STAAR SURGICAL CO - Quarter Report: 2010 July (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C.
20549
Form 10-Q
(Mark
One)
þ
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the quarterly period ended: July 2, 2010
Or
o
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the transition period from
to
Commission
file number: 0-11634
STAAR
SURGICAL COMPANY
(Exact
name of registrant as specified in its charter)
Delaware
|
95-3797439
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
|
(I.R.S.
Employer
Identification
No.)
|
1911
Walker Avenue
Monrovia,
California 91016
(Address
of principal executive offices)
(626) 303-7902
(Registrant’s
telephone number, including area code))
Indicate
by check mark whether the registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days. Yes þ
No o
Indicate
by check mark whether the Registrant 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 34,945,127 shares of common stock, par value $0.01 per share,
issued and outstanding as of August 10, 2010.
STAAR
SURGICAL COMPANY
INDEX
PAGE
|
|||
NUMBER
|
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PART
I – FINANCIAL INFORMATION
|
|||
Item
1.
|
Financial
Statements (Unaudited).
|
||
Condensed
Consolidated Balance Sheets – July 2, 2010 and January
1, 2010.
|
1
|
||
Condensed
Consolidated Statements of Operations – Three and Six Months Ended July 2,
2010 and July 3, 2009.
|
2
|
||
Condensed
Consolidated Statements of Cash Flows – Six Months Ended July 2, 2010 and
July 3, 2009.
|
3
|
||
Notes
to the Condensed Consolidated Financial Statements.
|
4
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations.
|
16
|
|
Item
3.
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Quantitative
and Qualitative Disclosures About Market Risk.
|
31
|
|
Item
4.
|
Controls
and Procedures.
|
31
|
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PART
II – OTHER INFORMATION
|
|||
Item
1.
|
Legal
Proceedings.
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32
|
|
Item
1A.
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Risk
Factors.
|
32
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Item
6.
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Exhibits.
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33
|
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Signatures
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34
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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)
July 2,
2010
|
January 1,
2010
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 7,896 | $ | 6,330 | ||||
Restricted
cash
|
136 | 7,396 | ||||||
Accounts
receivable trade, net
|
6,816 | 9,269 | ||||||
Inventories
|
10,916 | 14,820 | ||||||
Prepaids,
deposits and other current assets
|
1,816 | 2,591 | ||||||
Total
current assets
|
27,580 | 40,406 | ||||||
Property,
plant and equipment, net
|
3,318 | 5,005 | ||||||
Intangible
assets, net
|
3,890 | 4,148 | ||||||
Goodwill
|
1,474 | 7,879 | ||||||
Other
assets
|
1,276 | 1,243 | ||||||
Total
assets
|
$ | 37,538 | $ | 58,681 | ||||
LIABILITIES,
REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’
EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 3,013 | $ | 7,416 | ||||
Line
of credit
|
2,280 | 2,160 | ||||||
Deferred
income taxes
|
360 | 360 | ||||||
Obligations
under capital leases
|
444 | 795 | ||||||
Note
payable, net of discount
|
— | 4,503 | ||||||
Accrued
legal judgments
|
— | 4,000 | ||||||
Other
current liabilities
|
6,196 | 7,706 | ||||||
Total
current liabilities
|
12,293 | 26,940 | ||||||
Obligations
under capital leases
|
687 | 1,098 | ||||||
Deferred
income taxes
|
218 | 653 | ||||||
Pension
obligations
|
2,240 | 2,035 | ||||||
Other
long-term liabilities
|
238 | 101 | ||||||
Total
liabilities
|
15,676 | 30,827 | ||||||
Commitments
and contingencies (Note 13)
|
||||||||
Series
A redeemable convertible preferred stock, $0.01 par value; 10,000 shares
authorized; none and 1,700 shares issued and outstanding at July 2, 2010
and January 1, 2010, respectively. Liquidation value
$6,800.
|
— | 6,784 | ||||||
Stockholders’
equity:
|
||||||||
Common
stock, $0.01 par value; 60,000 shares authorized; issued and outstanding
34,806 at July 2, 2010 and 34,747 at January 1, 2010
|
348 | 348 | ||||||
Additional
paid-in capital
|
150,375 | 149,559 | ||||||
Accumulated
other comprehensive income
|
1,328 | 3,254 | ||||||
Accumulated
deficit
|
(130,189 | ) | (132,091 | ) | ||||
Total
stockholders’ equity
|
21,862 | 21,070 | ||||||
Total
liabilities, redeemable convertible preferred stock and stockholders’
equity
|
$ | 37,538 | $ | 58,681 |
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
|
Six Months Ended
|
|||||||||||||||
July 2,
2010
|
July 3,
2009
|
July 2,
2010
|
July 3,
2009
|
|||||||||||||
Net
sales
|
$ | 13,639 | $ | 13,158 | $ | 27,417 | $ | 25,316 | ||||||||
Cost
of sales
|
4,960 | 5,187 | 9,909 | 9,690 | ||||||||||||
Gross
profit
|
8,679 | 7,971 | 17,508 | 15,626 | ||||||||||||
General
and administrative
|
3,268 | 3,820 | 6,657 | 8,101 | ||||||||||||
Marketing
and selling
|
4,134 | 3,727 | 7,965 | 7,552 | ||||||||||||
Research
and development
|
1,376 | 1,441 | 2,909 | 2,853 | ||||||||||||
Other
operating expense
|
700 | — | 700 | — | ||||||||||||
Operating
loss
|
(799 | ) | (1,017 | ) | (723 | ) | (2,880 | ) | ||||||||
Other
income (expense):
|
||||||||||||||||
Interest
income
|
13 | 4 | 14 | 7 | ||||||||||||
Interest
expense
|
(224 | ) | (396 | ) | (630 | ) | (626 | ) | ||||||||
Gain
(loss) on foreign currency transactions
|
(389 | ) | 214 | (439 | ) | 146 | ||||||||||
Loss
on early extinguishment of note payable
|
(267 | ) | — | (267 | ) | — | ||||||||||
Other
income (expense), net
|
(53 | ) | 104 | (12 | ) | 159 | ||||||||||
Other
expense, net
|
(920 | ) | (74 | ) | (1,334 | ) | (314 | ) | ||||||||
Loss
before provision (benefit) for income taxes
|
(1,719 | ) | (1,091 | ) | (2,057 | ) | (3,194 | ) | ||||||||
Provision
(benefit) for income taxes
|
(91 | ) | 278 | 207 | 404 | |||||||||||
Loss
from continuing operations
|
(1,628 | ) | (1,369 | ) | (2,264 | ) | (3,598 | ) | ||||||||
Income
from discontinued operations, net of income taxes
|
— | 281 | 4,166 | 848 | ||||||||||||
Net
income (loss)
|
$ | (1,628 | ) | $ | (1,088 | ) | $ | 1,902 | $ | (2,750 | ) | |||||
Loss
per share from continuing operations – basic and diluted
|
$ | (0.05 | ) | $ | (0.04 | ) | $ | (0.07 | ) | $ | (0.12 | ) | ||||
Income
per share from discontinued operations – basic and diluted
|
$ | — | $ | 0.01 | $ | 0.12 | $ | 0.03 | ||||||||
Net
income (loss) per share
|
$ | (0.05 | ) | (0.04 | ) | $ | 0.05 | $ | (0.09 | ) | ||||||
Weighted
average shares outstanding – basic and diluted
|
34,790 | 30,911 | 34,770 | 30,276 |
See
accompanying notes to the condensed consolidated financial
statements.
2
STAAR
SURGICAL COMPANY
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
(Unaudited)
Six Months Ended
|
||||||||
July 2,
2010
|
July 3,
2009
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
income (loss)
|
$ | 1,902 | $ | (2,750 | ) | |||
Adjustments
to reconcile net income (loss) to net cash used in operating
activities:
|
||||||||
Income
from discontinued operations
|
(4,166 | ) | (848 | ) | ||||
Depreciation
of property and equipment
|
821 | 1,003 | ||||||
Amortization
of intangibles
|
399 | 390 | ||||||
Amortization
of discount
|
236 | 152 | ||||||
Loss
on early extinguishment of note payable
|
267 | — | ||||||
Fair
value adjustment of warrant
|
137 | 8 | ||||||
Loss
on disposal of property and equipment
|
2 | 37 | ||||||
Change
in net pension liability
|
157 | 106 | ||||||
Stock-based
compensation expense
|
649 | 884 | ||||||
Other
|
112 | 112 | ||||||
Changes
in working capital:
|
||||||||
Accounts
receivable
|
1,040 | (372 | ) | |||||
Inventories
|
777 | 765 | ||||||
Prepaids,
deposits and other current assets
|
272 | 546 | ||||||
Accounts
payable
|
(1,731 | ) | (464 | ) | ||||
Other
current liabilities
|
(5,338 | ) | (115 | ) | ||||
Net
cash provided by (used in) operating activities of discontinued
operations
|
(635 | ) | 384 | |||||
Net
cash used in operating activities
|
(5,099 | ) | (162 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Proceeds
from sale of subsidiary, net of transaction costs
|
11,824 | — | ||||||
Decrease
(increase) in restricted cash
|
7,337 | (7,341 | ) | |||||
Deposit
to restricted escrow account
|
(136 | ) | — | |||||
Acquisition
of property and equipment
|
(202 | ) | (232 | ) | ||||
Proceeds
from sale of property and equipment
|
— | 18 | ||||||
Net
change in other assets
|
5 | 5 | ||||||
Net
cash provided by (used in) investing activities of discontinued
operations
|
(50 | ) | 39 | |||||
Net
cash provided by (used in) investing activities
|
18,778 | (7,511 | ) | |||||
Cash
flows from financing activities:
|
||||||||
Repayment
of notes payable
|
(5,000 | ) | — | |||||
Redemption
of Series A preferred stock
|
(6,800 | ) | — | |||||
Net
proceeds from public sale of equity securities
|
— | 8,548 | ||||||
Repayment
of capital lease obligations
|
(495 | ) | (502 | ) | ||||
Borrowings
under line of credit
|
— | 630 | ||||||
Proceeds
from exercise of stock options
|
140 | — | ||||||
Net
cash used in financing activities of discontinued
operations
|
(50 | ) | (57 | ) | ||||
Net
cash provided by (used in) financing activities
|
(12,205 | ) | 8,619 | |||||
Effect
of exchange rate changes on cash and cash equivalents
|
92 | (184 | ) | |||||
Increase
in cash and cash equivalents
|
1,566 | 762 | ||||||
Cash
and cash equivalents, at beginning of the period
|
6,330 | 4,992 | ||||||
Cash
and cash equivalents, at end of the period
|
$ | 7,896 | $ | 5,754 |
See
accompanying notes to the condensed consolidated financial
statements.
