e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2009
Commission File No. 000-52082
CARDIOVASCULAR SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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No. 41-1698056 |
(State or Other Jurisdiction of
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(IRS Employer |
Incorporation or Organization)
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Identification No.) |
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651 Campus Drive
St. Paul, Minnesota 55112-3495
(Address of Principal Executive Offices)
Registrants telephone number (651) 259-1600
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the 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):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
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(Do not check if a smaller reporting company)
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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 number of shares outstanding of the registrants common stock as of November 9, 2009 was:
Common Stock, $0.001 par value per share, 14,691,397 shares.
Cardiovascular Systems, Inc.
Consolidated Financial Statements
Table of Contents
2
PART I. FINANCIAL INFORMATION
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ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) |
Cardiovascular Systems, Inc.
Consolidated Balance Sheets
(Dollars in Thousands, except per share and share amounts)
(Unaudited)
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September 30, |
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June 30, |
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2009 |
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2009 |
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ASSETS |
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Current assets |
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Cash and cash equivalents |
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$ |
30,754 |
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$ |
33,411 |
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Accounts receivable, net |
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8,181 |
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8,474 |
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Inventories |
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4,082 |
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3,369 |
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Auction rate securities put option |
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2,800 |
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Investments |
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19,900 |
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Prepaid expenses and other current assets |
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1,264 |
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798 |
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Total current assets |
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66,981 |
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46,052 |
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Auction rate securities put option |
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2,800 |
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Investments |
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20,000 |
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Property and equipment, net |
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1,636 |
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1,719 |
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Patents, net |
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1,490 |
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1,363 |
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Other assets |
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364 |
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436 |
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Total assets |
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$ |
70,471 |
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$ |
72,370 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities |
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Current maturities of long-term debt |
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$ |
25,802 |
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$ |
25,823 |
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Accounts payable |
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4,368 |
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4,751 |
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Accrued expenses |
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5,872 |
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5,600 |
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Total current liabilities |
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36,042 |
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36,174 |
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Long-term liabilities |
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Long-term debt, net of current maturities |
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3,597 |
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4,379 |
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Grant payable |
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2,975 |
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Lease obligation and other liabilities |
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1,219 |
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1,485 |
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Total long-term liabilities |
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7,791 |
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5,864 |
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Total liabilities |
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43,833 |
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42,038 |
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Commitments and contingencies |
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Stockholders equity |
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Common stock, $0.001 par value at September 30, 2009 and June 30, 2009;
authorized 100,000,000 common shares at September 30, 2009 and June
30, 2009; issued and outstanding 14,598,226 at September 30, 2009 and
14,113,904 at June 30, 2009, respectively |
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15 |
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14 |
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Additional paid in capital |
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148,963 |
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146,455 |
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Common stock warrants |
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11,279 |
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11,282 |
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Accumulated deficit |
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(133,619 |
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(127,419 |
) |
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Total stockholders equity |
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26,638 |
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30,332 |
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Total liabilities and stockholders equity |
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$ |
70,471 |
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$ |
72,370 |
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The accompanying notes are an integral part of these unaudited consolidated financial statements.
3
Cardiovascular Systems, Inc.
Consolidated Statements of Operations
(Dollars in thousands, except per share and share amounts)
(Unaudited)
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Three Months Ended |
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September 30, |
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2009 |
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2008 |
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Revenues |
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$ |
15,198 |
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$ |
11,646 |
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Cost of goods sold |
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3,488 |
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3,881 |
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Gross profit |
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11,710 |
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7,765 |
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Expenses |
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Selling, general and administrative |
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14,856 |
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16,424 |
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Research and development |
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2,781 |
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4,955 |
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Total expenses |
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17,637 |
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21,379 |
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Loss from operations |
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(5,927 |
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(13,614 |
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Other (expense) income |
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Interest expense |
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(371 |
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(227 |
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Interest income |
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98 |
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142 |
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Total other expense |
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(273 |
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(85 |
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Net loss |
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$ |
(6,200 |
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$ |
(13,699 |
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Net loss per common share: |
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Basic and Diluted |
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$ |
(0.43 |
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$ |
(2.75 |
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Weighted average common shares used in computation: |
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Basic and Diluted |
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14,516,843 |
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4,976,884 |
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The accompanying notes are an integral part of these unaudited consolidated financial statements.
4
Cardiovascular Systems, Inc.
Consolidated Statements of Changes in Stockholders Equity
(Dollars in thousands, except per share and share amounts)
(Unaudited)
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Common Stock |
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Additional |
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Accumulated |
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Shares |
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Amount |
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Warrants |
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Paid In Capital |
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Deficit |
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Total |
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Balances at June 30, 2008 |
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4,900,984 |
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$ |
35,933 |
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$ |
680 |
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$ |
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$ |
(118,305 |
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$ |
(81,692 |
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Issuance/forfeiture of
restricted stock awards |
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425,359 |
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2,464 |
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2,003 |
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4,467 |
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Stock-based compensation
related to stock options |
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756 |
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1,548 |
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2,304 |
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Exercise of stock
options and warrants at
$1.55-$8.83 per share |
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100,333 |
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640 |
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(422 |
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307 |
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525 |
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Issuance of common stock
warrants |
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10,031 |
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(8,217 |
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1,814 |
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Conversion of preferred
warrants to common
warrants |
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1,069 |
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1,069 |
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Expiration of warrants |
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76 |
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(76 |
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Decretion (accretion) of
redeemable convertible
preferred stock |
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22,781 |
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22,781 |
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Conversion of preferred
stock to common stock |
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5,954,389 |
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6 |
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75,456 |
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75,462 |
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Merger with Replidyne,
net of merger costs |
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2,732,839 |
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3 |
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35,494 |
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35,497 |
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To adjust common stock
to par value |
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(39,864 |
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39,864 |
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Net loss |
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(31,895 |
) |
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(31,895 |
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Balances at June 30, 2009 |
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14,113,904 |
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$ |
14 |
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$ |
11,282 |
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$ |
146,455 |
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$ |
(127,419 |
) |
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$ |
30,332 |
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Issuance/forfeiture of
restricted stock awards,
net |
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446,130 |
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1,182 |
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1,182 |
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Stock-based compensation
related to stock options |
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1,039 |
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1,039 |
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Exercise of stock
options and warrants at
$7.90-$8.83 per share |
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38,192 |
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1 |
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(3 |
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287 |
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285 |
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Net loss |
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(6,200 |
) |
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(6,200 |
) |
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Balances at September
30, 2009 |
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14,598,226 |
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$ |
15 |
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$ |
11,279 |
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$ |
148,963 |
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|
$ |
(133,619 |
) |
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$ |
26,638 |
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The accompanying notes are an integral part of these unaudited consolidated financial
statements.
5
Cardiovascular Systems, Inc.
Consolidated Statements Cash Flows
(Dollars in thousands, except per share and share amounts)
(Unaudited)
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Three Months Ended |
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September 30, |
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2009 |
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2008 |
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Cash flows from operating activities |
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Net loss |
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$ |
(6,200 |
) |
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$ |
(13,699 |
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Adjustments to reconcile net loss to net cash used in operations |
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Depreciation and amortization of property and equipment |
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124 |
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86 |
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Provision for doubtful accounts |
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28 |
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Amortization of patents |
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12 |
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9 |
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Decretion of redeemable convertible preferred stock warrants |
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(14 |
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Amortization of debt discount |
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72 |
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79 |
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Stock-based compensation |
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2,221 |
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|
1,672 |
|
Changes in assets and liabilities |
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Accounts receivable |
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293 |
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(570 |
) |
Inventories |
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(713 |
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(154 |
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Prepaid expenses and other assets |
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|
(394 |
) |
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1,118 |
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Accounts payable |
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(383 |
) |
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(701 |
) |
Accrued expenses and other liabilities |
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2,981 |
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|
124 |
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Net cash used in operations |
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(1,987 |
) |
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(12,022 |
) |
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Cash flows from investing activities |
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Expenditures for property and equipment |
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(41 |
) |
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(201 |
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Sales of investments |
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100 |
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Costs incurred in connection with patents |
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(139 |
) |
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(181 |
) |
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Net cash used in investing activities |
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(80 |
) |
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(382 |
) |
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Cash flows from financing activities |
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Issuance of common stock warrants |
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|
1,814 |
|
Issuance of convertible preferred stock warrants |
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|
75 |
|
Exercise of stock options and warrants |
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|
285 |
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|
13 |
|
Proceeds from long-term debt |
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|
17,712 |
|
Payments on long-term debt |
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|
(875 |
) |
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|
(78 |
) |
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Net cash (used in) provided by financing activities |
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|
(590 |
) |
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|
19,536 |
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Net change in cash and cash equivalents |
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|
(2,657 |
) |
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|
7,132 |
|
Cash and cash equivalents |
|
|
|
|
|
|
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|
Beginning of period |
|
|
33,411 |
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|
|
7,595 |
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|
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|
|
End of period |
|
$ |
30,754 |
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|
$ |
14,727 |
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|
The accompanying notes are an integral part of these unaudited consolidated financial statements.
