e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
FORM 10-Q
(Mark One)
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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, 2010
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) (Zip Code)
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 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.
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o |
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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 of the registrants Common Stock, $.05 par value per share, outstanding as of
August 2, 2010 was 17,409,044.
TABLE OF CONTENTS
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3 |
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21 |
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28 |
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28 |
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29 |
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29 |
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29 |
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29 |
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29 |
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29 |
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30 |
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31 |
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32 |
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Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Section 302 of
Sarbanes-Oxley Act of 2002 |
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Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Section 906 of
Sarbanes-Oxley Act of 2002 |
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EX-31.1 |
EX-32.1 |
2
PART I. FINANCIAL INFORMATION
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Item 1. |
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Financial Statements |
SurModics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
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June 30, |
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September 30, |
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2010 |
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2009 |
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(In thousands, except share data) |
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(Unaudited) |
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ASSETS |
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Current assets |
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Cash and cash equivalents |
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$ |
8,617 |
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$ |
11,636 |
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Short-term investments |
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13,101 |
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8,932 |
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Accounts receivable, net of allowance for doubtful
accounts of $442 and $82 as of June 30, 2010 and
September 30, 2009, respectively |
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10,752 |
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11,320 |
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Inventories |
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3,506 |
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3,330 |
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Deferred tax asset |
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722 |
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353 |
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Prepaids and other |
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4,139 |
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1,443 |
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Total current assets |
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40,837 |
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37,014 |
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Property and equipment, net |
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66,964 |
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66,915 |
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Long-term investments |
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33,033 |
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27,300 |
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Deferred tax asset |
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1,876 |
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2,548 |
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Intangible assets , net |
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16,238 |
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17,458 |
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Goodwill |
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21,820 |
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21,070 |
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Other assets, net |
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10,093 |
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13,257 |
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Total assets |
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$ |
190,861 |
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$ |
185,562 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities |
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Accounts payable |
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$ |
3,543 |
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$ |
3,468 |
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Accrued liabilities |
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2,601 |
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2,563 |
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Accrued income taxes payable |
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186 |
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Deferred revenue |
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744 |
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905 |
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Other current liabilities |
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1,018 |
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862 |
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Total current liabilities |
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7,906 |
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7,984 |
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Deferred revenue, less current portion |
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3,665 |
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623 |
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Other long-term liabilities |
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4,665 |
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4,583 |
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Total liabilities |
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16,236 |
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13,190 |
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Commitments and contingencies |
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Stockholders Equity |
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Series A Preferred stock- $.05 par value, 450,000
shares authorized; no shares issued and
outstanding |
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Common stock- $.05 par value, 45,000,000 shares
authorized; 17,415,313 and 17,471,472 shares
issued and outstanding |
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871 |
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874 |
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Additional paid-in capital |
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68,738 |
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66,005 |
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Accumulated other comprehensive income |
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452 |
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1,504 |
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Retained earnings |
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104,564 |
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103,989 |
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Total stockholders equity |
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174,625 |
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172,372 |
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Total liabilities and stockholders equity |
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$ |
190,861 |
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$ |
185,562 |
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The accompanying notes are an integral part of these unaudited condensed consolidated
financial statements.
3
SurModics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
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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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2010 |
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2009 |
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2010 |
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2009 |
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(In thousands, except per share data) |
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(unaudited) |
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(unaudited) |
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Revenue |
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Royalties and license fees |
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$ |
9,356 |
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$ |
8,200 |
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$ |
26,333 |
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$ |
65,999 |
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Product sales |
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5,769 |
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5,130 |
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15,586 |
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13,762 |
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Research and development |
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3,483 |
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4,856 |
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12,430 |
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22,566 |
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Total revenue |
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18,608 |
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18,186 |
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54,349 |
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102,327 |
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Operating costs and expenses |
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Product costs |
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2,388 |
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1,988 |
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6,820 |
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5,341 |
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Customer research and development |
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4,642 |
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3,184 |
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12,748 |
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10,257 |
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Other research and development |
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4,223 |
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4,443 |
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13,507 |
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15,207 |
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Selling, general and administrative |
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4,944 |
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3,910 |
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13,667 |
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12,996 |
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Purchased in-process research and development |
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3,200 |
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Restructuring charges |
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1,306 |
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1,798 |
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Asset impairment charges |
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191 |
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2,265 |
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Total operating costs and expenses |
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16,388 |
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13,525 |
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50,313 |
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48,799 |
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Income from operations |
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2,220 |
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4,661 |
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4,036 |
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53,528 |
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Other (loss) income |
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Investment income |
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241 |
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384 |
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819 |
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1,515 |
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Impairment loss on investments |
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(2,577 |
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(2,577 |
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Other income, net |
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298 |
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410 |
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301 |
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281 |
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Other (loss) income |
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(2,038 |
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794 |
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(1,457 |
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1,796 |
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Income before income taxes |
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182 |
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5,455 |
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2,579 |
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55,324 |
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Income tax provision |
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(1,098 |
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(1,916 |
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(2,005 |
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(20,484 |
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Net (loss) income |
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$ |
(916 |
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$ |
3,539 |
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$ |
574 |
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$ |
34,840 |
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Basic net (loss) income per share |
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$ |
(0.05 |
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$ |
0.20 |
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$ |
0.03 |
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$ |
2.00 |
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Diluted net (loss) income per share |
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$ |
(0.05 |
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$ |
0.20 |
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$ |
0.03 |
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$ |
1.99 |
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Weighted average shares outstanding |
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Basic |
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17,360 |
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17,356 |
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17,373 |
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17,458 |
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Dilutive effect of outstanding stock
options and non-vested stock |
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23 |
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12 |
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34 |
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Diluted |
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17,360 |
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17,379 |
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17,385 |
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17,492 |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial
statements.
4
SurModics, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
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Nine Months Ended |
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June, |
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2010 |
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2009 |
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(In thousands) |
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(unaudited) |
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Operating Activities: |
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Net income |
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$ |
574 |
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$ |
34,840 |
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Adjustments to reconcile net income to net cash provided by operating activities: |
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Depreciation and amortization |
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5,950 |
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4,352 |
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Gain on equity method investment and sales of investments |
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(300 |
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(200 |
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Amortization of premium on investments |
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101 |
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104 |
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Stock-based compensation |
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4,192 |
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4,988 |
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Purchased in-process research and development |
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3,200 |
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Restructuring charges |
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1,306 |
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1,798 |
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Deferred taxes |
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990 |
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8,616 |
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Asset impairment charges |
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2,265 |
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Impairment loss on investments |
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2,577 |
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Tax benefits from exercise of stock options |
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(72 |
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241 |
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Other |
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3 |
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(250 |
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Change in operating assets and liabilities: |
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Accounts receivable |
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568 |
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2,675 |
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Inventories |
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(176 |
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(458 |
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Accounts payable and accrued liabilities |
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(775 |
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(3,261 |
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Income taxes |
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(2,796 |
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3,302 |
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Deferred revenue |
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2,881 |
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(35,816 |
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Prepaids and other |
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(575 |
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638 |
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Net cash provided by operating activities |
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16,713 |
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24,769 |
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Investing Activities: |
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Purchases of property and equipment |
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(7,196 |
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(21,660 |
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Purchases of available-for-sale investments |
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(32,834 |
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(28,465 |
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Sales/maturities of investments |
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23,009 |
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40,407 |
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Business acquisition |
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(750 |
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(8,585 |
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Purchase of licenses and patents |
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(631 |
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Other investing activities |
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(500 |
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(189 |
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Net cash used in investing activities |
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(18,271 |
) |
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(19,123 |
) |
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Financing Activities: |
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Tax benefits from exercise of stock options |
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72 |
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(241 |
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Issuance of common stock |
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892 |
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|
655 |
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Repurchase of common stock |
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(2,032 |
) |
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(14,998 |
) |
Purchase of common stock to pay employee taxes |
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(393 |
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(458 |
) |
Repayment of notes payable |
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(236 |
) |
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Net cash used in financing activities |
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(1,461 |
) |
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(15,278 |
) |
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Net change in cash and cash equivalents |
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(3,019 |
) |
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(9,632 |
) |
Cash and Cash equivalents |
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Beginning of period |
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|
11,636 |
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|
15,376 |
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End of period |
|
$ |
8,617 |
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|
$ |
5,744 |
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Supplemental Information: |
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Cash paid for income taxes |
|
$ |
3,811 |
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$ |
8,764 |
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Noncash transaction acquisition of property, plant, and equipment on account |
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$ |
1,096 |
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$ |
2,467 |
|
Noncash transaction acquisition of intangible assets on account |
|
$ |
210 |
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$ |
210 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial
statements.
5
SurModics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
Period Ended June 30, 2010
(Unaudited)
(1) Basis of Presentation
The accompanying unaudited interim condensed consolidated financial statements have been
prepared in accordance with accounting principles generally accepted in the United States of
America (GAAP) and reflect all adjustments, consisting solely of normal recurring adjustments,
needed to fairly present the financial results for the 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 is identified. The results of operations for the three-month and
nine-month periods ended June 30, 2010 are not necessarily indicative of the results that may be
expected for the entire 2010 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
consolidated financial statements should be read together with the audited consolidated financial
statements for the year ended September 30, 2009, and footnotes thereto included in the Companys
Form 10-K/A as filed with the United States Securities and Exchange Commission on December 14,
2009.
In September 2008, following a strategic review of Merck & Co., Inc.s (Merck) business and
product development portfolio, Merck gave notice to SurModics of Mercks intent to terminate a
collaborative research and license agreement (Merck Agreement) and separate supply agreement
entered into in June 2007. The termination was effective December 16, 2008. The Company recognized
revenue of approximately $45 million in the first nine months of fiscal 2009 principally from
amounts that previously had been deferred and amortized under the then-existing accounting
treatment required for revenue arrangements with multiple deliverables and a $9 million milestone
payment associated with the termination of the triamcinolone acetonide development program under
the Merck Agreement. The fiscal 2009 nine month revenue associated with the Merck Agreement is
reflected in royalties and license fees ($37.6 million) and in research and development fees ($7.5
million).
Subsequent events have been evaluated through the date the financial statements were issued.
(2) Key Accounting Policies and Recent Accounting Pronouncements
Revenue recognition
This revenue recognition section includes the Companys historical policies as well as
adoption of any applicable accounting guidance that has been issued during fiscal 2010.
The Company recognizes revenue when all of the following criteria are met: (1) persuasive
evidence of an arrangement exists; (2) shipment has occurred or delivery has occurred if the terms
specify destination; (3) the sales price is fixed or determinable; and (4) collectability is
reasonably assured. When there are additional performance requirements, revenue is recognized when
all such requirements have been satisfied.
The Companys revenue is derived from three primary sources: (1) royalties and license fees
from licensing its proprietary drug delivery and surface modification technologies to customers;
(2) the sale of polymers and reagent chemicals, stabilization products, antigens, substrates and
microarray slides to the diagnostics and biomedical research industries; and (3) research and
development fees generated on customer projects.
Royalties and licenses fees. The Company licenses technology to third parties and collects
royalties. Royalty revenue is generated when a customer sells products incorporating the Companys
licensed technologies. Royalty revenue is recognized as licensees report it to the Company, and
payment is typically submitted concurrently with the report. This revenue recognition model is
similar to usage fee accounting. Minimum royalty fees are recognized in the period earned, provided
that collectability is reasonably assured. For stand-alone license agreements, up-front license
fees are recognized over economic life of the technology.
