e10vq
UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
FORM 10-Q
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2006
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number 0-23837
SurModics, Inc.
(Exact name of registrant as specified in its Charter)
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MINNESOTA
(State of incorporation)
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41-1356149
(I.R.S. Employer Identification No.) |
9924 West 74th Street
Eden Prairie, Minnesota 55344
(Address of principal executive offices)
Registrants telephone number, including area code: (952) 829-2700
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule
12b-2).
Yes o No þ
The number of shares of the registrants Common Stock, $.05 par value per share, outstanding as of
July 31, 2006 was 18,765,957.
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
SURMODICS, INC.
Condensed Balance Sheets
(In thousands, except share data)
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June 30, |
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September 30, |
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2006 |
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2005 |
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(unaudited) |
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ASSETS |
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Current Assets |
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Cash and cash equivalents |
|
$ |
1,870 |
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|
$ |
3,921 |
|
Short-term investments |
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|
48,726 |
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20,524 |
|
Accounts receivable, net |
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11,862 |
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10,996 |
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Income taxes receivable |
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|
|
|
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|
3,640 |
|
Inventories |
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1,115 |
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|
|
1,091 |
|
Deferred tax asset |
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|
366 |
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|
353 |
|
Prepaids and other |
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1,714 |
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|
1,079 |
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Total current assets |
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65,653 |
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41,604 |
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Property and equipment, net |
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11,776 |
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14,832 |
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Long-term investments |
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46,095 |
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48,874 |
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Deferred tax asset |
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3,789 |
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2,868 |
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Other assets, net |
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17,088 |
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16,047 |
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Total Assets |
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$ |
144,401 |
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$ |
124,225 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities
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Accounts payable |
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$ |
648 |
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$ |
1,163 |
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Accrued liabilities |
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2,569 |
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3,546 |
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Accrued income taxes payable |
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819 |
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Deferred revenue |
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577 |
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414 |
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Current portion of long-term liabilities |
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1,000 |
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Total current liabilities |
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5,613 |
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5,123 |
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Deferred revenue, less current portion |
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1,582 |
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1,521 |
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Other long-term liabilities |
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1,000 |
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2,000 |
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Total liabilities |
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8,195 |
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8,644 |
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Stockholders Equity |
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Series A Preferred stock- |
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$.05 par value, 450,000 shares authorized;
no shares issued and outstanding |
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Common stock- |
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$.05 par value, 45,000,000 shares authorized;
18,764,227 and 18,535,761 shares issued and outstanding |
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938 |
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|
927 |
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Additional paid-in capital |
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93,938 |
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89,721 |
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Unearned compensation |
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(2,621 |
) |
Accumulated other comprehensive loss |
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(649 |
) |
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(360 |
) |
Retained earnings |
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41,979 |
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27,914 |
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Total stockholders equity |
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136,206 |
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115,581 |
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Total Liabilities and Stockholders Equity |
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$ |
144,401 |
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$ |
124,225 |
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The accompanying notes are an integral part of these unaudited condensed financial statements.
2
Item 1. Financial Statements
SURMODICS, INC.
Condensed Statements of Operations
(In thousands, except per share data)
(unaudited)
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Three Months Ended |
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Nine Months Ended |
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June 30, |
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June 30, |
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2006 |
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2005 |
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2006 |
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2005 |
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Revenue |
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Royalties and license fees |
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$ |
13,948 |
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$ |
12,694 |
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$ |
39,514 |
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$ |
35,052 |
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Product sales |
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2,659 |
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2,663 |
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7,914 |
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6,984 |
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Research and development |
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1,532 |
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1,161 |
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|
4,883 |
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|
4,255 |
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Total revenue |
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18,139 |
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16,518 |
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52,311 |
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46,291 |
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Operating costs and expenses |
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Product |
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891 |
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|
743 |
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2,441 |
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2,092 |
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Research and development |
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5,281 |
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4,494 |
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14,935 |
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11,739 |
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Sales and marketing |
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|
348 |
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|
341 |
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1,052 |
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|
909 |
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General and administrative |
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2,156 |
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1,792 |
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6,887 |
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4,635 |
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Purchased in-process research & development |
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|
30,277 |
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Total operating costs and expenses |
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8,676 |
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7,370 |
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25,315 |
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49,652 |
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Income (loss) from operations |
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|
9,463 |
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|
9,148 |
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26,996 |
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(3,361 |
) |
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Other income (loss) |
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Investment income |
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1,113 |
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|
494 |
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|
2,894 |
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|
1,344 |
|
Impairment loss |
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|
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|
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(4,651 |
) |
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Other loss |
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(11 |
) |
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(25 |
) |
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(112 |
) |
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(588 |
) |
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|
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Other income (loss) |
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1,102 |
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|
469 |
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|
(1,869 |
) |
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|
756 |
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Income (loss) before income taxes |
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10,565 |
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|
9,617 |
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|
25,127 |
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|
(2,605 |
) |
Income tax provision |
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|
(4,207 |
) |
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|
(3,522 |
) |
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|
(11,087 |
) |
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(10,433 |
) |
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Net income (loss) |
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$ |
6,358 |
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|
$ |
6,095 |
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$ |
14,040 |
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($ |
13,038 |
) |
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Basic net income (loss) per share |
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$ |
0.34 |
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$ |
0.33 |
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$ |
0.76 |
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($ |
0.72 |
) |
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Diluted net income (loss) per share |
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$ |
0.34 |
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$ |
0.32 |
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$ |
0.75 |
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|
($ |
0.72 |
) |
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Weighted average shares outstanding |
|
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|
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Basic |
|
|
18,570 |
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|
18,322 |
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|
|
18,494 |
|
|
|
18,008 |
|
Dilutive effect of outstanding stock options |
|
|
155 |
|
|
|
606 |
|
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|
187 |
|
|
|
|
|
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|
|
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|
|
|
|
|
|
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|
Diluted |
|
|
18,725 |
|
|
|
18,928 |
|
|
|
18,681 |
|
|
|
18,008 |
|
The accompanying notes are an integral part of these unaudited condensed financial statements.
3
SURMODICS, INC.
