e10vkza
SECURITIES AND EXCHANGE
COMMISSION
Washington, DC 20549
Form 10-K/A
ANNUAL REPORT PURSUANT TO
SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT
OF 1934
For the
fiscal year ended September 30, 2009
Commission file number 0-23837
SURMODICS, INC.
(Exact Name of Registrant as
Specified in Its Charter)
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Minnesota
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41-1356149
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(State or other jurisdiction
of
incorporation or organization)
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(IRS Employer
Identification No.)
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9924 West
74th
Street
Eden Prairie, Minnesota
(Address of Principal
Executive Offices)
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55344
(Zip Code)
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(Registrants Telephone Number, Including Area Code)
(952) 829-2700
Securities registered pursuant to Section 12(b) of the
Act:
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Title of Each Class
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Name of Exchange on Which Registered
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Common Stock, $0.05 par value
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NASDAQ Global Select Market
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Securities registered pursuant to Section 12(g) of the
Act:
None
Indicate by check mark if the registrant is a well-known
seasoned issuer, as defined in Rule 405 of the Securities
Act. Yes o No þ
Indicate by check mark if the registrant is not required to file
reports pursuant to Section 13 or Section 15(d) of the
Act. Yes o No þ
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 Website, 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 if disclosure of delinquent filers
pursuant to Item 405 of
Regulation S-K
is not contained herein, and will not be contained, to the best
of registrants knowledge, in definitive proxy or
information statements incorporated by reference in
Part III of this
Form 10-K
or any amendment to this
Form 10-K. 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 definition of large
accelerated filer, accelerated filer and
smaller reporting company in
Rule 12b-2
of the Exchange Act. (Check one):
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Large accelerated
filer o
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Accelerated
filer 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)
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 aggregate market value of the Common Stock held by
shareholders other than officers, directors or holders of more
than 5% of the outstanding stock of the registrant as of
March 31, 2009 was approximately $197 million (based
upon the closing sale price of the registrants Common
Stock on such date).
The number of shares of the registrants Common Stock
outstanding as of December 7, 2009 was 17,471,760.
DOCUMENTS
INCORPORATED BY REFERENCE
None
EXPLANATORY NOTE
SurModics, Inc. (the Company) filed a Form 10-K for the fiscal year ended September 30,
2009 (the Original Filing) with the Securities and Exchange Commission on December 11, 2009. This
Amendment No. 1 is being filed solely for the purpose of adding the signature of DELOITTE & TOUCHE
LLP, the Companys Independent Registered Public Accounting
Firm, to Deloitte & Touche LLPs Report of
Independent Registered Public Accounting Firm (Report) on page F-1 included in this Amendment
No. 1, which signature was inadvertently omitted from the Original Filing.
For purposes of this Amendment No. 1, and in accordance with Rule 12b-15 under the
Securities Exchange Act of 1934, as amended, Item 8 of Part II and Item 15 of Part IV of the
Original Filing are amended and restated in their entirety. Other than adding Deloitte & Touche LLPs
signature to its Report on page F-1 of the financial statements, there are no other changes to Item
8 of Part II and Item 15 of Part IV of the Original Filing. Except as expressly set forth in this
Amendment No. 1, the Original Filing has not been amended, updated or otherwise modified.
In addition, as required by Rule 12b-15 under the Securities Exchange Act of 1934, as
amended, new certifications by our principal executive officer and principal financial officer are
being filed as exhibits to this Amendment No. 1.
Table of Contents
2
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
The consolidated balance sheets as of September 30, 2009 and 2008 and the consolidated
statements of income, stockholders equity and cash flows for each of the three years in the period
ended September 30, 2009, together with Report of Independent Registered Public Accounting Firm and
related footnotes (including selected unaudited quarterly financial data) begin on page F-1 of this
Form 10-K/A.
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
(a) 1. Financial Statements
The following statements are included in this report on the pages indicated:
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Page (s) |
Report of Independent Registered Public Accounting Firm
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F-1 |
Consolidated Balance Sheets
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F-2 |
Consolidated Statements of Income
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F-3 |
Consolidated Statements of Stockholders Equity
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F-4 |
Consolidated Statements of Cash Flows
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F-5 |
Notes to Consolidated Financial Statements
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F-6 to F-27 |
2. Financial Statement Schedules. See Schedule II Valuation and Qualifying Accounts in
this section of this Form 10-K/A. All other schedules are omitted because they are
inapplicable, not required, or the information is in the consolidated financial statements
or related notes.
