STAAR SURGICAL CO - Quarter Report: 2010 April (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
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For
the quarterly period ended: April 2, 2010
|
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Or
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o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
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For
the transition period
from to
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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)
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(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 has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T
(§ 232.405 of this chapter) during the preceding 12 months (or for
such shorter period that the Registrant was required to submit and post such
files). Yes o 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 34,906,961 shares of common stock, par value $0.01 per share,
issued and outstanding as of May 10, 2010.
STAAR
SURGICAL COMPANY
INDEX
PAGE
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NUMBER
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PART
I – FINANCIAL INFORMATION
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Item
1.
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Financial
Statements (Unaudited)
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||
Condensed
Consolidated Balance Sheets – April 2, 2010 and
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|||
January
1, 2010
|
1
|
||
Condensed
Consolidated Statements of Operations – Three Months
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|||
Ended
April 2, 2010 and April 3, 2009
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2
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Condensed
Consolidated Statements of Cash Flows –
|
|||
Three
Months Ended April 2, 2010 and April 3, 2009
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3
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Notes
to the Condensed Consolidated Financial Statements
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4
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Item
2.
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Management's
Discussion and Analysis of Financial Condition
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and
Results of Operations
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16
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Item
3.
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Quantitative
and Qualitative Disclosures About Market Risk
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33
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Item
4.
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Controls
and Procedures
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33
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PART
II – OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
33
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Item
1A.
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Risk
Factors
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34
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Item
6.
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Exhibits
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35
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Signatures
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36
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PART
I. FINANCIAL INFORMATION
ITEM
1. FINANCIAL
STATEMENTS
STAAR
SURGICAL COMPANY
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except par value amounts)
(Unaudited)
April 2,
2010
|
January 1,
2010
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 16,274 | $ | 6,330 | ||||
Restricted
cash
|
7,532 | 7,396 | ||||||
Accounts
receivable trade, net
|
6,903 | 9,269 | ||||||
Inventories,
net
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11,055 | 14,820 | ||||||
Prepaids,
deposits and other current assets
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2,413 | 2,591 | ||||||
Total
current assets
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44,177 | 40,406 | ||||||
Property,
plant and equipment, net
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3,538 | 5,005 | ||||||
Intangible
assets, net
|
3,926 | 4,148 | ||||||
Goodwill
|
1,614 | 7,879 | ||||||
Other
assets
|
1,231 | 1,243 | ||||||
Total
assets
|
$ | 54,486 | $ | 58,681 | ||||
LIABILITIES,
REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’
EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 3,589 | $ | 7,416 | ||||
Line
of credit
|
2,140 | 2,160 | ||||||
Deferred
income taxes
|
360 | 360 | ||||||
Obligations
under capital leases
|
560 | 795 | ||||||
Note
payable, net of discount
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4,628 | 4,503 | ||||||
Accrued
legal judgments
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4,000 | 4,000 | ||||||
Other
current liabilities
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6,161 | 7,706 | ||||||
Total
current liabilities
|
21,438 | 26,940 | ||||||
Obligations
under capital leases
|
730 | 1,098 | ||||||
Deferred
income taxes
|
653 | 653 | ||||||
Other
long-term liabilities
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2,241 | 2,136 | ||||||
Total
liabilities
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25,062 | 30,827 | ||||||
Commitments
and contingencies (Note 13)
|
||||||||
Series
A redeemable convertible preferred stock, $0.01 par value; 10,000 shares
authorized; 1,700 shares issued and outstanding at April 2, 2010 and
January 1, 2010, respectively. Liquidation value $6,800
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6,788 | 6,784 | ||||||
Stockholders’
equity:
|
||||||||
Common
stock, $0.01 par value; 60,000 shares authorized; issued and outstanding
34,752 at April 2, 2010 and 34,747 at January 1, 2010
|
348 | 348 | ||||||
Additional
paid-in capital
|
149,889 | 149,559 | ||||||
Accumulated
other comprehensive income
|
960 | 3,254 | ||||||
Accumulated
deficit
|
(128,561 | ) | (132,091 | ) | ||||
Total
stockholders’ equity
|
22,636 | 21,070 | ||||||
Total
liabilities, redeemable convertible preferred stock and stockholders’
equity
|
$ | 54,486 | $ | 58,681 |
See
accompanying notes to the condensed consolidated financial
statements.
1
STAAR
SURGICAL COMPANY
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except per share amounts)
(Unaudited)
Three Months Ended
|
||||||||
April 2,
2010
|
April 3,
2009
|
|||||||
Net
sales
|
$ | 13,778 | $ | 12,158 | ||||
Cost
of sales
|
4,949 | 4,503 | ||||||
Gross
profit
|
8,829 | 7,655 | ||||||
General
and administrative
|
3,389 | 4,281 | ||||||
Marketing
and selling
|
3,831 | 3,825 | ||||||
Research
and development
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1,533 | 1,412 | ||||||
Operating
income (loss)
|
76 | (1,863 | ) | |||||
Other
income (expense):
|
||||||||
Interest
income
|
1 | 3 | ||||||
Interest
expense
|
(406 | ) | (230 | ) | ||||
Loss
on foreign currency
|
(50 | ) | (68 | ) | ||||
Other
income, net
|
41 | 55 | ||||||
Total
other expense
|
(414 | ) | (240 | ) | ||||
Loss
before provision for income taxes
|
(338 | ) | (2,103 | ) | ||||
Provision
for income taxes
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298 | 126 | ||||||
Loss
from continuing operations
|
(636 | ) | (2,229 | ) | ||||
Income
from discontinued operations, net of income taxes
|
4,166 | 567 | ||||||
Net
income (loss)
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$ | 3,530 | $ | (1,662 | ) | |||
Loss
per share from continuing operations – basic and diluted
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$ | (0.02 | ) | $ | (0.08 | ) | ||
Income
per share from discontinued operations – basic and diluted
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$ | 0.12 | $ | 0.02 | ||||
Net
income (loss) per share – basic and diluted
|
$ | 0.10 | $ | (0.06 | ) | |||
Weighted
average shares outstanding –
basic
and diluted
|
34,750 | 29,641 |
See
accompanying notes to the condensed consolidated financial
statements.
2
STAAR
SURGICAL COMPANY
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
(Unaudited)
Three Months Ended
|
||||||||
April 2,
2010
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April 3,
2009
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
income (loss)
|
$ | 3,530 | $ | (1,662 | ) | |||
Income
from discontinued operations
|
(4,166 | ) | (567 | ) | ||||
Adjustments
to reconcile net income (loss) to net cash used in
operating activities:
|
||||||||
Depreciation
of property and equipment
|
442 | 498 | ||||||
Amortization
of intangibles
|
200 | 197 | ||||||
Amortization
of discount
|
125 | 68 | ||||||
Fair
value adjustment of warrant
|
25 | (50 | ) | |||||
Loss
on disposal of property and equipment
|
— | (5 | ) | |||||
Change
in net pension liability
|
93 | 64 | ||||||
Stock-based
compensation expense
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311 | 595 | ||||||
Other
|
95 | 3 | ||||||
Changes
in working capital:
|
||||||||
Accounts
receivable
|
881 | 1,035 | ||||||
Inventories
|
417 | 26 | ||||||
Prepaids,
deposits and other current assets
|
(405 | ) | 107 | |||||
Accounts
payable
|
(1,426 | ) | (248 | ) | ||||
Other
current liabilities
|
(888 | ) | (343 | ) | ||||
Net
cash used in operating activities of discontinued
operations
|
(635 | ) | (166 | ) | ||||
Net
cash used in operating activities
|
(1,401 | ) | (448 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Proceeds
from sale of subsidiary, net of transaction costs
|
12,051 | — | ||||||
Deposit
to restricted escrow account
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(136 | ) | — | |||||
Acquisition
of property and equipment
|
(106 | ) | (136 | ) | ||||
Proceeds
from sale of property and equipment
|
— | 17 | ||||||
Net
change in other assets
|
(2 | ) | (24 | ) | ||||
Net
cash provided by (used in) investing activities of discontinued
operations
|
(50 | ) | 3 | |||||
Net
cash provided by (used in) investing activities
|
11,757 | (140 | ) | |||||
Cash
flows from financing activities:
|
||||||||
Repayment
of capital lease obligations
|
(276 | ) | (253 | ) | ||||
Net
cash used in financing activities of discontinued
operations
|
(50 | ) | (29 | ) | ||||
Net
cash used in financing activities
|
(326 | ) | (282 | ) | ||||
Effect
of exchange rate changes on cash and cash equivalents
|
(86 | ) | (400 | ) | ||||
Increase
(decrease) in cash and cash equivalents
|
9,944 | (1,270 | ) | |||||
Cash
and cash equivalents, at beginning of the period
|
6,330 | 4,992 | ||||||
Cash
and cash equivalents, at end of the period
|
$ | 16,274 | $ | 3,722 |
See
accompanying notes to the condensed consolidated financial
statements.
3
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
April
2, 2010
(Unaudited)
Note
1 — Basis of Presentation and Significant Accounting Policies
The
condensed balance sheet as of January 1, 2010 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 months ended April 2, 2010 and April 3, 2009, 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
January 1, 2010.
The
results of operations for the three months ended April 2, 2010 and April 3, 2009
are not necessarily indicative of the results to be expected for any other
interim period or for the entire year. As fully discussed in Note 2,
on March 2, 2010, the Company disposed of all of its interests in its
subsidiary, Domilens GmbH (“Domilens”). The disposal has been
accounted for and reported as discontinued operations in the first quarter of
2010 in accordance with the provisions of ASC 205-20. All prior periods
presented in the accompanying consolidated statements of operations and of cash
flows have been adjusted to conform to this presentation; no adjustment has been
made to the prior period consolidated balance sheet as a result of the
divestiture.
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.
New
Accounting and Other Pronouncements
On April
14, 2010, the FASB issued Accounting Standard Codification (ASC) update 2010-12
to ASC 740-10, “Income taxes.” On March 30, 2010, the President signed the
Health Care and Education Reconciliation Act of 2010, which is a reconciliation
bill that amends the Patient Protection and Affordable Care Act that was signed
by the President on March 23, 2010 (collectively the "Acts"). Recently,
questions have arisen about the effect, if any, that the different signing dates
might have on the accounting for these two Acts. This timing difference, related
solely to the signing dates, should not have an impact on a majority of
registrants because the Acts were both signed within a relatively short time
period, which for the vast majority of companies falls into the same reporting
period. After consultation with the FASB staff, the Office of the Chief
Accountant would not object to a view that the two Acts should be considered
together for accounting purposes. The Company is currently assessing
any impact these Acts will have on its consolidated financial statements and
will treat them as one for accounting purposes under this
assessment.
On April
16, 2010, the FASB issued ASC update 2010-13 to ASC Topic 718, “Stock
Compensation.” The objective of this update is to address the
classification of an employee share-based payment award with an exercise price
denominated in the currency of a market in which the underlying equity security
trades. Topic 718 provides guidance on the classification of a share-based
payment award as either equity or a liability. A share-based payment award that
contains a condition that is not a market, performance, or service condition is
required to be classified as a liability. Under Topic 718, awards of equity
share options granted to an employee of an entity's foreign operation that
provide a fixed exercise price denominated in (1) the foreign operation's
functional currency or (2) the currency in which the employee's pay is
denominated should not be considered to contain a condition that is not a
market, performance, or service condition. However, U.S. generally accepted
accounting principles (GAAP) do not specify whether a share-based payment award
with an exercise price denominated in the currency of a market in which the
underlying equity security trades has a market, performance, or service
condition. This update provides amendments to Topic 718 to clarify that an
employee share-based payment award with an exercise price denominated in the
currency of a market in which a substantial portion of the entity's equity
securities trades should not be considered to contain a condition that is not a
market, performance, or service condition. Therefore, an entity would not
classify such an award as a liability if it otherwise qualifies as
equity. The amendments in this update are effective for fiscal years,
and interim periods within those fiscal years, beginning on or after December
15, 2010.
The
Company issues all its share-based awards to employees, domestic or foreign,
with an exercise price that is denominated in the U.S. Dollar, which is the same
currency that the underlying common stock of the Company trades
in. All awards have a service condition and are classified as
equity. The adoption of this update when effective in fiscal year
2011 is not expected to have any impact to the Company’s consolidated financial
statements.
4
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
April
2, 2010
(Unaudited)
Internal
Revenue Service (“IRS”): “Announcement 2010-30) – Draft Schedule and
Instructions for Uncertain Tax Positions Proposal”
Earlier
this year the Internal Revenue Service announced that it would require certain
business taxpayers to report uncertain tax positions (“UTP”) on their returns
for taxable years beginning in 2010. In a recent Announcement 2010-30 (the
“Announcement”), the IRS issued a draft of the "Schedule UTP" that will be used
for that reporting.
The
reporting requirement applies to a taxpayer if the taxpayer has total assets of
$10 million and has adopted a position that is treated as an uncertain tax
position for financial accounting purposes. Based on the draft, the reporting
requirement applies only to U.S. corporations required to file form 1120 (for
U.S. corporations), 1120-L (for U.S. life insurance companies, including foreign
life insurance companies that elect to be taxed as U.S. companies) or 1120-F
(for foreign corporations required to file U.S. tax
returns). Positions taken by related entities are also
covered.
An
uncertain tax position is defined as a position for which the taxpayer has
recorded a reserve in an audited financial statement. Taxpayers must
also report certain positions for which a reserve has not been recorded because
of litigation or IRS administrative practice considerations. Based on
the IRS' previous announcements, it appears that a position for which a taxpayer
should have recorded a reserve, but did not do so, will not be
reportable. The form contains a section for current-year positions
and another one for prior-year positions. Thus, in effect, it is retroactive to
the date of the taxpayer's first recorded reserve for an uncertain tax
position.
