAR Surgical AG.
The
Nidau manufacturing facility makes all of STAAR’s ICLs and TICLs and also
manufactures Collamer IOLs and the AquaFlow™ Collagen Glaucoma Drainage
Device. STAAR Surgical AG handles distribution and other administrative
affairs for Europe and other territories outside North America and
Japan.
|
•
|
Japan.
STAAR completed the acquisition of the remaining 50% interest in
its joint
venture Canon Staar, Co., Inc. during the first quarter of 2008,
following
which the entity’s name was changed to STAAR Japan, Inc. (“STAAR Japan”).
Through this new wholly owned subsidiary STAAR operates an administrative
facility in Tokyo, Japan and a manufacturing facility in Ichikawa
City.
All of STAAR’s preloaded injectors are manufactured at the Ichikawa City
facility. STAAR Japan is also currently seeking approval from the
Japanese
regulatory authorities to market in Japan STAAR’s Visian ICL, Collamer IOL
and AquaFlow Device.
|
•
|
Germany.
Domilens, a wholly owned subsidiary of STAAR Surgical AG, operates
its
distribution business at facilities in Hamburg, Germany.
|
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. These risks are
discussed in our Annual Report on Form 10-K for the fiscal year ended December
28, 2007 under Item 1.A – Risk Factors, under the headings “The
global nature of our business may result in fluctuations and declines in our
sales and profits” and
“The
success of our international operations depends on our successfully managing
our
foreign subsidiaries.”
Strategy
STAAR
is
currently focusing on the following four strategic goals:
•
|
improving
cash flow;
|
•
|
increasing
U.S. sales by reversing the decline in cataract sales and improving
the
growth of refractive sales;
|
•
|
successfully
integrating STAAR Japan; and
|
19
•
|
maintaining
and expanding international growth rates.
|
Strategic
Goal 1: Improve cash flow.
STAAR
used $6.1 million of cash in operations during the first half of 2008 and $7.0
million of cash in the first half of 2007. Approximately $3.0 million of the
total cash used in operating activities in the first half of 2008 was used
by
STAAR Japan in assuming distribution from Canon Marketing Japan, Inc. and for
payments on inventory purchased from Canon Marketing. STAAR seeks to reduce
its
use of cash both by cutting costs and by increasing U.S. revenue and profit
margin. Our strategy to increase U.S. revenue and profit margin is discussed
in
detail under Strategic
Goal 2.
While
STAAR’s international operations have generally generated cash or been cash flow
neutral in recent periods, losses from U.S. operations have been the principal
cause of cash use on a consolidated basis. To reduce these losses, STAAR
implemented cost cutting measures in the third fiscal quarter of 2007 and during
the first six months of 2008, including targeted reductions in the U.S.
workforce. Beginning in December 2007, STAAR began a process to closely
rationalize and evaluate its spending levels. This evaluation has identified
opportunities by which STAAR seeks to save approximately $3.5 million in
annualized costs. These initiatives include streamlining STAAR’s U.S.
organization by reducing spending levels in all areas of the business,
renegotiating or eliminating certain obligations, and eliminating all executive
bonus opportunities until STAAR shows positive trends toward achieving
profitability. STAAR has organized a task force comprised of senior management
to identify and implement during 2008 an additional $2 million to $3 million
in
global cost reduction initiatives.
STAAR
exited the second quarter with $8.9 million in cash and cash equivalents,
compared with $10.9 million at the end of fiscal year 2007.
STAAR
believes its cash management plans are achievable and continues to seek ways
to
reduce spending; however, STAAR cannot provide assurance that it will achieve
the level of intended savings. STAAR’s cash management plans depend on increases
in U.S. sales of high-margin refractive products as well as improvements in
revenue generated by U.S. sales of cataract products. During the second quarter
of 2008, STAAR experienced an increase of 38% in U.S. sales of refractive
products over the second quarter of 2007 and 33% over the first quarter of
2008;
however, U.S. sales of cataract products declined by 9% over the second quarter
of 2007 but increased 9% over the first quarter of 2008. If new cataract product
introductions by STAAR do not generate significant additional revenues, STAAR
may be required to more significantly reduce spending in its U.S. operations.
Strategic
Goal 2: Increase U.S. sales by reversing the decline in cataract sales and
improving the growth of refractive sales.
In
fiscal year 2007 STAAR experienced a flat rate of growth in U.S. refractive
sales and a decrease of 16% in U.S. cataract sales over fiscal year 2006. To
reverse these trends STAAR has significantly modified its U.S. selling strategy
and is continuing its efforts to introduce improved and enhanced products that
will compete better in the marketplace. As described in greater detail below,
U.S. refractive sales have already shown resumed growth during the first six
months of 2008.
Refractive
sales.
Because
the ICL’s design has advantages over other refractive procedures for many
patients and its proprietary nature permits STAAR to maintain its profit margin,
STAAR’s management believes that increased sales of the Visian ICL are the key
to the Company’s return to profitability. Notwithstanding strong and sustained
growth internationally, U.S. market growth is considered essential because
of
the size of the U.S. refractive surgery market and the perceived 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.
In
the
second quarter of 2008 STAAR’s U.S. sales of Visian ICLs increased 39% over the
second quarter of 2007 and 31% over the first quarter of 2008. STAAR believes
this represents a trend to resumed growth in U.S. refractive sales following
2007 sales levels that did not grow beyond those reached in the first year
of
introduction. STAAR believes that the following are among the factors that
may
have contributed to improved Visian ICL sales in the first half of
2008:
·
|
increasing
use of the ICL by a number of surgeons among STAAR’s established U.S.
customers as they have gained experience with the product and become
more
skilled at identifying, attracting and supporting those patients
most
likely to benefit from the ICL;
|
·
|
increased
patient awareness of the ICL as a result of favorable mass media
exposure
for the ICL;
|
·
|
a
change in marketing focus as STAAR, in its third year of ICL marketing
in
the U.S., has shifted from increasing its overall customer base to
devoting more attention to identifying and supporting those surgical
practices that show potential for significant repeat business through
a
professional commitment to the ICL technology; and
|
20
·
|
greater
stability and focus in STAAR’s refractive sales force following its
reorganization in the second half of 2007.
|
To
achieve its plans, STAAR will need not only to sustain, but to increase this
rate of growth. STAAR believes that such an increase is achievable because,
among other things, the favorable media coverage for the ICL and the
implementation of STAAR’s revised marketing approach had only begun to have
their effect late in the first quarter or early in the second quarter. For
example, a segment of the NBC News Today
show
featuring a successful live ICL surgery, aired on March 5, 2008. That show
and
similar local television news segments resulted in increased consumer interest
in ICL, as measured by web traffic and inquiries received on web sites
maintained by STAAR and by the surgeons involved. STAAR’s ICL Growth Program,
which is part of its revised marketing approach, was announced in April 2008,
and on April 22, 2008 held the first of nine webinars hosted by ICL surgeon
Dr.
Brian Boxer Wachler designed to help refractive physicians build their Visian
ICL practices.
Notwithstanding
the increasing Visian ICL sales in early 2008, STAAR will continue to face
challenges in marketing the ICL in the U.S., including the following:
· |
the
U.S. refractive surgery market has been dominated by corneal laser-based
techniques, which unlike the Visian ICL are already well known to
potential refractive patients;
|
· |
other
newly introduced surgical products will continue to compete with
the
Visian ICL for the attention of surgeons seeking to add new, high
value
surgical products, in particular multifocal and accommodating IOLs;
|
· |
an
economic downturn in the U.S. that has impacted LASIK volumes and
could
reduce demand for the Visian ICL;
|
· |
negative
publicity about complications of LASIK could reduce interest in all
refractive surgical procedures; and
|
· |
FDA
approval of the TICL, which STAAR sells in international markets
for
treating patients severely affected by both myopia and astigmatism,
has
been delayed.
|
Refractive
surgery is an elective procedure generally not covered by health insurance.
Patients must pay for the procedure, frequently through installment financing
arrangements. Some makers of lasers for refractive surgery have reduced their
U.S. sales projections for 2008 because worsening general economic conditions
are expected to reduce demand for laser vision correction. As of the date of
this filing, sales of the Visian ICL have not been similarly affected and have
continued to grow during 2008 despite reports of a general economic downturn.
However, STAAR cannot assure that U.S. Visian ICL sales will be unaffected
by a
deep or prolonged recession in the U.S.
On
April
25, 2008, the FDA Ophthalmic Devices Panel held a public meeting to discuss
issues of medical complications and customer satisfaction following refractive
surgery. While the panel also discussed phakic IOLs such as the Visian ICL,
most
of its discussions centered on LASIK and testimony regarding customer
dissatisfaction following LASIK surgery. The Panel recommended enhanced patient
warnings of possible complications for LASIK and created a task force to study
methods of better identifying those patients who are more likely to have an
unsatisfactory outcome from laser vision correction. The proceedings of the
Panel were widely reported in the U.S. While it is difficult to assess precisely
the impact of the panel hearings on patient attitudes or the recommendations
of
practicing surgeons, it is possible that reduced demand for laser eye surgery
observed in the first half of 2008 was caused in part by concerns regarding
complications and potential patient dissatisfaction. 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 if a patient is dissatisfied with the outcome may also be
appealing to some patients with new concerns about risks of refractive surgery.
