STAAR SURGICAL CO - Quarter Report: 2009 April (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C.
20549
Form 10-Q
(Mark
One)
þ
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the quarterly period ended: April 3, 2009
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 30,108,794 shares of common stock, par value $0.01 per share,
issued and outstanding as of May 1, 2009.
STAAR
SURGICAL COMPANY
INDEX
PAGE
|
|||
NUMBER
|
|||
PART
I – FINANCIAL INFORMATION
|
|||
Item 1.
|
Financial
Statements (Unaudited).
|
||
Condensed
Consolidated Balance Sheets – April 3, 2009 and January 2,
2009.
|
1
|
||
|
|||
Condensed
Consolidated Statements of Operations – Three Months Ended April 3, 2009
and March 28, 2008.
|
2
|
||
|
Condensed
Consolidated Statements of Cash Flows – Three Months Ended
April 3, 2009 and March 28, 2008.
|
3
|
|
Notes
to the Condensed Consolidated Financial Statements.
|
4
|
||
Item 2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations.
|
20
|
|
Item 3.
|
Quantitative
and Qualitative Disclosures About Market Risk.
|
35
|
|
Item 4.
|
Controls
and Procedures.
|
35
|
|
PART
II – OTHER INFORMATION
|
|||
Item 1.
|
Legal
Proceedings.
|
36
|
|
Item 1A.
|
Risk
Factors.
|
37
|
|
Item 6.
|
Exhibits.
|
38
|
|
Signatures
|
39
|
PART
I. FINANCIAL INFORMATION
ITEM
1. FINANCIAL
STATEMENTS
STAAR
SURGICAL COMPANY
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except par value amounts)
(Unaudited)
April 3,
2009
|
January 2,
2009
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 3,722 | $ | 4,992 | ||||
Short-term
investments - restricted
|
— | 179 | ||||||
Accounts
receivable trade, net
|
7,883 | 8,422 | ||||||
Inventories
|
16,301 | 16,668 | ||||||
Prepaids,
deposits and other current assets
|
2,474 | 2,009 | ||||||
Total
current assets
|
30,380 | 32,270 | ||||||
Property,
plant and equipment, net
|
5,629 | 5,974 | ||||||
Intangible
assets, net
|
5,162 | 5,611 | ||||||
Goodwill
|
7,545 | 7,538 | ||||||
Other
assets
|
1,140 | 1,189 | ||||||
Total
assets
|
$ | 49,856 | $ | 52,582 | ||||
LIABILITIES,
REDEEMABLE CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS’ EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 5,910 | $ | 6,626 | ||||
Line
of credit
|
2,020 | 2,200 | ||||||
Deferred
income taxes – current
|
282 | 282 | ||||||
Obligations
under capital leases – current
|
1,046 | 989 | ||||||
Note
payable – current, net of discount
|
4,482 | — | ||||||
Other
current liabilities
|
11,244 | 11,366 | ||||||
Total
current liabilities
|
24,984 | 21,463 | ||||||
Note
payable – long-term, net of discount
|
— | 4,414 | ||||||
Obligations
under capital leases – long-term
|
1,211 | 1,335 | ||||||
Deferred
income taxes – long-term
|
872 | 897 | ||||||
Other
long-term liabilities
|
1,623 | 1,678 | ||||||
Total
liabilities
|
28,690 | 29,787 | ||||||
Commitments,
contingencies and subsequent events (Notes 12 and 15)
|
||||||||
Series
A redeemable convertible preferred stock, $0.01 par value; 10,000 shares
authorized; 1,700 shares issued and outstanding at April 3, 2009 and
January 2, 2009, respectively. Liquidation value $6,800.
|
6,772 | 6,768 | ||||||
Stockholders’
equity:
|
||||||||
Common
stock, $0.01 par value; 60,000 shares authorized; issued and outstanding
30,103 at April 3, 2009 and 29,503 at January 2, 2009
|
301 | 295 | ||||||
Additional
paid-in capital
|
139,878 | 138,811 | ||||||
Accumulated
other comprehensive income
|
1,768 | 2,812 | ||||||
Accumulated
deficit
|
(127,553 | ) | (125,891 | ) | ||||
Total
stockholders’ equity
|
14,394 | 16,027 | ||||||
Total
liabilities, redeemable convertible preferred stock and stockholders’
equity
|
$ | 49,856 | $ | 52,582 |
See
accompanying notes to the condensed consolidated financial
statements.
1
STAAR
SURGICAL COMPANY
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except per share amounts)
(Unaudited)
Three Months Ended
|
||||||||
April 3,
2009
|
March 28,
2008
|
|||||||
Net
sales
|
$ | 18,283 | $ | 17,960 | ||||
Cost
of sales
|
7,944 | 10,205 | ||||||
Gross
profit
|
10,339 | 7,755 | ||||||
General
and administrative
|
4,282 | 4,441 | ||||||
Marketing
and selling
|
5,779 | 6,467 | ||||||
Research
and development
|
1,412 | 1,718 | ||||||
Loss
on settlement of pre-existing distribution arrangement
|
— | 3,850 | ||||||
Operating
loss
|
(1,134 | ) | (8,721 | ) | ||||
Other
income (expense):
|
||||||||
Interest
income
|
3 | 28 | ||||||
Interest
expense
|
(233 | ) | (201 | ) | ||||
Gain
on foreign currency
|
75 | 128 | ||||||
Other
income, net
|
63 | 84 | ||||||
Total
other income (expense), net
|
(92 | ) | 39 | |||||
Loss
before provision for income taxes
|
(1,226 | ) | (8,682 | ) | ||||
Provision
for income taxes
|
436 | 258 | ||||||
Net
loss
|
$ | (1,662 | ) | $ | (8,940 | ) | ||
Loss
per share – basic and diluted
|
$ | (0.06 | ) | $ | (0.30 | ) | ||
Weighted
average shares outstanding –
basic
and diluted
|
29,641 | 29,488 |
See
accompanying notes to the condensed consolidated financial
statements.
2
STAAR
SURGICAL COMPANY
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
(Unaudited)
Three Months Ended
|
||||||||
April 3,
2009
|
March 28,
2008
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$ | (1,662 | ) | $ | (8,940 | ) | ||
Adjustments
to reconcile net loss to net cash used in
operating activities:
|
||||||||
Depreciation
of property and equipment
|
575 | 802 | ||||||
Amortization
of intangibles
|
197 | 250 | ||||||
Amortization
of discount
|
68 | 59 | ||||||
Fair
value adjustment of warrant
|
(50 | ) | (24 | ) | ||||
Loss
on disposal of property and equipment
|
2 | 75 | ||||||
Change
in net pension liability
|
64 | — | ||||||
Stock-based
compensation expense
|
608 | 438 | ||||||
Loss
on settlement of pre-existing distribution arrangement
|
— | 3,850 | ||||||
Other
|
3 | 51 | ||||||
Changes
in working capital, net of business acquisition:
|
||||||||
Accounts
receivable
|
273 | (1,442 | ) | |||||
Inventories
|
(56 | ) | 1,984 | |||||
Prepaids,
deposits and other current assets
|
(72 | ) | (828 | ) | ||||
Accounts
payable
|
(120 | ) | 284 | |||||
Other
current liabilities
|
(278 | ) | 71 | |||||
Net
cash used in operating activities
|
(448 | ) | (3,370 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Cash
acquired in acquisition of Canon Staar, net of
acquisition
costs
|
— | 2,743 | ||||||
Acquisition
of property and equipment
|
(154 | ) | (234 | ) | ||||
Proceeds
from sale of short-term investments - restricted
|
— | 33 | ||||||
Proceeds
from sale of property and equipment
|
38 | — | ||||||
Net
change in other assets
|
(24 | ) | (1 | ) | ||||
Net
cash provided by (used in) investing activities
|
(140 | ) | 2,541 | |||||
Cash
flows from financing activities:
|
||||||||
Borrowings
under line of credit
|
— | 940 | ||||||
Repayment
under line of credit
|
— | (940 | ) | |||||
Repayment
of capital lease lines of credit
|
(282 | ) | (152 | ) | ||||
Net
cash used in financing activities
|
(282 | ) | (152 | ) | ||||
Effect
of exchange rate changes on cash and cash equivalents
|
(400 | ) | 608 | |||||
Decrease
in cash and cash equivalents
|
(1,270 | ) | (373 | ) | ||||
Cash
and cash equivalents, at beginning of the period
|
4,992 | 10,895 | ||||||
Cash
and cash equivalents, at end of the period
|
$ | 3,722 | $ | 10,522 |
See
accompanying notes to the condensed consolidated financial
statements.
3
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
April
3, 2009
(Unaudited)
Note
1 — Basis of Presentation and Significant Accounting Policies
The
condensed balance sheet as of January 2, 2009 included in this report, which has
been derived from audited financial statements, and the accompanying unaudited
interim condensed consolidated financial statements, have been prepared in
accordance with accounting principles generally accepted in the U.S. for interim
financial information and with the instructions to Form 10-Q and Article 10 of
Regulation S-X of the Securities Exchange Commission. Accordingly,
they do not include all the information and footnotes required by accounting
principles generally accepted in the U.S. for complete financial
statements. The condensed consolidated financial statements for the
three months ended April 3, 2009 and March 28, 2008, 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 2, 2009.
The
results of operations for the three months ended April 3, 2009 and March 28,
2008 are not necessarily indicative of the results to be expected for any other
interim period or for the entire year.
Each of the Company's reporting periods
ends on the Friday nearest to the quarter ending date and generally consists of
13 weeks. Unless the context indicates otherwise “we,” “us,” the
“Company,” and “STAAR” refer to STAAR Surgical Company and its consolidated
subsidiaries.
The
accompanying unaudited interim condensed consolidated financial statements have
been prepared assuming that the Company will continue as a going concern, which
contemplates the realization of assets and the liquidation of liabilities in the
normal course of business. For several years STAAR has incurred significant
losses, has not generated sufficient cash to sustain its operations, and has
relied on debt and equity financing to supplement cash from operations. As of
April 3, 2009, STAAR had approximately $3.7 million of cash and cash
equivalents. STAAR’s likely cash requirements rose considerably on March 2,
2009, when an adverse verdict against STAAR in Parallax Medical Systems, Inc.
(“Parallax”) v. STAAR
Surgical Company. This case, originally filed on September 21, 2007,
resulted in an award against STAAR of approximately $2.2 million in actual
damages and $2.7 million in punitive damages. The $4.9 million judgment is
included in “other current liabilities” on the consolidated balance sheets as
April 3, 2009 and January 2, 2009. The Parallax judgment, along with
STAAR’s history of recurring losses, negative cash flows and limited access to
capital, has raised substantial doubt regarding STAAR’s ability to continue as a
going concern. The accompanying unaudited interim condensed consolidated
financial statements do not include any adjustments that might result from the
outcome of this uncertainty.
Going Concern
STAAR seeks to overcome the substantial
doubt concerning its ability to continue as going concern by doing one or more
of the following: continuing to pursue its strategic operating goals for
enhanced profitability, by obtaining new debt and/or equity financing and by
exploring other financing options. STAAR’s strategic operating goals
include the following:
·
Improve cash flow and continue cost reduction
efforts. In the latter part of 2007 and throughout 2008, STAAR
implemented cost-cutting measures and began a process to closely rationalize and
evaluate its spending levels, which included a targeted reduction in the U.S.
workforce, streamlining the U.S. organization by reducing spending levels in all
areas of the business, renegotiating or eliminating certain obligations, and
eliminating all cash executive bonus opportunities until STAAR showed positive
trends toward achieving profitability. Through these efforts STAAR
has significantly reduced its cash used in operating activities in the first
quarter of 2009 as compared to both the same period in the prior year and the
fourth quarter in 2008 and, if recent operating trends continue, STAAR may
generate positive cash flow from operations during one or more quarters of
2009;
· Increase gross profit margins. In
recent periods STAAR has experienced increased sales in ICLs both domestically
and internationally and in IOLs internationally. STAAR believes that
the key to achieving profitability is to increase profit margins, primarily by
increasing ICL sales as a percentage of STAAR’s overall product
mix. ICLs and TICLs generally yield higher margins and continue to
represent the fastest growing product line of STAAR’s business. While
the ICL and TICL are approved for sale in over 50 countries, STAAR has achieved
increasing sales and market share of the refractive surgical market in a number
of select countries, including in the U.S., South Korea, China, India, Spain,
Germany and Latin America. Bringing ICL and TICL to new markets, and
expanding market share in existing markets, will improve STAAR’s profitability
and during 2009 STAAR will focus its sales efforts on this
goal;
4
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
April
3, 2009
(Unaudited)
· Secure key regulatory
approvals. Regulatory approval of higher margin products in
significant markets can yield rapid sales growth and improve
profitability. The principal regulatory approvals pursued by STAAR at
this time are the U.S. approval of the TICL and the approval of ICL and TICL in
Japan. Although the timing of the regulatory approval is never certain, the
Company believes approval of these products could be granted in
2009.
In addition, STAAR’s ability to
overcome this substantial doubt concerning its ability to continue as a going
concern depends on several factors involving certain current litigation
matters. On May 11, 2009 the court entered final judgment reaffirming
the $4.9 million judgment rendered in the jury verdict. The Court has
stayed the execution of judgment and collection of damages until June 22, 2009,
forty days after the rendering of final judgment. Following
expiration of the stay, to avoid enforcement of the judgment pending resolution
of the appeal, STAAR will be required to obtain a surety bond of up to 1.5 times
the judgment amount, or up to approximately $7.4 million, fully secured with
cash collateral, unless a court permits a lesser amount. On May 15,
2009, the court will hear argument on Parallax’s motion for legal
fees in the amount of approximately $314,000 related to its defense of STAAR’s
cross complaint. STAAR is opposing this motion on grounds that it has
no legal or factual basis, as well as on procedural grounds. STAAR
cannot predict the outcome of this hearing and cannot estimate the amount or
range of loss, if any, in the event of an unfavorable outcome related to the
motion for legal fees. If STAAR is unable to obtain additional
capital to satisfy the judgment or post an appeal bond before June 23, 2009
STAAR could be required to petition for protection under federal bankruptcy
laws, which could further impair its financial position and
liquidity. In addition, another lawsuit similar to the Parallax case, Moody v. STAAR Surgical Company, is
currently scheduled for trial in the Superior Court of California, County of
Orange, on October 19, 2009 and could result in further significant
liability. Because no two courts or trials are identical, the outcome
of the Moody case
cannot be predicted and STAAR cannot estimate the amount or range of loss, if
any, in the event of an unfavorable outcome.
Among the events of default in the
Amended and Restated, Senior Secured Promissory Note (“the Note”), amended and
restated on April 13, 2009 (see Note 8), held by Broadwood Partners, L.P. is any
judgment in excess of $500,000 against the Company that “shall remain unpaid.”
On April 2, 2009, after preliminary judgment was entered, Broadwood and STAAR
entered into a Temporary Waiver Agreement with respect to any event of default
that may occur, or may be deemed to have occurred, under the Note as a result of
the Parallax
judgment. The Temporary Waiver Agreement provides that no such default
will be deemed to have occurred until expiration of the stay of judgment.
If at that time STAAR cannot satisfy the judgment or fund an appeal bond, an
event of default will occur under the Note resulting in the Note becoming
immediately due and payable. As STAAR currently does not have cash or a
binding agreement to provide funds sufficient to satisfy the judgment or fund an
appeal bond, STAAR’s obligation under the Note, net of the related discount, has
been reclassified as current indebtedness in STAAR’s consolidated balance sheet
as of April 3, 2009.
The substantial doubt about STAAR’s
ability to continue as a going concern and this reclassification of the Note as
current indebtedness could also affect STAAR’s relationship with its trade
suppliers and their willingness to continue to conduct business with STAAR on
terms consistent with historical practice. These suppliers might respond to an
apparent weakening of our liquidity position and to address their own liquidity
needs may request faster payment of invoices, new or increased deposits or other
assurances. If this were to happen, the Company’s need for cash would
be intensified and we might be unable to make payments to our suppliers as they
become due.
If the Company is unable to satisfy the
judgment or fund an appeal bond it may be potentially required seek relief under
the U.S. Bankruptcy Code.
