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| CSII > SEC Filings for CSII > Form 10-Q on 13-Feb-2009 | All Recent SEC Filings |
13-Feb-2009
Quarterly Report
You should read the following discussion and analysis of our financial
condition and results of operations together with our financial statements and
the related notes appearing under Item 1 of Part 1. Some of the information
contained in this discussion and analysis or set forth elsewhere in this
quarterly report, including information with respect to our plans and strategy
for our business and expected financial results, includes forward-looking
statements that involve risks and uncertainties. You should review the "Risk
Factors" under Item 1A of the Company's Registration Statement on Form 10 for a
discussion of important factors that could cause actual results to differ
materially from the results described in or implied by the forward-looking
statements contained in the following discussion and analysis.
OVERVIEW
We are a medical device company focused on developing and commercializing
interventional treatment systems for vascular disease. Our initial product, the
Diamondback 360° Orbital Atherectomy System, is a minimally invasive catheter
system for the treatment of peripheral arterial disease, or PAD.
On November 3, 2008, we entered into an Agreement and Plan of Merger with
Replidyne, Inc., a Delaware corporation, and Responder Merger Sub, Inc., a
Minnesota corporation and wholly owned subsidiary of Replidyne. Pursuant to the
merger agreement, on the terms and conditions set forth therein, Responder
Merger Sub, Inc. will be merged with and into our company, with our company
surviving the merger as a wholly owned subsidiary of Replidyne. Immediately
prior to the effective time of the merger, each share of our preferred stock
outstanding at such time will be converted into shares of our common stock at
the conversion ratio determined pursuant to our articles of incorporation. At
the effective time of the merger, each share of our common stock outstanding
immediately prior to the effective time of the merger (excluding certain shares
to be canceled pursuant to the merger agreement, and shares held by stockholders
who have exercised and perfected dissenters' rights) will be converted into the
right to receive between 6.460 and 6.797 shares of Replidyne common stock,
assuming that the net assets of Replidyne are between $35.0 million and
$37.0 million as calculated in accordance with the terms of the merger agreement
and that the number of shares of Replidyne and our common stock outstanding on a
fully diluted basis using the treasury stock method of accounting for options
and warrants immediately prior to the effective time of the merger has not
changed from the number of such shares as of October 31, 2008, subject to
adjustment to account for the effect of a reverse stock split of Replidyne
common stock to be implemented prior to the consummation of the merger. As a
result of the merger, holders of our stock, options and warrants are expected to
own or have the right to acquire in the aggregate between 83.0% and 83.7% of the
combined company and the holders of Replidyne stock, options and warrants are
expected to own or have the right to acquire in the aggregate between 16.3% and
17.0% of the combined company. At the effective time of the merger, Replidyne
will change its corporate name to "Cardiovascular Systems, Inc." as required by
the merger agreement. The merger is subject to shareholder approval at meetings
of our shareholders and Replidyne's stockholders scheduled to be held on
February 24, 2009 and other closing conditions and is expected to be consummated
shortly thereafter. The combined company has applied for listing on the Nasdaq
Global Market under the symbol "CSII."
We were incorporated in Minnesota in 1989. From 1989 to 1997, we engaged in
research and development on several different product concepts that were later
abandoned. Since 1997, we have devoted substantially all of our resources to the
development of the Diamondback 360°.
From 2003 to 2005, we conducted numerous bench and animal tests in
preparation for application submissions to the FDA. We initially focused our
testing on providing a solution for coronary in-stent restenosis but later
changed the focus to PAD. In 2006, we obtained an investigational device
exemption from the FDA to conduct our pivotal OASIS clinical trial, which was
completed in January 2007. The OASIS clinical trial was a prospective 20-center
study that involved 124 patients with 201 lesions.
In August 2007, the FDA granted us 510(k) clearance for the use of the
Diamondback 360° as a therapy in patients with PAD. We commenced a limited
commercial introduction of the Diamondback 360° in the United States in
September 2007. This limited commercial introduction intentionally limited the
size of our sales force and the number of customers each member of the sales
force served in order to focus on obtaining quality and timely product feedback
on initial product usages.
We market the Diamondback 360° in the United States through a direct sales
force and commenced a full commercial launch in the quarter ended March 31,
2008. We plan to expend significant capital to increase the size of our sales
and marketing efforts to expand our customer base as we implement full
commercialization of the Diamondback 360°. We manufacture the Diamondback 360°
internally at our facilities.