6
CARDIOVASCULAR SYSTEMS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(For the three months ended September 30, 2009 and 2008)
(dollars in thousands, except per share and share amounts)
(unaudited)
1. Business Overview
Company Description and Merger
Cardiovascular Systems, Inc. was incorporated as Replidyne, Inc. in Delaware in 2000. On
February 25, 2009, Replidyne, Inc. completed its reverse merger with Cardiovascular Systems, Inc.,
a Minnesota corporation incorporated in 1989 (CSI-MN), in accordance with the terms of the
Agreement and Plan of Merger and Reorganization, dated as of November 3, 2008 (the Merger
Agreement). Pursuant to the Merger Agreement, CSI-MN continued after the merger as the surviving
corporation and a wholly owned subsidiary of Replidyne. At the effective time of the merger,
Replidyne, Inc. changed its name to Cardiovascular Systems, Inc. (CSI) and CSI-MN merged with and
into CSI, with CSI continuing after the merger as the surviving corporation. These transactions are
referred to herein as the merger.
Unless the context otherwise requires, all references herein to the Company, CSI, we,
us and our refer to CSI-MN prior to the completion of the merger and to CSI following the
completion of the merger and the name change, and all references to Replidyne refer to Replidyne
prior to the completion of the merger and the name change. CSI is considered the accounting
acquirer in the merger and financial results presented for all periods reflect historical CSI
results.
The Company develops, manufactures and markets devices for the treatment of vascular diseases.
The Company has completed a pivotal clinical trial in the United States to demonstrate the safety
and efficacy of the Companys Diamondback 360° PAD system in treating peripheral arterial disease.
On August 30, 2007, the U.S. Food and Drug Administration, or FDA, granted the Company 510(k)
clearance to market the Diamondback 360° for the treatment of peripheral arterial disease. The
Company commenced a limited commercial introduction of the Diamondback 360° in the United States in
September 2007. During the quarter ended March 31, 2008, the Company began its full commercial
launch of the Diamondback 360°. Prior to the merger, Replidyne was a biopharmaceutical company
focused on discovering, developing, in-licensing and commercializing innovative anti-infective
products.
2. Summary of Significant Accounting Policies
Interim Financial Statements
The Company has prepared the unaudited interim consolidated financial statements and related
unaudited financial information in the footnotes in accordance with accounting principles generally
accepted in the United States of America (GAAP) and the rules and regulations of the Securities
and Exchange Commission (SEC) for interim financial statements. The year end consolidated balance
sheet was derived from audited consolidated financial statements, but does not include all
disclosures as required by accounting principles generally accepted in the United States of
America. These interim consolidated financial statements reflect all adjustments consisting of
normal recurring accruals, which, in the opinion of management, are necessary to present fairly the
Companys consolidated financial position, the results of its operations and its cash flows for the
interim periods. These interim consolidated financial statements should be read in conjunction with
the consolidated annual financial statements and the notes thereto included in the Form 10-K filed
by the Company with the SEC on September 28, 2009. The nature of the Companys business is such
that the results of any interim period may not be indicative of the results to be expected for the
entire year.
Fair Value of Financial Instruments
Effective July 1, 2008, the Company adopted SFAS No. 157, Fair Value Measurements (ASC Topic
820), which provides a framework for measuring fair value under Generally Accepted Accounting
Principles and expands disclosures about fair value measurements. In February 2008, the Financial
Accounting Standards Board (FASB) issued FASB Staff Position No. 157-2, Effective Date of FASB
Statement No. 157, which provided a one-year deferral on the effective date of SFAS No. 157 for
non-financial assets and non-financial liabilities, except those that are recognized or disclosed
in the financial statements at least annually. SFAS 157-2 was adopted on July 1, 2009, and did not
have a material effect impact on the Companys financial position or
7
consolidated results of operations for the three months ended September 30, 2009.
SFAS 157 classifies these inputs into the following hierarchy:
Level 1 Inputs quoted prices in active markets for identical assets and liabilities
Level 2 Inputs observable inputs other than quoted prices in active markets for identical
assets and liabilities
Level 3 Inputs unobservable inputs
The following table sets forth the fair value of the Companys auction rate securities that
were measured on a recurring basis as of September 30, 2009. Assets are measured on a recurring
basis if they are remeasured at least annually:
|
|
|
|
|
|
|
|
|
|
|
Level 3 |
|
|
|
|
|
|
|
Auction Rate |
|
|
|
Trading |
|
|
Securities Put |
|
|
|
Securities |
|
|
Option |
|
Balance at June 30, 2009 |
|
$ |
20,000 |
|
|
$ |
2,800 |
|
Sale of investments |
|
|
(100 |
) |
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2009 |
|
$ |
19,900 |
|
|
$ |
2,800 |
|
|
|
|
|
|
|
|
As of September 30, 2009, the Company believes that the carrying amounts of its other
financial instruments, including accounts receivable, accounts payable and accrued liabilities
approximate their fair value due to the short-term maturities of these instruments. The carrying
amount of long-term debt approximates fair value based on interest rates currently available for
debt with similar terms and maturities.
Use of Estimates
The preparation of the Companys consolidated financial statements in conformity with
accounting principles generally accepted in the United States of America requires management to
make estimates and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. Actual results could differ
from those estimates.
Revenue Recognition
The Company sells the majority of its products via direct shipment to hospitals or clinics.
The Company recognizes revenue when all of the following criteria are met: persuasive evidence of
an arrangement exists; delivery has occurred; the sales price is fixed or determinable; and
collectability is reasonably assured. These criteria are met at the time of delivery when the risk
of loss and title passes to the customer. The Company records estimated sales returns, discounts
and rebates as a reduction of net sales in the same period revenue is recognized.
The Company also considers Emerging Issues Task Force Bulletin (EITF) No. 00-21, Revenue
Arrangements with Multiple Deliverables (ASC Topic 605), in revenue recognition. This standard
addresses the timing and method of revenue recognition for revenue arrangements that include the
delivery of more than one product or service. In these cases, the Company recognizes revenue from
each element of the arrangement as long as separate values for each element can be determined, the
Company has completed its obligation to deliver or perform on that element, and collection of the
resulting receivable is reasonably assured.
Costs related to products delivered are recognized in the period revenue is recognized.
Cost of goods sold consists primarily of raw materials, direct labor, and manufacturing overhead.
Recent Accounting Pronouncements
In October 2009, the FASB issued Emerging Issues Task Force (EITF) issue 08-01, Revenue
Arrangements with Multiple Deliverables (currently within the scope of FASB Accounting Standards
Codification (ASC) Subtopic 605-25). This statement provides principles for allocation of
consideration among its multiple-elements, allowing more flexibility in identifying and accounting
for separate deliverables under an arrangement. The EITF introduces an estimated selling price
method for valuing the elements of a bundled arrangement if vendor-specific objective evidence or
third-party evidence of selling price is not available, and significantly expands related
disclosure requirements. This standard is effective on a prospective basis for revenue arrangements
entered into or materially modified in fiscal years beginning on or after June 15, 2010.
Alternatively, adoption may be on a
8
retrospective basis, and early application is permitted. The Company is currently evaluating
the impact of adopting this pronouncement.
Subsequent Events
The Company has performed an evaluation of subsequent events through November 13, 2009, which
is the date the financial statements were issued.
3. Selected Consolidated Financial Statement Information
Inventories
Inventories are stated at the lower of cost or market with cost determined on a first-in,
first-out (FIFO) method of valuation. The establishment of inventory allowances for excess and
obsolete inventories is based on estimated exposure on specific inventory items.
At September 30, 2009, and June 30, 2009, respectively, inventories were comprised of the
following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2009 |
|
Inventories |
|
|
|
|
|
|
|
|
Raw materials |
|
$ |
1,410 |
|
|
$ |
1,536 |
|
Work in process |
|
|
301 |
|
|
|
348 |
|
Finished goods |
|
|
2,371 |
|
|
|
1,485 |
|
|
|
|
|
|
|
|
|
|
$ |
4,082 |
|
|
$ |
3,369 |
|
|
|
|
|
|
|
|
Investments
The Companys investments include AAA rated auction rate securities (ARS) issued primarily by
state agencies and backed by student loans substantially guaranteed by the Federal Family Education
Loan Program (FFELP). In February 2008, the Company was informed that there was insufficient demand
for auction rate securities, resulting in failed auctions for $23,000 of the Companys auction rate
securities. Currently, these affected securities are not liquid and will not become liquid until a
future auction for these investments are successful, they are redeemed by the issuer, or they
mature. The Company has collected all interest due on its auction rate securities and has no reason
to believe that it will not collect all interest due in the future.
On November 7, 2008, the Company accepted an offer from UBS AG (UBS), providing rights
related to the Companys ARS (the Rights). The Rights permit the Company to require UBS to
purchase the Companys 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 the Companys ARS at any time until July 2, 2012, so long as the Company receives
payment at par value upon any sale or disposition. The Company expects to sell its 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 the Companys ARS. So long as the Company holds ARS,
they will continue to accrue interest as determined by the auction process or the terms of the ARS
if the auction process fails. Prior to accepting the UBS offer, the Company recorded ARS as
investments available-for-sale. The Company recorded unrealized gains and losses on
available-for-sale securities in accumulated other comprehensive income in the stockholders equity
section of the balance sheet. Realized gains and losses were accounted for on the specific
identification method. After accepting the UBS offer, the Company recorded ARS as trading
investments and unrealized gains and losses are included in earnings. At September 30, 2009, the
Company recorded $19,900 as the fair value of the ARS. The ARS are classified as a current asset
at September 30, 2009, due to the expectation the Company will sell its ARS to UBS AG under the
Rights between July 1, 2010 and September 30, 2010.