6
Milestone payments. Revenue related to a performance milestone is recognized based upon the
achievement of the milestone, as defined in the respective agreements and provided the following
conditions have been met:
|
|
|
The milestone payment is non-refundable; |
|
|
|
|
The milestone involved a significant degree of risk, and was not reasonably assured
at the inception of the arrangement; |
|
|
|
|
Accomplishment of the milestone involved substantial past effort/performance; |
|
|
|
|
The amount of the milestone payment is commensurate with the related effort and
risk; |
|
|
|
|
The milestone payment is reasonable in comparison to all of the deliverables and
payment terms in the arrangement; and |
|
|
|
|
A reasonable amount of time passed between the initial license payment and the
first and subsequent milestone payments. |
If these conditions have not been met, the milestone payment is deferred and recognized over
the economic life of the technology.
Product sales. Product sales to third parties are recognized at the time of shipment, provided
that an order has been received, the price is fixed or determinable, collectability of the
resulting receivable is reasonably assured and returns can be reasonably estimated. The Companys
sales terms provide no right of return outside of the standard warranty policy. Payment terms are
generally set at 30-45 days.
Research and development. The Company performs third party research and development
activities, which are typically provided on a time and materials basis. Generally, revenue for
research and development is recorded as performance progresses under the applicable agreement.
Arrangements with multiple deliverables. Prior to October 1, 2009, arrangements such as
license and development agreements were analyzed to determine whether the deliverables, which often
include a license and performance obligations such as research and development, could be separated,
or whether they must be accounted for as a single unit of accounting in accordance with accounting
guidance. If the fair value of the undelivered performance obligations could be determined, such
obligations would then be accounted for separately. If the license was considered to either (i) not
have stand-alone value or (ii) have stand-alone value but the fair value of any of the undelivered
performance obligations could not be determined, the arrangement would then be accounted for as a
single unit of accounting, and the license payments and payments for performance obligations would
be recognized as revenue over the estimated period of when the performance obligations are
performed, or the economic life of the technology licensed to the customer. When the Company
determined that an arrangement should be accounted for as a single unit of accounting, it
recognized the related revenue on a time-based accounting model.
The Company had one significant multiple element arrangement prior to October 1, 2009 that was
accounted for as a single unit of accounting resulting in deferral and recognition of all related
payments received for license and research and development activities using a time-based model.
This arrangement was terminated during the first quarter of fiscal 2009 as described in Note 1
above.
In October 2009, the Financial Accounting Standards Board (FASB) amended the accounting
standards for multiple deliverable revenue arrangements to:
|
(i) |
|
provide updated guidance on whether multiple
deliverables exist, how the deliverables in an
arrangement should be separated, and how the
consideration should be allocated; |
|
|
(ii) |
|
require an entity to allocate revenue in an
arrangement using estimated selling prices (ESP) of
deliverables if a vendor does not have
vendor-specific objective evidence of selling price
(VSOE) or third-party evidence of selling price
(TPE); and |
|
|
(iii) |
|
eliminate the use of the residual method and
require an entity to allocate revenue using the
relative selling price method. |
The Company elected to early adopt this accounting guidance at the beginning of its first
quarter of fiscal 2010, on a prospective basis, for applicable transactions originating or
materially modified after October 1, 2009. In connection with the adoption of the amended
accounting standard the Company also changed its policy prospectively for multiple element
arrangements, whereby the Company accounts for revenue using a multiple attribution model in which
consideration allocated to research and development activities is recognized as performed, and
milestone payments are recognized when the milestone events are achieved, when such activities and
milestones are deemed substantive. Accordingly, in situations where a unit of accounting includes
both a license and research and development activities, and when a license does not have
stand-alone value, the Company applies a multiple attribution model in which consideration
allocated to the license is recognized ratably, consideration allocated to research and development
activities is recognized as performed and milestone payments are recognized when the milestone
events are achieved, when such activities and milestones are deemed substantive.
7
The Company enters into license and development arrangements that may consist of multiple
deliverables which could include a license(s) to SurModics technology, research and development
activities, manufacturing services, and product sales based on the needs of its customers. For
example, a customer may enter into an arrangement to obtain a license to SurModics intellectual
property which may also include research and development activities, and supply of products
manufactured by SurModics. For these services provided, SurModics could receive upfront license
fees upon signing of an agreement and granting the license, fees for research and development
activities as such activities are performed, milestone payments contingent upon advancement of the
product through development and clinical stages to successful commercialization, fees for
manufacturing services and supply of product, and royalty payments based on customer sales of
product incorporating SurModics technology. The Companys license and development arrangements
generally do not have refund provisions if the customer cancels or terminates the agreement.
Typically all payments made are non-refundable.
The Company evaluates each deliverable in a multiple element arrangement for separability. The
Company is then required to allocate revenue to each separate deliverable using a hierarchy of
VSOE, TPE, or ESP. In certain instances, the Company is not able to establish VSOE for all
deliverables in an arrangement with multiple elements which may be a result of the Company
infrequently selling each element separately. When VSOE cannot be established, the Company
establishes a selling price of each element based on TPE. TPE is determined based on competitor
prices for similar deliverables when sold separately.
When the Company is unable to establish a selling price using VSOE or TPE, the Company uses
ESP in its allocation of arrangement consideration. The objective of ESP is to determine the price
at which the Company would transact a sale if the product or service were sold on a stand-alone
basis. ESP is generally used for highly customized offerings.
The Company determines ESP for undelivered elements by considering multiple factors including,
but not limited to, market conditions, competitive landscape and past pricing arrangements with
similar characteristics.
Net sales as reported and pro forma net sales that would have been reported for the
three-month and nine-month periods ended June 30, 2010, if the transactions entered into or
materially modified after September 30, 2009 were subject to the Companys accounting policies
under the previous accounting guidance, are shown in the following table (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
June 30, 2010 |
|
|
June 30, 2010 |
|
|
|
|
|
|
|
Pro Forma Basis as if |
|
|
|
|
|
|
Pro Forma Basis as |
|
|
|
|
|
|
|
the Previous |
|
|
|
|
|
|
if the Previous |
|
|
|
|
|
|
|
Accounting Guidance |
|
|
|
|
|
|
Accounting Guidance |
|
|
|
As Reported |
|
|
Were in Effect |
|
|
As Reported |
|
|
Were in Effect |
|
Total multiple element arrangement revenue |
|
$ |
534 |
|
|
$ |
104 |
|
|
$ |
3,939 |
|
|
$ |
274 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The impact to revenue for the three-month and nine-month periods ended June 30, 2010
associated with adoption of the new accounting guidance was primarily related to research and
development activities. The Companys accounting policies under the previous accounting guidance
would have resulted in partial recognition of the research and development revenue in the current
periods with the remainder deferred and recognized over the economic life of the technology. Under
the new accounting guidance, the Company is recognizing research and development revenue as the
activities are performed. The Company notes that this new accounting guidance will result in
current revenue recognition of research and development activities in the period the activities are
performed with the revenue generated changing from period to period based on the stage of project
development. The amount of revenue that is recognized could be material in any reporting period.
In April 2010, the FASB issued updated authoritative accounting guidance which provides a
consistent framework for applying the milestone method of revenue recognition in arrangements that
include research or development deliverables. The amendments are effective on a prospective basis
for milestones achieved in fiscal years, and interim periods within those years, beginning on or
after June 15, 2010 with early adoption permitted. The Company is evaluating the guidance and does
not expect the adoption to have a material impact on the Companys consolidated financial
statements.
8
Other accounting areas
In April 2008, the FASB issued authoritative accounting guidance which amends the factors that
should be considered in developing renewal or extension assumptions used to determine the useful
life of intangible assets under goodwill and other intangible asset accounting. The authoritative
guidance is intended to improve the consistency between the useful life of a recognized intangible
asset under goodwill and intangible asset accounting and the period of the expected cash flows used
to measure the fair value of the asset under business combination accounting and other GAAP. The
adoption of the authoritative guidance did not have a material impact on the Companys consolidated
financial statements.
In September 2006, the FASB issued authoritative accounting guidance associated with fair
value measurements. This guidance defines fair value, establishes a consistent framework for
measuring fair value, gives guidance regarding methods used for measuring fair value and expands
disclosures about fair value measurements. These provisions were implemented in fiscal 2009. See
Note 3 for additional information regarding fair value measurements. However, in February 2008, the
FASB issued guidance that delayed the effective date from fiscal 2009 to fiscal 2010 for all
nonfinancial assets and liabilities, except those that are recognized or disclosed at fair value in
the financial statements on a recurring basis (at least annually). The adoption of the
authoritative guidance did not have a material impact on the Companys consolidated financial
statements.
No other new accounting pronouncement issued or effective has had, or is expected to have, a
material impact on the Companys consolidated financial statements.
(3) Fair Value Measurements
Effective October 1, 2008, the Company adopted the new accounting guidance on fair value
measurements. The new guidance defines fair value, establishes a framework for measuring fair value
under GAAP, and expands disclosures about fair value measurements. The guidance is applicable for
all financial assets and financial liabilities and for all nonfinancial assets and nonfinancial
liabilities recognized or disclosed at fair value in the financial statements on a recurring basis
(at least annually). Fair value is defined as the exchange price that would be received from
selling an asset or paid to transfer a liability (an exit price) in an orderly transaction between
market participants at the measurement date. When determining the fair value measurements for
assets and liabilities required or permitted to be recorded at fair value, the Company considers
the principal or most advantageous market in which it would transact and also considers assumptions
that market participants would use when pricing the asset or liability, such as inherent risk,
transfer restrictions and risk of nonperformance.
Fair Value Hierarchy
Accounting guidance on fair value measurements requires that assets and liabilities carried at
fair value be classified and disclosed in one of the following three categories:
Level 1 Quoted (unadjusted) prices in active markets for identical assets or liabilities.
The Companys Level 1 asset consists of its investment in OctoPlus, N.V. (see Note 7 for
further information). The fair market value of this investment is based on the quoted price of
OctoPlus shares traded on the Amsterdam Stock Exchange.
Level 2 Observable inputs other than quoted prices included in Level 1, such as quoted prices for
similar assets or liabilities in active markets; quoted prices for identical or similar assets or
liabilities in markets that are not active; or other inputs that are observable or can be
corroborated by observable market data for substantially the full term of the asset or liability.
The Companys Level 2 assets consist of money market funds, U.S. Treasury securities,
corporate bonds, municipal bonds, U.S. agency securities, agency and municipal securities, certain
asset-backed securities and mortgage-backed securities. Fair market values for these assets are
based on quoted vendor prices and broker pricing where all significant inputs are observable.
Level 3 Unobservable inputs to the valuation methodology that are supported by little or no
market activity and that are significant to the measurement of the fair value of the assets or
liabilities. Level 3 assets and liabilities include those whose fair value measurements are
determined using pricing models, discounted cash flow methodologies or similar valuation
techniques, as well as significant management judgment or estimation.
The
Companys Level 3 assets include other U.S. government agency
securities corporate, securities and
mortgage-backed securities. The fair market values of these investments were determined by broker
pricing where not all significant inputs were observable.
9
In valuing assets and liabilities, the Company is required to maximize the use of quoted
market prices and minimize the use of unobservable inputs. The Company did not significantly change
its valuation techniques from prior periods.
Transfers of assets from Level 2 to Level 3 classifications are made when there is a lack of
observable market data resulting from a decrease in market activity for the affected securities.
The Companys policy is to recognize transfers in and out of Level 3 using the value at the
beginning of the reporting period.
