e10vqza
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
FORM 10-Q/A
(Amendment No. 1)
(Mark One)
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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 December 31, 2010
or
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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) 500-7000
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
February 1, 2011 was 17,488,245.
SurModics, Inc.
EXPLANATORY NOTE
This Amendment No. 1 on Form 10-Q/A (Form 10-Q/A) to the Companys Quarterly Report on Form 10-Q
for the quarterly period ended December 31, 2010, as originally filed with the Securities and
Exchange Commission (the SEC) on February 4, 2011 (the Original Filing), is being filed to
reflect a restatement of its condensed consolidated financial statements as of December 31, 2010,
as discussed in Note 1 to the financial statements included at Item 1.
In connection with the Companys preparation of the Original Filing, the Company determined that
the conditions associated with a $4.9 million milestone payment obligation had not been met, and as
a result, no liability was recorded. In connection with the preparation of the Companys Quarterly
Report on Form 10-Q for the quarterly period ended March 31, 2011, the Company determined that it
should have recorded the $4.9 million milestone payment obligation in the fiscal quarter ended
December 31, 2010, and an associated increase to goodwill in the Pharmaceuticals reporting unit, as
the conditions associated with that milestone were determined to have been satisfied as of December
31, 2010. As a result, in this Form 10-Q/A, the Company is restating its condensed consolidated
financial statements and related disclosures to recognize the obligation, and the related goodwill
impairment charge and tax adjustments.
Although this Form 10-Q/A supersedes the Original Filing in its entirety, this Form 10-Q/A only
amends and restates Items 1, 2 and 4 of Part I solely as a result of, and to reflect, the
restatement, and no other information in the Original Filing is amended hereby. While the foregoing
items have been updated, this amended report does not reflect any other events occurring after the
filing of the Form 10-Q on February 4, 2011. In addition, pursuant to the rules of the SEC, Item 6
of Part II of the Original Filing has been amended to contain currently-dated certifications from
our Chief Executive Officer and Chief Financial Officer, as required by Sections 302 and 906 of the
Sarbanes-Oxley Act of 2002. The certifications of our Chief Executive Officer and Chief Financial
Officer are attached to this Form 10-Q/A as Exhibits 31.1, 31.2, 32.1 and 32.2, respectively.
2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
SurModics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
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December 31, |
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2010 |
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September 30, |
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(As Restated) |
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2010 |
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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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$ |
14,309 |
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$ |
11,391 |
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Short-term investments |
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10,149 |
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9,105 |
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Accounts receivable, net of allowance for doubtful
accounts of $350 and $461 as of December 31 and
September 30, 2010, respectively |
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8,764 |
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8,987 |
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Inventories |
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3,111 |
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3,047 |
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Deferred tax asset |
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678 |
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247 |
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Prepaids and other |
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2,814 |
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4,701 |
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Total current assets |
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$ |
39,825 |
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$ |
37,478 |
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Property and equipment, net |
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65,043 |
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65,395 |
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Long-term investments |
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35,247 |
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36,290 |
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Deferred tax asset |
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3,443 |
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2,606 |
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Intangible assets , net |
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14,869 |
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15,257 |
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Goodwill |
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8,010 |
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8,010 |
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Other assets, net |
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5,048 |
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5,243 |
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Total assets |
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$ |
171,485 |
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$ |
170,279 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities |
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Accounts payable |
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$ |
2,850 |
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$ |
3,341 |
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Accrued liabilities: |
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Compensation |
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1,516 |
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930 |
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Accrued other |
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6,403 |
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1,753 |
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Deferred revenue |
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1,793 |
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562 |
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Other current liabilities |
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1,474 |
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1,061 |
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Total current liabilities |
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14,036 |
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7,647 |
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Deferred revenue, less current portion |
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3,773 |
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3,598 |
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Other long-term liabilities |
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4,702 |
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4,675 |
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Total liabilities |
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$ |
22,511 |
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$ |
15,920 |
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Commitments and contingencies (Note 15) |
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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- $.05 par value, 45,000,000 shares
authorized; 17,488,634 and 17,423,601 shares issued
and outstanding |
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874 |
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871 |
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Additional paid-in capital |
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70,672 |
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69,702 |
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Accumulated other comprehensive income |
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699 |
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886 |
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Retained earnings |
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76,729 |
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82,900 |
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Total stockholders equity |
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148,974 |
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154,359 |
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Total liabilities and stockholders equity |
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$ |
171,485 |
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$ |
170,279 |
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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 Operations
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Three Months Ended |
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December 31, |
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2010 |
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(As Restated) |
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2009 |
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(In thousands, except net (loss) income per share) |
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(Unaudited) |
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Revenue |
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Royalties and license fees |
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$ |
7,566 |
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$ |
9,198 |
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Product sales |
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4,792 |
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4,548 |
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Research and development |
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2,810 |
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3,635 |
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Total revenue |
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15,168 |
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17,381 |
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Operating costs and expenses |
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Product |
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1,825 |
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1,957 |
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Customer research and development |
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4,731 |
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3,323 |
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Other research and development |
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2,132 |
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4,719 |
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Selling, general and administrative |
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5,214 |
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4,614 |
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Goodwill impairment |
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5,650 |
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Restructuring charges |
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1,236 |
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Total operating costs and expenses |
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20,788 |
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14,613 |
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(Loss) income from operations |
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(5,620 |
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2,768 |
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Other income |
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Investment income, net |
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185 |
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297 |
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Other income, net |
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36 |
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Other income, net |
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221 |
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297 |
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(Loss) income before income taxes |
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(5,399 |
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3,065 |
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Income tax provision |
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(772 |
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(1,148 |
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Net (loss) income |
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$ |
(6,171 |
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$ |
1,917 |
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Basic net (loss) income per share |
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$ |
(0.36 |
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$ |
0.11 |
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Diluted net (loss) income per share |
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$ |
(0.36 |
) |
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$ |
0.11 |
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Weighted average shares outstanding |
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Basic |
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17,383 |
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17,396 |
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Dilutive effect of outstanding stock options and non-vested stock |
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44 |
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Diluted |
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17,383 |
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17,440 |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial
statements.
5
SurModics, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
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Three Months Ended |
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December 31, |
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2010 |
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(As Restated) |
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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 (loss) income |
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$ |
(6,171 |
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$ |
1,917 |
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Adjustments to reconcile net (loss) income to net cash provided by operating activities |
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Depreciation and amortization |
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1,792 |
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1,744 |
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Amortization of premium on investments |
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27 |
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35 |
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Stock-based compensation |
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974 |
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1,535 |
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Deferred tax |
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(1,142 |
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2,840 |
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Goodwill impairment charge |
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5,650 |
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Excess tax benefit from stock-based compensation plans |
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2 |
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38 |
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Other |
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125 |
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Change in operating assets and liabilities: |
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Accounts receivable |
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223 |
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(341 |
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Inventories |
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(64 |
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(113 |
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Accounts payable and accrued liabilities |
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428 |
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(262 |
) |
Income taxes |
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1,950 |
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(2,501 |
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Deferred revenue |
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1,406 |
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3,370 |
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Prepaids and other |
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75 |
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(12 |
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Net cash provided by operating activities |
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5,275 |
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8,250 |
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Investing Activities |
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Purchases of property and equipment |
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(1,393 |
) |
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(3,572 |
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Purchases of available-for-sale investments |
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(1,412 |
) |
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(8,284 |
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Sales/maturities of investments |
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1,200 |
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3,970 |
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Payments related to prior business acquisitions |
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(750 |
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(750 |
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Net cash used in investing activities |
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(2,355 |
) |
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(8,636 |
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Financing Activities |
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Excess tax benefit from stock-based compensation plans |
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(2 |
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(38 |
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Issuance of common stock |
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282 |
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Purchase of common stock to pay employee taxes |
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(365 |
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Net cash used in financing activities |
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(2 |
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(121 |
) |
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Net change in cash and cash equivalents |
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2,918 |
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(507 |
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Cash and Cash Equivalents |
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Beginning of period |
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11,391 |
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11,636 |
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End of period |
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$ |
14,309 |
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$ |
11,129 |
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Supplemental Information |
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Cash paid for income taxes |
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$ |
(36 |
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$ |
809 |
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Noncash transaction acquisition of property, plant, and equipment on account |
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$ |
348 |
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$ |
214 |
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Noncash transaction acquisition of intangible assets on account |
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$ |
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$ |
210 |
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Noncash transaction milestone payment obligation |
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$ |
4,900 |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial
statements.