3. Listing of Exhibits. The exhibits which are filed with this report or which are
incorporated herein by reference are set forth in the Exhibit Index following the signature
page.
SurModics, Inc.
Valuation and Qualifying Accounts
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Column A |
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Column B |
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Column C |
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Column D |
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Column E |
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Balance at |
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Additions |
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Deductions |
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Balance at |
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Beginning |
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Charged to |
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From |
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End of |
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Description |
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of Period |
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Expenses |
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Reserves |
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Period |
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Year Ended September 30, 2007
Allowance for doubtful accounts |
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$ |
40 |
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$ |
7 |
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$ |
7 |
(a) |
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$ |
40 |
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Year Ended September 30, 2008
Allowance for doubtful accounts |
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$ |
40 |
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$ |
228 |
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$ |
133 |
(a) |
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$ |
135 |
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Year Ended September 30, 2009
Allowance for doubtful accounts |
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$ |
135 |
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$ |
(34 |
) |
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$ |
19 |
(a) |
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$ |
82 |
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Restructuring accrual |
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$ |
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$ |
1,763 |
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$ |
808 |
(b) |
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$ |
955 |
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(a) |
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Uncollectible accounts written off and adjustments to the allowance.
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(b) |
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Adjustments to the accrual account reflect payments or non-cash charges associated with the
accrual. |
3
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934,
the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto
duly authorized.
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SURMODICS, INC.
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Dated: December 14, 2009 |
By: |
/s/ Bruce J Barclay
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Bruce J Barclay |
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Chief Executive Officer |
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Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been
signed below by the following persons on behalf of the Registrant, in the capacities, and on the
dates indicated.
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Signature |
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Title |
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Date |
/s/ Bruce J Barclay
Bruce J Barclay
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President and Chief Executive Officer
(principal executive officer)
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December 14, 2009 |
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/s/ Philip D. Ankeny
Philip D. Ankeny
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Senior Vice President and Chief Financial
Officer (principal financial officer)
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December 14, 2009 |
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/s/ Mark A. Lehman
Mark A. Lehman
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Corporate Controller (principal accounting
officer)
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December 14, 2009 |
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Director
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December 14, 2009 |
José H. Bedoya |
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Director
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December 14, 2009 |
John W. Benson |
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Director
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December 14, 2009 |
Mary K. Brainerd |
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Director
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December 14, 2009 |
Robert C. Buhrmaster |
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Director
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December 14, 2009 |
Gerald B. Fischer |
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Director
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December 14, 2009 |
Kenneth H. Keller |
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Director
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December 14, 2009 |
Susan E. Knight |
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Director
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December 14, 2009 |
John A. Meslow |
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* BY:
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/s/ Bruce J Barclay
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Name: Bruce J Barclay |
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Attorney-in-Fact |
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4
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
EXHIBIT INDEX TO FORM 10-K/A
For the Fiscal Year Ended September 30, 2009
SURMODICS, INC.
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Exhibit |
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23
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Consent of Deloitte & Touche LLP.* |
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31.1
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Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of
2002.* |
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31.2
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Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of
2002.* |
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32.1
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Certification of Chief Executive Officer Pursuant to Section 906 of Sarbanes-Oxley Act of
2002.* |
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32.2
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Certification of Chief Financial Officer Pursuant to Section 906 of Sarbanes-Oxley Act of
2002.* |
5
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Stockholders
SurModics, Inc.
Eden Prairie, Minnesota
We have audited the accompanying consolidated balance sheets of
SurModics, Inc. and subsidiaries (the Company) as of
September 30, 2009 and 2008, and the related consolidated
statements of income, stockholders equity, and cash flows
for each of the three years in the period ended
September 30, 2009. Our audits also include the financial
statement schedule listed in the Index at Item 15. These
financial statements and financial statement schedule are the
responsibility of the Companys management. Our
responsibility is to express an opinion on the financial
statements and financial statement schedule based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, such consolidated financial statements present
fairly, in all material respects, the financial position of
SurModics, Inc. and subsidiaries as of September 30, 2009
and 2008, and the results of their operations and their cash
flows for each of the three years in the period ended
September 30, 2009, in conformity with accounting
principles generally accepted in the United States of America.