Assets and Liabilities Measured at Fair Value on a Recurring Basis
In instances where the inputs used to measure fair value fall into different levels of the
fair value hierarchy, the fair value measurement has been determined based on the lowest level
input that is significant to the fair value measurement in its entirety. The Companys assessment
of the significance of a particular item to the fair value measurement in its entirety requires
judgment, including the consideration of inputs specific to the asset or liability. The following
table presents information about the Companys financial assets and liabilities measured at fair
value on a recurring basis as of June 30, 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Prices |
|
|
|
|
|
|
|
|
|
|
|
|
in Active |
|
|
Significant |
|
|
|
|
|
|
|
|
|
Markets for |
|
|
Other |
|
|
Significant |
|
|
Total Fair |
|
|
|
Identical |
|
|
Observable |
|
|
Unobservable |
|
|
Value as of |
|
|
|
Instruments |
|
|
Inputs |
|
|
Inputs |
|
|
June 30, |
|
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
2010 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
$ |
|
|
|
$ |
7,193 |
|
|
$ |
|
|
|
$ |
7,193 |
|
Available for sale debt securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US government obligations |
|
|
|
|
|
|
22,138 |
|
|
|
788 |
|
|
|
22,926 |
|
Mortgage backed securities |
|
|
|
|
|
|
5,551 |
|
|
|
143 |
|
|
|
5,694 |
|
Municipal bonds |
|
|
|
|
|
|
3,276 |
|
|
|
|
|
|
|
3,276 |
|
Asset back securities |
|
|
|
|
|
|
1,125 |
|
|
|
|
|
|
|
1,125 |
|
Corporate bonds |
|
|
|
|
|
|
7,962 |
|
|
|
|
|
|
|
7,962 |
|
Other assets |
|
|
2,082 |
|
|
|
|
|
|
|
|
|
|
|
2,082 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured at fair value |
|
$ |
2,082 |
|
|
$ |
47,245 |
|
|
$ |
931 |
|
|
$ |
50,258 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term and long-term investments disclosed in the condensed
consolidated balance sheets include held-to-maturity investments
totaling $5.2 million as of June 30, 2010. Held-to-maturity
investments are carried at an amortized cost.
Changes in Level 3 Instruments Measured at Fair Value on a Recurring Basis
The following tables provide a reconciliation of fiscal 2010 financial assets and liabilities
measured at fair value on a recurring basis using significant unobservable inputs (Level 3) based
on accounting guidance that is applicable for periods ended June 30, 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) |
|
|
|
For the three months ended June 30, 2010 |
|
|
|
Available -for-Sale Debt Securities |
|
|
|
U.S. government obligations |
|
|
Mortgage Backed |
|
|
Total |
|
Balance, March 31, 2010 |
|
$ |
924 |
|
|
$ |
145 |
|
|
$ |
1,069 |
|
Transfers into Level 3 |
|
|
|
|
|
|
|
|
|
|
|
|
Total realized and unrealized gains (losses): |
|
|
|
|
|
|
|
|
|
|
|
|
Included in other comprehensive (loss) income |
|
|
(33 |
) |
|
|
1 |
|
|
|
(32 |
) |
Purchases, issuances, sales and settlements, net |
|
|
(103 |
) |
|
|
(3 |
) |
|
|
(106 |
) |
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2010 |
|
$ |
788 |
|
|
$ |
143 |
|
|
$ |
931 |
|
|
|
|
|
|
|
|
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) |
|
|
|
For the nine months ended June 30, 2010 |
|
|
|
Available -for-Sale Debt Securities |
|
|
|
U.S. government obligations |
|
|
Mortgage Backed |
|
|
Total |
|
Balance, September 30, 2009 |
|
$ |
1,130 |
|
|
$ |
73 |
|
|
$ |
1,203 |
|
Transfers into Level 3 |
|
|
|
|
|
|
147 |
|
|
|
147 |
|
Transfers out of Level 3 |
|
|
(36 |
) |
|
|
(73 |
) |
|
|
(109 |
) |
Total realized and unrealized gains (losses): |
|
|
|
|
|
|
|
|
|
|
|
|
Included in other comprehensive (loss) income |
|
|
(39 |
) |
|
|
4 |
|
|
|
(35 |
) |
Purchases, issuances, sales and settlements, net: |
|
|
(267 |
) |
|
|
(8 |
) |
|
|
(275 |
) |
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2010 |
|
$ |
788 |
|
|
$ |
143 |
|
|
$ |
931 |
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2010, marketable securities measured at fair value using Level 3 inputs were
comprised of $0.8 million of U.S. government agency securities and $0.1 million of mortgage-backed
securities within the Companys available-for-sale investment portfolio. These securities were
measured using observable market data and Level 3 inputs as a result of the lack of market activity
and liquidity. The fair value of these securities was based on the Companys assessment of the
underlying collateral and the creditworthiness of the particular issuer of the securities.
The following tables provide a reconciliation of fiscal 2009 financial assets and liabilities
measured at fair value on a recurring basis using significant unobservable inputs (Level 3) based
on accounting guidance that is applicable for periods ended June 30, 2009 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) |
|
|
|
For the three months ended June 30, 2009 |
|
|
|
Available -for-Sale Debt Securities |
|
|
|
U.S. government |
|
|
|
|
|
|
|
|
|
obligations |
|
|
Mortgage Backed |
|
|
Total |
|
Balance, March 31, 2009 |
|
$ |
47 |
|
|
$ |
|
|
|
$ |
47 |
|
Transfers into Level 3 |
|
|
400 |
|
|
|
79 |
|
|
|
479 |
|
Total realized and unrealized gains (losses): |
|
|
|
|
|
|
|
|
|
|
|
|
Included in other
comprehensive (loss)
income |
|
|
(6 |
) |
|
|
|
|
|
|
(6 |
) |
Purchases, issuances, sales and settlements, net |
|
|
(80 |
) |
|
|
(1 |
) |
|
|
(81 |
) |
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2009 |
|
$ |
361 |
|
|
$ |
78 |
|
|
$ |
439 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) |
|
|
|
For the nine months ended June 30, 2009 |
|
|
|
Available -for-Sale Debt Securities |
|
|
|
U.S. government |
|
|
|
|
|
|
|
|
|
|
|
|
obligations |
|
|
Corporate |
|
|
Mortgage Backed |
|
|
Total |
|
Balance, September 30, 2008 |
|
$ |
74 |
|
|
$ |
190 |
|
|
$ |
|
|
|
$ |
264 |
|
Transfers into Level 3 |
|
|
400 |
|
|
|
|
|
|
|
79 |
|
|
|
479 |
|
Transfers out of Level 3 |
|
|
(581 |
) |
|
|
(199 |
) |
|
|
|
|
|
|
(780 |
) |
Total realized and unrealized gains (losses): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Included in other
comprehensive (loss)
income |
|
|
10 |
|
|
|
9 |
|
|
|
|
|
|
|
19 |
|
Purchases, issuances, sales and settlements, net: |
|
|
458 |
|
|
|
|
|
|
|
(1 |
) |
|
|
457 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2009 |
|
$ |
361 |
|
|
$ |
|
|
|
$ |
78 |
|
|
$ |
439 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis
The Companys investments in non-marketable securities of private companies are accounted for
using the cost method as the Company does not exert significant influence over the investees
operating or financial activities. These investments as well as held-to-maturity securities are
measured at fair value on a non-recurring basis when they are deemed to be other-than-temporarily
impaired. In determining whether a decline in value of non-marketable equity investments in private
companies has occurred and is other-than-temporary, an assessment is made by considering available
evidence, including the general market conditions in the investees industry, the investees
product development status and subsequent rounds of financing and the related valuation and/or the
Companys participation in such financings. The Company also assesses the investees ability to
meet business milestones and the financial condition and near-term prospects of the individual
investee, including the rate at which the investee is using its cash and the investees need for
possible additional funding at a lower valuation. The valuation methodology for determining the
decline in value of non-marketable equity securities is based on inputs that require management
judgment and are Level 3 inputs. The Company wrote down two investments totaling $2.6 million in
the three-month period ended June 30, 2010, as the investments were deemed to be
other-than-temporarily impaired. A pending round of financing at a substantially lower valuation
at one of the private companies resulted in impairment loss of $2.4 million. The second company
sold off assets in light of current market conditions and this action resulted in impairment loss
of $0.2 million. See Note 7 for additional information.
(4) Investments
Investments consist principally of U.S. government and government agency obligations and
mortgage-backed securities and are classified as available-for-sale or held-to-maturity at June 30,
2010 and September 30, 2009. Available-for-sale investments are reported at fair value with
unrealized gains and losses net of tax excluded from operations and reported as a separate
component of stockholders equity, except for other-than-temporary impairments, which are reported
as a charge to current operations. A loss would be recognized when there is an other-than-temporary
impairment in the fair value of any individual security classified as available-for-sale with the
associated net unrealized loss reclassified out of accumulated other comprehensive income with a
corresponding adjustment to other (loss) income. This adjustment results in a new cost basis for
the investment. Investments which management has the intent and ability to hold to maturity are
classified as held-to-maturity and reported at amortized cost. If there is an other-than-temporary
impairment in the fair value of any individual security classified as held-to-maturity, the Company
will write down the security to fair value, with a corresponding
adjustment to other (loss) income.
Interest on debt securities, including amortization of premiums and accretion of discounts, is
included in other (loss) income . Realized gains and losses from the sales of debt securities, which
are included in other (loss) income, are determined using the specific identification method.
The original cost, unrealized holding gains and losses, and fair value of available-for-sale
investments as of June 30, 2010 and September 30, 2009 were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2010 |
|
|
|
Original Cost |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Fair Value |
|
U.S. government obligations |
|
$ |
22,690 |
|
|
$ |
275 |
|
|
$ |
(39 |
) |
|
$ |
22,926 |
|
Mortgage-backed securities |
|
|
5,603 |
|
|
|
153 |
|
|
|
(62 |
) |
|
|
5,694 |
|
Municipal bonds |
|
|
3,198 |
|
|
|
78 |
|
|
|
|
|
|
|
3,276 |
|
Asset-backed securities |
|
|
1,182 |
|
|
|
8 |
|
|
|
(65 |
) |
|
|
1,125 |
|
Corporate bonds |
|
|
7,952 |
|
|
|
10 |
|
|
|
|
|
|
|
7,962 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
40,625 |
|
|
$ |
524 |
|
|
$ |
(166 |
) |
|
$ |
40,983 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2009 |
|
|
|
Original Cost |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Fair Value |
|
U.S. government obligations |
|
$ |
10,837 |
|
|
$ |
253 |
|
|
$ |
|
|
|
$ |
11,090 |
|
Mortgage-backed securities |
|
|
7,938 |
|
|
|
177 |
|
|
|
(106 |
) |
|
|
8,009 |
|
Municipal bonds |
|
|
7,210 |
|
|
|
232 |
|
|
|
|
|
|
|
7,442 |
|
Asset-backed securities |
|
|
2,334 |
|
|
|
65 |
|
|
|
(143 |
) |
|
|
2,256 |
|
Corporate bonds |
|
|
1,181 |
|
|
|
3 |
|
|
|
|
|
|
|
1,184 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
29,500 |
|
|
$ |
730 |
|
|
$ |
(249 |
) |
|
$ |
29,981 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12
The original cost and fair value of investments by contractual maturity at June 30, 2010 were
as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
|
|
|
|
|
Cost |
|
|
Fair Value |
|
Debt securities due within: |
|
|
|
|
|
|
|
|
One year |
|
$ |
10,978 |
|
|
$ |
11,007 |
|
One to five years |
|
|
22,803 |
|
|
|
23,157 |
|
Five years or more |
|
|
6,844 |
|
|
|
6,819 |
|
|
|
|
|
|
|
|
Total |
|
$ |
40,625 |
|
|
$ |
40,983 |
|
|
|
|
|
|
|
|
The following table summarizes sales of available-for-sale securities for the three-month and
nine-month periods ended June 30, 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
|
Nine months |
|
|
|
ended |
|
|
ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2010 |
|
|
2010 |
|
Proceeds from sales |
|
$ |
16,837 |
|
|
$ |
22,009 |
|
Gross realized gains |
|
$ |
299 |
|
|
$ |
302 |
|
Gross realized losses |
|
$ |
(2 |
) |
|
$ |
(2 |
) |
At June 30, 2010, the amortized cost and fair market value of held-to-maturity debt securities
was $5.2 million and $5.3 million, respectively. Investments in securities designated as
held-to-maturity consist of tax-exempt municipal bonds and have maturity dates ranging between one
and two years from June 30, 2010. At September 30, 2009, the amortized cost and fair market value
of held-to-maturity debt securities were $6.3 million and $6.4 million, respectively. A
held-to-maturity security with an amortized cost of $1.0 million matured in the nine-month period
ended June 30, 2010.