The Rights represent a firm agreement in accordance with SFAS 133 (ASC Topic 815), which
defines a firm agreement as an agreement with an unrelated party, binding on both parties and
usually legally enforceable, with the following characteristics: a) the agreement specifies all
significant terms, including the quantity to be exchanged, the fixed price, and the timing of the
transaction, and b) the agreement includes a disincentive for nonperformance that is sufficiently
large to make performance probable. The enforceability of the Rights results in a put option and
should be recognized as a free standing asset separate from the ARS. At September 30, 2009, the
Company recorded $2,800 as the fair value of the put option asset. The Company considered the
expected time until the Rights are exercised, carrying costs of the Rights, and the expected credit
risk attributes of the Rights and UBS in their
9
valuation of the put option. The Company has elected to measure the put option at fair value
under SFAS 159 (ASC Topic 825), which permits an entity to elect the fair value option for
recognized financial assets, in order to match the changes in the fair value of the ARS. As a
result, unrealized gains and losses are included in earnings.
4. Debt
Loan and Security Agreement with Silicon Valley Bank
On September 12, 2008, the Company entered into a loan and security agreement with Silicon
Valley Bank, which agreement was amended on February 25, 2009 and April 30, 2009. The agreement
includes a $3,000 term loan, a $10,000 accounts receivable line of credit, and a $5,500 term loan
that reduces the availability of funds on the accounts receivable line of credit. The terms of each
of these loans are as follows:
|
|
The $3,000 term loan has a fixed interest rate of 10.5% and a final
payment amount equal to 3.0% of the loan amount due at maturity. This term loan
has a 36 month maturity, with repayment terms that include interest only
payments during the first six months followed by 30 equal principal and
interest payments. This term loan also includes an acceleration provision that
requires the Company to pay the entire outstanding balance, plus a penalty
ranging from 1.0% to 6.0% of the principal amount, upon prepayment or the
occurrence and continuance of an event of default. As part of the term loan
agreement, the Company granted Silicon Valley Bank a warrant to purchase
8,493 shares of Series B redeemable convertible preferred stock (which was
subsequently amended to common stock to reflect the conversion of all Series B
redeemable convertible preferred stock in the merger) at an exercise price of
$14.16 per share. This warrant was assigned a value of $75 for accounting
purposes, is immediately exercisable, and expires ten years after issuance. The
balance outstanding on the term loan at September 30, 2009 was $2,369. |
|
|
|
The $10,000 accounts receivable line of credit as amended has a
two year maturity and a floating interest rate equal to the prime rate, plus
2.0%, with an interest rate floor of 7.0%. Interest on borrowings is due
monthly and the principal balance is due at maturity. Borrowings on the line of
credit are based on 80% of eligible domestic receivables, which is defined as
receivables aged less than 90 days from the invoice date along with specific
exclusions for contra-accounts, concentrations, and government receivables. The
Companys accounts receivable receipts are deposited into a lockbox account in
the name of Silicon Valley Bank. The accounts receivable line of credit is
subject to non-use fees, annual fees, cancellation fees, and maintaining a
minimum liquidity ratio. There was no balance outstanding on the line of credit
at September 30, 2009. The $5,500 term loan reduces available borrowings under
the line of credit agreement. |
|
|
|
The $5,500 term loan has a fixed
interest rate of 9.0% and a final payment amount equal to 1.0% of the loan
amount due at maturity. This term loan has a 30 month maturity, with repayment
terms that include equal monthly payments of principal and interest beginning
June 1, 2009. This term loan also includes an acceleration provision that
requires the Company to pay the entire outstanding balance, plus a penalty
ranging from 1.0% to 3.0% of the principal amount, upon prepayment or the
occurrence and continuance of an event of default. The term loan reduces
available borrowings under the amended accounts receivable line of credit
agreement. The balance outstanding on the term loan at September 30, 2009 was
$4,827. |
One of the Companys directors and stockholders and two entities who held the Companys
preferred shares and were also affiliated with two of the Companys directors agreed to act as
guarantors of the original term loans. In consideration for the guarantees, the Company issued the
guarantors warrants to purchase an aggregate of 296,539 shares of the Companys common stock at an
exercise price of $9.28 per share. As a result of the refinancing, the guarantees on the original
term loans have been released. The guaranteed term loans and common stock warrants were allocated
using the relative fair value method. Under this method, the Company estimated the fair value of
the term loans without the guarantees and calculated the fair value of the common stock warrants
using the Black-Scholes method. The relative fair value of the loans and warrants were applied to
the loan proceeds of $5,500, resulting in an assigned value of $3,686 for the loans and $1,814 for
the warrants. The assigned value of the warrants of $1,814 is treated as a debt discount. The
balance of the debt discount at September 30, 2009 is $590 and is being amortized over the
remaining term of the $5,500 term loan.
Borrowings from Silicon Valley Bank are collateralized by all of the Companys assets,
other than the Companys ARS and intellectual property, and, until April 30, 2009, the investor
guarantees. The borrowings are subject to prepayment penalties and financial covenants, including the Companys achievement of minimum monthly net
revenue goals. The agreement also includes subjective acceleration clauses which permit Silicon
Valley Bank to accelerate the due date under certain circumstances, including, but not limited to,
material adverse effects on a Companys financial status or otherwise.
10
Any non-compliance by the Company under the terms of the Companys debt arrangements could
result in an event of default under the Silicon Valley Bank loan, which, if not cured, could result
in the acceleration of this debt. The Company was in compliance with all monthly financial
covenants through September 30, 2009. The Company was not in
compliance with one of the financial covenants at October 31, 2009, but Silicon Valley Bank waived this covenant for
such period.
Loan Payable
At September 30, 2009 and June 30, 2009, the Company maintained a margin loan with UBS Bank
USA with maximum available borrowings, including interest, equal to the par value of auction rate
securities held. At September 30, 2009 and June 30, 2009, maximum available borrowings were
$22,850 and $22,950, respectively. 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 bears interest at variable rates that equal the lesser of (i) 30 day LIBOR plus
1.25% or (ii) the applicable reset rate, maximum auction rate or similar rate as specified in the
prospectus or other documentation governing the pledged taxable student loan auction rate
securities; 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 the Company to
repay it in full from the proceeds received from a public equity offering where net proceeds exceed
$50,000. In addition, if at any time any of the Companys auction rate securities may be sold,
exchanged, redeemed, transferred or otherwise conveyed for no less than their par value, then the
Company 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. As of September 30,
2009 and June 30, 2009, the margin requirements include maximum borrowings, including interest, of
$22,850 and $22,950, respectively. If these margin requirements are not maintained, UBS Bank may
require the Company to make a loan payment in an amount necessary to comply with the applicable
margin requirements or demand repayment of the entire outstanding balance. The Company has
maintained the margin requirements under the loans from both UBS entities. The outstanding balance
on this loan at September 30, 2009 was $22,793 and is included in maturities during the nine months
ending June 30, 2010.
As of September 30, 2009, debt maturities (including debt discount) were as follows:
|
|
|
|
|
Nine months ending June 30, 2010 |
|
$ |
25,020 |
|
2011 |
|
|
3,253 |
|
2012 |
|
|
1,126 |
|
|
|
|
|
Total |
|
$ |
29,399 |
|
Less: Current Maturities |
|
|
(25,802 |
) |
|
|
|
|
Long-term debt |
|
$ |
3,597 |
|
|
|
|
|
5. Stock Options and Restricted Stock Awards
The Company has a 2007 Equity Incentive Plan (the 2007 Plan), which was assumed from CSI-MN,
under which options to purchase common stock and restricted stock awards have been granted to
employees, directors and consultants at exercise prices determined by the board of directors; and
also in connection with the merger the Company assumed options and restricted stock awards granted
by CSI-MN under its 1991 Stock Option Plan (the 1991 Plan) and 2003 Stock Option Plan (the 2003
Plan) (the 2007 Plan, the 1991 Plan and the 2003 Plan collectively, the Plans). The 1991 Plan
and 2003 Plan permitted the granting of incentive stock options and nonqualified options. A total
of 485,250 shares of common stock were originally reserved for issuance under the 1991 Plan, but
with the execution of the 2003 Plan no additional options were granted under it. A total of
2,458,600 shares of common stock were originally reserved for issuance under the 2003 Plan but with
the approval of the 2007 Plan no additional options will be granted under it. The 2007 Plan
originally allowed for the granting of up to 1,941,000 shares of common stock as approved by the
board of directors in the form of nonqualified or incentive stock options, restricted stock awards,
restricted stock unit awards, performance share awards, performance unit awards or stock
appreciation rights to officers, directors, consultants and employees of the Company. The Plan was
amended in February 2009 to increase the number of authorized shares to 2,509,969. The amended 2007
Plan also includes a renewal provision whereby the number of shares shall automatically be
increased on the first day of each fiscal year ending July 1, 2017, by the lesser of
(i) 970,500 shares, (ii) 5% of the outstanding common shares on such date, or (iii) a lesser amount
determined by the board of directors. On July 1, 2009 the number of shares available for grant was
increased by 705,695 under the 2007 Plans renewal provision.