6
SurModics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
Period Ended December 31, 2010
(Unaudited)
(1) Basis of Presentation and Restatement
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 in estimate is identified. The results of operations for the
three-month period ended December 31, 2010 are not necessarily indicative of the results that may
be expected for the entire 2011 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, 2010, and footnotes thereto included in the
Companys Form 10-K as filed with the United States Securities and Exchange Commission on December
14, 2010.
Restatement
In the three-month period ended December 31, 2010, the Company originally determined that the
conditions associated with a $4.9 million milestone payment obligation related to the 2007
acquisition of SurModics Pharmaceuticals, Inc. (SurModics Pharmaceuticals) had not been met, and
as a result, did not record a liability associated with this amount during such period. Subsequent
to the issuance of its condensed financial statements for such period, the Company determined that
it should have recorded this additional $4.9 million milestone payment obligation and an associated
increase to goodwill in the Pharmaceuticals reporting unit. The Company has further determined
that this additional goodwill should be impaired, as the operating performance of the
Pharmaceuticals reporting unit did not support continuing recognition of the goodwill asset.
Accordingly, the condensed consolidated financial statements have been restated to reflect the
increased goodwill impairment charge and tax adjustments.
The tables below show the net changes between the financial statements as previously reported
and as restated (in thousands).
Table 1 Condensed Consolidated Balance Sheets
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As Reported |
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Adjustment |
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As Restated |
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December 31, 2010 |
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December 31, 2010 |
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December 31, 2010 |
|
Prepaid and other |
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$ |
3,662 |
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|
$ |
(848 |
) |
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$ |
2,814 |
|
Total current assets |
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|
40,673 |
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|
|
(848 |
) |
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|
39,825 |
|
Total assets |
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172,333 |
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|
|
(848 |
) |
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|
171,485 |
|
Accrued other liabilities |
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|
1,503 |
|
|
|
4,900 |
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|
6,403 |
|
Total current liabilities |
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|
9,136 |
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|
|
4,900 |
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|
14,036 |
|
Other long-term liabilities |
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|
4,656 |
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|
46 |
|
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|
4,702 |
|
Total liabilities |
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|
17,565 |
|
|
|
4,946 |
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|
22,511 |
|
Retained earnings |
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|
82,523 |
|
|
|
(5,794 |
) |
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|
76,729 |
|
Total stockholders equity |
|
|
154,768 |
|
|
|
(5,794 |
) |
|
|
148,974 |
|
Total liabilities and stockholders equity |
|
$ |
172,333 |
|
|
$ |
(848 |
) |
|
$ |
171,485 |
|
|
Table 2 Condensed Consolidated Statements of Operations |
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As Reported |
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As Restated |
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|
Three months ended |
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Three months ended |
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|
December 31, 2010 |
|
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Adjustment |
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|
December 31, 2010 |
|
Goodwill impairment |
|
$ |
750 |
|
|
$ |
4,900 |
|
|
$ |
5,650 |
|
Total operating costs and expenses |
|
|
15,888 |
|
|
|
4,900 |
|
|
|
20,788 |
|
(Loss) income from operations |
|
|
(720 |
) |
|
|
(4,900 |
) |
|
|
(5,620 |
) |
(Loss) income before income taxes |
|
|
(499 |
) |
|
|
(4,900 |
) |
|
|
(5,399 |
) |
Income tax benefit (provision) |
|
|
122 |
|
|
|
(894 |
) |
|
|
772 |
|
Net loss |
|
$ |
(377 |
) |
|
$ |
(5,794 |
) |
|
$ |
(6,171 |
) |
Basic net (loss) income per share |
|
$ |
(0.02 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.36 |
) |
Diluted net (loss) income per share |
|
$ |
(0.02 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.36 |
) |
7
Table 3 Condensed Consolidated Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As Reported |
|
|
|
|
|
|
As Restated |
|
|
|
Three months ended |
|
|
|
|
|
|
Three months ended |
|
|
|
December 31, 2010 |
|
|
Adjustment |
|
|
December 31, 2010 |
|
Net (loss) income |
|
$ |
(377 |
) |
|
$ |
(5,794 |
) |
|
$ |
(6,171 |
) |
Goodwill impairment charge |
|
|
750 |
|
|
|
4,900 |
|
|
|
5,650 |
|
Income taxes |
|
$ |
1,056 |
|
|
$ |
894 |
|
|
$ |
1,950 |
|
Supplemental Information |
|
|
|
|
|
|
|
|
|
|
|
|
Noncash transaction
milestone payment
obligation |
|
$ |
0 |
|
|
$ |
4,900 |
|
|
$ |
4,900 |
|
(2) Key Accounting Policies
Revenue recognition
Revenue is recognized 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. Under revenue arrangements with multiple deliverables, the
Company recognizes each separable deliverable as it is earned.
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. For stand-alone license agreements,
up-front license fees are recognized over the term of the related licensing agreement. Minimum
royalty fees are recognized in the period earned and collectability is reasonably assured.
Revenue related to a performance milestone is recognized 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 is achieved, involved a significant degree of risk, and was not
reasonably assured at the inception of the arrangement; |
|
|
|
|
Accomplishment of the milestone involved substantial effort; |
|
|
|
|
The amount of the milestone payment is commensurate with the related effort and
risk; 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 term of the agreement.
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 contract.
8
Arrangements with multiple deliverables. 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 enters into license and development arrangements that may consist of multiple
deliverables that could include license 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 would 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 a contract 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.
Under the accounting guidance, the Company is still required to evaluate 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 many instances, the Company
is not able to establish VSOE for all deliverables in an arrangement with multiple elements. This
may be a result of the Company infrequently selling each element separately or having a limited
history with multiple element arrangements. When VSOE cannot be established, the Company attempts
to establish 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 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 features. The determination of ESP is made through consultation with the Companys
management, taking into consideration the marketing strategies for each business unit.
New Accounting Pronouncements
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
The accounting guidance on fair value measurements 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 6 for
further information). The fair market value of this investment is based on the quoted price of
OctoPlus shares traded on the Euronext Amsterdam Stock Exchange.
9
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 an other U.S. government agency security and two
mortgage-backed securities. The fair market values of these investments were determined by broker
pricing where not all significant inputs were observable.
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.