Condensed Statements of Cash Flows
(In thousands)
(unaudited)
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Nine months ended |
|
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June, |
|
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2006 |
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|
2005 |
|
Operating Activities |
|
|
|
|
|
|
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|
Net income (loss) |
|
$ |
14,040 |
|
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|
($13,038 |
) |
Adjustments to reconcile net income (loss) to net cash provided by
operating activities- |
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|
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|
Depreciation and amortization |
|
|
2,726 |
|
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|
2,840 |
|
Loss on equity method investment and sales of investments |
|
|
112 |
|
|
|
588 |
|
Amortization of discount on investments |
|
|
(941 |
) |
|
|
(91 |
) |
Noncash compensation |
|
|
4,358 |
|
|
|
405 |
|
Purchased in-process research & development |
|
|
|
|
|
|
30,277 |
|
Tax benefit from exercise of stock options |
|
|
(116 |
) |
|
|
(121 |
) |
Impairment loss |
|
|
4,651 |
|
|
|
|
|
Deferred taxes |
|
|
(758 |
) |
|
|
1,142 |
|
Other |
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|
24 |
|
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|
0 |
|
(Gain)/loss on disposals of property and equipment |
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|
83 |
|
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|
(91 |
) |
Change in operating assets and liabilities: |
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|
|
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|
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Accounts receivable |
|
|
(866 |
) |
|
|
(2,613 |
) |
Inventories |
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|
(24 |
) |
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|
11 |
|
Accounts payable and accrued liabilities |
|
|
(789 |
) |
|
|
191 |
|
Income taxes |
|
|
4,574 |
|
|
|
(1,909 |
) |
Deferred revenue |
|
|
(120 |
) |
|
|
(282 |
) |
Prepaids and other |
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|
120 |
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|
|
(60 |
) |
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Net cash provided by operating activities |
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|
27,074 |
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|
17,249 |
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Investing Activities |
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Purchases of property and equipment |
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|
(5,300 |
) |
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|
(996 |
) |
Purchases of available-for-sale investments |
|
|
(135,609 |
) |
|
|
(71,029 |
) |
Sales/maturities of available-for-sale investments |
|
|
110,357 |
|
|
|
70,417 |
|
Investments in OctoPlus and other |
|
|
(160 |
) |
|
|
(5,058 |
) |
Purchase of licenses and patents |
|
|
(906 |
) |
|
|
(5,223 |
) |
Investment in InnoRx |
|
|
|
|
|
|
(5,181 |
) |
|
|
|
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|
Net cash used in investing activities |
|
|
(31,618 |
) |
|
|
(17,070 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing Activities |
|
|
|
|
|
|
|
|
Tax benefit from exercise of stock options |
|
|
116 |
|
|
|
121 |
|
Issuance of common stock |
|
|
2,377 |
|
|
|
1,972 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
2,493 |
|
|
|
2,093 |
|
|
|
|
|
|
|
|
Net change in cash and cash equivalents |
|
|
(2,051 |
) |
|
|
2,272 |
|
|
|
|
|
|
|
|
|
|
Cash and Cash Equivalents |
|
|
|
|
|
|
|
|
Beginning of period |
|
|
3,921 |
|
|
|
2,709 |
|
|
|
|
|
|
|
|
End of period |
|
$ |
1,870 |
|
|
$ |
4,981 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for income taxes |
|
$ |
7,365 |
|
|
$ |
11,204 |
|
Noncash transaction-acquisition of property, plant, and equipment on account |
|
$ |
1,043 |
|
|
$ |
875 |
|
The accompanying notes are an integral part of these unaudited condensed financial statements.
4
SURMODICS, INC.
Notes to Condensed Financial Statements
Period Ended June 30, 2006
(Unaudited)
(1) Basis of Presentation
In the opinion of management, the accompanying unaudited condensed financial statements have
been prepared in accordance with accounting principles generally accepted in the United States and
reflect all adjustments, consisting solely of normal recurring adjustments, needed to fairly
present the financial results for the interim periods presented. These financial statements
include some amounts that are based on managements best estimates and judgments. These estimates
may be adjusted as more information becomes available, and any adjustment could be significant.
The impact of any change in estimates is included in the determination of earnings in the period in
which the change in estimate is identified. The results of operations for the three and nine month
periods ended June 30, 2006, are not necessarily indicative of the results that may be expected for
the entire 2006 fiscal year.
In accordance with the rules and regulations of the United States Securities and Exchange
Commission, the Company has omitted footnote disclosures that would substantially duplicate the
disclosures contained in the audited financial statements of the Company. These unaudited
condensed financial statements should be read together with the financial statements for the year
ended September 30, 2005, and footnotes thereto included in the Companys Form 10-K as filed with
the United States Securities and Exchange Commission on December 14, 2005.
(2) New Accounting Pronouncements
On July 13, 2006, FASB Interpretation (FIN) No. 48, Accounting for Uncertainty in Income Taxes
- - an Interpretation of FASB Statement No. 109, was issued. FIN 48 clarifies the accounting for
uncertainty in income taxes recognized in an enterprises financial statements in accordance with
FASB Statement No. 109, Accounting for Income Taxes. FIN 48 also prescribes a recognition threshold
and measurement attribute for the financial statement recognition and measurement of a tax position
taken or expected to be taken in a tax return. The new FASB standard also provides guidance on
derecognition, classification, interest and penalties, accounting in interim periods, disclosure,
and transition. The provisions of FIN 48 are effective for fiscal years beginning after December
15, 2006. The Company is currently evaluating the effect that the adoption of FIN 48 will have on
its consolidated results of operations and financial condition.
(3) Other assets (dollars in thousands)
Other assets consist principally of investments and acquired patents. The balance in
other assets increased primarily as a result of the long term portion of the note receivable the
Company recorded on the sale of its Bloomington property (see note 8), partially offset by the $4.7
million impairment loss we recorded on our investment in Novocell (see note 9) and accumulated
amortization on patents and other intangibles. The Company recorded amortization expense of
$436,000 and $1.3 million for the three months and nine months ended June 30, 2006, respectively.
We expect to incur approximately $1.7 million of amortization each year in fiscal years 2006
through 2008, $490,000 in fiscal 2009, and $71,000 in fiscal years 2010 and 2011. Management does
not believe an other-than-temporary impairment existed as of June 30, 2006, with respect to its
existing investments:
5
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
Abbott license |
|
|
7,037 |
|
|
$ |
7,037 |
|
Investment in Novocell |
|
|
559 |
|
|
|
5,210 |
|
Investment in OctoPlus |
|
|
4,095 |
|
|
|
3,935 |
|
Investment in ThermopeutiX |
|
|
1,000 |
|
|
|
1,000 |
|
Patents and other |
|
|
1,600 |
|
|
|
732 |
|
Note receivable (long-term portion) |
|
|
5,961 |
|
|
|
|
|
Less-accumulated amortization |
|
|
(3,164 |
) |
|
|
(1,867 |
) |
|
|
|
|
|
|
|
Other assets, net |
|
$ |
17,088 |
|
|
$ |
16,047 |
|
|
|
|
|
|
|
|
(4) Inventories (dollars in thousands)
Inventories are stated at the lower of cost or market using the specific identification method
and include direct labor, materials and overhead. Inventories consisted of the following
components:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
Raw materials |
|
$ |
557 |
|
|
$ |
512 |
|
Finished goods |
|
|
558 |
|
|
|
579 |
|
|
|
|
|
|
|
|
|
|
$ |
1,115 |
|
|
$ |
1,091 |
|
|
|
|
|
|
|
|
(5) Operating Segments (dollars in thousands)
Operating segments are defined as components of an enterprise about which separate
financial information is available that is evaluated regularly by the chief operating decision
maker, or decision making group, in deciding how to allocate resources and in assessing
performance.
SurModics manages its business on the basis of the operating segments noted in the table
below, which are composed of the Companys six business units. The three operating segments are
aggregated into one reportable segment. The Drug Delivery operating segment contains: (1) the
Drug Delivery business unit and (2) the Ophthalmology division. The Hydrophilic and Other
operating segment consists of three business units: (1) Hydrophilic Technologies, (2) Regenerative
Technologies, and (3) Orthopedics. The In Vitro operating segment contains the In Vitro
Technologies (formerly Diagnostics and Drug Discovery) business unit. Each operating segment has
similar economic characteristics, technology, manufacturing processes, customers, regulatory
environments, and shared infrastructures. The Company manages its expenses on a company-wide basis,
as many costs and activities are shared among the business units and a majority of the Companys
employees reside in shared resource units. The focus of the business units is providing solutions
to customers and maximizing revenue over the long-term. The accounting policies for segment
reporting are the same as for the Company as a whole. The table below presents revenue from the
three operating segments.