3
Note
1 — Basis of Presentation and Significant Accounting Policies
The
condensed consolidated balance sheet as of January 1, 2010 included in this
report, which has been derived from audited consolidated financial statements,
and the accompanying unaudited interim condensed consolidated financial
statements, have been prepared in accordance with accounting principles
generally accepted in the United States for interim financial information and
with the instructions to Form 10-Q and Article 10 of Regulation S-X of the
Securities Exchange Commission. Accordingly, they do not include all
the information and footnotes required by accounting principles generally
accepted in the U.S. for complete financial statements. The condensed
consolidated financial statements for the three and six months ended July 2,
2010 and July 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 and six months ended July 2, 2010 and July
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 and, accordingly, 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
28, 2010, the FASB issued Accounting Standard Codification (ASC) update 2010-17
to topic 605, “Revenue Recognition – Milestone Method.” The objective
of this Update is to provide guidance on defining a milestone and determining
when it may be appropriate to apply the milestone method of revenue recognition
for research or development transactions. Research or development arrangements
frequently include payment provisions whereby a portion or all of the
consideration is contingent upon milestone events such as successful completion
of phases in a drug study or achieving a specific result from the research or
development efforts. The amendments in this Update provide guidance
on the criteria that should be met for determining whether the milestone method
of revenue recognition is appropriate. The amendments in this Update are
effective on a prospective basis for milestones achieved in fiscal years, and
interim periods within those years, beginning on or after June 15,
2010. The adoption of this Update is not expected to have any impact
to the Company’s consolidated financial statements.
On July
21, 2010, the FASB issued Accounting Standard Codification (ASC) update 2010-20
to topic 310, “Receivables.” This Update requires companies to
provide extensive new disaggregated disclosures about the credit quality of
their financing receivables and the allowance for credit losses. The objective
of the expanded disclosure is to provide greater transparency about (1) the
nature of credit risk inherent in an entity’s portfolio of financing
receivables, (2) how the entity analyzes that risk in estimating its allowance
for credit losses, and (3) the changes and reasons for those changes in the
allowance for credit losses.
Update
2010-20 requires a company to disaggregate new and existing disclosures based on
how it develops its allowance for credit losses and how it manages credit
exposures. The disclosures are required to be presented by class of financing receivable
and by portfolio
segment, two new defined terms. A portfolio segment is the level at
which an entity develops and documents a systematic method for determining its
allowance for credit losses (e.g., by type of receivable, industry, or risk
rates). Classes of financing receivable generally are a disaggregation of a
portfolio segment. A class is defined as a group of financing receivables
determined on the basis of all of the following: (1) their initial measurement
attribute (e.g., amortized cost or purchased credit impaired), (2) risk
characteristics, and (3) an entity’s method for monitoring and assessing credit
risk. This Update applies to all companies, public and private, and with few
exceptions to all financing receivables. A financing receivable is
defined as an arrangement that has both a contractual right to receive money on
demand or on fixed or determinable dates and, that is recognized as an asset in
the company’s statement of financial position. Examples include (1) loans, (2)
trade accounts receivable, (3) notes receivable, (4) credit card receivables,
and (5) lease receivables (other than from operating leases).
Some of
the more significant new disclosures are listed below. The first two disclosures
are required to be presented by portfolio segment and the remainder presented by
class.
4
·
|
A
rollforward of the allowance for credit losses from the beginning of the
period to the end of the period, by portfolio segment, with the ending
balance further disaggregated based on impairment methodology (e.g.,
individually evaluated for impairment, collectively evaluated for
impairment and loans acquired with deteriorated credit
quality)
|
·
|
Significant
purchases and sales of financing receivables during the
period
|
·
|
At
period end, the amount of nonaccrual financing receivables and those past
due 90 days or more and still
accruing
|
|
·
|
At
period end, the aging of financing receivables past due, as determined by
the entity’s policy
|
|
·
|
At
period end, the amount of impaired financing
receivables
|
|
·
|
At
period end, the recorded investment by credit quality
indicator
|
|
·
|
The
nature and extent of troubled debt restructurings that occurred during the
period and their impact on the allowance for credit
losses
|
|
·
|
The
nature and extent of financing receivables modified as troubled debt
restructurings within the previous 12 months that defaulted during the
period and the effect on the allowance for credit
losses.
|
The
amendments that require disclosures as of the end of a reporting period (e.g.,
credit quality information and impaired loan information) are effective for both
annual and interim periods ending on or after December 15, 2010. For
STAAR, these amendments are effective for the fourth quarter and year ending
December 31, 2010. The amendments that require disclosures about
activity that occurs during a reporting period (e.g., the allowance rollforward
and modification disclosures) are effective for interim or annual periods
beginning on or after December 15, 2010. For STAAR, these amendments
are effective for the first quarter ending April 1, 2011. The Company
is currently assessing the impact of adopting this Update which, when effective,
will require the Company to provide enhanced disclosures and additional
information in its consolidated financial statements regarding the entity’s
credit risk exposures and evaluation of its allowance for credit
losses.
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 became a newly formed entity 74% owned by
BPE and 26% owned by management of Domilens.
After
deducting expenses of the sale totaling approximately $1.2 million, including
estimated taxes of $46,000, the net cash proceeds from the transaction were
approximately $11.8 million.
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. 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.
5
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 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 and six months ended
July 3, 2009 (in thousands, except per share amounts):
For the Period
From
January 2, -
March 2,
2010
|
Three Months
Ended
July 3,
2009
|
Six Months
Ended
July 3,
2009
|
||||||||||
Net
sales
|
$ | 3,584 | $ | 5,959 | $ | 12,084 | ||||||
Gross
profit
|
1,544 | 2,694 | 5,378 | |||||||||
Net
gain on disposal, net of $46 of taxes
|
4,118 | — | — | |||||||||
Income
from operations of Domilens before taxes
|
64 | 283 | 1,159 | |||||||||
Provision
for income taxes from operations of Domilens
|
(16 | ) | (2 | ) | (311 | ) | ||||||
Income
from discontinued operations, net of income taxes
|
$ | 4,166 | $ | 281 | $ | 848 | ||||||
Income
per share from discontinued operations – basic and diluted
|
$ | 0.12 | $ | 0.01 | $ | 0.03 |
Note 3 —
Restricted Cash
On June
22, 2009, the Company posted a $7.3 million deposit with the Superior Court of
California, County of Orange, required as a deposit of 150% of the judgment in
the case of Parallax Medical
Systems, Inc. v. STAAR Surgical Company amount while the judgment was on
appeal (see Note 13). As fully discussed in Note 13, on March 30, 2010 the
Company settled both the Parallax and Scott C. Moody, Inc. v. STAAR
Surgical Company lawsuits. In exchange for complete mutual
releases, the settlement provided for payment by STAAR of $4.0 million from the
restricted deposit as its contribution to the global settlement. In
June 2010, the Court released the $7.3 million deposit, $4.0 million of which
was used by the Company to pay for its portion of the global
settlement. As of July 2, 2010, the Company has approximately $65,000
of interest receivable from the Court related to the deposit which the Company
expects the Court to pay in the third quarter of 2010.
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 the Closing
Date.
6
Note 4 — Inventories
Inventories,
net are stated at the lower of cost, determined on a first-in, first-out basis,
or market and consisted of the following (in thousands):
July
2,
|
January
1,
|
|||||||
2010
|
2010(1)
|
|||||||
Raw
materials and purchased parts
|
$ | 2,115 | $ | 1,846 | ||||
Work-in-process
|
2,419 | 2,480 | ||||||
Finished
goods
|
7,278 | 11,736 | ||||||
11,812 | 16,062 | |||||||
Inventory
reserves
|
(896 | ) | (1,242 | ) | ||||
$ | 10,916 | $ | 14,820 |
(1)
Includes Inventories held by Domilens as of January 1, 2010. No
adjustment has been made to the January 1, 2010 consolidated balance sheet as a
result of the Domilens divestiture completed on March 2, 2010.