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 December 31, 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Prices in |
|
|
Significant |
|
|
|
|
|
|
|
|
|
Active Markets |
|
|
Other |
|
|
Significant |
|
|
Total Fair |
|
|
|
for Identical |
|
|
Observable |
|
|
Unobservable |
|
|
Value as of |
|
|
|
Instruments |
|
|
Inputs |
|
|
Inputs |
|
|
December 31, |
|
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
2010 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
$ |
|
|
|
$ |
12,628 |
|
|
$ |
|
|
|
$ |
12,628 |
|
Available for sale debt securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US government obligations |
|
|
|
|
|
|
28,698 |
|
|
|
695 |
|
|
|
29,393 |
|
Mortgage backed securities |
|
|
|
|
|
|
4,263 |
|
|
|
685 |
|
|
|
4,948 |
|
Municipal bonds |
|
|
|
|
|
|
3,079 |
|
|
|
|
|
|
|
3,079 |
|
Asset backed securities |
|
|
|
|
|
|
1,273 |
|
|
|
|
|
|
|
1,273 |
|
Corporate bonds |
|
|
|
|
|
|
2,607 |
|
|
|
|
|
|
|
2,607 |
|
Other assets |
|
|
2,496 |
|
|
|
|
|
|
|
|
|
|
|
2,496 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured at fair value |
|
$ |
2,496 |
|
|
$ |
52,548 |
|
|
$ |
1,380 |
|
|
$ |
56,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term and long-term investments disclosed in the condensed consolidated balance sheets
include held-to-maturity investments totaling $4.1 million as of December 31, 2010.
Held-to-maturity investments are carried at an amortized cost.
10
The following table presents information about the Companys financial assets and liabilities
measured at fair value on a recurring basis as of September 30, 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Prices in |
|
|
Significant |
|
|
|
|
|
|
|
|
|
Active Markets |
|
|
Other |
|
|
Significant |
|
|
Total Fair |
|
|
|
for Identical |
|
|
Observable |
|
|
Unobservable |
|
|
Value as of |
|
|
|
Instruments |
|
|
Inputs |
|
|
Inputs |
|
|
September 30, |
|
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
2010 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
$ |
|
|
|
$ |
10,128 |
|
|
$ |
|
|
|
$ |
10,128 |
|
Available for sale debt securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US government obligations |
|
|
|
|
|
|
25,626 |
|
|
|
704 |
|
|
|
26,330 |
|
Mortgage backed securities |
|
|
|
|
|
|
4,757 |
|
|
|
69 |
|
|
|
4,826 |
|
Municipal bonds |
|
|
|
|
|
|
3,150 |
|
|
|
|
|
|
|
3,150 |
|
Asset backed securities |
|
|
|
|
|
|
1,113 |
|
|
|
|
|
|
|
1,113 |
|
Corporate bonds |
|
|
|
|
|
|
5,852 |
|
|
|
|
|
|
|
5,852 |
|
Other assets |
|
|
2,624 |
|
|
|
|
|
|
|
|
|
|
|
2,624 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured at fair value |
|
$ |
2,624 |
|
|
$ |
50,626 |
|
|
$ |
773 |
|
|
$ |
54,023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in Level 3 Instruments Measured at Fair Value on a Recurring Basis
The following table is a reconciliation of financial assets and liabilities measured at fair
value on a recurring basis using significant unobservable inputs (Level 3) (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using Significant |
|
|
|
Unobservable Inputs (Level 3) |
|
|
|
For Three Months Ended December 31, 2010 |
|
|
|
Available-for-Sale Debt Securities |
|
|
|
U.S. Government |
|
|
Mortgage |
|
|
|
|
|
|
Obligations |
|
|
Backed |
|
|
Total |
|
Balance, September 30, 2010 |
|
$ |
704 |
|
|
$ |
69 |
|
|
$ |
773 |
|
Transfers into Level 3 |
|
|
|
|
|
|
|
|
|
|
|
|
Transfers out of Level 3 |
|
|
|
|
|
|
|
|
|
|
|
|
Total realized and unrealized gains (losses): |
|
|
|
|
|
|
|
|
|
|
|
|
Included in other comprehensive (loss) income |
|
|
19 |
|
|
|
(4 |
) |
|
|
15 |
|
Purchases, issuances, sales and settlements, net |
|
|
(28 |
) |
|
|
620 |
|
|
|
592 |
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2010 |
|
$ |
695 |
|
|
$ |
685 |
|
|
$ |
1,380 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using Significant |
|
|
|
Unobservable Inputs (Level 3) |
|
|
|
For Three Months Ended December 31, 2009 |
|
|
|
Available-for-Sale Debt Securities |
|
|
|
U.S. Government |
|
|
Mortgage |
|
|
|
|
|
|
Obligations |
|
|
Backed |
|
|
Total |
|
Balance, September 30, 2009 |
|
$ |
1,130 |
|
|
$ |
73 |
|
|
$ |
1,203 |
|
Transfers into Level 3 |
|
|
|
|
|
|
78 |
|
|
|
78 |
|
Transfers out of Level 3 |
|
|
(36 |
) |
|
|
(73 |
) |
|
|
(109 |
) |
Total realized and unrealized gains (losses): |
|
|
|
|
|
|
|
|
|
|
|
|
Included in other comprehensive (loss) income |
|
|
|
|
|
|
|
|
|
|
|
|
Purchases, issuances, sales and settlements, net |
|
|
(92 |
) |
|
|
(3 |
) |
|
|
(95 |
) |
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2009 |
|
$ |
1,002 |
|
|
$ |
75 |
|
|
$ |
1,077 |
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2010, marketable securities measured at fair value using Level 3 inputs was
comprised of a $0.7 million U.S. government agency security and $0.7 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
11
and liquidity. The fair value of these securities was based on the Companys assessment of
the underlying collateral and the creditworthiness of the issuer of the securities.
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 potentially 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.
(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 December
31 and September 30, 2010. 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 income (loss). 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 income (loss). Interest on debt securities, including amortization of premiums
and accretion of discounts, is included in other income (loss). Realized gains and losses from the
sales of debt securities, which are included in other income (loss), 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 December 31, 2010 and September 30, 2010 were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2010 |
|
|
|
Original Cost |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Fair Value |
|
U.S. government obligations |
|
$ |
29,153 |
|
|
$ |
284 |
|
|
$ |
(45 |
) |
|
$ |
29,392 |
|
Mortgage-backed securities |
|
|
4,855 |
|
|
|
143 |
|
|
|
(51 |
) |
|
|
4,947 |
|
Municipal bonds |
|
|
3,037 |
|
|
|
47 |
|
|
|
(5 |
) |
|
|
3,079 |
|
Asset-backed securities |
|
|
1,299 |
|
|
|
6 |
|
|
|
(32 |
) |
|
|
1,273 |
|
Corporate bonds |
|
|
2,601 |
|
|
|
11 |
|
|
|
(6 |
) |
|
|
2,606 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
40,945 |
|
|
$ |
491 |
|
|
$ |
(139 |
) |
|
$ |
41,297 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2010 |
|
|
|
Original Cost |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Fair Value |
|
U.S. government obligations |
|
$ |
25,968 |
|
|
$ |
395 |
|
|
$ |
(34 |
) |
|
$ |
26,329 |
|
Mortgage-backed securities |
|
|
4,711 |
|
|
|
164 |
|
|
|
(48 |
) |
|
|
4,827 |
|
Municipal bonds |
|
|
3,079 |
|
|
|
72 |
|
|
|
|
|
|
|
3,151 |
|
Asset-backed securities |
|
|
1,146 |
|
|
|
8 |
|
|
|
(42 |
) |
|
|
1,112 |
|
Corporate bonds |
|
|
5,828 |
|
|
|
24 |
|
|
|
|
|
|
|
5,852 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
40,732 |
|
|
$ |
663 |
|
|
$ |
(124 |
) |
|
$ |
41,271 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12
The original cost and fair value of investments by contractual maturity at December 31, 2010
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amortized Cost |
|
|
Fair Value |
|
Debt securities due within: |
|
|
|
|
|
|
|
|
One year |
|
$ |
9,059 |
|
|
$ |
9,144 |
|
One to five years |
|
|
26,188 |
|
|
|
26,429 |
|
Five years or more |
|
|
5,698 |
|
|
|
5,726 |
|
|
|
|
|
|
|
|
Total |
|
$ |
40,945 |
|
|
$ |
41,299 |
|
|
|
|
|
|
|
|
The following table summarizes sales of available-for-sale securities for the three-month
period ended December 31, 2010
(in thousands):
|
|
|
|
|
Proceeds from sales |
|
$ |
1,200 |
|
Gross realized gains |
|
$ |
2 |
|
Gross realized losses |
|
$ |
(2 |
) |
At December 31, 2010, the amortized cost and fair market value of held-to-maturity debt
securities was $4.1 million and $4.3 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 December 31, 2010. At September 30, 2010, the amortized cost and fair
market value of held-to-maturity debt securities were $4.1 million and $4.3 million, respectively.