As of December 31, 2008, we had an accumulated deficit of $143.7 million.
We expect our losses to continue and to increase as we continue our
commercialization activities, develop additional product enhancements and make
further regulatory submissions. To date, we have financed our operations
primarily through the private placement of equity securities.
Our consolidated financial statements have been prepared on a going concern
basis, which contemplates the realization of assets and the satisfaction of
liabilities in the normal course of business. Since our inception, we have
experienced substantial operating losses and negative cash flows from
operations. We had cash and cash equivalents of $6.3 million at December 31,
2008. During the six months ended December 31, 2008 and 2007, net cash used in
operations amounted to $20.3 million and $15.3 million, respectively. In
February 2008, we were notified that recent conditions in the global credit
markets have caused insufficient demand for auction rate securities, resulting
in failed auctions for $23.0 million of our auction rate securities held at
December 31, 2008. These securities are currently not liquid, as we have an
inability to sell the securities due to continued failed auctions. On March 28,
2008, we obtained a margin loan from UBS Financial Services, Inc., the entity
through which we originally purchased our auction rate securities, for up to
$12.0 million, which was secured by the $23.0 million par value of our auction
rate securities. The outstanding balance on this loan at June 30, 2008 was
$11.9 million. On August 21, 2008, we replaced this loan with a margin loan from
UBS Bank USA, which increased maximum borrowings available to $23.0 million.
This maximum borrowing amount is not set forth in the written agreement for the
loan and may be adjusted from time to time by UBS Bank in its sole discretion.
The margin loan has a floating interest rate equal to 30-day LIBOR, plus 1.0%;
however, interest expense charged on the loan will not exceed interest income
earned on the auction rate securities. The loan is due on demand and UBS Bank
will require us to repay it in full from the proceeds received from a public
equity offering where net proceeds exceed $50.0 million. In addition, if at any
time any of our auction rate securities may be sold, exchanged, redeemed,
transferred or otherwise conveyed for no less than their par value, then we must
immediately effect such a transfer and the proceeds must be used to pay down
outstanding borrowings under this loan. The margin requirements are determined
by UBS Bank but are not included in the written loan agreement and are therefore
subject to change. From August 21, 2008, the date this loan was initially
funded, through the date of this Form 10-Q, the margin requirements included
maximum borrowings, including interest, of $23.0 million. If these margin
requirements are not maintained, UBS Bank may require us to make a loan payment
in an amount necessary to comply with the applicable margin requirements or
demand repayment of the entire outstanding balance. We have maintained the
margin requirements under the loans from both UBS entities. The outstanding
balance on this loan at December 31, 2008 was $22.7 million.
In addition, on September 12, 2008, we entered into a loan and security
agreement with Silicon Valley Bank with maximum available borrowings of
$13.5 million. The agreement includes a $3.0 million term loan, a $5.0 million
accounts receivable line of credit, and two term loans for an aggregate of
$5.5 million that are guaranteed by certain of our affiliates. See "Liquidity
and Capital Resources" for further information regarding this loan.
Our ability to continue as a going concern ultimately depends on our ability
to either complete the merger with Replidyne or raise additional debt or equity
capital prior to or during the quarter ending September 30, 2009. If the merger
is not consummated or we are unable to raise additional debt or equity financing
on terms acceptable to us, there will continue to be substantial doubt about our
ability to continue as a going concern.
During the remainder of fiscal year 2009, we plan to continue to expand our
sales and marketing efforts, conduct research and development of product
improvements and increase our manufacturing capacity to support anticipated
future growth.
CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES
Our management's discussion and analysis of our financial condition and results
of operations are based on our consolidated financial statements, which have
been prepared in accordance with accounting principles generally accepted in the
United States. The preparation of our consolidated financial statements requires
us to make estimates, assumptions and judgments that affect amounts reported in
those statements. Our estimates, assumptions and judgments, including those
related to revenue recognition, excess and obsolete inventory, stock-based
compensation, preferred stock and preferred stock warrants are updated as
appropriate at least quarterly. We use authoritative pronouncements, our
technical accounting knowledge, cumulative business experience, judgment and
other factors in the selection and application of our accounting policies. While
we believe that the estimates, assumptions and judgments that we use in
preparing our consolidated financial statements are appropriate, these
estimates, assumptions and judgments are subject to factors and uncertainties
regarding their outcome. Therefore, actual results may materially differ from
these estimates.