Schedule
UTP will make the process of tax return preparation somewhat more burdensome. It
will make tax provision work for financial audit purposes much more burdensome,
as it will place additional pressure on the analysis of whether each tax
position is uncertain. While the government has not yet raised the issue,
it seems possible that a financial auditor who made an inappropriate decision
about whether a position should be reported as uncertain could be subject to
sanctions applicable to tax return preparers.
The IRS
will determine the timing of the requirement to file Schedule UTP for these
entities after comments have been received and considered. Comment
deadline is June 1, 2010. While the Company does not have any
reserves for uncertain tax positions as of April 2, 2010 and January 1, 2010, it
is still assessing the impact, if any, this Announcement will have on its
consolidated financial statements and tax returns.
Note 2 —
Disposal of Domilens subsidiary
On
March 2, 2010 (the “Closing Date”), STAAR Surgical Company completed the
divestiture (the “Transaction”) of all of its interest in its German
distribution subsidiary, Domilens GmbH (“Domilens”) through a management buyout
led by funds managed by Hamburg-based Small Cap Buyout Specialist BPE
Unternehmensbeteiligungen GmbH (“BPE”). To effectuate the Transaction
STAAR Surgical AG (“STAAR AG”), STAAR’s Swiss subsidiary and holder of 100% of
the shares of Domilens, signed a Stock Purchase Agreement (the “Agreement”) with
Domilens Akquisitions GmbH (“Domilens Akquisitions”) on February 24,
2010. Domilens Akquisitions is a newly formed entity 74% owned by BPE
and 26% owned by management of Domilens.
The
Agreement provided for a gross Purchase Price (before Earn-Outs) of €10.5
million (approximately $14.3 million based on the foreign currency exchange rate
on the Closing Date). At closing on March 2, 2010, the gross purchase
price was adjusted for €0.8 million (approximately $1.1 million) in cash
dividends received by STAAR from Domilens, €26,000 (approximately $35,000)
related to certain expenses of compliance with the Sarbanes-Oxley Act of 2002,
and €100,000 (approximately $136,000) which was used to fund an escrow account
(see Note 3) for the payment of unaccrued taxes which might be assessed in a tax
examination for periods prior to December 31, 2009. The balance of
the escrow account, after the resolution of such potential liabilities, if any,
will be distributed to STAAR, no later than December 31, 2011. After
deducting expenses of sale totaling approximately $1.2 million, including
estimated taxes of $46,000, the net cash proceeds from the transaction are
expected to be approximately $11.8 million. Approximately $227,000 of the
transaction expenses are expected to be paid in the second quarter of
2010.
5
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
April
2, 2010
(Unaudited)
Based on
the performance of Domilens in fiscal years 2010, 2011 and 2012, STAAR may earn
up to an additional €675,000 (approximately $920,000 at Closing Date foreign
exchange rates). These additional “earn-out” payments will be paid on
achievement of specified earnings before income tax (“EBIT”) as set forth
below. If a target is missed in any year, but in the following year
Domilens achieves the target and also makes up for the earlier shortfall, the
payments for both years will be earned and paid.
Fiscal Year
|
Domilens EBIT
|
Earn-Out Payment
|
||
2010
|
€2,500,000 (~ $3.4 million)
|
€200,000 (~$273,000)
|
||
2011
|
€2,900,000 (~ $3.9 million)
|
€225,000 (~$307,000)
|
||
2012
|
€3,500,000 (~ $4.7 million)
|
€250,000 (~$340,000)
|
In
connection with the Stock Purchase Agreement, STAAR on February 24, 2010 also
entered into a Distribution Agreement with Domilens providing for the continued
sale of certain STAAR products following the transfer of
ownership. The Distribution Agreement has a term of five
years. The Company will pay a $64,000 marketing allowance in 2010 for
Domilens to use in marketing STAAR’s products post the
Transaction. During the first three years of the term, Domilens will
be the exclusive distributor of covered products in Germany and Austria, subject
to Domilens’ achieving minimum purchase levels. After the initial
three-year period, Domilens will have non-exclusive distribution rights for
these STAAR products, unless the parties agree to an extension of the
exclusivity. The following STAAR products are covered by the Distribution
Agreement: preloaded silicone and acrylic IOL injectors, the Visian ICL,
Visian Toric ICL and Visian Hyperopic ICL.
The
Company considers Domilens to be a component of an entity as defined by ASC
205-20-20, since Domilens is the lowest level at which the operations and cash
flows can be clearly distinguished, operationally and for financial reporting
purposes. The Transaction was accounted for as a divestiture as of
the closing date, March 2, 2010, and Domilens was deconsolidated as of that
date. The net gain on sale of Domilens was $4.1 million, calculated
and recorded as of the closing date, as the difference between the fair value of
consideration received of approximately $11.8 million in cash (net of taxes and
direct transaction costs) and the $7.7 million carrying value of Domilens’ net
assets (assets, excluding cash which was offset as part of net proceeds
received, less liabilities) pursuant to ASC 810-10-40. Included in
the net assets disposed of was goodwill of approximately $6.3 million resulting
from the acquisition of Domilens by STAAR, which was completed in stages during
a five-year period between 1998 and 2003.
The
Company has determined that that the continuing cash flows from the Distribution
Agreement are considered to be insignificant and STAAR will not have significant
continuing involvement in the operations of the disposed
subsidiary. Accordingly, the disposal was accounted for and reported as
discontinued operations beginning in the first quarter of 2010 under the
provisions of ASC 205-20-55, “Discontinued Operations.” The Company
will continue to make this assessment periodically or as necessary.
The
Company’s results of operations for the divested Domilens subsidiary have been
reported as discontinued operations for all periods presented and, accordingly,
all prior periods reported in the consolidated statements of operations and of
cash flows have been adjusted to conform to this presentation. All
sales made by STAAR after the closing date to unaffiliated Domilens GmbH,
pursuant to the Distribution Agreement, have been included in STAAR’s continuing
operations.
The
following table summarizes certain unaudited selected components of discontinued
operations for the divested Domilens subsidiary for the period through the
Transaction closing date, March 2, 2010 and for the three months ended April 3,
2009 (in thousands, except per share amounts):
2010
|
2009
|
|||||||
Net
sales
|
$ | 3,584 | $ | 6,125 | ||||
Gross
profit
|
$ | 1,544 | $ | 2,684 | ||||
Net
gain on disposal, net of $46 of taxes
|
$ | 4,118 | $ | — | ||||
Income
from operations of Domilens before taxes
|
$ | 64 | $ | 877 | ||||
Provision
for income taxes from operations
|
$ | (16 | ) | $ | (310 | ) | ||
Income
from discontinued operations, net of income taxes
|
$ | 4,166 | $ | 567 | ||||
I Income
per share from discontinued operations – basic and diluted
|
$ | 0.12 | $ | 0.02 |
6
Note 3 —
Restricted cash
On June
22, 2009, the Company posted a $7.3 million deposit (150% of the Parallax judgment amount)
with the Superior Court of California, County of Orange (the “Court”) (see Note
13). The Court maintains full control of, and access to the deposit,
including the ultimate disbursement of any and all amounts, plus
interest. The Company has no access to these funds and limited
information as to their investment status. The Court will pay
approximately 1% interest per annum on the deposit, which will be reinvested
into the deposit account by the Court and is subject to the same restrictions as
the principal amount. The Company has classified this restricted cash
deposit as a current asset commensurate with the Parallax judgment being
included in current liabilities. As fully discussed in Note 13, on
March 30, 2010 the Company settled both the Parallax and Moody
lawsuits. In exchange for complete mutual releases, the settlement
provides for payment by STAAR of $4.0 million from the restricted deposit as its
contribution to the global settlement. The approximate $3.4 million
residual deposit, including interest, will be returned to STAAR. The
Company considers this deposit to be akin to a purchase of a temporary
investment with the Court and any activity in this account from its inception to
liquidation will be included as investing cash outflows and inflows in the
Company’s consolidated statements of cash flows.
On March
2, 2010, as part of the disposition of the Domilens subsidiary, the Company
deposited $136,000 into a restricted escrow account to be held against payment
of any unaccrued taxes assessed for periods prior to December 31,
2009. Funds remaining after the resolution of such potential
liabilities, if any, will be distributed to STAAR from the escrow
account, no later than December 31, 2011. The Company has
classified this restricted cash as a current asset commensurate with the related
contingent tax liability included in other current liabilities as of April 2,
2010.
Note 4 — Inventories,
net
Inventories,
net are stated at the lower of cost, determined on a first-in, first-out basis,
or market and consisted of the following (in thousands):
April 2,
|
January 1,
|
|||||||
2010
|
2010
|
|||||||
Raw
materials and purchased parts
|
$ | 2,101 | $ | 1,846 | ||||
Work-in-process
|
2,404 | 2,480 | ||||||
Finished
goods
|
7,509 | 11,736 | ||||||
12,014 | 16,062 | |||||||
Inventory
reserves
|
(959 | ) | (1,242 | ) | ||||
$ | 11,055 | $ | 14,820 |
Note 5 —
Prepaids, Deposits, and Other Current Assets
Prepaids,
deposits, and other current assets consisted of the following (in
thousands):
April 2,
2010
|
January 1,
2010
|
|||||||
Prepaids
and deposits
|
$ | 1,383 | $ | 1,169 | ||||
Insurance
receivable
|
55 | 438 | ||||||
Other
current assets*
|
975 | 984 | ||||||
|
$ | 2,413 | $ | 2,591 |
* No item
in “other current assets” above exceeds 5% of total current
assets.
7
Note 6
– Goodwill and Other Intangible Assets
Amortizable
intangible assets consisted of the following (in thousands):
April 2, 2010
|
January 1, 2010
|
|||||||||||||||||||||||
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
|
|||||||||||||||||||
Amortized
intangible assets:
|
||||||||||||||||||||||||
Patents
and licenses
|
$ | 10,719 | $ | (8,725 | ) | $ | 1,994 | $ | 10,725 | $ | (8,619 | ) | $ | 2,106 | ||||||||||
Customer
relationships
|
1,678 | (377 | ) | 1,301 | 1,694 | (339 | ) | 1,355 | ||||||||||||||||
Developed
technology
|
1,066 | (435 | ) | 631 | 1,077 | (390 | ) | 687 | ||||||||||||||||
Total
|
$ | 13,463 | $ | (9,537 | ) | $ | 3,926 | $ | 13,496 | $ | (9,348 | ) | $ | 4,148 |
As of
April 2, 2010 the gross carrying amount of the amortizable intangible assets had
decreased by $33,000 as a result of changes in the foreign exchange
rate.
The
change in the carrying amount of goodwill from $7,879,000 as of January 1, 2010
to $1,614,000 as of April 2, 2010 is due principally to the disposition of
Domilens as discussed in Note 2 and approximately $37,000 as a result of changes
in foreign exchange rates related to the remaining goodwill.
Note 7
– Other Current Liabilities
Other
current liabilities consisted of the following (in thousands):
April 2,
2010
|
January 1,
2010
|
|||||||
Accrued
salaries and wages
|
$ | 1,839 | $ | 2,122 | ||||
Commissions
due to outside sales representatives
|
190 | 230 | ||||||
Accrued
audit fees
|
273 | 460 | ||||||
Customer
credit balances
|
610 | 589 | ||||||
Accrued
income taxes
|
1,090 | 905 | ||||||
Accrued
legal expenses
|
202 | 273 | ||||||
Accrued
insurance
|
423 | 386 | ||||||
Accrued
interest on Broadwood Note
|
244 | 499 | ||||||
Accrued
bonuses
|
263 | 530 | ||||||
Other*
|
1,027 | 1,712 | ||||||
$ | 6,161 | $ | 7,706 |
* No item
in “other” above exceeds 5% of total current liabilities.
Note 8
– Employee Benefits
The following table summarizes the
components of net periodic pension cost recorded in general and administrative
expenses for the Company’s defined benefit plans (in thousands):
Three Months
Ended
April 2,
2010
|
Three Months
Ended
April 3,
2009
|
|||||||
Service
cost
|
$ | 139 | $ | 138 | ||||
Interest
cost
|
33 | 33 | ||||||
Expected
return on plan assets
|
(23 | ) | (24 | ) | ||||
Amortization
of unrecognized transition obligation or asset
|
— | 6 | ||||||
Amount
of gain recognized due to a settlement or curtailment
|
— | (5 | ) | |||||
Recognized
actuarial loss
|
14 | 8 | ||||||
$ | 163 | $ | 156 |
8
During
the three months ended April 2, 2010 and April 3, 2009, the Company made cash
contributions totaling approximately $68,000 and $84,000 to its defined benefit
pension plans. The Company expects to make additional cash
contributions totaling approximately $204,000 to its defined benefit pension
plans during the remainder of 2010.
9
Note 9 —
Note Payable
Broadwood
Promissory Notes
The
Company has $5 million principal amount of indebtedness under an Amended and
Restated Senior Secured Promissory Note (the “Note”) held by Broadwood Partners,
L.P. (“Broadwood.”), which was issued on April 13, 2009 and matures on December
14, 2010. STAAR’s obligations under the Note are secured by
substantially all of STAAR’s assets pursuant to a Security Agreement with
Broadwood also dated April 13, 2009. The Note evidences indebtedness
that STAAR originally incurred on December 14, 2007 under a Senior Promissory
Note.
The Note
bears interest at an annual rate of 7%, which increases to 20% in the event of a
default. Among the events of default under the Note is a judgment
against the Company in excess of $500,000 that “shall remain
unpaid.” Under a Temporary Waiver Agreement dated April 2, 2009, and
amended on June 24, 2009, the Company cured any default that may be deemed to
have occurred as a result of the $4.9 million Parallax judgment when it
secured a stay on enforcement of the judgment, while appeal was pending, by
placing a $7.3 million deposit with the court. However, the Company
agreed that the Note would bear interest at the default rate of 20% until the
Company satisfied the Parallax judgment and
resolved all other material litigation that was pending on June 24,
2009. On March 30, 2010, the Company entered into a Stipulation for
Settlement that satisfied the judgment and also resolved the Moody case, the only other
material litigation that was pending on June 24, 2009, which caused the annual
rate of interest on the Note to return to 7%.