(5) 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):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
September 30, |
|
|
|
2010 |
|
|
2010 |
|
Raw materials |
|
$ |
949 |
|
|
$ |
1,140 |
|
Finished products |
|
|
2,162 |
|
|
|
1,907 |
|
|
|
|
|
|
|
|
Total |
|
$ |
3,111 |
|
|
$ |
3,047 |
|
|
|
|
|
|
|
|
(6) Other Assets
Other assets consist principally of strategic investments as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
September 30, |
|
|
|
2010 |
|
|
2010 |
|
Investment in OctoPlus N.V. |
|
$ |
2,496 |
|
|
$ |
2,624 |
|
Investment in Nexeon MedSystems |
|
|
285 |
|
|
|
285 |
|
Investment in ThermopeutiX |
|
|
1,185 |
|
|
|
1,185 |
|
Investment in Novocell |
|
|
559 |
|
|
|
559 |
|
Other |
|
|
523 |
|
|
|
590 |
|
|
|
|
|
|
|
|
Other assets |
|
$ |
5,048 |
|
|
$ |
5,243 |
|
|
|
|
|
|
|
|
The Company accounts for most of its strategic investments under the cost method. The Company
accounts for its investment in OctoPlus N.V. (OctoPlus) common stock, whose shares are traded on
the Euronext Amsterdam Stock Exchange, as an available-for-sale investment. 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 income (loss) section of the condensed
consolidated statements of operations. The cost basis in the Companys investment in OctoPlus is
$1.7 million.
The Company recognized revenue of less than $0.1 million for each of the three-month periods
ended December 31, 2010 and 2009, respectively, from activity with companies in which it had a
strategic investment.
13
(7) 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
in each of the three-month periods ended December 31, 2010 and 2009, respectively.
Intangible assets consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Useful life |
|
|
December 31, |
|
|
September 30, |
|
|
|
(in years) |
|
|
2010 |
|
|
2010 |
|
Customer list |
|
|
9 11 |
|
|
$ |
8,657 |
|
|
$ |
8,657 |
|
Core technology |
|
|
8 18 |
|
|
|
8,330 |
|
|
|
8,330 |
|
Patents and other |
|
|
2 20 |
|
|
|
2,376 |
|
|
|
2,376 |
|
Trademarks |
|
|
|
|
|
|
600 |
|
|
|
600 |
|
Less accumulated amortization of intangible assets |
|
|
|
|
|
|
(5,094 |
) |
|
|
(4,706 |
) |
|
|
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
|
|
|
|
$ |
14,869 |
|
|
$ |
15,257 |
|
|
|
|
|
|
|
|
|
|
|
|
Based on the intangible assets in service as of December 31, 2010, estimated amortization
expense for each of the next five fiscal years is as follows (in thousands):
|
|
|
|
|
Remainder of 2011 |
|
$ |
1,158 |
|
2012 |
|
|
1,544 |
|
2013 |
|
|
1,544 |
|
2014 |
|
|
1,544 |
|
2015 |
|
|
1,533 |
|
2016 |
|
|
1,395 |
|
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.
(8) Goodwill
The following table summarizes the changes in carrying amount of goodwill (in thousands):
|
|
|
|
|
Balance at September 30, 2010 |
|
$ |
8,010 |
|
Accrued liability related to prior business acquisitions |
|
|
4,900 |
|
Payments related to prior business acquisitions |
|
|
750 |
|
Goodwill impairment |
|
|
(5,650 |
) |
Balance at December 31, 2010 |
|
$ |
8,010 |
|
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.
During the Companys fiscal 2010 annual test of goodwill impairment, the Company determined
that goodwill related to the SurModics Pharmaceutical, Inc. (SurModics Pharma) reporting unit was
fully impaired and a non-cash goodwill impairment charge totaling $13.8 million was recognized in
the fourth quarter of fiscal 2010
In the first quarter of fiscal 2011, two milestones were achieved associated with the July
2007 acquisition of SurModics Pharma and $5.7 million of additional purchase price was recorded as
an increase to goodwill. There have been no substantial changes in operating results for SurModics
Pharma in fiscal 2011 and as such the Company concluded the goodwill associated with these
milestone events was fully impaired as well and a $5.7 million non-cash goodwill impairment charge
was recognized in the first quarter of fiscal 2011.
14
(9) 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. As of December 31,
2010, the Company had no debt outstanding under the credit facility. In connection with the credit
facility, the Company is required to maintain certain financial and nonfinancial covenants. The
Company was not in compliance with certain covenants in fiscal 2010, however, the Company is in
compliance with all covenants for the first quarter of fiscal 2011. The Company is working with
the bank to obtain waivers for certain fiscal 2010 covenants and expects to complete these
activities by the end of the second quarter of fiscal 2011. The Company believes that
noncompliance will not cause liquidity issues given the Companys investment holdings and cash
generated by operations.
(10) 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 |
|
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
Product costs |
|
$ |
51 |
|
|
$ |
35 |
|
Customer research and development |
|
|
94 |
|
|
|
153 |
|
Other research and development |
|
|
209 |
|
|
|
615 |
|
Selling, general and administrative |
|
|
620 |
|
|
|
732 |
|
|
|
|
|
|
|
|
Total |
|
$ |
974 |
|
|
$ |
1,535 |
|
|
|
|
|
|
|
|
As of December 31, 2010, approximately $7.3 million of total unrecognized compensation costs
related to non-vested awards is expected to be recognized over a weighted average period of
approximately 3 years. The unrecognized compensation costs above exclude $2.0 million associated
with performance share awards that are currently not anticipated to be fully expensed because the
performance conditions for certain award periods 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 December 31, 2010 and 2009 was $3.91 and
$8.40, respectively. The assumptions used as inputs in the model were as follows:
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
Risk-free interest rates |
|
|
1.4 |
% |
|
|
1.8 |
% |
Expected life (years) |
|
|
4.8 |
|
|
|
4.8 |
|
Expected volatility |
|
|
44.9 |
% |
|
|
41.4 |
% |
Dividend yield |
|
|
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 expire in seven years or upon termination of employment and are exercisable at a rate of 20%
per year commencing one year after the date of grant. Nonqualified stock options are granted at
fair market value on the date of grant. Nonqualified stock options 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.
15
No stock options were exercised during the three-month period ended December 31, 2010. The
total pre-tax intrinsic value of options exercised during the three-month period ended December 31,
2009 was not meaningful as the Companys stock price of $22.60 on December 31, 2009 was below the
value of options exercised earlier in the quarter. 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.
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 $0.3 million during three-month
periods ended December 31, 2010 and 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 recognized expenses of approximately $0.1 million related to
Performance Shares for each of the three-month periods ended December 31, 2010 and 2009,
respectively.