However, the negative publicity concerning LASIK could decrease 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.
21
STAAR’s
TICL corrects both myopia and astigmatism, and has been shown to be highly
effective in treating individuals severely affected by these conditions. When
STAAR has introduced the TICL in international markets it has generally
experienced rapid growth, and the TICL may also lead to increased ICL sales
by
introducing more patients and physicians to the ICL technology. STAAR has
applied for approval of the TICL in the U.S., but the FDA has suspended review
of the application pending resolution of concerns regarding STAAR’s oversight of
the TICL clinical study. This agency action is discussed below under the caption
“Other
Highlights: Medical Device Regulatory Compliance, Clinical Oversight and TICL
Approval.”
Based
on experience in international markets, STAAR believes that U.S. sales of the
ICL will increase even if TICL approval continues to be delayed. Nevertheless,
STAAR believes that approval and introduction of the TICL would significantly
enhance refractive sales in the U.S. Obtaining approval remains a part of
STAAR’s long-term strategy.
Cataract
Sales.
For
several years STAAR has experienced a decline in U.S. market share of IOLs.
U.S.
IOL sales declined 22% in the second quarter of 2008 and 17% in the second
quarter of 2007. Factors contributing to long term decline in U.S. cataract
sales include the slow pace of cataract product improvement and enhancement
during a period when we devoted most of our research and development resources
to introducing the ICL and to resolving the regulatory and compliance issues
raised by the FDA. This long-term trend was exacerbated in 2007 by disruption
in
STAAR’s independent sales force when STAAR elected not to renew its last two
contracts with regional manufacturer’s representative, in the third quarter of
2007. In addition the trend was exacerbated by STAAR's lagging behind its
competitors in the introduction of IOLs with advanced aspheric optics, and
by
the entry of Alcon as a competitor in the Toric IOL market.
STAAR’s
strategy to achieve profitability in its U.S. cataract business is to
rationalize its cataract product offering around its higher value products,
including recently introduced products and products planned for introduction
in
the near future. This will include aspheric optics across all IOL platforms,
improved delivery systems for Collamer IOLs to broaden their appeal and
preloaded delivery systems for silicone lenses. Successful implementation of
this strategy is subject to risks, including the risk of delays in developing
new products, securing regulatory approval and obtaining favorable reimbursement
status.
STAAR’s
initiatives to enhance its cataract product line have resulted in the following
recent developments:
· |
The
introduction of STAAR’s aspheric three-piece Collamer IOL in April
2007;
|
· |
The
introduction of STAAR’s aspheric three-piece silicone IOL November
2007;
|
· |
The
April 2008 introduction of the nanoPOINT™ injector, which delivers STAAR’s
single piece Collamer IOL through a 2.2 mm
incision;
|
· |
The
grant of New Technology IOL (“NTIOL”) status for the aspheric three-piece
Collamer IOL in March, 2008;
|
· |
The
introduction of an aspheric single-piece Collamer IOL in 2008, which
brings advanced aspheric optics to the micro-incision nanoPOINT platform;
and
|
· |
The
grant of NTIOL status for the aspheric single-piece Collamer IOL
and the
aspheric three-piece silicone IOL in July,
2008.
|
The
addition of aspheric optics to STAAR’s IOL designs has been a primary focus of
STAAR’s recent development efforts. Aspheric IOLs use advanced optical designs
intended to provide a clearer image than traditional spherical lenses,
especially in low light, which has led to significant market share gains for
aspheric designs. In recognition of these advantages the Centers for Medicare
and Medicaid Services (“CMS”) will grant NTIOL status to aspheric IOLs that can
demonstrate improved visual performance over conventional IOLs, allowing an
extra $50 reimbursement per lens implanted in an ASC (ambulatory surgical
center). Because the overwhelming majority of IOL purchases in the U.S. are
implanted at ASCs and reimbursed through Medicare, NTIOL status will
significantly increase STAAR’s margin on qualifying lenses.
All
of
STAAR's aspheric lenses feature a proprietary optical design (patent pending)
that is optimized for the naturally curved surface of the retina and certain
other anatomical features of the human eye, and provides outstanding image
quality even if decentered.
STAAR
intends to continue to focus on the following projects designed to make our
cataract product offering more competitive:
· |
developing
a Collamer Toric IOL to complement our pioneering silicone Toric
IOL and
better compete with the Alcon acrylic Toric
IOL;
|
· |
developing
an all new injector system for the three-piece Collamer IOL; and
|
22
· |
Adapting
our proprietary Preloaded Injector system for our new silicone aspheric
IOLs.
|
STAAR’s
development efforts aim to realize the full market potential for Collamer IOLs
by improving lens delivery systems and differentiating STAAR’s silicone IOL
offering through the Preloaded Injector. The majority of IOLs sold by STAAR
in
the U.S. are made of silicone, which was the original material used for foldable
IOLs. However, physician preferences in the U.S. have strongly shifted to
acrylic IOLs which currently account for an approximately 72% share of the
U.S.
IOL market. STAAR believes that its Collamer lenses have outstanding optical
qualities and superior biocompatibility, and should be capable of competing
with
any of our competitor’s acrylic lens products in the advanced material sector.
In addition, increasing use of the ICL, which relies on the outstanding optical
properties of Collamer, has also introduced the advantages of the Collamer
material to a growing number of surgeons. However, growth of the Collamer IOL
market has been limited by the difficulty of perfecting delivery systems for
the
soft Collamer material. Although acrylic lenses do not have the same level
of
optical performance in the eye as Collamer and often introduce glare or
glistenings into the visual field, the stiffness and toughness of the acrylic
material makes design of delivery systems simpler. STAAR has a number of
development projects in place intended to make Collamer lenses easier to deliver
and broaden customer appeal. The nanoPOINT injector system, which delivers
the
one-piece Collamer IOL through a 2.2 mm incision, was the first of these
projects to reach market and was launched in April 2008.
While
the
U.S. market share for silicone IOLS has been slowly declining overall, a
significant number of surgeons continue to select silicone lenses for their
patients. STAAR believes that recently introduced aspheric, three-piece silicone
IOL offers outstanding optical performance and with its recently granted NTIOL
status could enable STAAR to retain or possibly increase its market share
within the silicone IOL sector, especially if STAAR’s efforts are successful in
securing FDA approval to make it available in a Preloaded Injector.
We
have
developed and currently market globally the Toric IOL, a toric version of our
single-piece silicone IOL, which is specifically designed for cataract patients
who also have pre-existing astigmatism. Until 2006 only STAAR sold Toric IOLs
in
the U.S. Because CMS allows cataract patients receiving reimbursement to pay
a
premium for the correction of pre-existing astigmatism, while Medicare provides
the customary reimbursement for cataract surgery, Toric IOLs can be sold at
a
higher price and higher profit margin than standard IOLs. CMS also permits
the
patient to separately remunerate the surgeon for the significant additional
services needed to prescribe and implant a lens with toric correction for
astigmatism. The increased revenues and profit margin originally expected by
STAAR as a result of the CMS ruling have, to date, not been realized because
of
the introduction of a competing acrylic toric IOL by Alcon Laboratories. In
particular, STAAR believes that in 2007 a number of customers who previously
had
purchased STAAR’s Toric IOL but had otherwise been customers of Alcon’s
ophthalmic products, converted to use of the Alcon Toric IOL, and that new
potential customers have generally selected the Alcon alternative. STAAR
believes that its planned introduction of a collamer-based Toric IOL will be
essential to regaining market share in this technology.
STAAR
believes that it has continued to face a challenge in marketing its products
in
the U.S. as a result of Warning Letters, Form 483 Inspectional Observations
and
other correspondence received from the FDA between December 29, 2003 and July
5,
2005, which indicated that the FDA deemed STAAR’s Monrovia, California facility
to be violating the FDA’s Quality System Regulations and Medical Device
Reporting regulations, warning of possible enforcement action and suspending
approval of Class III medical devices to which the violations related. STAAR
believes that it has resolved the issues giving rise to those agency actions
to
the satisfaction of the FDA staff. Nevertheless, STAAR believes that it has
not
yet fully overcome the reputational harm caused by the FDA’s past findings of
compliance deficiencies, which may continue to present a challenge in increasing
U.S. product sales. In the opinion of STAAR’s management, the recent warning
letter from BIMO and the integrity hold placed on STAAR’s clinical activities by
the Office of Device Evaluation, which concern STAAR’s oversight of clinical
activities rather than its quality systems, have perpetuated the reputational
harm resulting from the earlier FDA actions, and made it more difficult for
STAAR to regain its former market share.