6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Operating segment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug Delivery |
|
$ |
8,647 |
|
|
$ |
7,857 |
|
|
$ |
25,580 |
|
|
$ |
22,244 |
|
Hydrophilic and Other |
|
|
5,522 |
|
|
|
4,833 |
|
|
|
15,988 |
|
|
|
13,826 |
|
In Vitro Technologies |
|
|
3,970 |
|
|
|
3,828 |
|
|
|
10,743 |
|
|
|
10,221 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
18,139 |
|
|
$ |
16,518 |
|
|
$ |
52,311 |
|
|
$ |
46,291 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6) Stock-based Compensation (in thousands, except per share data)
Commencing October 1, 2005, the Company adopted Statement of Financial Accounting Standards
No. 123(R), Share Based Payment (SFAS 123(R)), which requires all share-based payments,
including grants of stock options, to be recognized in the income statement as an operating
expense, based on their fair values, over the requisite service period. The Company recorded $1.6
million and $4.4 million of related compensation expense, before taxes, for the three and nine
months ended June 30, 2006, respectively. The compensation expense reduced basic earnings per share
by $.06 and diluted earnings per share by $.05 for the three month period ended June 30, 2006.
Stock-based compensation expense reduced basic earnings per share by $.15 and diluted earnings per
share by $.15 for the nine month period ended June 30, 2006.
As of June 30, 2006, $22.0 million of total unrecognized compensation costs related to
non-vested awards is expected to be recognized over a weighted average period of approximately 3.48
years.
Prior to adopting SFAS 123(R), the Company accounted for stock-based compensation under
Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees. The Company
has applied the modified prospective method in adopting SFAS 123(R). Accordingly, periods prior to
adoption have not been restated. The Company did not amend or alter outstanding stock-based awards
in anticipation of adopting SFAS 123(R). The following table illustrates the effect on net income
and earnings per share if the fair value based method had been applied to the three and nine months
ended June 30, 2005.
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
|
Nine months |
|
|
|
ended |
|
|
ended |
|
|
|
June 30, 2005 |
|
Reported net income (loss) |
|
$ |
6,095 |
|
|
($ |
13,038 |
) |
Restricted stock expense previously recorded under APB 25,
net of tax |
|
|
101 |
|
|
|
255 |
|
Stock-based compensation determined under the fair value based
method, net of related tax effects |
|
|
(950 |
) |
|
|
(2,447 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proforma net income (loss) |
|
$ |
5,246 |
|
|
($ |
15,230 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) per common equivalent share: |
|
|
|
|
|
|
|
|
Basic as reported |
|
$ |
.33 |
|
|
($ |
.72 |
) |
Diluted as reported |
|
$ |
.32 |
|
|
($ |
.72 |
) |
|
|
|
|
|
|
|
|
|
Basic pro forma |
|
$ |
.29 |
|
|
($ |
.85 |
) |
Diluted pro forma |
|
$ |
.28 |
|
|
($ |
.85 |
) |
7
The Company uses the Black-Scholes option pricing model to determine the weighted average fair
value of options. The weighted average fair value of options granted during the three month periods
ended June 30, 2006 and 2005 were $14.37 and $25.80, respectively. The fair market value of each
option is estimated on the date of grant using the Black-Scholes option pricing model with the
following weighted-average assumptions for the three months ended June 30, 2006 and June 30, 2005,
respectively: risk-free interest rates of 5.04% and 3.83%; expected lives of 4.6 years and 7.0
years; and expected volatility of 42.3% and 62.7%. The weighted average fair value of options
granted during the nine month periods ended June 30, 2006 and 2005 were $17.55 and $19.17,
respectively. The following weighted-average assumptions were used for the nine months ended June
30, 2006 and June 30, 2005, respectively: risk-free interest rates of 4.67% and 3.70%; expected
lives of 4.9 years and 7.0 years; and expected volatility of 47.6% and 62.7%.
The Companys Incentive Stock Options (ISO) are granted at a price of at least 100% of the
fair market value of the Common Stock on the date of the grant or 110% with respect to optionees
who own more than 10% of the total combined voting power of all classes of stock. Options expire in
seven years or upon termination of employment and are exercisable at a rate of 20% per year
commencing one year after the date of grant. Nonqualified stock options are granted at fair
market value on the date of grant. Options expire in 7 to 10 years and are exercisable at rates of
20% per year from the date of grant or 20% to 33% per year commencing one year after the date of
grant. The Company has authorized 2,400,000 shares for grant under the 2003 Plan, of which
approximately 1,006,000 remain available for future awards. As of June 30, 2006, the aggregate
intrinsic value of the option shares outstanding and the option shares exercisable was $12.9
million and $7.4 million, respectively with an average remaining contractual life of 4.47 years.
The intrinsic value and the cash proceeds of options exercised during the nine month period ended
June 30, 2006 was $1.8 million and $2.0 million respectively. The intrinsic value and the cash
proceeds of options exercised during the nine month period ended June 30, 2005 was $2.1 million and
$1.6 million respectively. Option transactions under the prior plans and the 2003 Equity Incentive
Plan during the nine-month period ended June 30, 2006 are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
Weighted Average |
|
|
|
shares |
|
|
Exercise Price |
|
Outstanding at September 30, 2005 |
|
|
1,529,935 |
|
|
$ |
26.60 |
|
Granted |
|
|
231,800 |
|
|
|
37.47 |
|
Exercised |
|
|
(108,220 |
) |
|
|
20.45 |
|
Forfeited |
|
|
(78,640 |
) |
|
|
29.26 |
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2006 |
|
|
1,574,875 |
|
|
$ |
28.49 |
|
|
|
|
|
|
|
|
|
|
Exercisable at June 30, 2006 |
|
|
590,023 |
|
|
$ |
23.68 |
|
8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Shares |
|
Weighted |
Exercise Price |
|
Shares Outstanding |
|
Exercise |
|
Contractual |
|
Exercisable at |
|
Average Exercise |
Range |
|
at June 30, 2006 |
|
Price |
|
Life (in years) |
|
June 30, 2006 |
|
Price |
$2.50-$10.25 |
|
|
114,115 |
|
|
$ |
6.67 |
|
|
|
1.18 |
|
|
|
114,115 |
|
|
$ |
6.67 |
|
$14.06-$21.82 |
|
|
281,290 |
|
|
|
21.24 |
|
|
|
5.07 |
|
|
|
122,630 |
|
|
|
20.89 |
|
$22.46-$27.00 |
|
|
102,220 |
|
|
|
24.93 |
|
|
|
1.90 |
|
|
|
90,008 |
|
|
|
25.06 |
|
$28.78-$29.89 |
|
|
585,880 |
|
|
|
29.36 |
|
|
|
5.33 |
|
|
|
167,580 |
|
|
|
29.35 |
|
$30.13-$53.00 |
|
|
491,370 |
|
|
|
37.40 |
|
|
|
5.82 |
|
|
|
95,690 |
|
|
|
36.34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,574,875 |
|
|
$ |
28.49 |
|
|
|
4.91 |
|
|
|
590,023 |
|
|
$ |
23.68 |
|
Restricted Stock Awards
The Company has entered into restricted stock agreements with certain key employees, covering
the issuance of Common Stock (Restricted Stock). The Restricted Stock will be released to the key
employees if they are employed by the Company at the end of the vesting period. Compensation has
been recognized for the estimated fair value of the 155,000 common shares and is being charged to
income over the vesting term. Stock compensation expense recognized related to these awards
totaled $324,000 and $161,000 during the three month periods ended June 30, 2006 and 2005,
respectively. Stock compensation expense recognized related to these awards totaled $648,000 and
$405,000 during the nine month periods ended June 30, 2006 and 2005, respectively. Common shares
with an approximate fair value of $126,000 were issued during the nine months ended June 30, 2006.