5
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
April
3, 2009
(Unaudited)
New
Accounting Pronouncements
In May
2008 the Financial Accounting Standards Board (FASB) issued FASB Staff Position
(FSP No. APB 14-1), Accounting
for Convertible Debt Instruments That
May Be Settled in Cash upon Conversion (Including Partial Cash
Settlement). This FSP applies to convertible debt instruments
that, by their stated terms, may be settled in cash (or other assets) upon
conversion, including partial cash settlement, unless the embedded conversion
option is required to be separately accounted for as a derivative under SFAS No.
133, Accounting for Derivative
Instruments and Hedging Activities. This FSP clarifies that
convertible debt instruments that may be settled in cash upon conversion
(including partial cash settlement) are not addressed by paragraph 12 of APB
Opinion No. 14, Accounting for
Convertible Debt and Debt Issued with Stock Purchase Warrants.
Additionally, this FSP specifies that issuers of such instruments should
separately account for the liability and equity components in a manner that will
reflect the entity’s nonconvertible debt borrowing rate when interest cost is
recognized in subsequent periods. This FSP is effective for financial
statements issued for fiscal years beginning after December 15, 2008, and
interim periods within those fiscal years. As the Company has no
convertible debt instruments, the provisions of this FSP did not have an impact
on the Company’s consolidated financial statements.
In June
2008, the Emerging Issues Task Force (EITF) issued EITF Abstracts Issue no.
07-5, Determining Whether an
Instrument (or Embedded Feature) Is Indexed to an Entity's Own Stock,
(EITF 07-5). The objective of this Issue is to provide guidance for
determining whether an equity-linked financial instrument (or embedded feature)
is indexed to an entity's own stock. This Issue applies to any
freestanding financial instrument or embedded feature that has all the
characteristics of a derivative in paragraphs 6–9 of SFAS No. 133 for purposes
of determining whether that instrument or embedded feature qualifies for the
first part of the scope exception in paragraph 11(a) of SFAS No. 133. Paragraph
11(a) of SFAS No. 133 specifies that a contract that would otherwise meet the
definition of a derivative under that Statement issued or held by the reporting
entity that is both (a) indexed to its own stock and (b) classified in
stockholders' equity in its statement of financial position shall not be
considered a derivative financial instrument for purposes of applying that
Statement. If a freestanding financial instrument (for example, a
stock purchase warrant) meets the scope exception in paragraph 11(a) of
Statement 133, it is classified as an equity instrument and is not accounted for
as a derivative instrument. This Issue also applies to any
freestanding financial instrument that is potentially settled in an entity's own
stock, regardless of whether the instrument has all the characteristics of a
derivative in paragraphs 6–9 of SFAS No. 133, for purposes of determining
whether the instrument is within the scope of EITF Issue No. 00-19, Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company's Own
Stock. EITF 07-5 is effective for financial statements issued
for fiscal years beginning after December 15, 2008, and interim periods within
those fiscal years. Earlier application by an entity that has
previously adopted an alternative accounting policy is not
permitted. The provisions of EITF 07-5 were effective for the
Company’s current fiscal year beginning January 3, 2009. After
evaluating the applicable financial instruments the Company has outstanding,
management determined that the provisions of this issue had no impact on the
Company’s consolidated financial position and results of
operations.
On April
9, 2009, the Financial Accounting Standards Board issued FASB Staff Position No.
157-4 (FSP No. 157-4), Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly
Decreased and Identifying Transactions That Are Not
Orderly. This FSP provides additional guidance for estimating
fair value in accordance with SFAS No. 157, Fair Value Measurements, when
the volume and level of activity for the asset or liability have significantly
decreased. This FSP also includes guidance on identifying circumstances that
indicate a transaction is not orderly. This FSP shall be effective
for interim and annual reporting periods ending after June 15, 2009, and shall
be applied prospectively. The Company does not believe that the
provisions of this FSP, when effective, will result in a significant impact to
its consolidated financial statements.
On April
9, 2009, the FASB issued FSP No. 107-1 and APB-28-1, Interim Disclosures about Fair Value
of Financial Instruments. This FSP amends SFAS No. 107, Disclosures about Fair Value of
Financial Instruments, to require disclosures about fair value of
financial instruments for interim reporting periods of publicly traded companies
as well as in annual financial statements. This FSP also amends APB
Opinion (APB) No. 28, Interim
Financial Reporting, to require those disclosures in summarized financial
information at interim reporting periods. This FSP applies to all
financial instruments within the scope of SFAS No. 107 held by publicly traded
companies, as defined by APB 28. This FSP shall be effective for
interim and annual reporting periods ending after June 15, 2009, and shall be
applied prospectively. The Company does not believe that the
provisions of this FSP, when effective, will result in a significant impact to
its consolidated financial statements.
6
STAAR
SURGICAL COMPANY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
April
3, 2009
(Unaudited)
On April
1, 2009, the FASB issued FSP No. 141(R)-1, Accounting for Assets Acquired and
Liabilities Assumed in a Business Combination That Arise from
Contingencies. This FSP amends and clarifies SFAS No.
141 (revised 2007), Business
Combinations, to address application issues raised by preparers,
auditors, and members of the legal profession on initial recognition and
measurement, subsequent measurement and accounting, and disclosure of assets and
liabilities arising from contingencies in a business
combination. This FSP shall be effective for assets or liabilities
arising from contingencies in business combinations for which the acquisition
date is on or after the beginning of the first annual reporting period beginning
on or after December 15, 2008. The adoption of the provisions of this
FSP did not have any impact to the Company’s consolidated financial
statements.
7
Note 2 —
Short-Term Investments-Restricted
Short-term
investments at January 2, 2009 consisted of an original maturity four-month
Certificate of Deposit at 7.5% held by our subsidiary in Australia, which
matured in February 2009. The Company does not have any other
short-term investments.
Note 3 — Inventories
Inventories
are stated at the lower of cost, determined on a first-in, first-out basis, or
market and consisted of the following (in thousands):
April
3,
|
January
2,
|
|||||||
2009
|
2009
|
|||||||
Raw
materials and purchased parts
|
$ | 1,380 | $ | 1,462 | ||||
Work-in-process
|
3,025 | 3,028 | ||||||
Finished
goods
|
11,896 | 12,178 | ||||||
$ | 16,301 | $ | 16,668 |
Note 4 —
Prepaids, Deposits, and Other Current Assets
Prepaids,
deposits, and other current assets consisted of the following (in
thousands):
April 3,
2009
|
January 2,
2009
|
|||||||
Prepaids
and deposits
|
$ | 1,568 | $ | 1,703 | ||||
Other
current assets*
|
906 | 306 | ||||||
$ | 2,474 | $ | 2,009 |
* No item
in “other current assets” above exceeds 5% of total current
assets.
Note 5
– Goodwill and Other Intangible Assets
Amortizable
intangible assets consisted of the following (in thousands):
April 3, 2009
|
January 2, 2009
|
|||||||||||||||||||||||
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
|
|||||||||||||||||||
Amortized
intangible assets:
|
||||||||||||||||||||||||
Patents
and licenses
|
$ | 10,678 | $ | (7,681 | ) | $ | 2,997 | $ | 10,739 | $ | (7,578 | ) | $ | 3,161 | ||||||||||
Customer
relationships
|
1,584 | (198 | ) | 1,386 | 1,725 | (172 | ) | 1,553 | ||||||||||||||||
Developed
technology
|
1,007 | (228 | ) | 779 | 1,096 | (199 | ) | 897 | ||||||||||||||||
Total
|
$ | 13,269 | $ | (8,107 | ) | $ | 5,162 | $ | 13,560 | $ | (7,949 | ) | $ | 5,611 |
As of
April 3, 2009 the gross carrying amount of the amortizable intangible assets had
decreased by $291,000 as a result of changes in the exchange
rate. The change in the carrying amount of goodwill for the three
months ended April 3, 2009, is due to the effects of foreign currency
translation.
8
Note 6
– Other Current Liabilities
Other
current liabilities consisted of the following (in thousands):
April 3,
2009
|
January 2,
2009
|
|||||||
Accrued
salaries and wages
|
$ | 2,351 | $ | 2,467 | ||||
Commissions
due to outside sales representatives
|
298 | 395 | ||||||
Accrued
audit fees
|
220 | 413 | ||||||
Customer
credit balances
|
608 | 546 | ||||||
Accrued
income taxes
|
677 | 486 | ||||||
Accrued
legal
|
445 | 383 | ||||||
Accrued
insurance
|
290 | 380 | ||||||
Accrued
legal judgment
|
4,900 | 4,900 | ||||||
Other*
|
1,455 | 1,396 | ||||||
$ | 11,244 | $ | 11,366 |
* No item
in “other” above exceeds 5% of total current liabilities.
Note 7
– Employee Benefits
The Company has historically maintained
a passive pension plan (the “Swiss Plan”) covering employees of its Swiss
subsidiary, which has been accounted for as a defined benefit plan under the
provisions of Statement of Financial Accounting Standards (“SFAS”) No. 158,
“Employers’ Accounting for Defined Benefit Pension and Other Postretirement
Plans,” an amendment of SFAS Nos. 87, 88, 106 and 132R (“SFAS
158”).
In connection with the Company’s
acquisition of the remaining interest in STAAR Japan, Inc., STAAR assumed the
net pension liability under STAAR Japan’s noncontributory defined benefit
pension plan (“Japan Plan”) substantially covering all of the employees of STAAR
Japan. STAAR Japan accounts for the Japan Plan under the requirements
of SFAS 158.
The following table summaries the
components of net periodic pension cost recorded in general and administrative
expenses for the Company’s defined benefit plans (in thousands):
Three Months
Ended
April 3,
2009
|
Three Months
Ended
March 28,
2008
|
|||||||
Service
cost
|
$ | 138 | $ | 97 | ||||
Interest
cost
|
33 | 33 | ||||||
Expected
return on plan assets
|
(24 | ) | (27 | ) | ||||
Amortization
of unrecognized transition obligation or asset
|
6 | 6 | ||||||
Amount
of gain recognized due to a settlement or curtailment
|
(5 | ) | (4 | ) | ||||
Recognized
actuarial loss
|
8 | 5 | ||||||
$ | 156 | $ | 110 |
During
the three months ended April 3, 2009 and March 28, 2008, the Company made cash
contributions totaling approximately $84,000 and $62,000 to its defined benefit
pension plans. The Company expects to make additional cash
contributions totaling approximately $254,000 to its defined benefit pension
plans during the remainder of 2009.
9
Note 8 —
Note Payable
Broadwood
Promissory Notes
On December 14, 2007, the Company
borrowed $5 million from Broadwood Partners, L.P. (“Broadwood”), a stockholder
in the Company, pursuant to a Senior Promissory Note between the Company and
Broadwood. On April 2, 2009, after the preliminary Parallax judgment was entered, Broadwood and
STAAR entered into a Temporary Waiver Agreement with respect to any event of
default that may occur, or may be deemed to have occurred, under the Note as a
result of the Parallax
judgment. In consideration of the Temporary Waiver Agreement, STAAR
agreed to amend the Senior Promissory Note to grant to Broadwood a security
interest in substantially all of STAAR’s assets to secure STAAR’s obligations
under the original Senior Promissory Note. To effectuate this grant of a
security interest, as of April 13, 2009, the Company and Broadwood entered into
an Amended and Restated Senior Secured Promissory Note (the “Note”) and Security
Agreement (see Note 15). All other key terms of the Note remained
unchanged. The Note has a term of three years and bears interest at a rate
of 7% per annum, increasing to 20% per annum if there is a
default. The Note may be pre-paid by the Company at any time without
penalty, with prior notice, and is not subject to covenants based on financial
performance or financial condition (except for insolvency). The Note
provides that, with certain exceptions, the Company will not incur indebtedness
senior to or at parity with its indebtedness under the Note without the consent
of Broadwood. Based on representations made by Broadwood in the
Promissory Note, on the date of the initial transaction, Broadwood beneficially
owned 4,396,231 shares of the Company’s common stock, comprising 15% of the
Company’s common stock as of December 14, 2007. Based on publicly
available information filed by Broadwood, Neal Bradsher, President of Broadwood
Partners, L.P., may have been deemed to beneficially own all of the 4,396,231
shares. Based on publicly available information, as of March 30, 2009,
Broadwood beneficially owned 4,869,276 shares of the Company’s common stock
comprising approximately 16% of the Company’s common stock.
As additional consideration for the
loan, the Company also entered into a Warrant Agreement with Broadwood (the
“December 2007 Warrant Agreement”) with Broadwood granting the right to purchase
up to 700,000 shares of Common Stock at an exercise price of $4.00 per share,
exercisable for a period of six years. The December 2007 Note also provides that
if any indebtedness remains outstanding under the Note on June 1, 2009, the
Company will issue additional warrants on the same terms as set forth in the
December 2007 Warrant Agreement in a number equal to 700,000 times the
percentage of the original $5 million principal that remains
outstanding. As of the date of this report, these additional 700,000
warrants are issuable because the Company has not given notice of pre-payment,
and does not intend to pre-pay, any of the outstanding principal balance by June
1, 2009. The issuance of these additional warrants will be treated as
an additional discount on the Note and amortized to interest expense over the
remaining term of the Note using the effective interest method. The
December 2007 Warrant Agreement also provides that the Company will register for
resale with the Securities Exchange Commission (“SEC”) the 700,000 shares
issuable on exercise of the December 2007 Warrant, and the 700,000 shares that
are issuable under additional warrants if indebtedness remains outstanding on
the Note on June 1, 2009. The Company filed and secured effectiveness
of a registration statement covering resale of the shares. If the
registration statement is not kept effective by the Company and the lapse
exceeds permitted suspensions, the Company is obligated to issue additional
30,000 warrants per month for each month that the Company remains non-compliant
with maintaining registration requirement through the term of the warrants as
the sole remedy to the warrant holder (a maximum of approximately 1,700,000
warrants issuable as of April 3, 2009 under an assumed noncompliance as of that
date). The December 2007 Warrant Agreement has been accounted for as
an equity instrument in accordance with the provisions of EITF
00-19. Additionally, in accordance with Accounting Principles Board
(“APB”) Opinion No. 14, “Accounting for Convertible Debt and Debt Issued with
Stock Purchase Warrants,” the total $5 million proceeds were allocated to the
December 2007 Warrant and Note based on their relative fair values,
approximating $842,000 and $4.2 million on the issuance date, respectively. The
$842,000 was treated as an additional discount on the loan and is being
amortized using the effective interest method over the life of the loan (which
approximates an effective interest rate of 14% per annum as of April 3, 2009).
See Note 13 for the disclosures related to the March 2007 Warrant
Agreement.
The fair value of the warrant was
estimated on the December 14, 2007 issuance date using a Black-Scholes option
valuation model applying the assumptions noted in the following
table.
As of
December 14, 2007
|
||||
Expected
dividends
|
0 | % | ||
Expected
volatility
|
67.3 | % | ||
Risk-free
rate
|
3.88 | % | ||
Remaining
life (in years)
|
6.0 |
10
Capital
Lease Agreements
The Company’s lease agreement with
Farnam Street Financial, Inc. (“Farnam”), as amended on October 9, 2006,
provides for purchases of up to $1,500,000 of property, plant and equipment. In
accordance with the requirements of SFAS 13 “Accounting for Leases,” purchases
under this facility are accounted for as capital leases and generally have a
thirty-month to three-year term. Under the agreement, the Company has the option
to purchase any item of the leased property at the end of that item’s lease
term, at a mutually agreed-upon fair value. On April 1, 2007, the
Company signed an additional leasing schedule with Farnam, which provided for
additional purchases of $800,000 during 2008. The terms of this new schedule
conform to the amended agreement dated October 9, 2006.
Lines
of Credit
The Company’s German subsidiary,
Domilens, entered into a credit agreement on August 30, 2005. The credit
agreement provides for borrowings of up to 100,000 EUR ($134,000 at the rate of
exchange on April 3, 2009), at a rate of 8.5% per annum and does not have a
termination date. The credit agreement is automatically renewed on an annual
basis based on the same terms. The credit agreement may be terminated
by the lender in accordance with its general terms and conditions. The credit
facility is not collateralized. There were no borrowings outstanding
as of April 3, 2009 and January 2, 2009 and the full amount of the line was
available for borrowing as of April 3, 2009.