STAAR
comprehensively reorganized its U.S. sale force in the latter part of 2007
and
early 2008. STAAR now directly employs its regional sales managers. At the
local
level STAAR continues to rely chiefly on independent sales representatives
to
promote sales and demonstrate products. STAAR believes that its reorganized
sales force will position the company to capitalize on enhancements to its
cataract product line intended to make the line more competitive.
23
Reversing
the decline in U.S. IOL sales will require STAAR to overcome several short
and
long-term challenges, including successfully meeting its objectives to develop
new and enhanced products, organizing, training and managing a specialized
cataract sales force, competing with much larger companies and overcoming
reputational harm from the FDA’s findings of compliance deficiencies. We cannot
assure that this strategy will ultimately be successful.
Strategic
Goal 3: Successfully integrate STAAR Japan.
Early in
fiscal year 2008 STAAR completed the acquisition of the remaining interests
in
its Japan-based joint venture, Canon Staar Co., Inc. (“Canon Staar”). Canon,
Inc. and its affiliated marketing company, Canon Marketing Japan Inc. (“Canon
Marketing”) collectively owned 50% of Canon Staar prior to the closing of the
acquisition on December 29, 2007, and STAAR owned the other 50%. Following
the
closing of this transaction (the “Acquisition”) on December 29, 2007, Canon
Staar became a wholly owned subsidiary of STAAR operating under the name “STAAR
Japan, Inc.”
Canon
Staar was created in 1988 pursuant to a Joint Venture Agreement between STAAR
and the Canon companies for the principal purpose of designing, manufacturing,
and selling in Japan intraocular lenses and other ophthalmic products. Its
current business consists of manufacturing and selling the Preloaded Injector.
It has also been working to secure approval from Japanese regulatory authorities
to sell the ICL, Collamer IOLs and AquaFlow Collagen Glaucoma Drainage Device
in
Japan. Canon Staar recorded worldwide sales of $8.1 million in fiscal year
2007.
Although
STAAR participated as a shareholder and had appointees serve as directors in
the
oversight of Canon Staar over its approximately twenty-year history, STAAR
and
its officers were not involved in day-to-day management of the joint venture.
In
completing the acquisition STAAR relied on the completeness and accuracy of
the
information provided during pre-closing due diligence. As a result, integrating
STAAR Japan with STAAR faces some of the same challenges typically faced by
the
acquirer of an unrelated company.
When
comparing STAAR Japan’s financial performance in the first and second quarters
of 2008, investors should be aware that rules of purchase accounting and other
effects of the acquisition affected results, especially in the first quarter.
The financial impact of the STAAR Japan acquisition on STAAR recognized in
the
first fiscal quarter of 2008 includes approximately $3.9 million in non-cash
charges relating to the settlement loss on pre-existing arrangements and $1.5
million in charges to cost of goods sold as a result of rules of purchase
accounting that require acquired inventory to be written up in value, reducing
reported margins until that inventory is sold off. The full amount of the
stepped-up inventory was sold off in the first fiscal quarter of
2008. In
addition, the joint venture’s exclusive distributor in Japan, in anticipation of
the transfer of the distribution business in connection with the acquisition,
curtailed inventory purchases during the latter part of 2007, resulting in
a
shortfall in receivables of STAAR Japan below projected levels in the first
quarter of 2008.
Through
the acquisition STAAR seeks to achieve the following goals:
·
|
to
better exploit the Japanese market for STAAR’s technology and the
worldwide market for the Preloaded Injector technology through greater
control of distribution;
|
·
|
to
re-acquire control of world-wide exclusive rights to STAAR’s technology,
especially the ICL and Collamer IOL, previously licensed to the joint
venture;
|
·
|
to
eliminate the risk that Canon Staar could become a competitor of
STAAR,
especially after a change in control of STAAR;
|
·
|
to
increase access to the Preloaded Injector technology; and
|
·
|
to
develop a more effective global R&D strategy by leveraging the
combined technical resources in Japan and the U.S. and taking advantage
of
STAAR Japan’s proven expertise in injector
design.
|
Control
of Distribution. Canon
Marketing has been the exclusive distributor of Canon Staar products in Japan
throughout the joint venture’s history. While the Canon companies are a global
leader in optics, Canon Staar’s IOLs have been the only surgical product of the
Canon companies and represented an insignificant portion of their total
business. As a smaller company exclusively focused on ophthalmic implants,
STAAR
believes that it will be better positioned to exploit the value of the products
developed and manufactured for the Japanese market by STAAR Japan. In addition,
STAAR’s Switzerland subsidiary has already served as Canon Staar’s distributor
for Preloaded Injectors in Europe and Australia and (on a non-exclusive basis)
in China. STAAR believes distribution of Preloaded Injectors outside Japan
can
yield greater sales in the future, in particular following the 2007 introduction
of an acrylic Preloaded Injector.
24
The
cataract market in Japan is one of the world’s largest, and enjoys high average
selling prices. Mean myopia rates in Japan also make it an attractive market
for
refractive surgery. While Canon Staar experienced losses in 2007, it has
historically earned modest profits and higher gross margins than STAAR’s
world-wide average. In addition, by absorbing the distribution business
previously operated by Canon Marketing, STAAR expects to add substantially
all
of the distributor’s historical margins to STAAR Japan’s gross margin.
Accordingly, STAAR believes that the acquisition of the Canon companies’
interests in Canon Staar will likely improve its financial results in the short
term and could lead to long-term improvements if control of distribution leads
to better marketing and increased sales.
Re-acquisition
of World-Wide Exclusive Rights to STAAR Technology. In
1988, pursuant to the Canon Staar Joint Venture Agreement and a Technical
Assistance and License Agreement (“TALA”), STAAR granted to Canon Staar an
irrevocable, exclusive right to make, have made and sell products using its
technology in Japan, and an irrevocable, non-exclusive license to sell products
using our technology in the rest of the world. Under a 2001 Settlement Agreement
STAAR also granted to Canon Staar an irrevocable, exclusive license to make
and
have made products using our technology in China and to sell such products
made
in China and Japan. As a result of these licenses, Canon Staar had the ability
to become a worldwide competitor of STAAR using STAAR’s own technology. In
addition, the worldwide non-exclusive rights held by Canon Staar limited STAAR’s
ability to exploit the value of its own intellectual property through license
agreements, because they prevented STAAR from granting any another company
exclusive rights in any territory or assigning all rights under any of its
patents.
The
TALA
covered not only the license and transfer to Canon Staar of STAAR’s intellectual
property in existence at the time the joint venture was formed, but all
intellectual property STAAR might develop in the future. Accordingly, STAAR
believes the reacquisition of the rights granted under the TALA and the 2001
Settlement Agreement is of significant value to STAAR and its shareholders.
Eliminate
the risk that Canon Staar could become a competitor of STAAR, especially after
a
change in control of STAAR. Prior
to the acquisition, if STAAR had entered into a merger or other reorganization,
had been acquired or was subject of a take-over attempt or experienced other
events of default under the Joint Venture Agreement, the Canon companies would
have had the right to acquire STAAR’s interest in Canon Staar at book value.
(Book value of STAAR’s 50% interest in Canon Staar was approximately $2.3
million as of December 28, 2007). STAAR believes that book value would not
have
represented the fair value of its interest in the joint venture, especially
because following the purchase of its interests by the Canon Companies, STAAR
would lose its rights under the Joint Venture Agreement to control the worldwide
exploitation of STAAR’s technology in competition with STAAR. STAAR also
believes that elimination of this risk has greatly enhanced its opportunity
to
enter into strategic transactions that may benefit its stockholders.
Increase
Access to the Preloaded Injector Technology.
Canon
Staar introduced the world’s first Preloaded Injector in 2003, and STAAR
believes that Canon Staar remains a leader in this technology. Foldable IOLs
are
typically stored and shipped in an unfolded state, and then folded just before
surgery to ensure that they quickly resume their proper shape on implantation.
As a result, designing an effective Preloaded Injector involves many challenges.
Among other things, it requires the engineering of an injector that is
mechanically sound but also safe as a long-term container for the IOL that
can
reliably fold the lens for delivery, smoothly compress and deliver the lens
through a small incision, typically less than 3 mm in width, then release the
lens in a safe and predictable manner. In the course of developing the first
practical preloaded injector Canon Staar filed patents on various innovations
in
Japan, the U.S. and elsewhere in the world. These are among the 33 patents
of
Canon Staar acquired in the acquisition. All rights under these patents were
held exclusively by Canon Staar, with no express license for use by STAAR or
any
other company (except a limited license to Nidek Inc. in connection with
distributing the acrylic Preloaded Injector).
While
STAAR has many injector patents of its own, as a result of past transactions
or
disputes, it entered into cross licenses or covenants not to sue covering
existing injector technology with the other major U.S. ophthalmic companies,
Alcon, Advanced Medical Optics (“AMO”) and Bausch & Lomb. STAAR believes the
existing patents acquired in the acquisition of Canon Staar will not be subject
to those agreements. STAAR is still evaluating the newly acquired patents,
but
believes that in addition to securing its own access to Preloaded Injector
technology these patents enhance STAAR’s proprietary position in the technology
vis-à-vis its competitors.