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. 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 December 31, 2010 and 2009, there were $0.4 million and $0.5 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 December 31, 2010 and 2009 totaled $0.1 million in each
period. The stock-based compensation table above includes the Stock Purchase Plan expenses.
(11) Restructuring Charges
The Company recorded total restructuring charges of approximately $1.2 million in connection
with the reorganization announced in October 2010. The charges for fiscal 2011 have been presented
separately as restructuring charges in the condensed consolidated statements of operations. These
pre-tax charges consisted of $1.2 million of severance pay and benefit expenses and $0.1 million of
facility-related costs. The restructuring is expected to result in approximately $3.0 to $3.5
million in annualized cost savings. Cash payments associated with the fiscal 2011 restructuring
event totaled $0.8 million as of December 31, 2010 leaving a balance of $0.5 million. There were
also payments of $0.1 million associated with facility-related costs in the period related to the
fiscal 2009 and 2010 restructuring events. The remaining balance for all restructuring charges is
expected to be paid within the next 36 months. The current portion totaling $1.3 million is
recorded as a current liability within other accrued liabilities and the long-term portion totaling
$0.2 million is recorded as a long-term liability within other long-term liabilities within the
condensed consolidated balance sheets.
The following table summarizes the restructuring accrual activity for the quarter ended
December 31, 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee |
|
|
Facility- |
|
|
|
|
|
|
severance and |
|
|
related |
|
|
|
|
|
|
benefits |
|
|
costs |
|
|
Total |
|
Balance at September 30, 2010 |
|
$ |
4 |
|
|
$ |
1,179 |
|
|
$ |
1,183 |
|
Accruals during the period |
|
|
1,174 |
|
|
|
62 |
|
|
|
1,236 |
|
Cash payments |
|
|
(805 |
) |
|
|
(133 |
) |
|
|
(938 |
) |
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2010 |
|
$ |
373 |
|
|
$ |
1,108 |
|
|
$ |
1,481 |
|
|
|
|
|
|
|
|
|
|
|
16
(12) Comprehensive (Loss) Income
The components of comprehensive (loss) income are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
Net (loss) income |
|
$ |
(6,171 |
) |
|
$ |
1,917 |
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
Unrealized holding losses on available-for-sale securities
arising during the period |
|
|
(187 |
) |
|
|
(512 |
) |
Less reclassification adjustment for realized gains included in
net income, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss |
|
|
(187 |
) |
|
|
(512 |
) |
|
|
|
|
|
|
|
Comprehensive (loss) income |
|
$ |
(6,358 |
) |
|
$ |
1,405 |
|
|
|
|
|
|
|
|
(13) Income Taxes
The Company recorded an income tax provision of $0.8 million and $1.1 million for the
three-month periods ended December 31, 2010 and 2009, respectively. The effective tax rate for the
three-month period ended December 31, 2010 was not meaningful because a tax expense was recorded on
a pretax loss. The effective tax rate for the three-month period ended December 31, 2009 was 37.5%.
The difference between the U.S. federal statutory tax rate of 35% and the Companys effective tax
rate for the three-months ended December 31, 2010 reflects the impact of permanent tax items and a
discrete tax benefit discussed below. For the three-months ended December 31, 2009 the difference
between the U.S. federal statutory rate and the Companys effective tax rate reflects state income
taxes.
The December adoption of the Tax Relief, Unemployment Insurance Reauthorization and Job
Creation Act of 2010, retroactively extended the term of the federal tax credit for research
activities to the beginning of calendar 2010 and extending the credit through the end of calendar
2011. The Company recognized a discrete benefit of approximately $0.1 million in the three-month
period ended December 31, 2010 related to the nine-month period ended September 30, 2010. The tax
credit recognized for research activities for each of the three-month periods ended December 31,
2010 and 2009, was less than $0.1 million.
The total amount of unrecognized tax benefits including interest and penalties that, if
recognized, would affect the effective tax rate as of December 31, 2010 and September 30, 2010,
respectively, are $2.0 million and $1.9 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. The Internal Revenue Service has
commenced an examination of the Companys U.S. income tax return for fiscal 2009 in the first
quarter of fiscal 2011. U.S. tax returns for fiscal years ended September 30, 2007 and 2008
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.
(14) 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.
The Company manages its revenue according to its three business units, as follows: (1) the
Medical Device unit, which is comprised of surface modification coating technologies to improve
access, deliverability, and predictable deployment of medical devices, as well as drug delivery
coating technologies to provide site-specific drug delivery from the surface of a medical device.
End markets include coronary, peripheral, and neuro-vascular, and urology, among others; (2) the
Pharmaceuticals unit, which incorporates a broad range of drug delivery technologies for injectable
therapeutics, including microparticles, nanoparticles, and implants addressing a range of clinical
applications including ophthalmology, oncology, dermatology and neurology, among others. Based in
Birmingham, Alabama, the Pharmaceuticals business includes the Companys cGMP manufacturing
facility; and (3) the In Vitro Diagnostics unit, which consists of component products and
technologies for diagnostic test kits and biomedical research applications. Products include
microarray slide technologies, protein stabilization reagents, substrates, and antigens.
17
The Company manages its expenses on a company-wide basis, as many costs and activities are
shared among the business units. The focus of the business units is providing solutions to
customers and maximizing financial performance over the long term. The table below presents revenue
from the business units, for the three-month periods in fiscal 2011 and 2010, as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
Medical Device |
|
$ |
9,808 |
|
|
$ |
11,514 |
|
Pharmaceuticals |
|
|
2,673 |
|
|
|
3,581 |
|
In Vitro Diagnostics |
|
|
2,687 |
|
|
|
2,286 |
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
15,168 |
|
|
$ |
17,381 |
|
|
|
|
|
|
|
|
(15) 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.
SurModics Pharmaceuticals, Inc. In July 2007, the Company acquired 100% of the capital stock
of SurModics Pharmaceuticals, Inc. (SurModics Pharma) a drug delivery company that provides
proprietary polymer-based technologies to companies developing pharmaceutical products. The
sellers of SurModics Pharma are still eligible to receive up to $2.9 million in additional
consideration based on successful achievement of specified milestones through calendar 2011.
PR Pharmaceuticals, Inc. In November 2008, the Companys subsidiary SurModics Pharma
acquired certain contracts and assets of PR Pharmaceuticals, to enhance its portfolio of drug
delivery technologies for the pharmaceutical and biotechnology industries. The sellers of PR
Pharmaceuticals are still eligible to receive up to $3.0 million in additional consideration based
on successful achievement of specific milestones for successful patent issuances and product
development.
Alabama Jobs Commitment. In April 2008, the Company purchased a 286,000 square foot
office and warehouse facility to support cGMP needs of customers and the anticipated growth of the
SurModics Pharma business. At the same time, SurModics Pharma 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
Pharma or could not have been reasonably anticipated by SurModics Pharma. As of December 31, 2010,
SurModics Pharma has received $1.7 million in connection with the agreement, and the Company has
recorded the payment in other long-term liabilities.
18
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis provides information that we believe is useful in
understanding our operating results, cash flows and financial condition. The discussion should be
read in conjunction with both the unaudited condensed consolidated financial statements and related
notes included in this Form 10-Q/A, and Managements Discussion and Analysis of Financial Condition
and Results of Operations included in our Annual Report on Form 10-K for the year ended September
30, 2010. This discussion contains various Forward-Looking Statements within the meaning of the
Private Securities Litigation Reform Act of 1995. We refer readers to the statement entitled
Forward-Looking Statements located at the end of Part I of this report.