Some of our significant accounting policies require us to make subjective or
complex judgments or estimates. An accounting estimate is considered to be
critical if it meets both of the following criteria: (1) the estimate requires
assumptions about matters that are highly uncertain at the time the accounting
estimate is made, and (2) different estimates that reasonably could have been
used, or changes in the estimate that are reasonably likely to occur from period
to period, would have a material impact on the presentation of our financial
condition, results of operations, or cash flows. We believe that the following
are our critical accounting policies and estimates:
Revenue Recognition. We recognize revenue in accordance with SEC Staff
Accounting Bulletin (SAB) No. 104, Revenue Recognition and EITF No. 00-21,
Revenue Arrangements with Multiple Deliverables. Revenue is recognized when all
of the following criteria are met: (1) persuasive evidence of an arrangement
exists; (2) shipment of all components has occurred or delivery of all
components has occurred if the terms specify that title and risk of loss pass
when products reach their destination; (3) the sales price is fixed or
determinable; and (4) collectability is reasonably assured. We have no
additional post-shipment or other contractual obligations or performance
requirements and do not provide any credits or other pricing adjustments
affecting revenue recognition once these criteria have been met. The customer
has no right of return on any component once the above criteria have been met.
Payment terms are generally set at 30 days.
We derive our revenue through the sale of the Diamondback 360°, which includes
single-use catheters, guidewires and control units used in the atherectomy
procedure. Initial orders from all new customers require the customer to
purchase the entire Diamondback 360° system, which includes multiple single-use
catheters and guidewires and one control unit. Due to delays in the final FDA
clearance of a new control unit and early production constraints of the new
control unit, we were not able to deliver all components of the initial order
for some transactions. For these initial orders, we shipped and billed only for
the single-use catheters and guidewires. In addition, we sent an older version
of our control unit as a loaner unit with the customer's expectation that we
would deliver and bill for a new control unit once it became available. As we
had not delivered each of the individual components to all customers, we had
deferred the revenue for the entire amount billed for single-use catheters and
guidewires shipped to the customers that had not received the new control unit.
Those billings totaled $116,000 at June 30, 2008, which amount had been deferred
pending receipt of a customer purchase order and shipment of a new control unit.
After the initial order, customers are not required to purchase any additional
disposable products from us. Once we had delivered the new control unit to a
customer, we recognized revenue that was previously deferred and revenue for
subsequent reorders of single-use catheters, guidewires and additional new
control units when the criteria of SAB No. 104 were met. We are currently
meeting production demands for the new control units and all deferred revenue
was recognized during the six months ended December 31, 2008.
Investments. Our investments consist solely of auction rate securities (ARS).
ARS were previously classified as short-term based on their liquid nature. ARS
had certain economic characteristics of short-term investments due to a
rate-setting mechanism and the ability to sell them through a Dutch auction
process that occurred at pre-determined intervals of less than one year.
Our ARS are AAA rated and issued primarily by state agencies and backed by
student loans substantially guaranteed by the Federal Family Education Loan
Program (FFELP). The federal government insures loans in the FFELP so that
lenders are reimbursed at least 97% of the loan's outstanding principal and
accrued interest if a borrower defaults. Approximately 99.2% of the par value of
the our ARS are supported by student loan assets that are guaranteed by the
federal government under the FFELP.
Our ARS are debt instruments with a long-term maturity and with an interest
rate that is reset in short intervals, primarily every 28 days, through
auctions. Conditions in the global credit markets have prevented us from
liquidating our holdings of ARS because the amount of securities submitted for
sale has exceeded the amount of purchase orders for such securities. When
auctions for these securities fail, the investments may not be readily
convertible to cash until a future auction of these investments is successful or
they are redeemed by the issuer or they mature.
In February 2008, we were informed that there was insufficient demand for
ARS, resulting in failed auctions for $23.0 million of our ARS held at
December 31, 2008 and June 30, 2008. Currently, these affected securities are
not liquid and will not become liquid until a future auction for these
investments is successful or they are redeemed by the issuer or they mature. As
a result, at December 31, 2008 and June 30, 2008, we classified the fair value
of the ARS as a long-term asset. Interest rates on all failed ARS were reset to
a temporary predetermined "penalty" or "maximum" rate. These maximum rates are
generally limited to a maximum amount payable over a 12 month period equal to a
rate based on the trailing 12-month average of 90-day treasury bills, plus 120
basis points. These maximum allowable rates range from 2.7% to 4.0% of par value
per year. We have collected all interest due on our ARS and have no reason to
believe that we will not collect all interest due in the future. We expect to
receive the principal associated with our ARS upon the earlier of a successful
auction, their redemption by the issuer or their maturity. All ARS held by us
continue to be AAA rated subsequent to the failed auctions that began in
February 2008.