The Company’s Japanese subsidiary,
STAAR Japan, has an agreement, as amended, with Mizuho Bank providing borrowings
of up to 400,000,000 Japanese Yen (approximately $4.0 million based on the rate
of exchange on April 3, 2009), at an interest rate equal to the Tokyo short-term
prime interest rate (approximately 1.475% as of April 3, 2009) and terminates on
April 20, 2010, but may be renewed annually. The credit facility is
not collateralized. The Company had 200,000,000 Japanese Yen
outstanding on the line of credit as of April 3, 2009 and January 2, 2009
(approximately $2.0 million based on the exchange rate on April 3,
2009).
Covenant
Compliance
On March 2, 2009, a verdict was
rendered in the case of Parallax Medical Systems,
Inc. v. STAAR Surgical
Company whereby a jury awarded Parallax approximately $4.9
million, comprising of $2.2 million in actual damages and $2.7 million in
punitive damages. On May 11, 2009, the court entered final judgment
in accordance with the jury. Among the events of default in the
Amended and Restated Senior Secured Promissory Note (“the Note”), originally
entered into on December 14, 2007 and amended and restated on April 13, 2009,
held by Broadwood Partners, L.P. is any judgment in excess of $500,000 against
the Company that “shall remain unpaid.” On April 2, 2009, after
preliminary judgment was entered, Broadwood and STAAR entered into a Temporary
Waiver Agreement with respect to any event of default that may occur, or may be
deemed to have occurred, under the Note as a result of the Parallax judgment. The
Temporary Waiver Agreement provides that no such default will be deemed to have
occurred until expiration of the stay of final judgment in the case, or June 23,
2009. If STAAR cannot satisfy the judgment or fund an appeal bond before
June 23, 2009, an event of default will occur under the Note resulting in the
Note becoming immediately due and payable, including interest accruing on the
Note at the maximum default rate of 20%, an increase of approximately $650,000
per year in interest costs. As STAAR currently does not have cash or a
binding agreement to provide funds sufficient to satisfy the judgment or fund an
appeal bond, STAAR’s obligation under the Note, net of the related discount, has
been reclassified as current indebtedness in STAAR’s consolidated balance sheet
as of April 3, 2009.
Note
9 — Redeemable, Convertible Preferred Stock
Under its Certificate of Incorporation
the Company has 10,000,000 shares of “blank check” preferred stock that the
Board of Directors is authorized to issue with such rights, preferences and
privileges as the Board may determine of which 8,300,000 remain available for
issuance. On October 22, 2007, the Board approved the designation of
1,700,000 shares of the preferred stock as Series A Redeemable Convertible
Preferred Stock (“Preferred Stock”) to be issued in connection with the
acquisition of the 50% interest in Canon Staar Co., Inc. which was consummated
on December 29, 2007. On December 29, 2007, the Company issued
the 1,700,000 shares of Preferred Stock to the Canon companies as partial
consideration for their shares of Canon Staar Co., Inc. at an estimated fair
value of $4.00 per share, or $6.8 million in the aggregate.
The
Preferred Stock is redeemable by the Company at any time on or after the first
anniversary of the issuance date at a price of $4.00 per share plus any accrued
or declared but unpaid dividends (“Redemption Price”). The holders of
the Preferred Stock have a right, exercisable at any time on or after the third
anniversary of the issuance date by a majority vote of the Preferred Stock
holders, to require the Company to redeem the Preferred Stock at the Redemption
Price.
The
Preferred Stock is convertible into shares of the Company’s common stock at any
time after the issuance date at a one-to-one conversion ratio that is adjustable
only for stock splits, combinations, subdivisions, dividends or
recapitalizations (“Conversion Ratio”). On the fifth anniversary of
the issuance date, the Preferred Stock expires and each share of Preferred Stock
will be automatically converted to common stock of the Company at the Conversion
Ratio.
11
The fair
value of the Preferred Stock was determined on the issuance date by the Company
with the assistance of a valuation specialist using the Binomial Tree option
valuation model. This model considers the Preferred Stock to be a
derivative asset of the Company’s common stock where the preferred stockholder
has options to choose certain payoffs that maximize returns and therefore
maximize the value of the preferred stock. The payoff available to
the preferred stockholder is contingent on the future market value of the
Company’s common stock. Therefore the model, based on certain
significant management assumptions, analyzes various payoff patterns for
different possible paths that might be followed by the common stock price over
the life of the Preferred Stock until the automatic conversion on the fifth
anniversary of the issuance date.
The significant assumptions used in the
valuation were as follows:
Average
common stock price*
|
$ | 3.12 | ||
Expected
volatility
|
67.4 | % | ||
Expected
dividend yield
|
0 | % | ||
Risk-free
interest rate
|
3.43 | % | ||
Issuer’s
call price per share
|
$ | 4.00 | ||
Redemption
price per share
|
$ | 4.00 |
* Average
common stock price used in the valuation represents the average closing market
price per share of the Company’s common stock a few days before and after the
announcement date of the Canon Staar acquisition.
The Company filed and secured
effectiveness of a registration statement with the SEC for the public resale of
the common stock issuable upon conversion of the Preferred Stock and must
maintain effectiveness for the remainder of the two-year period following
issuance, subject to permitted suspensions of thirty days up to twice a year
under specified circumstances. Other than such permitted suspensions,
if the Company fails to keep the registration statement effective for the
two-year period, as the holders’ sole remedy the Company will be obligated to
issue an additional 30,000 shares of common stock to the holders for each
calendar month that the Company does not meet this effectiveness requirement
(“Penalty Shares”). The Company does not consider the issuance of any
Penalty Shares to be likely.
The rights, preferences and privileges
of the Preferred Stock are specified in a Certificate of Designation that the
Company filed with the Delaware Secretary of State on December 24,
2007. The Preferred Stock does not have voting rights in the election
of directors or any other matter, except as may be required under the Delaware
General Corporation. However, the Company cannot, without the consent
of at least two-thirds of the holders of the Preferred Stock, authorize or issue
any other equity security senior to or at parity with the Preferred Stock as to
dividend, conversion or redemption rights or liquidation
preferences.
The Preferred Stock has the right to
participate equally, on an as-converted basis, in any dividend or distribution
paid to the common stockholders.
On or prior to the effective date of
certain change in control or liquidation events of the Company specified in the
Certificate of Designation, the Preferred Stock is redeemable at the option of
the holder at the Redemption Price; however, the holder will continue to have
the right to convert the Preferred Stock into Common Stock of the Company until
the close of the second business day of the effective date of such an
event.
In the event of a liquidation of the
Company, as defined in the Certificate of Designation, the Preferred
Stockholders have a right to receive a distribution equal to the Redemption
Price prior to the distribution of any funds to the common
stockholders. After payment of the Redemption Price the Preferred
Stockholders do not participate in the distribution of the remaining proceeds of
the liquidation, which will be distributed to the common
stockholders. However, until the effective date of the liquidation,
each Preferred Stockholder may convert their shares to common stock of the
Company and participate in the proceeds of the liquidation to be paid to Common
stockholders in lieu of any liquidation preference.
On
a liquidation or change in control of the Company, if a Preferred Stockholder
does not make a timely election to either receive the Redemption Price or
convert the Preferred shares to common stock, the Certificate of Designation
provides that the Preferred Stockholder will be deemed to have elected the
higher in value of the two alternatives, to be calculated as provided in the
Certificate of Designation.
12
Because after the third anniversary of
issuance the Preferred Stock is redeemable at the option of the holders, which
is not within the control of the Company, the Company has presented the
Preferred Stock in the mezzanine section of the consolidated balance sheet in
accordance with the provisions of EITF Abstracts, Topic No. D-98 (“Topic D-98”),
“Classification and Measurement of Redeemable Securities.” Because
the Preferred Stock fair value recorded on the issuance date approximates the
redemption price, no further accretion will be required by the Company to
redemption value and no subsequent revaluation will be necessary so long as the
Preferred Stock is still considered a temporary equity
instrument. However, issuance and registration costs of approximately
$48,000 were incurred related to the Preferred Stock which were offset against
the fair value of the Preferred Stock on the issuance date and will be accreted
to the redemption value using the interest method with a corresponding charge to
Additional Paid-In Capital over a three-year period.
Note 10 —
Stockholders’ Equity
The
consolidated interim condensed financial statements include “basic” and
“diluted” per share information. Basic per share information is
calculated by dividing net loss by the weighted average number of shares
outstanding. Diluted per share information is calculated by also
considering the impact of potential issuances of common stock on both net income
and the weighted number of shares outstanding. As the Company
was in a net loss position, the potential issuance of 6,275,002 shares of common
stock for the three months ended April 3, 2009 and 6,143,524 for the three
months ended March 28, 2008 were excluded from the computation as the issuance
of those shares would have had an anti-dilutive effect.
Comprehensive
loss
The
components of comprehensive loss are as follows (in thousands):
April 3,
2009
|
March 28,
2008
|
|||||||
Net
loss
|
$ | (1,662 | ) | $ | (8,940 | ) | ||
Minimum
pension liability adjustment
|
(1 | ) | 2 | |||||
Foreign
currency translation adjustment
|
(1,043 | ) | 1,923 | |||||
Total
comprehensive loss
|
$ | (2,706 | ) | $ | (7,015 | ) |
Note
11 — Geographic and Product Data
The
Company reports segment information in accordance with SFAS No. 131,
“Disclosures about Segments of an Enterprise and Related Information” (“SFAS
131”). Under SFAS 131 all publicly traded companies are required to report
certain information about the operating segments, products, services and
geographical areas in which they operate and their major customers.
The
Company markets and sells its products in approximately 50 countries and has
manufacturing sites in the United States, Japan and Switzerland. Other than the
United States, Germany, Japan and now 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, Germany, Japan, South Korea and other locations for each
year, is set forth below (in thousands):
Three Months Ended
|
||||||||
April
3,
|
March
28,
|
|||||||
2009
|
2008
|
|||||||
United
States
|
$ | 4,238 | $ | 4,524 | ||||
Germany
|
6,125 | 6,440 | ||||||
Japan
|
3,700 | 2,952 | ||||||
Korea
|
986 | 750 | ||||||
Other
|
3,234 | 3,294 | ||||||
Total
|
$ | 18,283 | $ | 17,960 |
100% of
the Company’s sales are generated from the ophthalmic surgical product segment
and, therefore, the Company operates as one operating segment for financial
reporting purposes. The Company’s principal products are intraocular lenses
(“IOLs”) used in cataract surgery, implantable collamer lenses (“ICLs”) used in
refractive surgery and other surgical products used primarily in cataract
surgery. The composition of the Company’s net sales by product line
is as follows (in thousands):
13
Three Months Ended
|
||||||||
April
3,
|
March
28,
|
|||||||
2009
|
2008
|
|||||||
IOLs
|
$ | 8,146 | $ | 7,948 | ||||
ICLs
|
5,065 | 4,279 | ||||||
Other
Surgical Products
|
5,072 | 5,733 | ||||||
Total
|
$ | 18,283 | $ | 17,960 |
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
12 — Commitments and Contingencies
Litigation and Claims
Parallax Medical Systems, Inc. v.
STAAR Surgical Company (California Superior Court, County of Orange, Case
No. 07CC10136). Final judgment in this case was entered on May 11,
2009, in accordance with a March 2, 2009 jury verdict awarding
approximately $2.2 million in actual damages and $2.7 million in punitive
damages to Parallax Medical
Systems, Inc. Parallax is a
former independent regional manufacturer’s representative (“RMR”) of
STAAR. Parallax promoted sales of STAAR products in the southeastern
region of the U.S. under a contract that expired on July 31,
2007. Parallax originally filed its complaint against STAAR on
September 21, 2007, claiming, among other things, that STAAR interfered with
Parallax’s prospective economic advantage when it informed a regional IOL
distributor that Parallax had a covenant restricting the sale of competing
products, and that STAAR interfered with Parallax’s contracts when STAAR caused
some of its current or former subcontractors to enter into new agreements to
represent STAAR products. STAAR filed a cross-complaint alleging
breach of contract and misappropriation of trade secrets; the jury found in
favor of Parallax on
the cross-complaint. The complaint sought $48 million in actual
damages and unspecified punitive damages.
Final
judgment was entered following a hearing on principal post-trial motions on May
8, 2009. On May 15, 2009, the court will hear argument on Parallax’s motion for legal
fees in the amount of approximately $314,000 related to its defense of STAAR’s cross
complaint. STAAR is opposing this motion on grounds that it has no
legal or factual basis, as well as on procedural grounds. STAAR
cannot predict whether the ruling on the motion for legal fees will be
granted.
STAAR
believes that the Parallax case was incorrectly
decided as to liability, the amount of compensatory damages and the
appropriateness and amount of punitive damages, and intends to vigorously appeal
the outcome of this case. The court has stayed the execution of
judgment and collection of damages until June 22, 2009, forty days after the
rendering of final judgment. Following expiration of the stay, to
avoid enforcement of the judgment pending resolution of the appeal, STAAR will
be required to obtain a surety bond of up to 1.5 times the judgment amount,
fully secured with cash collateral unless a court permits a lesser
amount.
Moody v. STAAR Surgical Company;
(California Superior Court, County of Orange, Case
No. 07CC10132). Scott C. Moody, Inc., also a former RMR of
STAAR, filed a complaint against STAAR on the same day that Parallax filed its
complaint. Moody promoted sales of STAAR products in the southwestern
region of the U.S., under a contract that, like Parallax’s, expired on July 31,
2007. Like Parallax, Moody claims that STAAR
interfered with Moody’s
prospective economic advantage when it informed a regional IOL distributor that
Moody had a covenant restricting the sale of competing products. The
complaint seeks $32 million in actual damages and unspecified punitive
damages. STAAR has filed a cross-complaint alleging breach of
contract and misappropriation of trade secrets.
The Moody case is currently
scheduled to be tried before a jury on October 19, 2009. STAAR
believes that the evidence to be presented in Moody does not support
liability for interference with prospective business advantage or interference
with Moody’s contracts with former subcontractors, and does not support damages
at a level that is material to STAAR. However, the Parallax and Moody cases have many facts
in common; the plaintiff in Moody alleges that the same
conduct of STAAR interfered with its prospective business advantage, and Moody will also be tried
before a jury. The Moody plaintiff has also
indicated it will seek punitive damages. But because no two courts or
trials are identical, the outcome of the Moody case cannot be
predicted. In particular, important factual differences exist between
the two cases, it is possible that the Moody court will permit
different evidence or arguments to be presented at trial, and the outcome of
jury trials is inherently uncertain. On May 4, 2009, STAAR retained
new counsel for the Moody case following the
appointment of its former lead counsel to a judgeship on the California Superior
Court.
14
Note
13 — Stock-Based Compensation
The Company has adopted Statement of
Financial Accounting Standards No. 123 (revised) “Share Based Payment”, (“SFAS
123R”) effective December 31, 2005. The Company has elected to apply the
Modified Prospective Application (“MPA”) in its implementation of SFAS No. 123R
and its subsequent amendments and clarifications. Under this method, the Company
has recognized stock based compensation expense only for awards newly made or
modified on or after the effective date and for the portion of the outstanding
awards for which requisite service will be performed on or after the effective
date.
15
As of April 3, 2009, the Company has
multiple share-based compensation plans, which are described below. The Company
issues new shares upon option exercise once the optionee remits payment for the
exercise price. The compensation cost that has been charged against income for
the 2003 Omnibus Plan and the 1998 Stock Option Plan is set forth below (in
thousands):
Three Months Ended
|
||||||||
April 3,
2009
|
March 28,
2008
|
|||||||
SFAS
123R expense
|
$ | 276 | $ | 364 | ||||
Common
stock issued to employees
|
287 | — | ||||||
Restricted
stock expense
|
66 | 74 | ||||||
Consultant
compensation
|
(21 | ) | — | |||||
Total
|
$ | 608 | $ | 438 |
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 $33,000 and $49,000
of SFAS No. 123R compensation to inventory for the three months ended April 3,
2009 and March 28, 2008, respectively, and recognizes those amounts as expense
under in Cost of Sales as the inventory is sold.