Overview
SurModics is a leading provider of drug delivery and surface modification technologies to the
healthcare industry. In October 2010, we announced a change in our organizational structure moving
from a functional structure into one consisting of three business units: Medical Device,
Pharmaceuticals, and In Vitro Diagnostics. We believe this structure improves the visibility,
marketing and adoption of the Companys broad array of technologies within specific markets and
helps our customers in the medical device, pharmaceutical and life science industries better solve
unmet clinical needs.
The organizational change resulted in the Company now presenting revenue as follows: (1)
the Medical Device unit, which is comprised of surface modification coating technologies to improve
access, deliverability, and predictable deployment of medical devices, as well as drug delivery
coating technologies to provide site-specific drug delivery from the surface of a medical device.
End markets include coronary, peripheral, and neuro-vascular, and urology, among others; (2) the
Pharmaceuticals unit, which incorporates a broad range of drug delivery technologies for injectable
therapeutics, including microparticles, nanoparticles, and implants addressing a range of clinical
applications including ophthalmology, oncology, dermatology and neurology, among others. Based in
Birmingham, Alabama, the Pharmaceuticals business includes our cGMP manufacturing facility; and
(3) the In Vitro Diagnostics unit, which consists of component products and technologies for
diagnostic test kits and biomedical research applications. Products include microarray slide
technologies, protein stabilization reagents, substrates, and antigens.
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 (R&D) 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.
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 will have an exclusive
license to develop and commercialize a sustained drug delivery formulation of Lucentis®
(ranibizumab injection) utilizing SurModics proprietary biodegradable microparticles drug delivery
system. 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 done on these products. Roche and Genentech will have the right to obtain
manufacturing services from SurModics. In the event a commercial product is developed, we will
also receive royalties on sales of such product. During fiscal 2010 and continuing into fiscal
2011, the focus of our development activities has changed, primarily as a result of technical
issues experienced in the Lucentis® microparticle product development program. Such technical
issues reflect the inherent challenges often experienced in the development of new or reformulated
pharmaceutical products. We are continuing to collaborate with Genentech under our agreement on
sustained drug delivery products utilizing our proprietary biodegradable microparticle drug
delivery system. However, the program remains subject to a number of risks and uncertainties,
including those detailed under the heading Risk Factors in Item 1A of the Companys 2010 Form
10-K.
In addition, in December 2010, we announced that the Board of Directors of the Company had
authorized the Company to explore strategic alternatives for our Pharmaceuticals business,
including a potential sale of that business. This decision by the Board reflects our focus on
returning the Company to profitable growth, and our renewed commitment to pursuing growth
opportunities and investments in our Medical Device and In Vitro Diagnostics businesses. We have
retained Piper Jaffray & Co. as our financial advisor in connection with this process. We have made
no decision to enter into any transaction regarding the Pharmaceuticals business, and there can be
no assurance that we will enter into such a transaction in the future.
19
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 likely to
result in materially different results under different assumptions and conditions. For a detailed
description of our critical accounting policies, see the notes to the consolidated financial
statements included in our Annual Report on Form 10-K for the year ended September 30, 2010.
Results of Operations
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
Increase |
|
|
|
|
(Dollars in thousands) |
|
2010 |
|
|
2009 |
|
|
(Decrease) |
|
|
Change |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical Device |
|
$ |
9,808 |
|
|
$ |
11,514 |
|
|
$ |
(1,706 |
) |
|
|
(15 |
)% |
Pharmaceuticals |
|
|
2,673 |
|
|
|
3,581 |
|
|
|
(908 |
) |
|
|
(25 |
)% |
In Vitro Diagnostics |
|
|
2,687 |
|
|
|
2,286 |
|
|
|
401 |
|
|
|
18 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
15,168 |
|
|
$ |
17,381 |
|
|
$ |
(2,213 |
) |
|
|
(13 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue. Revenue during the first quarter of fiscal 2011 was $15.2 million, a decrease
of $2.2 million, or 13%, compared with the first quarter of fiscal 2010. The decrease in revenue,
as detailed in the table above, is further explained in the narrative below.
Medical Device. Revenue in Medical Device was $9.8 million in the first quarter of fiscal
2011, a decrease of 15% compared with $11.5 million in the first quarter of fiscal 2010. The
decrease in total revenue reflects lower royalties and licenses fees and lower R&D revenue,
partially offset by higher product sales. Our royalty revenue from Cordis decreased as a result of
40% lower CYPHER® stent sales.
Medical Device 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. For the last several
years, royalty revenue and reagent product sales have decreased as a result of lower
CYPHER® stent sales. We anticipate that royalty revenue from the
CYPHER® stent is likely to decrease in fiscal 2011 and beyond as the various
marketers of drug-eluting stents compete, and as others enter the marketplace. We also receive a
royalty on sales of delivery systems used to deliver the Medtronic Endeavor®
and Endeavor® Resolute drug-eluting stents. These stent delivery
systems incorporate our proprietary hydrophilic technology and are sold in the United States and
internationally.
Pharmaceuticals. Pharmaceuticals revenue was $2.7 million in the first quarter of fiscal 2011,
a decrease of $0.9 million, or 25%, compared with the first quarter of fiscal 2010. The decrease
principally reflects lower R&D revenue, as well as lower product sales. While the Pharmaceuticals
business unit continues to experience softness in the R&D environment, certain R&D customers have
increased activity in recent months. However, there continues to be select customers that have
delayed, slowed or cancelled development projects as a result of various factors, including current
economic conditions.
In Vitro Diagnostics. Revenue in In Vitro Diagnostics was $2.7 million in the first quarter
of fiscal 2011, an increase of 18% compared with $2.3 million in the prior-year period. This
increase was attributable to higher sales of our BioFX branded products and higher antigen sales,
partially offset by lower microarray slide sales.
Product costs. Product costs were $1.8 million in the first quarter of fiscal 2011, compared
with $2.0 million in the prior-year period. The $0.2 million decrease in product costs principally
reflects the mix of products sold. Overall product margins averaged 62%, compared with 57%
reported last year.
Customer research and development expenses. Customer research and development (Customer
R&D) expenses were $4.7 million, an increase of 42% compared with the first quarter of fiscal
2010. The increase principally reflects the fixed overhead costs attributable to our Alabama
research and development operations, including our current Good Manufacturing Practices (cGMP)
manufacturing facility. Customer R&D margins were negative 68%, compared with positive 9% in the
first quarter of fiscal 2010.
20
Other research and development expenses. Other research and development (Other R&D)
expenses were $2.1 million for the first quarter of fiscal 2011, a decrease of 55% compared with
the first quarter of fiscal 2010. The decrease is primarily a result of therapeutic grant income
recognized (which is recorded as a reduction of expenses) of approximately $0.8 million associated
with awards received under the federal qualified therapeutic discovery project program and the
impact of lower labor costs resulting from the October 2010 organizational changes.
Selling, general and administrative expenses. Selling, general and administrative expenses
were $5.2 million for the three months ended December 31, 2010, an increase of 13% compared with
$4.6 million in the prior-year period. The increase was primarily attributable to non-recurring
advisory services expenses related to the 2011 Annual Meeting of shareholders and higher variable
compensation costs.
Goodwill impairment charge. In the first quarter of fiscal 2011, we recorded a $5.7 million
goodwill impairment charge associated with our SurModics Pharmaceuticals, Inc. (SurModics Pharma)
reporting unit. Two milestone events were achieved during the quarter associated with the July
2007 acquisition of SurModics Pharma and $5.7 million of additional purchase price was recorded as
an increase to goodwill. There have been no substantial changes in operating results for SurModics
Pharma in fiscal 2011 when compared with fiscal 2010 and as such we concluded the goodwill
associated with the milestone events was fully impaired. There may be additional earn-out milestone
payments in the future and if operations do not improve for the SurModics Pharma reporting unit,
there could be additional goodwill impairments.