Note 5 —
Prepaids, Deposits, and Other Current Assets
Prepaids,
deposits, and other current assets consisted of the following (in
thousands):
|
July 2,
2010
|
January 1,
2010(1)
|
||||||
Prepaids
and deposits
|
$ | 1,149 | $ | 1,169 | ||||
Insurance
receivable
|
60 | 438 | ||||||
Other
current assets*
|
607 | 984 | ||||||
|
$ | 1,816 | $ | 2,591 |
* No item
in “other current assets” above exceeds 5% of total current assets.
(1) No
adjustment has been made to the January 1, 2010 consolidated balance sheet as a
result of the Domilens divestiture completed on March 2, 2010.
Note 6
– Goodwill and Other Intangible Assets
Amortizable
intangible assets consisted of the following (in thousands):
July 2, 2010
|
January 1, 2010
|
|||||||||||||||||||||||
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
|
|||||||||||||||||||
Amortized
intangible assets:
|
||||||||||||||||||||||||
Patents
and licenses
|
$ | 10,766 | $ | (8,838 | ) | $ | 1,928 | $ | 10,725 | $ | (8,619 | ) | $ | 2,106 | ||||||||||
Customer
relationships
|
1,788 | (447 | ) | 1,341 | 1,694 | (339 | ) | 1,355 | ||||||||||||||||
Developed
technology
|
1,136 | (515 | ) | 621 | 1,077 | (390 | ) | 687 | ||||||||||||||||
Total
|
$ | 13,690 | $ | (9,800 | ) | $ | 3,890 | $ | 13,496 | $ | (9,348 | ) | $ | 4,148 |
As of
July 2, 2010 the gross carrying amount of the amortizable intangible assets had
increased by $194,000 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 $1,474,000 as of July 2, 2010 is due principally to the disposition of
Domilens as discussed in Note 2 and approximately $103,000 as a result of
changes in foreign exchange rates related to the remaining
goodwill.
7
Note 7
– Other Current Liabilities
Other
current liabilities consisted of the following (in thousands):
July 2,
2010
|
January 1,
2010(1)
|
|||||||
Accrued
salaries and wages
|
$ | 2,171 | $ | 2,122 | ||||
Accrued
termination benefits
|
700 | — | ||||||
Accrued
audit fees
|
288 | 460 | ||||||
Customer
credit balances
|
598 | 589 | ||||||
Accrued
income taxes
|
892 | 905 | ||||||
Accrued
insurance
|
266 | 386 | ||||||
Accrued
interest on Broadwood Note**
|
— | 499 | ||||||
Accrued
bonuses
|
111 | 530 | ||||||
Other*
|
1,170 | 2,215 | ||||||
$ | 6,196 | $ | 7,706 |
* No item
in “other” above exceeds 5% of total current liabilities.
**
Broadwood Note principal and interest were fully paid off on June 22, 2010 (Note
9).
(1) No
adjustment has been made to the January 1, 2010 consolidated balance sheet as a
result of the Domilens divestiture completed on March 2, 2010.
Note 8
– Employee Benefits
The following table summarizes the
components of net periodic pension cost recorded for the Company’s defined
benefit plans (in thousands):
Three Months
Ended
July 2,
2010
|
Three Months
Ended
July 3,
2009
|
Six Months
Ended
July 2,
2010
|
Six Months
Ended
July 3,
2009
|
|||||||||||||
Service
cost
|
$ | 138 | $ | 135 | $ | 277 | $ | 273 | ||||||||
Interest
cost
|
35 | 33 | 68 | 66 | ||||||||||||
Expected
return on plan assets
|
(25 | ) | (24 | ) | (48 | ) | (48 | ) | ||||||||
Amortization
of unrecognized transition obligation or asset
|
— | 6 | — | 12 | ||||||||||||
Amount
of gain recognized due to a settlement or curtailment
|
— | (4 | ) | — | (9 | ) | ||||||||||
Recognized
actuarial loss
|
14 | 8 | 28 | 16 | ||||||||||||
$ | 162 | $ | 154 | $ | 325 | $ | 310 |
During
the six months ended July 2, 2010 and July 3, 2009, the Company made cash
contributions totaling approximately $121,000 and $168,000 to its defined
benefit pension plans. The Company expects to make additional cash
contributions totaling approximately $121,000 to its defined benefit pension
plan during the remainder of 2010. Since the Japan Plan is self
funded and there are no Plan assets, the Company paid approximately $45,000 to
retirees during the six months ended July 2, 2010.
8
Note 9 —
Note Payable and Lines of Credit
Broadwood
Promissory Note
The
Company had a $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 was scheduled to
mature on December 14, 2010. STAAR’s obligations under the Note were
secured by substantially all of STAAR’s assets pursuant to a Security Agreement
with Broadwood also dated April 13, 2009.
On June
22, 2010, the Company repaid the full outstanding amount of the $5 million
principal plus $322,000 in accrued interest. As a result of repaying
the Note, the Company recorded a $267,000 loss on early extinguishment due to a
write-off of the remaining unamortized debt discount and issuance costs on the
date of the repayment; this loss is included in Other expenses, net, on the
accompanying consolidated statements of operations for the three and six months
ended July 2, 2010.
Capital
Lease Agreements
The Company has certain agreements with
Farnam Street Financial, Inc. (“Farnam”) which provides lease financing to the
Company for purchases of property, plant and equipment. These
agreements are under various individual lease “Schedules” which commit the
Company to lease a set contractual amount of assets per
Schedule. Each Schedule has its own term, required commitment amount
and lease factor (interest rate). In accordance with the requirements
of ASC 840-10-25, all purchases under these Schedules are accounted for as
capital leases. 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 within its Schedule of assets at the
end of that Schedule’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. Amortization of the total capital lease obligation under any
lease Schedule does not begin until the Company draws on the full amount of the
commitment under that particular Schedule which is referred to as the Schedule
“Commencement Date”. However, as individual asset leases are entered
into pursuant to a particular Schedule but prior to the Commencement Date, the
Company pays Farnam “interim rent” based on a predetermined lease factor applied
to the actual principal amount of the purchases. Below is a
table for all existing Schedules the Company has with Farnam as of July 2, 2010
(in thousands):
As of July 2, 2010
|
|||||||||||||||||||
Schedule
|
Commencement
|
Expiration
|
Original
Required
|
Obligation
|
Available
|
||||||||||||||
Number
|
Date
|
Term
|
Date
|
Commitment
|
Balance
|
Credit
|
|||||||||||||
001
|
April
1, 2007
|
36
Months
|
April
1, 2010
|
$ | 959 | $ | - | $ | - | ||||||||||
002
|
September
1, 2007
|
36
Months
|
September
1, 2010
|
527 | 17 | - | |||||||||||||
003
|
January
1, 2008
|
36
Months
|
January
1, 2011
|
387 | 63 | - | |||||||||||||
004
|
March
1, 2009
|
30
Months
|
September
1, 2011
|
150 | 73 | - | |||||||||||||
005
|
Pending
|
Pending
|
N/A
|
250 | 31 | 219 | |||||||||||||
$ | 2,273 | $ | 184 | $ | 219 |
On April
1, 2010, Schedule 001 matured and on April 26, 2010, the Company entered into a
new Schedule 005 and, after making contractual monthly payments thereon, Farnam
will transfer title to the assets under the previous Schedule 001 lease to the
Company at termination and provide the Company $250,000 of availability for new
equipment financing. Schedule 005 term will not commence until the
Company draws on the full $250,000 for new asset purchases and will terminate
twenty-four months after the Commencement Date, assuming all payments are made
timely; the monthly payments currently being made to Farnam under Schedule 005
are all considered “interim rents” and include both the previous assets leased
under Schedule 001 and the new assets financed under Schedule 005.
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 May 24, 2010, STAAR redeemed all
outstanding shares of preferred stock in cash for $4.00 per share, or $6.8
million in aggregate. There are no Preferred Shares outstanding as of
July 2, 2010.
9
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. 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
6,346,267 and 6,680,573 shares of common stock for the three and six months
ended July 2, 2010 and 6,588,822 and 6,494,218 for the three and six months
ended July 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):
Three Months Ended
|
Six Months Ended
|
|||||||||||||||
July 2,
2010
|
July 3,
2009
|
July 2,
2010
|
July 3,
2009
|
|||||||||||||
Net
income (loss)
|
$ | (1,628 | ) | $ | (1,088 | ) | $ | 1,902 | $ | (2,750 | ) | |||||
Minimum
pension liability adjustment
|
3 | (1 | ) | 6 | (2 | ) | ||||||||||
Foreign
currency translation adjustment
|
364 | 818 | (1,933 | ) | (225 | ) | ||||||||||
Total
comprehensive loss
|
$ | (1,261 | ) | $ | (271 | ) | $ | (25 | ) | $ | (2,977 | ) |
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 period, is set forth
below (in thousands):
Three Months Ended
|
Six Months Ended
|
|||||||||||||||
July
2,
|
July
3,
|
July
2,
|
July
3,
|
|||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
United
States
|
$ | 3,810 | $ | 4,116 | $ | 7,832 | $ | 8,312 | ||||||||
Japan
|
3,940 | 3,857 | 7,972 | 7,556 | ||||||||||||
Korea
|
1,161 | 1,614 | 2,647 | 2,600 | ||||||||||||
Other
|
4,728 | 3,571 | 8,966 | 6,848 | ||||||||||||
Total
|
$ | 13,639 | $ | 13,158 | $ | 27,417 | $ | 25,316 |
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, also referred to as our “core” products, and other surgical
products used primarily in cataract surgery, sometimes referred to as “non-core”
products. The composition of the Company’s net sales by product line
is as follows (in thousands):
10
Three Months Ended
|
Six Months Ended
|
|||||||||||||||
July
2,
|
July
3,
|
July
2,
|
July
3,
|
|||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
IOLs
|
$ | 7,006 | $ | 6,691 | $ | 13,883 | $ | 12,895 | ||||||||
ICLs
|
5,864 | 5,384 | 11,724 | 10,270 | ||||||||||||
Core
products
|
12,870 | 12,075 | 25,607 | 23,165 | ||||||||||||
Other
Surgical Products
|
769 | 1,083 | 1,810 | 2,151 | ||||||||||||
Total
|
$ | 13,639 | $ | 13,158 | $ | 27,417 | $ | 25,316 |
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 and
Moody were settled on March 30, 2010. The settlement, part of
a global settlement among all parties to the matters, satisfied 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 paid $4.0 million as its
contribution to the global settlement upon the Court’s release of the $7.3
million deposit in June 2010.