Following is a summary of Restricted Stock transactions for the nine months ended June 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
Weighted Average |
|
|
shares |
|
Exercise Price |
Balance at September 30, 2005 |
|
|
108,000 |
|
|
$ |
30.15 |
|
Granted |
|
|
65,000 |
|
|
|
36.07 |
|
Issued |
|
|
(3,500 |
) |
|
|
36.00 |
|
Cancelled |
|
|
(14,500 |
) |
|
|
33.24 |
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2006 |
|
|
155,000 |
|
|
$ |
32.21 |
|
Performance Share Awards
The Company has entered into Performance Share agreements with certain key employees, covering
the issuance of Common Stock (Performance Shares). The Performance Shares will vest upon the
achievement of all or a portion of certain performance objectives which must be achieved during the
performance period. Compensation has been recognized for the estimated fair value of the 42,000
shares awarded in March 2006 that are estimated to vest during fiscal 2006. Stock compensation
expense related to the Performance Share awards expected to vest totaled $183,000 and $0 during the
three month periods ended June 30, 2006 and 2005, respectively. Stock compensation expense related
to these awards totaled $540,000 and $0 during the nine month periods ended June 30, 2006 and 2005,
respectively.
1999 Employee Stock Purchase Plan
Under the 1999 Employee Stock Purchase Plan (Stock Purchase Plan) the Company is authorized
to issue up to 200,000 shares of Common Stock. All full-time and
part-time employees can choose to have up to 10% of their annual compensation withheld to purchase the
9
Companys
Common Stock at purchase prices defined within the provisions of the Stock Purchase Plan. As of
June 30, 2006, there was approximately $170,000 of employee contributions included in accrued
liabilities in the accompanying balance sheets. Stock compensation expense recognized related to
Stock Purchase Plan totaled $40,000 and $0 during the three month periods ended June 30, 2006 and
2005, respectively and totaled $123,000 and $0 during the nine month periods ended June 30, 2006
and 2005, respectively.
(7) Comprehensive Income (dollars in thousands)
The components of comprehensive income for the three-month and nine-month periods are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Net income (loss) |
|
$ |
6,358 |
|
|
$ |
6,095 |
|
|
$ |
14,040 |
|
|
($ |
13,038 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized holding gains (losses) on
available-for-sale securities arising
during the period, net of tax |
|
|
(90 |
) |
|
|
171 |
|
|
|
(359 |
) |
|
|
(239 |
) |
Less reclassification adjustment
for realized gains included in net
income, net of tax |
|
|
7 |
|
|
|
15 |
|
|
|
70 |
|
|
|
55 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income (loss) |
|
|
(83 |
) |
|
|
186 |
|
|
|
(289 |
) |
|
|
(184 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss) |
|
$ |
6,275 |
|
|
$ |
6,281 |
|
|
$ |
13,751 |
|
|
($ |
13,222 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
(8) Property and Equipment
In September 2005,
the Company entered into an agreement to sell a building and 27 acres of
land located in Bloomington, Minnesota. The company vacated the
Bloomington facility at the beginning of the third quarter of fiscal
2006 and consolidated operations at its headquarters in Eden Prairie,
Minnesota. Management is accounting for the transaction as an
installment sale and believes the $6.6 million balance on the
note receivable is collectible as of June 30, 2006. Management
does not anticipate recording any additional gain or loss on the sale.
(9) Impairment Loss
The Company has invested a total of $5.2 million in Novocell, Inc., a privately-held Irvine,
California-based biotech firm that is developing a unique treatment for diabetes. The investment,
which is accounted for under the cost method, is included in other assets and represents an
ownership interest of less than 5%. During the quarter ended March 31, 2006, utilizing the recent
guidance provided by FASB Staff Position 115-1 (FSP 115-1), The Meaning of Other-Than-Temporary
Impairment and its Application to Certain Investments, combined with Novocell valuation information
gathered in conjunction with a prospective round of financing, the Company determined its
investment in Novocell was impaired and that the impairment was other-than-temporary. During the
three months ended March 31, 2006, the Company recorded an impairment loss of approximately $4.7
million. Since the Company does not currently forsee future offsetting capital gains to offset
this capital loss, no tax benefit has been recorded.
10
|
|
|
ITEM 2. |
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Overview
SurModics is a leading provider of surface modification and drug delivery technologies to the
healthcare industry. The Company is organized into three operating segments composed of six
technology-centered and industry-focused business units. The Drug Delivery operating segment
contains: (1) the Drug Delivery business unit, which is responsible for technologies dedicated to
site-specific delivery of drugs, and (2) the Ophthalmology division, which is dedicated to the
advancement of treatments for eye diseases, such as age-related macular degeneration (AMD) and
diabetic macular edema (DME), two of the leading causes of blindness. The Hydrophilic and Other
operating segment consists of three business units: (1) Hydrophilic Technologies business unit,
which focuses on enhancing medical devices with advanced lubricious coatings that facilitate their
placement and maneuverability in the body; (2) Regenerative Technologies business unit, which is
developing platforms intended to augment or replace tissue/organ function (e.g., cell encapsulation
applications), or to modify medical devices to facilitate tissue/organ recovery through natural
repair mechanisms (e.g., hemo/biocompatible coatings); and (3) Orthopedics business unit, which is
committed to innovative solutions for orthopedics patients using proven SurModics technologies, and
creating new technology solutions to existing patient care gaps in the orthopedics field. The In
Vitro operating segment contains the In Vitro Technologies (formerly Diagnostics and Drug
Discovery) business unit, which includes our genomics slide technologies, our stabilization
products for immunoassay diagnostic tests, our in vitro diagnostic format technology and the work
being performed to develop synthetic cell culture products.
Revenue in each of our operating segments is derived from three primary sources: (1) royalties
and license fees from licensing our patented surface modification and drug delivery technologies
and in vitro diagnostic formats to customers; (2) the sale of reagent chemicals to licensees of our
technologies, stabilization products to the diagnostics industry and coated glass slides to the
genomics market; and (3) research and development fees generated on customer projects. Revenue
should be expected to fluctuate from quarter to quarter depending on, among other factors: our
customers success in selling products incorporating our technologies; the timing of introductions
of coated products by customers; the timing of introductions of products that compete with our
customers products; the number and size of development projects that are entered into; the number
and terms of new license agreements that are finalized; the value of reagent chemicals and other
products sold to licensees; and the timing of future acquisitions we complete, if any.
For financial accounting and reporting purposes, we treat our three operating segments as one
reportable segment. We made this determination because our operating segments currently share the
same facilities; a significant percentage of our employees provide support services (including
research and development) to each operating segment; technology and products from each operating
segment are marketed to the same or similar customers; each operating segment uses the same sales
and marketing resources; and each operating segment operates in the same regulatory environment.
Critical Accounting Policies
Critical accounting policies are those policies that require the application of managements
most challenging subjective or complex judgment, often as a result of the need to make estimates
about the effect of matters that are inherently uncertain and may change in subsequent periods.
Critical accounting policies involve judgments and uncertainties that are sufficiently sensitive to
result in materially different results under different assumptions and conditions. For a detailed
description of our critical accounting policies, see the notes to the financial statements included
in our Annual Report on Form 10-K for the year ended September 30, 2005. There have been no changes in critical accounting policies
subsequent to September 30, 2005 other than the adoption of Statement of Financial Accounting
Standards No. 123(R), Share Based Payment (SFAS 123(R)) as discussed in note 6.