(5) Acquisitions
PR Pharmaceuticals, Inc. On November 4, 2008, the Companys SurModics Pharmaceuticals, Inc.
subsidiary entered into an asset purchase agreement with PR Pharmaceuticals, Inc. (PR Pharma)
whereby it acquired certain contracts and assets of PR Pharma for $5.6 million, consisting of $2.9
million in cash on the closing date, additional consideration of $2.4 million upon successful
achievement of specified milestones, and $0.3 million in transaction costs. $5.5 million of the
total consideration was paid in the nine-month period ended June 30, 2009. PR Pharma is eligible to
receive up to an additional $3.6 million in cash upon the successful achievement of milestones for
contract signing and invoicing, successful patent issuances and product development. Management
believes this acquisition strengthens the Companys portfolio of drug delivery technologies for the
pharmaceutical and biotechnology industries. As part of the acquisition, the Company recognized
fair value associated with in-process research and development (IPR&D) of $3.2 million. The IPR&D
was expensed on the date of acquisition and relates to polymer-based drug delivery technologies.
The value assigned to IPR&D is related to projects for which the related products have not achieved
commercial feasibility and have no future alternative use. The amount of purchase price allocated
to IPR&D was based on estimating the future cash flows of each project and discounting the net cash
flows back to their present values. The discount rate used was determined at the time of
acquisition in accordance with accepted valuation methods. These methodologies include
consideration of the risk of the project not achieving commercial feasibility. The research efforts
ranged from 5% to 50% complete at the date of acquisition. The Company used the Relief from Royalty
valuation method to assess the fair value of the projects with a risk-adjusted discount rate of
25%. The Company determined the method was appropriate based on the nature of the projects and
future cash flow streams. The research and development work performed is billed to customers, in
most cases, using standard commercial billing rates, which include a reasonable markup.
Accordingly, the Company has no fixed cost obligations to carry projects forward. There have been
no significant changes to the development plans for the acquired incomplete projects. Significant
net cash inflows would commence with the commercial launch of customer products that are covered by
the intellectual property rights and related agreements acquired from PR Pharma.
13
(6) Inventories
Inventories are principally 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 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
September 30, |
|
|
|
2010 |
|
|
2009 |
|
Raw materials |
|
$ |
1,572 |
|
|
$ |
1,287 |
|
Finished products |
|
|
1,934 |
|
|
|
2,043 |
|
|
|
|
|
|
|
|
Total |
|
$ |
3,506 |
|
|
$ |
3,330 |
|
|
|
|
|
|
|
|
(7) Other Assets
Other assets consist principally of strategic investments. The Company accounts for its
strategic investments under the cost method. The Company accounts for its investment in OctoPlus
N.V. common stock as an available-for-sale investment rather than a cost method investment
following an initial public offering of OctoPlus N.V. common stock in October 2006.
Available-for-sale investments are reported at fair value with unrealized gains and losses reported
as a separate component of stockholders equity, except for other-than-temporary impairments, which
are reported as a charge to current operations, recorded in the other
(loss) income section of the
condensed consolidated statements of operations. The cost basis in the Companys investment in
OctoPlus N.V. was adjusted to $1.7 million in fiscal 2008 based on a significant decline in the
stock price of OctoPlus N.V. that was determined to be an other-than-temporary impairment.
The Company had made investments in Paragon Intellectual Properties, LLC (Paragon) and a
Paragon subsidiary, Apollo Therapeutics, LLC (Apollo) that were accounted for under the equity
method. In October 2008, Paragon announced that it had restructured, along with its subsidiaries,
including Apollo, moving from a limited liability company with seven subsidiaries to a single
C-corporation named Nexeon MedSystems, Inc. (Nexeon). During fiscal 2009, the Company began
accounting for the investment in Nexeon under the cost method as the Companys ownership level is
less than 20% and the Company did not exert significant influence over Nexeons operating or
financial activities. The Company made an additional investment of $0.5 million in Nexeon in fiscal
2009.
In August 2009, the Company invested $2.0 million in a medical technology company and made a
follow-on investment of $0.5 million in March 2010. The Company recognized an impairment loss on
this investment totaling $2.4 million in the three-month period ended June 30, 2010 based on market
valuations and a pending financing round for this company. The Companys investment in the medical
technology company is accounted for under the cost method, as the Companys ownership interest is
less than 20% and the Company did not exert significant influence over the medical technology
companys operating or financial activities. Another entity in which the Company had a strategic
investment sold the majority of its assets in the three-month period ended June 30, 2010 resulting
in an impairment loss of $0.2 million to the Company. These
investments are included in the
category titled Other in the table below
Other assets consisted of the following components (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
September 30, |
|
|
|
2010 |
|
|
2009 |
|
Investment in OctoPlus N.V. |
|
$ |
2,082 |
|
|
$ |
3,700 |
|
Investment in Nexeon MedSystems |
|
|
5,651 |
|
|
|
5,651 |
|
Investment in ThermopeutiX |
|
|
1,185 |
|
|
|
1,185 |
|
Investment in ViaCyte (formerly Novocell) |
|
|
559 |
|
|
|
559 |
|
Other |
|
|
616 |
|
|
|
2,162 |
|
|
|
|
|
|
|
|
Other assets |
|
$ |
10,093 |
|
|
$ |
13,257 |
|
|
|
|
|
|
|
|
The Company recognized revenue of $1.3 million and $0.6 million for the three-month period
ended June 30, 2010 and 2009, respectively, and recognized revenue of $1.5 million and $1.2 million
for the nine-month period ended June 30, 2010 and 2009, respectively, from activity with companies
in which it had a strategic investment.
14
(8) Intangible Assets
Intangible assets consist principally of acquired patents and technology, customer
relationships, licenses, and trademarks. The Company recorded amortization expense of $0.4 million
for each of the three-month periods ended June 30, 2010 and 2009. The Company recorded amortization
expense of $1.2 million and $1.7 million for the nine-month periods ended June 30, 2010 and 2009,
respectively.
Intangible assets consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Useful life |
|
|
June 30, |
|
|
September 30, |
|
|
|
(in years) |
|
|
2010 |
|
|
2009 |
|
Customer list |
|
|
9 11 |
|
|
$ |
8,657 |
|
|
$ |
8,657 |
|
Core technology |
|
|
8 18 |
|
|
|
8,330 |
|
|
|
8,330 |
|
Patents and other |
|
|
2 20 |
|
|
|
3,076 |
|
|
|
3,076 |
|
Trademarks |
|
|
|
|
|
|
600 |
|
|
|
600 |
|
Less accumulated amortization of intangible assets |
|
|
|
|
|
|
(4,425 |
) |
|
|
(3,205 |
) |
|
|
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
|
|
|
|
$ |
16,238 |
|
|
$ |
17,458 |
|
|
|
|
|
|
|
|
|
|
|
|
Based on the intangible assets in service as of June 30, 2010, estimated amortization expense
for each of the next five fiscal years is as follows (in thousands):
|
|
|
|
|
Remainder of 2010 |
|
$ |
407 |
|
2011 |
|
|
1,604 |
|
2012 |
|
|
1,602 |
|
2013 |
|
|
1,602 |
|
2014 |
|
|
1,602 |
|
2015 |
|
|
1,591 |
|
Future amortization amounts presented above are estimates. Actual future amortization expense
may be different, as a result of future acquisitions, impairments, changes in amortization periods,
or other factors.
(9) Goodwill
Goodwill represents the excess of the cost of the acquired entities over the fair value
assigned to the assets purchased and liabilities assumed in connection with the Companys
acquisitions. The carrying amount of goodwill is evaluated annually, and between annual evaluations
if events occur or circumstances change indicating that the carrying amount of goodwill may be
impaired.
In the nine months of fiscal 2010 a milestone was achieved associated with the July 2007
acquisition of SurModics Pharmaceuticals, Inc. and $0.8 million of additional purchase price was
recorded as an increase to goodwill.
(10) Revolving Credit Facility
In February 2009, the Company entered into a two-year $25.0 million unsecured revolving credit
facility. Borrowings under the credit facility, if any, will bear interest at a benchmark rate plus
an applicable margin based upon the Companys funded debt to EBITDA ratio. In connection with the
credit facility, the Company is required to maintain certain financial and nonfinancial covenants.
As of June 30, 2010, the Company had no debt outstanding under this credit facility and was in
compliance with all covenants.
15
(11) Stock-based Compensation
The Company has stock-based compensation plans under which it grants stock options and
restricted stock awards. Accounting guidance requires all share-based payments to be recognized as
an operating expense, based on their fair values, over the requisite service period. The Companys
stock-based compensation expenses were allocated as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Product costs |
|
$ |
29 |
|
|
$ |
19 |
|
|
$ |
95 |
|
|
$ |
65 |
|
Customer research and development |
|
|
202 |
|
|
|
225 |
|
|
|
505 |
|
|
|
591 |
|
Other research and development |
|
|
659 |
|
|
|
522 |
|
|
|
1,718 |
|
|
|
1,975 |
|
Selling, general and administrative |
|
|
542 |
|
|
|
590 |
|
|
|
1,874 |
|
|
|
2,357 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,432 |
|
|
$ |
1,356 |
|
|
$ |
4,192 |
|
|
$ |
4,988 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2010, approximately $8.1 million of total unrecognized compensation costs
related to non-vested awards could be recognized over the remaining weighted average period of
approximately 1.8 years. The $8.1 million of total unrecognized compensation costs include $2.1
million associated with performance share awards that are currently not anticipated to be fully
expensed because the performance conditions are not expected to be met.
Stock Option Plans
The Company uses the Black-Scholes option pricing model to determine the weighted average
grant date fair value of stock options granted. The weighted average per share fair value of stock
options granted during the three-month periods ended June 30, 2010 and 2009 was $7.05 and $7.28,
respectively. The weighted average per share fair value of stock options granted during the
nine-month periods ended June 30, 2010 and 2009 was $6.91 and $8.39, respectively. The assumptions
used as inputs in the model were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Risk-free interest rates |
|
|
2.2 |
% |
|
|
2.0 |
% |
|
|
2.0 |
% |
|
|
2.2 |
% |
Expected life (years) |
|
|
4.8 |
|
|
|
4.8 |
|
|
|
4.8 |
|
|
|
4.8 |
|
Expected volatility |
|
|
41.2 |
% |
|
|
40.2 |
% |
|
|
41.4 |
% |
|
|
38.2 |
% |
Dividend yield |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
The risk-free interest rate assumption was based on the U.S. Treasurys rates for U.S.
Treasury zero-coupon bonds with maturities similar to those of the expected term of the award. The
expected life of options granted is determined based on the Companys experience. Expected
volatility is based on the Companys stock price movement over a period approximating the expected
term. Based on managements judgment, dividend rates are expected to be zero for the expected life
of the options. The Company also estimates forfeitures of options granted, which are based on
historical experience.
The Companys Incentive Stock Options (ISO) are granted at a price of at least 100% of the
fair market value of the common stock of the Company 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. ISOs
generally expire in seven years or upon termination of employment and generally 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. Nonqualified stock options generally expire in 7
to 10 years or upon termination of employment or service as a Board member. Nonqualified stock
options granted prior to May 2008 generally become exercisable with respect to 20% of the shares on
each of the first five anniversaries following the grant date, and nonqualified stock options
granted subsequent to May 2008 generally become exercisable with respect to 25% on each of the
first four anniversaries following the grant date.