Accrued
Termination Benefits for Executive
On May
24, 2010, STAAR accrued $700,000 in executive termination benefit costs in
connection with the non-renewal of an executive employment
agreement. This accrual represents STAAR’s current best estimate of
the contractual termination benefits due to the executive. The actual
amount ultimately paid to the executive may be different than the amount
estimated. These costs are expected to be paid out to the executive over 15
months, including a three-month period during which the executive will remain
employed but have no further obligation to perform his duties as an employee,
beginning in September 2010.
Note
14 — Stock-Based Compensation
The
Company has adopted ASC 718, “Stock Compensation” effective December 31,
2005.
As of
July 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
|
Six Months Ended
|
|||||||||||||||
July 2,
2010
|
July 3,
2009
|
July 2,
2010
|
July 3,
2009
|
|||||||||||||
Stock-based
compensation expense
|
$ | 194 | $ | 216 | $ | 442 | $ | 489 | ||||||||
Common
stock issued to employees
|
— | — | — | 278 | ||||||||||||
Restricted
stock expense
|
103 | 53 | 137 | 118 | ||||||||||||
Consultant
compensation
|
41 | 20 | 70 | (1 | ) | |||||||||||
Total
|
$ | 338 | $ | 289 | $ | 649 | $ | 884 |
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
$20,000 and $43,000 of stock compensation to inventory for the three and six
months ended July 2, 2010, and $21,000 and $54,000, respectively, for the three
and six months ended July 3, 2009, and recognizes those amounts as expense in
Cost of Sales as the inventory is sold.
11
Stock
Option Plans
In fiscal
year 2003, the Board of Directors approved the 2003 Omnibus Equity Incentive
Plan (the “2003 Plan”) authorizing awards of equity compensation, including
options to purchase common stock and restricted shares of common stock. The 2003
Plan amends, restates and replaces the 1991 Stock Option Plan, the 1995
Consultant Stock Plan, the 1996 Non-Qualified Stock Plan and the 1998 Stock
Option Plan (the “Restated Plans”). On May 19, 2010, the stockholders
of STAAR approved the Restated 2003 Omnibus Plan, which increased the number of
shares available for grants under the plan by 2,000,000 shares and extended the
term of the plan to May 18, 2020. As of July 2, 2010, there were
2,284,497 shares authorized and available for grants under the Restated 2003
Omnibus Plan. The 2003 Plan provides for various forms of stock-based
incentives. To date, of the available forms of awards under the 2003
Plan, the Company has granted only stock options, restricted stock and
unrestricted share grants. Options under the plan are granted at fair market
value on the date of grant, become exercisable over a three- or four-year
period, or as determined by the Board of Directors, and expire over periods not
exceeding 10 years from the date of grant. Certain option and share awards
provide for accelerated vesting if there is a change in control (as defined in
the 2003 Plan). Pursuant to the plan, options for 2,905,336 shares were
outstanding at July 2, 2010 with exercise prices ranging between $0.95 and $8.12
per share. Restricted stock grants under the 2003 Plan generally vest
over a period of one, three or four years. There were 113,667 shares
of restricted stock outstanding at July 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. Pursuant to this
plan, options for 500,000 were outstanding at July 2, 2010, with an exercise
price of $11.13.
In fiscal
year 1998, the Board of Directors approved the 1998 Stock Option Plan,
authorizing the granting of options to purchase common stock or awards of common
stock. Pursuant to the plan, options for 337,300 were outstanding at July 2,
2010 with exercise prices ranging between $3.35 and $3.81 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. Pursuant to this plan, options for 25,100 shares were
outstanding at July 2, 2010 with an exercise price of $1.70 per share. No
further awards may be made under this plan.
Assumptions
The fair
value of each option award is estimated on the date of grant using a
Black-Scholes option valuation model applying the assumptions noted in the
following table. Expected volatilities are based on historical
volatility of the Company’s stock. The Company uses historical data to estimate
option exercise and employee termination behavior. The expected term of options
granted is derived from the historical exercise activity over the past 15 years,
and represents the period of time that options granted are expected to be
outstanding. Options granted with a three-year vesting life during
the three and six months ended July 2, 2010 and had an expected term of 5.60
years derived from historical exercise and termination activity. The
Company has calculated a 10.24% estimated forfeiture rate used in the model for
fiscal year 2010 option grants based on historical forfeiture
experience. The risk-free rate for periods within the contractual
life of the option is based on the U.S. Treasury yield curve in effect at the
time of grant.
Three
Months Ended
|
Six
Months Ended
|
|||||||||||||||
July
2,
2010
|
July
3,
2009
|
July
2,
2010
|
July
3,
2009
|
|||||||||||||
Expected
dividend yield
|
0 | % | 0 | % | 0 | % | 0 | % | ||||||||
Expected
volatility
|
81.07 | % | 79.06 | % | 80.61 | % | 73.43 | % | ||||||||
Risk-free
interest rate
|
2.13 | % | 2.66 | % | 2.31 | % | 1.89 | % | ||||||||
Expected
term (in years)
|
5.6 | 5.5 | 5.6 | 5.5 |
A summary
of option activity under the Plans as of July 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
|
356 | 3.92 | ||||||||||||||
Exercised
|
(54 | ) | 2.58 | |||||||||||||
Forfeited
or expired
|
(277 | ) | 7.71 | |||||||||||||
Outstanding
at July 2, 2010
|
3,768 | $ | 5.09 | 5.38 | $ | 5,996 | ||||||||||
Exercisable
at July 2, 2010
|
3,087 | $ | 5.50 | 4.62 | $ | 4,282 |
12
The
weighted-average grant-date fair value of options granted during the six months
ended July 2, 2010 was $2.68 per option. The total fair value of
options vested during the six months ended July 2, 2010 and July 3, 2009 was
$874,000 and $983,000, respectively. There were 54,399 options
exercised with an intrinsic value of $124,000 during the six months ended July
2, 2010 and no options were exercised during the six months ended July 3,
2009.
13
A summary
of the status of the Company’s non-vested shares as of July 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
|
356 | 2.68 | ||||||
Vested
|
(411 | ) | 2.12 | |||||
Forfeited
|
(23 | ) | 2.26 | |||||
Nonvested
at July 2, 2010
|
681 | $ | 2.28 |
As of
July 2, 2010, there was $1.1 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 1.73 years.
14
Note 15 —
Supplemental Disclosure of Cash Flow Information
Interest
paid was $900,000 and $132,000 for the six months ended July 2, 2010 and July 3,
2009, respectively. Income taxes paid amounted to approximately $695,000 and
$318,000 for the six months ended July 2, 2010 and July 3, 2009,
respectively.
The
Company’s non-cash investing and financing activities for the six months ended
were as follows (in thousands):
July 2,
2010
|
July 3,
2009
|
|||||||
Non-cash
investing and financing activities:
|
||||||||
Assets
obtained by capital lease
|
$ | 31 | $ | 479 | ||||
Issuance
of common stock to attorneys for legal services performed
|
— | 425 | ||||||
Warrants
issued to Broadwood
|
— | 290 |
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.
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 we supply 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.
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Sales of
IOLs during the three and six months ended July 2, 2010 were $7.0 million and
$13.9 million, compared to $6.7 million and $12.9 million for the same periods
in the prior year, representing approximately 51% of total net sales in the
three month period as well as year-to-date.
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), hyperopia (far-sightedness) and astigmatism. These disorders
of vision affect a large proportion of the population. Unlike the IOL, which
replaces a cataract patient’s cloudy lens, these products are designed to work
with the patient’s natural lens to correct refractive disorders. The surgeon
implants the foldable Visian lens through a tiny incision, 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. In May 2010, STAAR received CE Mark approval for an expanded
range of Visian ICL products, including lenses with lower levels of myopia
correction in quarter-diopter increments, Toric hyperopic lenses to treat
astigmatism and far-sightedness, and Toric lenses in the low to zero range of
myopia to treat patients primarily affected by astigmatism. These
product line extensions approximately double the number of patients for whom a
Visian-based solution will be available in Europe and other territories that
accept the CE Mark. 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 and six months ended July 2, 2010 were $5.9 million and
$11.7 million compared to $5.4 million and $10.3 million for the same periods in
the prior year, representing approximately 43% of total net sales in the three
month period as well as year-to-date.
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 and six months ended July 2, 2010 were
$0.8 million and $1.8 million compared to $1.1 million and $2.2 million for the
same periods in the prior year, representing approximately 6% of total net sales
in the three month period as well as year-to-date.