All options granted under the Plans become exercisable over periods established at the
date of grant. The option exercise price is determined by the closing price of the Companys common
stock at the date of grant. In addition, the Company has granted nonqualified stock options to
employees, directors and consultants outside of the Plans.
11
In estimating the value of the Companys common stock prior to the merger for purposes of
granting options and determining stock-based compensation expense, the Companys management and
board of directors conducted stock valuations using two different valuation methods: the option
pricing method and the probability weighted expected return method. Both of these valuation methods
took into consideration the following factors: financing activity, rights and preferences of the
Companys preferred stock, growth of the executive management team, clinical trial activity, the
FDA process, the status of the Companys commercial launch, the Companys mergers and acquisitions
and public offering processes, revenues, the valuations of comparable public companies, the
Companys cash and working capital amounts, and additional objective and subjective factors
relating to the Companys business. The Companys management and board of directors set the
exercise prices for option grants based upon their best estimate of the fair market value of the
common stock at the time they made such grants, taking into account all information available at
those times.
Following the merger, the Companys stock valuations are based upon the market price for
the common stock.
Stock option activity for the three months ended September 30, 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Number of |
|
Average |
|
|
Options(a) |
|
Exercise Price |
Options outstanding at June 30, 2009 |
|
|
3,637,882 |
|
|
$ |
10.24 |
|
Options exercised |
|
|
(37,313 |
) |
|
$ |
8.36 |
|
Options forfeited or expired |
|
|
(20,273 |
) |
|
$ |
8.15 |
|
|
|
|
|
|
|
|
|
|
Options outstanding at September 30, 2009 |
|
|
3,580,296 |
|
|
$ |
10.27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Includes the effect of options granted, exercised, forfeited or expired from the 1991 Plan,
2003 Plan, 2007 Plan, and options granted outside the stock option plans described above. |
Options typically vest over two to three years. An employees unvested options are forfeited
when employment is terminated; vested options must be exercised at or within 90 days of termination
to avoid forfeiture. The Company determines the fair value of options using the Black-Scholes
option pricing model. The estimated fair value of options, including the effect of estimated
forfeitures, is recognized as expense on a straight-line basis over the options vesting periods.
The Company also maintains its 2006 Equity Incentive Plan (the 2006 Plan), relating to
Replidyne activity prior to the merger in February 2009. A total of 794,641 shares were originally
reserved under the 2006 Plan but effective with the merger no additional options will be granted
under it. Vested options granted to employees terminate 90 days after termination. At September
30, 2009, and June 30, 2009, 70,000 shares were outstanding at an average exercise price of $18.15.
As of September 30, 2009, the Company had granted 1,544,426 restricted stock awards. The fair
value of each restricted stock award was equal to the fair market value of the Companys common
stock at the date of grant. Vesting of restricted stock awards range from one to three years. The
estimated fair value of restricted stock awards, including the effect of estimated forfeitures, is
recognized on a straight-line basis over the restricted stocks vesting period. Restricted stock
award activity for the three months ended September 30, 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Number of |
|
Average Fair |
|
|
Shares |
|
Value |
Restricted stock awards outstanding at June 30, 2009 |
|
|
744,377 |
|
|
$ |
10.81 |
|
Restricted stock awards granted |
|
|
468,822 |
|
|
$ |
8.60 |
|
Restricted stock awards forfeited |
|
|
(22,692 |
) |
|
$ |
13.54 |
|
Restricted stock awards vested |
|
|
(72,932 |
) |
|
$ |
9.29 |
|
|
|
|
|
|
|
|
|
|
Restricted stock awards outstanding at September 30, 2009 |
|
|
1,117,575 |
|
|
$ |
9.49 |
|
|
|
|
|
|
|
|
|
|
6. Texas Production Facility
Effective on September 9, 2009, the Company entered into the Build-To-Suit Lease Agreement
(the Lease Agreement) with the Pearland Economic Development Corporation (the PEDC) for the
construction and lease of an approximately 46,000 square foot production facility located in
Pearland, Texas (the Facility). The Facility will primarily serve as an additional manufacturing
location for the Company.
12
The Lease Agreement provides that the PEDC will lease the Facility and the land
immediately surrounding the Facility (the Leased Premises) to the Company for an initial term of
ten years, beginning the later of the date of Substantial Completion of the project (as that term
is defined in the Lease Agreement) or April 1, 2010 (the Commencement Date). Annual fixed rent
payments are $414 for each of the first five years of the initial term and $460 for each of the
last five years of the initial term. Rent is payable in monthly installments beginning thirty days
after the Commencement Date. The Company will also be responsible for paying the future taxes and
operating expenses on the Leased Premises. The lease has been classified as an operating lease for
financial statement purposes. Upon an event of default under the Lease Agreement, the Company will
be liable for the difference between the balance of the rent owed for the remainder of the term and
the fair market rental value of the Leased Premises for such period.
The Company has the option to renew the lease for up to two additional periods of five
years each. If the Company elects to exercise one or both of these options, the rent for such
extended terms will be set at the prevailing market rental rates at such times, as determined in
the Lease Agreement. After the Commencement Date and until shortly before the tenth anniversary of
the Commencement Date, the Company will have the option to purchase all, but not less than all, of
the Leased Premises at fair market value, as determined in the Lease Agreement. Further, within six
years of the Commencement Date and subject to certain conditions, the Company has options to cause
the PEDC to make two additions or expansions to the Facility of a minimum of 34,000 and 45,000
square feet each.
The Company and the PEDC previously entered into a Corporate Job Creation Agreement (the
Job Creation Agreement), dated June 17, 2009 (the Effective Date). The Job Creation Agreement
provided the Company with $2,975 in net cash incentive funds upon signing the Lease Agreement,
which the Company received on or about September 9, 2009. The Company has recognized the net cash
incentive funds received of $2,975 as a long term liability on the balance sheet. The liability
will be reduced over a 60 month period as expenditures are incurred using a systematic methodology
that is intended to reduce the majority of the liability in the first 24 months of the agreement.
The Company believes it will be able to comply with the conditions specified in the grant
agreement. The PEDC will provide the Company with an additional $1,700 of net cash incentive funds
(collectively with the $2,975 that the Company previously received, the Cash Incentives), in the
following amounts and upon achievement of the following milestones:
|
|
|
$1,020, upon the hiring of the 75th full-time employee at the Facility; and |
|
|
|
|
$680, upon the hiring of the 125th full-time employee at the Facility. |
In order to retain all of the Cash Incentives, beginning one year and 90 days after the
Commencement Date, the Company must not have fewer than 25 full-time employees at the Facility for
more than 120 consecutive days. Failure to meet this requirement will result in an obligation to
make reimbursement payments to the PEDC in the following percentages during the following time
periods:
|
|
|
100% of all the Cash Incentives received, if the failure occurs within 24 months from the Effective Date; |
|
|
|
|
60% of all the Cash Incentives received, if the failure occurs between 24 and 36 months from the Effective Date; |
|
|
|
|
40% of all the Cash Incentives received, if the failure occurs between 36 and 48 months from the Effective Date; and |
|
|
|
|
20% of all the Cash Incentives received, if the failure occurs between 48 and 60 months from the Effective Date. |
The Company will not have any reimbursement requirements for the Cash Incentives after
60 months from the Effective Date.
The Job Creation Agreement also provides the Company with a net $1,300 award that is expected
to be funded in part by a grant from the State of Texas for which the Company has applied through
the Texas Enterprise Fund program (the TEF Award). The PEDC has committed, by resolution, to
guarantee the TEF Award and will make payment to the Company for the difference between $1,300 and
the actual grant amount from the State of Texas. The Company expects that the grant from the State
of Texas for the TEF Award will also be subject to reimbursement if the Company fails to meet
certain job creation targets, as will be established and agreed to by the Company and the State of
Texas.
7. Commitment and Contingencies
ev3 Legal Proceedings
The Company is party to a legal proceeding with ev3 Inc., ev3 Endovascular, Inc. and FoxHollow
Technologies, Inc., together referred to as the Plaintiffs, which filed a complaint on December 28,
2007 in the Ramsey County District Court for the State of Minnesota against the Company and former
employees of FoxHollow currently employed by the Company, which complaint was subsequently amended.
13
The complaint, as amended, alleges the following:
|
|
|
That certain of the Companys employees (i) violated provisions in their employment
agreements with their former employer FoxHollow, barring them from misusing FoxHollow
confidential information and from soliciting or encouraging employees of FoxHollow to join
the Company, and (ii) breached a duty of loyalty owed to FoxHollow. |
|
|
|
That the Company and certain of its employees misappropriated trade secrets of one or
more of the Plaintiffs. |
|
|
|
That all defendants engaged in unfair competition and conspired to gain an unfair
competitive and economic advantage for the Company to the detriment of the Plaintiffs. |
|
|
|
That (i) the Company tortiously interfered with the contracts between FoxHollow and
certain of the Companys employees by allegedly procuring breaches of the non-solicitation
encouragement provision in those agreements, and (ii) one of the Companys employees
tortiously interfered with the contracts between certain of the Companys employees and
FoxHollow by allegedly procuring breaches of the confidential information provision in those
agreements. |
The Plaintiffs seek, among other forms of relief, an award of damages in an amount greater
than $50, a variety of forms of injunctive relief, exemplary damages under the Minnesota Trade
Secrets Act, and recovery of their attorney fees and litigation costs. Although the Company has
requested the information, the Plaintiffs have not yet disclosed what specific amount of damages
they claim.