There were no stock options exercised during the three-month period ended June 30, 2010. The
total pre-tax intrinsic value of options exercised during the three-month period ended June 30,
2009 was $145,000. The total pre-tax intrinsic value of options exercised during the nine-month
period ended June 30, 2010 was not meaningful as our stock price of $16.41 on June 30, 2010 was
below the value of options exercised. During the nine-month period ended June 30, 2009, the total
pre-tax intrinsic value of options exercised was $242,000. The intrinsic value represents the
difference between the exercise price and the fair market value of the Companys common stock on
the last day of the respective fiscal period end.
16
Restricted Stock Awards
The Company has entered into restricted stock agreements with certain key employees, covering
the issuance of common stock (Restricted Stock). Under accounting guidance these shares are
considered to be non-vested shares. The Restricted Stock will be released to the key employees if
they are employed by the Company at the end of the vesting period. The stock-based compensation
table above includes Restricted Stock expenses of $0.2 million, and $0.8 million during three-month
and nine-month periods ended June 30, 2010, respectively, and $0.3 million and $1.5 million for the
three-month and nine-month periods ended June 30, 2009, respectively.
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 vest upon the
achievement of all or a portion of certain performance objectives, which must be achieved during
the performance period. Compensation is recognized in each period based on managements best
estimate of the achievement level of the grants specified performance objectives and the resulting
vesting amounts. The Company did not recognize expense in the three-month period ended June 30,
2010 and recognized expense of $32,000 for the nine-month period ended June 30, 2010 related to the
Performance Shares granted. For the three-month and nine-month periods ended June 30, 2009, the
Company reversed expenses previously recognized of $144,000 and $173,000, respectively, associated
with the Performance Shares granted. The stock-based compensation table above includes the
Performance Shares expenses and expense reversal.
1999 Employee Stock Purchase Plan
Under the 1999 Employee Stock Purchase Plan (Stock Purchase Plan), the Company is authorized
to issue up to 400,000 shares of common stock. The number of authorized shares was increased by
200,000 effective with shareholder approval at the February 8, 2010 Annual Meeting. All full-time
and part-time employees can choose to have up to 10% of their annual compensation withheld, with a
limit of $25,000, to purchase the Companys common stock at purchase prices defined within the
provisions of the Stock Purchase Plan. As of June 30, 2010 and 2009, there were $0.2 million of
employee contributions, respectively, included in accrued liabilities in the accompanying condensed
consolidated balance sheets. Stock compensation expense recognized related to the Stock Purchase
Plan for the three-month periods ended June 30, 2010 and 2009 totaled $0.1 million in each period.
Stock compensation expense for the nine-month periods ended June 30, 2010 and 2009 totaled $0.2
million in each period. The stock-based compensation table above includes the Stock Purchase Plan
expenses.
(12) Restructuring Charges
In March 2010, the Company announced an organizational change designed to support future
growth by better meeting customer needs, leveraging its multiple competencies across the
organization, and building on its pharmaceutical industry experience. As a result of the
reorganization, the Company eliminated 11 positions, or approximately 4% of the Companys
workforce. These employee terminations occurred across various functions and the reorganization
plan was completed by the end of the third quarter of fiscal 2010. The Company also announced that
it was vacating its leased sales office in Irvine, California and a leased warehouse in Birmingham,
Alabama, as part of the reorganization plan. The leased space was
vacated by March 31, 2010.
The Company recorded total restructuring charges of approximately $1.3 million in connection
with the fiscal 2010 reorganization. These pre-tax charges consisted of $0.8 million of severance
pay and benefits expenses and $0.5 million of facility-related costs. The restructuring is expected
to result in approximately $0.5 million to $1.0 million in annualized cost savings. Cash payments
totaled $0.9 million as of June 30, 2010, resulting in a balance of $0.4 million.
In November 2008, the Company announced a functional reorganization to better serve its
customers and improve its operating performance. As a result of the reorganization, the Company
eliminated 15 positions, or approximately 5% of the Companys workforce. These employee
terminations occurred across various functions and the reorganization plan was completed by the end
of the first quarter of fiscal 2009. The Company also vacated a leased facility in Eden Prairie,
Minnesota, consolidating into its owned office and research facility also in Eden Prairie, as part
of the reorganization plan.
The Company recorded total restructuring charges of approximately $1.8 million in connection
with the fiscal 2009 reorganization. These pre-tax charges consisted of $0.5 million of severance
pay and benefits expenses and $1.3 million of facility-related costs. The restructuring was
expected to result in approximately $2.2 million in annualized cost savings. Cash payments totaled
$1.0 million as of June 30, 2010, resulting in a balance of $0.8 million.
The charges above for fiscal 2010 have been presented separately as restructuring charges in
the condensed consolidated
17
statements
of operations. The remaining balance for both the fiscal 2010 and 2009
restructurings is expected to be paid within the next 42
months. The current portion totaling $1.3 million is recorded as a current liability
within other accrued liabilities and the long-term portion totaling $0.3 million is recorded as a
long-term liability within other long-term liabilities on the condensed consolidated balance
sheets.
The following table summarizes the restructuring accrual activity for the first nine months of
fiscal 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee |
|
|
Facility- |
|
|
|
|
|
|
severance and |
|
|
related |
|
|
|
|
|
|
benefits |
|
|
costs |
|
|
Total |
|
Balance at September 30, 2009 |
|
$ |
|
|
|
$ |
955 |
|
|
$ |
955 |
|
Accruals during the period |
|
|
818 |
|
|
|
488 |
|
|
|
1,306 |
|
Cash payments |
|
|
(814 |
) |
|
|
(174 |
) |
|
|
(988 |
) |
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2010 |
|
$ |
4 |
|
|
$ |
1,269 |
|
|
$ |
1,273 |
|
|
|
|
|
|
|
|
|
|
|
(13) Asset impairment charges
In the nine months ended June 30, 2010, the Company recorded a $1.9 million asset impairment
charge associated with one of its facilities in Alabama as the Company works to consolidate its multiple
facilities in Birmingham, Alabama into its newly opened cGMP manufacturing and development
facility. The original charge of $2.1 million was adjusted by $0.2 million in the three-month
period ended June 30, 2010 as the facility assets were reclassified from held for sale at March 31,
2010 to held and used at June 30, 2010 based on a decision to retain the facility. The assets were
written down to their fair value of $2.3 million, and the net amount is classified as property,
plant and equipment on the condensed consolidated balance sheets. Depreciation expense continues to
be recognized on these assets using the lower valuation.
In addition the Company recorded a $0.4 million asset impairment charge associated with
prototypes and other equipment related to a development project for which no ongoing business is
expected in the near term in light of current market conditions.
Long-lived assets are measured at fair value on a non-recurring basis. Long-lived assets are
not measured at fair value on an ongoing basis but are subject to fair value adjustments only in
certain circumstances. These circumstances include assets that are written down to fair value when
they are held for sale or are determined to be impaired.
(14) Comprehensive
(Loss) Income
The
components of comprehensive (loss) income are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Net (loss) income |
|
$ |
(916 |
) |
|
$ |
3,539 |
|
|
$ |
574 |
|
|
$ |
34,840 |
|
Other comprehensive (loss) income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized holding gains
(losses) on available-for-sale
securities arising during the
period, net of tax |
|
|
(260 |
) |
|
|
980 |
|
|
|
(869 |
) |
|
|
1,586 |
|
Less reclassification adjustment
for realized gains included in
net income, net of tax |
|
|
(179 |
) |
|
|
(285 |
) |
|
|
(184 |
) |
|
|
(479 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive (loss) income |
|
|
(439 |
) |
|
|
695 |
|
|
|
(1,053 |
) |
|
|
1,107 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive (loss) income |
|
$ |
(1,355 |
) |
|
$ |
4,234 |
|
|
$ |
(479 |
) |
|
$ |
35,947 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18
(15) Income Taxes
The Company recorded an income tax provision of $1.1 million and $1.9 million for the
three-month periods ended June 30, 2010 and 2009, respectively, representing effective tax rates of
603.3% and 35.1%, respectively. The Company recorded income tax provisions of $2.0 million and
$20.5 million for the nine-month periods ended June 30, 2010 and 2009, respectively, representing
effective tax rates of 77.7% and 37.0%, respectively. Excluding the impact of the $2.6 million
impairment loss on investments in the three-month and nine-month periods ended June 30, 2010 (since
the Company does not currently foresee offsetting capital gains that could offset this capital
loss, no tax benefit has been recorded), the effective tax rate was 39.8% and 38.9%, respectively.
The difference between the U.S. federal statutory tax rate of 35% and the Companys effective tax
rate, adjusted for the impact of the impairment loss noted above, reflects state taxes and other
permanent items.
The October 2008 adoption of the Emergency Economic Stabilization Act of 2008 retroactively
extended the term of the federal tax credit for research activities through calendar 2009. The tax
credit for research activities for the nine-month period ended June 30, 2010 was $34,000. During
the nine-month period ended June 30, 2009, the Company recognized a discrete benefit of
approximately $120,000 related to research activities in the nine-month period ended September 30,
2008.
The total amount of unrecognized tax benefits including interest and penalties that, if
recognized, would affect the effective tax rate as of June 30, 2010 and September 30, 2009,
respectively, are $2.0 million. Currently, the Company does not expect the liability for
unrecognized tax benefits to change significantly in the next twelve months. Interest and penalties
related to the unrecognized tax benefits are recorded in income tax expense.
The Company files income tax returns, including returns for its subsidiaries, in the United
States (U.S.) federal jurisdiction and in various state jurisdictions. Uncertain tax positions are
related to tax years that remain subject to examination. U.S. tax returns for fiscal years ended
September 30, 2007, 2008 and 2009 remain subject to examination by federal tax authorities. Tax
returns for state and local jurisdictions for fiscal years ended September 30, 2003 through 2009
remain subject to examination by state and local tax authorities.
(16) Operating Segments
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.
In March 2010, the Company announced it changed its operational structure to better align
functional expertise, which also resulted in the elimination of the Companys business units. The
Company evaluates revenue results and opportunities on the basis of the clinical market areas in
which the Companys customers participate as noted in the table below. The Therapeutic market
includes revenue from: (1) Cardiovascular, which provides drug delivery and surface modification
technologies to customers in the cardiovascular market; (2) Ophthalmology, which is focused on 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; and (3) Other Markets, which
is focused on a variety of clinical markets principally in the pharmaceutical and biotechnology
industries. The Diagnostic market includes revenue from the Companys microarray slide
technologies, stabilization products, antigens and substrates for immunoassay diagnostics tests,
and its in vitro diagnostic format technology.