11
Results of Operations
Three Months Ended June 30, 2006 and 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Dollars in thousands) |
|
2006 |
|
|
2005 |
|
|
Increase |
|
|
% Increase |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug Delivery |
|
$ |
8,647 |
|
|
$ |
7,857 |
|
|
$ |
790 |
|
|
|
10 |
% |
Hydrophilic and Other |
|
|
5,522 |
|
|
|
4,833 |
|
|
|
689 |
|
|
|
14 |
% |
In Vitro |
|
|
3,970 |
|
|
|
3,828 |
|
|
|
142 |
|
|
|
4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
18,139 |
|
|
$ |
16,518 |
|
|
$ |
1,621 |
|
|
|
10 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue. Third quarter revenue was $18.1 million, an increase of $1.6 million or 10% compared
with the same period in fiscal 2005. Growth was distributed across all three operating segments as
detailed in the table above and further explained in the narrative below.
Drug Delivery. Revenue in the Drug Delivery segment increased 10% to $8.6 million for the
three-month period ended June 30, 2006, compared with $7.9 million for the prior year period. The
growth in total revenue reflects increases in royalties and license fees, and research and
development revenue. Drug Delivery derives a substantial majority of its revenue from royalties
and license fees and product sales attributable to Cordis Corporation, a Johnson & Johnson company,
on its Cypher Sirolimus-eluting Coronary Stent. The Cypher stent incorporates a proprietary
SurModics polymer coating that delivers a therapeutic drug designed to reduce the occurrence of
restenosis in coronary artery lesions. Approximately one half of the overall increase in drug
delivery revenue reflects increased royalty revenue from Cordis (as a result of higher Cypher
sales) and increased research and development fees from drug delivery customers. Sales of reagent
chemicals (chemicals that we manufacture and sell to licensees for coating their medical devices)
to Cordis decreased when compared with the prior year quarter. The unit volume of reagents sold to
Cordis will likely be directly impacted by anticipated continued improvements in manufacturing
efficiencies by Cordis in addition to relative market share positions of drug-eluting stent
players. The remainder of the increase in drug delivery revenue reflects increased licensing
revenue and research and development revenue on ophthalmic applications.
Future royalty and reagent sales revenue could decrease because of lower Cypher stent sales as
a result of continuing competition from Boston Scientific Corporations Taxus drug-eluting stent,
which is sold within and outside the U.S., and stents from Medtronic and Conor Medsystems sold
outside the U.S. In addition, drug-eluting stents from Guidant Corporation (whose vascular
intervention unit was recently acquired by Abbott Laboratories), Abbott Vascular and others are
expected to be approved in the next two years. These stents compete directly with the Cypher
stent. We anticipate that quarterly royalty revenue from the Cypher stent may be volatile as the
various marketers of drug-eluting stents continue competing in the marketplace and as others enter
the marketplace. Management expects royalties from the Cypher stent to constitute a significant
portion of our revenue for the remainder of fiscal year 2006 and fiscal year 2007. However,
whether and the extent to which royalties from the Cypher stent continue to constitute a
significant source of revenue is subject to a number of risks, including intellectual property
litigation generally, and specifically the damages, settlements and mutual agreements that may
result from various infringement suits between Boston Scientific and Cordis in which each has been
found to have violated certain intellectual property rights of the other.
12
Hydrophilic and Other. Revenue in the Hydrophilic and Other segment increased 14% to $5.5
million compared with the third quarter of fiscal 2005 primarily as a result of growth in royalties
and license fees. In contrast to our Drug Delivery segment, where a significant percentage of
revenue is attributable to Cordis, there are several dozen licensees and an even larger number of
coated products generating royalties in our Hydrophilic and Other segment. While we believe
royalty revenue will continue to increase in the fourth quarter of the fiscal year, growth is
unlikely to be as strong as the third quarter.
In Vitro. Revenue in the In Vitro segment (formerly Diagnostics and Drug Discovery) increased
4% to $4.0 million compared with the prior year period. A majority of the increase was attributable
to growth in product sales as a result of higher sales of our stabilization products (used by
diagnostic kit manufacturers in immunoassay diagnostic tests) and increased sales of genomics
slides to GE Healthcare. The In Vitro segment derives a significant percentage of its revenue from
Abbott Laboratories and GE Healthcare.
Product costs. Product costs were $891,000 for the third quarter of fiscal 2006, a 20%
increase from $743,000 in the third quarter of fiscal 2005. Overall product margins averaged 66%
compared with 72% for the comparable period last year. The decrease in product margins reflects
higher depreciation costs on our recently-constructed manufacturing space at our Eden Prairie
facility, stock-based compensation and to a lesser extent, the mix of products sold in the period
(some of our reagent products carry higher margins than our stabilization products and genomics
slides). We anticipate that product margins will continue to be lower on a year over year basis
through the second quarter of fiscal 2007.
Research and development expenses. Research and development expenses were $5.3 million in the
third quarter of fiscal 2006, an increase of 18% compared with the same period in fiscal 2005.
Approximately $714,000 of the $787,000 increase was related to stock-based compensation following
the adoption of SFAS No. 123(R). Research and development expenses included no such charge in the
third quarter of fiscal 2005. Excluding stock-based compensation, research and development
expenses increased less than 2%. The balance of the increase reflects higher costs associated with
the clinical trial on our I-vation intravitreal implant, increased costs of operating the
recently-constructed clean rooms and drug coating suites at our Eden Prairie headquarters, and
increased personnel costs. These increased costs were partially offset by reduced legal costs.
Research and development expenses will likely increase for the balance of the fiscal year in
support of the clinical trial of our I-vation intravitreal implant. In April 2006, we ceased
operations at our Bloomington, Minnesota contract manufacturing facility and consolidated our
operations at Eden Prairie. While research and development expenses will increase reflecting
increased depreciation on our Eden Prairie facility, the cost of operating the Bloomington facility
(reported in general and administrative expenses) has been eliminated.
Sales and marketing expenses. Sales and marketing expenses were $348,000 for the third
quarter of fiscal 2006, a 2% increase from the prior year period. Approximately $55,000 in the
quarter was related to stock-based compensation. Sales and marketing expenses included no such
costs in the third quarter of fiscal 2005. Excluding stock-based compensation, sales and marketing
expenses decreased about 14% on lower personnel costs and reduced travel. We expect sales and
marketing expenses to increase sequentially in the fourth quarter of fiscal 2006 and into fiscal
2007.
General and administrative expenses. General and administrative expenses were $2.2 million
for the third quarter of fiscal, a 20% increase compared with $1.8 million in same period in fiscal
2005. We recorded approximately $808,000 in expense related to stock-based compensation compared
with $161,000 in the third quarter of fiscal 2005. Excluding the impact of stock-based
compensation, general and administrative expenses decreased 17% as a result of the cost savings
realized since we exited our contract manufacturing facility in Bloomington in April 2006. We
expect general and administrative expenses to be lower when compared with prior year results for
the next several quarters reflecting lower facility operating costs. The majority of the operating costs of the Bloomington facility
were reported in general and administrative expenses.
13
Other income, net. Other income was $1.1 million in the third quarter of fiscal 2006, an
increase of 135% compared to fiscal 2005. The increase reflects higher levels of investable cash
and higher yields generated from our investment portfolio.
Income tax expense. The Companys income tax provision was $4.2 million in the third quarter
of fiscal 2006 compared with $3.5 million in the same period of fiscal 2005 resulting in an
effective tax rate of 39.8% for the third quarter of fiscal 2006, compared with 36.6% for the same
period last year. The increase in the effective tax rate principally reflects discrete items and
the treatment of incentive stock options upon the adoption of SFAS 123(R).