Operations
STAAR has
significant operations both within and outside the U.S. Sales from activities
outside the U.S. accounted for about 72% of our total sales.
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,
California.
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Switzerland. STAAR
operates an administrative, manufacturing and distribution facility in
Nidau, Switzerland under its wholly owned subsidiary, STAAR Surgical AG.
The Nidau manufacturing facility makes all of STAAR’s ICLs and TICLs and
also manufactures the AquaFlow Device. STAAR Surgical AG handles
distribution and other administrative affairs for Europe, the Middle East
and Africa.
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Japan. STAAR
operates administrative, manufacturing and distribution facilities in
Japan under its wholly owned subsidiary, STAAR Japan Inc. STAAR
Japan’s administrative and distribution facility is located in
Shin-Urayasu and its manufacturing facility is located in Ichikawa City.
All of STAAR’s preloaded injectors are manufactured at the Ichikawa City
facility. Following its approval by the Japanese Ministry of
Health, Labor and Welfare on February 2, 2010, STAAR Japan began marketing
and distributing the Visian ICL in Japan. STAAR Japan will also
handle distribution and other administrative affairs for the Pacific Asia
region under the re-alignment of STAAR’s global business discussed
below.
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During
the second quarter of 2010 STAAR realigned its global business into three
regional commercial zones: North America; Europe (including the
Middle East and Africa) and Asia Pacific. Prior to the re-alignment,
all territories outside North America and Japan were overseen from Switzerland
by STAAR Surgical AG. The realignment is intended to bring a
specialized, Asia-based focus to our expanding business in China, Korea, Japan
and neighboring territories, while enabling our Switzerland-based managers to
focus on deepening our penetration in Europe and neighboring territories and
capitalizing on the opportunity presented by the new approval of the expanded
Visian product offering.
17
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"). STAAR is continuing to assess the impact,
if any, the Acts will have on its consolidated financial
statements.
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 which enables 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. STAAR achieved approximately 14%
growth in worldwide ICL sales during the first half of 2010 compared to the
first half of 2009 and 15% growth in worldwide ICL sales during 2009 compared to
2008. STAAR currently 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 and sales efforts in the key
territories where it has established significant market share, based on the
success of this strategy in 2009. Based on our potential market share
in Japan, it has been added to the list of targeted territories in 2010; like
other Asian countries, Japan has a higher prevalence rate of myopia than other
countries, which makes it a promising new market. STAAR’s post
approval launch in Japan has proceeded more slowly than expected, chiefly
because of the need to obtain certification for STAAR’s surgeon training
program. STAAR expects ICL sales in Japan to accelerate during the
second half of 2010. 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 11% of the total volume of
refractive surgery procedures. During the second quarter of 2010,
STAAR’s Korean distributor organized a new entity specifically to handle Visian
products. During the transfer of the business to the new entity and
its warehouse facility, STAAR and the distributor agreed to delay inventory
purchases, resulting in a shortfall in expected sales during the second quarter
and a decline in sales of 28% as compared to the prior year second quarter,
compared to a year-over-year increase of 51% in the first quarter of 2010 (Korea
is one of the few territories where STAAR’s independent distributor maintains
significant inventory.) Sales by the distributor to its own end
customers have remained strong; STAAR expects the shortfall in orders to be made
up during the third quarter and for Korea to resume its rapid growth pattern for
the remainder of the year. STAAR is using Korea as a model of best
practices for marketing that may serve to significantly increase market share in
other key territories.
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. An unexpected drop in military purchases during the second
quarter of 2010, combined with continued weakness in private sector sales,
resulted in an overall decline of 6% in U.S. ICL sales. 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.
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STAAR’s
global IOL sales continued to increase, approximately 5% higher as compared to
the prior year second quarter and increased by 7.7% in the first half of 2010
compared to the first half of 2009. The increases 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 8.5%
over the second quarter of 2009 and grew by approximately 7% during the first
six months of 2010 as compared to the first six months 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.
In
meeting its growth targets STAAR continues to face challenges in the U.S. IOL
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
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,
with which STAAR has experienced a 15% increase in global sales and over 20%
increase year-to-date and a 17% increase in U.S. sales during the second quarter
of 2010. Preloaded IOL sales increased by 12% 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 was 63.6% in the second quarter of 2010 and 63.9% for the six months
ended July 2, 2010. 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. Products sold by Domilens are presented in
discontinued operations, including third party products, supplies and
disposables like surgical drapes, and assembly of custom surgical
kits. In contrast, STAAR’s own products previously distributed to
Domilens will continue to be sold to Domilens as an unaffiliated
distributor. Those sales are therefore treated as continuing
operations of STAAR and are included in net sales in STAAR’s consolidated
financial statements after the disposition; however, the volume of these sales
is expected to be insignificant in relation to STAAR’s consolidated net
sales.
STAAR’s
recent improvements in gross profit margin do not derive solely from the sale of
Domilens. Even when compared with STAAR’s adjusted gross profit
margins in the second quarter of 2009, STAAR experienced a 300 basis point
increase in the second 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.
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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 $1.9 million or $0.05
per share in the first six months of 2010. However, 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. While the net
income reported for the first half of the year does not signify that STAAR has
achieved sustainable net income from its continuing operations, STAAR has set a
goal of achieving net income for the full year, other than from non-recurring
items.
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. However, STAAR
had an operating loss of $799,000 for the second quarter of 2010 which also
includes a $700,000 termination benefits accrual resulting from non-renewal of
an executive employment agreement. 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 and second quarters of 2010 due mainly
to the $4.0 million litigation settlement payment that was made in the second
quarter of 2010. While this payment negatively affected cash flow
from operating activities in the second quarter and possibly for the full year,
the negative effect was more than offset by the return of the $7.3 million bond
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 $3.7
million in cash used in operating activities in the second quarter included the
$4.0 million used to pay the global litigation settlement. Also
reflected in $5.1 million in cash used in operating activities for the first six
months of 2010 were non-recurring cash outlays, including $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, approximately
$0.8 million in interest paid on the Senior Secured Promissory Note, including
the early repayment interest of $0.3 million, and the $4.0 million payment of
the global settlement. 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. These
factors cause 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 second quarter, and the seasonal demands on
cash in the first quarter are not expected to affect STAAR’s use of cash during
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 had two significant financial obligations that were
scheduled to mature in 2010: repayment of the $5 million principal balance on
the Broadwood Note, originally 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.
In the
second quarter of 2010, STAAR achieved its goals of resolving 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, who
had a right to convert some or all of the Preferred Stock to common stock at a
1:1 ratio through May 17, 2010, allowed the conversion right to lapse and
accepted cash redemption of the Preferred Stock at the price of $4 per
share. On May 24, 2010, STAAR redeemed all of the outstanding
shares of Preferred Stock by paying the aggregate cash purchase price of $6.8
million.
On June
22, 2010, STAAR prepaid the $5 million Broadwood Note, plus the accrued interest
as of that date, without any penalty. Since the Note was scheduled to
mature in December 2010, STAAR also wrote off the remaining unamortized discount
and issuance costs related to the Note and recognized a non-cash loss of
$267,000. STAAR expects to save approximately $168,000 in cash
interest cost due to the prepayment of this Note for the remainder of
2010.
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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.
Other
Highlights
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. declined by 6% during the second quarter of 2010 over the
prior year period. This follows a 7% year-over-year increase during
the first quarter of 2010 and a 2.5% increase over the prior year in
2009. STAAR believes the decrease in sales in the second quarter
reflects the continued overall negative trend in refractive surgical procedures
in the U.S., which are believed to have declined significantly during the
quarter. Most of STAAR’s recent 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.
During
the second quarter of 2010, STAAR added two new marketing associates who will
focus on the professional and consumer market segments for Visian ICL products.
STAAR also added five new direct sales representatives to promote sales of core
products (both ICLs and IOLs). STAAR expects that these additional
personnel will help reverse the decline in U.S. ICL sales, and will position
STAAR for further growth if the general market improves.
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:
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the
U.S. refractive surgery market has been dominated by corneal laser-based
techniques, which continue to be better known than the Visian ICL among
potential refractive patients;
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other
newly introduced surgical products will continue to compete with the
Visian ICL for the attention of surgeons seeking to add new, high value
surgical products, in particular multifocal and accommodating
IOLs;
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concerns
about medical complications and patient dissatisfaction following LASIK
could reduce interest in all refractive surgical procedures;
and
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FDA
approval of the TICL, which STAAR sells in 45 international markets for
treating patients affected by both myopia and astigmatism, has not yet
been realized.
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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 trend of reduced demand for laser surgery that began in 2008, 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.
21
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.
STAAR has
recently 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.
In
addition, STAAR intends to focus on the following projects to enhance the
competitiveness of its ICL product offering:
|
·
|
Marketing
ICLs in the expanded diopter power range recently approved outside the
United States so that patients with lower refractive error can be treated
with the ICL;
|
·
|
Making
other modifications to improve the performance of the ICL:
and
|
·
|
Extending
the shelf life of Collamer products (both IOLs and
ICLs).
|
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. For example, in
the second quarter of 2010, overall U.S. IOL sales declined by 7%, primarily due
to decreased sales of lower priced silicone IOLs. However, nanoFLEX™
sales rose by 17% during the same period, leading to an 11% increase in average
selling price that partially offset the effect of decreased silicone IOL sales
and helped increase STAAR’s gross margins in the U.S. by 350 basis
points. U.S. IOL sales declined 5.3% in the first quarter of 2010 and
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;
|
22
|
·
|
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.
|
As noted
above, during the second quarter of 2010 STAAR added five new direct sales
representatives to promote sales of core products (both ICLs and
IOLs). STAAR expects that these additional personnel will help build
the market for STAAR’s newer and higher value IOL products and will position
STAAR to make greater gains with its expected new product
introductions.