Also, in our opinion, such financial statement schedule, when
considered in relation to the basic consolidated financial
statements taken as a whole, presents fairly, in all material
respects, the information set forth therein.
We have also audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
Companys internal control over financial reporting as of
September 30, 2009, based on the criteria established in
Internal Control Integrated Framework issued
by the Committee of Sponsoring Organizations of the Treadway
Commission and our report dated December 11, 2009 expressed
an unqualified opinion on the Companys internal control
over financial reporting.
As discussed in Note 8 to the consolidated financial
statements, on October 1, 2007, the Company adopted new
accounting guidance on the accounting for uncertainty in income
taxes.
DELOITTE & TOUCHE LLP
Minneapolis, Minnesota
December 11, 2009
F-1
SurModics,
Inc. and Subsidiaries
As of
September 30
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2009
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2008
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(In thousands, except share data)
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ASSETS
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Current Assets
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Cash and cash equivalents
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$
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11,636
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$
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15,376
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Short-term investments
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8,932
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9,251
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Accounts receivable, net of allowance for doubtful accounts of
$82 and $135 as of
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September 30, 2009 and 2008, respectively
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11,320
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|
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14,589
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Inventories
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3,330
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|
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2,651
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Deferred tax asset
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|
353
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1,058
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Prepaids and other
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1,443
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3,584
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Total Current Assets
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37,014
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46,509
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Property and equipment, net
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66,915
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41,897
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Long-term investments
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27,300
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47,351
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Deferred tax asset
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|
2,548
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|
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11,099
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Intangible assets, net
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17,458
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16,870
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Goodwill
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21,070
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18,001
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Other assets, net
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13,257
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9,301
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Total Assets
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$
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185,562
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|
$
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191,028
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LIABILITIES AND STOCKHOLDERS EQUITY
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Current Liabilities
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Accounts payable
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$
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3,468
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$
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3,466
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Accrued liabilities:
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Compensation
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926
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3,015
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Accrued income taxes payable
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186
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Accrued other
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1,637
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1,407
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Deferred revenue
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905
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4,335
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Other current liabilities
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862
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303
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Total Current Liabilities
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7,984
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12,526
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Deferred revenue, less current portion
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623
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33,243
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Other long-term liabilities
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4,583
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3,453
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Total Liabilities
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13,190
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49,222
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Commitments and Contingencies (Note 9)
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Stockholders Equity
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Series A preferred stock $.05 par value,
450,000 shares authorized;
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no shares issued and outstanding
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Common stock $.05 par value,
45,000,000 shares authorized; 17,471,472
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and 18,030,270 shares issued and outstanding
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874
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901
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Additional paid-in capital
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66,005
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74,573
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Accumulated other comprehensive income (loss)
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1,504
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(107
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)
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Retained earnings
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103,989
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66,439
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Total Stockholders Equity
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172,372
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141,806
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Total Liabilities and Stockholders Equity
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$
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185,562
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$
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191,028
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The accompanying notes are an integral part of these
consolidated financial statements.