Nine months Ended June 30, 2006 and 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Dollars in thousands) |
|
2006 |
|
|
2005 |
|
|
Increase |
|
|
% Increase |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug Delivery |
|
$ |
25,580 |
|
|
$ |
22,244 |
|
|
$ |
3,336 |
|
|
|
15 |
% |
Hydrophilic and Other |
|
|
15,988 |
|
|
|
13,826 |
|
|
|
2,162 |
|
|
|
16 |
% |
In Vitro |
|
|
10,743 |
|
|
|
10,221 |
|
|
|
522 |
|
|
|
5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
52,311 |
|
|
$ |
46,291 |
|
|
$ |
6,020 |
|
|
|
13 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue. Total revenue was $52.3 million for the first nine months of fiscal 2006, an
increase of $6.0 million, or 13%, compared with the same period of fiscal 2005. Growth was
distributed across all three operating segments as detailed above in the table and further
explained in the narrative below.
Drug Delivery. Drug Delivery revenue increased 15% to $25.6 million in the first nine months
of fiscal 2006, compared with $22.2 million for the same period last year. The increase primarily
reflects growth in royalties and license fees and to a lesser extent research and development
revenue.
Hydrophilic and Other. Hydrophilic and Other revenue increased 16% to $16.0 million for the
nine months ended June 30, 2006, driven principally by increased royalties and license fees, and
reagent sales.
In Vitro. In Vitro revenue increased 5% to $10.7 million. The increase principally reflects
higher stabilization product sales and higher minimum royalty revenue from GE Healthcare, offset
partially by reduced royalties from Abbott.
Product costs. Product costs were $2.4 million for the nine months ended June 30, 2006, a 17%
increase from $2.1 million in the prior year period. Overall product margins averaged 69% compared
with 70% for the comparable period last year. We anticipate that the decrease in product margins
will continue into fiscal 2007 as we have shifted a portion of our manufacturing activities to
newly-constructed space at our Eden Prairie facility, which will result in higher depreciation
expense.
Research and development expenses. Research and development expenses were $14.9 million for
the first nine months of fiscal 2006, an increase of 27% compared with the same period in fiscal
year 2005. Approximately $1.9 million of the $3.2 million increase was related to stock-based
compensation following the adoption of SFAS No. 123(R). Research and development expenses included
no such costs in fiscal 2005. The remainder of the increase reflects higher costs associated with
the clinical trial on our I-vation intravitreal implant and increased personnel costs in our
research and development organization and particularly in our new Ophthalmology division, partially
offset by lower legal
expenses. Excluding the impact of stock-based compensation, research and development expenses
increased 11% from the comparable period last year.
14
Sales and marketing expenses. Sales and marketing expenses were $1.1 million for the nine
months ending June 30, 2006, a 16% increase from prior year period. Approximately $133,000 of the
increase was related to stock-based compensation. Sales and marketing expenses included no such
costs in the same period of fiscal 2005.
General and administrative expenses. General and administrative expenses were $6.9 million
for the first nine months of fiscal 2006, a 49% increase compared with $4.6 million in fiscal 2005.
We recorded approximately $2.2 million in expense related to stock-based compensation, compared
with $405,000 in fiscal 2005. The balance of the increase reflects increased compensation and
professional service fees when compared with the same period last year, partially offset by lower
facility operating costs due to exiting our contract manufacturing facility in April 2006.
Excluding the impact of stock-based compensation, general and administrative expenses increased 11%
from the comparable period last year.
Purchased in-process research and development. On January 18, 2005, the Company acquired all
of the assets of InnoRx, Inc. by paying cash and issuing shares of SurModics common stock to InnoRx
stockholders. Results in the second quarter of fiscal 2005 include a non-cash in-process research
and development charge of $30.3 million. The fair value of the in-process research and development
was determined by an outside valuation consultant.
Other income, net. Other income resulted in a loss of $1.9 million for the first nine months
of fiscal 2006 compared with income of $756,000 in the same period of fiscal 2005, primarily as a
result of the $4.7 million impairment loss on our investment in Novocell we recorded in the second
quarter of fiscal 2006. Income from investments was $2.8 million through the first nine months
fiscal 2006, an increase of $1.5 million, compared with $1.3 million for the same period of fiscal
2005. The increase reflects higher levels of investable cash and higher yields generated from our
investment portfolio. Prior year other income results also include a $500,000 loss related to the
impact of accounting for the InnoRx acquisition under the equity method. We recorded no such
comparable transaction in fiscal 2006.
Income tax expense. The income tax provision was $11.1 million for the first nine months of
fiscal 2006 compared with $10.4 million in the same period of fiscal 2005. Excluding the impact of
the $4.7 million impairment loss, which is not currently tax deductible, the effective tax rate was
37.2% for the first nine months of fiscal 2006, compared with 37% for the same period last year
when the impact of non-tax deductible purchased in-process research and development is excluded.
Liquidity and Capital Resources
As of June 30, 2006, the Company had working capital of $60.0 million and cash, cash
equivalents and investments totaling $96.7 million. The Companys investments principally consist
of U.S. government and government agency obligations and investment grade, interest-bearing
corporate debt securities with varying maturity dates, the majority of which are five years or
less. The Companys policy requires that no more than 5% of investments be held in any one credit
issue, excluding U.S. government and government agency obligations. The primary investment
objective of the portfolio is to provide for the safety of principal
and appropriate liquidity
while generating an above benchmark (Lehman Brothers 1-3 Year Government Index) total rate of
return. Management plans to continue to direct its investment advisors to manage the Companys
investments primarily for the safety of principal for the foreseeable future as it assesses other
investment opportunities and uses of its investments. The
Company had positive cash flows from operating activities of approximately $27.1 million in
the first nine months of fiscal 2006, compared with $17.2 million in the first nine months of
fiscal 2005.
15
We conduct a significant majority of our operations at our Eden Prairie, Minnesota
headquarters. During our third quarter of fiscal year 2005, construction began to improve the
research and development capabilities at the Eden Prairie facility. Management estimates expending
a total of approximately $6 million, of which approximately $5.9 million has been incurred through
June 30, 2006. The capital improvements were sufficiently complete by the end of second quarter of
fiscal year 2006, allowing us to vacate our contract manufacturing facility in Bloomington,
Minnesota and consolidate our Minnesota operations at our Eden Prairie headquarters. In addition
to our Eden Prairie location, we lease approximately 3,000 square feet of commercial office space
in Irvine, California, where our ophthalmic division conducts a portion of its operations.
In January 2005, we entered into a merger agreement whereby SurModics acquired all of the
assets of InnoRx, Inc. by paying approximately $4.1 million in cash and issuing 600,064 shares of
SurModics common stock to InnoRx stockholders. In July 2005, we issued 60,002 shares of SurModics
common stock to the shareholders of InnoRx upon the successful completion of the first milestone
involving the InnoRx technology acquired in the purchase of InnoRx. In March 2006, we issued an
additional 60,007 shares as a result of completion of the second milestone. Upon the successful
completion of the remaining development and commercial milestones involving InnoRx technology
acquired in the transaction, we will be required to issue up to an aggregate 480,060 additional
shares of our common stock to the stockholders of InnoRx.
In January 2005, we made an equity investment of approximately $3.9 million in OctoPlus, a
privately-owned company based in the Netherlands active in the development of pharmaceutical
formulations incorporating novel biodegradable polymers. In May 2006, we made an additional
investment of approximately $160,000. The $4.1 million investment, which is accounted for under
the cost method, represents an ownership interest of less than 20%.