Develop
a more effective global R&D strategy by combining STAAR Japan’s proven
expertise in injector design with STAAR’s expertise in ophthalmic lenses and
materials.
Both
STAAR and Canon Staar have devoted substantial resources to R&D. Through
working with the joint venture STAAR believes that the Japanese and U.S. R&D
teams have complementary skills. For example, although STAAR first developed
and
patented the concept of a preloaded injector and experimented with its design,
it was Canon Staar’s R&D staff that developed the first practical working
model. STAAR believes that the complementary talents of the U.S. and Japan
teams
will provide opportunities for greater synergies and efficiencies and the
development of new products that could continue STAAR’s tradition of innovation.
25
As
in any
acquisition, the integration of STAAR Japan will present STAAR with a number
of
challenges, including, but not limited to, the following;
·
|
the
risk that STAAR may not successfully integrate the former Canon Staar
business or its employees into its overall business,
|
·
|
the
risk that key employees of STAAR Japan may leave,
|
·
|
the
risk that removal of the Canon name from STAAR Japan and its products
may
reduce its goodwill or the acceptance of its products,
|
·
|
the
risk that STAAR Japan may not sustain current or prior sales levels
or
achieve projected levels,
|
·
|
the
risk that STAAR's limited access to information has limited its ability
to
accurately assess the projections of management of STAAR Japan,
|
·
|
the
risk that Japanese regulators may not approve the sale of the ICL
or
Collamer IOLs,
|
·
|
the
risk of operating a foreign subsidiary with limited direct
oversight,
|
·
|
the
risk that applying U.S. accounting standards and controls and procedures
over financial reporting may be more difficult, more expensive or
more
time-consuming than anticipated,
|
·
|
the
risk that STAAR’s need to rely on the completeness and accuracy of
information provided by the sellers during STAAR’s investigation of the
STAAR Japan business prevented discovery of material problems, and
|
·
|
the
risk that STAAR Japan may find financing for its operations or for
additional working capital purposes difficult to maintain on reasonable
terms, if at all.
|
In
the
period immediately following the closing of the acquisition, STAAR has seen
no
negative impact on sales from ceasing use of the Canon name or operating as
a
company independent of Canon, and STAAR Japan reported a profit in the second
quarter of 2008, STAAR cautions that it is too early to definitively determine
that no negative effects of this change will emerge in the future.
Because
of the strategic importance of the STAAR Japan business to STAAR, and the risks
to realizing the full value of the transaction listed above STAAR has been
devoting significant resources to completing the integration of STAAR Japan
in
2008. Failure to successfully integrate STAAR Japan could significantly harm
STAAR and its business.
Strategic
Goal 4: Maintain and expand international growth rates.
STAAR’s
revenue from international markets has grown steadily in recent periods. During
the first six months of 2008, this growth primarily resulted from increased
sales of ICL and TICL and the effects of changes in currency.
The
ICL
and TICL are sold in more than 40 countries. International refractive sales
have
continued at a steady rate of growth, increasing approximately 40% in 2007
and
33% in the first two quarters of 2008. STAAR believes that the international
market for its refractive products has the potential for further growth, both
through the introduction of the ICL and TICL in new territories and expanded
market share in existing territories. STAAR received approval for the ICL in
China on July 31, 2006 and received approval of the TICL and Hyperopic ICL
in China in March 2008. We also continue to seek new approvals for the ICL
and
TICL in other countries, including Japan and Taiwan, and expanded indications
in countries where they are already approved, but the timing of such
approvals is at the discretion of the local authorities.
Domilens
Vertrieb fuer medizinische Produkte GmbH is a leading distributor of ophthalmic
products in Germany. Products sold by Domilens include implantable lenses,
related surgical equipment, consumables and other supplies. Domilens sells
custom surgical kits that incorporate a surgeon’s preferred supplies and
consumables in a single ready-to-use package, and services phacoemulsification
and other surgical equipment made by third parties. In addition to distributing
and servicing products of third party manufacturers, Domilens distributes
STAAR’s refractive products and Preloaded Injectors. Domilens sales in the first
half of 2008 were $13.4 million, an increase of $1.7 million over the comparable
period of 2007, but this increase was a result of favorable changes in currency.
Domilens generated total sales of $23.7 during fiscal year 2007. During 2007
STAAR’s efforts to further integrate Domilens resulted in a significant increase
in ICL and TICL sales in Germany, where STAAR believes its market potential
remains significantly unrealized. STAAR intends to foster resumed growth at
Domilens by encouraging the continuation of its historically successful
customer-focused business model as a distributor, and by working to further
develop Domilens as platform for selling STAAR’s own higher value proprietary
products.
STAAR
Japan’s silicone Preloaded Injectors are sold in Japan, China, Europe and
Australia, among other countries. STAAR believes the convenience and reliability
of the Preloaded Injector can yield further growth in international markets.
In
particular, STAAR believes that the acrylic Preloaded Injector jointly developed
by STAAR Japan and Nidek, Inc. will provide opportunities to expand STAAR’s
presence in international cataract surgery.
26
Other
Highlights
Medical
Device Regulatory Compliance, Clinical Oversight and TICL
Approval.
STAAR’s
ability to develop, manufacture and distribute its products depends heavily
on
maintaining good standing with the FDA and other regulatory agencies. STAAR
believes that it is substantially in compliance with the FDA’s Quality System
Regulations and Medical Device Reporting regulations. STAAR has invested
significant resources in maintaining regulatory compliance and expects to
continue to do so in the future.
STAAR’s
business activities as a sponsor of biomedical research are subject to review
by
the Bioresearch Monitoring Program of the FDA Office of Regulatory Affairs
(“BIMO”). Following STAAR’s submission of a Pre-Market Approval application
(PMA) supplement for the TICL to the FDA on April 28, 2006, BIMO conducted
an
inspection of STAAR’s clinical study procedures, practices, and documentation
related to the TICL between February 15 and March 14, 2007. At the close of
the
inspection, STAAR received eight inspectional observations on Form 483, to
which
it responded on April 5, 2007. Notwithstanding the response, on June 26, 2007
the FDA’s BIMO branch issued a Warning Letter to STAAR noting four areas of
noncompliance observed during the BIMO inspection. STAAR provided its written
response to the Warning Letter to the FDA on July 31, 2007.
On
August
3, 2007 STAAR received a letter from the FDA Office of Device Evaluation (“ODE”)
notifying STAAR that the TICL application would be placed on integrity hold
until STAAR completed specified actions to the satisfaction of the FDA. Noting
the same deficiencies cited in the June 26, 2007 Warning Letter from the BIMO
Branch, and other deficiencies noted in an audit of a clinical study site,
ODE
requested that STAAR engage a third party auditor to conduct an audit of patient
records along with a clinical systems audit to ensure accuracy and completeness
of data before resubmitting the application.
The
third
party auditor has substantially completed its inspections and is advising STAAR
on the amendments to clinical data required for re-submission to the FDA and
revision to STAAR’s clinical quality systems. STAAR expects that the auditor’s
final report will generally confirm the scientific validity of the TICL clinical
data through the process outlined by the FDA. The third party auditor is
conducting the audit under the oversight of the FDA and STAAR’s communications
with the auditors are limited until the project is complete. While STAAR
believes these actions, if successful, should resolve the issues raised in
the
recent Warning Letter and enable STAAR to resubmit the TICL application in
an
approvable form, STAAR cannot assure investors that the results of the
independent audit or STAAR’s corrective actions will be satisfactory, that ODE
will grant approval to the TICL, or that the scope of requested TICL approval,
if granted, would not be limited by the FDA.
Other
Recent Highlights
Competition
with Multifocal IOLs. The
U.S.
IOL market continues to be affected by sales of multifocal and accommodating
lenses resulting from a ruling of the Centers for Medicare and Medicaid Services
(“CMS”). The ruling permits Medicare-covered cataract patients to receive more
highly priced multifocal or accommodating IOLs (sometimes referred to as
“presbyopic lenses”) by paying only the additional cost of the lens and surgical
procedure while still receiving reimbursement for the basic cost of cataract
surgery and a monofocal IOL. This has increased the number of patients to whom
surgeons offer the alternative of the higher-priced lenses. Presbyopic lenses
will likely continue to claim a significant share of the US cataract market,
and
STAAR does not currently offer a lens of this type.
Dual
Payment for Toric IOLs.