Restructuring charges. In October 2010, we announced initiatives to reduce our cost structure
and renew our focus on business units to more closely match operations and cost structure with the
current customer environment. As a result of the organization change, we eliminated 30 positions,
or approximately 13% of our workforce. These employee terminations occurred across various
functions, and the reorganization plan was completed by the end of the first quarter of fiscal
2011. The reorganization also resulted in SurModics vacating a leased production facility in
Birmingham, Alabama with the production activities relocated to one of our owned facilities in
Birmingham.
We recorded total restructuring charges of $1.2 million in connection with the reorganization.
These pre-tax charges consisted of $1.2 million of severance pay and benefits expenses and less
than $0.1 million of facility-related costs. Costs totaling $0.8 million have been paid, and we
anticipate paying the remaining $0.4 million within the next twelve months.
Other income, net. Other income was $0.2 million in the first quarter of fiscal 2011,
compared with $0.3 million in the first quarter of fiscal 2010. Income from investments was $0.2
million, compared with $0.3 million in the prior-year period. The decrease primarily reflects
lower yields on our investment balances.
Income tax provision. The income tax provision was $0.8 million in the first quarter of
fiscal 2011, compared with $1.1 million in the first quarter of fiscal 2010. The effective tax
rate for the three-month period ended December 31, 2010 was not meaningful because a tax expense
was recorded on a pretax loss. The effective tax rate was 37.5% in the prior-year period. The
difference between the U.S. federal statutory tax rate of 35% and the Companys effective tax rate
for the three-month period ended December 31, 2010 reflects the impact of permanent tax items and a
discrete tax benefit associated with extension of the term of the federal tax credit for research
activities. For the three-month period ended December 31, 2009 the difference between the U.S.
federal statutory rate and the Companys effective tax rate reflects state income taxes.
Liquidity and Capital Resources
Operating Activities. As of December 31, 2010, we had working capital of $25.8 million, of
which $24.5 million consisted of cash, cash equivalents and short-term investments. Working
capital decreased $4.0 million from the September 30, 2010 level, driven principally by an increase
in accrued liabilities associated with a $4.9 million milestone payment obligation related to the
2007 SurModics Pharma acquisition, offset somewhat by higher cash and short-term investment
balances. Our cash and cash equivalents, short-term and long-term investments totaled $59.7
million at December 31, 2010, an increase of $2.9 million from $56.8 million at September 30, 2010.
Our 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. Our policy requires that no more than 5% of investments
be held in any one credit issue, excluding U.S. government and government agency obligations. The
primary investment objective of the portfolio is to provide for the safety of principal and
appropriate liquidity while meeting or exceeding a benchmark (Merrill Lynch 1-3 Year
Government-Corporate Index) total rate of return. Management continues to direct its investment
advisors to manage the 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 $5.3 million in the first quarter
of fiscal 2011, compared with $8.3 million in the first three months of fiscal 2010. The decrease
compared with prior-year results primarily reflects lower operating
21
results in fiscal 2011 as well as the fiscal 2010 receipt of a $3.5 million up-front licensing
fee from Genentech associated with a license and development agreement.
Investing Activities. We invested $1.4 million in property and equipment in the first quarter
of fiscal 2011, compared with $3.6 million in the prior-year period. The lower property and
equipment investment in fiscal 2011 is a return to more historical investment levels. Fiscal 2010
investment reflects higher spending associated with the final phase of completion of the
Birmingham, Alabama cGMP facility. In addition, both fiscal periods included $0.8 million milestone
payments associated with the SurModics Pharmaceuticals acquisition in July 2007.
Financing Activities. 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. No shares were repurchased during the three months ended December 31, 2010.
Under the current authorization, we have $5.3 million remaining available for share repurchases at
December 31, 2010.
As of December 31, 2010, the Company had no debt outstanding under our $25 million unsecured
revolving credit facility. In connection with the credit facility, we are required to maintain
certain financial and nonfinancial covenants. We were not in compliance with certain covenants in
fiscal 2010, however, we are in compliance with all covenants for the first quarter of fiscal 2011.
We are working with the bank to obtain waivers for certain fiscal 2010 covenants and expect to
complete these activities by the end of the second quarter of fiscal 2011. We believe that
noncompliance will not cause liquidity issues given our investment holdings and cash generated by
operations.
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 our ability to access
capital in a timely manner and on attractive terms, if at all. Our anticipated liquidity needs for
the remainder of fiscal 2011 include, but are not limited to, the following: general capital
expenditures in the range of $2.5 million to $4.0 million; contingent consideration payments,
related to our acquisitions of SurModics Pharma of $4.9 million, 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 December 31, 2010, the Company did not have any off-balance sheet arrangements with any
unconsolidated entities.
Forward-Looking Statements
This Quarterly Report on Form 10-Q/A, including Managements Discussion and Analysis of
Financial Condition and Results of Operations in Item 2, contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995. These statements
include expectations concerning our growth strategy, product development programs, future cash flow
and sources of funding, short-term liquidity requirements, the impact of potential lawsuits or
claims, and the impact of the Cordis and Genentech agreements, as well as other significant
customer agreements. Without limiting the foregoing, words or phrases such as anticipate,
believe, could, estimate, expect, forecast, intend, may, plan, possible,
project, will and similar terminology, generally identify forward-looking statements.
Forward-looking statements may also represent challenging goals for us. These statements, which
represent the Companys expectations or beliefs concerning various future events, are based on
current expectations that involve a number of risks and uncertainties that could cause actual
results to differ materially from those of such forward-looking statements. We caution that undue
reliance should not be placed on such forward-looking statements, which speak only as of the date
made. Some of the factors which could cause results to differ from those expressed in any
forward-looking statement are set forth under Part II, Item 1A of this Form 10-Q/A. We disclaim any
intent or obligation to update publicly these forward-looking statements, whether because of new
information, future events or otherwise.
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:
|
|
|
our ability to successfully identify, negotiate, sign and close a potential
strategic transaction related to our Pharmaceuticals business; |
|
|
|
the inability to realize the anticipated benefits of any potential transaction
regarding our Pharmaceuticals business, if consummated, or of our other recent cost savings
initiatives; |
|
|
|
the potential adverse impact to our business as a result of our announcement to
pursue strategic alternatives for our
|
22
|
|
|
Pharmaceuticals business; |
|
|
|
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 could
adversely affect our growth strategy and the royalty revenue we derive; |
|
|
|
general economic conditions which are beyond our control, including the impact
of recession, business investment and changes in consumer confidence; |
|
|
|
the Companys change in its organizational structure may not increase the
number of market segments and applications that use its technologies; |
|
|
|
a decrease in the Companys available cash or the value of its investment
holdings could impact short-term liquidity requirements; |
|
|
|
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; |
|
|
|
the development of new products or technologies by competitors, technological
obsolescence and other changes in competitive factors; |
|
|
|
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; 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.
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 $0.8
million decrease in the fair value of the Companys available-for-sale and held-to-maturity
securities as of December 31, 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 originally 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
23
decisions regarding required disclosures.
In connection with the Companys preparation of the Form 10-Q for the quarterly period ended
December 31, 2010, to which this Form 10-Q/A relates, the Company determined that the conditions
associated with a $4.9 million milestone payment obligation related to the July 2007 acquisition of
SurModics Pharmaceuticals had not been met. On April 25, 2011, in connection with the preparation
of the Companys Form 10-Q for the quarterly period ended March 31, 2011, the Company determined
that it should have recorded the additional $4.9 million milestone payment obligation in the
quarterly period ended December 31, 2010, and an associated increase to goodwill in the
Pharmaceuticals reporting unit, as the conditions associated with that milestone were determined to
have been satisfied as of December 31, 2010. The Company further determined that this additional
goodwill should be impaired, as the operating performance of the Pharmaceuticals reporting unit did
not support continuing recognition of the goodwill asset.