We have invested a total of $5.2 million in Novocell, Inc., a privately-held Irvine,
California-based biotech firm that is developing a unique treatment for diabetes. Working with
Novocell, our researchers have created a coating that encapsulates pancreatic islet cells, the
cells that produce insulin in the human body. If successful, this treatment using coated islet
cells could dramatically change the treatment of diabetes. During the quarter ended March 31,
2006, we recorded an impairment loss of approximately $4.7 million (see note 9). The balance of
our $560,000 investment, which is accounted for under the cost method, is included in other assets
and represents an ownership interest of less than 5%. Novocells primary technology is in its
development stage, and we anticipate that it will be years before commercialization may be
realized, if ever.
In May 2005, we invested $1.0 million in ThermopeutiX, an early stage company developing novel
medical devices for the treatment of vascular and neurovascular diseases, including stroke. In
addition to the investment, we have licensed our hydrophilic and hemocompatible coating
technologies to ThermopeutiX for use with its devices. The $1.0 million investment, which is
accounted for under the cost method, represents an ownership interest of less than 20%.
Risks and uncertainties surrounding a development-stage companys ability to obtain on a
timely and frequent basis financing needed to continue its development activities currently affect,
and will continually affect, the prospects of our investments in Novocell, OctoPlus and
ThermopeutiX and the revenue they may ultimately generate. There is no assurance that the
development stage companies listed above will successfully meet their immediate or future financing
needs or that their financing needs will be met when required. If adverse results occur in the
development of their respective technology, or if their respective financing needs are not
continually met, the viability of such companies, the value of our
investment and their ability to be future sources of revenue for the Company will be in
jeopardy, and our investment in such companies would likely be considered impaired and charged
against earnings at such time.
16
In September 2004, we made a commitment to purchase for $7 million certain additional
sublicense rights and the accompanying future royalty revenue streams under certain sublicenses
through an amendment to our diagnostic format patent license with Abbott Laboratories. Prior to
such amendment, we were receiving only a portion of the royalties under such sublicenses. The first
$5 million installment was paid in November 2004. The two remaining $1 million installments are
reflected in other current and long-term liabilities.
As of June 30, 2006, we had no debt, nor did we have any credit agreements. We believe that
our existing capital resources will be adequate to fund our operations into the foreseeable future.
As of June 30, 2006, the Company did not have any off-balance sheet arrangements with any
unconsolidated entitites.
Certain information in this Quarterly Report on Form 10-Q pertaining to the effects of
stock-based compensation may be considered non-GAAP financial information as contemplated by SEC
Regulation G. Management believes the presentation of financial measures that identify the
magnitude of the impact of stock-based compensation charges on its results of operations provide
useful information to investors as the information allows investors to better evaluate ongoing
business performance and factors that influenced performance during the period under report,
including when comparing against prior periods. Management also uses such financial measures
internally to monitor performance of the business. These potential non-GAAP financial measures
should be considered in addition to, and not a substitute for, financial measures prepared in
accordance with GAAP.
Forward-Looking Statements
Certain statements contained in this report and other written and oral statements made from
time to time by the Company do not relate strictly to historical or current facts. As such, they
are considered forward-looking statements that provide current expectations or forecasts of
future events. These forward-looking statements are made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. Such statements can be identified by the use
of terminology such as anticipate, believe, could, estimate, expect, forecast,
intend, may, plan, possible, project, will and similar words or expressions. Any
statement that is not an historical fact, including estimates, projections, future trends and the
outcome of events that have not yet occurred, are forward-looking statements. The Companys
forward-looking statements generally relate to its growth strategy, financial results, product
development programs, sales efforts, and the impact of the Cordis agreement and other significant
customer agreements. You should carefully consider forward-looking statements and understand that
such statements involve a variety of risks and uncertainties, known and unknown, and may be
affected by inaccurate assumptions. Consequently, no forward-looking statement can be guaranteed
and actual results may vary materially. The Company undertakes no obligation to update any
forward-looking statement.
Although it is not possible to create a comprehensive list of all factors that may cause
actual results to differ from the Companys forward-looking statements, such factors include, among
others: (i) the Companys significant dependence upon Cordis, which causes our financial results
and stock price to be subject to factors affecting Cordis and its Cypher stent program, including
among others, the rate of market penetration by Cordis, the timing of market introduction of
competing products, product safety or efficacy concerns and intellectual property
17
litigation
generally and specifically the
litigation involving Boston Scientific Scimed, Inc. and Cordis in the U.S. District Court for
the District of Delaware in which each was reported in June and July 2005 to have been found to
have infringed the patent rights of the other; (ii) frequent intellectual property litigation in
the medical device industry that may directly or indirectly adversely affect our customers ability
to market their products incorporating our technologies; (iii) our ability to protect our own
intellectual property; (iv) healthcare reform efforts and reimbursement rates for medical device
products that may adversely affect our customers ability to cost effectively market and sell
devices incorporating our technologies; (v) the Companys ability to attract new licensees and to
enter into agreements for additional product applications with existing licensees, the willingness
of potential licensees to sign license agreements under the terms offered by the Company, and the
Companys ability to maintain satisfactory relationships with its licensees; (vi) the Companys
ability to increase the number of market segments and applications that use its coating
technologies through its sales and marketing and research and development efforts; (vii) the
Companys ability to facilitate through strategic investment and research and development support
the creation of new medical device market segments and applications that incorporate its coating
technologies; (viii) market acceptance of products sold by customers incorporating our technologies
and the timing of new product introductions by licensees; (ix) market acceptance of products sold
by customers competitors and the timing and pricing of new product introductions by customers
competitors; (x) the difficulties and uncertainties associated with the lengthy and costly new
product development and foreign and domestic regulatory approval processes, such as delays,
difficulties or failures in achieving acceptable clinical results or obtaining foreign or FDA
marketing clearances, which may result in lost market opportunities or postpone or preclude product
commercialization by licensees; (xi) efficacy or safety concerns with respect to products marketed
by us and our licensees, whether scientifically justified or not, that may lead to product recalls,
withdrawals or declining sales; (xii) the ability to secure raw materials for reagents the Company
sells; (xiii) the Companys ability to manage successfully clinical trials and related foreign and
domestic regulatory processes for the I-vation intravitreal implant or other acquired products from
InnoRx under development by the Companys ophthalmology division, whether delays, difficulties or
failures in achieving acceptable clinical results or obtaining foreign or FDA marketing clearances
postpone or preclude product commercialization of the intravitreal implant or other acquired
products, and whether the intravitreal implant and any other acquired products remain viable
commercial prospects; (xiv) product liability claims not covered by insurance; (xv) the development
of new products or technologies by competitors, technological obsolescence and other changes in
competitive factors; (xvi) the trend of consolidation in the medical device industry, resulting in
more significant, complex and long term contracts than in the past and potentially greater pricing
pressures; (xvii) the Companys ability to identify suitable businesses to acquire or with whom to
form strategic relationships to expand its technology development and commercialization, its
ability to successfully integrate the operations of companies it may acquire from time to time and
its ability to create synergies from acquisitions and other strategic relationships; (xviii) the
Companys ability to successfully internally perform certain product development activities and
governmental and regulatory compliance activities with respect to acquired technology, including
InnoRx technology, which activities the Company has not previously undertaken in any significant
manner; (xix) economic and other factors over which the Company has no control, including changes
in inflation and consumer confidence; (xx) acts of God or terrorism which impact the Companys
personnel or facilities; and (xxi) other factors described in the Risk Factors and other sections
of SurModics Annual Report on Form 10-K, which you are encouraged to read carefully. Many of
these factors are outside the control and knowledge of the Company and could result in increased
volatility in period-to-period results. Investors are advised not to place undue reliance upon the
Companys forward-looking information and to consult any further disclosures by the Company on this
subject in its filings with the Securities and Exchange Commission.