F-2
SurModics,
Inc. and Subsidiaries
For
the Years Ended September 30
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2009
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2008
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2007
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(In thousands, except net
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income per share)
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Revenue
|
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Royalties and license fees
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$
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75,464
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$
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51,788
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$
|
52,679
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Product sales
|
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19,333
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20,052
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13,543
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Research and development
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|
26,737
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|
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25,211
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6,942
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|
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Total revenue
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121,534
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|
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|
97,051
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73,164
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Operating Costs and Expenses
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|
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|
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Product
|
|
|
7,508
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|
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|
8,476
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|
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|
5,584
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Customer research and development
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|
|
13,183
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|
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|
19,187
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|
|
|
5,840
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Other research and development
|
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|
21,179
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|
|
|
21,311
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|
|
|
22,625
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Selling, general and administrative
|
|
|
17,200
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|
|
|
20,816
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|
|
|
13,643
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Purchased in-process research and development
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|
|
3,200
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|
|
|
|
|
|
|
15,573
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Restructuring charges
|
|
|
1,763
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Total operating costs and expenses
|
|
|
64,033
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|
|
|
69,790
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|
|
|
63,265
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|
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|
|
|
|
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|
|
|
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Income from Operations
|
|
|
57,501
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|
|
|
27,261
|
|
|
|
9,899
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income (Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment income, net
|
|
|
1,839
|
|
|
|
3,329
|
|
|
|
4,844
|
|
Impairment loss on investment
|
|
|
|
|
|
|
(4,314
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)
|
|
|
|
|
Other income (loss), net
|
|
|
184
|
|
|
|
616
|
|
|
|
(75
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (loss), net
|
|
|
2,023
|
|
|
|
(369
|
)
|
|
|
4,769
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income Before Income Taxes
|
|
|
59,524
|
|
|
|
26,892
|
|
|
|
14,668
|
|
Income Tax Provision
|
|
|
(21,974
|
)
|
|
|
(12,153
|
)
|
|
|
(11,321
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income
|
|
$
|
37,550
|
|
|
$
|
14,739
|
|
|
$
|
3,347
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share