Stock
Option Plans
In fiscal
year 2003, the Board of Directors approved the 2003 Omnibus Equity Incentive
Plan (the “2003 Plan”) authorizing awards of equity compensation, including
options to purchase common stock and restricted shares of common stock. The 2003
Plan amends, restates and replaces the 1991 Stock Option Plan, the 1995
Consultant Stock Plan, the 1996 Non-Qualified Stock Plan and the 1998 Stock
Option Plan (the “Restated Plans”). Under provisions of the 2003 Plan, all of
the unissued shares in the Restated Plans are reserved for issuance in the 2003
Plan. Each year the number of shares reserved for issuance under the 2003 Plan
is increased if necessary to provide that 2% of the total shares of common stock
outstanding on the immediately preceding December 31 will be reserved for
issuance, up to a maximum of 1,586,371 additional shares, and a maximum total of
6,500,000 shares issuable under the 2003 Plan and all of the Restated Plans
incorporated in it. The 6,500,000 maximum shares were reached on January 1,
2007, and no additional shares will be available for issuance as incentives to
employees without stockholder approval. Shares subject to grants under the 2003
Omnibus Plan that lapse or terminate in accordance with their terms become
available for new grants under the 2003 Omnibus Plan. As of April 3, 2009, there
were no shares authorized and available for grants under the 2003 Omnibus Plan.
The 2003 Plan provides for various forms of stock-based incentives. To date, of
the available forms of awards under the 2003 Plan, the Company has granted only
stock options, restricted stock and unrestricted share grants. Options under the
plan are granted at fair market value on the date of grant, become exercisable
over a three- or four-year period, or as determined by the Board of Directors,
and expire over periods not exceeding 10 years from the date of grant. Certain
option and share awards provide for accelerated vesting if there is a change in
control (as defined in the 2003 Plan). Pursuant to the plan, options for
2,640,500 shares were outstanding at April 3, 2009 with exercise prices ranging
between $0.95 and $9.18 per share. Restricted stock grants under the
2003 Plan generally vest over a period of one, three or four
years. There were 88,177 shares of restricted stock outstanding at
April 3, 2009.
In fiscal year 2000, the Board of
Directors approved the Stock Option Plan and Agreement for the Company’s Chief
Executive Officer authorizing the granting of options to purchase common stock
or awards of common stock. The options under the plan were granted at fair
market value on the date of grant, become exercisable over a three-year period,
and expire 10 years from the date of grant. Pursuant to this plan, options for
500,000 were outstanding at April 3, 2009, with an exercise price of
$11.125.
In fiscal year 1998, the Board of
Directors approved the 1998 Stock Option Plan, authorizing the granting of
options to purchase common stock or awards of common stock. Under the provisions
of the plan, 1.0 million shares were reserved for issuance; however, the maximum
number of shares authorized may be increased provided such action is in
compliance with Article IV of the plan. During fiscal year 2001, pursuant to
Article IV of the plan, the stockholders of the Company authorized an additional
1.5 million shares. Generally, options under the plan are granted at fair market
value at the date of the grant, become exercisable over a three-year period, or
as determined by the Board of Directors, and expire over periods not exceeding
10 years from the date of grant. Pursuant to the plan, options for 556,000 were
outstanding at April 3, 2009 with exercise prices ranging between $3.350 and
$13.625 per share. No further awards may be made under this plan.
In fiscal year 1995, the Company
adopted the 1995 Consultant Stock Plan, authorizing the granting of options to
purchase common stock or awards of common stock. Generally, options under the
plan were granted at fair market value at the date of the grant, become
exercisable on the date of grant and expire 10 years from the date of grant.
Pursuant to this plan, options for 45,000 shares were outstanding at April 3,
2009 with an exercise price of $1.70 per share. No further awards may be made
under this plan.
16
Under provisions of the Company’s 1991
Stock Option Plan, 2.0 million shares were reserved for issuance. Generally,
options under this plan were granted at fair market value at the date of the
grant, become exercisable over a three-year period, or as determined by the
Board of Directors, and expire over periods not exceeding 10 years from the date
of grant. Pursuant to this plan, options for 60,000 shares were outstanding at
April 3, 2009 with exercise prices ranging from $9.56 to $10.18 per share. No
further awards may be made under this plan.
During fiscal years 1999 and 2000, the
Company issued non-qualified options to purchase shares of its Common Stock to
employees and consultants. Pursuant to these agreements, options for 45,000
shares were outstanding at April 3, 2009 with exercise prices ranging between
$9.375 and $10.63.
Assumptions
The fair value of each option award is
estimated on the date of grant using a Black-Scholes option valuation model
applying the assumptions noted in the following table. Expected volatilities are
based on historical volatility of the Company’s stock. The Company uses
historical data to estimate option exercise and employee termination behavior.
The expected term of options granted is derived from the historical exercise
activity over the past 15 years, and represents the period of time that options
granted are expected to be outstanding. Options granted with a three-year
vesting life during the three months ended April 3, 2009 and March 28, 2008 had
an expected term of 5.50 years derived from historical exercise and termination
activity. The Company has calculated a 9.73% estimated forfeiture rate used in
the model for fiscal year 2008 option grants based on historical forfeiture
experience. The risk-free rate for periods within the contractual life of the
option is based on the U.S. Treasury yield curve in effect at the time of
grant.
April 3,
2009
|
March 28,
2008
|
|||||||
Expected
dividend yield
|
0 | % | 0 | % | ||||
Expected
volatility
|
72.20 | % | 62.48 | % | ||||
Risk-free
interest rate
|
1.72 | % | 2.85 | % | ||||
Expected
term (in years)
|
5.50 | 5.50 |
A summary
of option activity under the Plans as of April 3, 2009 is presented
below:
Options
|
Shares
(000’s)
|
Weighted-
Average
Exercise
Price
|
Weighted-
Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
(000’s)
|
||||||||||||
Outstanding
at January 2, 2009
|
3,854 | $ | 5.80 | |||||||||||||
Granted
|
95 | 0.95 | ||||||||||||||
Exercised
|
— | — | ||||||||||||||
Forfeited
or expired
|
(103 | ) | 6.64 | |||||||||||||
Outstanding
at April 3, 2009
|
3,846 | $ | 5.66 | 5.64 | $ | - | ||||||||||
Exercisable
at April 3, 2009
|
2,982 | $ | 6.37 | 4.74 | $ | - |
The weighted-average grant-date fair
value of options granted during the three months ended April 3, 2009 and March
28, 2008 was $0.59 and $1.31 per option, respectively. The total fair value of
options vested during three months ended April 3, 2009 and March 28, 2008 was
$739,000 and $286,000, respectively. There were no options exercised
in the three months ended April 3, 2009 and March 28, 2008.
17
A summary of the status of the
Company’s non-vested shares as of April 3, 2009 and changes during the period is
presented below:
Nonvested Shares
|
Shares
(000’s)
|
Weighted-
Average
Grant Date
Fair Value
|
||||||
Nonvested
at January 2, 2009
|
1,092 | $ | 2.25 | |||||
Granted
|
95 | 0.59 | ||||||
Vested
|
(297 | ) | 2.48 | |||||
Forfeited
|
(26 | ) | 2.04 | |||||
Nonvested
at April 3, 2009
|
864 | $ | 1.94 |
As of April 3, 2009, there was
$1.2 million of total unrecognized compensation cost related to non-vested
share-based compensation arrangements granted under the Plans. That cost is
expected to be recognized over a weighted-average period of
1.35 years.
March
2007 Broadwood Warrant
On March 21, 2007, STAAR entered into a
loan arrangement with Broadwood Partners, L.P. (“Broadwood”), a stockholder in
the Company. Pursuant to a Promissory Note (the “March 2007 Note”) between STAAR
and Broadwood, STAAR borrowed $4 million from Broadwood. The loan was
subsequently repaid on June 27, 2007.
As
additional consideration for the loan, STAAR also entered into a Warrant
Agreement (the “March 2007 Warrant Agreement”) with Broadwood granting the right
to purchase up to 70,000 shares of STAAR’s Common Stock at an exercise price of
$6.00 per share, exercisable for a period of six years. The warrant
agreement also provides that STAAR will register the shares underlying the
warrant agreement for resale with the SEC by a specified date and maintain
registration. The warrants were registered with the SEC on March 19,
2008, with an effective date of May 1, 2008. Accordingly, in
accordance with the provisions of Emerging Issues Task Force 00-19, “Accounting
for Derivative Financial Instruments Indexed to, and Potentially Settled in, a
Company’s Own Stock” (“EITF 00-19”), the warrant is accounted for as a liability
because the Company is required to assume that a warrant exercised if
registration requirements have not been satisfied may be settled in
cash. The warrant liability must be revalued at each reporting period
with changes in fair value being reflected in the consolidated statements of
operations. STAAR used the Black-Scholes valuation model to estimate the
warrant’s fair value as of and subsequent to the issuance date. The
fair value of the warrant as of April 3, 2009 and January 2, 2009 approximated
$11,000 and $61,000, respectively. The change in fair value of
($50,000) and ($24,000) for the three months ended April 3, 2009 and March
28, 2008 was recorded in other income and expense.
The fair
value of the warrant was estimated on April 3, 2009 and January 2, 2009 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 expected life of the warrant is determined by the amount of
time remaining on the original six year term of the agreement. The risk-free
rate for periods within the contractual life of the warrant is based on the U.S.
Treasury yield curve in effect at each reporting period.
As of
April 3, 2009
|
As of
January 2, 2009
|
|||||||
Expected
dividends
|
0 | % | 0 | % | ||||
Expected
volatility
|
74.3 | % | 73.5 | % | ||||
Risk-free
rate
|
1.87 | % | 1.72 | % | ||||
Remaining
life (in years)
|
4.0 | 4.25 |
18
Note 14 —
Supplemental Disclosure of Cash Flow Information
Interest paid was $74,000 and $57,000
for the three months ended April 3, 2009 and March 28, 2008, respectively.
Income taxes paid amounted to approximately $267,000 and $305,000 for the three
months ended April 3, 2009 and March 28, 2008, respectively.
The Company’s non-cash investing and
financing activities were as follows (in thousands):
April 3,
2009
|
March 28,
2008
|
|||||||
Non-cash
investing activities:
|
||||||||
Acquisition
of Canon Staar
|
$ | — | $ | 7,147 | ||||
Applied
2007 advance payment on acquisition of Canon Staar
|
— | (4,000 | ) | |||||
Applied
2007 deferred acquisition costs
|
— | (197 | ) | |||||
Acquisition
costs in accounts payable and accrued liabilities
|
— | 528 | ||||||
Assets
obtained by capital lease
|
238 | — | ||||||
Non-cash
financing activities:
|
||||||||
Issuance
of preferred stock
|
— | 6,800 | ||||||
Issuance
and registration costs of preferred stock included in accrued
liabilities
|
— | (48 | ) | |||||
Issuance
of common stock to consultants for services performed
|
425 | — | ||||||
Fair
value of Warrants
|
— | — |
Note 15 —
Subsequent Events
On April 13, 2009, the Compnay entered
into an Amended and Restated Senior Secured Promissory Note (the “Secured Note”)
and Security Agreement with Broadwood, collateralizing substantially all of the
assets of the Company to Broadwood under the Secured Note. All other
key terms of the original Senior Promissory Note remained
unchanged.
On May 11, 2009, the court entered
final judgment in the Parallax case in the amount
of the $4.9 million jury verdict. The Court has stayed the execution
of judgment and collection of damages until forty days after rendering of the
final judgment by the court or June 22, 2009 (stay expiration
date). In order to avoid enforcement of the judgment pending
resolution of the appeal, STAAR will be required to obtain a surety bond of up
to 1.5 times the judgment amount, or up to approximately $7.4 million, fully
secured with cash collateral unless a court permits a lesser
amount. On May 15, 2009, the court will hear argument on Parallax’s
motion for legal fees in the amount of approximately $314,000 related to its
defense of STAAR’s cross complaint. STAAR is opposing this motion on
grounds that it has no legal or factual basis, as well as on procedural
grounds.
19
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, to those described in our Annual Report on Form 10-K for the fiscal
year ended January 2, 2009 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 develops, manufactures and sells visual implants and other
innovative ophthalmic products to improve or correct the vision of patients with
cataracts and refractive conditions. We manufacture products in the
U.S., Switzerland and Japan and distribute our products worldwide.
Originally
incorporated in California in 1982, STAAR Surgical Company reincorporated in
Delaware in 1986. Unless the context indicates otherwise “we,” “us,”
the “Company,” and “STAAR” refer to STAAR Surgical Company and its consolidated
subsidiaries.
STAAR
Surgical Company, Visian®, Collamer®, STAARVISC®, Elastimide®, SonicWAVE™ and
AquaFlow™ are trademarks or registered trademarks of STAAR in the U.S. and other
countries.
Collamer®
is the brand name for STAAR’s proprietary collagen copolymer lens
material.
Principal
Products
Intraocular
lenses
We
generate most of our revenue by manufacturing and selling foldable intraocular
lenses, known as IOLs, and related products for cataract
surgery. STAAR pioneered the foldable IOL, a flexible prosthetic lens
used to replace a cataract patient’s natural lens after it has been extracted in
minimally invasive small incision cataract extraction. STAAR makes
IOLs out of silicone and out of our proprietary Collamer lens
material. STAAR’s IOLs are available in both three-piece and
one-piece designs. STAAR’s range of IOLs includes the
following:
|
·
|
three-piece
IOLs, available in silicone or
Collamer;
|
|
·
|
single-piece
IOLs, available in silicone or
Collamer;
|
|
·
|
The
silicone Toric IOL, used in cataract surgery to treat preexisting
astigmatism; and
|
|
·
|
The
Preloaded Injector, a silicone or acrylic IOL preloaded into a single-use
disposable injector, which is currently available outside the
U.S.
|
Most of
STAAR’s IOLs sold worldwide feature aspheric optics, an advanced design intended
to provide a clearer image than traditional spherical lenses, especially in low
light. STAAR has developed a proprietary aspheric design (patent
pending) that is optimized for the naturally curved surface of the retina and
certain other anatomical features of the human eye, and that provides
outstanding image quality even if accidentally moved off center.
Because
the great majority of cataract patients are elderly and qualify for Medicare,
most of STAAR’s U.S. cataract revenue derives indirectly from reimbursement
payments by the Center for Medicaid and Medicare Services, or
CMS. STAAR’s aspheric lenses have been granted “New Technology
Intraocular Lens” status, which provides an additional $50 reimbursement to
doctors or hospitals that use these lenses in ambulatory surgical centers,
enabling STAAR to increase the average selling price for these
lenses.
Outside
the U.S. as well, government agencies or government sponsored entities generally
pay the cost of IOLs for cataract patients. As a result, STAAR
believes that IOL revenues are likely to remain relatively stable even under
adverse conditions in the general economy.
20
Visian
ICL
Manufacturing
and selling lenses used in refractive surgery is an increasingly important
source of revenue 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, generally under local
anesthesia. STAAR began selling the Visian ICL outside the U.S. in
1996 and inside the U.S. in 2006. STAAR began selling the Visian TICL
outside the U.S. in 2002. These products are sold in more than 50
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.
ICL sales
in the U.S. increased by approximately 24% in the first quarter of 2009 over the
same period in the prior year. However, refractive surgery is an
elective procedure generally not covered by health
insurance. Patients must pay for the procedure, frequently through
installment financing arrangements. Patients can defer the choice to
have refractive surgery if they lack the disposable income to pay for it, they
do not feel their income is secure, or they cannot obtain credit. As
a result, if the current recession continues it may lead to reduced sales of
ICLs.
Other
surgical products
We offer
a number of other products used in ophthalmic surgery that complement our IOL
and Visian ICL product lines. We market STAARVISC II, a viscoelastic
material which is used as a protective lubricant and to maintain the shape of
the eye during surgery. We also manufacture Cruise Control™, a
single-use disposable filter used in phacoemulsification, which is the process
of removing a cataract patient’s cloudy lens through a small incision using
ultrasound and suction. Cruise Control allows for a faster, cleaner
phacoemulsification procedure and is compatible with all phacoemulsification
equipment. We also make the AquaFlow Collagen Glaucoma Drainage
Device, an implantable device used for the surgical treatment of
glaucoma. We also sell other instruments, devices and equipment that
we manufacture or that others in the ophthalmic industry
manufacture.
Sales of
other surgical products accounted for approximately 28% of our total revenues
during the three months ended April 3, 2009, and 32% during the three months
ended March 28, 2008.