The CMS
has also ruled that a Medicare patient receiving a cataract lens that also
corrects astigmatism, such as STAAR’s Toric IOL, may be reimbursed by Medicare
for the basic cost of the surgery and pay only the additional costs of the
premium lens and specialized surgical procedure. While this ruling permits
STAAR
to increase the average selling price of its silicone Toric IOL, STAAR has
seen
revenue from this product line decline as a result of market share lost
following Alcon’s introduction of an acrylic Toric IOL. STAAR is seeking FDA
approval for a Toric IOL based on its Collamer single-piece IOL, which it
believes will better compete with the Alcon Toric IOL and enable STAAR to
benefit from dual payment under the CMS ruling. In particular, STAAR believes
that the bioadhesive qualities of Collamer will provide an exceptionally stable
platform for correction of astigmatism, which depends on correct angular
positioning of the lens. In addition, STAAR plans to supply the nanoPOINT
injector for use with the Collamer Toric IOL. Because larger incisions can
themselves create astigmatism, STAAR believes a 2.2 millimeter incision for
its
Collamer Toric IOL will provide a competitive advantage. STAAR cautions that
FDA
approval of any product may be delayed or denied, and even if approved it cannot
be assured that the Collamer Toric IOL will gain sufficient sales to materially
improve the results of STAAR’s U.S. cataract business.
27
Foreign
Currency Fluctuations. Our
products are sold in approximately 50 countries. During the second quarter
of
fiscal year 2008, sales from international operations represented 75% of total
sales. The results of operations and the financial position of certain of our
foreign operations are reported in the relevant local currencies and then
translated into U.S. dollars at the applicable exchange rates for inclusion
in
our consolidated financial statements, exposing us to currency translation
risk.
During the second fiscal quarter of 2008, changes in currency exchange rates
had
a $1.1 million favorable impact on net sales.
New
Accounting Pronouncements
In
March
2008, the Financial Accounting Standards Board (“FASB”) issued Statement of
Financial Accounting Standards No. 161 (“SFAS No. 161”), “Disclosures about
Derivative Instruments and Hedging Activities- An Amendment of FASB Statement
No. 133.” SFAS No. 161 requires enhanced disclosures about an entity’s
derivative and hedging activities and thereby improves the transparency of
financial reporting. It is effective for financial statements issued for fiscal
years and interim periods beginning after November 15, 2008, with early
application encouraged. Management does not believe that the provisions of
this
statement will have any impact on the Company’s consolidated financial position
and results of operations when they become effective on January 3,
2009.
In
May
2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted
Accounting Principles,” which identifies the sources of accounting principles
and the framework for selecting the principles to be used in the preparation
of
financial statements of nongovernmental entities that are presented in
conformity with generally accepted accounting principles (GAAP) in the United
States (the GAAP hierarchy). The FASB believes that the GAAP hierarchy should
be
directed to entities because it is the entity that is responsible for selecting
accounting principles for financial statements that are presented in conformity
with GAAP. Accordingly, the FASB concluded that the GAAP hierarchy should reside
in the accounting literature established by the FASB and is issuing this
Statement to achieve that result. The FASB does not expect that this Statement
will result in a change in current practice.
Critical
Accounting Policies
Management's
Discussion and Analysis of Financial Condition and Results of Operations is
based on our unaudited Consolidated Condensed Financial Statements, which we
have prepared in accordance with U.S. generally accepted accounting principles.
The 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 results may differ from these estimates under different
assumptions or conditions.
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 six months ended June 27, 2008 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 28,
2007.
Results
of Operations
The
following table sets forth the percentage of total sales represented by certain
items reflected in the Company's statements of operations for the periods
indicated and the percentage increase or decrease in such items over the prior
period.
Percentage of Net Sales for
Three
Months
|
Percentage
Change for
Three
Months
|
Percentage of Net Sales for
Six
Months
|
Percentage
Change for
Six
Months
|
||||||||||||||||
June
27.
2008
|
June
29,
2007
|
2008
vs. 2007
|
June
27.
2008
|
June
29,
2007
|
2008
vs. 2007
|
||||||||||||||
Net
sales
|
100.0
|
%
|
100.0
|
%
|
38.4
|
%
|
100.0
|
%
|
100.0
|
%
|
29.4
|
%
|
|||||||
Cost
of sales
|
44.2
|
51.5
|
18.7
|
50.1
|
51.3
|
26.2
|
|||||||||||||
Gross
profit
|
55.8
|
48.5
|
59.4
|
49.9
|
48.7
|
32.7
|
|||||||||||||
General
and administrative
|
17.0
|
20.9
|
12.5
|
20.5
|
22.4
|
18.6
|
|||||||||||||
Marketing
and selling
|
37.0
|
41.2
|
24.4
|
36.5
|
38.4
|
23.3
|
|||||||||||||
Research
and development
|
11.4
|
11.0
|
44.2
|
10.6
|
10.9
|
25.6
|
|||||||||||||
Loss
on settlement of pre-existing distribution arrangement
|
—
|
—
|
—
|
10.0
|
—
|
—*
|
|||||||||||||
65.4
|
73.1
|
24.0
|
77.6
|
71.7
|
40.1
|
||||||||||||||
Operating
loss
|
(9.6
|
)
|
(24.6
|
)
|
(45.8
|
)
|
(27.7
|
)
|
(23.0
|
)
|
55.8
|
||||||||
Other
expense, net
|
(0.8
|
)
|
(2.8
|
)
|
(61.8
|
)
|
(0.3
|
)
|
(1.6
|
)
|
(74.3
|
)
|
|||||||
Loss
before provision for income
taxes
|
(10.4
|
)
|
(27.4
|
)
|
(47.5
|
)
|
(28.0
|
)
|
(24.6
|
)
|
47.5
|
||||||||
Provision
for income taxes
|
1.9
|
1.8
|
48.9
|
1.7
|
1.8
|
22.5
|
|||||||||||||
Net
loss
|
(12.3
|
)%
|
(29.2
|
)%
|
(41.6
|
)
|
(29.7
|
)%
|
(26.4
|
)%
|
45.8
|
______________
*
Denotes
change is greater than 100%
28
In
comparing results of operations for the three months and six months ended June
27, 2008 with prior periods, readers should be aware that results for these
periods have been significantly affected by the acquisition of the remaining
interests in STAAR Japan, including both non-recurring charges resulting from
the accounting treatment of the transaction and the consolidation of the results
of STAAR Japan from the first quarter of 2008 forward. On the December 29,
2007,
closing date of the acquisition, STAAR Japan became a wholly owned subsidiary
of
STAAR, and its financial information was included in the Company’s consolidated
financial statements as of that date. As a result of the acquisition, the
Company’s net sales and expenses have increased significantly compared to the
first half of 2007. Additionally, the Company, during the first quarter of
2008,
recorded an approximate $3.9 million loss on settlement of pre-existing
distribution arrangement and a $1.5 million increase to cost of sales resulting
from the sales of inventory that had a stepped-up basis required under GAAP
which have significantly contributed to the Company’s operating loss. Note 2 of
the Notes to the Condensed Consolidated Financial Statements of STAAR provide
details on the accounting for the STAAR Japan acquisition.
Net
Sales
Net
sales
for the three and six months ended June 27, 2008 increased 38% and 29% to $20.1
million and $38.6 million, respectively, compared with $14.9 million and $29.8
million reported for the for the same periods of 2007. Changes in currency
accounted for $1.1 million and $1.9 million, respectively, and STAAR Japan
sales
accounted for $3.3 million and $6.1 million, respectively, of the increase
in
sales for the three and six months ended June 27, 2008.
International
sales for the second quarter of 2008 were $15.5 million, an increase of 58%
compared with $9.8 million reported for the same period of 2007. The increase
in
international sales for the quarter is due primarily to the inclusion of STAAR
Japan sales and the effect of currency (both described above), and increased
sales of ICLs and TICLs resulting in a 41% increase in refractive product sales,
from $2.9 million in the second quarter of 2007 to $4.0 million in the second
quarter of 2008.
International
sales for the first six months of 2008 were $28.9 million, an increase of 48%
compared with $19.6 million reported in the same period of 2007. The increase
in
international sales for six months is due primarily to the inclusion of STAAR
Japan sales and the effect of currency (both described above), and increased
sales of ICLs and TICLs resulting in a 33% increase in refractive product sales,
from $5.5 million in the first six months of 2007 to $7.3 million in the first
six months of 2008.
U.S.
net
sales for second quarter of 2008 increased approximately 1% to $5.2 million
compared with the second quarter of 2007, due to a 38% increase in refractive
product sales to $1.5 million from $1.1 million. The increase in refractive
product sales was due to increased sales of ICLs. Increased sales of refractive
products were largely offset by a 9% decrease in cataract product sales from
$4.0 million to $3.6 million. The decline in cataract product sales was due
to a
decrease in sales of non-aspheric silicone and collamer IOLs and Toric IOLs,
partially offset by an increase in sales of aspheric IOLs and other cataract
products.
U.S.
net
sales for the six months of 2008 decreased approximately 5% to $9.7 million
compared with the first six months of 2007 mainly due to a $0.9 million (12%)
decrease in cataract product sales, partially offset by a $0.5 million (21%)
increase in refractive product sales.
Gross
Profit Margin
Gross
profit margin for the three and six months ended June 27, 2008 was 55.8% and
49.9% compared with 48.5% and 48.7% for the three and six months ended June
29,
2007, respectively. The increase for both periods was primarily due to increased
sales of ICLs globally and Japan cataract product sales which yield higher
average selling prices than in other countries. First quarter gross profit
margin was reduced approximately $1.5 million, or 8%, due to non-cash
purchase accounting revaluations of inventory acquired in the STAAR Japan
acquisition and sold in that quarter.