The Company is defending this litigation vigorously, and believes that the outcome of this
litigation will not have a materially adverse effect on the Companys business, operations, cash
flows or financial condition. The Company has not recognized any expense related to the settlement
of this matter as an adverse outcome of this action is not probable. If the Company is not
successful in this litigation, it could be required to pay substantial damages and could be subject
to equitable relief that could include a requirement that the Company terminate or otherwise alter
the terms or conditions of employment of certain employees, including certain key sales personnel
who were formerly employed by FoxHollow. In any event, the defense of this litigation, regardless
of the outcome, could result in substantial legal costs and diversion of managements time and
efforts from the operation of business.
8. Earnings Per Share
Basic
The following table presents a reconciliation of the numerators and denominators used in the
basic and diluted earnings per common share computations:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
|
|
2009 |
|
|
2008 |
|
Numerator |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(6,200 |
) |
|
$ |
(13,699 |
) |
|
|
|
|
|
|
|
Denominator |
|
|
|
|
|
|
|
|
Weighted average common shares basic |
|
|
14,516,843 |
|
|
|
4,976,884 |
|
Effect of dilutive stock options and warrants (a)(b) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding diluted |
|
|
14,516,843 |
|
|
|
4,976,884 |
|
|
|
|
|
|
|
|
Net loss per common share basic and diluted |
|
$ |
(0.43 |
) |
|
$ |
(2.75 |
) |
|
|
|
|
|
|
|
|
|
|
(a) |
|
At September 30, 2009 and 2008, 3,115,246 and 880,953 warrants, respectively, were
outstanding. The effect of the shares that would be issued upon exercise of these warrants has
been excluded from the calculation of diluted loss per share because those shares are
anti-dilutive. |
|
(b) |
|
At September 30, 2009 and 2008, 3,650,296 and 3,779,434 stock options, respectively, were
outstanding. The effect of the shares that would be issued upon exercise of these options has
been excluded from the calculation of diluted loss per share because those shares are
anti-dilutive. |
14
|
|
|
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
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 discussed in our Form 10-K for the year ended
June 30, 2009 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°, is a minimally
invasive catheter system for the treatment of peripheral arterial disease, or PAD.
We were incorporated as Replidyne, Inc. in Delaware in 2000. On February 25, 2009,
Replidyne, Inc. completed its business combination with Cardiovascular Systems, Inc., a Minnesota
corporation (CSI-MN), in accordance with the terms of the Agreement and Plan of Merger and
Reorganization, dated as of November 3, 2008 (the Merger Agreement). Pursuant to the Merger
Agreement, CSI-MN continued after the merger as the surviving corporation and a wholly owned
subsidiary of Replidyne. Replidyne changed its name to Cardiovascular Systems, Inc. (CSI) and
CSI-MN merged with and into CSI, with CSI continuing after the merger as the surviving corporation.
These transactions are referred to herein as the merger. Unless the context otherwise requires,
all references herein to the Company, CSI, we, us and our refer to CSI-MN prior to the
completion of the merger and to CSI following the completion of the merger and the name change, and
all references to Replidyne refer to Replidyne prior to the completion of the merger and the name
change. Replidyne was a biopharmaceutical company focused on discovering, developing, in-licensing
and commercializing anti-infective products.
At the closing of the merger, Replidynes net assets, as calculated pursuant to the terms
of the Merger Agreement, were approximately $36.6 million as adjusted. As of immediately following
the effective time of the merger, former CSI-MN stockholders owned approximately 80.2% of the
outstanding common stock of the combined company, and Replidyne stockholders owned approximately
19.8% of the outstanding common stock of the combined company.
CSI-MN was 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 expend significant
capital on our sales and marketing efforts to expand our customer base and utilization per
customer. We manufacture the Diamondback 360° internally at our facilities.
As of September 30, 2009, we had an accumulated deficit of $133.6 million. We expect our
losses to continue but generally decline as we continue our commercialization activities, develop
additional product enhancements, and accumulate clinical data on our products, and make further
regulatory submissions. To date, we have financed our operations primarily through the private
placement of equity securities and completion of the merger.
15
CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES
Our managements 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, allowance for doubtful accounts, excess and obsolete inventory, investments,
and stock-based compensation 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 sell the majority of our products via direct shipment to
hospitals or clinics. We recognize revenue when all of the following criteria are met: persuasive
evidence of an arrangement exists; delivery has occurred; the sales price is fixed or determinable;
and collectability is reasonably assured. These criteria are met at the time of delivery when the
risk of loss and title passes to the customer. We record estimated sales returns, discounts and
rebates as a reduction of net sales in the same period revenue is recognized.
We also consider Emerging Issues Task Force Bulletin (EITF) No. 00-21, Revenue
Arrangements with Multiple Deliverables (ASC Subtopic 605-25), in revenue recognition. This
standard addresses the timing and method of revenue recognition for revenue arrangements that
include the delivery of more than one product or service. In these cases, we recognize revenue from
each element of the arrangement as long as separate values for each element can be determined, we
have completed our obligation to deliver or perform on that element, and collection of the
resulting receivable is reasonably assured.
Costs related to products delivered are recognized in the period revenue is recognized.
Cost of goods sold consists primarily of raw materials, direct labor, and manufacturing overhead.
Allowance for Doubtful Accounts. We maintain allowances for doubtful accounts. This
allowance is an estimate and is regularly evaluated for adequacy by taking into consideration
factors such as past experience, credit quality of the customer base, age of the receivable
balances, both individually and in the aggregate, and current economic conditions that may affect a
customers ability to pay. Provisions for the allowance for doubtful accounts attributed to bad
debt are recorded in general and administrative expenses.
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 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.
Investments. Our investments include AAA rated auction rate securities (ARS) issued
primarily by state agencies and backed by student loans substantially guaranteed by the Federal
Family Education Loan Program (FFELP). In February 2008, we were informed that there was
insufficient demand for auction rate securities, resulting in failed auctions for $23.0 million of
our auction rate securities. Currently, these affected securities are not liquid and will not
become liquid until a future auction for these investments are successful, they are redeemed by the
issuer, or they mature. We have collected all interest due on our auction rate securities and have
no reason to believe that we will not collect all interest due in the future.
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
16
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. 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 stockholders
equity section of the balance sheet. Realized gains and losses were accounted for on the specific
identification method. After accepting the UBS offer, we recorded the ARS as trading investments
and realized gains and losses are included in earnings. At September 30, 2009, we recorded $19.9
million as the fair value of the ARS. The ARS are classified as a current asset at September 30,
2009, due to the expectation the Company will sell its ARS to UBS AG under the Rights between July
1, 2010 and September 30, 2010.
The Rights represent a firm agreement in accordance with SFAS 133 (ASC Topic 815), which
defines a firm agreement as an agreement with an unrelated party, binding on both parties and
usually legally enforceable, with the following characteristics: a) the agreement specifies all
significant terms, including the quantity to be exchanged, the fixed price, and the timing of the
transaction, and b) the agreement includes a disincentive for nonperformance that is sufficiently
large to make performance probable. The enforceability of the Rights results in a put option and
should be recognized as a free standing asset separate from the ARS. At September, 2009, we
recorded $2.8 million as the fair value of the put option asset. We considered the expected time
until the Rights are exercised, carrying costs of the Rights, and the expected credit risk
attributes of the Rights and UBS in their valuation of the put option. We have elected to measure
the put option at fair value under SFAS 159 (ASC Topic 825), which permits an entity to elect the
fair value option for recognized financial assets, in order to match the changes in the fair value
of the ARS. As a result, unrealized gains and losses are included in earnings.
Stock-Based Compensation. We account for stock-based compensation expense in accordance
with SFAS No. 123(R) (ASC Topic 718), Share-Based Payment, as interpreted by SAB No. 107 to account
for stock-based compensation expense associated with the issuance or amendment of stock options and
restricted stock awards. 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 stock option and restricted awards are expensed in the consolidated statements of
operations over the related vesting period. We calculate the fair value on the date of grant using
a Black-Scholes 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 stocks volatility; |
|
|
|
|
the length of our options lives, which is based on future exercises and
cancellations; |
|
|
|
|
the risk-free rate of return; and |
|
|
|
|
future dividends |
Prior to the consummation of the merger, we used comparable public company data to
determine volatility for option grants. Since we have a limited history of stock purchase and sale
activity, expected volatility is based on historical data from several public companies similar to
us in size and nature of operations. We will continue to use comparable public company data to
determine expected volatility for option grants until our historical volatility is relevant to
measure. We use a weighted average calculation to estimate the time our options will be
outstanding. We estimated 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.
All options we have granted become exercisable over periods established at the date of
grant. The option exercise price is generally not less than the estimated fair market value of our
common stock at the date of grant, as determined by management and board of directors.