The Company has one reportable segment as its sales and marketing efforts and its expenses are
managed on a company-wide basis. The table below presents revenue from the markets, with
Therapeutic broken out further by focus area, for the three-month and nine-month periods in fiscal
2010 and 2009, (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
June 30, |
|
|
June 30, 2010 |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Therapeutic |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular |
|
$ |
11,036 |
|
|
$ |
10,063 |
|
|
$ |
30,994 |
|
|
$ |
30,036 |
|
Ophthalmology |
|
|
1,099 |
|
|
|
1,770 |
|
|
|
7,001 |
|
|
|
50,252 |
|
Other Markets |
|
|
3,260 |
|
|
|
3,500 |
|
|
|
8,033 |
|
|
|
10,197 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Therapeutic |
|
|
15,395 |
|
|
|
15,333 |
|
|
|
46,028 |
|
|
|
90,485 |
|
Diagnostic |
|
|
3,213 |
|
|
|
2,853 |
|
|
|
8,321 |
|
|
|
11,842 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
18,608 |
|
|
$ |
18,186 |
|
|
$ |
54,349 |
|
|
$ |
102,327 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19
(17) Commitments and Contingencies
Litigation. From time to time, the Company has been, and may become, involved in various legal
actions involving its operations, products and technologies, including intellectual property and
employment disputes. The outcomes of these legal actions are not within the Companys complete
control and may not be known for prolonged periods of time. In some actions, the claimants seek
damages, as well as other relief, including injunctions barring the sale of products that are the
subject of the lawsuit, which, if granted, could require significant expenditures or result in lost
revenues. The Company records a liability in the consolidated financial statements for these
actions when a loss is known or considered probable and the amount can be reasonably estimated. If
the reasonable estimate of a known or probable loss is a range, and no amount within the range is a
better estimate, the minimum amount of the range is accrued. If a loss is possible but not known or
probable, and can be reasonably estimated, the estimated loss or range of loss is disclosed. In
most cases, significant judgment is required to estimate the amount and timing of a loss to be
recorded.
InnoRx, Inc. In January 2005, the Company entered into a merger agreement whereby SurModics
acquired all of the assets of InnoRx, Inc. (InnoRx), an early stage company developing drug
delivery devices and therapies for the ophthalmology market. SurModics will be required to issue up
to approximately 480,059 additional shares of its common stock to the stockholders of InnoRx upon
the successful completion of the remaining development and commercial milestones involving InnoRx
technology acquired in the transaction.
BioFX Laboratories, Inc. In August 2007, the Company acquired 100% of the capital stock of
BioFX Laboratories, Inc. (BioFX), a provider of substrates to the in vitro diagnostics industry.
The sellers of BioFX are still eligible to receive up to $3.5 million in additional consideration
based on specific revenue targets through calendar 2011.
SurModics Pharmaceuticals, Inc. In July 2007, the Company acquired 100% of the capital stock
of Brookwood Pharmaceuticals Inc. (now known as SurModics Pharmaceuticals, Inc.) (SurModics
Pharmaceuticals), a drug delivery company that provides proprietary polymer-based technologies to
companies developing pharmaceutical products. The sellers of SurModics Pharmaceuticals are still
eligible to receive up to $15.5 million in additional consideration based on successful achievement
of specific milestones through calendar 2011.
Alabama Jobs Commitment. In April 2008, the Company purchased a 286,000 square foot
office and warehouse facility to support Current Good Manufacturing Practices manufacturing needs
of customers and the anticipated growth of the SurModics Pharmaceuticals business. At the same
time, SurModics Pharmaceuticals entered into an agreement with various governmental authorities to
obtain financial incentives associated with creation of jobs in Alabama. Some of the governmental
agencies have recapture rights in connection with the financial incentives if a specific number of
full-time employees are not hired by June 2012, with an extension to June 2013 if circumstances or
events occur that are beyond the control of SurModics Pharmaceuticals or could not have been
reasonably anticipated by SurModics Pharmaceuticals. As of June 30, 2010, SurModics Pharmaceuticals
has received $1.7 million in connection with the agreement, and the Company has recorded the
payment in other long-term liabilities. If the additional jobs are created, the Company will
recognize the $1.7 million as an offset to operating expenses in the period the contingency is
resolved.
20
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition, results of operations and
trends for the future should be read together with our unaudited condensed consolidated financial
statements and related notes appearing elsewhere in this report. Any discussion and analysis
regarding trends in our future financial condition and results of operations are forward-looking
statements that involve risks, uncertainties and assumptions, as more fully identified in
Forward-Looking Statements. Our actual future financial condition and results of operations may
differ materially from those anticipated in the forward-looking statements.
Overview
SurModics is a leading provider of drug delivery and surface modification technologies to the
healthcare industry. In March 2010 we announced a change in our operational structure to better
align functional expertise, which resulted in the elimination of the Companys business units. This
new structure is designed to support future growth by better meeting customer needs, leveraging our
multiple competencies across our organization, and building on our pharmaceutical industry
experience.
The organization change did not impact the Companys continued market focus. The
Therapeutic market includes revenue from: (1) Cardiovascular, which provides drug delivery and
surface modification technologies to customers in the cardiovascular market; (2) Ophthalmology,
which is focused on 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; and
(3) Other Markets, which is focused on a variety of clinical markets principally in the
pharmaceutical and biotechnology industries. The Diagnostic market includes revenue from the
Companys microarray slide technologies, our stabilization products, antigens and substrates for
immunoassay diagnostic tests, and our in vitro diagnostic format technology.
The Companys revenue is derived from three primary sources: (1) royalties and license
fees from licensing our proprietary drug delivery and surface modification technologies to
customers; the vast majority (typically in excess of 90%) of revenue in the royalties and license
fees category is in the form of royalties; (2) the sale of polymers and reagent chemicals,
stabilization products, antigens, substrates and microarray slides to the diagnostics and
biomedical research industry; and (3) research and development fees generated on customer projects.
Revenue fluctuates from quarter to quarter depending on, among other factors: our customers
success in selling products incorporating our technologies; the timing of introductions of licensed
products by customers; the timing of introductions of products that compete with our customers
products; the number and activity level associated with customer development projects; the number
and terms of new license agreements that are finalized; the value of reagent chemicals and other
products sold to customers; and the timing of future acquisitions we complete, if any.
For financial accounting and reporting purposes, we report our results in one reportable
segment. We made this determination because we manage our sales and marketing efforts and our
expenses on a company-wide basis. In addition, a significant percentage of our employees provide
support services (including research and development) to a variety of customers; and technology and
products are marketed to the same or similar customers.
In June 2007, we signed a collaborative research and license agreement with Merck & Co.,
Inc. (Merck) to pursue the joint development and commercialization of the I-vationTM
sustained drug delivery system with triamcinolone acetonide and other products that combine Merck
proprietary drug compounds with the I-vation system for the treatment of serious retinal diseases.
Under the terms of our agreement with Merck, we received an up-front license fee of $20 million and
had the potential to receive up to an additional $288 million in fees and development milestones
associated with the successful product development and attainment of appropriate U.S. and EU
regulatory approvals for these new combination products.
In September 2008, Merck gave notice that it was terminating the collaborative research
and license agreement, as well as the supply agreement entered into in June 2007, following a
strategic review of Mercks business and product development portfolio. The termination was
effective December 16, 2008. SurModics recognized revenue previously deferred, totaling $34.8
million, under the accounting treatment required for revenue arrangements with multiple
deliverables. In addition, we received and recognized a $9 million milestone payment from Merck
associated with the termination of the triamcinolone acetonide development program in the first
quarter of fiscal 2009.
On October 5, 2009, we entered into a License and Development Agreement with F.
Hoffmann-La Roche, Ltd. (Roche) and Genentech, Inc., a wholly owned member of the Roche Group
(Genentech). Under the terms of the agreement, Roche and Genentech have an exclusive license to
develop and commercialize a sustained drug delivery formulation of Lucentis® (ranibizumab
injection) utilizing SurModics proprietary biodegradable microparticles drug delivery
technologies. We received an up-front licensing fee of $3.5 million and are eligible to receive
potential payments of up to approximately $200 million in fees and milestone payments in the event
of the successful development and commercialization of multiple products, as well as payment for
development work
21
done on these products. In addition, Roche and Genentech could request that SurModics provide
manufacturing services. In the event a commercial product is developed, we would also receive
royalties on sales of such product.
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. See Note 2 to
the condensed consolidated financial statements for disclosures related to key accounting policies
and recently adopted accounting pronouncements.
Our revenue recognition accounting policy regarding arrangements with multiple deliverables
was changed effective October 1, 2009, as a direct effect of the early adoption of the new
accounting guidance regarding multiple element arrangements. We have applied the new accounting
guidance on a prospective basis for applicable transactions that originated or were materially
modified after October 1, 2009.
For a detailed description of our other critical accounting policies, see the notes to the
consolidated financial statements included in our Annual Report on Form 10-K for the year ended
September 30, 2009.
Results of Operations Three Months Ended June 30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase |
|
|
|
|
(Dollars in thousands) |
|
2010 |
|
|
2009 |
|
|
(Decrease) |
|
|
Change % |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Therapeutic |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular |
|
$ |
11,036 |
|
|
$ |
10,063 |
|
|
$ |
973 |
|
|
|
10 |
% |
Ophthalmology |
|
|
1,099 |
|
|
|
1,770 |
|
|
|
(671 |
) |
|
|
(38 |
)% |
Other Markets |
|
|
3,260 |
|
|
|
3,500 |
|
|
|
(240 |
) |
|
|
(7 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Therapeutic |
|
|
15,395 |
|
|
|
15,333 |
|
|
|
62 |
|
|
|
|
% |
Diagnostic |
|
|
3,213 |
|
|
|
2,853 |
|
|
|
360 |
|
|
|
13 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
18,608 |
|
|
$ |
18,186 |
|
|
$ |
422 |
|
|
|
2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue. Revenue during the third quarter of fiscal 2010 was $18.6 million, an increase
of $0.4 million or 2%, compared with the third quarter of fiscal 2009. The increases in Therapeutic
and Diagnostic revenue, as detailed in the table above, are further explained in the narrative
below.
Therapeutic. Revenue in Therapeutic was $15.4 million in the third quarter of fiscal 2010,
slightly higher compared with $15.3 million in the third quarter of fiscal 2009. The increase in
total revenue was driven by higher royalties and license fees and product sales, offset by lower
research and development (R&D) revenue. Therapeutic revenue is further characterized by the
market-focused areas detailed above.
Cardiovascular derives a substantial amount of 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. The CYPHER®
stent faces continuing competition from Boston Scientific, Medtronic and Abbott Laboratories.
Stents from these companies compete directly with the CYPHER® stent both
domestically and internationally. Future royalty and reagent sales revenue could decrease as a
result of lower CYPHER® stent sales from ongoing and expected future
competition. We anticipate that royalty revenue from the CYPHER® stent may be
volatile throughout fiscal 2010 and beyond as the various marketers of drug-eluting stents compete
in the marketplace and as other companies enter the marketplace. We also receive a royalty on the
Medtronic Endeavor® and Endeavor® Resolute drug-eluting
stent delivery systems incorporating our hydrophilic technology, which is sold in the United States
and internationally and commenced sales in Japan in May 2009.
Cardiovascular revenue increased $1.0 million, or 10%, in the third quarter of fiscal 2010,
compared with the third quarter of fiscal 2009 with the increase principally from license fees
which included recognition of one-time fees of $1.25 million, offset by a modest decrease in
royalties. Royalties from our broad portfolio of royalty generating
customers nearly offset the decrease in royalty revenue from Cordis reflecting a 29%
decrease in Cordis CYPHER® stent sales.
22
Ophthalmology revenue decreased $0.7 million, or 38%, in the third quarter of fiscal 2010,
compared with the third quarter of fiscal 2009. The decrease principally reflects lower R&D revenue
as certain customer programs required a lower level of SurModics involvement.
Other Markets revenue decreased 7% in the third quarter of fiscal 2010, compared with the
third quarter of fiscal 2009 principally as a result of lower product sales. Other Markets revenue
is derived from more than 50 customers.
Diagnostic. Revenue in Diagnostic was $3.2 million in the third quarter of fiscal 2010, an
increase of 13% compared with $2.9 million in the prior-year period. This increase was attributable
to higher sales of our component in vitro diagnostic products.
Product costs. Product costs were $2.4 million in the third quarter of fiscal 2010, compared
with $2.0 million in the prior-year period. The $0.4 million increase principally reflects the
impact of overall product sales increases. Overall product margins averaged 59%, compared with 61%
reported last year.