Operations
STAAR has
significant operations both within and outside the U.S., and receives the
majority of its revenue from its activities outside the U.S. STAAR’s
principal business units and their operations are as follows:
|
·
|
United
States. STAAR operates its global administrative
headquarters and a manufacturing facility in Monrovia,
California. The Monrovia manufacturing facility principally
makes Collamer and silicone IOLs and injector systems for IOLs and
ICLs. STAAR also manufactures the Collamer material in the
U.S.
|
|
·
|
Switzerland. STAAR
operates an administrative and manufacturing facility in Nidau,
Switzerland under its wholly owned subsidiary, STAAR Surgical
AG. The Nidau manufacturing facility makes all of STAAR’s ICLs
and TICLs and also manufactures Collamer IOLs. STAAR Surgical
AG handles distribution and other administrative affairs for Europe and
other territories outside North America and
Japan.
|
|
·
|
Japan. Through
its wholly owned subsidiary, STAAR Japan, Inc., STAAR maintains executive
offices and distribution facilities in Shin-Urayasu, Japan and a
manufacturing facility in Ichikawa City. All of STAAR’s
preloaded injectors are manufactured at the Ichikawa City
facility. STAAR Japan is also currently seeking approval from
the Japanese regulatory authorities to market in Japan STAAR’s Visian ICL
and TICL, Collamer IOL and AquaFlow
Device.
|
|
·
|
Germany. STAAR’s
wholly owned subsidiary, Domilens Vertrieb Für Medizinische Produkte GmbH,
is headquartered in Hamburg, Germany. Products sold by Domilens
include implantable lenses, related surgical equipment, consumables and
other supplies. Domilens sells custom surgical kits that
incorporate a surgeon’s preferred supplies and consumables in a single
ready-to-use package, and services phacoemulsification and other surgical
equipment. Domilens distributes and services products of third
party manufacturers and distributes STAAR’s ICLs, IOLs, and Preloaded
Injectors.
|
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 that protect intellectual property or regulate medical devices, political
risks, and the challenge of managing foreign subsidiaries. These
risks are discussed in our Annual Report on Form 10-K for the fiscal year ended
January 2, 2009 under Item 1.A – Risk Factors, under the headings “The global nature of our business
may result in fluctuations and declines in our sales and profits” and
“The success of our
international operations depends on our successfully managing our foreign
subsidiaries.”
21
Strategy
During
2009, STAAR is focused on the following five strategic operational
goals:
|
•
|
to
improve cash flow;
|
|
•
|
to
increase gross profit margin;
|
|
•
|
to
continue cost reduction efforts;
|
|
•
|
to
secure key regulatory approvals;
|
|
•
|
to
increase the ICL’s share of the refractive market in key
territories.
|
Improve cash
flow. For several years STAAR has not generated enough cash to
sustain its operations and has relied on financing activity to supplement cash
from operations. Through a combination of cost cutting and increased
sales STAAR has reduced its use of cash significantly in recent periods and, if
recent trends continue, STAAR expects to generate positive cash flow from
operations within 2009. While STAAR’s goal is to achieve
profitability and generate positive earnings per share, achievement of positive
cash flow would be an important milestone for STAAR, would enhance its ability
to obtain financing on favorable terms, and would permit STAAR to further invest
in expansion of its business.
STAAR
used $448,000 of cash in operations during the first quarter of fiscal year 2009
compared to $3.4 million of cash used during the first quarter of
2008. The use of cash in the first quarter includes approximately
$700,000 in legal fees and expense, which included defense of the Parallax litigation and was
significantly higher than typical levels for legal expense in the past several
years. The improved cash flow in the first quarter continues a trend
established in fiscal year 2008, when STAAR used $3.4 million of cash in
operations in the first quarter of 2008 and $8.2 million of cash used
during fiscal year 2008. Approximately $3.2 million of the total cash
used in operating activities in 2008 was used by STAAR Japan in assuming the IOL
distribution business acquired from Canon Marketing Japan, Inc. and for payments
on inventory purchased from Canon Marketing.
STAAR
seeks to further improve cash flow by cutting costs and increasing profit
margins, which are separately discussed in greater detail
below. STAAR’s cost-cutting efforts in the U.S., described in greater
detail under the heading Continue Cost Reduction
Efforts yielded savings in operating expenses during the first quarter of
2009 of approximately $5.0 million, or 30%, when compared to the first quarter
of 2008.
During
fiscal year 2008 and the first quarter of 2009 STAAR’s cash flow has been
significantly affected by the cost of defending two lawsuits brought by former
independent regional manufacturer’s representatives. On March 2,
2009, in the first of these cases (Parallax), a jury rendered a
verdict against STAAR for a total of $4.9 million in actual and punitive
damages. On May 11, 2009, the court entered final judgment in the
amount of the $4.9 million jury verdict. Appealing this judgment,
litigating the second case, and either satisfying the final judgment or securing
a bond for appeal, will require significant additional cash and enhancement of
STAAR’s existing cash resources. Management is seeking to meet this
extraordinary short-term need for cash, but at the same time is focusing on cash
management, increased revenue and improved profit margins as the keys to its
long-term success and as the most important factor in attracting future
investment. See “Liquidity and Capital
Resources” below.
STAAR
believes its cash management plans are achievable and continues to seek ways to
reduce spending; however, STAAR cannot provide assurance that it will achieve
the level of intended savings. Factors affecting the success of
STAAR’s cash management plans include the ultimate payment, if any, required
under the Parallax
judgment and our degree of success in increasing the amount of cash generated by
our business through increased sales and improved profit margins.
Increase gross profit
margins. In recent periods, sales of STAAR products have
generally increased, except U.S. IOL sales. U.S. IOL sales revenue
has continued to decline, but the rate of decline appears to have slowed as
STAAR has begun replacing older lens designs with higher priced NTIOL
lenses. In the first quarter of 2009 U.S. IOL sales declined 8%
year-over-year, while the rate of decline was 16% in 2008 and 20% in
2007. If our new IOL product introductions are successful, U.S. IOL
sales may resume growing in 2009, but if this does not occur, STAAR may find it
necessary to reduce spending in its U.S. operations more deeply.
While
expanded market share and increased gross revenue remain key goals, STAAR
believes that it can achieve profitability even at modest growth levels by
increasing its profit margin through the following means:
|
·
|
Increasing ICL sales as a
percentage of STAAR’s overall product mix. ICLs and
TICLs generally yield high margins and are STAAR’s most profitable
products. ICLs continue to represent the fastest growing
product line of STAAR’s business and are the largest contributor to
enhanced profit margins. Bringing ICL and TICL to new markets,
and expanding market share in existing markets, will improve STAAR’s
profitability. This initiative is described in greater detail
under “Other Highlights – ICL Sales”
below.
|
22
|
·
|
Shifting to higher value
IOLs. 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 CMS reimbursement as
NTIOLs. STAAR has now added aspheric optics to all of its IOL
platforms. While STAAR hopes to regain lost U.S. IOL market
share through new product introductions, the enhanced profitability of
these designs should significantly improve the performance of the U.S. IOL
business even if market share gains are minimal. New delivery
systems for Collamer lenses introduced in 2008 and planned for 2009 are
intended to improve the market uptake for these advanced, higher value
lenses. In addition, STAAR believes it can significantly
improve gross margins in 2009 through continued growth in sales of its
preloaded IOL offering, especially in Japan, where selling prices for IOLs
are relatively high.
|
|
·
|
Improve product mix and
pricing of other surgical products. STAAR distributes a
variety of complimentary products used in ophthalmic surgery as a service
to its customers. In an effort to improve margins of other
surgical products, STAAR is reviewing all pricing to determine if products
are priced appropriately and is discontinuing product lines with lower
than average margins.
|
|
·
|
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. As the first initiative in this
area as STAAR will make its U.S. facility the center of excellence for
optical design and manufacturing of IOLs and Japan the center of
excellence for design and manufacturing of delivery systems. By
moving all IOL manufacturing to STAAR’s Monrovia facility STAAR expects to
significantly reduce costs by increasing volume without significantly
increasing fixed costs, and to supply IOLs to STAAR Japan at a significant
reduction to its current manufacturing cost. Similarly, the
transfer of delivery system development and manufacturing to Japan is
expected to lead to cost savings and a greater focus on STAAR Japan’s more
advanced lens injector designs.
|
Continue Cost Reduction
Efforts. While STAAR’s international operations, outside of
Japan, have generally generated cash or been cash flow neutral in recent
periods, losses from U.S. operations have been the principal cause of cash use
on a consolidated basis. To reduce these losses, STAAR implemented
cost-cutting measures in the third fiscal quarter of 2007 and throughout 2008,
including targeted reductions in the U.S. workforce. Beginning in
December 2007, STAAR began a process to closely rationalize and evaluate its
spending levels. These initiatives included streamlining STAAR’s U.S.
organization by reducing spending levels in all areas of the business,
renegotiating or eliminating certain obligations, and eliminating all executive
bonus opportunities until STAAR showed positive trends toward achieving
profitability. During the first quarter of 2009, despite unusually
high legal expenses of approximately $700,000, operating expenses declined $5
million from the first quarter of 2008; however, this decline partly reflects
$3.8 million in acquisition costs related to STAAR Japan that we incurred in
2008. The reduction in expense was nevertheless significant and
continued the trend established in 2008, when STAAR achieved a $4.5 million
reduction in U.S. annual operating expenses over the prior
year. These reductions have been offset, in part, by the need to
increase expenses outside the U.S. to support STAAR’s 26% international ICL
sales growth in 2008, and in 2009 STAAR seeks to identify opportunities for
savings in its international operations.
Secure Key Regulatory
Approvals. Regulatory approvals of high margin products in
significant markets can yield rapid growth in sales and improvements in
profitability. The principal approvals pursued by STAAR at this time
are the U.S. approval of the TICL and the approval of ICL and TICL in
Japan.
STAAR’s
TICL corrects both myopia and astigmatism, and has been shown to be highly
effective in treating individuals affected by both conditions. When
STAAR has introduced the TICL in international markets it has generally
experienced rapid growth, and the TICL may also lead to increased ICL sales by
making the product family a more complete solution that physicians can offer to
patients. STAAR has applied for approval of the TICL in the U.S., but
the FDA has suspended review of the application pending resolution of concerns
regarding STAAR’s oversight of the TICL clinical study. This agency
action, and STAAR’s progress in resolving it, is discussed below under the
caption “Other Highlights:
Medical Device Regulatory Compliance, Clinical Oversight and TICL
Approval.” Based on experience in international markets, STAAR believes
that U.S. sales of the ICL will increase even if TICL approval continues to be
delayed. Nevertheless, STAAR believes that approval and introduction
of the TICL would significantly enhance refractive sales in the U.S. Obtaining
approval remains a part of STAAR’s long-term strategy.
Approval
of ICL and TICL by Japanese regulators is pending. Like other Asian
countries, Japan has a high mean rate of myopia, which is often accompanied by
astigmatism. As a result STAAR believes that the Japanese market for
ICL and TICL is promising. STAAR Japan’s preloaded IOL injectors have
established a presence in the Japanese cataract IOL market that could also help
establish a market for the Collamer IOL.
23
Increase the ICL’s Share of the
Refractive Market in Key Territories. While the ICL and TICL
are approved for sale in over 50 countries, a smaller group of countries where
we have achieved significant sales volume and market share yields the bulk of
our ICL and TICL sales revenue. STAAR currently views the
following as its key markets for the ICL and TICL:
|
·
|
United
States
|
|
·
|
China
|
|
·
|
Germany
|
|
·
|
India
|
|
·
|
Korea
|
|
·
|
Spain
|
|
·
|
Latin
America
|
To date,
the highest penetration rate achieved by STAAR for ICL and TICL within any
particular refractive surgery market has been 5%. STAAR believes it
has the opportunity to achieve significant profits if it can achieve a 5% or
greater penetration rate in all of its key markets, and during 2009 will focus
its international sales efforts on that goal.
Other
Highlights
U.S. ICL
Sales. ICL sales growth in the U.S. market is a key goal
because of the size of the U.S. refractive surgery market and the perceived
worldwide leadership of the U.S. in adopting innovative medical
technologies. The Visian ICL was approved by the FDA for treatment of
myopia on December 22, 2005.
Visian
ICL sales in the U.S. grew 14% in the first quarter of 2009 compared to prior
year, and grew 18% in 2008 when compared to 2007 levels. This
represents a trend of resumed growth in U.S. ICL sales following 2007 sales
levels that did not grow beyond those reached in the first year of
introduction. STAAR believes that the following are among the factors
that may have contributed to recent growth:
|
·
|
increasing
use of the ICL by a number of surgeons among STAAR’s established U.S.
customers as they have gained experience with the product and become more
skilled at identifying, attracting and supporting those patients most
likely to benefit from the ICL, including some 40 surgeons referred to as
“advocates” who are the highest volume users of the
ICL;
|
|
·
|
increased
patient awareness of the ICL as a result of an increased number of
favorable reports on the benefits of ICL in the U.S. mass
media;
|
|
·
|
a
change in marketing focus as STAAR has shifted from increasing its overall
customer base to devoting more attention to identifying and supporting
those surgical practices that show potential for significant repeat
business through a professional commitment to the ICL technology;
and
|
|
·
|
greater
stability and focus in STAAR’s refractive support team following its
reorganization in 2007 and 2008.
|
To
achieve its plans, STAAR will need not only to sustain, but to increase this
rate of growth.
STAAR
believes that the global recession represents the largest challenge to increased
growth in U.S. ICL sales. Refractive surgery is an elective procedure
generally not covered by health insurance. Patients must pay for the
procedure, frequently through installment financing arrangements. ICL
sales grew during 2008 and in the first quarter of 2009 despite worsening
conditions in the general economy, decreased consumer spending, and reduced
availability of credit. However, STAAR believes that the recession
has decreased the growth rate for U.S. ICL sales. Refractive surgeons
in the U.S. have reported a significantly lower volume of patients seeking
refractive surgery, which reduces the number of patients to whom the ICL is
offered. While ICL sales have been more resistant to the recession
than laser-based procedures, if severe recession conditions continue ICL sales
may decline until consumer spending levels begin to recover. STAAR
believes that its share of the U.S. refractive market has grown during the past
years, which will position the ICL for strong sales growth when conditions
improve.
Other
challenges to sustained growth in U.S. Visian ICL sales include the
following:
|
·
|
the
U.S. refractive surgery market has been dominated by corneal laser-based
techniques, which continue to be better known than the Visian ICL among
potential refractive patients;
|
24
|
·
|
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;
|
|
·
|
negative
publicity about complications of LASIK could reduce interest in all
refractive surgical procedures; and
|
|
·
|
FDA
approval of the TICL, which STAAR sells in international markets for
treating patients severely affected by both myopia and astigmatism, has
been delayed.
|
On April
25, 2008, the FDA Ophthalmic Devices Panel held a public meeting to discuss
issues of medical complications and customer satisfaction following refractive
surgery. While the panel also discussed phakic IOLs such as the
Visian ICL, most of its discussions centered on LASIK and testimony regarding
customer dissatisfaction following LASIK surgery. The Panel
recommended enhanced patient warnings of possible complications for LASIK and
created a task force to study methods of better identifying those patients who
are more likely to have an unsatisfactory outcome from laser vision
correction. The proceedings of the Panel were widely reported in the
U.S. While it is difficult to assess precisely the impact of the panel hearings
on patient attitudes or the recommendations of practicing surgeons, it is
possible that reduced demand for laser eye surgery observed in 2008 was caused
in part by concerns regarding complications and potential patient
dissatisfaction. Patient concerns about LASIK could increase interest
in the Visian ICL as an alternative for patients who have a greater risk of
complications from LASIK. The fact that the Visian ICL is removable
if a patient is dissatisfied with the outcome may also be appealing to some
patients with new concerns about risks of refractive
surgery. However, the negative publicity concerning LASIK could
decrease patient interest in all refractive surgery, including Visian
ICL. Because nearly all candidates for refractive surgery can achieve
acceptable vision through the use of spectacles or contact lenses, for most
patients the decision to have refractive surgery is a lifestyle choice that
depends on high confidence in achieving a satisfactory outcome.
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.
U.S. IOL
Sales. For several years STAAR has experienced a decline in
U.S. market share of IOLs. The rate of decline appears to have slowed
as STAAR has begun replacing older lens designs with higher priced NTIOL
lenses. In the first quarter of 2009 U.S. IOL sales declined 8%
year-over-year, while the rate of decline was 16% in 2008 and 20% in 2007.