For
purposes of disclosure requirements under ASC 825-10-50-10, “Financial
Instruments – Disclosure,” the Company performed a valuation of the Broadwood
Note as of April 2, 2010, with the assistance of a valuation specialist using
the discounted cash flows method. Under this method, the Company used
the expected future cash flows, consisting wholly of principal and interest
payments contractually to be made to Broadwood under the terms of the Note, and
discounted each of those cash flows to present value using an appropriate
discount rate.
Using
discount rates of 8.0% and 8.9%, the fair value of the Broadwood Note
approximated $5.0 million and $5.5 million as of April 2, 2010 and January 1,
2010, respectively. The Broadwood Note was valued as of April 2, 2010
and January 1, 2010 based on Level 3 inputs.
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 ASC 840-10-25, purchases under this facility
are accounted for as capital leases and generally have a thirty-month to
three-year term. Title to all assets under the Farnam leases remains with
Farnam. 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-upon fair value. If the Company does not choose to
purchase the asset under lease, it may rent the assets on a month-to-month basis
or return them to Farnam. The Company must provide a 120-day notice
prior to termination of its intent to purchase or return the
assets. On April 1, 2010, Schedule I, of IV Farnam lease schedules,
matured and on April 26, 2010, the Company entered into a new lease agreement
(Schedule V) and, after making contractual monthly payments thereon, Farnam will
transfer title to the assets under the previous Schedule I lease to the Company
at termination and provide the Company up to $250,000 of availability for new
equipment financing. Schedule V term will not commence until the
Company draws on the full $250,000 for new asset purchases (“Commencement Date”)
and will terminate twenty-four months after the Commencement Date, assuming all
payments are made timely; the monthly payments will include both the previous
assets under Schedule I and the new assets financed under Schedule
V. As of April 2, 2010, total remaining capital lease obligations
under the Farnam leases for Schedules II-IV was $293,000 scheduled to terminate
in August 2010, December 2010 and August 2011.
Covenant
Compliance
The
Company is in compliance with the covenants of its credit facilities as of the
date of this report.
Note
10 — Redeemable, Convertible Preferred Stock
On April
23, 2010, STAAR issued a call notice to the holders of its 1,700,000 outstanding
shares of Preferred Stock establishing May 24, 2010 as the redemption date
for the Preferred Stock. On the redemption date each share of
preferred stock shall be redeemed for $4.00 per share unless it has previously
been converted to STAAR’s common stock. The holders of the preferred stock may
convert their shares of Preferred Stock into common stock at a one-to-one
ratio at any time until the close of business on May 17,
2010. Any remaining unconverted shares of Preferred Stock will be
purchased by STAAR at the redemption price of $4.00 per share on May
24, 2010, or on the soonest subsequent date when the shares are tendered to
STAAR. If none of the shares of Preferred Stock are converted, the
aggregate purchase price payable by STAAR to redeem the 1,700,000 shares will be
$6.8 million.
10
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 income or loss by the weighted average number of
shares outstanding (“EPS”). 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. As
the Company is reporting discontinued operations for the disposition of Domilens
(see Note 2), the Company will use its results from continuing operations as the
“control number” for determining whether including potential common shares in
the diluted EPS computation would be dilutive or anti-dilutive in accordance
with ASC 260-10-45-18 and 19. That is, the same number of potential
common shares used in computing the diluted per-share amount for income or loss
from continuing operations should be used in computing all other reported
diluted per-share amounts even if those amounts will be anti-dilutive to their
respective basic per-share amounts. Accordingly, since the Company had a
loss from continuing operations for all periods presented, potential issuance of
7,045,614 shares of common stock for the three months ended April 2, 2010 and
6,275,002 for the three months ended April 3, 2009 were excluded from the
computation as the issuance of those shares would have had an anti-dilutive
effect.
Comprehensive
loss
The
components of comprehensive loss are as follows (in thousands):
April 2,
2010
|
April 3,
2009
|
|||||||
Net
income (loss)
|
$ | 3,530 | $ | (1,662 | ) | |||
Minimum
pension liability adjustment
|
3 | (1 | ) | |||||
Foreign
currency translation adjustment
|
(2,297 | ) | (1,043 | ) | ||||
Total
comprehensive income (loss)
|
$ | 1,236 | $ | (2,706 | ) |
Note
12 — Geographic and Product Data
The
Company reports segment information in accordance with ASC 280, “Segment
Reporting”. Under ASC 280 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, Japan and South 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, Japan, South Korea and other locations for each year, is set forth below
(in thousands):
Three Months Ended
|
||||||||
April 2,
|
April 3,
|
|||||||
2010
|
2009
|
|||||||
United
States
|
$ | 4,022 | $ | 4,196 | ||||
Japan
|
4,032 | 3,699 | ||||||
Korea
|
1,486 | 986 | ||||||
Other
|
4,238 | 3,277 | ||||||
Total
|
$ | 13,778 | $ | 12,158 |
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”) used in cataract surgery, implantable collamer lenses (“ICLs”) used in
refractive surgery and other surgical products used primarily in cataract
surgery. The composition of the Company’s net sales by product line
is as follows (in thousands):
11
Three Months Ended
|
||||||||
April 2,
|
April 3,
|
|||||||
2010
|
2009
|
|||||||
IOLs
|
$ | 6,877 | $ | 6,204 | ||||
ICLs
|
5,860 | 4,886 | ||||||
Other
Surgical Products
|
1,041 | 1,068 | ||||||
Total
|
$ | 13,778 | $ | 12,158 |
The Company sells its products
internationally, which subjects the Company to several potential risks,
including fluctuating foreign currency exchange rates, 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 and Claims
Two
lawsuits against STAAR,
Parallax Medical Systems, Inc. v. STAAR Surgical Company (California
Superior Court, County of Orange, Case No. 07CC10136) and Scott C. Moody, Inc. v. STAAR
Surgical Company; (California Superior Court, County of Orange, Case No.
07CC10132) were settled on March 30, 2010. The settlement and the
underlying cases are more fully described under Item 1 of Part II, “Legal
Proceedings.”
The
settlement, part of a global settlement among all parties to the matters,
satisfies in full the $4.9 million judgment against STAAR in the Parallax matter and the $6.5
million judgment against STAAR in the Moody matter. In
exchange for complete mutual releases, STAAR will pay $4 million as its
contribution to the global settlement. STAAR’s contribution will be
paid from a $7.4 million restricted deposit that STAAR placed with the Court on
June 22, 2009 in order to secure a stay on enforcement of the Parallax judgment during
STAAR’s appeal of the judgment. The approximate $3.4 million residual
deposit, including interest, will be returned to STAAR. As part of
the settlement, STAAR has agreed to dismiss its appeal in both
cases.
In
October 2009, STAAR’s general liability insurer agreed to pay a portion of the
legal fees incurred by STAAR after July 1, 2009 for the defense of the Moody case and the appeal in
the Parallax
judgment. The insurer’s agreement to defend was subject to a full
reservation of its rights and defenses, but in connection with the settlement of
the case the insurer has agreed not to seek recovery of any amounts it paid to
defend the cases.
Prior to
the settlement, and in addition to the $4 million contribution to the
settlement, STAAR separately paid to the plaintiff approximately $150,000 in
costs, legal fees and other assessments in the Moody case.
Note
14 — Stock-Based Compensation
The Company has adopted ASC 718, “Stock
Compensation” effective December 31, 2005.
As of April 2, 2010, 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
|
||||||||
April 2,
2010
|
April 3,
2009
|
|||||||
Stock
based compensation expense
|
$ | 248 | $ | 273 | ||||
Common
stock issued to employees
|
— | 278 | ||||||
Restricted
stock expense
|
34 | 65 | ||||||
Consultant
compensation
|
29 | (21 | ) | |||||
Total
|
$ | 311 | $ | 595 |
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 $23,000 and $33,000
of stock compensation to inventory for the three months ended April 2, 2010 and
April 3, 2009, respectively, and recognizes those amounts as expense under in
Cost of Sales as the inventory is sold.
12
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 will 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 April 2, 2010, there
were 177,831 shares 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 2,900,501 shares were outstanding at April 2, 2010 with
exercise prices ranging between $0.95 and $8.80 per share. Restricted
stock grants under the 2003 Plan generally vest over a period of one, three or
four years. There were 114,667 shares of restricted stock outstanding
at April 2, 2010.
In fiscal year 2000, the Board of
Directors approved the Stock Option Plan and Agreement for the Company’s Chief
Executive Officer 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 April 2, 2010, 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 472,300 were
outstanding at April 2, 2010 with exercise prices ranging between $3.350 and
$13.625 per share. No further awards may be made under this plan.
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 April 2,
2010 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 10,000 shares were outstanding at
April 2, 2010 with exercise price of $9.56 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 15,000
shares were outstanding at April 2, 2010 with exercise price of $10.19 per
share.
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 months ended April 2, 2010 and April 3, 2009 had
an expected term of 5.60 and 5.50 years derived from historical exercise and
termination activity, respectively. The Company has calculated a 10.24%
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.
13
April 2,
2010
|
April 3,
2009
|
|||||||
Expected
dividend yield
|
0 | % | 0 | % | ||||
Expected
volatility
|
80.49 | % | 72.20 | % | ||||
Risk-free
interest rate
|
2.35 | % | 1.72 | % | ||||
Expected
term (in years)
|
5.60 | 5.50 |
A summary
of option activity under the Plans as of April 2, 2010 is presented
below:
Options
|
Shares
(000’s)
|
Weighted-
Average
Exercise
Price
|
Weighted-
Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
(000’s)
|
||||||||||||
Outstanding
at January 1, 2010
|
3,743 | $ | 5.36 | |||||||||||||
Granted
|
224 | 3.43 | ||||||||||||||
Exercised
|
— | — | ||||||||||||||
Forfeited
or expired
|
(24 | ) | 3.26 | |||||||||||||
Outstanding
at April 2, 2010
|
3,943 | $ | 5.26 | 5.27 | $ | - | ||||||||||
Exercisable
at April 2, 2010
|
3,269 | $ | 5.78 | 4.53 | $ | - |
The weighted-average grant-date fair
value of options granted during the three months ended April 2, 2010 and April
3, 2009 was $2.36 and $0.59 per option, respectively. The total fair value of
options vested during three months ended April 2, 2010 and April 3, 2009 was
$285,000 and $739,000, respectively. There were no options exercised
in the three months ended April 2, 2010 and April 3, 2009.
A summary of the status of the
Company’s non-vested shares as of April 2, 2010 and changes during the period is
presented below:
Nonvested Shares
|
Shares
(000’s)
|
Weighted-
Average
Grant Date
Fair Value
|
||||||
Nonvested
at January 1, 2010
|
759 | $ | 1.84 | |||||
Granted
|
224 | 2.36 | ||||||
Vested
|
(285 | ) | 2.36 | |||||
Forfeited
|
(24 | ) | 2.21 | |||||
Nonvested
at April 2, 2010
|
674 | $ | 1.79 |
As of April 2, 2010, there was
$1.0 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
1.67 years.
14
Note 15 —
Supplemental Disclosure of Cash Flow Information
Interest paid was $552,000 and $74,000
for the three months ended April 2, 2010 and April 3, 2009, respectively. Income
taxes paid amounted to approximately $583,000 and $267,000 for the three months
ended April 2, 2010 and April 3, 2009, respectively.
The Company’s significant non-cash
investing and financing activities were as follows (in thousands):
April 2,
2010
|
April 3,
2009
|
|||||||
Non-cash
investing activities:
|
||||||||
Disposal
of Domilens transaction costs included in accounts payable
|
$ | 273 | $ | — | ||||
Assets
obtained by capital lease
|
— | 238 | ||||||
Non-cash
financing activities:
|
||||||||
Issuance
of common stock to consultants for services performed
|
— | 425 |
15
ITEM
2. MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The
matters addressed in this Item 2 that are not historical information constitute
“forward-looking statements” within the meaning of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. Although we believe that the expectations reflected in
these forward-looking statements are reasonable, such statements are inherently
subject to risks and STAAR can give no assurances that its expectations will
prove to be correct. Actual results could differ materially from
those described in this report because of numerous factors, many of which are
beyond the control of STAAR. These factors include, without
limitation, those described in our Annual Report on Form 10-K for the fiscal
year ended January 1, 2010 under the heading “Risk
Factors.” STAAR undertakes no obligation to update these
forward-looking statements that may be made to reflect events or circumstances
after the date of this report or to reflect actual outcomes.
The
following discussion should be read in conjunction with STAAR’s interim
condensed financial statements and the related notes provided under “Item 1— Financial Statements”
above.
Overview
STAAR
Surgical Company designs, develops, manufactures and sells implantable lenses
for the eye. We make lenses both for use in surgery that treats
cataracts, and for use in corrective or “refractive” surgery. All of
the lenses we make are foldable, which permits the surgeon to insert them
through a small incision in minimally invasive surgery. Cataract surgery is a
relatively common outpatient procedure where the eye’s natural lens is removed
and replaced with an artificial lens called an intraocular lens (IOL) to restore
the patient’s vision. Refractive surgery is performed to correct the
type of visual disorders that have traditionally been treated with glasses or
contact lenses. We refer to our lenses used in refractive surgery as
“implantable Collamer® lenses” or “ICLs.” The field of refractive
surgery includes both lens-based procedures, using products like our ICL, and
laser-based procedures like LASIK. Successful refractive surgery can
correct common vision disorders such as myopia, hyperopia and
astigmatism.
Originally
incorporated in California in 1982, STAAR Surgical Company reincorporated in
Delaware in 1986. Unless the context indicates otherwise “we,” “us,” the
“Company,” and “STAAR” refer to STAAR Surgical Company and its consolidated
subsidiaries.