18
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The Companys investment policy requires investments with high credit quality issuers and
limits the amount of credit exposure to any one issuer. The Companys investments principally
consist of U.S. government and government agency obligations and investment-grade, interest-bearing
corporate debt securities with varying maturity dates, the majority of which are five years or
less. Because of the credit criteria of the Companys investment policies, the primary market risk
associated with these investments is interest rate risk. SurModics does not use derivative
financial instruments to manage interest rate risk or to speculate on future changes in interest
rates. A one percentage point increase in interest rates would result in an approximate $1,420,000
decrease in the fair value of the Companys available-for-sale securities as of June 30, 2006, but
no material impact on the results of operations or cash flows. Management believes that a
reasonable change in raw material prices would not have a material impact on future earnings or
cash flows because the Companys inventory exposure is not material.
Although we conduct business in foreign countries, our international operations consist
primarily of sales of reagent and stabilization chemicals. Additionally, all sales transactions are
denominated in U.S. dollars. Accordingly, we do not expect to be subject to material foreign
currency risk with respect to future costs or cash flows from our foreign sales. To date, we have
not entered into any foreign currency forward exchange contracts or other derivative financial
instruments to hedge the effects of adverse fluctuations in foreign currency exchange.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this report, the Company conducted an evaluation under
the supervision and with the participation of the Companys management, including the Companys
Chief Executive Officer and Chief Financial Officer regarding the effectiveness of the design and
operation of the Companys disclosure controls and procedures pursuant to Rule 13a-15(b) of the
Securities Exchange Act of 1934 (the Exchange Act). Based upon that evaluation, the Chief
Executive Officer and Chief Financial Officer concluded that the Companys disclosure controls and
procedures are effective to ensure that information that is required to be disclosed by the Company
in reports that it files under the Exchange Act is recorded, processed, summarized and reported
within the time period specified in the rules of the Securities Exchange Commission.
Changes in Internal Controls
There were no changes in the Companys internal control over financial reporting that occurred
during the period covered by this report that have materially affected, or are reasonably likely to
materially affect, the Companys internal control over financial reporting.
19
PART II OTHER INFORMATION
Item 1. Legal Proceedings.
None.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
In April 2006, we issued 60,007 additional shares of common stock for former stockholders of
InnoRx pursuant to the terms of and as a result of our January 2005 acquisition of InnoRx and
successful completion of the second milestone established in the acquisition. (See Liquidity and
Capital Resources for more information related to our InnoRx acquisition). Such milestone shares
were issued only for the former stockholders of InnoRx as a part of the InnoRx acquisition terms
established at the time of that acquisition and without receipt of any additional consideration
from such stockholders. An exemption from registration therefore was claimed at the time of the
acquisition under Section 4(2) of such securities Act.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Submission of Matters to a Vote of Security Holders.
Information regarding matters submitted to a vote of the Companys security holders during the
period cover by this report was previously reported in the Companys Form 10-Q for the quarterly
period ended December 31, 2005.
Item 5. Other Information.
None.
Item 6. Exhibits.
Exhibits
|
|
|
10.1#
|
|
Change of Control Agreement with Bruce J Barclay, dated April 19, 2006(1) |
|
|
|
10.2#
|
|
Change of Control Agreement with Philip D. Ankeny, dated April 19, 2006(1) |
|
|
|
31.1**
|
|
Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
|
|
31.2**
|
|
Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
|
|
32.1**
|
|
Certification of Chief Executive Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
|
|
|
32.2**
|
|
Certification of Chief Financial Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
|
|
|
# |
|
Management contract or compensatory plan or arrangement. |
|
** |
|
Filed herewith. |
|
(1) |
|
Incorporated by reference to the Companys Form 8-K filed April 25, 2006. |
20
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
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|
|
|
|
|
|
|
|
SurModics, Inc. |
|
|
|
|
|
|
|
|
|
August 9, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
/s/ Philip D. Ankeny |
|
|
|
|
|
|
Philip D. Ankeny
|
|
|
|
|
|
|
Chief Financial Officer |
|
|
21
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
EXHIBIT INDEX TO FORM 10-Q
For the Quarter Ended June 30, 2006
SURMODICS, INC.
|
|
|
Exhibit |
|
Description |
|
|
|
10.1#
|
|
Change of Control Agreement with Bruce J Barclay, dated April 19, 2006(1) |
|
|
|
10.2#
|
|
Change of Control Agreement with Philip D. Ankeny, dated April 19, 2006(1) |
|
|
|
31.1**
|
|
Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
|
|
31.2**
|
|
Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
|
|
32.1**
|
|
Certification of Chief Executive Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
|
|
|
32.2**
|
|
Certification of Chief Financial Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
|
|
|
# |
|
Management contract or compensatory plan or arrangement. |
|
** |
|
Filed herewith. |
|
(1) |
|
Incorporated by reference to the Companys Form 8-K filed April 24, 2006. |
22
exv31w1
EXHIBIT 31.1
CERTIFICATION PURSUANT TO SECTION 302
OF SARBANES-OXLEY ACT OF 2002
I, Bruce J Barclay, Chief Executive Officer, certify that:
1. I have reviewed this quarterly report on Form 10-Q of SurModics, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included
in this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d- 15(f)) for the registrant and we have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls
and procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being
prepared;
b) Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such evaluation;
and
d) Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter (the
registrants fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrants internal control over
financial reporting.
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect the
registrants ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting.
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Dated: August 9, 2006
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Signature:
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/s/ Bruce J Barclay |
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Bruce J Barclay
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Chief Executive Officer |
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23
exv31w2
EXHIBIT 31.2
CERTIFICATION PURSUANT TO SECTION 302
OF SARBANES-OXLEY ACT OF 2002
I, Philip D. Ankeny, Chief Financial Officer, certify that:
1. I have reviewed this quarterly report on Form 10-Q of SurModics, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included
in this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d- 15(f)) for the registrant and we have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls
and procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being
prepared;
b) Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such evaluation;
and
d) Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter (the
registrants fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrants internal control over
financial reporting.
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect the
registrants ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting.
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Dated: August 9, 2006
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Signature:
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/s/ Philip D. Ankeny |
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Philip D. Ankeny
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Chief Financial Officer |
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24
exv32w1
EXHIBIT 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of SurModics, Inc. (the Company) on Form 10-Q for
the quarter ended June 30, 2006, as filed with the Securities and Exchange Commission (the
Report), I, Bruce J Barclay, Chief Executive Officer of the Company, certify, pursuant to 18
U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
Dated: August 9, 2006
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/s/ Bruce J Barclay |
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Bruce J Barclay
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Chief Executive Officer |
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25
exv32w2
EXHIBIT 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of SurModics, Inc. (the Company) on Form 10-Q for
the quarter ended June 30, 2006, as filed with the Securities and Exchange Commission (the
Report), I, Philip D. Ankeny, Chief Financial Officer of the Company, certify, pursuant to 18
U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
Dated: August 9, 2006
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/s/ Philip D. Ankeny |
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Philip D. Ankeny
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Chief Financial Officer |
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26