Factors contributing to long-term decline in U.S. IOL sales include the slow
pace of product improvement and enhancement during a period when we devoted most
of our research and development resources to introducing the ICL and to
resolving the regulatory and compliance issues raised by the
FDA. This long-term trend was intensified in 2007 by disruption in
STAAR’s independent sales force when STAAR was unable to reach a new contract
with regional manufacturer’s representatives in the third quarter of
2007. In addition the trend was exacerbated by STAAR’s lagging behind
its competitors in the introduction of IOLs with advanced aspheric optics, and
by the entry of Alcon as a competitor in the Toric IOL market.
STAAR’s
strategy to achieve profitability in its U.S. 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 aspheric single-piece Collamer IOL and the
aspheric three-piece silicone IOL in July, 2008;
and
|
|
·
|
the
introduction of an aspheric single-piece Collamer IOL in the second
quarter of 2009, which brings advanced aspheric optics to the
micro-incision nanoPOINT platform.
|
25
The
addition of aspheric optics to STAAR’s IOL designs has been a primary focus of
STAAR’s recent development efforts. Aspheric IOLs use advanced
optical designs intended to provide a clearer image than traditional spherical
lenses, especially in low light, which has led to significant market share gains
for aspheric designs. In recognition of these advantages the Centers
for Medicare and Medicaid Services (“CMS”) will grant NTIOL status to aspheric
IOLs that can demonstrate improved visual performance over conventional IOLs,
allowing an extra $50 reimbursement per lens implanted in an ASC (ambulatory
surgical center). Because the majority of IOL purchases in the U.S.
are implanted at ASCs and reimbursed through Medicare, NTIOL status
significantly increases STAAR’s potential margin on qualifying
lenses.
All of
STAAR’s aspheric lenses sold in the U.S. feature a proprietary optical design
(patent pending) that is optimized for the naturally curved surface of the
retina and certain other anatomical features of the human eye, and provides
outstanding image quality even if decentered.
STAAR
intends to continue to focus on the following projects designed to make our IOL
product offering more competitive:
|
·
|
developing
a Collamer Toric IOL to complement our pioneering silicone Toric IOL and
better compete with the Alcon acrylic Toric
IOL;
|
|
·
|
introduction
of an all new injector system for the three-piece Collamer IOL;
and
|
|
·
|
adapting
our proprietary Preloaded Injector system to our new silicone aspheric
IOLs for use in the U.S. market.
|
STAAR
cautions that the successful development and introduction of new products is
subject to risks and uncertainties, including the risk of unexpected delays and,
in some cases, approval of regulatory authorities.
STAAR’s
development efforts aim to realize the full market potential for Collamer IOLs
by improving lens delivery systems and differentiating STAAR’s silicone IOL
offering through the Preloaded Injector. The majority of IOLs sold by
STAAR in the U.S. are made of silicone, which was the original material used for
foldable IOLs. However, physician preferences in the U.S. have
strongly shifted to acrylic IOLs which currently account for an approximately
76% share of the U.S. IOL market. STAAR believes that its Collamer
lenses have outstanding optical qualities and superior biocompatibility, and
should be capable of competing with any of our competitor’s acrylic lens
products in the advanced material sector. In addition, increasing use
of the ICL, which relies on the outstanding optical properties of Collamer, has
also introduced the advantages of the Collamer material to a growing number of
surgeons. However, growth of the Collamer IOL market has been limited
by the difficulty of perfecting delivery systems for the soft Collamer
material. Although acrylic lenses do not have the same level of
optical performance in the eye as Collamer and often introduce glare or
glistening into the visual field, the stiffness and toughness of the acrylic
material makes design of delivery systems simpler. STAAR has a number
of development projects in place intended to make Collamer lenses easier to
deliver and broaden customer appeal. The nanoPOINT injector system,
which delivers the one-piece Collamer IOL through a 2.2 mm incision, was the
first of these projects to reach market and was launched in April
2008.
While the
U.S. market share for silicone IOLs has been slowly declining overall, a
significant number of surgeons continue to select silicone lenses for their
patients. STAAR believes that its recently introduced aspheric,
three–piece silicone IOL offers outstanding optical performance and with its
recently granted NTIOL status could enable STAAR to retain or possibly increase
its market share within the silicone IOL sector, especially if STAAR’s efforts
are successful in securing FDA approval to make it available in a Preloaded
Injector.
We have
developed and currently market the Toric IOL, a toric version of our
single-piece silicone IOL, which is specifically designed for cataract patients
who also have pre-existing astigmatism. Until 2006 only STAAR sold
Toric IOLs in the U.S. because CMS allows cataract patients receiving
reimbursement to pay a premium for the correction of pre-existing astigmatism,
while Medicare provides the customary reimbursement for cataract surgery, Toric
IOLs can be sold at a higher price and higher profit margin than standard
IOLs. CMS also permits the patient to separately remunerate the
surgeon for the significant additional services needed to prescribe and implant
a lens with toric correction for astigmatism. The increased revenues
and profit margin originally expected by STAAR as a result of the CMS ruling
have, to date, not been realized because of the introduction of a competing
acrylic toric IOL by Alcon Laboratories. In particular, STAAR
believes that in 2007 a number of customers who previously had purchased STAAR’s
Toric IOL but had otherwise been customers of Alcon’s ophthalmic products,
converted to use of the Alcon Toric IOL.
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,
competing with much larger companies and overcoming reputational harm from the
FDA’s findings of compliance deficiencies. We cannot assure that this
strategy will ultimately be successful.
Reorganization of U.S. Sales
Force. STAAR has comprehensively reorganized its U.S. sales
force. STAAR now directly employs its regional sales managers and both direct
and independent representatives sell the IOL product lines. STAAR believes that
its reorganized sales force will position the company to capitalize on the ICL
opportunity and enhancements to its cataract product line intended to make the
line more competitive.
26
Medical Device Regulatory
Compliance, Clinical Oversight and TICL Approval. STAAR’s
ability to develop, manufacture and distribute its products depends heavily on
maintaining good standing with the FDA and other regulatory
agencies. Based on the results of the FDA inspections of STAAR’s
Monrovia, California facilities in 2005 and 2006, 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.
Notwithstanding
its success in overcoming past concerns regarding its quality systems, STAAR
believes that it has not yet fully overcome the reputational harm caused by the
FDA’s past findings of compliance deficiencies, which may continue to present a
challenge in increasing U.S. product sales. In the opinion of STAAR’s
management, the June 26, 2007 warning letter from the Bioresearch Monitoring
Program of the FDA Office of Regulatory Affairs (“BIMO”) and the integrity hold
placed on STAAR’s clinical activities by the Office of Device Evaluation,
although they concern STAAR’s oversight of clinical activities rather than its
quality systems, have perpetuated the reputational harm resulting from the
earlier FDA actions, and have made it more difficult for STAAR to regain its
former market share. STAAR believes that U.S. approval of the TICL,
if granted, and continued evidence of good standing with the FDA will reduce and
may eventually eliminate the reputational harm caused by past agency
actions.
Status of TICL
Submission. STAAR’s activities as a sponsor of biomedical
research are subject to review by the FDA. BIMO inspections are part of a
program designed to ensure that data and information contained in requests for
Investigational Device Exemptions (IDE), Premarket Approval (PMA) applications,
and Premarket Notification submissions (510k) are scientifically valid and
accurate. Another objective of the program is to ensure that human subjects are
protected from undue hazard or risk during the course of scientific
investigations. While the past procedural violations noted in the Warning Letter
are serious in nature and required comprehensive corrective and preventative
actions, the Company does not believe that these nonconformities undermine the
scientific validity and accuracy of its clinical data, or that human subjects
were subjected to undue hazard or risk.
Following
STAAR’s submission of a Pre-Market Approval application (PMA) supplement for the
TICL to the FDA on April 28, 2006, FDA’s BIMO conducted an inspection of STAAR’s
clinical study procedures, practices, and documentation related to the TICL
between February 15 and March 14, 2007. At the close of the inspection, STAAR
received eight inspectional observations on Form 483, to which it responded on
April 5, 2007. Notwithstanding the response, on June 26, 2007 the FDA’s BIMO
branch issued a Warning Letter to STAAR noting four areas of noncompliance
observed during the BIMO inspection. STAAR provided its written response to the
Warning Letter to the FDA on July 31, 2007.
On August
3, 2007 STAAR received a letter from the FDA Office of Device Evaluation (“ODE”)
notifying STAAR that the review of the TICL application would be placed on
integrity hold (i.e., halted) until STAAR completes specified actions
establishing the integrity and reliability of the clinical data under the TICL
application and the robustness of STAAR’s clinical trial procedures and systems.
Noting the same deficiencies cited in the June 26, 2007 Warning Letter from
BIMO, and other deficiencies noted in an audit of a clinical study site, ODE
requested that STAAR engage an independent third party auditor to conduct an
audit of patient records along with a clinical systems audit to ensure accuracy
and completeness of data before resubmitting the application.
STAAR’s
independent third party auditor has completed its audits, has reviewed and
certified the amended clinical data that is the source for the data to be
included in the resubmission of the TICL application, and has completed its
audit report on STAAR’s quality systems related to clinical oversight. The third
party auditor has submitted its findings directly to the FDA for its
examination. The submission of findings from the third party auditor to FDA was
in two audit reports, dated October 8, 2008 and December 15,
2008. The FDA considers the October 8, 2008 report to be complete and
has allowed the third party auditor to release it to STAAR.
The
December 15, 2008 report was revised and resubmitted by the third party auditor,
based on questions from the FDA. The revised report dated March 13, 2009
was approved for release to STAAR on May 6, 2009. This
permits STAAR to complete its corrective action plan to address the findings of
the third party auditor as reported to FDA and ensure that it is aligned with
all of the auditor’s filings. Once the corrective action plan is
submitted and accepted by the FDA, an inspection by the local office will be
scheduled. The inspector will forward a report to FDA headquarters
and it is expected that the FDA would then lift the integrity hold if the
inspection results are satisfactory. After the hold is lifted, STAAR will be
permitted to resubmit the clinical data for the TICL application, as certified
by the third party auditor, and FDA will resume substantive review of the TICL
data. STAAR cannot assure investors that its corrective actions will
be satisfactory to FDA, that ODE will grant approval to the TICL, or that the
scope of requested TICL approval, if granted, would not be limited by the
FDA.
27
Financing
Strategy
While
STAAR’s international business generates more than 75% of STAAR’s revenue, STAAR
has reported losses on a consolidated basis over the last several years due to a
number of factors, including eroding sales of cataract products in the U.S. and
FDA compliance issues that consumed additional resources while delaying the
introduction of new products in the U.S. market. On
December 14, 2007, STAAR borrowed $5 million from Broadwood Partners, L.P., at
an interest rate of 7% per annum, primarily to fund the acquisition of STAAR’s
remaining interest in the Canon Staar Joint Venture.
On April
2, 2009, after preliminary judgment was entered, Broadwood and the Company
entered into a Temporary Waiver Agreement with respect to any event of default
that may occur, or may be deemed to have occurred, under the Broadwood note as a
result of the judgment in the case of Parallax Medical Systems,
Inc. v. STAAR. In
consideration of the Temporary Waiver Agreement, STAAR agreed to amend the
Original Note to grant to Broadwood a security interest in substantially all of
STAAR’s assets to secure STAAR’s obligations under the Original
Note. To effectuate this grant of a security interest, as of April
13, 2009 the Company and Broadwood entered into an Amended and Restated Senior
Secured Promissory Note and Security Agreement.
The $4.9
million final judgment in the Parallax case, and the cost
and exposure to a negative outcome in subsequent litigation, will exceed STAAR’s
current capital resources. Accordingly, STAAR expects to seek
additional equity and/or debt financing and to explore other financing options
to meet its need for working capital in 2009. STAAR may also seek new
capital to expand its business or fund efforts to improve
efficiency. However, STAAR does not expect to require significant new
working capital to support operations if its initiatives for cash management and
improved profitability continue in line with present trends.
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.”
New
Accounting Pronouncements
In May
2008 the Financial Accounting Standards Board (FASB) issued FASB Staff Position
(FSP No. APB 14-1), Accounting
for Convertible Debt Instruments That
May Be Settled in Cash upon Conversion (Including Partial Cash
Settlement). This FSP applies to convertible debt instruments
that, by their stated terms, may be settled in cash (or other assets) upon
conversion, including partial cash settlement, unless the embedded conversion
option is required to be separately accounted for as a derivative under SFAS No.
133, Accounting for Derivative
Instruments and Hedging Activities. This FSP clarifies that
convertible debt instruments that may be settled in cash upon conversion
(including partial cash settlement) are not addressed by paragraph 12 of APB
Opinion No. 14, Accounting for
Convertible Debt and Debt Issued with Stock Purchase Warrants.
Additionally, this FSP specifies that issuers of such instruments should
separately account for the liability and equity components in a manner that will
reflect the entity’s nonconvertible debt borrowing rate when interest cost is
recognized in subsequent periods. This FSP is effective for financial
statements issued for fiscal years beginning after December 15, 2008, and
interim periods within those fiscal years. As the Company has no
convertible debt instruments, the provisions of this FSP did not have an impact
on the Company’s consolidated financial statements.
In June
2008, the Emerging Issues Task Force (EITF) issued EITF Abstracts Issue no.
07-5, Determining Whether an
Instrument (or Embedded Feature) Is Indexed to an Entity's Own Stock,
(EITF 07-5). The objective of this Issue is to provide guidance for
determining whether an equity-linked financial instrument (or embedded feature)
is indexed to an entity's own stock. This Issue applies to any
freestanding financial instrument or embedded feature that has all the
characteristics of a derivative in paragraphs 6–9 of SFAS No. 133 for purposes
of determining whether that instrument or embedded feature qualifies for the
first part of the scope exception in paragraph 11(a) of SFAS No. 133. Paragraph
11(a) of SFAS No. 133 specifies that a contract that would otherwise meet the
definition of a derivative under that Statement issued or held by the reporting
entity that is both (a) indexed to its own stock and (b) classified in
stockholders' equity in its statement of financial position shall not be
considered a derivative financial instrument for purposes of applying that
Statement. If a freestanding financial instrument (for example, a
stock purchase warrant) meets the scope exception in paragraph 11(a) of
Statement 133, it is classified as an equity instrument and is not accounted for
as a derivative instrument. This Issue also applies to any
freestanding financial instrument that is potentially settled in an entity's own
stock, regardless of whether the instrument has all the characteristics of a
derivative in paragraphs 6–9 of SFAS No. 133, for purposes of determining
whether the instrument is within the scope of EITF Issue No. 00-19, Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company's Own
Stock. EITF 07-5 is effective for financial statements issued
for fiscal years beginning after December 15, 2008, and interim periods within
those fiscal years. Earlier application by an entity that has
previously adopted an alternative accounting policy is not
permitted. The Company provisions of EITF 07-5 were effective for the
Company’s current fiscal year beginning January 3, 2009. After
evaluating the applicable financial instruments the Company has outstanding,
management determined that the provisions of this issue had no impact on the
Company’s consolidated financial position and results of
operations.
28
On April
9, 2009, the Financial Accounting Standards Board issued FASB Staff Position No.
157-4 (FSP No. 157-4), Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly
Decreased and Identifying Transactions That Are Not
Orderly. This FSP provides additional guidance for estimating
fair value in accordance with SFAS No. 157, Fair Value Measurements, when
the volume and level of activity for the asset or liability have significantly
decreased. This FSP also includes guidance on identifying circumstances that
indicate a transaction is not orderly. This FSP shall be effective
for interim and annual reporting periods ending after June 15, 2009, and shall
be applied prospectively. The Company does not believe that the
provisions of this FSP, when effective, will result in a significant impact to
its consolidated financial statements.
On April
9, 2009, the FASB issued FSP No. 107-1 and APB-28-1, Interim Disclosures about Fair Value
of Financial Instruments. This FSP amends SFAS No. 107, Disclosures about Fair Value of
Financial Instruments, to require disclosures about fair value of
financial instruments for interim reporting periods of publicly traded companies
as well as in annual financial statements. This FSP also amends APB
Opinion (APB) No. 28, Interim
Financial Reporting, to require those disclosures in summarized financial
information at interim reporting periods. This FSP applies to all
financial instruments within the scope of SFAS No. 107 held by publicly traded
companies, as defined by APB 28. This FSP shall be effective for
interim and annual reporting periods ending after June 15, 2009, and shall be
applied prospectively. The Company does not believe that the
provisions of this FSP, when effective, will result in a significant impact to
its consolidated financial statements.