29
General
and administrative
General
and administrative expenses for the three and six months ended June 27, 2008
were $3.5 million and $8.0 million, respectively, compared with $3.1 million
and
$6.7 million reported for the for the three and six months ended June 29, 2007.
The increase for the three and six months ended June 27, 2008 was primarily
due
to incremental costs of STAAR Japan of $0.2 million and $1.7 million,
respectively, including the reclassification of costs from general and
administrative expenses to research and development, and increased general
and
administrative costs in Europe resulting from increased headcount partially
offset by decreased costs in the US.
Marketing
and Selling
Marketing
and selling expenses for the three and six months ended June 27, 2008 increased
by 24% and 23% to $7.6 million and $14.1 million, respectively, compared with
$6.1 million and $11.4 million reported for the three and six months ended
June
29, 2007, respectively. Changes in currency accounted for $0.4 million and
$0.7
million, respectively, and the incremental costs of STAAR Japan accounted for
$1.2 million and $2.1 million, respectively, of the increase in marketing and
selling costs for the quarter and year-to-date periods. Additionally, spending
increased outside of Japan to drive continued sales growth and salaries
increased in the U.S. as a result of the new refractive sales organization.
The
increase in marketing and selling expenses was partially offset by decreased
commissions and promotional activities in the U.S.
Research
and Development
Research
and development expenses, including regulatory and clinical expenses, for the
second quarter of 2008, increased 44% to $2.4 million, compared with $1.6
million reported for the second quarter of 2007, and for the first six months
of
2008 increased 26% to $4.1 million compared with $3.2 million reported for
the
first six months of 2007. The increases for the three and six months of 2008,
were primarily due to incremental costs of STAAR Japan of $0.9 million and
$1.0
million, respectively, including the reclassification of costs from general
and
administrative expenses to research and development, partially offset by cost
reductions in the U.S.
Loss
on Settlement of Pre-existing Distribution
Arrangement
In
connection with the Company’s acquisition of STAAR Japan, the Company recorded a
$3.9 million loss at the close of the Acquisition (first quarter of fiscal
2008). This loss represents the portion of the consideration paid by STAAR
for
the Acquisition that was deemed to represent the settlement amount of the
preexisting relationship between Canon Staar and the Canon companies, in
particular for the termination of the pre-existing distribution arrangement
that
was deemed unfavorable to STAAR Japan and to STAAR when compared to a comparable
at-market arrangement as of the December 29, 2007 closing date.
Liquidity
and Capital Resources
The
Company has funded its activities over the past several years principally from
cash flow generated from International operations, credit facilities provided
by
institutional domestic and foreign lenders, the private placement and public
offering of common stock, the repayment of former directors’ notes, and the
exercise of stock options.
As
of
June 27, 2008 and December 28, 2007, the Company had $8.9 million and $10.9
million, respectively, of cash and cash equivalents.
Net
cash
used in operating activities was $6.1 million for the six months ended June
27,
2008, compared with $7.0 million for the six months ended June 29, 2007. The
$6.1 million used for operating activities for the first six months of 2008
included $3.0 million used by STAAR Japan, $2.5 million was used in the first
quarter of 2008 as STAAR Japan began selling direct versus through a
distributor. STAAR Japan effectively had no receivables at the end of 2007
and
had to use existing cash balances until they generated cash from sales. STAAR
Japan’s days sales outstanding “DSO” is approximately 65 days, indicating they
did not start seeing cash from direct sales until the end of the first quarter
and as a result utilized much of their cash on hand. During the second quarter,
cash used in operating activities at STAAR Japan improved to $0.5 million as
receivables from sales were collected and the Company improved its margins.
The
rest of the Company used approximately $3.1 million for operating activities
which is a 56% improvement over the $7.0 million used for operating activities
in the first six months of 2007. This significant improvement is the result
of
increased sales of high margin products globally, including the US, and
operating cost reductions in the US.
30
Net
cash
provided in investing activities was $2.2 million for the six months ended
June
27, 2008 compared to net cash used in investing activities of $0.1 million
for
the six months ended June 29, 2007. Cash acquired in connection with the
acquisition of STAAR Japan was approximately $3.0 million, reduced by $0.5
million related to transactions costs paid during the six months ended June
27,
2008. The consideration for the STAAR Japan acquisition was $11.8 million,
of
which approximately 60% of the total consideration was settled by issuing
redeemable, convertible preferred stock on the closing date and the remaining
40% of the total consideration was in cash, which was advanced to the Canon
companies just prior to the closing date and included in STAAR’s non-current
assets on its consolidated balance sheet as of the end of fiscal year 2007.
Upon
completion of the Acquisition on the closing date, the advance payment was
credited to the Canon companies as part of the total consideration paid by
STAAR. STAAR also incurred approximately $1 million in direct transaction and
related costs, of which $0.7 million were paid and $0.3 million included in
accounts payable and accrued liabilities as of June 27, 2008.
Net
cash
provided in financing activities was $1.5 million for the six months ended
June
27, 2008 compared to net cash provided by financing activities of $15.3 million
for the six months ended June 29, 2007. Net cash provided by financing
activities in the first six months of 2008 resulted primarily from borrowings
on
the Japan revolving credit facility. Net cash provided in financing activities
in the second quarter of 2007 included $16.8 million in net proceeds from the
public offering of 3.6 million shares of common stock and $0.6 million from
proceeds related to stock option exercises, offset by repayment of lines of
credit.
Financial
Position
As
a
result of the acquisition of STAAR Japan during the first quarter of STAAR’s
fiscal year 2008, STAAR acquired assets having a value of approximately $7.9
million, which is the total purchase price of $11.8 million less the $3.9
million loss on settlement of a pre-existing distribution arrangement. The
$7.9
million net assets acquired were preliminarily allocated among the various
assets acquired and liabilities assumed on STAAR’s balance sheet based on
estimated fair values of the date of acquisition of STAAR Japan. Note 2 of
the
Notes to the Condensed Consolidated Financial Statements of STAAR provide
details on the estimated fair values of the assets acquired and liabilities
assumed.
Accounts
receivable at June 27, 2008 increased $3.5 million relative to December 28,
2007. The increase in accounts receivable relates primarily to the inclusion
of
STAAR Japan. DSO was 46 days at June 27, 2008 compared to 40 days at December
28, 2007. The increase in DSO days at June 27, 2008 was primarily due to the
inclusion of STAAR Japan’s results beginning as of the first quarterly period of
fiscal 2008. The Company expects to maintain DSO within a range of 40 to 45
days
during the course of the 2008 fiscal year.
Prepaid
expenses, deposits and other current assets at June 27, 2008 increased $0.9
million to $2.5 million, as compared to $1.6 million at December 28, 2007.
The
increase was primarily due to increases at the Switzerland and Germany
subsidiaries.
Accounts
payable at June 27, 2008 increased $3.1 million to $7.9 million, as compared
to
$4.8 million at December 28, 2007. The increase was primarily due to the
inclusion of STAAR Japan’s accounts payable of approximately $2.4 million and
increases in accounts payable in the US and Germany subsidiary.
Credit
Facilities, Contractual Obligations and Commitments
Redeemable,
Convertible Preferred Stock
On
December 29, 2007, the Company issued 1,700,000 shares of Series A Redeemable
Convertible Preferred Stock (“Preferred Stock”) to the Canon companies as
partial consideration for their 50% interest in Canon Staar Co., Inc. (see
Note
2).
The
Preferred Stock is redeemable by the Company at any time on or after the first
anniversary of the issuance date at a price of $4.00 per share plus any accrued
or declared but unpaid dividends (“Redemption Price”). The holders of the
Preferred Stock have a right, exercisable at any time on or after the third
anniversary of the issuance date by a majority vote of the Preferred Stock
holders, to require the Company to redeem the Preferred Stock at the Redemption
Price. Because after the third anniversary of issuance the Preferred Stock
is
redeemable at the option of the holders, which is not within the control of
the
Company, the aggregate $6.8 million Redemption Price of the Preferred Stock
is
presented in the mezzanine section of the consolidated balance sheet.
31
The
Preferred Stock is convertible into shares of the Company’s common stock at any
time after the issuance date at a one-to-one conversion ratio that is adjustable
only for stock splits, combinations, subdivisions, dividends or
recapitalizations (“Conversion Ratio”). On the fifth anniversary of the issuance
date, each share of Preferred Stock will expire and be automatically converted
to common stock of the Company at the Conversion Ratio. Once a share of
Preferred Stock is converted to common stock the holder's right to redeem the
Preferred Stock is extinguished.
Broadwood
Loan Notes
On
March
21, 2007, STAAR entered into a loan arrangement with Broadwood Partners, L.P.