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 surgeons to
bill patients directly for an additional price premium when they use aspheric
rather than conventional lenses. This has been permitted for previous
NTIOL-designated technologies, such as Toric IOLs. 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
and ICL product offering more competitive:
|
·
|
Introducing
a preloaded injector with a single piece acrylic IOL in addition to the
current three-piece acrylic
offering;
|
·
|
Extending
the shelf life of Collamer products (both IOLs and
ICLs);
|
|
·
|
Completing
the development of the Collamer Toric IOL to complement our pioneering
silicone Toric IOL and better compete with the Alcon acrylic Toric IOL.
The Collamer Toric IOL should provide a product with advanced optic
materials and rotational stability to provide superior outcomes for
cataract patients with astigmatism;
|
|
·
|
Gaining
approval for a preloaded silicone IOL injector system in the U.S. in
2010;
|
|
·
|
Developing
a preloaded injector system for our Collamer
IOLs;
|
|
·
|
Initiating
a formal post-market clinical evaluation to support a possible submission
to the FDA of claims that the lens offers patients less spectacle
dependence or accommodation; and
|
|
·
|
Initiating
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 IOLs by continuously improving the
Collamer lens design, enhancing delivery systems and differentiating STAAR’s
silicone IOL offering through the Preloaded Injector. 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. STAAR has completed a number of development projects
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.
23
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. STAAR has
submitted a clinical protocol to the FDA which is intended to duplicate the
results of the CAST evaluation in a formal clinical trial. STAAR is requesting
that the results of the clinical trial be included in the labeling for the
nanoFLEX product.
While
increased sales of the nanoFLEX were not sufficient to fully offset other
declines in U.S. IOL sales in the first half of 2010, sales of the product have
continued to grow and STAAR believes 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.
The 2009
introduction of the Epiphany injector, an advanced system that makes delivery of
the three-piece Collamer aspheric IOL more reliable and predictable did not
result in increased sales of this advanced lens. Based on surgeon feedback,
STAAR developed an easier loading mechanism for this injector, which it
introduced 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. Concerted marketing efforts for the three-piece Collamer
aspheric lens are underway now that the improved Epiphany injector is
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 aspheric,
three-piece silicone IOL offers outstanding optical performance and with its
NTIOL status could enable STAAR to retain or possibly increase its market share
within the silicone IOL sector. STAAR plans to aggressively market the preloaded
version of the product once FDA approves the product.
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. In August 2007, following negative inspectional
observations and a Warning Letter from FDA’s Division of Bioresearch Monitoring
(“BIMO”), the FDA Office of Device Evaluation placed an integrity hold on
STAAR’s TICL application. Over a two-year period STAAR took a number
of corrective actions to address BIMO’s concerns and to remove the integrity
hold, including engaging an independent third party auditor to conduct an audit
of patient records in the TICL clinical study, along with an audit of clinical
systems to ensure accuracy and completeness of data before resubmitting the
application. On July 21, 2009, the FDA notified STAAR that as a
result of STAAR’s corrective actions the FDA had removed 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. STAAR has submitted a comprehensive response to the
letter. Among the requests of the FDA was further analysis of data on corneal
endothelial cell loss gathered during five-year follow-up of subjects
from the original Visian ICL clinical study. Though not required, STAAR elected
to sponsor a clinical study to obtain data at approximately the 10-year point
on10 eyes identified as statistical outliers. The 10 eyes, despite being
outliers, had loses that were consistent with the confidence limits in the
endothelial cell table of the approved labeling for the Visian ICL, and STAAR
confirmed that the annualized rate of decrease in endothelial cells declined in
the second five years by approximately 25% compared to the first five years.
STAAR expects to work interactively with FDA to resolve the questions in the
February 3 letter, the majority of which involve labeling of the Toric ICL.
STAAR cannot predict when, or if, the FDA may grant approval of the Visian Toric
ICL.
Status of Japan TICL Submission. On February, 2,
2010, Japan’s Ministry of Health, Labor and Welfare (MHLW) approved the sale of
the Visian ICL. STAAR submitted a partial change application for
approval of the Visian Toric ICL to the Pharmaceuticals and Medical Device
Agency (PMDA) on April 9, 2010. While STAAR did 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.
24
Effect
of Domilens Divestiture on Financial Reporting
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, 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.
New
Accounting Pronouncements
On April
28, 2010, the FASB issued Accounting Standard Codification (ASC) update 2010-17
to topic 605, “Revenue Recognition – Milestone Method.” The objective
of this Update is to provide guidance on defining a milestone and determining
when it may be appropriate to apply the milestone method of revenue recognition
for research or development transactions. Research or development arrangements
frequently include payment provisions whereby a portion or all of the
consideration is contingent upon milestone events such as successful completion
of phases in a drug study or achieving a specific result from the research or
development efforts. The amendments in this Update provide guidance
on the criteria that should be met for determining whether the milestone method
of revenue recognition is appropriate. The amendments in this Update are
effective on a prospective basis for milestones achieved in fiscal years, and
interim periods within those years, beginning on or after June 15,
2010. The adoption of this Update is not expected to have any impact
to the Company’s consolidated financial statements.
On July
21, 2010, the FASB issued Accounting Standard Codification (ASC) update 2010-20
to topic 310, “Receivables.” This Update requires companies to
provide extensive new disaggregated disclosures about the credit quality of
their financing receivables and the allowance for credit losses. The objective
of the expanded disclosure is to provide greater transparency about (1) the
nature of credit risk inherent in an entity’s portfolio of financing
receivables, (2) how the entity analyzes that risk in estimating its allowance
for credit losses, and (3) the changes and reasons for those changes in the
allowance for credit losses.
Update
2010-20 requires a company to disaggregate new and existing disclosures based on
how it develops its allowance for credit losses and how it manages credit
exposures. The disclosures are required to be presented by class of financing receivable
and by portfolio
segment, two new defined terms. A portfolio segment is the level at
which an entity develops and documents a systematic method for determining its
allowance for credit losses (e.g., by type of receivable, industry, or risk
rates). Classes of financing receivable generally are a disaggregation of a
portfolio segment. A class is defined as a group of financing receivables
determined on the basis of all of the following: (1) their initial measurement
attribute (e.g., amortized cost or purchased credit impaired), (2) risk
characteristics, and (3) an entity’s method for monitoring and assessing credit
risk. This Update applies to all companies, public and private, and with few
exceptions to all financing receivables. A financing receivable is
defined as an arrangement that has both a contractual right to receive money on
demand or on fixed or determinable dates and, that is recognized as an asset in
the company’s statement of financial position. Examples include (1) loans, (2)
trade accounts receivable, (3) notes receivable, (4) credit card receivables,
and (5) lease receivables (other than from operating leases).
Some of
the more significant new disclosures are listed below. The first two disclosures
are required to be presented by portfolio segment and the remainder presented by
class.
·
|
A
rollforward of the allowance for credit losses from the beginning of the
period to the end of the period, by portfolio segment, with the ending
balance further disaggregated based on impairment methodology (e.g.,
individually evaluated for impairment, collectively evaluated for
impairment and loans acquired with deteriorated credit
quality)
|
·
|
Significant
purchases and sales of financing receivables during the
period
|
25
·
|
At
period end, the amount of nonaccrual financing receivables and those past
due 90 days or more and still
accruing
|
|
·
|
At
period end, the aging of financing receivables past due, as determined by
the entity’s policy
|
|
·
|
At
period end, the amount of impaired financing
receivables
|
|
·
|
At
period end, the recorded investment by credit quality
indicator
|
|
·
|
The
nature and extent of troubled debt restructurings that occurred during the
period and their impact on the allowance for credit
losses
|
|
·
|
The
nature and extent of financing receivables modified as troubled debt
restructurings within the previous 12 months that defaulted during the
period and the effect on the allowance for credit
losses.
|
The
amendments that require disclosures as of the end of a reporting period (e.g.,
credit quality information and impaired loan information) are effective for both
annual and interim periods ending on or after December 15, 2010. For
STAAR, these amendments are effective for the fourth quarter and year ending
December 31, 2010. The amendments that require disclosures about
activity that occurs during a reporting period (e.g., the allowance rollforward
and modification disclosures) are effective for interim or annual periods
beginning on or after December 15, 2010. For STAAR, these amendments
are effective for the first quarter ending April 1, 2011. The Company
is currently assessing the impact of adopting this Update which, when effective,
will require the Company to provide enhanced disclosures and additional
information in its consolidated financial statements regarding the entity’s
credit risk exposures and evaluation of its allowance for credit
losses.
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.
An
accounting policy is deemed critical if it requires an accounting estimate to be
made based on assumptions about matters that are highly uncertain at the time
the estimate is made, if different estimates reasonably could have been used, or
if changes in the estimate that are reasonably likely to occur could materially
impact the financial statements. Management believes that there have been no
significant changes during the six months ended July 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.