STAAR
Surgical Company, Visian®, Collamer®, STAARVISC®, Elastimide®, nanoFLEX™,
nanoPOINT™, Epiphany™, 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.
Effect
of Domilens Divestiture on Financial Reporting
As more
fully discussed below, on March 2, 2010 STAAR disposed of all of its interests
in its former subsidiary, Domilens GmbH. In accordance with U.S.
generally accepted accounting principles, in particular the provisions of FASB’s
Accounting Standard Codification (ASC) 205-20, “Discontinued Operations,”
STAAR is accounting for the divestiture of Domilens as discontinued operations
in the first quarter of 2010.
As a
result of this accounting treatment, in all historical periods presented,
Domilens’ results of operations and cash flows, which formerly were consolidated
with those of STAAR and its other subsidiaries, are now segregated into a
separate line item as “discontinued operations,” and the consolidated results of
operations and cash flows of STAAR and its other subsidiaries have been adjusted
to exclude the results of Domilens. This presentation is intended to
better enable the reader to compare current results from continuing operations
of STAAR’s business ex-Domilens with the corresponding elements of the business
in historical periods.
STAAR
continues to sell products to Domilens GmbH – now an unaffiliated distributor –
for distribution in Germany and Austria. As a result, all sales made
by STAAR to Domilens after the completion of the divestiture pursuant to the
Distribution Agreement will be included in STAAR’s continuing
operations.
Principal
Products
Intraocular
lenses. We generate approximately half of our sales by
manufacturing and selling foldable IOLs. 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 manufactures 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. STAAR also markets internationally an
independently sourced acrylic IOL, which is supplied in a preloaded injector
using STAAR technology. Over the years, we have expanded our range of
IOLs to include the following:
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The
silicone Toric IOL, used in cataract surgery to treat preexisting
astigmatism. Astigmatism is a condition that causes blurred
vision due to the irregular shape of the cornea which prevents light from
focusing properly on the retina;
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The
Preloaded Injector, a three-piece silicone or acrylic IOL preloaded into a
single-use disposable injector;
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Aspheric IOLs,
available in silicone or Collamer, designed to provide a clearer image
than traditional spherical IOLs, by reducing spherical aberrations and
improving contrast sensitivity;
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The
nanoFLEX IOL, a single-piece Collamer aspheric IOL that can be implanted
through a 2.2 mm incision with the nanoPOINT injector
system.
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Because
most cataract patients are elderly, government agencies or government sponsored
entities generally pay the cost of IOLs in our major markets, including the
U.S. As a result, IOL revenues will likely remain relatively stable
even under adverse conditions in the general economy. However,
changes in reimbursement policy under these agencies and entities can adversely
affect our selling prices or reduce the volume of cataract
procedures.
Sales of
IOLs during the three months ended April 2, 2010 were $6.9 million compared to
$6.2 million for the same period in the prior year, representing approximately
50% and 51% of total net sales, respectively.
Implantable Collamer
lenses. Manufacturing and selling lenses used in refractive
surgery is an increasingly important source of sales for STAAR. We
have used our proprietary biocompatible Collamer material to develop and
manufacture implantable Collamer lenses, or ICLs. STAAR’s VISIAN ICL
and VISIAN Toric ICL, or TICL™, treat refractive disorders such as myopia
(near-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, under topical anesthesia. STAAR began
selling the Visian ICL outside the U.S. in 1996 and inside the U.S. in 2006.
STAAR began selling the Visian TICL outside the U.S. in 2002. These products are
marketed and sold in more than 45 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. STAAR is currently seeking
approval of the TICL in the U.S. and Japan.
Sales of
ICLs during the three months ended April 2, 2010 were $5.9 million compared to
$4.9 million for the same period in the prior year, representing approximately
42% and 40% of total net sales, respectively.
Other Surgical
Products. We also sell other instruments, devices, surgical
packs and equipment used in cataract or refractive surgery, which we either
manufacture or have manufactured for us. However, we began
deemphasizing these products in 2009 due to their lower overall gross profit
margins. We also make the AquaFlow Collagen Glaucoma Drainage Device,
an implantable device used for surgical treatment of glaucoma.
Sales of
other surgical products during the three months ended April 2, 2010 were $1.0
million compared to $1.1 million for the same period in the prior year,
representing approximately 8% and 9% of total net sales,
respectively.
Divestiture of German Distribution
Business. Until March 2, 2010, STAAR owned Domilens GmbH
(“Domilens”), 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 has distributed STAAR’s IOLs, ICLs and
Preloaded Injectors in Germany. On March 2, 2010, STAAR sold all of
its interests in Domilens through a management buyout led by funds managed by
Hamburg-based Small Cap Buyout Specialist BPE Unternehmensbeteiligungen
GmbH. STAAR and Domilens have entered into a Distribution Agreement
providing for the continued sale of STAAR products in Germany and
Austria.
Operations
STAAR has
significant operations both within and outside the U.S. Sales from activities
outside the U.S. accounted for 79% of our total sales in fiscal year 2009
(approximately 68% after divestiture of Domilens), and 71% of our total sales in
the first quarter of 2010 after divestiture of Domilens.
STAAR’s
principal business units and their operations are as follows:
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United
States. STAAR operates its global administrative headquarters
and a manufacturing facility in Monrovia, California. The
Monrovia manufacturing facility principally makes Collamer and silicone
IOLs and injector systems for IOLs and ICLs. STAAR also manufactures the
Collamer material in a facility in Aliso Viejo,
CA.
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Switzerland. STAAR
operates an administrative, manufacturing and distribution facility in
Nidau, Switzerland under its wholly owned subsidiary, STAAR Surgical AG.
The Nidau manufacturing facility makes all of STAAR’s ICLs and TICLs and
also manufactures the AquaFlow Device. STAAR Surgical AG handles
distribution and other administrative affairs for Europe and other
territories outside North America and
Japan.
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Japan. STAAR
operates administrative, manufacturing and distribution facilities in
Japan under its wholly owned subsidiary, STAAR Japan Inc. STAAR
Japan’s administrative and distribution facility is located in
Shin-Urayasu and its manufacturing facility is located in Ichikawa City.
All of STAAR’s preloaded injectors are manufactured at the Ichikawa City
facility. Following its approval by the Japanese Ministry of
Health, Labor and Welfare on February 2, 2010, STAAR Japan began marketing
and distributing the Visian ICL in
Japan.
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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.
On March
30, 2010, the President signed the Health Care and Education Reconciliation Act
of 2010, which is a reconciliation bill that amends the Patient Protection and
Affordable Care Act that was signed by the President on March 23, 2010
(collectively the "Acts"). The Acts have a number of provisions that may
affect medical device manufacturers. STAAR is currently assessing the
impact, if any, the Acts will have on its business.
Strategy/Key
Operational Metrics
STAAR’s
strategy is to be valued as a leading global provider of innovative intraocular
lens system technologies. STAAR will employ a focused
commercialization strategy to enable sustainable, profitable
growth.
STAAR’s
key operational metrics in 2010 are guided by two overriding strategic
goals: to generate a profit in 2010 and to lay the groundwork for
sustainable profitability into the future. In pursuit of these goals,
STAAR has aligned its principal business initiatives during 2010 along the
following five key operational metrics, which STAAR will also use to gauge its
progress during the year:
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Achievement
of double digit percentage growth in sales from core ICL and IOL products
as compared to the same quarter in the prior
year;
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Improvement
in gross profit margins to the mid-60% level for the
year;
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Progress
toward profitability throughout the year, with a goal of achieving net
income for the full year;
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Continued
generation of cash flow from operations;
and
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Improvement
in financial condition by retiring obligations and strengthening the
balance sheet.
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Double digit growth in sales from
core ICL and IOL products. To continue generating cash from
operations and reach profitability, STAAR must significantly improve sales
derived from its higher value products. The sale of Domilens, which has
significantly reduced the portion of STAAR’s sales derived from lower gross
profit margin sales such as third party products, disposables and surgical kits,
provides an opportunity for STAAR to focus on its core ICL and IOL
products.
STAAR
achieved approximately 20% growth in worldwide ICL sales during the first
quarter of 2010 compared to the first quarter of 2009 and 15% growth in
worldwide ICL sales during 2009 compared to 2008. STAAR believes that
it should be able to achieve growth at double digit levels throughout the year,
especially in light of expansion in the Japanese market following the February
2, 2010 approval of the ICL. However, the rate of growth in Visian
ICL sales will partly depend on continued improvement in worldwide economic
conditions. ICL surgery is a relatively expensive elective procedure
and is seldom reimbursed by insurers or government agencies. STAAR
believes that the global recession has reduced overall demand for refractive
surgery, and it has been reported that consumer spending and consumer confidence
has not returned to pre-recession levels.
STAAR
will continue to focus its ICL marketing efforts in the key territories where it
has established significant market share, based on the success of this strategy
in 2009. Japan will be added to the list in 2010; like other Asian
countries, Japan has a high mean rate of myopia, which makes it a promising new
market. The key territories in which STAAR will seek to enhance
Visian sales during 2010 are the U.S., Japan, Korea, China, India, Italy, Spain,
Germany, U.K., and France.
During
2009 STAAR experienced a breakthrough in market penetration in Korea, where it
believes implants of Visian products have exceeded 10% of the total volume of
refractive surgery procedures and revenues for the Visian ICL products increased
by 51% during the first quarter of 2010 as compared to the prior year first
quarter. STAAR is using Korea as a model of best practices for
marketing that may serve to significantly increase market share in other key
territories.
18
U.S.
military forces currently represent the largest group of customers for ICLs in
the U.S. Military purchases of ICLs accounted for most of STAAR’s
2.5% growth in 2009 U.S. ICL sales over 2008. STAAR does not believe
that private sector purchases of ICLs will resume growing significantly until
consumer confidence improves, which depends on continued recovery in the U.S.
economy. STAAR’s initiatives to increase its U.S. sales of ICLs are
discussed in greater detail under the heading “Other Highlights - U.S. ICL
Sales” below.
STAAR’s
global IOL sales increased by 10.8% in the first quarter of 2010 compared to the
first quarter of 2009. The increases in the first quarter were led by
growing sales of nanoFLEX and STAAR’s KS-X Acrylic Preloaded Injector in France
and by resumed growth in Preloaded Injector sales in Japan, where sales grew by
5% over the first quarter of 2009. While average IOL selling prices
generally remain higher in Japan than in most other countries, STAAR has
experienced more aggressive price competition than usual in that market
beginning in 2009.
STAAR’s
target of double digit growth in IOL sales for the remainder of 2010 will be
most challenged by the need for progress in the U.S. market, where STAAR has
seen its U.S. IOL sales volume decline for the last several
years. However, the rate of decline has recently decreased with and
STAAR’s introduction of aspheric IOLs with NTIOL status in 2008 and 2009 has
resulted in higher average selling prices for STAAR’s IOLs in the U.S., further
reducing erosion in sales. STAAR introduced three new products in the
U.S. in 2009 in pursuit of growth in its IOL market: the nanoFLEX IOL, the
nanoPOINT injection system, and the advanced Epiphany injector for STAAR’s
three-piece Collamer aspheric lens. These products did not have a
significant impact on sales within 2009 due to timing of introduction, but STAAR
believes they will have greater impact in 2010, especially the nanoFLEX™ IOL
which STAAR has experienced a 26% increase in global
sales. Preloaded IOL sales increased by 18% driven by the
launch of the KS-X Hydrophobic Acrylic Preloaded IOL in new
markets. STAAR believes its recent product introductions have given
the company a much more competitive IOL product line with unique features and
benefits, and offer an opportunity to regain lost IOL market
share. STAAR intends to support these products with sales and
marketing initiatives in 2010. Among these initiatives is the
“nanoFLEX Challenge,” a program that facilitates an interested surgeon’s
evaluation of the visual outcomes for patients receiving nanoFLEX IOLs compared
with the outcomes from any other IOL currently used by the surgeon.
STAAR
also seeks to obtain U.S. Food and Drug Administration (“FDA”) approval to sell
its silicone Preloaded Injectors in the U.S. during 2010. STAAR
believes this product will further enhance its U.S. IOL offering, and will help
STAAR maintain or increase its market share in the silicone IOL
segment. STAAR’s initiatives to increase its U.S. sales of IOLs are
discussed in greater detail under the heading “Other Highlights - U.S.
IOL Sales” below.
Improvement in gross profit margins
to the mid-60% level for the year. To achieve sustainable
profitability, STAAR must not only increase its revenues but also increase the
gross profit margin yielded by those revenues. STAAR’s gross profit
margin in the first quarter of 2010 was 64.1%. This represents a
substantial increase over profit margins previously reported on a consolidated
basis including Domilens, the sale of which removed some of the lowest gross
profit margin sales from STAAR’s product mix. These products are
presented in discontinued operations: third party products, supplies and
disposables like surgical drapes, and assembly of custom surgical kits; however
STAAR products sold to unaffiliated Domilens after the disposal will be included
in continuing operations but is expected to be insignificant in relation to
STAAR’s consolidated net sales. However, even when compared with
STAAR’s adjusted gross profit margins in the first quarter of 2009, STAAR
experienced a 110 basis point increase in the first quarter of
2010. This increase was due to a reduction in royalty expense
resulting from the November 2009 expiration of a patent related to collagen
copolymer lens material, which STAAR had licensed in 1996 from the Federov
Institution of Russia.
STAAR
will seek to further increase gross profit margin during 2010 through the
following:
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Increasing ICL sales as a
percentage of STAAR’s overall product mix. Visian ICLs
and TICLs generally yield an 80% gross profit margin. The
Visian product line is STAAR’s most profitable product family and the
largest contributor to enhanced gross profit margins. During
2010 we expect the launch of ICL sales in Japan, and expanding market
share in existing markets, to improve STAAR’s gross profit
margins. The sale of Domilens, whose products were
overwhelmingly in the cataract area and included many non-lens products,
has significantly increased the portion of our sales derived from the
Visian product line.