The absence of an active market for our common stock prior to the merger required 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.
17
In response to these requirements, prior to the merger our management and board of directors
estimated the fair market value of common stock at each date at which options are granted based
upon stock valuations and other qualitative factors. Our management and board of directors
conducted stock valuations using two different valuation methods: the option pricing method and the
probability weighted expected return method. Both of these valuation methods took into
consideration the following factors: financing activity, rights and preferences of our preferred
stock, growth of the executive management team, clinical trial activity, the FDA process, the
status of our commercial launch, our mergers and acquisitions and public offering processes,
revenues, the valuations of comparable public companies, our cash and working capital amounts, and
additional objective and subjective factors relating to our business. Our management and board of
directors set the exercise prices for option grants based upon their best estimate of the fair
market value of the common stock at the time they made such grants, taking into account all
information available at those times.
Following the merger, our stock valuations are based upon the market price for our common
stock.
RESULTS OF OPERATIONS
The following table sets forth, for the periods indicated, our results of operations expressed as
dollar amounts (in thousands), and, for certain line items, the changes between the specified
periods expressed as percent increases or decreases:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
|
|
|
|
|
|
|
|
|
Percent |
|
|
|
2009 |
|
|
2008 |
|
|
Change |
|
Revenues |
|
$ |
15,198 |
|
|
$ |
11,646 |
|
|
|
30.5 |
% |
Cost of goods sold |
|
|
3,488 |
|
|
|
3,881 |
|
|
|
(10.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
11,710 |
|
|
|
7,765 |
|
|
|
50.8 |
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
14,856 |
|
|
|
16,424 |
|
|
|
(9.5 |
) |
Research and development |
|
|
2,781 |
|
|
|
4,955 |
|
|
|
(43.9 |
) |
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
|
17,637 |
|
|
|
21,379 |
|
|
|
(17.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(5,927 |
) |
|
|
(13,614 |
) |
|
|
(56.5 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(371 |
) |
|
|
(227 |
) |
|
|
63.4 |
|
Interest income |
|
|
98 |
|
|
|
142 |
|
|
|
(31.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
Total other expense |
|
|
(273 |
) |
|
|
(85 |
) |
|
|
221.2 |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(6,200 |
) |
|
|
(13,699 |
) |
|
|
(54.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
Comparison of Three Months Ended September 30, 2009 with Three Months Ended September 30, 2008
Revenues. Revenues increased by $3.5 million, or 30.5%, from $11.6 million for the three
months ended September 30, 2008 to $15.2 million for the three months ended September 30, 2009.
This increase was attributable to a 25% increase in sales of the Diamondback 360° and a 5% increase
in sales of supplemental products during the three months ended September 30, 2009 compared to the
three months ended September 30, 2008. As of September 30, 2009, we had a 132-person direct sales
organization that was selling the Diamondback 360° in 611 accounts. As of September 30, 2008, we
had a 100-person direct sales organization that was selling the Diamondback 360° in 283 accounts.
We expect our revenue to increase as we continue to increase the number of physicians using the
devices, we increase the usage rate per physician in the U.S. PAD market, and introduce new and
improved products.
Cost of Goods Sold. Cost of goods sold decreased by $393,000, or 10.1%, from
$3.9 million for the three months ended September 30, 2008 to $3.5 million for the three months
ended September 30, 2009. This decrease in cost of goods sold resulted in an increase to gross
margin of 10%, from 67% for the three months ended September 30, 2008 to 77% for the three months
ended September 30, 2009. Cost of goods sold represents the cost of materials, labor and overhead
for single-use catheters, guidewires, control units, and other ancillary products. The increase in
gross margin from the three months ended September 30, 2008 to September 30, 2009 is primarily due
to higher production volumes, manufacturing efficiencies, product cost reductions, and shipment of
fewer control units. Cost of goods sold for the three months ended September 30, 2009 and 2008
includes $129,000 and $176,000, respectively, for stock-based compensation. We expect that gross
margin will stay fairly consistent in the future as sales volumes increase, although quarterly
fluctuations could occur based on timing of new product introductions, sales mix, or other
unanticipated circumstances.
Selling, General and Administrative Expenses. Our selling, general and administrative
expenses decreased by $1.5 million, or 9.5%, from $16.4 million for the three months ended
September 30, 2008 to $14.9 million for the three months ended September 30, 2009. The primary
reason for the decrease was reduced consulting and professional services, including $1.7 million in
previously
18
capitalized initial public offering costs, contributing $2.2 million. Selling, general, and
administrative expenses for the three months ended September 30, 2009 and 2008 includes
$1.8 million and $1.4 million, respectively, for stock-based compensation. We expect our selling,
general and administrative expenses to increase in the future due primarily to the costs associated
with expanding our sales and marketing programs and organization to further commercialize our
products.
Research and Development Expenses. Research and development expenses decreased by
$2.2 million, or 43.9%, from $5.0 million for the three months ended September 30, 2008 to
$2.8 million for the three months ended September 30, 2009. Research and development expenses
relate to specific projects to improve our product or expand into new markets, such as the
development of a new control unit, shaft designs, crown designs, and PAD and coronary clinical
trials. The reduction in expense related to costs of a coronary clinical trial occurring during the
three months ended September 30, 2008, along with fewer PAD development projects in 2009. Research
and development for the three months ended September 30, 2009 and 2008 includes $281,000 and
$112,000, respectively, for stock-based compensation. As we continue to expand our product
portfolio within the market for the treatment of peripheral arteries and leverage our core
technology into the coronary market, we expect to incur research and development expenses for the
remainder of the fiscal year at a rate similar to that incurred for the three months ended
September 30, 2009, although fluctuations could occur based on the number of projects and studies
and the timing of expenditures.
Interest Expense. Interest expense increased by $144,000, from $227,000 for the three
months ended September 30, 2008 to $371,000 for the three months ended September 30, 2009. The
increase was due to higher average outstanding debt facilities during the three months ended
September 30, 2009.
Interest Income. Interest income decreased by $42,000, from $142,000 for the three
months ended September 30, 2008 to $98,000 for the three months ended September 30, 2009. The
decrease was primarily due to reduced yields on cash, cash equivalent and investment balances.
LIQUIDITY AND CAPITAL RESOURCES
We had cash and cash equivalents of $30.8 million at September 30, 2009 and $33.4 million at
June 30, 2009. During the three months ended September 30, 2009, net cash used in operations
amounted to $2.0 million. As of September 30, 2009, we had an accumulated deficit of
$133.6 million. We have historically funded our operating losses primarily from the issuance of
common and preferred stock, convertible promissory notes, and debt. We have incurred negative cash
flows and net losses since inception.
On February 25, 2009, we completed the merger, in accordance with the terms of the Merger
Agreement. At closing, Replidynes net assets, as calculated pursuant to the terms of the Merger
Agreement, were approximately $36.6 million as adjusted.
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. These securities are currently not liquid, as we have
an inability to sell the securities due to continued failed auctions. At September 30, 2009, we
maintained a margin loan with UBS Bank USA with maximum available borrowings, including interest,
equal to the par value of auction rate securities held. At September 30, 2009, maximum available
borrowings were $22.9 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 bears interest at variable rates that equal the lesser of (i) 30 day LIBOR plus
1.25% or (ii) the applicable reset rate, maximum auction rate or similar rate as specified in the
prospectus or other documentation governing the pledged taxable student loan auction rate
securities; 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. As of September 30, 2009, the margin
requirements include maximum borrowings, including interest, of $22.9 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 September 30, 2009 was $22.8 million.