26
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
for
Three Months
|
Percentage
Change
for
Three
Months
|
Percentage of Net Sales for
Six Months
|
Percentage
Change
for
Six
Months
|
|||||||||||||||||||||
July 2,
2010
|
July 3,
2009
|
2010
vs. 2009
|
July 2,
2010
|
July 3,
2009
|
2010
vs. 2009
|
|||||||||||||||||||
Net
sales
|
100.0 | % | 100.0 | % | 3.7 | % | 100.0 | % | 100.0 | % | 8.3 | % | ||||||||||||
Cost
of sales
|
36.4 | 39.4 | (4.4 | ) | 36.1 | 38.3 | 2.3 | |||||||||||||||||
Gross
profit
|
63.6 | 60.6 | 8.9 | 63.9 | 61.7 | 12.0 | ||||||||||||||||||
General
and administrative
|
24.0 | 29.0 | (14.5 | ) | 24.3 | 32.0 | (17.8 | ) | ||||||||||||||||
Marketing
and selling
|
30.3 | 28.3 | 10.9 | 29.1 | 29.8 | 5.5 | ||||||||||||||||||
Research
and development
|
10.1 | 11.0 | (4.5 | ) | 10.6 | 11.3 | 2.0 | |||||||||||||||||
Other
operating expense
|
5.1 | — | — | * | 2.5 | — | — | * | ||||||||||||||||
69.5 | 68.3 | 5.5 | 66.5 | 73.1 | (1.5 | ) | ||||||||||||||||||
Operating
loss
|
(5.9 | ) | (7.7 | ) | (21.4 | ) | (2.6 | ) | (11.4 | ) | (74.9 | ) | ||||||||||||
Other
expense, net
|
(6.7 | ) | (0.6 | ) | — | * | (4.9 | ) | (1.2 | ) | — | * | ||||||||||||
Loss
before provision (benefit) for income taxes
|
(12.6 | ) | (8.3 | ) | 57.6 | (7.5 | ) | (12.6 | ) | (35.6 | ) | |||||||||||||
Provision
(benefit) for income taxes
|
(0.7 | ) | 2.1 | — | * | 0.8 | 1.6 | (48.8 | ) | |||||||||||||||
Loss
from continuing operations
|
(11.9 | ) | (10.4 | ) | 18.9 | (8.3 | ) | (14.2 | ) | (37.1 | ) | |||||||||||||
Income
from discontinued operations, net of taxes
|
— | 2.1 | (100.0 | ) | 15.2 | 3.3 | — | * | ||||||||||||||||
Net
income (loss)
|
(11.9 | )% | (8.3 | )% | 49.6 | 6.9 | % | (10.9 | )% | — | * |
* Denotes change is greater than
+100%.
Net
Sales
Net sales
for the three and six months ended July 2, 2010 were $13.6 million and $27.4
million, an increase of approximately 3.7% and 8.3%, respectively, compared with
$13.2 million and $25.3 million for the three and six months ended July 3,
2009. The increase in net sales was due mainly to increases in sales
of both IOLs and ICLs globally, offset by decreases in other surgical
products. Changes in foreign currency had a $0.3 million and $0.5
million favorable impact on net sales for the three and six months of 2010
primarily due to the stronger Japanese Yen compared to the U.S.
Dollar.
U.S.
sales for the three and six months ended July 2, 2010 were $3.8 million and $7.8
million, a decrease of 7.4% and 6.0%, respectively, compared with $4.1 million
and $8.3 million reported for the three and six months ended July 3, 2009. The
primary reason for the decrease in both periods is a decrease in IOL and ICL
sales. U.S. ICL sales decreased 6.3% in the second quarter of 2010,
but were relatively unchanged for the six months ended July 2, 2010 compared to
the six months ended July 3, 2009. STAAR believes the decline in ICL
sales for the quarter results from the continued negative trends in the overall
growth rate of refractive surgery procedures. U.S. IOL sales for the
three and six months ended July 2, 2010 decreased 6.9% and 6.1% due to decreased
sales of lower priced silicone IOLs. The rate of decline has slowed
significantly from the levels of 2009 and 2008, which STAAR believes resulted
from its introduction of new products. The decline in volume was
offset somewhat by an 11% increase in average selling price (“ASP”) driven by a
17% increase in nanoFLEX™ IOL sales.
International
sales for the three and six months ended July 2, 2010 were $9.8
million and $19.6 million, up 8.7% and 15.2% compared with $9.0 million and
$17.0 million reported in the three and six months ended July 3,
2009. During the quarter and year to date periods, international
Visian ICL sales grew to $4.7 million and $9.1 million, a 13.4% and 18.7%
increase compared to the $4.2 million and $7.7 million reported in the same
periods of 2009. The sales increase in 2010 is due to increases in
both volume and average selling prices. The Visian Toric ICL, which
is available in 45 markets, accounted for 44% of ICL sales in those markets
during the quarter as compared to 34% for the second quarter of
2009; Visian Toric sales in those markets increased by 48% during the
quarter. During the quarter the Company received approval to sell an
expanded range of Visian ICL products, which more than doubles the current
Visian-addressable market in Europe. Included in the CE Mark approval
was the STAAR Hyperopic Toric ICL, which is designed for patients with both
hyperopia and astigmatism.
27
International
IOL sales also increased approximately 11% to $4.8 million for the current
quarter from $4.4 million compared to the same quarter in the prior year and
increased 15% over the first six months of 2009. Unit volume and
average selling prices were higher in the quarter compared to the prior year
quarter. Preloaded IOL sales increased by 12% driven by the launch of
the KS-X Hydrophobic Acrylic Preloaded IOL to expand market
presence. Despite continued pricing pressures in Japan, IOL sales
grew 8.5% over the second quarter of 2009. France again led in IOL
market increases for the Company during the second quarter and overall IOL sales
in Europe increased by about 35% for the quarter and about 80% for the first
half of the year.
Other
products decreased 29% to $0.8 million from $1.1 million reported in the second
quarter of 2009 and decreased 16% to $1.8 million from the $2.2 million reported
in the first six months of 2009. Other product sales decreased as a result of
STAAR’s decision to de-emphasize low margin, non-core products.
Gross
Profit Margin
Gross
profit margin for the second quarter was 63.6%, a 300 basis point improvement
compared with 60.6% in same quarter in the prior year. Gross profit
margin for the first six months of 2010 was $17.5 million, or 63.9% of net
sales, compared with $15.6 million, or 61.7% of net sales in the prior year
period. A significant portion of the year over year increases was due
to a decrease in royalty expense resulting from the 2009 expiration of a patent
licensed to STAAR. Royalty expense was $203,000 and $427,000 in the
second quarter and during the first six months of 2009,
respectively. In addition, gross profit margins were favorably
impacted by higher IOL and ICL average selling prices and improved mix of higher
profit margin products.
General
and Administrative
General
and administrative expenses decreased by 14.5% to $3.3 million in the second
quarter of 2010 from $3.8 million over the second quarter of
2009. General and administrative expenses for the six months ended
July 2, 2010 were $6.7 million, a decrease of 17.8% when compared with $8.1
million reported last year. The decreases in both periods were mainly
due to decreased legal expenses, lower insurance premiums and lower
headcount.
Marketing
and Selling
Marketing
and selling expenses for the second quarter of 2010 increased by 10.9% to $4.1
million as compared with $3.7 million in the same period in 2009. For
the first six months of 2010, marketing and selling expenses were $8.0 million,
up $0.4 million or 5.5%, from $7.6 million reported for the first six months of
2009. The increase in marketing and selling expenses was due mainly
to the timing of trade show expenses and the expansion of the U.S. sales team to
foster higher growth in the later part of 2010 and 2011.
Research
and Development
Research
and development expenses for the second quarter of 2010 were $1.4 million, a
4.5% decline compared with the second quarter of 2009 due to decreased salaries,
legal fees and general cost containment efforts. For the six months
ended July 2, 2010, research and development expenses were $2.9 million,
essentially flat as compared to the comparable period in 2009.
Other
Operating Expense
Other
operating expense reflects the $700,000 charge for executive termination
benefits costs recorded in connection with the non-renewal of an executive
employment agreement. These costs are expected to be paid out over 15 months
beginning September 2010.
Other
Expenses, net
Other
expenses, net, were $920,000 compared with $74,000 in the second quarter of 2009
due primarily to foreign exchange losses recorded during the quarter due to a
weakened Euro, coupled with the approximate $267,000 non-cash loss on early
extinguishment of the Broadwood note payable as a result of the write-off of the
remaining unamortized note discount, and a decrease in royalty
income.
28
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 those years STAAR raised additional funds to support
operations through sales of equity and debt securities.
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. The
Domilens divestiture yielded a total of approximately $11.8 million in net cash
proceeds to STAAR. On March 30, 2010, a global settlement of the
Parallax and Moody cases was reached and in June 2010, STAAR’s $4.0 million
contribution to the global settlement was paid from the $7.3 million release of
the restricted deposit by the Court. The significant improvement in
the Company’s cash position enabled STAAR to both redeem all the outstanding
shares of its Series A preferred stock at an aggregate redemption value of $6.8
million and repay the $5.0 million Broadwood note, plus interest, thereby
significantly enhancing its balance sheet and financial position.
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 flows from operating
activities, proceeds from the Domilens divestiture, sale of STAAR common stock,
and borrowings under the Company’s credit facilities. 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.
The
Company believes its current cash balances coupled with cash flow from operating
activities will be sufficient to meet its working capital requirements for the
foreseeable future. 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.
Overview
of Changes in Cash and Cash Equivalents and Other Working Capital
Accounts.
As of
July 2, 2010 and January 1, 2010, the Company had $8.0 million and $13.7
million, respectively, of cash and cash equivalents and restricted
cash.