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Increasing Sales of Higher
Value IOLs in the U.S. In 2007 and 2008 STAAR began converting its
U.S. IOL product offering from lower value legacy products to newer
aspheric designs that are eligible for enhanced Centers for Medicare and
Medicaid Services (“CMS”) reimbursement as NTIOLs. With the
introduction of the nanoFLEX IOL in 2009, STAAR has introduced aspheric
versions for both of its IOL product platforms. As STAAR’s
customers switch to aspheric lenses, U.S. IOL gross profit margins have
increased. In addition, results for the past year marketing
efforts for the nanoFLEX lens suggest that this product has attracted new
customers to STAAR IOLs and may rebuild U.S. IOL market share, further
enhancing gross profit margins.
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Continuing to Implement
Centers of Excellence Program. STAAR believes that it
has an opportunity to reduce costs while continuing its history of
innovation by rationalizing its business among its worldwide operations
through its Centers of Excellence program. During 2009 STAAR
moved the production of silicone IOLs for use in Preloaded Injectors from
Japan to the U.S., centralizing all silicone lens production in the U.S.,
thereby reducing STAAR’s overall IOL costs. During 2010 STAAR
intends to complete the transfer of IOL and ICL injector system
manufacturing and R&D from the U.S. to Japan, which is expected to
lead to cost savings and a greater focus on STAAR Japan’s more advanced
lens injector designs. STAAR also intends to take further
efforts to improve silicone manufacturing efficiency in the U.S., based in
part on the efficiencies of scale made possible by centralized
manufacturing.
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Progress toward profitability
throughout the year, with a goal of achieving net income for the full
year. STAAR is reporting net income of $3.5 million or $0.10
per share in the first quarter of 2010, its first reported net income since
1999. These earnings result from the $4.1 million net gain recognized
by STAAR from the March 2, 2010 sale of Domilens, which is a non-recurring
event. However, while the net income reported for the first quarter
does not signify that STAAR has achieved sustainable net income from its
continuing operations, STAAR’s loss from continuing operations continues to
decline and STAAR has set a goal of achieving net income for the full
year.
STAAR
achieved operating income from continuing operations of $76,000 during the first
quarter of 2010, marking the first time since the third quarter of 2000 that it
generated operating income during a quarterly period. This follows
STAAR’s milestone of achieving positive cash flow from operating activities in
2009 after six consecutive negative years. Achieving the goal of net
income for the full year will require further reductions in STAAR’s expenses,
increase in sales and success in the initiatives to improve profitability
contained in our other 2010 objectives.
Continued generation of cash flow
from operations. STAAR achieved positive cash flow from
operating activities in 2009 including the Domilens subsidiary, and intends to
continue its initiatives to improve cash flow in 2010. STAAR used
cash in operating activities in the first quarter of 2010 and expects to
continue to use cash in operating activities due mainly to the $4.0 million
litigation settlement payment that is expected to be paid in the second quarter
of 2010. While this payment will negatively affect cash flow from
operating activities in the second quarter and possibly for the full year, the
negative effect will be more than offset by the return of the $7.4 million bond
which will be reflected as an inflow from investing activities. To be
successful, STAAR will need to offset the loss of the cash previously generated
by Domilens, which usually provided cash from operating activities on a
stand-alone basis and accounted for $1.8 million of STAAR’s cash from operations
in 2009.
The $1.4
million in cash used in operating activities in the first quarter included $0.6
million used in discontinued operations. Also reflected in cash used
in operating activities were $0.4 million of previously incurred transaction
costs related to the disposition of Domilens, $0.2 million in legal fees related
to the Moody case and
approximately $0.5 million in interest paid on the Senior Secured Promissory
Note during the quarter. In addition, the first quarter is typically STAAR’s
most challenging for cash because of accounting fees related to the annual audit
of our financial statements, professional fees for our consultant on internal
controls pursuant to the Sarbanes-Oxley Act of 2002, and holiday closures of
facilities during December that reduce the processing and payment of invoices by
STAAR during the last weeks of the fourth quarter, resulting in a significant
increase in cash payments by STAAR as it catches up during the first month of
the first quarter.
The
exceptional demands on STAAR’s cash experienced in the first quarter are not
expected to recur, and it is anticipated that following the March 30, 2010
settlement of the Parallax and Moody litigation STAAR’s
reduction in legal expense will largely offset the loss of cash previously
generated by Domilens. STAAR would have expected this to result in
resumption of positive cash provided by operations, but for the effect of the $4
million cash settlement payment to be made by STAAR in the second fiscal quarter
of 2010. This payment will be made from the $7.4 million in
restricted cash STAAR has on deposit with the California Superior Court for the
County of Orange, with the balance of $3.4 million returned to
STAAR. While this payment will negatively affect reported cash flow
for the second quarter and the full year, STAAR does not otherwise expect that
it will need to use cash to support operations for the remainder of the
year.
Improve financial condition by
retiring obligations and strengthening the balance sheet. Although the
net proceeds of approximately $11.8 million in cash raised from the sale of
Domilens significantly improved the cash position of STAAR, as discussed below
under “Liquidity and Capital
Resources,” STAAR has two significant financial obligations that mature
in 2010: repayment of the $5 million principal balance on the
Broadwood Note due on December 14, 2010; and the right of the holders of
1,700,000 shares of our Series A Redeemable, Convertible Preferred Stock (the
“Preferred Stock”) to redeem these shares at $4.00 per share, or $6.8 million in
cash in aggregate, which right by its terms would have matured on December 29,
2010.
STAAR’s
goal is to resolve all of its major obligations with existing capital reserves
and cash generated from operations. In keeping with this goal, STAAR
elected to call all of the outstanding shares of Preferred Stock by delivering a
Call Notice to the holders on April 23, 2010. The holders of the
Preferred Stock may, through May 17, 2010, convert all or some of their shares
to common stock on a one-to-one basis. Any remaining unconverted
shares of Preferred Stock will be purchased by STAAR in cash at a redemption
price of $4.00 per share on May 24, 2010, or on the soonest subsequent date when
the shares are tendered to STAAR. Because the market price of STAAR’s
common stock currently exceeds $4 per share, STAAR believes it is more likely
that the holders will elect to convert their shares rather than redeeming
them.
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STAAR
expects to be able to repay the Broadwood Note from working capital when it
matures, and STAAR also has the right to prepay the note without
penalty. The Broadwood Note currently bears interest at a rate of 7%
per annum.
STAAR
seeks to reserve any future capital raising efforts for initiatives to expand
its business, rather than meeting existing obligations. Nevertheless,
depending on STAAR’s cash position during the remainder of 2010, it may find it
necessary to seek additional financing. See “Liquidity and Capital
Resources” below.
Highlights
Divestiture
of Domilens
On March
2, 2010 we completed the divestiture of all of our interest in our former German
distribution subsidiary, Domilens GmbH through a management buyout led by funds
managed by Hamburg-based Small Cap Buyout Specialist BPE
Unternehmensbeteiligungen GmbH (“BPE”). STAAR’s financial advisor in
the transaction was Berenberg Bank, a German investment bank headquartered in
Hamburg.
STAAR
originally purchased Domilens in a series of stock purchases from the founder of
the business between 1998 and 2003. STAAR originally intended to use
Domilens as a channel for increased sales in the German
market. However, by 2009 sales of STAAR product accounted for only
approximately 7.6% of Domilens sales. The majority of Domilens sales
have been third party products, including IOLs of other manufacturers,
disposables and other supplies such as surgical drapes, and the assembly of
custom surgical kits containing a package of mostly third party products needed
for a single procedure. While profitable, this business operated at
gross profit margins that are significantly lower than STAAR’s overall
average.
A
distribution agreement between STAAR and Domilens provides that Domilens will
continue to purchase STAAR products at the unit sales volume previously
projected for 2010 through 2012. Because of the nature of the
Domilens business and the promise of continued distribution in Germany and
Austria at projected levels, STAAR determined that the sale of Domilens would
not impede its core business, and would permit management to focus on its higher
value core business of developing, manufacturing and selling its own advanced
ophthalmic products. STAAR also determined that the gross purchase price for
Domilens, at approximately 6.9 times Domilens’ earnings before income taxes,
represented a reasonable value for its investment in Domilens, and that these
funds were of greater use to STAAR as working capital.
The terms
and conditions of the sale of Domilens are set forth in a Stock Purchase
Agreement dated February 14, 2010 (the “Stock Purchase Agreement”), a copy
of which is filed with this report as Exhibit 2.1. The summary
description of the terms of the Stock Purchase Agreement included in the
following discussion is qualified in its entirety by the full text of the Stock
Purchase Agreement, which is incorporated herein by this reference.
The
Agreement provided for a gross Purchase Price (before Earn-Outs) of €10.5
million (approximately $14.3 million based on the foreign currency exchange rate
on the Closing Date). At closing on March 2, 2010, the gross purchase
price was adjusted for €0.8 million (approximately $1.1 million) in cash
dividends received by STAAR from Domilens, €26,000 (approximately $35,000)
related to certain expenses of compliance with the Sarbanes-Oxley Act of 2002,
and €100,000 (approximately $136,000) which was used to fund an escrow account
for the payment of unaccrued taxes which might be assessed in a tax examination
for periods prior to December 31, 2009. The balance of the escrow
account, after the resolution of such potential liabilities, if any, will be
distributed to STAAR, no later than December 31, 2011. After
deducting expenses of sale totaling approximately $1.2 million, including
estimated taxes of $46,000, the net cash proceeds from the transaction are
expected to be approximately $11.8 million. Approximately $227,000 of the
transaction expenses are expected to be paid in the second quarter of
2010.
Based on
the performance of Domilens in fiscal years 2010, 2011 and 2012, STAAR may earn
up to an additional €675,000 (approximately $920,000 at the closing date
exchange rate). These additional “earn-out” payments will be paid on
achievement of specified earnings before interest and tax (“EBIT”) as set forth
below. If a target is missed in any year, but in the following year
Domilens achieves the target and also makes up for the earlier shortfall, the
payments for both years will be earned and paid.
Fiscal Year
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Domilens EBIT
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Earn-Out Payment
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2010
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€2,500,000 (~ $3.4 million)
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€200,000 (~$273,000)
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2011
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€2,900,000 (~ $3.9 million)
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€225,000 (~$307,000)
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2012
|
€3,500,000 (~ $4.7 million)
|
€250,000 (~$340,000)
|
The
benefits expected to be achieved from the Domilens divestiture include the
following: approximately $11.8 million in net cash proceeds; greater focus on
STAAR’s core business; significantly enhanced gross profit margins; and a
contractual commitment to meet projected sales levels for STAAR products in
Germany and Austria through 2012.
21
The
earn-out payments will be earned only if Domilens significantly improves its
performance over levels it has historically been able to achieve. Domilens may
not be able to achieve these improvements. The escrow account will be
used to pay any additional unaccrued taxes that the German tax authorities may
assess after their next tax audit, which STAAR cannot predict and may leave
little or no funds in the escrow account remaining for distribution to
STAAR.
Call of Series A Redeemable,
Convertible Preferred Stock. On April 23, 2010, subsequent to
the end of the first fiscal quarter, STAAR issued a call notice to the holders
of its 1.7 million outstanding shares of Series A Convertible Preferred Stock
(the “Preferred Stock”), establishing May 24, 2010 as the redemption date
for the Preferred Stock. On the redemption date each share of
preferred stock shall be redeemed for $4.00 per share unless it has previously
been converted to common stock. The holders of the preferred stock may convert
their shares of Preferred Stock into common stock at a 1:1 ratio at any time
until the close of business on May 17, 2010. Because the value
of STAAR’s common stock currently exceeds $4 per share, STAAR believes it is
more likely that the holders of the Preferred Stock will convert their shares
rather than tendering them for redemption. Any remaining unconverted
shares of Preferred Stock will be purchased by STAAR at a redemption price of
$4.00 per share on May 24, 2010, or on the soonest subsequent date when the
shares are tendered to STAAR. If none of the shares of Preferred
Stock are converted, the aggregate purchase price payable by STAAR to redeem the
1.7 million shares would be $6.8 million.
U.S.
ICL Sales
We
consider ICL sales growth in the U.S. market to be important because of the size
of the U.S. refractive surgery market and the perceived worldwide leadership of
the U.S. in adopting innovative medical technologies. The Visian ICL was
approved by the FDA for treatment of myopia on December 22, 2005.
Visian
ICL sales in the U.S. grew by 7% during the first quarter of 2010 over the prior
year period, after growing 2.5% over the prior year in 2009. Most of
the U.S. growth in ICL sales has been in sales to the military, while most of
the private sector suffered similar declines to the overall refractive surgery
market in the U.S.
The ICL
has continued to benefit from positive media coverage during early
2010. For example, in February 2010, it was widely reported that
Steve Holcomb, who won a gold medal in 2010 Winter Olympics as pilot of the U.S.
four-man bobsled team, had been able to continue his successful athletic career
only because he had received ICLs to correct his severe myopia approximately two
years ago.