At December 31, 2008, we concluded that no weight should be given to the
value indicated by the secondary markets for student loan backed ARS similar to
those we hold because these markets have very low transaction volumes and
consist primarily of private transactions with minimal disclosure and
transactions may not be representative of the actions of typically-motivated
buyers and sellers and we do not currently intend to sell in the secondary
markets. However, we did consider the secondary markets for certain
mortgage-backed securities to estimate the market yields attributable to our
ARS, but determined that these secondary markets do not provide a sufficient
basis of comparison for the ARS that we hold and, accordingly, attributed no
weight to the values of these mortgage-backed securities indicated by the
secondary markets.
At December 31, 2008, we concluded that no weight should be given to the
likelihood and potential timing of issuers of the ARS exercising their
redemption rights at par value based on low issuer call activity, so we
attributed a weight of 100.0% to estimates of present value of the ARS based
upon expected cash flows. The attribution of weights to the valuation factors
required the exercise of valuation judgment. The selection of a weight of 100.0%
attributed to the present value of the ARS based upon expected cash flows
reflects the expectation that no certainty exists regarding how the ARS will be
eventually converted to cash and this methodology represents the fair value
today of a future conversion of the ARS to cash. To derive estimates of the
present value of the ARS based upon expected cash flows, we used the securities'
expected annual interest payments, ranging from 1.3% to 5.3% of par value,
representing estimated maximum annual rates under the governing documents of the
ARS; annual market interest rates, ranging from 5.2% to 6.4%, based on observed
traded, state sponsored, taxable certificates rated AAA or lower and issued
between December 1 and December 30, 2008; certain mortgage-backed securities and
indices; and a range of expected terms to liquidity.
Our weighting of the valuation methods as of December 31, 2008 indicates an
implied term to liquidity of approximately five years. The implied term to
liquidity of approximately five years is a result of considering a range in
possible timing of the various scenarios that would allow a holder of the ARS to
convert the ARS to cash ranging from zero to ten years, with the highest
probability assigned to five years. From mid-September 2008, UBS began to
provide loans at no net cost to its clients for the par value of their ARS
holdings. In addition, UBS has also committed to provide liquidity solutions to
institutional investors and has agreed to purchase all or any of a remaining
$10.3 billion in ARS at par value from its institutional clients beginning
June 30, 2010. The value of these rights were not included in the fair value of
our ARS but rather recognized as a free standing asset separate from our ARS.
On November 7, 2008, we accepted an offer from UBS AG ("UBS"), providing
rights related to our ARS (the "Rights"). The Rights permit us to require UBS to
purchase our ARS at par value, which is defined for this purpose as the
liquidation preference of the ARS plus accrued but unpaid dividends or interest,
at any time during the period of June 30, 2010 through July 2, 2012. Conversely,
UBS has the right, in its discretion, to purchase or sell our ARS at any time
until July 2, 2012, so long as we receive payment at par value upon any sale or
disposition. We expect to sell our ARS under the Rights. However, if the Rights
are not exercised before July 2, 2012 they will expire and UBS will have no
further rights or obligation to buy our ARS. So long as we hold ARS, they will
continue to accrue interest as determined by the auction process or the terms of
the ARS if the auction process fails.
UBS's obligations under the Rights are not secured by its assets and do not
require UBS to obtain any financing to support its performance obligations under
the Rights. Furthermore, UBS will only purchase up to an aggregate of
$10.3 billion in ARS from its institutional clients. UBS has disclaimed any
assurance that it will have sufficient financial resources to satisfy its
obligations under the Rights.
Prior to accepting the UBS offer, we recorded ARS as investments
available-for-sale. We recorded unrealized gains and losses on
available-for-sale securities in accumulated other comprehensive income in the
shareholders' deficiency section of the balance sheet. Realized gains and losses
were accounted for on the specific identification method.
In connection with our acceptance of the UBS offer in November 2008,
resulting in our right to require UBS to purchase ARS at par value beginning on
June 30, 2010, we transferred the ARS from investments available-for-sale to
trading securities in accordance with SFAS 115. The transfer to trading
securities reflects management's intent to exercise its put option during the
period June 30, 2010 to July 3, 2012. Prior to our agreement with UBS, our
intent was to hold the ARS until the market recovered. At the time of transfer,
the unrealized loss on our ARS was $343,000. This unrealized loss was included
in accumulated other comprehensive income (loss). Upon transfer to trading
securities, we immediately recognized a loss of $343,000, included in impairment
on investments, for the amount of the unrealized loss not previously recognized
in earnings.