Customer research and development expenses. Customer research and development (Customer R&D)
expenses were $4.6 million, an increase of 46% compared with the third quarter of fiscal 2009. The
increase principally reflects the impact of higher fixed overhead costs attributable to our Alabama
research and development operations. The margin on R&D revenue were negative 33% in the third
quarter of fiscal 2010, compared with positive margin of 34% for the third quarter of fiscal 2009.
Other research and development expenses. Other research and development (Other R&D) expenses
were $4.2 million for the third quarter of fiscal 2010, a decrease of 5% compared with the third
quarter of fiscal 2009. The decrease principally reflects lower allocated overhead costs.
Selling, general and administrative expenses. Selling, general and administrative (SG&A)
expenses were $4.9 million for the three months ended June 30, 2010, which were $1.0 million, or
26% higher, compared with $3.9 million in the prior-year period. Higher outside service costs, bad
debt expense and increased costs at our Alabama operations were the principal contributors to the
increase.
Asset impairment charges. In the third quarter ended June 30, 2010, we recorded net asset
impairment charges of $0.2 million. We recognized an impairment charge of $0.4 million associated
with prototypes and other equipment related to a development project for which no ongoing business
is expected in the near term in light of current market conditions. We also reversed $0.2 million
of previously recorded asset impairment charges associated with a facility in Alabama. The facility
was presented as an asset held for sale and was recorded at fair
value less estimated selling costs during
the second quarter of fiscal 2010, resulting in an asset impairment charge of $2.1 million. During
the current quarter we re-classified the facility to held and used property following further
analysis of various factors associated with the consolidation of facilities, which resulted in the
property being recorded at its current fair value, which was $0.2 million higher than the fair
value less estimated selling costs at the time we determined it to be available for sale in the
second quarter of fiscal 2010 and recorded the initial asset impairment charge.
Other (loss) income. Other (loss) income was a loss of $2.0 million in the third quarter of
fiscal 2010, compared with income of $0.8 million in the third quarter of fiscal 2009. The decrease
primarily reflects an impairment loss on investments of $2.6 million in two of our strategic
investments. Partially offsetting the fiscal 2010 impairment loss was income from investments of
$0.2 million, compared with $0.4 million in the third quarter of fiscal 2009. There were realized
gains from our investment portfolio of $0.3 million and $0.4 million in fiscal 2010 and 2009,
respectively.
Income tax expense. The Company recorded an income tax expense of $1.1 million in the third
quarter of fiscal 2010, compared with $1.9 million in the prior-year period. The effective tax rate
was 603.3%, compared with 35.1% in the prior-year period. Excluding the impact of the $2.6 million
in investment impairment losses (since we do not currently foresee offsetting capital gains that
could offset these capital losses, no tax benefit has been recorded), the effective rate was 39.8%.
The increase in the adjusted effective tax rate was primarily attributable to state income taxes,
lower incentive stock option deductions and income tax reserve adjustments.
23
Results of Operations Nine Months Ended June 30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended June 30, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase |
|
|
|
|
(Dollars in thousands) |
|
2010 |
|
|
2009 |
|
|
(Decrease) |
|
|
Change % |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Therapeutic |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular |
|
$ |
30,994 |
|
|
$ |
30,036 |
|
|
$ |
958 |
|
|
|
3 |
% |
Ophthalmology |
|
|
7,001 |
|
|
|
50,252 |
|
|
|
(43,251 |
) |
|
|
(86 |
)% |
Other Markets |
|
|
8,033 |
|
|
|
10,197 |
|
|
|
(2,164 |
) |
|
|
(21 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Therapeutic |
|
|
46,028 |
|
|
|
90,485 |
|
|
|
(44,457 |
) |
|
|
(49 |
)% |
Diagnostic |
|
|
8,321 |
|
|
|
11,842 |
|
|
|
(3,521 |
) |
|
|
(30 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
54,349 |
|
|
$ |
102,327 |
|
|
$ |
(47,978 |
) |
|
|
(47 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue. Revenue for the first nine months of fiscal 2010 was $54.3 million, a decrease
of $48.0 million or 47% compared with the first nine months of fiscal 2009. The decreases in
Therapeutic and Diagnostic revenue, as detailed in the table above, are further explained in the
narrative below.
Therapeutic. Revenue in Therapeutic was $46.0 million in the first nine months of fiscal 2010,
a decrease of 49% compared with $90.5 million in the first nine months of fiscal 2009. The decrease
in total revenue reflects the recognition of revenue of approximately $45 million associated with
the terminated Merck collaborative research and license agreement, which was terminated effective
in the first quarter of fiscal 2009. Excluding this significant event-specific item in fiscal 2009,
revenue increased $0.5 million in the first nine months of fiscal 2010 compared with the comparable
prior period. Therapeutic revenue is further characterized by the market-focused areas detailed
above.
Cardiovascular revenue increased 3% in the first nine months of fiscal 2010 compared with the
first nine months of fiscal 2009. Increased royalties and license fees and product sales were
partially offset by a decrease in R&D revenue. Royalty revenue from Cordis decreased, reflecting a
23% decrease in Cordis CYPHER® stent sales.
Ophthalmology revenue decreased $43.3 million, or 86%, in the first nine months of fiscal
2010, compared with the first nine months of fiscal 2009. The significant decrease relates to the
recognition of previously deferred revenue associated with the terminated collaborative research
and license agreement with Merck. In September 2008, following a strategic review of Mercks
business and product development portfolio, Merck gave notice that it was terminating the
collaborative research and license agreement as well as the supply agreement entered into in June
2007. The termination became effective in December 2008. In the first nine months of fiscal 2009,
we recognized the revenue previously deferred totaling $34.8 million, and we received and
recognized a $9 million milestone payment from Merck associated with the termination of the
triamcinolone acetonide development program.
Ophthalmology revenue, when excluding the Merck event-specific items in the first nine months
of fiscal 2009, increased by $1.7 million, or 33%, principally as a result of higher R&D revenue.
Other Markets revenue decreased $2.2 million, or 21%, in the first nine months of fiscal 2010,
compared with the first nine months of fiscal 2009. Lower R&D revenue was the main contributor to
the decrease. Select customers have delayed, slowed or canceled development projects as a result of
various factors, including current economic conditions.
Diagnostic. Revenue in Diagnostic was $8.3 million in the first nine months of fiscal 2010, a
decrease of 30% compared with $11.8 million in the prior-year period. The decrease was attributable
to $3.8 million lower royalties and license fees. In past periods, Diagnostic derived a significant
percentage of revenue from royalties generated under our diagnostic format patent license agreement
with Abbott Laboratories. Our agreement with Abbott Laboratories ceased following the expiration of
licensed patents, which occurred in December 2008. Product sales increased 4% over prior-period
levels.
Product costs. Product costs were $6.8 million in the first nine months of fiscal 2010,
compared with $5.3 million in the prior-year period. The $1.5 million increase in product costs
principally reflects higher product sales. Overall product margins averaged 56%, compared with 61%
reported in the first nine months of fiscal 2009. The decrease in product margins reflects a shift
in the mix of products sold and cost increases related to certain product lines.
24
Customer research and development expenses. Customer R&D expenses were $12.7 million, an
increase of 24% compared with the first nine months of fiscal 2009. The increase principally
reflects the impact of increased fixed overhead costs (depreciation, utilities and other
building-related costs) attributable to our Alabama research and development operations. Our new
cGMP facility was placed in service in fiscal 2010, leading to higher operating costs. Customer R&D
margins were negative 3%, compared with positive 32% in the first nine months of fiscal 2009.
Other research and development expenses. Other R&D expenses were $13.5 million for the first
nine months of fiscal 2010, a decrease of 11% compared with the first nine months of fiscal 2009.
The decrease principally reflects lower labor costs as a result of more employees dedicated to
customer research and development activities, a decrease in our overall R&D headcount and lower
overhead costs being allocated to Other R&D, offset by higher material expenses.
Selling, general and administrative expenses. SG&A expenses were $13.7 million for the nine
months ended June 30, 2010, a 5% increase compared with $13.0 million in the prior-year period.
Higher costs incurred for outside services, an increase in the allowance for doubtful accounts and
our new Alabama facility costs allocated to SG&A were the primary contributors to higher expenses.
Purchased in-process research and development. In November 2008, we acquired certain assets
comprised of intellectual property and collaborative programs from PR Pharmaceuticals, Inc. The
fair value of $3.2 million associated with the in-process research and development intangible asset
was determined by management and recognized as an expense in the nine months ended June 30, 2009.
Restructuring charges. In March 2010, we announced an organizational change designed to
support future growth by better meeting customer needs, leveraging our multiple competencies across
the organization, and building on our pharmaceutical industry experience.
SurModics recorded total restructuring charges of approximately $1.3 million in connection
with the fiscal 2010 reorganization. These pre-tax charges consisted of $0.8 million of severance
pay and benefits expenses and $0.5 million of facility-related costs.
In November 2008, we announced a functional reorganization to better serve our customers and
improve our operating performance and recorded total restructuring charges of approximately $1.8
million in connection with the 2009 reorganization. These pre-tax charges consisted of $0.5 million
of severance pay and benefits expenses and $1.3 million of facility-related costs.
Asset impairment charges. In the nine months ended June 30, 2010, we recorded a $1.9 million
asset impairment charge associated with one of our facilities in Alabama. We also recognized a $0.4
million asset impairment charge associated with prototypes and other equipment related to a
development project for which no ongoing business is expected in the near term in light of current
market conditions.
Other (loss) income. Other (loss) income was a loss of $1.5 million in the first nine months
of fiscal 2010, compared with income of $1.8 million in the first nine months of fiscal 2009. The
decrease primarily reflects impairment loss on investments of $2.6 million in fiscal 2010 in two of
our strategic investments. Partially offsetting the fiscal 2010 impairment loss was income from
investments of $0.8 million, compared with investment income of $1.5 million in the prior-year
period. The decrease in investment income primarily reflects lower investment balances. We also
recognized gains from our investment portfolio of $0.3 million and $0.8 million in fiscal 2010 and
2009, respectively. Our fiscal 2009 realized gains were partially offset by our pro rata net loss
on equity method investments.
Income tax expense. The income tax provision was $2.0 million in the first nine months of
fiscal 2010, compared with $20.5 million in the prior-year period. The effective tax rate was
77.7%, compared with 37.0% in the prior-year period. Excluding the impact of the $2.6 million in
investment impairment losses, the effective rate was 38.9%. The increase over the federal statutory
rate of 35% was primarily related to lower incentive stock option deductions and state income
taxes.
Liquidity and Capital Resources
As of June 30, 2010, the Company had working capital of $32.9 million, of which $21.7 million
consisted of cash, cash equivalents and short-term investments. Working capital increased $3.9
million from September 30, 2009, principally reflecting higher
short-term investments and prepaid and
other current assets offset by lower accounts receivable balances. Our cash, cash
equivalents and short-term and long-term investments totaled $54.8 million at June 30, 2010, an
increase of $6.9 million from $47.9 million at September 30, 2009. 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.
25
government and government agency obligations. The primary investment objective of the
portfolio is to provide for the safety of principal and appropriate liquidity, while meeting or
exceeding a benchmark (Merrill Lynch 1-3 Year Government-Corporate 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.
We had cash flows from operating activities of approximately $16.7 million in the first nine
months of fiscal 2010, compared with $24.8 million in the first nine months of fiscal 2009. The
decrease primarily reflects lower operating results, adjusted for
one-time events, and receipt of a $3.5 million up-front license
fee from Genentech, compared with fiscal
2009 when we received a $9 million contract termination payment from Merck.