Net cash
used in operating activities was $5.1 million for the six months ended July 2,
2010, compared to $0.2 for the six months ended July 3, 2009. This
use of cash from operations in the period included the following significant
items: payment of $4.0 million related to the global settlement of the legal
judgments and $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 $0.8 million interest paid
for the Broadwood note.
Net cash
provided by investing activities was $18.8 million for the six months ended July
2, 2010, compared to cash used in investing activities of $7.5 million for the
six months ended July 3, 2009. Net cash provided by investing
activities was mainly due to the $11.8 million net cash proceeds from the sale
of our German subsidiary in March 2010 and the release of the $7.3 million
restricted deposit by the Court in June 2010, offset by $0.2 million of
acquisitions of property, plant and equipment. For the six months
ended July 3, 2009, net cash used in investing activities includes the $7.3
million of posted as a deposit with the Court in June 2009 for the then Parallax appeal and $0.2
million in acquisition of property, plant and equipment.
Net cash
used in financing activities was $12.2 million for the six months ended July 2,
2010 compared to $8.6 million in net cash provided by financing activities for
the six months ended July 3, 2009. Net cash used in financing
activities includes the $5 million principal payment of the Broadwood note, the
$6.8 million cash redemption of the Series A preferred shares and repayment of
principal of our capital lease obligations of $0.5 million, offset by cash
proceeds from stock option exercises of $0.1 million. Net cash
provided by financing activities for the comparable period in 2009 includes the
$8.5 million net proceeds from the June 17, 2009 Common Stock offering to
certain institutional investors and additional $0.6 million from borrowings from
our Japanese line of credit, offset by capital lease principal repayments of
$0.5 million.
29
Credit
Facilities, Contractual Obligations and Commitments
Accrued
Termination Benefits for Executive
On May 24, 2010, STAAR accrued $700,000
in executive termination benefit costs in connection with the non-renewal of an
executive employment agreement. This accrual represents STAAR’s
current best estimate of the contractual termination benefits due to the
executive. The actual amount ultimately paid to the executive may be
different than the amount estimated. These costs are expected to be
paid out to the executive over 15 months, including a three-month period during
which the executive will remain employed but have no further obligation to
perform his duties as an employee, beginning in September 2010.
Credit
Facilities
As
detailed below, STAAR’s only significant credit facilities are the following
arrangements:
Capital
Lease Agreements
The Company has certain agreements with
Farnam Street Financial, Inc. (“Farnam”) which provides lease financing to the
Company for purchases of property, plant and equipment. These
agreements are under various individual lease “Schedules” which commit the
Company to lease a set contractual amount of assets per
Schedule. Each Schedule has its own term, required commitment amount
and lease factor (interest rate). In accordance with the requirements
of ASC 840-10-25, all purchases under these Schedules are accounted for as
capital leases. 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 within its Schedule of assets at the
end of that Schedule’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. Amortization of the total capital lease obligation under any
lease Schedule does not begin until the Company draws on the full amount of the
commitment under that particular Schedule which is referred to as the Schedule
“Commencement Date”. However, as individual asset leases are entered
into pursuant to a particular Schedule but prior to the Commencement Date, the
Company pays Farnam “interim rent” based on a predetermined lease factor applied
to the actual principal amount of the purchases. Below is a table for
all existing Schedules the Company has with Farnam as of July 2, 2010 (in
thousands):
As of July 2, 2010
|
|||||||||||||||||||
Schedule
|
Commencement
|
Expiration
|
Original
Required
|
Obligation
|
Available
|
||||||||||||||
Number
|
Date
|
Term
|
Date
|
Commitment
|
Balance
|
Credit
|
|||||||||||||
001
|
April
1, 2007
|
36
Months
|
April
1, 2010
|
$ | 959 | $ | - | $ | - | ||||||||||
002
|
September
1, 2007
|
36
Months
|
September
1, 2010
|
527 | 17 | - | |||||||||||||
003
|
January
1, 2008
|
36
Months
|
January
1, 2011
|
387 | 63 | - | |||||||||||||
004
|
March
1, 2009
|
30
Months
|
September
1, 2011
|
150 | 73 | - | |||||||||||||
005
|
Pending
|
Pending
|
N/A
|
250 | 31 | 219 | |||||||||||||
$ | 2,273 | $ | 184 | $ | 219 |
On April 1, 2010, Schedule 001 matured
and on April 26, 2010, the Company entered into a new Schedule 005 and, after
making contractual monthly payments thereon, Farnam will transfer title to the
assets under the previous Schedule 001 lease to the Company at termination and
provide the Company $250,000 of availability for new equipment
financing. Schedule 005 term will not commence until the Company
draws on the full $250,000 for new asset purchases and will terminate
twenty-four months after the Commencement Date, assuming all payments are made
timely; the monthly payments currently being made to Farnam under Schedule 005
are all considered “interim rent” and include both the previous assets leased
under Schedule 001 and the new assets financed under Schedule 005.
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 $3.4 million based on the rate of exchange on July 2, 2010),
at an interest rate equal to the Tokyo short-term prime interest rate
(approximately 1.475% as of July 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 July 2, 2010 and January 1, 2010,
(approximately $2.3 million and $2.2 million based on the foreign exchange rates
on July 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.
30
Covenant
Compliance
The Company is in compliance with the
covenants of its credit facilities as of the date of this report.
Off-Balance
Sheet Arrangements
We
do not have any off-balance sheet arrangements, as that term is defined in the
rules of the SEC, that have or are reasonably likely to have a current or future
effect on our financial condition, changes in financial condition, revenues or
expenses, results of operations, liquidity, capital expenditures or capital
resources that are material to investors.
ITEM
3. QUANTITATIVE AND
QUALITATIVE DISCLOSURES ABOUT MARKET RISK
There have been no material changes in
the Company’s qualitative and quantitative market risk since the disclosure in
the Company’s Annual Report on Form 10-K for the year ended January 1,
2010.
ITEM
4. CONTROLS AND
PROCEDURES
Disclosure
Controls and Procedures
As of the
end of the period covered by this report, we carried out an evaluation, under
the supervision and with the participation of our management, including our CEO
and CFO, of the effectiveness of the design and operation of the disclosure
controls and procedures of STAAR Surgical Company and its subsidiaries (the
“Company”). Based on that evaluation, our CEO and CFO concluded, as
of the end of the period covered by this quarterly report on Form 10-Q, that our
disclosure controls and procedures were effective. For purposes of
this statement, the term “disclosure controls and procedures” means controls and
other procedures of the Company that are designed to ensure that information
required to be disclosed by the Company in the reports that it files or submits
under the Securities Exchange Act (15 U.S.C. 78a et seq.) is recorded,
processed, summarized and reported, within the time periods specified in the
Commission's rules and forms. Disclosure controls and procedures include,
without limitation, controls and procedures designed to ensure that information
required to be disclosed by an issuer in the reports that it files or submits
under the Act is accumulated and communicated to the issuer's management,
including its principal executive and principal financial officers, or persons
performing similar functions, as appropriate to allow timely decisions regarding
required disclosure.
Our
management, including the CEO and the CFO, do not expect that our disclosure
controls and procedures or our internal control over financial reporting will
necessarily prevent all fraud or material errors. An internal control system, no
matter how well conceived and operated, can provide only reasonable, not
absolute, assurance that the objectives of the control system are met. Further,
the design of a control system must reflect the fact that there are resource
constraints, and the benefits of controls must be considered relative to their
costs. Because of the inherent limitations on all internal control systems, our
internal control system can provide only reasonable assurance of achieving its
objectives and no evaluation of controls can provide absolute assurance that all
control issues and instances of fraud, if any, within our Company have been
detected. These inherent limitations include the realities that judgments in
decision-making can be faulty, and that breakdowns can occur because of simple
error or mistake. Additionally, controls can be circumvented by the individual
acts of some persons, by collusion of two or more people, or by management
override of the control. The design of any system of internal control is also
based in part upon certain assumptions about the likelihood of future events,
and can provide only reasonable, not absolute, assurance that any design will
succeed in achieving its stated goals under all potential future conditions.
Over time, controls may become inadequate because of changes in circumstances,
or the degree of compliance with the policies and procedures may
deteriorate.
Internal
Control over Financial Reporting
There
were no changes in our internal control over financial reporting during the
quarter ended July 2, 2010 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial
reporting.
31
PART
II – OTHER INFORMATION
ITEM
1. LEGAL
PROCEEDINGS
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.
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.
32
ITEM
6. EXHIBITS
Exhibits
3.1
|
Certificate
of Incorporation, as amended to date.(1)
|
3.2
|
By-laws,
as amended to date.(2)
|
4.1
|
Certificate
of Elimination of Series A Convertible Preferred
Stock.(*)
|
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
|
Amended
and Restated 2003 Omnibus Equity Incentive Plan, and form of Option Grant
and Stock Option Agreement.*
|
31.1
|
Certification
Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, Adopted
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*
|
31.2
|
Certification
Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, Adopted
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*
|
32.1
|
Certification
Pursuant to 18 U.S.C. Section 1350, Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. *
|
(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.
|
*
|
Filed
herewith.
|
33
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
STAAR
SURGICAL COMPANY
|
||
Date: August
11, 2010
|
By: /s/ DEBORAH ANDREWS
|
|
Deborah
Andrews
|
||
Chief
Financial Officer
|
||
(on
behalf of the Registrant and as its
|
||
principal
financial officer)
|
34