On April
1, 2009, the FASB issued FSP No. 141(R)-1, Accounting for Assets Acquired and
Liabilities Assumed in a Business Combination That Arise from
Contingencies. This FSP amends and clarifies SFAS No.
141 (revised 2007), Business
Combinations, to address application issues raised by preparers,
auditors, and members of the legal profession on initial recognition and
measurement, subsequent measurement and accounting, and disclosure of assets and
liabilities arising from contingencies in a business
combination. This FSP shall be effective for assets or liabilities
arising from contingencies in business combinations for which the acquisition
date is on or after the beginning of the first annual reporting period beginning
on or after December 15, 2008. The adoption of the provisions of this
FSP did not have any impact to the Company’s consolidated financial
statements.
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 three months ended April 3, 2009 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
2, 2009.
29
Results
of Operations
The
following table sets forth the percentage of total sales represented by certain
items reflected in the Company's statements of operations for the periods
indicated and the percentage increase or decrease in such items over the prior
period.
Percentage of Net Sales
|
Percentage Change
|
|||||||||||
April 3, 2009
|
March 28, 2008
|
2009
vs. 2008
|
||||||||||
Net
sales
|
100.0 | % | 100.0 | % | 1.8 | % | ||||||
Cost
of sales
|
43.5 | 56.8 | (22.2 | ) | ||||||||
Gross
profit
|
56.5 | 43.2 | 33.3 | |||||||||
General
and administrative
|
23.4 | 24.8 | (3.6 | ) | ||||||||
Marketing
and selling
|
31.6 | 36.0 | (10.6 | ) | ||||||||
Research
and development
|
7.7 | 9.6 | (17.8 | ) | ||||||||
Loss
on settlement of pre-existing distribution arrangement
|
— | 21.4 | (100.0 | ) | ||||||||
62.7 | 91.8 | (30.4 | ) | |||||||||
Operating
loss
|
(6.2 | ) | (48.6 | ) | (87.0 | ) | ||||||
Other
income (expense), net
|
(0.5 | ) | 0.2 | — | * | |||||||
Loss
before provision for
income
taxes
|
(6.7 | ) | (48.4 | ) | (85.9 | ) | ||||||
Provision
for income taxes
|
2.4 | 1.4 | 69.0 | |||||||||
Net
loss
|
(9.1 | )% | (49.8 | )% | (81.4 | ) % |
* Denotes
change is greater than 100%
Net
Sales
Net sales
for the first quarter of 2009 were $18.3 million, an increase of approximately
2% compared with $18.0 million for the same period of 2008. The
change in net sales was due mainly to a 5% increase in international product
sales, offset by a an approximate decrease of 6% in U.S. net
sales. Changes in currency had a $0.6 million unfavorable impact on
net sales for first quarter of 2009.
International
sales for the first quarter 2009 were $14.0 million, up 5% compared with $13.4
million reported in the same period of 2008. During the current
quarter, international Visian ICL sales grew to $3.7 million, a 17% increase
compared to the $3.2 million sales reported in the prior
year. Revenue grew in several key countries, including Korea at 33%
growth, India at 201%, Japan at 17%, Spain at 16%, France at 92% and the U.K.
19%. International IOL sales grew to $6 million, which is a 7%
increase over sales of $5.6 million in the prior year. During the quarter
preloaded IOL sales increased by 13% over prior year, and sales in STAAR Japan
increased by 26%.
U.S.
sales declined by 6% to $4.2 million compared with the same period in 2008 due
to a 33% decline in other product sales and an 8% decline in IOL
sales. These declines were partially offset by a 24% increase
in U.S. Visian ICL as U.S. Visian ICL sales grew to $1.4 million, compared to
$1.1 million in 2008.
U.S. IOL
sales declined by 8% for the quarter, despite the fact that during the first two
months sales were flat compared to the prior year. Unit volume of low
margin IOLs decreased as the Company continued its strategy to deemphasize low
margin product lines. Decreased sales of low margin IOLs were largely
offset by increased average selling prices of NTIOL products.
Global
Visian ICL® sales grew to $5.1 million, which is an 18% increase over the $4.3
million reported in same period of the prior year. Global IOL sales
increased by 3% while the non IOL portion of cataract sales declined by 12%,
reflecting the strategy in the U.S. to deemphasize product lines that have
historically yielded low gross margins.
30
Gross
Profit Margin
Gross
profit for the first quarter was $10.3 million, or 57% of revenue, compared with
$7.8 million, or 43% of revenue, in the prior year period. The gross
margin for the first quarter of 2008 was negatively impacted by costs associated
with the acquisition of the remaining interests of STAAR Japan. The
increase in gross margin was due to the Company’s sales and marketing focus on
higher margin products such as ICLs, Preloaded IOLs and NTIOLs and the
corresponding decrease in lower margin product sales. As a percentage of
revenue, the U.S. reported a 10 percentage point gross profit improvement, while
international operations reported a 2 percentage point improvement, led by STAAR
Japan with a 7 percentage point improvement.
General
and administrative
General
and administrative expenses for the quarter were $4.3 million, a decrease of 4%
when compared with $4.4 million last year. The decrease resulted from
across-the-board cost reduction efforts implemented during 2008, which were
largely offset by legal expenses during the quarter. Legal expenses
were approximately $0.7 million for the quarter, which included the cost of
trial in the Parallax
case.
Marketing
and Selling
Marketing
and selling expenses for the first quarter of 2009 dropped approximately $0.7
million to $5.8 million as compared with $6.5 million in the same period in
2008. This 11% decrease was due to reduced salaries, travel,
commissions and consulting fees in the U.S. and reduced promotional activities
internationally.
Research
and Development
Research
and development expenses for the quarter were $1.4 million, an 18% decline
compared with the first quarter of 2008. The decrease was due to
reduced expenses and reorganization of the Regulatory and Clinical Affairs area,
as well as more focused use of resources as we rationalize our global research
and development activities.
Loss
on Settlement of Pre-existing Distribution Arrangement
In
connection with the Company’s acquisition of STAAR Japan, the Company recorded
an approximate $3.9 million loss at the close of the acquisition on December 29,
2007, the first quarter of 2008. This loss represents the portion of
the consideration paid by STAAR for the Acquisition that was deemed to represent
the amount paid to settle the preexisting relationship between Canon Staar and
the Canon companies, in particular for the termination of the pre-existing
distribution arrangement that was deemed unfavorable to STAAR Japan and to STAAR
when compared to a comparable at-market arrangement as of the December 29, 2007
closing date.
Liquidity
and Capital Resources
Going Concern
The
accompanying unaudited interim condensed consolidated financial statements have
been prepared assuming that the Company will continue as a going concern, which
contemplates the realization of assets and the liquidation of liabilities in the
normal course of business. For several years STAAR has incurred
significant losses, has not generated sufficient cash to sustain its operations,
and has relied on debt and equity financing to supplement cash from
operations. As of April 3, 2009, STAAR had approximately $3.7 million
of cash and cash equivalents. STAAR’s likely cash requirements rose
considerably on March 2, 2009, when an adverse verdict against STAAR in Parallax Medical Systems, Inc.
v. STAAR Surgical
Company. This case, originally filed on September 21, 2007,
resulted in an award against STAAR of approximately $2.2 million in actual
damages and $2.7 million in punitive damages. The $4.9 million
judgment is included in “other current liabilities” on the consolidated balance
sheets as April 3, 2009 and January 2, 2009. The Parallax judgment, along with
STAAR’s history of recurring losses, negative cash flows and limited access to
capital, has raised substantial doubt regarding STAAR’s ability to continue as a
going concern. The accompanying unaudited interim condensed
consolidated financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
31
STAAR seeks to overcome the
substantial doubt concerning its ability to continue as going concern by doing
one or more of the following: continuing to pursue its strategic operating goals
for enhanced profitability, by obtaining new debt and/or equity financing and by
selling non-strategic assets. STAAR’s strategic operating goals
include the following:
· Improve cash flow and continue cost reduction
efforts. In the latter part of 2007 and throughout 2008, STAAR
implemented cost-cutting measures and began a process to closely rationalize and
evaluate its spending levels, which included a targeted reduction in the U.S.
workforce, streamlining the U.S. organization by reducing spending levels in all
areas of the business, renegotiating or eliminating certain obligations, and
eliminating all cash executive bonus opportunities until STAAR showed positive
trends toward achieving profitability. Through these efforts STAAR
has significantly reduced its cash used in operating activities in the first
quarter of 2009 as compared to both the same period in the prior year and the
fourth quarter in 2008 and, if recent operating trends continue, STAAR may
generate positive cash flow from operations during one or more quarters of
2009;
· Increase gross profit margins. In
recent periods STAAR has experienced increased sales in ICLs both domestically
and internationally and in IOLs internationally. STAAR believes that
the key to achieving profitability is to increase profit margins, primarily by
increasing ICL sales as a percentage of STAAR’s overall product
mix. ICLs and TICLs generally yield higher margins and continue to
represent the fastest growing product line of STAAR’s business. While
the ICL and TICL are approved for sale in over 50 countries, STAAR has achieved
increasing sales and market share of the refractive surgical market in a number
of select countries, including in the U.S., South Korea, China, India, Spain,
Germany and Latin America. Bringing ICL and TICL to new markets, and
expanding market share in existing markets, will improve STAAR’s profitability
and during 2009 STAAR will focus its sales efforts on this goal;
· Secure key regulatory
approvals. Regulatory approval of higher margin products in
significant markets can yield rapid sales growth and improve
profitability. The principal regulatory approvals pursued by STAAR at
this time are the U.S. approval of the TICL and the approval of ICL and TICL in
Japan. Although the timing of the regulatory approval is never certain, the
Company believes approval of these products could be granted in
2009.
In
addition, STAAR’s ability to overcome this substantial doubt concerning its
ability to continue as a going concern depends on several factors involving
certain current litigation matters. On May 11, 2009 the court entered
final judgment in the Parallax case
reaffirming the $4.9 million jury verdict. The Court has stayed
the execution of judgment and collection of damages until June 22, 2009, forty
days after the entry of final judgment. Following expiration of
the stay, to avoid enforcement of the judgment pending resolution of the appeal,
STAAR will be required to obtain a surety bond of up to 1.5 times the judgment
amount, or up to approximately $7.4 million, fully secured with cash collateral
unless a court permits a lesser amount. On May 15, 2009, the court
will hear argument on Parallax’s motion for legal
fees in the amount of approximately $314,000 related to its defense of STAAR’s
cross complaint. STAAR is opposing this motion on grounds that it has
no legal or factual basis, as well as on procedural grounds. STAAR
cannot predict the outcome of this hearing and cannot estimate the amount or
range of loss, if any, in the event of an unfavorable outcome related to the
motion for legal fees. If STAAR is unable to obtain additional
capital to satisfy the judgment or post an appeal bond before June 23, 2009
STAAR expects it will be required to petition for protection under
federal bankruptcy laws, which could further impair its financial position and
liquidity. In addition, another lawsuit similar to the Parallax case, Moody v. STAAR Surgical Company, is
currently scheduled for trial in the Superior Court of California, County of
Orange, on October 19, 2009 and could result in further significant
liability. Because no two courts or trials are identical, the outcome
of the Moody case
cannot be predicted and STAAR cannot estimate the amount or range of loss, if
any, in the event of an unfavorable outcome.
Among the
events of default in the Amended and Restated, Senior Secured Promissory Note
(“the Note”), amended and restated on April 13, 2009, held by Broadwood
Partners, L.P. is any judgment in excess of $500,000 against the Company that
“shall remain unpaid.” On April 2, 2009, after preliminary judgment was entered,
Broadwood and STAAR entered into a Temporary Waiver Agreement with respect to
any event of default that may occur, or may be deemed to have occurred, under
the Note as a result of the Parallax judgment. The
Temporary Waiver Agreement provides that no such default will be deemed to have
occurred until June 23, 2009, expiration of the stay of judgment. If at
that time STAAR cannot satisfy the judgment or fund an appeal bond, an event of
default will occur under the Note resulting in the Note becoming immediately due
and payable and triggering rights under the Security Agreement with
Broadwood. As STAAR currently does not have cash or a binding agreement to
provide funds sufficient to satisfy the judgment or fund an appeal bond, STAAR’s
obligation under the Note, net of the related discount, has been reclassified as
current indebtedness in STAAR’s consolidated balance sheet as of April 3,
2009.
The
substantial doubt about STAAR’s ability to continue as a going concern and this
reclassification of the Note as current indebtedness could also affect STAAR’s
relationship with its trade suppliers and their willingness to continue to
conduct business with STAAR on terms consistent with historical practice. These
suppliers might respond to an apparent weakening of our liquidity position and
to address their own liquidity needs may request faster payment of invoices, new
or increased deposits or other assurances. If this were to happen,
the Company’s need for cash would be intensified and we might be unable to make
payments to our suppliers as they become due.
32
If the
Company is unable to satisfy the judgment or fund an appeal bond it expects
to be potentially required seek relief under the U.S. Bankruptcy
Code.
Overview
of Changes in Cash and Cash Equivalents and Other Working Capital
Accounts.
As of
April 3, 2009 and January 2, 2009, the Company had $3.7 million and $5.0
million, respectively, of cash and cash equivalents.
Net cash
used in operating activities was $0.4 million for the three months ended April
3, 2009, compared to $3.4 million for the three months ended March 28,
2008. Approximately $2.5 million of the total cash used in operating
activities in the first quarter of 2008 was used by STAAR Japan in assuming
distribution from Canon Marketing and for payments on inventory purchased from
Canon Marketing.
Net cash
used in investing activities was $0.1 million for the three months ended April
3, 2009, compared to net cash provided by investing activities of $2.5 million
for the three months ended March 28, 2008. Cash acquired in
connection with the acquisition of STAAR Japan approximated $3.0 million,
reduced by $0.3 million related to transactions costs paid during the three
months ended March 28, 2008. STAAR also incurred approximately $1
million in direct transaction and related costs, of which $472,000 were paid and
$528,000 included in accounts payable and accrued liabilities as of March 28,
2008.
Net cash
used in financing activities was $0.3 million for the three months ended April
3, 2009 compared to $0.2 million for the three months ended March 28, 2008
wholly due to repayment of capital lease lines of credit.
Accounts
receivable at April 3, 2009 decreased $0.5 million relative to January 2,
2009. Days sales outstanding (“DSO”) were 39 days at April 3, 2009
compared to 47 days at March 28, 2008. The Company expects to
maintain DSO within a range of 40 to 45 days during the course of the 2009
fiscal year.
Credit
Facilities, Contractual Obligations and Commitments
Credit
Facilities
As
detailed below, the Company has credit facilities with different lenders to
support operations in the U.S., Germany and Japan.
Broadwood
Promissory Note
On December 14, 2007, the Company
borrowed $5 million from Broadwood Partners, L.P. (“Broadwood”), a stockholder
in the Company, pursuant to a Senior Promissory Note between the Company and
Broadwood. On April 2, 2009, after the preliminary Parallax judgment was entered, Broadwood and
STAAR entered into a Temporary Waiver Agreement with respect to any event of
default that may occur, or may be deemed to have occurred, under the Note as a
result of the Parallax
judgment. In consideration of the Temporary Waiver Agreement, STAAR
agreed to amend the Senior Promissory Note to grant to Broadwood a security
interest in substantially all of STAAR’s assets to secure STAAR’s obligations
under the original Senior Promissory Note. To effectuate this grant of a
security interest, as of April 13, 2009, the Company and Broadwood entered into
an Amended and Restated Senior Secured Promissory Note (the “Note”) and Security
Agreement. All other key terms of the Note remained unchanged. The
Note has a term of three years and bears interest at a rate of 7% per annum,
increasing to 20% per annum if there is a default. The Note may be
pre-paid by the Company at any time without penalty, with prior notice, and is
not subject to covenants based on financial performance or financial condition
(except for insolvency). The Note provides that, with certain exceptions,
the Company will not incur indebtedness senior to or at parity with its
indebtedness under the Note without the consent of
Broadwood.