In November 2007, our Board of Directors authorized the repurchase of $35.0 million of the
Companys common stock in open-market transactions, private transactions, tender offers, or other
transactions. The repurchase authorization does not have a fixed expiration date. During the nine
months ended June 30, 2010, the Company repurchased 102,533 shares for $2.0 million at an average
price of $19.81 per share, leaving $5.3 million remaining available for future share repurchases
under the repurchase program.
As of June 30, 2010, we had no debt under our $25 million unsecured revolving credit facility.
As of June 30, 2010, the Company was in compliance with all covenants.
We do not have any other credit agreements and believe that our existing cash, cash
equivalents and investments, together with cash flow from operations, will provide liquidity
sufficient to meet the below stated needs and fund our operations for the next twelve months. There
can be no assurance, however, that SurModics business will continue to generate cash flows at
current levels, and disruptions in financial markets may negatively impact the Companys ability to
access capital in a timely manner and on attractive terms, if at all. Our anticipated liquidity
needs for the remainder of fiscal 2010 include, but are not limited to, the following: capital
expenditures related to the Alabama cGMP facility in the range of $1.5 million to $2.0 million;
general capital expenditures in the range of $1.5 million to $2.0 million; contingent consideration
payments, if any, related to our acquisitions of SurModics Pharmaceuticals, BioFX Laboratories,
Inc., as well as the purchase of certain assets from PR Pharmaceuticals, Inc.; and any amounts
associated with the repurchase of common stock under the authorization discussed above.
Off-Balance Sheet Arrangements
As of June 30, 2010, the Company did not have any off-balance sheet arrangements with any
unconsolidated entities.
Forward-Looking Statements
Certain statements contained in this report, or in other reports of the Company 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 a 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 prospects, product development programs, sales efforts, revenue expectations
and the impact of the Cordis and Genentech agreements, as well as other significant customer
agreements, and capital and liquidity expectations and needs. 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:
|
|
|
the Companys reliance on a small number of significant customers, which causes
our financial results and stock price to be subject to factors affecting those significant
customers and their products, the timing of market introduction of their or competing
products, product safety or efficacy concerns and intellectual property litigation, the
outcome of which could adversely affect the royalty revenue we derive based on the sales of
licensed products; |
|
|
|
|
general economic conditions which are beyond our control, including the impact
of recession, business investment and changes in consumer confidence; |
|
|
|
|
frequent intellectual property litigation in the medical device and
pharmaceutical industries that may directly or indirectly adversely affect our customers
ability to market their products incorporating our technologies; |
26
|
|
|
our ability to protect our own intellectual property; |
|
|
|
|
healthcare reform efforts, including reduced reimbursement rates and new taxes
on medical devices and pharmaceutical products that may adversely affect our customers
ability to cost-effectively market and sell devices incorporating our technologies or
affect the prices they receive for such products thereby affecting the Companys revenue; |
|
|
|
|
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, changes in the
development and marketing priorities of our licensees and development partners and the
Companys ability to maintain satisfactory relationships with its licensees; |
|
|
|
|
the Companys ability to increase the number of market segments and
applications that use its technologies through its sales and marketing and research and
development efforts; |
|
|
|
|
the decrease in available financing for the Companys customers and for new
ventures which could potentially become customers can reduce the Companys potential
opportunities; |
|
|
|
|
market acceptance of products sold by customers incorporating our technologies
and the timing of new product introductions by licensees; |
|
|
|
|
market acceptance of products sold by customers competitors and the timing and
pricing of new product introductions by customers competitors; |
|
|
|
|
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 or approvals, which may result in lost market opportunities or
postpone or preclude product commercialization by licensees; |
|
|
|
|
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; |
|
|
|
|
the ability to secure raw materials for reagents the Company sells; |
|
|
|
|
the Companys ability to successfully manage clinical trials and related
foreign and domestic regulatory processes for the I-vation intravitreal implant or other
products under development by the Company, whether delays, difficulties or failures in
achieving acceptable clinical results or obtaining foreign or FDA marketing clearances or
approvals postpone or preclude product commercialization of the intravitreal implant or
other products, and whether the intravitreal implant and any other products remain viable
commercial prospects; |
|
|
|
|
product liability claims against which we are not indemnified or that are not
covered by insurance; |
|
|
|
|
the development of new products or technologies by competitors, technological
obsolescence and other changes in competitive factors; |
|
|
|
|
the trend of consolidation in the medical device and pharmaceutical industries,
resulting in more significant, complex and long term contracts than in the past and
potentially greater pricing pressures; |
|
|
|
|
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; |
|
|
|
|
the Companys ability to successfully internally perform certain product
development activities and governmental and regulatory compliance activities which the
Company has not previously undertaken in any significant manner; |
|
|
|
|
acts of God or terrorism which impact the Companys personnel or facilities;
and |
|
|
|
|
other factors described below in 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 statements and to consult any further disclosures by
the Company on this subject in its filings with the Securities and Exchange Commission.
27
Item 3. Quantitative and Qualitative Disclosures About Market Risk
The Companys investment policy requires the Company to invest in 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. The Company 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 $0.7
million decrease in the fair value of the Companys available-for-sale and held-to-maturity
securities as of June 30, 2010, 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, 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 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 Securities Exchange Commission rules and forms, and to ensure that
information required to be disclosed by the Company in the reports the Company files or submits
under the Exchange Act is accumulated and communicated to the Companys management, including its
principal executive and principal financial officers, as appropriate, to allow timely decisions
regarding required disclosures.
Changes in Internal Controls
There was no change in the Companys internal control over financial reporting that occurred
during the period covered by this report that has materially affected, or is reasonably likely to
materially affect, the Companys internal control over financial reporting.
28
PART II OTHER INFORMATION
Item 1. Legal Proceedings.
There have been no material developments in the legal proceedings previously disclosed in the
Companys Form 10-K for the fiscal year ended September 30, 2009.
Item 1A. Risk Factors.
There have been no material changes from risk factors as previously disclosed in the Companys
Form 10-K for the fiscal year ended September 30, 2009 in response to Item 1A to Part I of Form
10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
(c) Issuer Purchases of Equity Securities
The following table presents information with respect to purchases of common stock of the
Company made during the three months ended June 30, 2010, by the Company or on behalf of the
Company or any affiliated purchaser of the Company, as defined in Rule 10b-18(a)(3) under the
Exchange Act.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(c) |
|
|
(d) |
|
|
|
|
|
|
|
|
|
|
|
Total Number of |
|
|
Dollar Value of |
|
|
|
|
|
|
|
|
|
|
|
Shares Purchased as |
|
|
Shares that May Yet |
|
|
|
(a) |
|
|
(b) |
|
|
Part of Publicly |
|
|
Be Purchased Under |
|
|
|
Total Number of Shares |
|
|
Average Price Paid |
|
|
Announced Plans or |
|
|
the Plans or |
|
Period |
|
Purchased(1) |
|
|
Per Share |
|
|
Programs |
|
|
Programs(2) |
|
04/01/10 04/30/10 |
|
|
0 |
|
|
NA |
|
|
|
0 |
|
|
$ |
5,302,113 |
|
05/01/10 05/31/10 |
|
|
896 |
|
|
$ |
17.93 |
|
|
|
0 |
|
|
$ |
5,302,113 |
|
06/01/10 06/30/10 |
|
|
0 |
|
|
NA |
|
|
|
0 |
|
|
$ |
5,302,113 |
|
|
Total |
|
|
896 |
|
|
$ |
17.93 |
|
|
|
0 |
|
|
$ |
5,302,113 |
|
|
|
|
|
(1) |
|
The purchases in this column included 896 shares repurchased by the Company to satisfy tax
withholding obligations in connection with so-called stock swap exercises related to the
vesting of restricted stock awards. |
|
(2) |
|
On November 15, 2007, our Board of Directors announced the authorization of the repurchase of
$35 million of outstanding common stock. As of June 30, 2010, we have repurchased a cumulative
1,024,181 shares at an average price of $29.00 per share. Under the current authorization the
Company has $5.3 million available for authorized share repurchases as of June 30, 2010. The
repurchase authorization does not have an expiration date. |
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Removed and Reserved.
Item 5. Other Information.
Asset impairment charges
In the third quarter ended June 30, 2010, the Company recorded net asset impairment charges of
$0.2 million. The Company recognized an impairment charge of $0.4 million associated with
prototypes and other equipment related to a development project for which no ongoing business is
expected in the near term in light of current market conditions. The Company also recorded an
adjustment to expenses of $0.2 million associated with our facilities in Alabama as we further
analyzed various factors associated with the consolidation of one facility and determined to not
continue with the sale of the facility at this time, and as such, the estimated selling expenses to
sell the facility have been adjusted.
Impairment loss on investments
The Company wrote down two investments totaling $2.6 million in the third quarter ended June
30, 2010, as the investments were deemed to be other-than-temporarily
impaired. A pending round
of financing at a substantially lower valuation at one of the private companies resulted in an
impairment loss of $2.4 million. The second company sold a majority of its assets in light of
current market conditions and this action resulted in an impairment
loss of $0.2 million.
29
Item 6. Exhibits.
|
|
|
|
Exhibit |
|
Description |
3.1
|
|
|
Restated Articles of Incorporation, as amended incorporated
by reference to Exhibit 3.1 of the Companys Quarterly Report
on Form 10-QSB for the quarter ended December 31, 1999, SEC
File No. 0-23837. |
|
3.2
|
|
|
Restated Bylaws of SurModics, Inc., as amended November 30,
2009 incorporated by reference to Exhibit 3.2 of the
Companys Quarterly Report on Form 10-Q for the quarter ended
December 31, 2009, SEC File No. 0-23837. |
|
31.1
|
* |
|
Certification of Chief Executive Officer and Chief Financial
Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002. |
|
32.1
|
* |
|
Certification of Chief Executive Officer and Chief Financial
Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002. |
30
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.
|
|
|
|
|
Dated: August 6, 2010 |
SurModics, Inc.
|
|
|
By: |
/s/ Philip D. Ankeny
|
|
|
|
Philip D. Ankeny |
|
|
|
Senior Vice President and
Chief Financial Officer |
|
31
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
EXHIBIT INDEX TO FORM 10-Q
For the Quarter Ended June 30, 2010
SURMODICS, INC.
|
|
|
|
Exhibit |
|
Description |
3.1
|
|
|
Restated Articles of Incorporation, as amended incorporated
by reference to Exhibit 3.1 of the Companys Quarterly Report
on Form 10-QSB for the quarter ended December 31, 1999, SEC
File No. 0-23837 |
|
|
3.2
|
|
|
Restated Bylaws of SurModics, Inc., as amended November 30,
2009 incorporated by reference to Exhibit 3.2 of the
Companys Quarterly Report on Form 10-Q for the quarter ended
December 31, 2009, SEC File No. 0-23837 |
|
|
31.1
|
* |
|
Certification of Chief Executive Officer and Chief Financial
Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002. |
|
|
32.1
|
* |
|
Certification of Chief Executive Officer and Chief Financial
Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002. |
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exv31w1
EXHIBIT 31.1
CERTIFICATION PURSUANT TO SECTION 302
OF SARBANES-OXLEY ACT OF 2002
I, Philip D. Ankeny, 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.
I am 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 have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under my supervision, to ensure that material information relating
to the registrant, including its consolidated subsidiaries, is made
known to me 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 my 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 my 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; and
5.
I have disclosed, based on my 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 6, 2010 |
Signature: |
/s/ Philip D. Ankeny
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Philip D. Ankeny |
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Chief Executive Officer, Senior Vice
President and Chief Financial Officer |
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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, 2010, as filed with the Securities and Exchange Commission (the
Report), I, Philip D. Ankeny, 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 6, 2010
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/s/ Philip D. Ankeny
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Philip D. Ankeny |
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Chief Executive Officer, Senior Vice
President and Chief Financial Officer |
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