On September 12, 2008, we entered into a loan and security agreement with Silicon Valley
Bank, which agreement was amended on February 25, 2009 and April 30, 2009. The agreement includes a
$3.0 million term loan, a $10.0 million accounts
19
receivable line of credit, and a $5.5 million term loan that reduces availability of
borrowings on the accounts receivable line of credit. The terms of each of these loans are as
follows:
|
|
|
The $3.0 million term loan has a fixed interest rate of 10.5% and a final payment
amount equal to 3.0% of the loan amount due at maturity. This term loan has a 36 month
maturity, with repayment terms that include interest only payments during the first six
months followed by 30 equal principal and interest payments. This term loan also
includes an acceleration provision that requires us to pay the entire outstanding
balance, plus a penalty ranging from 1.0% to 6.0% of the principal amount, upon
prepayment or the occurrence and continuance of an event of default. As part of the
term loan agreement, we granted Silicon Valley Bank a warrant to purchase 8,493 shares
of Series B redeemable convertible preferred stock (which was subsequently amended to
common stock to reflect the conversion of all Series B redeemable convertible preferred
stock in the merger) at an exercise price of $14.16 per share. This warrant was
assigned a value of $75,000 for accounting purposes, is immediately exercisable, and
expires ten years after issuance. The balance outstanding on the term loan at
September 30, 2009 was $2.4 million. |
|
|
|
|
The $10.0 million accounts receivable line of credit has a two year maturity and a
floating interest rate equal to the prime rate, plus 2.0%, with an interest rate floor
of 7.0%. Interest on borrowings is due monthly and the principal balance is due at
maturity. Borrowings on the line of credit are based on 80% of eligible domestic
receivables, which is defined as receivables aged less than 90 days from the invoice
date along with specific exclusions for contra-accounts, concentrations, and government
receivables. Accounts receivable receipts are deposited into a lockbox account in the
name of Silicon Valley Bank. The accounts receivable line of credit is subject to
non-use fees, annual fees, cancellation fees, and maintaining a minimum liquidity
ratio. There was no balance outstanding on the line of credit at June 30, 2009 and
September 30, 2009. The $5.5 million term loan reduces available borrowings under the
line of credit agreement. |
|
|
|
|
The $5.5 million term loan has a fixed interest rate of 9.0% and a final payment
amount equal to 1.0% of the loan amount due at maturity. This term loan has a 30 month
maturity, with repayment terms that include equal monthly payments of principal and
interest beginning June 1, 2009. This term loan also includes an acceleration provision
that requires us to pay the entire outstanding balance, plus a penalty ranging from
1.0% to 3.0% of the principal amount, upon prepayment or the occurrence and continuance
of an event of default. The term loan reduces available borrowings under the amended
accounts receivable line of credit agreement. The balance outstanding on the term loan
at September 30, 2009 was $4.8 million (excluding debt discount of 0.6 million). |
One of our directors and stockholders and two entities who held preferred shares and were also
affiliated with two of our directors agreed to act as guarantors of the original term loans. In
consideration for the guarantees, we issued the guarantors warrants to purchase an aggregate of
296,539 shares of our common stock at an exercise price of $9.28 per share. As a result of the
refinancing, the guarantees on the original term loans have been released. The guaranteed term
loans and common stock warrants were allocated using the relative fair value method. Under this
method, we estimated the fair value of the term loans without the guarantees and calculated the
fair value of the common stock warrants using the Black-Scholes method. The relative fair value of
the loans and warrants were applied to the loan proceeds of $5.5 million resulting in an assigned
value of $3.7 million for the loans and $1.8 million for the warrants. The assigned value of the
warrants of $1.8 million is treated as a debt discount. The balance of the debt discount at
September 30, 2009 is $0.6 million and is being amortized over the remaining term of the
$5.5 million term loan.
Borrowings from Silicon Valley Bank are secured by all of our assets, other than our
auction rate securities and intellectual property, and, until April 30, 2009, the investor
guarantees. The borrowings are subject to prepayment penalties and financial covenants and our achievement of minimum monthly net revenue goals.
The agreement also includes subjective acceleration clauses which permit Silicon Valley Bank to
accelerate the due date under certain circumstances, including, but not limited to, material
adverse effects on our financial status or otherwise. Any non-compliance by us under the terms of
our debt arrangements could result in an event of default under the Silicon Valley Bank loan,
which, if not cured, could result in the acceleration of this debt. We were in compliance with all
financial covenants through
September 30, 2009. We were not in compliance with one of the financial covenants at October 31, 2009, but Silicon Valley Bank waived this covenant for such period.
The reported changes in cash and cash equivalents and investments for the three months
ended September 30, 2009 and 2008 are summarized below.
20
Cash and Cash Equivalents. Cash and cash equivalents was $30.8 million and $33.4 million
at September 30, 2009 and June 30, 2009, respectively. This decrease is primarily attributable to
net cash used from operations offset by net cash of $3.0 million received under the agreement to
establish a manufacturing facility in Texas.
Investments. Investments were $19.9 million and $20.0 million at September 30, 2009 and
June 30, 2009, respectively. Our investments include AAA rated auction rate securities issued primarily by state agencies
and backed by student loans substantially guaranteed by the Federal Family Education Loan Program,
or FFELP. The federal government insures loans in the FFELP so that lenders are reimbursed at least
97% of the loans outstanding principal and accrued interest if a borrower defaults. Approximately
99.2% of the par value of our auction rate securities is supported by student loan assets that are
guaranteed by the federal government under the FFELP.
In February 2008, we were informed that there was insufficient demand for auction rate
securities, resulting in failed auctions for $23.0 million of our auction rate securities.
Currently, these affected securities are not liquid and will not become liquid until a future
auction for these investments is successful, they are redeemed by the issuer, they mature, or they
are repurchased by UBS. As a result, we have determined the fair value of our auction rate
securities at September 30, 2009 and June 30, 2009 to be $19.9 million and $20.0 million,
respectively.
On November 7, 2008, we accepted an offer from UBS AG (UBS), providing rights related
to our auction rate securities (the Rights). The Rights permit us to require UBS to purchase our
auction rate securities at par value, which is defined for this purpose as the liquidation
preference of the auction rate securities 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 auction rate securities 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 auction
rates securities under the Rights. 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 auction rate securities. At
September 30, 2009 and June 30, 2009, we have determined the fair value of our auction rate
security rights to be $2.8 million. As long as we hold auction rate securities, they will continue
to accrue interest as determined by the auction process or the terms of the auction rate securities
if the auction process fails.
Operating Activities. Net cash used in operating activities was $2.0 million and
$12.0 million for the three months ended September 30, 2009 and 2008, respectively. For the three
months ended September 30, 2009 and 2008, we had a net loss of $6.2 million and $13.7 million,
respectively. Changes in working capital accounts also contributed to the net cash used in the
three months ended September 30, 2009 and 2008. Significant changes in working capital during these
periods included:
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cash used in (provided by) accounts receivable of
$(293,000) and $570,000 during the three months ended
September 30, 2009 and 2008, respectively; |
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cash used in inventories of $713,000 and $154,000 during
the three months ended September 30, 2009 and 2008,
respectively; |
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cash used in (provided by) prepaid expenses and other
current assets of $394,000 and $(1.1) million during the
three months ended September 30, 2009 and 2008,
respectively; |
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cash used in accounts payable of $383,000 and $701,000
during the three months ended September 30, 2009 and 2008,
respectively; and |
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cash (provided by) accrued expenses and other liabilities
of $(3.0) million and $(124,000) during the three months
ended September 30, 2009 and 2008, respectively. |
Investing Activities. Net cash used in investing activities was $80,000 and $382,000 for
the three months ended September 30, 2009 and 2008, respectively. Cash used in investing activities
primarily related to the purchase of property and equipment. Purchases of property and equipment
used cash of $41,000 and $201,000 for the three months ended September 30, 2009 and 2008,
respectively.
Financing Activities. Net cash used in (provided by) financing activities was $590,000 and
$(19.5) million in the three months ended September 30, 2009 and 2008, respectively. Cash provided
by financing activities during these periods included:
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proceeds from long-term debt of $17.7 million during the three months ended September 30, 2008; |
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exercise of stock options and warrants of $285,000 and $13,000 during the three months ended September 30,
2009 and 2008, respectively; |
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Issuance of common stock warrants of $1.8 million during the three months ended September 30, 2008; and |
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Issuance of convertible preferred stock warrants of $75,000 during the three months ended September 30, 2008. |
Cash used in financing activities in these periods included:
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payment of long-term debt of $875,000 and $78,000 during the three
months ended September 30, 2009 and 2008, respectively. |
Our future liquidity and capital requirements will be influenced by numerous factors,
including the extent and duration of future operating losses, the level and timing of future
revenue and expenditures, the results and scope of ongoing research and product development
programs, working capital required to support our revenue growth, the receipt of and time required
to obtain regulatory clearances and approvals, our sales and marketing programs, the continuing
acceptance of our products in the marketplace, competing technologies and market and regulatory
developments. As of September 30, 2009, we believe our current cash and cash equivalents and
available debt capacity will be sufficient to fund working capital requirements, capital
expenditures and operations for the foreseeable future. We intend to retain any future earnings to
support operations and to finance the growth and development of our business, and we do not
anticipate paying any dividends in the foreseeable future.
INFLATION
We do not believe that inflation has had a material impact on our business and operating results
during the periods presented.
OFF-BALANCE SHEET ARRANGEMENTS
Since inception, we have not engaged in any off-balance sheet activities as defined in Item
303(a)(4) of Regulation S-K.
RECENT ACCOUNTING PRONOUNCEMENTS
In October 2009, the FASB issued Emerging Issues Task Force (EITF) issue 08-01, Revenue
Arrangements with Multiple Deliverables (currently within the scope of FASB Accounting Standards
Codification (ASC) Subtopic 605-25). This statement provides principles for allocation of
consideration among its multiple-elements, allowing more flexibility in identifying and accounting
for separate deliverables under an arrangement. The EITF introduces an estimated selling price
method for valuing the elements of a bundled arrangement if vendor-specific objective evidence or
third-party evidence of selling price is not available, and significantly expands related
disclosure requirements. This standard is effective on a prospective basis for revenue arrangements
entered into or materially modified in fiscal years beginning on or after June 15, 2010.
Alternatively, adoption may be on a retrospective basis, and early application is permitted. We are
currently evaluating the impact of adopting this pronouncement.