33
As additional consideration for the
loan, the Company also entered into a Warrant Agreement with Broadwood (the
“December 2007 Warrant Agreement”) with Broadwood granting the right to purchase
up to 700,000 shares of Common Stock at an exercise price of $4.00 per share,
exercisable for a period of six years. The December 2007 Note also provides that
if any indebtedness remains outstanding under the Note on June 1, 2009, the
Company will issue additional warrants on the same terms as set forth in the
December 2007 Warrant Agreement in a number equal to 700,000 times the
percentage of the original $5 million principal that remains
outstanding. As of the date of this report, these additional 700,000
warrants are issuable because the Company has not given notice of pre-payment,
and does not intend to pre-pay, any of the outstanding principal balance by June
1, 2009. The issuance of these additional warrants will be treated as
an additional discount on the Note and amortized to interest expense over the
remaining term of the Note using the effective interest method. The
December 2007 Warrant Agreement also provides that the Company will register for
resale with the Securities Exchange Commission (“SEC”) the 700,000 shares
issuable on exercise of the December 2007 Warrant, and the 700,000 shares that
are issuable under additional warrants if indebtedness remains outstanding on
the Note on June 1, 2009. The Company filed and secured effectiveness
of a registration statement covering resale of the shares. If the
registration statement is not kept effective by the Company and the lapse
exceeds permitted suspensions, the Company is obligated to issue additional
30,000 warrants per month for each month that the Company remains non-compliant
with maintaining registration requirement through the term of the warrants as
the sole remedy to the warrant holder (a maximum of approximately 1,700,000
warrants issuable as of April 3, 2009 under an assumed noncompliance as of that
date).
Covenant
Compliance
On March
2, 2009, a verdict was rendered in the case of Parallax Medical Systems,
Inc. v. STAAR Surgical
Company whereby a jury awarded Parallax approximately $4.9
million, comprising of $2.2 million in actual damages and $2.7 million in
punitive damages. On May 11, 2009, the court entered final judgment
reaffirming this jury awarded judgment amount. Among the events of
default in the Note is any judgment in excess of $500,000 against the Company
that “shall remain unpaid.” April 2, 2009, after the preliminary Parallax judgment was entered, Broadwood and
STAAR entered into a Temporary Waiver Agreement with respect to any event of
default that may occur, or may be deemed to have occurred, under the Note as a
result of the Parallax
judgment. The Temporary Waiver Agreement provides that no such
default will be deemed to have occurred until expiration of the stay of final
judgment in the case, or June 23, 2009. If STAAR cannot satisfy the
judgment or fund an appeal bond before June 23, 2009, an event of default will
occur under the Note resulting in the Note becoming immediately due and payable,
including interest accruing on the Note at the maximum default rate of 20%, an
increase of approximately $650,000 per year in interest costs. As STAAR
currently does not have cash or a binding agreement to provide funds sufficient
to satisfy the judgment or fund an appeal bond, STAAR’s obligation under the
Note, net of the related discount, has been reclassified as current indebtedness
in STAAR’s consolidated balance sheet as of April 3, 2009.
Capital
Lease Agreements
The Company’s lease agreement with
Farnam Street Financial, Inc., as amended on October 9, 2006, provides for
purchases of up to $1,500,000 of property, plant and equipment. In accordance
with the requirements of SFAS 13 “Accounting for Leases,” purchases under this
facility are accounted for as capital leases and generally have a thirty-month
to three-year term. Under the agreement, the Company has the option to purchase
any item of the leased property at the end of that item’s lease term, at a
mutually agreed-upon fair value. On April 1, 2007, the Company signed
an additional leasing schedule with Farnam, which provided for additional
purchases of $800,000 during 2008. The terms of this new schedule conform to the
amended agreement dated October 9, 2006.
Lines
of Credit
The Company’s German subsidiary,
Domilens, entered into a credit agreement on August 30, 2005. The credit
agreement provides for borrowings of up to 100,000 EUR ($134,000 at the rate of
exchange on April 3, 2009), at a rate of 8.5% per annum and does not have a
termination date. The credit agreement is automatically renewed on an annual
basis based on the same terms. The credit agreement may be terminated
by the lender in accordance with its general terms and conditions. The credit
facility is not collateralized. There were no borrowings outstanding
as of April 3, 2009 and January 2, 2009 and the full amount of the line was
available for borrowing as of April 3, 2009.
The Company’s Japanese subsidiary,
STAAR Japan, has an agreement, as amended, with Mizuho Bank providing borrowings
of up to 400,000,000 Japanese Yen (approximately $4.0 million based on the rate
of exchange on April 3, 2009), at an interest rate equal to the Tokyo short-term
prime interest rate (approximately 1.475% as of April 3, 2009) and terminates on
April 20, 2010, but may be renewed annually. The credit facility is
not collateralized. The Company had 200,000,000 Japanese Yen
outstanding on the line of credit as of April 3, 2009 and January 2, 2009
(approximately $2.0 million based on the exchange rate on April 3,
2009).
34
Redeemable,
Convertible Preferred Stock
On December 29, 2007, the Company
issued 1,700,000 shares of Series A Redeemable Convertible Preferred Stock
(“Preferred Stock”) to the Canon companies as partial consideration for their
50% interest in Canon Staar Co., Inc.
The Preferred Stock is redeemable by
the Company at any time on or after the first anniversary of the issuance date
at a price of $4.00 per share plus any accrued or declared but unpaid dividends
(“Redemption Price”). The holders of the Preferred Stock have a
right, exercisable at any time on or after the third anniversary of the issuance
date by a majority vote of the Preferred Stock holders, to require the Company
to redeem the Preferred Stock at the Redemption Price. Because after
the third anniversary of issuance the Preferred Stock is redeemable at the
option of the holders, which is not within the control of the Company, the
aggregate $6.8 million Redemption Price of the Preferred Stock is presented on a
separate line of the consolidated balance sheet, as neither debt nor
equity.
The Preferred Stock is convertible into
shares of the Company’s common stock at any time after the issuance date at a
one-to-one conversion ratio that is adjustable only for stock splits,
combinations, subdivisions, dividends or recapitalizations (“Conversion
Ratio”). On the fifth anniversary of the issuance date, each share of
Preferred Stock will expire and be automatically converted to common stock of
the Company at the Conversion Ratio. Once a share of Preferred Stock
is converted to common stock the holder’s right to redeem the Preferred Stock is
extinguished.
The Company’s liquidity requirements
arise from the funding of its working capital needs, primarily inventory,
work-in-process and accounts receivable. The Company’s primary sources for
working capital and capital expenditures are cash flow from operations, which
will largely depend on the success of the ICL, proceeds from option exercises,
borrowings under the Company’s credit facility and proceeds from the sale of
common stock. Any withdrawal of support from its lenders could have serious
consequences on the Company’s liquidity. The Company’s liquidity also depends,
in part, on customers paying within credit terms, and any extended delays in
payments or changes in credit terms given to major customers may have an impact
on the Company’s cash flow. In addition, any abnormal product returns or pricing
adjustments may also affect the Company’s short-term funding. Changes in the
market price of our common stock affect the value of our outstanding options,
and lower market prices could reduce our expected revenue from option
exercises.
The business of the Company is subject
to numerous risks and uncertainties that are beyond its control, including, but
not limited to, those set forth above and in the other reports filed by the
Company with the Securities and Exchange Commission. Such risks and
uncertainties could have a material adverse effect on the Company’s business,
financial condition, operating results and cash flows.
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 2,
2009.
ITEM
4. CONTROLS AND
PROCEDURES
Disclosure
Controls and Procedures
Our
management, with the participation of the CEO and the CFO, evaluated the
effectiveness of our disclosure controls and procedures as required by Exchange
Act Rule 13a-15(b) as of the end of the period covered by this
report. Based on that evaluation, the CEO and the CFO have concluded
that our disclosure controls and procedures (as defined in Exchange Act Rule 13a
– 15e) are effective.
Our
management, including the CEO and the CFO, do not expect that our disclosure
controls and procedures or our internal control over financial reporting will
necessarily prevent all fraud or material errors. An internal control system, no
matter how well conceived and operated, can provide only reasonable, not
absolute, assurance that the objectives of the control system are met. Further,
the design of a control system must reflect the fact that there are resource
constraints, and the benefits of controls must be considered relative to their
costs. Because of the inherent limitations on all internal control systems, our
internal control system can provide only reasonable assurance of achieving its
objectives and no evaluation of controls can provide absolute assurance that all
control issues and instances of fraud, if any, within our Company have been
detected. These inherent limitations include the realities that judgments in
decision-making can be faulty, and that breakdowns can occur because of simple
error or mistake. Additionally, controls can be circumvented by the individual
acts of some persons, by collusion of two or more people, or by management
override of the control. The design of any system of internal control is also
based in part upon certain assumptions about the likelihood of future events,
and can provide only reasonable, not absolute, assurance that any design will
succeed in achieving its stated goals under all potential future conditions.
Over time, controls may become inadequate because of changes in circumstances,
or the degree of compliance with the policies and procedures may
deteriorate.
35
Internal
Control over Financial Reporting
There
were no changes in our internal control over financial reporting during the
quarter ended April 3, 2009 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial
reporting.
PART
II – OTHER INFORMATION
ITEM
1. LEGAL
PROCEEDINGS
Litigation and Claims
Parallax Medical Systems, Inc. v.
STAAR Surgical Company (California Superior Court, County of Orange, Case
No. 07CC10136). Final judgment in this case was entered on May
11, 2009, in accordance with a March 2, 2009 jury verdict awarding
approximately $2.2 million in actual damages and $2.7 million in punitive
damages to Parallax Medical
Systems, Inc. Parallax is a
former independent regional manufacturer’s representative (“RMR”) of
STAAR. Parallax promoted sales of STAAR products in the southeastern
region of the U.S. under a contract that expired on July 31,
2007. Parallax originally filed its complaint against STAAR on
September 21, 2007, claiming, among other things, that STAAR interfered with
Parallax’s prospective economic advantage when it informed a regional IOL
distributor that Parallax had a covenant restricting the sale of competing
products, and that STAAR interfered with Parallax’s contracts when STAAR caused
some of its current or former subcontractors to enter into new agreements to
represent STAAR products. STAAR filed a cross-complaint alleging
breach of contract and misappropriation of trade secrets; the jury found in
favor of Parallax on
the cross-complaint. The complaint sought $48 million in actual
damages and unspecified punitive damages.
Final
judgment was entered following a hearing on principal post-trial motions on
May 8, 2009. On May 15, 2009, the court will hear argument on
Parallax’s motion for
legal fees in the amount of approximately $314,000 related to its defense of
STAAR’s cross
complaint. STAAR is opposing this motion on grounds that it has no
legal or factual basis, as well as on procedural grounds. STAAR
cannot predict whether the ruling on the motion for legal fees will be
granted.
STAAR
believes that the Parallax case was incorrectly
decided as to liability, the amount of compensatory damages and the
appropriateness and amount of punitive damages, and intends to vigorously appeal
the outcome of this case. The court has stayed the execution of
judgment and collection of damages until June 22, 2009, forty days after the
rendering of final judgment. Following expiration of the stay, to
avoid enforcement of the judgment pending resolution of the appeal, STAAR will
be required to obtain a surety bond of up to 1.5 times the judgment amount,
fully secured with cash collateral unless a court permits a lesser
amount.
Moody v. STAAR Surgical Company;
(California Superior Court, County of Orange, Case
No. 07CC10132). Scott C. Moody, Inc., also a former RMR of
STAAR, filed a complaint against STAAR on the same day that Parallax filed its
complaint. Moody promoted sales of STAAR products in the southwestern
region of the U.S., under a contract that, like Parallax’s, expired on July 31,
2007. Like Parallax, Moody claims that STAAR
interfered with Moody’s
prospective economic advantage when it informed a regional IOL distributor that
Moody had a covenant restricting the sale of competing products. The
complaint seeks $32 million in actual damages and unspecified punitive
damages. STAAR has filed a cross-complaint alleging breach of
contract and misappropriation of trade secrets.
The Moody case is currently
scheduled to be tried before a jury on October 19, 2009. STAAR
believes that the evidence to be presented in Moody does not support
liability for interference with prospective business advantage or interference
with Moody’s contracts with former subcontractors, and does not support damages
at a level that is material to STAAR. However, the Parallax and Moody cases have many facts
in common; the plaintiff in Moody alleges that the same
conduct of STAAR interfered with its prospective business advantage, and Moody will also be tried
before a jury. The Moody plaintiff has also
indicated it will seek punitive damages. But because no two courts or
trials are identical, the outcome of the Moody case cannot be
predicted. In particular, important factual differences exist between
the two cases, it is possible that the Moody court will permit
different evidence or arguments to be presented at trial, and the outcome of
jury trials is inherently uncertain. On May 4, 2009, STAAR retained
new counsel for the Moody case following the
appointment of its former lead counsel to a judgeship on the California Superior
Court.
36
In
addition to the lawsuits discussed above, STAAR is from time to time subject to
various claims and legal proceedings arising out of the normal course of its
business. These claims and legal proceedings relate to contractual rights and
obligations, employment matters, and claims of product liability. STAAR
maintains insurance coverage for product liability claims. While the Company
does not believe that any of the claims known is likely to have a material
adverse effect on its financial condition or results of operations, new claims
or unexpected results of existing claims could lead to significant financial
harm.
ITEM
1A. RISK
FACTORS
There
have been no material changes to the risk factors disclosed in Item 1A of Part 1
of our Annual Report on Form 10-K for the fiscal year ended January 2,
2009.
37
ITEM
6. EXHIBITS
Exhibits
|
||
3.1
|
Certificate
of Incorporation, as amended to date.(1)
|
|
3.2
|
By-laws,
as amended to date.(2)
|
|
4.1
|
Certificate
of Designation of Series A Convertible Preferred
Stock.(1)
|
|
4.2
|
1991
Stock Option Plan of STAAR Surgical Company.(3)
|
|
4.3
|
1998
STAAR Surgical Company Stock Plan, adopted April 17,
1998.(4)
|
|
4.4
|
Form
of Certificate for Common Stock, par value $0.01 per
share.(5)
|
|
4.5
|
2003
Omnibus Equity Incentive Plan, as amended, and form of Option Grant and
Stock Option Agreement.(6)
|
|
10.71
|
Temporary
Waiver Agreement, dated April 2, 2009, by and between Broadwood Partners,
L.P. and the Company.(7)
|
|
10.72
|
Amended
and Restated Senior Secured Promissory Note between the Company and
Broadwood Partners, L.P., dated April 13, 2009.(8)
|
|
10.73
|
Security
Agreement by and between the Company and Broadwood Partners, L.P., dated
April 13, 2009.(8)
|
|
31.1
|
Certification
Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, Adopted
Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.(*)
|
|
31.2
|
Certification
Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, Adopted
Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.(*)
|
|
32.1
|
Certification
Pursuant to 18 U.S.C. Section 1350, Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of
2002.(*)
|
|
(1)
|
Incorporated
by reference to the Company’s Annual Report on Form 10-K for the fiscal
year ended December 28, 2007, as filed with the Commission on
March 12, 2008.
|
|
(2)
|
Incorporated
by reference to the Company’s Current Report on Form 8-K filed with the
Commission on May 23, 2006.
|
|
(3)
|
Incorporated
by reference to the Company’s Registration Statement on Form S-8, File No.
033-76404, as filed with the Commission on March 11,
1994.
|
|
(4)
|
Incorporated
by reference to the Company’s Proxy Statement for its Annual Meeting of
Stockholders held on May 29, 1998, filed with the Commission on
May 1, 1998.
|
|
(5)
|
Incorporated
by reference to Exhibit 4.1 to Amendment No. 1 to the Company’s
Registration Statement on Form 8-A/A, as filed with the Commission on
April 18, 2003.
|
|
(6)
|
Incorporated
by reference to the Company’s Current Report on Form 8-K filed with the
Commission on January 8, 2009.
|
|
(7)
|
Incorporated
by reference to the Company’s Annual Report on Form 10-K for the fiscal
year ended January 2, 2009, as filed with the Commission on April 2,
2009.
|
|
(8)
|
Incorporated
by reference to the Company’s Current Report on Form 8-K filed with the
Commission on April 17, 2009.
|
(*)
|
Filed
herewith.
|
38
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
STAAR
SURGICAL COMPANY
|
||
Date: May
13, 2009
|
By: /s/ DEBORAH ANDREWS
|
|
Deborah
Andrews
|
||
Chief
Financial Officer
|
||
(on
behalf of the Registrant and as its
|
||
principal
financial officer)
|
39