|
|
$
|
2.15
|
|
|
$
|
0.82
|
|
|
$
|
0.19
|
|
Diluted net income per share
|
|
$
|
2.15
|
|
|
$
|
0.80
|
|
|
$
|
0.18
|
|
Weighted Average Shares Outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
17,435
|
|
|
|
18,026
|
|
|
|
18,033
|
|
Dilutive effect of outstanding stock options
|
|
|
34
|
|
|
|
304
|
|
|
|
184
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
|
17,469
|
|
|
|
18,330
|
|
|
|
18,217
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
F-3
SurModics,
Inc. and Subsidiaries
For
the Years Ended September 30, 2009, 2008 and 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
Other
|
|
|
|
|
|
Total
|
|
|
|
Common Stock
|
|
|
Paid-in
|
|
|
Comprehensive
|
|
|
Retained
|
|
|
Stockholders
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Income (Loss)
|
|
|
Earnings
|
|
|
Equity
|
|
|
|
(In thousands)
|
|
|
Balance September 30, 2006
|
|
|
18,830
|
|
|
$
|
942
|
|
|
$
|
96,281
|
|
|
$
|
(293
|
)
|
|
$
|
48,273
|
|
|
$
|
145,203
|
|
Components of comprehensive income, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,347
|
|
|
|
3,347
|
|
Unrealized holding gains on available-for-sale securities
arising during the period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,999
|
|
|
|
|
|
|
|
1,999
|
|
Add reclassification for losses included in net income, net of
tax benefit of $10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17
|
|
|
|
|
|
|
|
17
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,363
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock
|
|
|
14
|
|
|
|
1
|
|
|
|
457
|
|
|
|
|
|
|
|
|
|
|
|
458
|
|
Common stock repurchased
|
|
|
(1,008
|
)
|
|
|
(50
|
)
|
|
|
(34,980
|
)
|
|
|
|
|
|
|
|
|
|
|
(35,030
|
)
|
Common stock options exercised, net
|
|
|
217
|
|
|
|
11
|
|
|
|
4,778
|
|
|
|
|
|
|
|
|
|
|
|
4,789
|
|
Purchase of common stock to pay employee taxes
|
|
|
112
|
|
|
|
5
|
|
|
|
(379
|
)
|
|
|
|
|
|
|
|
|
|
|
(374
|
)
|
Excess tax benefit from exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
466
|
|
|
|
|
|
|
|
|
|
|
|
466
|
|
Stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
10,312
|
|
|
|
|
|
|
|
|
|
|
|
10,312
|
|
Other
|
|
|
|
|
|
|
|
|
|
|
(265
|
)
|
|
|
|
|
|
|
|
|
|
|
(265
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance September 30, 2007
|
|
|
18,165
|
|
|
|
909
|
|
|
|
76,670
|
|
|
|
1,723
|
|
|
|
51,620
|
|
|
|
130,922
|
|
Components of comprehensive income, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,739
|
|
|
|
14,739
|
|
Unrealized holding losses on available-for-sale securities
arising during the period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,882
|
)
|
|
|
|
|
|
|
(5,882
|
)
|
Add reclassification for losses included in net income, net of
tax provision of $167
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,052
|
|
|
|
|
|
|
|
4,052
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,909
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock
|
|
|
16
|
|
|
|
1
|
|
|
|
516
|
|
|
|
|
|
|
|
|
|
|
|
517
|
|
Common stock repurchased
|
|
|
(342
|
)
|
|
|
(17
|
)
|
|
|
(13,954
|
)
|
|
|
|
|
|
|
|
|
|
|
(13,971
|
)
|
Common stock options exercised, net
|
|
|
114
|
|
|
|
4
|
|
|
|
2,514
|
|
|
|
|
|
|
|
|
|
|
|
2,518
|
|
Purchase of common stock to pay employee taxes
|
|
|
77
|
|
|
|
4
|
|
|
|
(1,678
|
)
|
|
|
|
|
|
|
|
|
|
|
(1,674
|
)
|
Excess tax benefit from exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
1,081
|
|
|
|
|
|
|
|
|
|
|
|
1,081
|
|
Stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
9,652
|
|
|
|
|
|
|
|
|
|
|
|
9,652
|
|
Other
|
|
|
|
|
|
|
|
|
|
|
(228
|
)
|
|
|
|
|
|
|
|
|
|
|
(228
|
)
|
Accounting change for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
80
|
|
|
|
80
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance September 30, 2008
|
|
|
18,030
|
|
|
|
901
|
|
|
|
74,573
|
|
|
|
(107
|
)
|
|
|
66,439
|
|
|
|
141,806
|
|
Components of comprehensive income, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37,550
|
|
|
|
37,550
|
|
Unrealized holding gains on available-for-sale securities
arising during the period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,123
|
|
|
|
|
|
|
|
2,123
|
|
Add reclassification for gains included in net income, net of
tax provision of $299
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(512
|
)
|
|
|
|
|
|
|
(512
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
39,161
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock
|
|
|
40
|
|
|
|
2
|
|
|
|
611
|
|
|
|
|
|
|
|
|
|
|
|
613
|
|
Common stock repurchased
|
|
|
(624
|
)
|
|
|
(31
|
)
|
|
|
(14,967
|
)
|
|
|
|
|
|
|
|
|
|
|
(14,998
|
)
|
Common stock options exercised, net
|
|
|
15
|
|
|
|
1
|
|
|
|
65
|
|
|
|
|
|
|
|
|
|
|
|
66
|
|
Purchase of common stock to pay employee taxes
|
|
|
10
|
|
|
|
1
|
|
|
|
(569
|
)
|
|
|
|
|
|
|
|
|
|
|
(568