In addition to the valuation procedures described above, we considered
(i) our current inability to hold these securities for a period of time
sufficient to allow for an unanticipated recovery in fair value based on our
current liquidity, history of operating losses, and management's estimates of
required cash for continued product development and sales and marketing
expenses, and (ii) failed auctions and the anticipation of continued failed
auctions for all of our ARS.
Based on the factors described above, we recorded an impairment loss for the
three and six months ended December 31, 2008 of $2.2 million, which includes
$343,000 of an unrealized loss not previously recognized in earnings. We
continue to monitor the market for ARS and consider its impact (if any) on the
fair market value of investments. If the market conditions deteriorate further,
we may be required to record additional unrealized losses in earnings, offset by
corresponding increases in the put option.
Excess and Obsolete Inventory. We have inventories that are principally
comprised of capitalized direct labor and manufacturing overhead, raw materials
and components, and finished goods. Due to the technological nature of our
products, there is a risk of obsolescence to changes in our technology and the
market, which is impacted by exogenous technological developments and events.
Accordingly, we write down our inventories as we become aware of any situation
where the carrying amount exceeds the estimated realizable value based on
assumptions about future demands and market conditions. The evaluation includes
analyses of inventory levels, expected product lives, product at risk of
expiration, sales levels by product and projections of future sales demand.
Stock-Based Compensation. We account for stock-based compensation expense in
accordance with SFAS No. 123(R), Share-Based Payment, as interpreted by SAB
No. 107, using the prospective application method, for the issuance of stock
options to employees and directors on or after July 1, 2006. The unvested
compensation costs at July 1, 2006, which relate to grants of options that
occurred prior to the date of adoption of SFAS No. 123(R), are continuing to be
accounted for under Accounting Principles Board (APB) No. 25, Accounting for
Stock Issued to Employees. SFAS No. 123(R) requires us to recognize stock-based
compensation expense in an amount equal to the fair value of share-based
payments computed at the date of grant. The fair value of all employee and
director stock options is expensed in the consolidated statements of operations
over the related vesting period of the options. We calculated the fair value on
the date of grant using a Black-Scholes option pricing model.
To determine the inputs for the Black-Scholes option pricing model, we are
required to develop several assumptions, which are highly subjective. These
assumptions include:
• our common stock's volatility;
• the length of our options' lives, which is based on future exercises and cancellations;
• the number of shares of common stock pursuant to which options which will ultimately be forfeited;
• the risk-free rate of return; and
• future dividends.
We use comparable public company data to determine volatility, as our common
stock has not yet been publicly traded. We use a weighted average calculation to
estimate the time our options will be outstanding as prescribed by Staff
Accounting Bulletin No. 107, Share-Based Payment. We estimate the number of
options that are expected to be forfeited based on our historical experience.
The risk-free rate is based on the U.S. Treasury yield curve in effect at the
time of grant for the estimated life of the option. We use our judgment and
expectations in setting future dividend rates, which is currently expected to be
zero.
The absence of an active market for our common stock also requires our
management and board of directors to estimate the fair value of our common stock
for purposes of granting options and for determining stock-based compensation
expense. In response to these requirements, our management and board of
directors estimate the fair market value of common stock at each date at which
options are granted based upon stock valuations and other qualitative factors.
We have conducted stock valuations using the probability weighted expected
return method, or PWERM at June 30, 2008, September 30, 2008, and December 31,
2008, as of which times we had commenced significant efforts in connection with
our initial public offering process or merger with Replidyne and the probability
of a liquidation event had increased. Accordingly, management and the board of
directors determined that the PWERM would be more appropriate than the option
pricing method. For the PWERM, we estimated the likely return to stockholders
based upon our becoming a public company through the merger with Replidyne or an
initial public offering, being acquired or remaining a private company, and
employed comparable public company, merger and acquisition transaction, and
discounted cash flow analysis. These values were adjusted and weighted based on
probability of occurrence. As of December 31, 2008, we assumed a 90% probability
of completing the merger with Replidyne, a 5% probability of completing an
initial public offering, and a 5% probability of being acquired.
Our management and board of directors also considered the valuations of comparable public companies, our cash and working capital amounts, and . . .
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