In
addition to poor conditions in the general economy and in particular the
refractive surgery market, other challenges to sustained growth in U.S. Visian
ICL sales include the following:
|
·
|
the
U.S. refractive surgery market has been dominated by corneal laser-based
techniques, which continue to be better known than the Visian ICL among
potential refractive patients;
|
|
·
|
other
newly introduced surgical products will continue to compete with the
Visian ICL for the attention of surgeons seeking to add new, high value
surgical products, in particular multifocal and accommodating
IOLs;
|
|
·
|
concerns
about medical complications and patient dissatisfaction following LASIK
could reduce interest in all refractive surgical procedures;
and
|
|
·
|
FDA
approval of the TICL, which STAAR sells in 45 international markets for
treating patients affected by both myopia and astigmatism, has not yet
been realized.
|
22
Concerns
about complications and levels of patient satisfaction following refractive
surgery first gained wide publicity in the U.S. following an April 25, 2008
public meeting on the subject conducted by the FDA Ophthalmic Devices
Panel. 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. On October 15,
2009, the FDA announced a three-phase collaborative study on the potential
impact of LASIK surgery on a patient’s quality of life, and also issued warning
letters to seventeen ambulatory surgery centers citing inadequate systems for
reporting adverse events resulting from LASIK. Concerns of patients
and doctors about the quality of refractive surgery outcomes may have played a
role in the reduced demand for laser surgery observed in 2008 and 2009, but
because the emergence of those concerns coincided with a severe economic
recession, it will be difficult to assess their impact until the general
consumer economy substantially recovers. Patient concerns about LASIK
could provide an opportunity for STAAR to differentiate the Visian ICL product
based on superior quality of vision, reduced risk of complications for many
patients eligible for either procedure, and the ability to remove the ICL if a
patient is dissatisfied with results. However, STAAR believes that
concerns about the safety and effectiveness of LASIK have likely decreased
patient interest in all refractive surgery, including the 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.
STAAR
makes the ICL available to selected surgeons only after completion of a training
program that includes proctoring of selected supervised surgeries. STAAR
believes that this carefully guided method of product release is essential to
help ensure the consistent quality of patient outcomes and the high levels of
patient satisfaction needed to establish wide acceptance of the ICL as a primary
choice for refractive surgery.
As the
U.S. market for ICLs has matured, STAAR has placed less emphasis on increasing
its overall physician customer base and devoted more attention to identifying
and supporting those practices that show potential for significant repeat
business through a professional commitment to the ICL technology.
In April
2010 STAAR introduced its nanoPOINT 2.0 injector system for the ICL, which
is capable of delivering the ICL through a 2.0 mm incision. The
reduced incision size decreases the chance of inducing astigmatism during lens
implantation surgery, and is also believed to reduce healing time and decrease
the risk of infection. Because the potential for infection is
reduced, STAAR believes the nanoPOINT 2.0 may encourage more surgeons to
consider implanting the ICL in an office-based procedure. Implanting
the ICL in an office surgical suite, rather than a hospital or surgery center,
makes the ICL more competitive with laser-based procedures in cost and
convenience. The nanoPOINT 2.0 design is based on the same
nanoPOINT injector used to deliver STAAR’s nanoFLEX single piece aspheric
Collamer lens.
U.S. IOL
Sales. For several years STAAR has experienced a decline in
U.S. market share of IOLs. The rate of decline has slowed as STAAR has begun
replacing older lens designs with higher priced NTIOL lenses. U.S. IOL sales
declined 5.3% in the first quarter of 2010 compared to the same quarter of 2009
due to decreased sales of lower priced silicone IOLs as long term pricing
agreements with customers expire. This decline was offset somewhat by
a 16% increase in average selling price and a 17% increase in nanoFLEX™ IOL
sales. U.S. IOL sales declined 8% in 2009 compared to the prior
year. Factors contributing to long-term decline in U.S. IOL sales
include STAAR’s relatively late introduction of advanced aspheric optics, the
decreasing market for silicone IOLs, and the popularity of hydrophobic acrylic
lenses in the U.S. market.
STAAR’s
strategy to achieve its gross profit margin target in its U.S. IOL business is
to rationalize its product offering around its higher value products, including
recently introduced products and products planned for introduction in the near
future. This has included aspheric optics across all IOL platforms, approval of
higher reimbursement from Medicare for these lenses, 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 or securing regulatory
approval.
STAAR’s
initiatives to enhance its IOL 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
grant of NTIOL status for the nanoFLEX aspheric single-piece Collamer IOL
and the aspheric three-piece silicone IOL in July
2008;
|
|
·
|
the
introduction of the nanoFLEX aspheric single-piece Collamer IOL in the
second quarter of 2009, which brings advanced aspheric optics to the
micro-incision nanoPOINT platform;
and
|
|
·
|
the
launch of the Epiphany injector for the Collamer three-piece lens in the
third quarter of 2009 which brings smoother and more controlled delivery
to one of STAAR’s most advanced lenses and paves the way for U.S.
introduction of the silicone preloaded
injector.
|
23
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 will grant NTIOL status to aspheric IOLs that can
demonstrate improved visual performance over conventional IOLs, allowing an
extra $50 reimbursement, per lens implanted, to an ASC (ambulatory surgical
center). This additional reimbursement expires on February 26, 2011 for all IOLs
in this class. Upon expiration of the NTIOL status, CMS may allow pass through
billing by the facility to the patient as they have for previous NTIOL
designations. Because the majority of IOL purchases in the U.S. are
implanted at ASCs and reimbursed through Medicare, NTIOL status significantly
increases STAAR’s potential margin on qualifying lenses.
All of
STAAR’s aspheric lenses sold in the U.S. 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 IOL
product offering more competitive:
|
·
|
Complete
the development of the Collamer Toric IOL to complement our pioneering
silicone Toric IOL and better compete with the Alcon acrylic Toric IOL.
The Collamer Toric IOL should provide a product with advanced optic
materials and rotational stability to provide superior outcomes for
cataract patients with astigmatism;
|
|
·
|
Gain
approval for a preloaded silicone IOL injector system in the U.S. in
2010;
|
|
·
|
Develop
a preloaded injector system for our Collamer
IOLs;
|
|
·
|
Initiate
a formal post-market clinical evaluation to support a possible submission
to the FDA of claims that the lens offers patients less spectacle
dependence or accommodation; and
|
|
·
|
Initiate
a clinical study of a new IOL we have designed to enhance the near and
intermediate visual results with
Collamer.
|
STAAR
cautions investors that the successful development and introduction of new
products is subject to risks and uncertainties, including the risk of unexpected
delays and, in some cases, approval of regulatory authorities.
STAAR’s development efforts aim to
realize the full market potential for Collamer IOLs by continuously improving
lens delivery systems and differentiating STAAR’s silicone IOL offering through
the Preloaded Injector. Approximately one-half of IOLs sold by STAAR in the U.S.
are made of silicone, which was the original material used for foldable IOLs.
Physician preferences in the U.S. have shifted to toward acrylic IOLs and
silicone IOLs now account for approximately 18% 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 glistening into
the visual field, the stiffness and toughness of the acrylic material makes
design of delivery systems less difficult. STAAR has completed a number of
development projects intended to make Collamer lenses easier to deliver and
broaden customer appeal. The nanoPOINT injector system, which delivers the
nanoFLEX single-piece Collamer IOL through a 2.2 mm incision, was the first of
these projects to reach market and was launched in April 2008. In addition the
launch of the Epiphany injector for the Collamer three-piece lens in the third
quarter of 2009 brings smoother and more controlled delivery to one of STAAR’s
most advanced lenses.
Over the
past several years surgeons implanting single piece Collamer IOLS (including the
current nanoFLEX IOL) have reported that their cataract patients have better
than expected near vision. In late 2008, STAAR organized the Collamer
Accommodating Study Team or “CAST.” The CAST consists of eight prominent
physicians across the U.S. who are implanting the recently introduced nanoFLEX
IOL and are checking both near and intermediate vision approximately one month
post operation. Feedback from the group indicates that the near vision achieved
is better than that of any conventional IOL where we have comparative data. The
feedback also indicates that the intermediate vision is better than “presbyopia
correcting” IOLs that have been studied and near vision approaches that of
presbyopia correcting IOLs that are already on the market.
While
introduction of the nanoFLEX lens did not result in increased U.S. IOL sales in
2009, STAAR believes that surgeon interest in the product is growing and that it
represents a significant opportunity to increase STAAR’s U.S. IOL market
share. To further pursue this opportunity, in the first quarter of
2010 STAAR initiated a program called the “nanoFLEX challenge” which is intended
to facilitate an interested surgeon’s evaluation of the visual outcomes for
patients receiving nanoFLEX IOLs compared with the outcomes from any other
standard IOL currently used by the surgeon.
24
The 2009
introduction of the Epiphany injector, an advanced system which makes delivery
of the three-piece Collamer aspheric IOL more reliable and predictable, has not
resulted in increased sales of this advanced lens. Based on surgeon feedback,
STAAR has developed an easier loading mechanism for this injector, which it
intends to introduce in the first half of 2010. STAAR believes that
this lens also has the potential to improve STAAR’s market share, particularly
among surgeons who prefer loop haptics to the plate haptic design of the
nanoFLEX. It plans concerted marketing efforts for the three-piece
Collamer aspheric lens once the improved Epiphany injector becomes
available.
While the
market share of silicone IOLs has been slowly declining overall, a significant
number of surgeons continue to select silicone lenses for their patients. Among
U.S. IOL sales, STAAR believes that its 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.
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, managing independent local sales representatives, and
competing with much larger companies. We cannot assure that this strategy will
ultimately be successful.
Medical Device Regulatory
Compliance, Clinical Oversight and TICL Approval. As discussed
above under the caption
“Business — Regulatory Matters,” STAAR’s ability to develop, manufacture
and distribute its products depends heavily on maintaining good standing with
the FDA and other regulatory agencies. Based, in part, on the results
of the FDA inspections of STAAR’s California facilities in 2009 and 2006 and
STAAR’s Nidau, Switzerland facility in 2009, 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.
Status of U.S. TICL Submission.
STAAR submitted a Pre-Market Approval Application (PMA) supplement
for the TICL to the FDA on April 28, 2006, which the agency has designated as a
panel-track supplement. Following a two-year process in which STAAR
addressed a number of agency concerns, on July 21, 2009, the FDA notified STAAR
that as a result of STAAR’s corrective actions the FDA had removed an integrity
hold on our application for approval of the TICL, and would resume its
consideration of the application. During August and September 2009,
the agency and STAAR resolved a number of questions related to the TICL
supplement in an interactive process. On February 3, 2010, STAAR
received a letter of deficiency from the FDA outlining additional questions and
requested labeling changes related to the TICL application. The letter
provides that STAAR has 180 days to present its response to the FDA; STAAR is
actively working on the preparation of the comprehensive response to the items
in this letter.
Status of Japan TICL Submission. On February, 2,
2010, Japan’s Ministry of Health, Labor and Welfare (MHLW) approved the sale of
the Visian ICL. STAAR submitted a partial change application for
approval of the Visian Toric ICL to the Pharmaceuticals and Medical Device
Agency (PMDA) on April 9, 2010. While STAAR may receive initial
comments within approximately two months of submission, MHLW generally requires
approximately one year to eighteen months to fully process a partial change
application. That timeline can change based on the nature of
the product under review.
New
Accounting and Other Pronouncements
On April
14, 2010, the FASB issued Accounting Standard Codification (ASC) update 2010-12
to ASC 740-10, “Income taxes”. On March 30, 2010, the President
signed the Health Care and Education Reconciliation Act of 2010, which is a
reconciliation bill that amends the Patient Protection and Affordable Care Act
that was signed by the President on March 23, 2010 (collectively the
"Acts"). Recently, questions have arisen about the effect, if any, that the
different signing dates might have on the accounting for these two Acts. This
timing difference, related solely to the signing dates, should not have an
impact on a majority of registrants because the Acts were both signed within a
relatively short time period, which for the vast majority of companies falls
into the same reporting period. After consultation with the FASB staff,
the Office of the Chief Accountant would not object to a view that the two Acts
should be considered together for accounting purposes. The Company is
currently assessing any impact these Acts will have on its consolidated
financial statements and will treat them as one for accounting purposes under
this assessment.
25
On April
16, 2010, the FASB issued ASC update 2010-13 to ASC Topic 718, “Stock
Compensation”. The objective of this update is to address the classification of
an employee share-based payment award with an exercise price denominated in the
currency of a market in which the underlying equity security trades. Topic
718 provides guidance on the classification of a share-based payment award as
either equity or a liability. A share-based payment award that contains a
condition that is not a market, performance, or service condition is required to
be classified as a liability. Under Topic 718, awards of equity share
options granted to an employee of an entity's foreign operation that provide a
fixed exercise price denominated in (1) the foreign operation's functional
currency or (2) the currency in which the employee's pay is denominated should
not be considered to contain a condition that is not a market, performance, or
service condition. However, U.S. generally accepted accounting principles (GAAP)
do not specify whether a share-based payment award with an exercise price
denominated in the currency of a market in which the underlying equity security
trades has a market, performance, or service condition. This update
provides amendments to Topic 718 to clarify that an employee share-based payment
award with an exercise price denominated in the currency of a market in which a
substantial portion of the entity's equity securities trades should not be
considered to contain a condition that is not a market, performance, or service
condition. Therefore, an entity would not classify such an award as a liability
if it otherwise qualifies as equity. The amendments in this update
are effective for fiscal years, and interim periods within those fiscal years,
beginning on or after December 15, 2010.
The
Company issues all its share-based awards to employees, domestic or foreign,
with an exercise price that is denominated in the U.S. Dollar, which is the same
currency that the underlying common stock of the Company trades
in. All awards have a service condition and are equity
classified. The adoption of this update, when effective in fiscal
year 2011 is not expected to have any impact to the Company’s consolidated
financial statements.
Internal
Revenue Service (“IRS”): “Announcement 2010-30) – Draft Schedule and
Instructions for Uncertain Tax Positions Proposal”
Earlier
this year the Internal Revenue Service announced that it would require certain
business taxpayers to report uncertain tax positions (“UTP”) on their returns
for taxable years beginning in 2010. In a recent Announcement 2010-30 (the
“Announcement”), the IRS issued a draft of the "Schedule UTP" that will be used
for that reporting.
The
reporting requirement applies to a taxpayer if the taxpayer has total assets of
$10 million and has adopted a position that is treated as an uncertain tax
position for financial accounting purposes. Based on the draft, the reporting
requirement applies only to U.S. corporations required to file form 1120 (for
U.S. corporations), 1120-L (for U.S. life insurance companies, including foreign
life insurance companies that elect to be taxed as U.S. companies) or 1120-F
(for foreign corporations required to file U.S. tax
returns). Positions taken by related entities are also
covered.