(“Broadwood”). Pursuant to a Promissory Note (the “March 2007 Note”) between
STAAR and Broadwood, Broadwood loaned $4 million to STAAR. The March 2007 Note
was repaid by STAAR on June 27, 2007. As additional consideration for the loan,
STAAR also entered into a Warrant Agreement (the “March 2007 Warrant Agreement”)
as further described in Note 14 of the Notes to the Condensed Consolidated
Financial Statements of STAAR.
On
December 14, 2007, the Company borrowed $5 million from Broadwood Partners,
L.P.
(“Broadwood”) pursuant to a Senior Promissory Note (the “Note”) between the
Company and Broadwood. The borrowed funds were used to finance the cash
consideration and related transaction costs in the Company’s purchase of the
remaining interests of the Canon companies in its Canon Staar Co., Inc. joint
venture. The Note has a term of three years and bears interest at a rate of
7%
per annum, increasing to 20% per annum if there is a default. The Note is not
secured by any collateral, may be pre-paid by the Company at any time without
penalty, and is not subject to covenants based on financial performance or
financial condition (except for insolvency). The Note provides that, with
certain exceptions, the Company will not incur indebtedness senior to or at
parity with its indebtedness under the Note without the consent of Broadwood.
Based on representations made by Broadwood in the Promissory Note, on the date
of the transaction Broadwood beneficially owned 4,396,231 shares of the
Company’s common stock, comprising 15% of the Company’s common stock as of
December 14, 2007. Based on publicly available information filed by Broadwood,
Neal Bradsher, President of Broadwood Partners, L.P., may have been deemed
to
beneficially own all of the 4,396,231 shares. As additional consideration for
the loan, STAAR also entered into a Warrant Agreement (the “December 2007
Warrant Agreement”) as further described in Note 14 of the Notes to the
Condensed Consolidated Financial Statements of STAAR.
Lines
of Credit
The
Company’s German subsidiary, Domilens, entered into a credit agreement on August
30, 2005. The renewed credit agreement provides for borrowings of up to 100,000
EUR ($157,000 at the rate of exchange on June 27, 2008), at a rate of 8.5%
per
annum and does not have a termination date. The credit agreement may be
terminated by the lender in accordance with its general terms and conditions.
The credit facility is not collateralized. There were no borrowings outstanding
as of June 27, 2008 and December 28, 2007 and the full amount of the line was
available for borrowing as of June 27, 2008.
The
Company’s Japanese subsidiary, STAAR Japan, has an agreement with Mizuho Bank
providing borrowings of up to 400,000,000 Japanese Yen (approximately $3.7
million based on the rate of exchange on June 27, 2008), at an interest rate
equal to the Tokyo short-term prime interest rate (approximately 1.875% as
of
June 27, 2008) and terminates on April 20, 2009, but may be renewed annually.
The credit facility is not collateralized. As of June 27, 2008, the Company
had
200,000,000 Japanese Yen outstanding on the line of credit with a remaining
200,000,000 Japanese Yen available for use (approximately $1.9 million based
on
the rate of exchange as of June 27, 2008).
Lease
Agreements
The
Company’s lease agreement with Farnam Street Financial, Inc. (“Farnam”), as
amended on October 9, 2006, provides for purchases of up to $1.5 million of
property, plant and equipment. In accordance with the requirements of SFAS
13
“Accounting for Leases,” purchases under this facility are accounted for as
capital leases and have a three-year term. Under the agreement, the Company
has
the option to purchase any item of the leased property at the end of that item’s
lease term, at a mutually agreed fair value. On April 1, 2007, the Company
signed an additional leasing schedule with Farnam, which provides for additional
purchases of $0.8 million during fiscal year 2008. The terms of this new
schedule conform to the amended agreement dated October 9, 2006. Approximately
$0.3 million in borrowings for future purchases are available under this
facility as of June 27, 2008.
The
Company’s lease agreement with Mazuma Capital Corporation (“Mazuma”), as amended
on August 16, 2006, provides for purchases of up to $301,000 of property, plant
and equipment. In accordance with the requirements of SFAS 13 “Accounting for
Leases,” purchases under this facility are accounted for as capital leases and
have a two-year term. The Company was required to open a certificate of deposit
as collateral in STAAR Surgical Company’s name at the underwriting bank for 50%
of the assets funded by Mazuma. As of June 27, 2008, the Company had a
certificate of deposit for approximately $71,000 recorded as “short-term
investment - restricted” with a three-month term at a fixed interest
rate of 3.25%. The agreement also provides that the Company may elect to
purchase any item of the leased property at the end of its lease term for $1.
No
borrowings were available under this facility as of June 27, 2008.
32
STAAR
Japan Secondment Agreements
At
the
close of the Acquisition by STAAR of the remaining shares of Canon STAAR, the
Canon companies and STAAR entered into a Current Employees Secondment Agreement
under which Canon Marketing agreed for a term of two years to lease certain
employees who had served as officers of Canon STAAR to STAAR Japan to serve
in
the same capacities after the acquisition. STAAR Japan is required to make
monthly payments to Canon Marketing for the services provided by the seconded
employees in an amount equal to the costs of the employees’ salaries and
benefits (“fee”) as calculated by Canon Marketing, however, the fee may not
exceed 69 million Japanese Yen (approximately $641,000 based on the rate of
exchange on June 27, 2008) per annum in the aggregate. Similarly, Canon
Marketing and STAAR entered into a New Employees Secondment Agreement under
which Canon Marketing agreed to lease to STAAR Japan for a term of one year
certain employees who previously conducted the IOL distribution business of
Canon Marketing. STAAR Japan is required to make monthly payments to the Canon
companies for the services provided by the seconded employees in an amount
equal
to the costs of the employees’ salaries and benefits as calculated by Canon,
however, the fee may not exceed 190 million Japanese Yen (approximately $1.8
million based on the rate of exchange on June 27, 2008) per annum in the
aggregate.
As
of
June 27, 2008, the Company had a current ratio of 2.2:1, net working capital
of
$20.1 million and net equity of $33.8 million compared to December 28, 2007
when
the Company’s current ratio was 2.9:1, its net working capital was $21.0
million, and its net equity was $36.2 million.
While
the
Company’s international business generates positive cash flow and represents
approximately 75% of consolidated net sales, the Company has reported losses
on
a consolidated basis for several years due to a number of factors, including
eroding sales of cataract products in the U.S. and FDA compliance issues that
consumed additional resources while delaying the introduction of new products
in
the U.S. market. During these years the Company has secured additional capital
to sustain operations through private and public sales of equity
securities.
The
Company believes that its best prospect for returning its U.S. and consolidated
operations to profitability is through the growth in sales of the ICL in the
U.S. and cost reduction efforts in the U.S. combined with continued growth
in
international markets. In the longer term the Company seeks to develop and
introduce products in the U.S. cataract market to stop further erosion of its
market share, increase gross profit margins and resume growth in that sector.
Nevertheless, success of these strategies is not assured and, even if
successful, the Company is not likely to achieve positive cash flow on a
consolidated basis during fiscal 2008.
The
Company believes that based on current cash balances, combined with expected
cash from international operations, it currently has sufficient cash to meet
its
funding requirements at least through the first quarter of 2009. However, given
its history of losses and negative cash flows, it is possible that the Company
will find it necessary to supplement these sources of capital with additional
financing to sustain operations until the Company returns to
profitability.
If
our
losses continue, we risk defaulting on the terms of our credit facilities.
Our
limited borrowing capacity could cause a shortfall in working capital or prevent
us from making expenditures to expand or enhance our business. A default on
any
of our credit facilities could cause our long term obligations to be
accelerated, make further borrowing difficult and more expensive and jeopardize
our ability to continue operations.
If
the
Company is unable to rely solely on existing debt financing and is unable to
obtain additional debt financing, the Company may find it necessary to raise
additional capital in the future through the sale of equity or debt
securities.
The
Company’s liquidity requirements arise from the funding of its working capital
needs, primarily inventory, work-in-process and accounts receivable. The
Company’s primary sources for working capital and capital expenditures are cash
flow from operations, which will largely depend on the success of the ICL,
proceeds from option exercises, borrowings under the Company’s credit facility
and proceeds from the sale of common stock. Any withdrawal of support from
its
lenders could have serious consequences on the Company’s liquidity. The
Company’s 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 the Company’s cash flow. In addition, any
abnormal product returns or pricing adjustments may also affect the Company’s
short-term funding. Changes in the market price of our common stock affect
the
value of our outstanding options, and lower market prices could reduce our
expected revenue from option exercises.
The
business of the Company is subject to numerous risks and uncertainties that
are
beyond its control, including, but not limited to, those set forth above and
in
the other reports filed by the Company with the Securities and Exchange
Commission. Such risks and uncertainties could have a material adverse effect
on
the Company’s business, financial condition, operating results and cash
flows.
33
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 28, 2007.
ITEM
4.
CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures
Our
management, with the participation of the CEO and the CFO, evaluated the
effectiveness of our disclosure controls and procedures as required by Exchange
Act Rule 13a-15(b) as of the end of the period covered by this report.
Based on that evaluation, the CEO and the CFO have concluded that our disclosure
controls and procedures (as defined in Exchange Act Rule 13a – 15e) are
effective.