After evaluating the events that led to the need for the restatement, the Companys Chief
Executive Officer and Chief Financial Officer concluded on April 25, 2011 that the design of the
Companys disclosure controls and procedures was effective but that in this instance, a material
weakness occurred in the operation of such controls and procedures for determining milestone
payment obligations related to the acquisition of SurModics Pharmaceuticals, Inc. As a result, the
Companys Chief Executive and Chief Financial Officer concluded that the disclosure controls and
procedures were not effective as of December 31, 2010. The Company has taken action to remediate
the controls and procedures for determining milestone payment obligations related to the
acquisition of SurModics Pharmaceuticals, Inc. to ensure such controls and procedures operate
effectively.
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.
24
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, 2010.
Item 1A. Risk Factors.
In our report on Form 10-K for the fiscal year ended September 30, 2010, filed with the
Securities and Exchange Commission on December 14, 2010, we identify under Item 1A important
factors which could affect our financial performance and could cause our actual results for future
periods to differ materially from our anticipated results or other expectations, including those
expressed in any forward-looking statements made in this Form 10-Q/A.
There have been no material change in our risk factors subsequent to the filing of our Form
10-K for the fiscal year ended September 30, 2010.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. (Removed and Reserved).
Item 5. Other Information.
None.
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 |
|
|
|
10.1*
|
|
Offer Letter dated as of December 14, 2010 (in favor of Gary R. Maharaj executed by SurModics, Inc.)** |
|
|
|
10.2*
|
|
Severance Agreement by and between Gary R. Maharaj and SurModics, Inc. dated as of December 14, 2010** |
|
|
|
10.3
|
|
Agreement by and among SurModics, Inc. and the Ramius Group dated as of January 5, 2011
incorporated by reference to Exhibit 10.1 of the Companys Current Report on Form 8-K filed on
January 5, 2011, SEC File No. 0-23837 |
|
|
|
31.1*
|
|
Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
|
|
31.2*
|
|
Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
|
|
32.1*
|
|
Certification of Chief Executive Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
|
|
|
32.2*
|
|
Certification of Chief Financial Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
|
|
|
* |
|
These exhibits were previously included or incorporated by reference in the Companys
Quarterly Report on Form 10-Q for the quarterly period ended December 31, 2010, filed with the
Securities and Exchange Commission on February 4, 2011 |
|
** |
|
Management contract or compensatory plan or arrangement |
25
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.
|
|
|
|
|
May 6, 2011 |
SurModics, Inc.
|
|
|
By: |
/s/ Philip D. Ankeny
|
|
|
|
Philip D. Ankeny |
|
|
|
Senior Vice President and
Chief Financial Officer
(duly authorized signatory and
principal financial officer) |
|
26
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
EXHIBIT INDEX TO FORM 10-Q/A
For the Quarter Ended December 31, 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 |
|
|
|
10.1*
|
|
Offer Letter dated as of December 14, 2010 (in favor of Gary R. Maharaj executed by SurModics, Inc.)** |
|
|
|
10.2*
|
|
Severance Agreement by and between Gary R. Maharaj and SurModics, Inc. dated as of December 14, 2010** |
|
|
|
10.3
|
|
Agreement by and among SurModics, Inc. and the Ramius Group dated as of January 5, 2011
incorporated by reference to Exhibit 10.1 of the Companys Current Report on Form 8-K filed on
January 5, 2011, SEC File No. 0-23837 |
|
|
|
31.1*
|
|
Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
|
|
31.2*
|
|
Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
|
|
32.1*
|
|
Certification of Chief Executive Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
|
|
|
32.2*
|
|
Certification of Chief Financial Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
|
|
|
* |
|
These exhibits were previously included or incorporated by reference in the Companys
Quarterly Report on Form 10-Q for the quarterly period ended December 31, 2010, filed with the
Securities and Exchange Commission on February 4, 2011 |
|
** |
|
Management contract or compensatory plan or arrangement |
27
exv31w1
EXHIBIT 31.1
CERTIFICATION PURSUANT TO SECTION 302
OF SARBANES-OXLEY ACT OF 2002
I, Gary R. Maharaj, certify that:
|
1. |
|
I have reviewed this quarterly report on Form 10-Q/A of SurModics, Inc.; |
|
|
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
|
|
3. |
|
Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods
presented in this report; |
|
|
4. |
|
The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and we have: |
|
a. |
|
Designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made
known to us by others within those entities, particularly during the period in which
this report is being prepared; |
|
|
b. |
|
Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally
accepted accounting principles; |
|
|
c. |
|
Evaluated the effectiveness of the registrants disclosure controls and
procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report
based on such evaluation; and |
|
|
d. |
|
Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrants
internal control over financial reporting; and |
|
5. |
|
The registrants other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the registrants
auditors and the audit committee of the registrants board of directors (or persons
performing the equivalent functions): |
|
a. |
|
All significant deficiencies and material weaknesses in the design or operation
of internal control over financial reporting which are reasonably likely to adversely
affect the registrants ability to record, process, summarize and report financial
information; and |
|
|
b. |
|
Any fraud, whether or not material, that involves management or other employees
who have a significant role in the registrants internal control over financial
reporting. |
|
|
|
|
|
|
|
|
Dated: May 6, 2011 |
Signature: |
/s/ Gary R. Maharaj
|
|
|
|
Gary R. Maharaj |
|
|
|
President and
Chief Executive Officer |
|
28
exv31w2
EXHIBIT 31.2
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/A of SurModics, Inc.; |
|
|
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
|
|
3. |
|
Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods
presented in this report; |
|
|
4. |
|
The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and we have: |
|
a. |
|
Designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made
known to us by others within those entities, particularly during the period in which
this report is being prepared; |
|
|
b. |
|
Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally
accepted accounting principles; |
|
|
c. |
|
Evaluated the effectiveness of the registrants disclosure controls and
procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report
based on such evaluation; and |
|
|
d. |
|
Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrants
internal control over financial reporting; and |
|
5. |
|
The registrants other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the registrants
auditors and the audit committee of the registrants board of directors (or persons
performing the equivalent functions): |
|
a. |
|
All significant deficiencies and material weaknesses in the design or operation
of internal control over financial reporting which are reasonably likely to adversely
affect the registrants ability to record, process, summarize and report financial
information; and |
|
|
b. |
|
Any fraud, whether or not material, that involves management or other employees
who have a significant role in the registrants internal control over financial
reporting. |
|
|
|
|
|
|
|
|
Dated: May 6, 2011 |
Signature: |
/s/ Philip D. Ankeny
|
|
|
|
Philip D. Ankeny |
|
|
|
Senior Vice President and
Chief Financial Officer |
|
29
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/A for
the quarter ended December 31, 2010, as filed with the Securities and Exchange Commission (the
Report), I, Gary R. Maharaj, 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: May 6, 2011 |
Signature: |
/s/ Gary R. Maharaj
|
|
|
|
Gary R. Maharaj |
|
|
|
President and
Chief Executive Officer |
|
30
exv32w2
EXHIBIT 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of SurModics, Inc. (the Company) on Form 10-Q/A for
the quarter ended December 31, 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: May 6, 2011 |
Signature: |
/s/ Philip D. Ankeny
|
|
|
|
Philip D. Ankeny |
|
|
|
Senior Vice President and
Chief Financial Officer |
|
|
31