An
uncertain tax position is defined as a position for which the taxpayer has
recorded a reserve in an audited financial statement. Taxpayers must
also report certain positions for which a reserve has not been recorded because
of litigation or IRS administrative practice considerations. Based on
the IRS' previous announcements, it appears that a position for which a taxpayer
should have recorded a reserve, but did not do so, will not be
reportable. The form contains a section for current-year positions
and another one for prior-year positions. Thus, in effect, it is retroactive to
the date of the taxpayer's first recorded reserve for an uncertain tax
position.
Schedule
UTP will make the process of tax return preparation somewhat more burdensome. It
will make tax provision work for financial audit purposes much more burdensome,
as it will place additional pressure on the analysis of whether each tax
position is uncertain. While the government has not yet raised the issue, it
seems possible that a financial auditor who made an inappropriate decision about
whether a position should be reported as uncertain could be subject to sanctions
applicable to tax return preparers.
The IRS
will determine the timing of the requirement to file Schedule UTP for these
entities after comments have been received and considered. Comment
deadline is June 1, 2010. While the Company does not have any
reserves for uncertain tax positions as of April 2, 2010 and January 1, 2010, it
is still assessing the impact, if any, this Announcement will have on its
consolidated financial statements and tax returns.
Critical
Accounting Policies
Management's
Discussion and Analysis of Financial Condition and Results of Operations are
based on our unaudited Condensed Consolidated 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.
26
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 three months ended April 2, 2010 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 January
1, 2010.
27
Results
of Operations
The
following table shows the percentage of our total sales represented by the
specific items listed in our statements of operations for the periods indicated,
and the percentage by which these items increased or decreased over the prior
period. We have adjusted all prior periods presented to account for
the Domilens divestiture on March 2, 2010 and present Domilens as a discontinued
operation.
Percentage of Net Sales
|
Percentage Change
|
|||||||||||
April 2,
2010
|
April 3,
2009
|
2010
vs. 2009
|
||||||||||
Net
sales
|
100.0 | % | 100.0 | % | 13.3 | % | ||||||
Cost
of sales
|
35.9 | 37.0 | 9.9 | |||||||||
Gross
profit
|
64.1 | 63.0 | 15.3 | |||||||||
General
and administrative
|
24.6 | 35.2 | (20.8 | ) | ||||||||
Marketing
and selling
|
27.8 | 31.5 | 0.2 | |||||||||
Research
and development
|
11.1 | 11.6 | 8.6 | |||||||||
63.5 | 78.3 | (8.0 | ) | |||||||||
Operating
income (loss)
|
0.6 | (15.3 | ) | — | * | |||||||
Other
expense
|
(3.0 | ) | (2.0 | ) | 72.5 | |||||||
Loss
before provision for income taxes
|
(2.4 | ) | (17.3 | ) | (83.9 | ) | ||||||
Provision
for income taxes
|
2.2 | 1.0 | — | * | ||||||||
Loss
from continuing operations
|
(4.6 | ) | (18.3 | ) | (71.5 | ) | ||||||
Income
from discontinued operations, net of income taxes
|
30.2 | 4.7 | — | * | ||||||||
Net
income (loss)
|
25.6 | % | (13.6 | %) | — | * |
Net
sales
Net sales
for the first quarter of 2010 were $13.8 million, an increase of 13.3% compared
with $12.2 million for the same period of 2009. The change in net
sales was principally due to a 23% increase in international product sales,
partially offset by an approximate decrease of 4% in U.S. net
sales. Changes in currency had a $0.2 million favorable impact on net
sales for first quarter of 2010.
International
sales for the first quarter 2010 were $9.8 million, up 23% compared with $8.0
million reported in the same period of 2009. During the current
quarter, international Visian ICL sales grew to $4.4 million, a 25% increase
compared to the $3.5 million in sales reported in the prior year, due to a 22%
increase in volume and a 3% increase in average selling prices
(ASP). During the quarter the Company received approval for the
Visian ICL in Japan and began training surgeons for certification for
surgery.
International
IOL sales grew to $4.8 million, which is a 19% increase over sales of $4.1
million reported in the prior year, principally due to a 29% increase in units
sold partially offset by lower ASPs due to continued pricing pressures in
Japan.
U.S.
sales declined by 4% to $4.0 million from $4.2 million compared to the same
period in 2009 due to a 22% decline in other product sales and a 5% decline in
IOL sales, partially offset by an increase in Visian ICL sales. In
the U.S., which is still the largest refractive surgery market, Visian ICL sales
increased by 7% despite continued negative trends for the overall growth rate of
refractive procedures.
U.S. IOL
sales declined by 5.3% due to decreased sales of lower priced silicone IOLs as
long term pricing agreements with customers expire. This decline was
offset somewhat by a 16% increase in average selling prices resulting from a 17%
increase in nanoFLEX™ IOL sales.
28
Gross
profit margin
Gross
profit margin for the first quarter was $8.8 million, or 64.1% of revenue,
compared with $7.7 million, or 63.0% of revenue, in the prior year
period. The year-over-year increase is due to a decrease in royalty
expense resulting from the 2009 expiration of a patent licensed to
STAAR. Royalty expense in the first quarter of 2009 was $0.2
million. The increase in gross profit margin was partially offset by
the effect of a 17.5% increase in sales of preloaded IOLs in regions that yield
a lower gross profit margin and a 3% decrease in IOL average selling prices due
to price competition in the Japanese market.
General
and administrative
General
and administrative expenses for the quarter were $3.4 million, a decrease of 21%
when compared with $4.3 million reported last year due to decreased legal
expenses, lower insurance premiums and headcount reductions in
Japan.
Marketing
and selling
Marketing
and selling expenses were essentially flat compared to prior year despite the
13% growth in revenues.
Research
and development
Research
and development expenses increased slightly due to reclassification of certain
expenses in Japan from general and administrative to research and
development.
Other
expenses, net
Other
expenses, net, were $0.4 million compared with $0.2 million in the first quarter
of 2009 due primarily to a change in the stated interest rate in the second
quarter of 2009 on the Broadwood note from 7% to 20% as a result of the Parallax litigation
judgment. The settlement of all outstanding litigation on March 30,
2010 has resulted in a return of the interest rate to 7% beginning in the second
quarter of 2010.
Income
from discontinued operations, net of taxes
On March
2, 2010, the Company sold all of its interests in its German subsidiary,
Domilens. As a result of the transaction the Company recorded a net
gain on sale of $4.1 million in the first quarter of 2010; the Company also
recorded income from discontinued operations of $48,000 in the current quarter
compared to $567,000 in first quarter of 2009.
Liquidity
and Capital Resources
While
STAAR has recently made significant progress in generating operating income and
improving cash flow, it has a history of losses and negative cash flows on a
consolidated basis over the last several years, primarily as a result of losses
in the U.S. business. During this period STAAR has raised additional funds to
support operations through sales of equity and debt securities. As cash flow
improved in recent quarters, STAAR has sought to avoid further financings and to
operate exclusively on self-generated cash. This strategy was challenged in
2009, when cash reserves were drawn down to low levels, positive cash flow had
not yet been achieved, and STAAR suffered an adverse litigation judgment in the
amount of approximately $4.9 million in the case Parallax Medical System, Inc. v.
STAAR. On June 17, 2009, STAAR completed a registered public
offering (the “Offering”) with certain existing institutional investors, raising
a total of $8.5 million in cash by issuing 4.6 million shares of Company’s
common stock. The proceeds were primarily applied to posting a required $7.3
million deposit with the Superior Court of California, County of Orange, in
order to secure a stay on enforcement of the Parallax judgment during
STAAR’s then-pending appeal.
The
ability to avoid a subsequent short-term cash shortfall without selling
additional equity securities was a principal consideration in STAAR’s
divestiture of Domilens on March 2, 2010. Among the expected demands
on STAAR’s capital resources underlying this decision, the most pressing was the
$6.5 million verdict rendered in the Moody case, and the
potential need to post a $9.8 million appeal bond on or before April 30,
2010. The Domilens divestiture yielded a total of approximately $11.8
million in net cash proceeds to STAAR. The potential need to post an
appeal bond was, however, eliminated by the global settlement of the Parallax and Moody cases on March 30,
2010. STAAR’s $4 million contribution to the global settlement will
be paid from the $7.4 million (inclusive of interest) restricted deposit that
STAAR already had placed with the Court on June 22, 2009 in connection with
the Parallax
case. As a result, STAAR will be able to apply the entire $11.8
million in net cash proceeds from the Domilens sale to working capital and
repayment of the $5 million Broadwood note, along with approximately the $3.4
million residual amount that will be refunded to STAAR from the restricted
deposit.
29
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 provided by operating
activities, proceeds from the Domilens divestiture, sale of STAAR common stock,
and borrowings under the Company’s credit facilities. Any withdrawal
of support from its lenders could have adverse consequences on the Company’s
liquidity. In addition, if none of the shares of Preferred Stock are
converted, the aggregate purchase price payable by STAAR to redeem the 1.7
million shares would be $6.8 million, thus requiring further reduction in cash
available for working capital. 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.
STAAR’s
need for working capital, and the terms on which financing may be available,
will depend in part on its degree of success in achieving and maintaining
positive cash flow and earnings through the strategies described above under the
caption “Strategy.” STAAR cannot assure that such financing will be available on
acceptable terms, if at all, if the need arises.
Other
financing activity includes the December 14, 2007 borrowing by STAAR of $5
million from Broadwood Partners, L.P., at an interest rate of 7% per annum,
primarily to fund the acquisition of STAAR’s remaining interest in the Canon
Staar Joint Venture. On April 2, 2009, after preliminary judgment was entered in
the Parallax case, Broadwood and STAAR entered into a Temporary Waiver Agreement
with respect to any event of default that may occur, or may be deemed to have
occurred, under the Broadwood note as a result of the judgment. In consideration
of the Temporary Waiver Agreement, STAAR agreed to amend the Original Note to
grant to Broadwood a security interest in substantially all of STAAR’s assets to
secure STAAR’s obligations under the Original Note. To effectuate this grant of
a security interest, as of April 13, 2009, STAAR and Broadwood entered into an
Amended and Restated Senior Secured Promissory Note and Security Agreement. The
Temporary Waiver Agreement had provided that no such default was deemed to have
occurred until June 23, 2009, when a temporary stay of judgment
expired.
On June
24, 2009, following the posting of the deposit and satisfaction of conditions of
the Temporary Waiver, Broadwood and STAAR again amended the Note by replacing
the Temporary Waiver with a provision stating that because STAAR secured a stay
of enforcement of judgment until the completion of the appeal by posting the
required deposit with the Court, any default that may have otherwise resulted
from the Parallax judgment is cured. Broadwood remained entitled to receive
interest at the rate of 20% per annum beginning on June 23, 2009, as would have
been applicable in the event a default had occurred under the original terms of
the Note. Under the terms of the amended Note, the final resolution
of the Parallax
and Moody cases results
in the interest rate on the loan returning to the 7% pre-default
level. Such final resolution occurred on March 30, 2010.
The
Broadwood Note prohibits STAAR and its subsidiaries from disposing of any of its
assets without prior written consent of Broadwood. On February 23,
2010, Broadwood provided written consent to the sale of all of STAAR’s interests
in Domilens.
On
October 14, 2009, STAAR’s general liability insurer agreed to pay a portion of
the legal fees incurred by STAAR after July 1, 2009 for its defense of the Moody case. On
October 22, 2009 the insurer agreed to pay a portion of the legal fees incurred
by STAAR after July 1, 2009 for the appeal in the Parallax case. The
insurer’s agreement to defend these cases was subject to a full reservation of
its rights and defenses. STAAR received $780,000 in reimbursement
payments related to the Moody case in 2009, and
through the date of this report has received $548,000 in 2010. In
connection with the settlement of the case the insurer has agreed not to seek
recovery of any amounts it paid to defend the case. Prior to the
March 30, 2010 global settlement of the Parallax and Moody cases, the
availability of reimbursement for our legal fees from our insurance carrier,
along with the transition of the lawsuits from trial to appeal, began to reduce
our legal defense expenses significantly. In connection with the
global settlement, STAAR will voluntarily dismiss its appeals, and except for
minor post-settlement matters legal expenditures related to the cases will
cease.
Overview
of Changes in Cash and Cash Equivalents and Other Working Capital
Accounts.
As of
April 2, 2010 and January 1, 2010, the Company had $23.8 million and $13.7
million, respectively, of cash and cash equivalents and restricted
cash.
Net cash
used in operating activities was $1.4 million for the three months ended April
2, 2010, compared to $0.4 million for the three months ended April 3,
2009. This use of cash from operations in the current quarter
included the following: $0.6 million used in operating activities of
discontinued operations of the disposed Domilens subsidiary, payment of $0.4
million of Domilens transaction related costs and approximately $0.5 million
interest paid for the Broadwood note.
30
Net cash
provided by investing activities was $11.8 million for the three months ended
April 2, 2010, compared to net cash used of $0.1 million for the three months
ended April 3, 2009. The sale of Domilens yielded the Company net
cash proceeds of approximately $11.8 million in the first quarter of 2010 offset
by approximately $0.1 million in cash payments made to purchase property, plant
and equipment and this amount was relatively unchanged from the amount paid in
the first quarter of 2009. STAAR also incurred approximately $0.3
million in direct transaction related costs during the current quarter which
were included in accounts payable as of April 2, 2010 and will be offset against
net proceeds of the sale in the second quarter of 2010 when they are expected to
be paid.
Net cash
used in financing activities was $0.3 million for the three months ended April
2, 2010 and April 3, 2009 wholly due to repayment of capital lease lines of
credit and cash used in financing activities of discontinued
operations.
Credit
Facilities, Contractual Obligations and Commitments
Credit
Facilities
As
detailed below, the Company has credit facilities with different lenders to
support operations in the U.S. and Japan.