PRIVATE SECURITIES LITIGATION REFORM ACT
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking
statements. Such forward-looking information is included in this Form 10-Q, including Item 2 of
Part I, and in other materials filed or to be filed by the Company with the Securities and Exchange
Commission (as well as information included in oral statements or other written statements made or
to be made by the Company). Forward-looking statements include all statements based on future
expectations. This Form 10-Q contains forward-looking statements that involve risks and
uncertainties, including our expectation that our losses will continue but generally decline; our
plans to continue to expand our sales and marketing efforts, conduct research and development and
increase our manufacturing capacity to support anticipated future growth; the expected benefits of
the Rights from UBS; our expectation of increased revenue, and selling, general and administrative
expenses; our expectation that research and development expenses for the remainder of the fiscal
year will be incurred at a similar rate as for the three months ended September 30, 2009; our
expectation that gross margin will stay fairly consistent; the sufficiency of our current and
anticipated financial resources; and our belief that our current cash and cash equivalents and
available debt will be sufficient to fund working capital requirements, capital expenditures and
operations for the foreseeable future. In some cases, you can identify forward-looking statements
by the following words: anticipate, believe, continue, could, estimate, expect,
intend, may, ongoing, plan, potential, predict, project, should, will, would,
or the negative of these terms or other comparable terminology, although not all forward-looking
statements contain these words. Forward-looking statements are only predictions and are not
guarantees of performance. These statements are based on our managements beliefs and assumptions,
which in turn are based on their interpretation of currently
22
available information.
These statements involve known and unknown risks, uncertainties and other factors that may cause
our results or our industrys actual results, levels of activity, performance or achievements to be
materially different from the information expressed or implied by these forward-looking statements.
These factors include regulatory developments in the U.S. and foreign countries; the experience of
physicians regarding the effectiveness and reliability of the Diamondback 360º; competition from
other devices; unanticipated developments affecting our estimates regarding expenses, future
revenues and capital requirements; our inability to expand our sales and marketing organization;
our actual research and development efforts and needs; the sufficiency of UBSs financial resources
to purchase our auction rate securities; our ability to obtain and maintain intellectual property
protection for product candidates; our actual financial resources; and general economic conditions.
These and additional risks and uncertainties are described more fully in our Form 10-K filed with
the SEC on September 28, 2009. Copies of filings made with the SEC are available through the SECs
electronic data gathering analysis and retrieval system (EDGAR) at www.sec.gov.
You should read these risk factors and the other cautionary statements made in this Form 10-Q as
being applicable to all related forward-looking statements wherever they appear in this Form 10-Q.
We cannot assure you that the forward-looking statements in this Form 10-Q will prove to be
accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may
be material. You should read this Form 10-Q completely. Other than as required by law, we undertake
no obligation to update these forward-looking statements, even though our situation may change in
the future.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
The primary objective of our investment activities is to preserve our capital for the purpose
of funding operations while at the same time maximizing the income we receive from our investments
without significantly increasing risk or availability. To achieve these objectives, our investment
policy allows us to maintain a portfolio of cash equivalents and investments in a variety of
marketable securities, including money market funds and U.S. government securities. Our cash and
cash equivalents as of September 30, 2009 include liquid money market accounts. Due to the
short-term nature of these investments, we believe that there is no material exposure to interest
rate risk.
In February 2008, we were informed that there was insufficient demand for ARS, resulting in
failed auctions for $23.0 million of our ARS. 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. For discussion of the related risks, see Managements
Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting
Policies and Significant Judgments and Estimates Investments.
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ITEM 4T. CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls and Procedures
Our Chief Executive Officer and Chief Financial Officer, referred to collectively herein as
the Certifying Officers, are responsible for establishing and maintaining our disclosure controls
and procedures. The Certifying Officers have reviewed and evaluated the effectiveness of the
Companys disclosure controls and procedures (as defined in Rules 240.13a-15(e) and 15d-15(e)
promulgated under the Securities Exchange Act of 1934 (the Exchange Act) as of September 30,
2009. Based on that review and evaluation, which included inquiries made to certain other employees
of the Company, the Certifying Officers have concluded that, as of the end of the period covered by
this Report, the Companys disclosure controls and procedures, as designed and implemented, are
effective in ensuring that information relating to the Company required to be disclosed in the
reports that the Company files or submits under the Exchange Act is recorded, processed, summarized
and reported within the time periods specified in the Securities and Exchange Commissions rules
and forms, including ensuring that such information is accumulated and communicated to the
Companys management, including the Chief Executive Officer and the Chief Financial Officer, as
appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal controls over financial reporting (as defined in Rules
13a-15(f) and 15d-15(f) under the Exchange Act) during the three months ended September 30, 2009
that have materially affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
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PART II. OTHER INFORMATION
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ITEM 1. LEGAL PROCEEDINGS |
Refer to Item 3 (Legal Proceedings) in the Companys Annual Report on Form 10-K for the year
ended June 30, 2009.
In addition, on October 27, 2009, Dr. Leonid Shturman, CSI-MNs founder, filed a complaint in
the U.S. District Court in Minnesota against CSI. The complaint asserted that the filing by CSI of
an action in Switzerland against Dr. Shturman violated provisions of a settlement agreement that
CSI and Dr. Shturman entered into in September 2008. The 2008 settlement resolved a lawsuit CSI had
brought against Dr. Shturman for breach of his employment agreement with CSI. Dr. Shturmans
complaint seeks an award of damages and injunctive relief to bar CSI from litigating the action in
Switzerland. We believe Dr. Shturmans claims are without merit. We recently learned that Dr.
Shturman died and, accordingly, the future of the lawsuit is uncertain.
In addition to the other information set forth in this report, including the important
information in Private Securities Litigation Reform Act, you should carefully consider the Risk
Factors discussed in our Form 10-K for the year ended June 30, 2009 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 this report, and materially adversely affect
our financial condition or future results. Although we are not aware of any other factors that we
currently anticipate will cause our forward-looking statements to differ materially from our future
actual results, or materially affect the Companys financial condition or future results,
additional risks and uncertainties not currently known to us or that we currently deem to be
immaterial might materially adversely affect our actual business, financial condition and/or
operating results.
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ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
During the quarterly period ended September 30, 2009, we sold an aggregate of 879 shares of
common stock pursuant to the exercise of warrants with an exercise price of $8.83 per share. These
sales were made in reliance on Section 4(2) of the Securities Act of 1933, as amended.
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ITEM 3. DEFAULTS UPON SENIOR SECURITIES |
None.
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ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS |
None.
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ITEM 5. OTHER INFORMATION |
Cash
Incentive Program
On July 16, 2009, our Board adopted an executive officer annual cash incentive compensation
program for fiscal 2010. The program provides as follows: our executive officers are eligible to
receive annual cash incentive compensation based on our achievement of revenue and adjusted EBITDA
financial goals in fiscal 2010. Target bonus amounts will be split evenly between these two goals.
None of the executive officers is subject to individual goals under this plan. Target bonus levels
as a percentage of base salary are 75% for the President and Chief Executive Officer and 50% for
the other executive officers. Depending upon our performance against the goals, participants are
eligible to earn 50% to 200% of their target bonus amount for adjusted EBITDA and 50% to 150% of
their target bonus amount for revenue; however, in the event of extraordinary revenue performance
above the goals set by the Board, the participants could receive incentive payments greater than
150% of their targets for the revenue goal based upon a formula established by the Board, with no
maximum payout set under the plan. The plan criteria are the same for all of the executive
officers. In addition to incentives under this plan, our Vice President of Sales and Vice President
of Business Development are eligible to receive monthly sales commissions. The Board also has the
authority to grant additional discretionary cash bonuses of up to 15% of annual base salary for any
executive officer.
Silicon Valley Bank Agreement
Under our
loan and security agreement with Silicon Valley Bank, as amended, we are required to maintain
certain financial covenants. We did not meet one of these covenants
at October 31, 2009, which would have constituted an event of default
under the agreement and all amounts outstanding under the agreement would have been due to
Silicon Valley Bank. However, Silicon Valley Bank waived this covenant for such period.
The amount outstanding under the agreement with Silicon Valley Bank as of October 31, 2009
was $6.9 million.
(a) Exhibits See Exhibit Index on page following signatures
24
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the
Company has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Dated: November 13, 2009 |
CARDIOVASCULAR SYSTEMS, INC.
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By |
/s/ David L. Martin
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David L. Martin |
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President and Chief Executive Officer
(Principal Executive Officer) |
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By |
/s/ Laurence L. Betterley
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Laurence L. Betterley |
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Chief Financial Officer
(Principal Financial and Accounting Officer) |
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EXHIBIT INDEX
CARDIOVASCULAR SYSTEMS, INC.
FORM 10-Q
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Exhibit No. |
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Description |
10.1
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Corporate Job Creation Agreement between Pearland Economic Development Corporation and Cardiovascular Systems,
Inc., dated June 17, 2009. (1) |
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10.2
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Build-To-Suit Lease Agreement between Pearland Economic Development Corporation and Cardiovascular Systems,
Inc., dated September 9, 2009. (1) |
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10.3
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Letter Agreement between Silicon Valley Bank and Cardiovascular Systems, Inc., dated September 9, 2009. (1) |
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10.4*
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Summary of Fiscal 2010 Executive Officer Annual Cash Incentive Compensation. |
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31.1*
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Certification of President and Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2*
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Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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32.1*
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Certification of President and Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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32.2*
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Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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* |
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Filed herewith. |
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Compensatory plan or agreement. |
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(1) |
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Previously filed with the SEC as an Exhibit to and incorporated herein by reference from the
Companys Annual Report on Form 10-K filed on September 28, 2009. |
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