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.
Internal
Control over Financial Reporting
There
were no changes in our internal control over financial reporting during the
six
months ended June 27, 2008 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial reporting,
other than as necessary to extend our controls and procedures to STAAR Japan.
PART
II – OTHER INFORMATION
ITEM
1. LEGAL
PROCEEDINGS
Moody
v.
STAAR Surgical Company; Parallax Medical Systems, Inc. v. STAAR Surgical Company
(California Superior Court, County of Orange, Cases No. 07CC10132
and 07CC10136). On September 21, 2007, Scott C. Moody, Inc. and Parallax Medical
Systems, Inc. filed substantially identical complaints against STAAR in the
Superior Court of California, County of Orange. Moody and Parallax are former
independent regional manufacturer’s representatives (“RMRs”) of STAAR whose
contracts with STAAR expired on July 31, 2007. They claim, among other things,
that STAAR interfered with the plaintiffs’ contracts when it caused some of
their current or former subcontractors to enter into new agreements to represent
STAAR products, and that STAAR interfered with the plaintiffs’ prospective
economic advantage when it informed a regional IOL distributor that each of
the
RMR’s contracts had a covenant restricting the sale of competing products. Moody
claims general and compensatory damages of $32 million and Parallax claims
general and compensatory damages of $48 million and both plaintiffs request
punitive damages.
34
On
December 7, 2007 STAAR filed a general denial of the Parallax and Moody claims
along with cross-complaints against Parallax and Moody for breach of contract
and for misappropriation of trade secrets. STAAR believes that the Parallax
and
Moody claims are without merit. It also believes that its cross complaints
are
well founded. Nevertheless, the outcome of litigation is never certain and
the
possibility that the plaintiffs will recover under their claims, or that STAAR
will not recover on its cross-complaints, cannot be eliminated at this time.
If
STAAR does not succeed in obtaining dismissal of all of the plaintiffs’ claims
through motions for summary adjudication, remaining issues of fact are likely
to
be determined by a jury, which adds additional uncertainty as to the outcome
and
the potential for damages. STAAR has not reserved funds against a negative
outcome in the lawsuits. Costs of defending these lawsuits will be substantial,
and even if STAAR prevails legal fees are likely to be unrecoverable. An
unexpected negative outcome in these cases or litigation costs that are greater
than anticipated could result in material harm to STAAR’s business.
The
disclosure of the Moody and Parallax lawsuits in this Item 1 of Part III of
STAAR’s Quarterly Report on Form 10-Q is not intended to imply that these
lawsuits, either individually or in aggregate, are material to
STAAR.
In
addition to the lawsuits discussed above, STAAR is from time to time subject
to
various claims and legal proceedings arising out of the normal course of its
business. These claims and legal proceedings relate to contractual rights and
obligations, employment matters, and 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.
There
have been no material changes to the risk factors disclosed in Item 1A of Part
1
of our Annual Report on Form10-K for the fiscal year ended December 28, 2007,
except for the following:
An
economic downturn could reduce sales of our refractive products.
Refractive
surgery is an elective procedure generally not covered by health insurance.
Patients must pay for the procedure, frequently through installment financing
arrangements, and they can defer the choice to have refractive surgery if they
do not feel confident that they can comfortably pay for it under current
economic conditions. An economic downtown in the U.S. or any of our significant
markets could reduce the ability of candidates for the ICL to pay for the
procedure, or reduce their willingness to incur a significant expense because
of
economic uncertainty. Depending on the severity of the downturn this could
reduce the rate of growth in ICL sales in the affected market, or cause ICL
sales to decline. While cataract product sales are less affected by general
market conditions, because of the higher margins STAAR receives for its
refractive products, reduced ICL sales in an economic downturn could
significantly reduce STAAR’s earnings.
Negative
publicity concerning complications of laser eye surgery could reduce the demand
for our refractive products as well.
On
April
25, 2008, the FDA Ophthalmic Devices Panel held a public meeting to discuss
issues of medical complications and customer satisfaction following refractive
surgery, which received wide publicity in the United States. The panel
discussion and resulting publicity have broadened public awareness of the
potential complications of refractive surgery and potential patient
dissatisfaction, in particular as a result of LASIK and other corneal
laser-based procedures. Concerns about complications of refractive laser eye
surgery could encourage more patients and doctors to select the Visian ICL
as an
alternative. However, negative publicity concerning LASIK could decrease patient
interest in all refractive surgery, including Visian ICL. Depending on the
nature and severity of future negative publicity about refractive surgery,
the
growth of ICL sales in the U.S. could be limited or sales could decline as
a
result. 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.
Legal
costs may be material.
STAAR
has
incurred increased expenses for legal fees, such as fees related to the defense
of the lawsuits by former regional manufacturers’ representatives and STAAR’s
related cross-complaints that are described in Item 1 of Part III of this
Report. While STAAR maintains insurance coverage for a number of litigation
risks, including the cost of defending product liability claims, such insurance
does not cover those lawsuits or some other types of commercial disputes. The
defense of litigation, including fees of external legal counsel, expert
witnesses and related costs, is expensive and may be difficult to project
accurately. In general, such costs are unrecoverable even if STAAR ultimately
prevails in litigation, and could represent a significant portion of STAAR’s
limited capital resources. To defend lawsuits, STAAR also finds it necessary
to
divert officers and other employees from their normal business functions to
gather evidence, give testimony and otherwise support litigation efforts. Higher
than expected costs of litigation could reach levels that materially reduce
the
amount of capital available for STAAR to pursue its business strategies.
35
STAAR
may
also in the future find it necessary to file lawsuits to recover damages or
protect its interests. The cost of such litigation could also be significant
and
unrecoverable, which may also deter STAAR from aggressively pursuing even
legitimate claims.
ITEM
4. SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
a. The
annual meeting of the stockholders of the Company (the “Annual Meeting”) was
held on May 15, 2008.
b. At
the
Annual Meeting, each of the six nominated candidates for director was elected
to
serve until the annual meeting of stockholders in 2009 and until his successor
is duly elected and qualified. The vote was as follows:
|
Number of Shares
|
||||||
|
For
|
Withheld
|
|||||
|
|
|
|||||
Mr.
Don Bailey
|
23,714,693
|
698,705
|
|||||
Mr.
David Bailey
|
19,600,177
|
4,813,221
|
|||||
Mr.
Barry Caldwell
|
23,862,937
|
550,461
|
|||||
Mr.
Donald Duffy
|
20,241,214
|
4,172,184
|
|||||
Mr.
John C. Moore
|
23,836,837
|
574,561
|
|||||
Mr.
David Morrison
|
20,537,078
|
3,876,320
|
36
ITEM
6. EXHIBITS
Exhibits
3.1
|
Certificate
of Incorporation, as amended to date.(1)
|
|
3.2
|
By-laws,
as amended to date.(2)
|
|
4.1
|
Certificate
of Designation of Series A Convertible Preferred
Stock.(1)
|
|
4.2
|
1991
Stock Option Plan of STAAR Surgical Company(3)
|
|
4.3
|
1998
STAAR Surgical Company Stock Plan, adopted April 17,
1998(4)
|
|
4.4
|
Form
of Certificate for Common Stock, par value $0.01 per
share(5)
|
|
4.5
|
2003
Omnibus Equity Incentive Plan and form of Option Grant and Stock
Option
Agreement(6)
|
|
31.1
|
Certification
Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934,
Adopted
Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.(*)
|
|
31.2
|
Certification
Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934,
Adopted
Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.(*)
|
|
Certification
Pursuant to 18 U.S.C. Section 1350, Adopted Pursuant to Section
906 of the
Sarbanes-Oxley Act of
2002.(*)
|
_____________________
(1)
|
Incorporated
by reference to the Company’s Annual Report on Form 10-K for the fiscal
year ended December 28, 2007, as filed with the Commission on
March 12, 2008.
|
(2)
|
Incorporated
by reference to the Company’s Current Report on Form 8-K filed with the
Commission on May 23, 2006.
|
(3)
|
Incorporated
by reference to the Company’s Registration Statement on Form S-8, File No.
033-76404, as filed with the Commission on March 11,
1994.
|
(4)
|
Incorporated
by reference to the Company’s Proxy Statement for its Annual Meeting of
Stockholders held on May 29, 1998, filed with the Commission on May
1, 1998.
|
(5)
|
Incorporated
by reference to Exhibit 4.1 to Amendment No. 1 to the Company’s
Registration Statement on Form 8-A/A, as filed with the Commission on
April 18, 2003.
|
(6)
|
Incorporated
by reference to the Company’s Proxy Statement for its Annual Meeting of
Stockholders held on June 18, 2003, as filed with the Commission on
May 19, 2003.
|
(*) | Filed herewith. |
37
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:
August 6, 2008
|
By:
|
/s/
DEBORAH ANDREWS
|
|
Deborah
Andrews
|
|||
Chief
Financial Officer
|
|||
(on
behalf of the Registrant and as its
|
|||
principal
financial officer)
|
38