Broadwood
Promissory Note
The
Company has $5 million principal amount of indebtedness under an Amended and
Restated Senior Secured Promissory Note (the “Note”) held by Broadwood Partners,
L.P. (“Broadwood.”), which was issued on April 13, 2009 and matures on December
14, 2010. STAAR’s obligations under the Note are secured by
substantially all of STAAR’s assets pursuant to a Security Agreement with
Broadwood also dated April 13, 2009. The Note evidences indebtedness
that STAAR originally incurred on December 14, 2007 under a Senior Promissory
Note.
The Note
bears interest at an annual rate of 7%, which increases to 20% in the event of a
default. Among the events of default under the Note is a judgment
against the Company in excess of $500,000 that “shall remain
unpaid.” Under a Temporary Waiver Agreement dated April 2, 2009, and
amended on June 24, 2009, the Company cured any default that may be deemed to
have occurred as a result of the $4.9 million Parallax judgment when it
secured a stay on enforcement of the judgment, while appeal was pending, by
placing a $7.3 million deposit with the court. However, the Company
agreed that the Note would bear interest at the default rate of 20% until the
Company satisfied the Parallax judgment and
resolved all other material litigation that was pending on June 24,
2009. On March 30, 2010, the Company entered into a Stipulation for
Settlement that satisfied the judgment and also resolved the Moody case, the only other
material litigation that was pending on June 24, 2009, which caused the annual
rate of interest on the Note to return to 7%.
The Note
may be pre-paid by the Company at any time without penalty, with prior notice,
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 publicly available information, as of June 23,
2009, Broadwood beneficially owned 6,028,638 shares of the Company’s common
stock comprising approximately 17.4% of the Company’s issued and outstanding
common stock.
As
additional consideration for the loan, the Company issued a warrant to purchase
700,000 shares of the Company’s Common Stock on December 14, 2007, and a warrant
to purchase an additional 700,000 shares on June 1, 2009. The
purchase price for all shares under both warrants is $4.00 per share, and each
warrant is exercisable for a period of six years from the date of
issue.
The
Warrant Agreement covering the initial December 14, 2007 warrant (the “December
2007 Warrant Agreement”) required the Company to register the 1,700,000 shares
of Common Stock issuable upon exercise of the warrants for resale under the
Securities Act of 1933, as amended. The Company filed and secured
effectiveness of a registration statement covering resale of the
shares. If the Company fails to keep the registration statement
effective and the lapse exceeds permitted suspensions, as the holder’s sole
remedy, the Company will be obligated to issue an additional 30,000 warrants for
each month that the Company does not meet this effectiveness requirement through
the term of the warrants (“Penalty Warrants”) (a maximum of approximately
1,860,000 warrants issuable as of April 2, 2010 under an assumed noncompliance
as of that date). The Company does not consider the issuance of
Penalty Warrants likely.
31
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 ASC 840-10-25, purchases under this facility
are accounted for as capital leases and generally have a thirty-month to
three-year term. Title to all assets under the Farnam leases remains with
Farnam. 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-upon fair value. If the Company does not choose to
purchase the asset under lease, it may rent the assets on a month-to-month basis
or return them to Farnam. The Company must provide a 120-day notice
prior to termination of its intent to purchase or return the
assets. On April 1, 2010, Schedule I, of IV Farnam lease schedules,
matured and on April 26, 2010, the Company entered into a new lease agreement
(Schedule V) and, after making contractual monthly payments thereon, Farnam will
transfer title to the assets under the previous Schedule I lease to the Company
at termination and provide the Company up to $250,000 of availability for new
equipment financing. Schedule V term will not commence until the
Company draws on the full $250,000 for new asset purchases (“Commencement Date”)
and will terminate twenty-four months after the Commencement Date, assuming all
payments are made timely; the monthly payments will include both the previous
assets under Schedule I and the new assets financed under Schedule
V. As of April 2, 2010, total remaining capital lease obligations
under the Farnam leases for Schedules II-IV was $293,000 scheduled to terminate
in August 2010, December 2010 and August 2011.
Line
of Credit
The
Company’s Japanese subsidiary, STAAR Japan, has an agreement, as amended on June
30, 2009, with Mizuho Bank which provides for borrowings of up to 300,000,000
Yen (approximately $3.2 million based on the rate of exchange on April 2, 2010),
at an interest rate equal to the Tokyo short-term prime interest rate
(approximately 1.475% as of April 2, 2010) plus 1.125% and may be renewed
annually (the current line expires on April 2, 2011). The credit
facility is not collateralized. The Company had 200,000,000 Yen
outstanding on the line of credit as of April 2, 2010 and January 1, 2010,
(approximately $2.1 million and $2.2 million based on the foreign exchange rates
on April 2, 2010 and January 1, 2010) and approximates fair value due to the
short-term maturity and market interest rates of the line of
credit. In case of default, the interest rate will be increased to
14% per annum.
Covenant
Compliance
The Company is in compliance with the
covenants of its credit facilities as of the date of this
report.
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.
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.
On April 23, 2010, STAAR issued a call
notice to the holders of its 1,700,000 outstanding shares of Preferred Stock
establishing May 24, 2010 as the redemption date for the Preferred
Stock. On the redemption date each share of preferred stock shall be
redeemed for $4.00 per share unless it has previously been converted to STAAR’s
common stock. The holders of the preferred stock may convert their shares of
Preferred Stock into common stock at the one-to-one ratio at any time until the
close of business on May 17, 2010. Any remaining unconverted
shares of Preferred Stock will be purchased by STAAR at a redemption price of
$4.00 per share on May 24, 2010, or on the soonest subsequent date when the
shares are tendered to STAAR. If none of the shares of Preferred
Stock are converted, the aggregate purchase price payable by STAAR to redeem the
1,700,000 shares would be $6.8 million.
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.
32
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 January 1,
2010.
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-15(e)) are effective. For purposes of Rule
13a-15(e), the term “disclosure controls and procedures” means controls and
other procedures of an issuer that are designed to ensure that information
required to be disclosed by the issuer in the reports that it files or submits
under the Act (15 U.S.C. 78a et seq.) is recorded, processed, summarized and
reported, within the time periods specified in the Commission’s rules and forms.
Disclosure controls and procedures include, without limitation, controls and
procedures designed to ensure that information required to be disclosed by an
issuer in the reports that it files or submits under the Act is accumulated and
communicated to the issuer’s management, including its principal executive and
principal financial officers, or persons performing similar functions, as
appropriate to allow timely decisions regarding required
disclosure.
Our
management, including the CEO and the CFO, do not expect that our disclosure
controls and procedures or our internal control over financial reporting will
necessarily prevent all fraud or material errors. An internal control system, no
matter how well conceived and operated, can provide only reasonable, not
absolute, assurance that the objectives of the control system are met. Further,
the design of a control system must reflect the fact that there are resource
constraints, and the benefits of controls must be considered relative to their
costs. Because of the inherent limitations on all internal control systems, our
internal control system can provide only reasonable assurance of achieving its
objectives and no evaluation of controls can provide absolute assurance that all
control issues and instances of fraud, if any, within our Company have been
detected. These inherent limitations include the realities that judgments in
decision-making can be faulty, and that breakdowns can occur because of simple
error or mistake. Additionally, controls can be circumvented by the individual
acts of some persons, by collusion of two or more people, or by management
override of the control. The design of any system of internal control is also
based in part upon certain assumptions about the likelihood of future events,
and can provide only reasonable, not absolute, assurance that any design will
succeed in achieving its stated goals under all potential future conditions.
Over time, controls may become inadequate because of changes in circumstances,
or the degree of compliance with the policies and procedures may
deteriorate.
Internal
Control over Financial Reporting
There
were no changes in our internal control over financial reporting during the
quarter ended April 2, 2010 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial
reporting.
PART
II – OTHER INFORMATION
ITEM
1.
|
LEGAL
PROCEEDINGS
|
Litigation and Claims
Two
lawsuits against STAAR,
Parallax Medical Systems, Inc. v. STAAR Surgical Company (California
Superior Court, County of Orange, Case No. 07CC10136) and Scott C. Moody, Inc. v. STAAR
Surgical Company; (California Superior Court, County of Orange, Case No.
07CC10132) were settled on March 30, 2010. On that date STAAR and all
other parties to the matters entered into a Stipulation for Settlement that
globally resolved all pending disputes among them. This settlement
satisfies in full the $4.9 million judgment against STAAR in the Parallax matter
and the $6.5 million judgment against STAAR in the Moody matter.
In
exchange for complete mutual releases, STAAR will pay $4 million as its
contribution to the global settlement. STAAR’s contribution will be
paid from the $7.4 million restricted deposit that STAAR placed with the Court
on June 22, 2009. The balance of those funds, approximately $3.4
million, will be returned to STAAR. In connection with the
settlement, STAAR will voluntarily dismiss its appeals in both
cases. The cases are described in greater detail
below.
33
The
Parallax Case.
The
California Superior Court, County of Orange, rendered final judgment in the Parallax case on May 11,
2009, in accordance with a March 2, 2009 jury verdict finding that STAAR was
liable for approximately $2.2 million in actual damages and $2.7 million in
punitive damages to Parallax Medical Systems, Inc. for intentional and negligent
interference with prospective business advantage. Parallax is a
former independent regional manufacturer’s representative (“RMR”) of
STAAR. Parallax promoted sales of STAAR products in the southeastern
region of the U.S. under a contract that expired on July 31,
2007. The jury found that STAAR had interfered with Parallax’s
prospective economic advantage when it informed a regional IOL distributor that
Parallax had a covenant restricting the sale of competing products. With
trial-related costs of approximately $56,000 awarded to Parallax and
pre-judgment interest, the total judgment was for $4,966,000.
On
October 22, 2009, STAAR’s general liability insurer agreed to pay a portion of
the legal fees incurred by STAAR after July 1, 2009 for the appeal in the Parallax
case. The insurer’s agreement to defend was subject to a full
reservation of its rights and defenses, but in connection with the settlement of
the case the insurer has agreed not to seek recovery of any amounts it paid to
defend the case.
STAAR
filed notice of appeal of the
Parallax judgment, and on June 22, 2009, deposited $7.3 million into a
restricted account with the Court to assure payment of the judgment, thereby
staying any enforcement of the judgment pending the appeal. The
deposit account bears interest, and as of the date of this Report the account
balance is approximately $7.4 million. STAAR filed its appellate
Opening Brief on January 22, 2010. Pursuant to the March 30, 2010
global settlement of the
Parallax and
Moody matters STAAR will voluntarily dismiss its appeal of the Parallax judgment; $4
million of the funds deposited with the Court will be disbursed as directed by
counsel for the
Parallax and
Moody plaintiffs. The balance of approximately $3.4 million
will be refunded to STAAR.
The
Moody Case
The
California Superior Court, County of Orange, rendered judgment in the Moody case against STAAR on
December 8, 2009 in accordance with a December 1, 2009 jury verdict finding that
STAAR was liable for $4 million in actual damages and $2.5 million in punitive
damages to Scott C. Moody, Inc. (“SMI”) for intentional and negligent
interference with prospective business advantage. SMI, also a former
RMR of STAAR, filed a complaint against STAAR on the same day that Parallax filed its
complaint. SMI promoted sales of STAAR products in the southwestern
region of the U.S., under a contract that, like Parallax’s, expired on July 31,
2007. The jury found that STAAR had interfered with SMI’s prospective
economic advantage when it informed a regional IOL distributor that SMI had a
covenant restricting the sale of competing products. Notice of
judgment on post-trial motions in the case was served on February 8,
2010. In post-trial motions the court awarded the plaintiff
approximately $150,000 in costs, legal fees and other assessments, which STAAR
has already paid separately from the funds to be contributed to the March 30,
2010 global settlement.
On
October 14, 2009, STAAR’s general liability insurer agreed to pay a portion of
the legal fees incurred by STAAR after July 1, 2009 for its defense of the Moody case. The
insurer’s agreement to defend was subject to a full reservation of its rights
and defenses, but in connection with the settlement of the case the insurer has
agreed not to seek recovery of any amounts it paid to defend the
case.
On
January 29, 2010, attorneys representing STAAR and SMI signed a stipulation
extending the date for potential enforcement and execution of the $6.5
million Moody judgment
to April 30, 2010. The purpose of the extension was to allow the
parties involved, including certain insurers, to attempt to negotiate a global
settlement, along with the
Parallax matter, in a mediation that took place on March 29-30, 2010, and
to avoid the necessity of STAAR posting an appeal bond during the term of the
stipulation.
STAAR
filed notice of its appeal of the Moody judgment on March 8,
2010. Pursuant to the March 30, 2010 global settlement of the Parallax and Moody matters STAAR will
voluntarily dismiss its appeal of the Moody judgment.
From time
to time the Company is subject to various claims and legal proceedings arising
out of the normal course of our 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.
RISK
FACTORS
|
There
have been no material changes to the risk factors disclosed in Item 1A of Part 1
of our Annual Report on Form 10-K for the fiscal year ended January 1,
2010.
34
ITEM
6.
|
EXHIBITS
|
Exhibits
2.1
|
Share
Purchase Agreement between STAAR Surgical AG and Domilens Akquisitions
GmbH, dated February 24, 2010 (*) (**)
|
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, as amended, 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.(*)
|
32.1
|
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 Current Report on Form 8-K filed with the
Commission on January 8, 2009.
|
(*)
|
Filed
herewith.
|
(**)
|
Certain
schedules and attachments have been omitted pursuant to Rule 601(b)(2) of
Regulation S-K. The Company agrees to furnish supplementally a copy of any
omitted schedule or attachment to the Commission upon request.
|
35
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: May 12, 2010
|
By:
|
/s/ DEBORAH ANDREWS
|
|
Deborah Andrews
|
|||
Chief Financial Officer
|
|||
(on behalf of the Registrant and as its
|
|||
principal financial officer)
|
36