|
)
|
Excess tax benefit from exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
(366
|
)
|
|
|
|
|
|
|
|
|
|
|
(366
|
)
|
Stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
6,853
|
|
|
|
|
|
|
|
|
|
|
|
6,853
|
|
Other
|
|
|
|
|
|
|
|
|
|
|
(195
|
)
|
|
|
|
|
|
|
|
|
|
|
(195
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance September 30, 2009
|
|
|
17,471
|
|
|
$
|
874
|
|
|
$
|
66,005
|
|
|
$
|
1,504
|
|
|
$
|
103,989
|
|
|
$
|
172,372
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
F-4
SurModics,
Inc. and Subsidiaries
For
the Years Ended September 30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
|
(In thousands)
|
|
|
Operating Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
37,550
|
|
|
$
|
14,739
|
|
|
$
|
3,347
|
|
Adjustments to reconcile net income to net cash provided by
|
|
|
|
|
|
|
|
|
|
|
|
|
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
5,912
|
|
|
|
6,071
|
|
|
|
4,214
|
|
(Gain) loss on equity method investments and sales of investments
|
|
|
(103
|
)
|
|
|
415
|
|
|
|
75
|
|
Amortization of premium (discount) on investments
|
|
|
139
|
|
|
|
70
|
|
|
|
(1,388
|
)
|
Impairment loss on investment
|
|
|
|
|
|
|
4,314
|
|
|
|
|
|
Stock-based compensation
|
|
|
6,853
|
|
|
|
9,652
|
|
|
|
10,312
|
|
Purchased in-process research & development
|
|
|
3,200
|
|
|
|
|
|
|
|
15,573
|
|
Restructuring charges
|
|
|
1,763
|
|
|
|
|
|
|
|
|
|
Deferred tax
|
|
|
8,229
|
|
|
|
(3,428
|
)
|
|
|
(9,434
|
)
|
Excess tax benefit from exercise of stock options
|
|
|
366
|
|
|
|
(1,081
|
)
|
|
|
(466
|
)
|
Loss on disposals of property and equipment
|
|
|
291
|
|
|
|
78
|
|
|
|
379
|
|
Other
|
|
|
(250
|
)
|
|
|
|
|
|
|
|
|
Change in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
3,269
|
|
|
|
1,548
|
|
|
|
1,940
|
|
Inventories
|
|
|
(679
|
)
|
|
|
(154
|
)
|
|
|
(850
|
)
|
Accounts payable and accrued liabilities
|
|
|
(2,387
|
)
|
|
|
(264
|
)
|
|
|
2,594
|
|
Income taxes
|
|
|
2,656
|
|
|
|
(5,003
|
)
|
|
|
5,501
|
|
Deferred revenue
|
|
|
(36,050
|
)
|
|
|
11,452
|
|
|
|
19,166
|
|
Prepaids and other
|
|
|
562
|
|
|
|
1,413
|
|
|
|
(248
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities
|
|
|
31,321
|
|
|
|
39,822
|
|
|
|
50,715
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(29,364
|
)
|
|
|
(23,866
|
)
|
|
|
(3,626
|
)
|
Sales of property and equipment
|
|
|
|
|
|
|
32
|
|
|
|
37
|
|
Purchases of
available-for-sale
investments
|
|
|
(33,568
|
)
|
|
|
(22,857
|
)
|
|
|
(136,498
|
)
|
Sales/maturities of
available-for-sale
investments
|
|
|
55,263
|
|
|
|
29,258
|
|
|
|
185,075
|
|
Purchases of
held-to-maturity
investments
|
|
|
|
|
|
|
(6,485
|
)
|
|
|
|
|
Investment in other strategic assets
|
|
|
(2,500
|
)
|
|
|
(2,562
|
)
|
|
|
(5,749
|
)
|
Purchase of licenses and patents
|
|
|
(631
|
)
|
|
|
(2,452
|
)
|
|
|
(1,355
|
)
|
Acquisitions, net of cash acquired
|
|
|
(8,585
|
)
|
|
|
(3,219
|
)
|
|
|
(49,112
|
)
|
Repayment of notes receivable
|
|
|
|
|
|
|
5,870
|
|
|
|
530
|
|
Other investing activities
|
|
|
(187
|
)
|
|
|
(228
|
)
|
|
|
(265
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(19,572
|
)
|
|
|
(26,509
|
)
|
|
|
(10,963
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Excess tax benefit from exercise of stock options
|
|
|
(366
|
)
|
|
|
1,081
|
|
|
|
466
|
|
Issuance of common stock
|
|
|
679
|
|
|
|
3,037
|
|
|
|
5,247
|
|
Repurchase of common stock
|
|
|
(14,998
|
)
|
|
|
(13,971
|
)
|
|
|
(35,030
|
)
|
Purchase of common stock to pay employee taxes
|
|
|
(568
|
)
|
|
|
(1,674
|
)
|
|
|
(374
|
)
|
Repayment of notes payable
|
|
|
(236
|
)
|
|
|
(222
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in financing activities
|
|
|
(15,489
|
)
|
|
|
(11,749
|
)
|
|
|
(29,691
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in cash and cash equivalents
|
|
|
(3,740
|
)
|
|
|
1,564
|
|
|
|
10,061
|
|
Cash and Cash Equivalents
|
|
|
|
|
|
|
|
|
|
|
|
|
Beginning of year
|
|
|
15,376
|
|
|
|
13,812
|
|
|
|
3,751
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
End of year
|
|
$
|
11,636
|
|
|
$
|
15,376
|
|
|
$
|
13,812
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Information
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for income taxes
|
|
$
|
11,285
|
|
|
$
|
21,058
|
|
|
$
|
14,930
|
|
Noncash transaction acquisition of property,
|
|
|
|
|
|
|
|
|
|
|
|
|
plant, and equipment on account
|
|
$
|
1,247
|
|
|
$
|
1,745
|
|
|
$
|
252
|
|
Noncash transaction acquisition of intangibles on
account
|
|
$
|
210
|
|
|
$
|
|
|
|
$
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
F-5
SurModics,
Inc. and Subsidiaries
September 30, 2009 and 2008
SurModics, Inc. and subsidiaries (the Company)
develops, manufactures and markets innovative drug delivery and
surface modification technologies for the healthcare industry.
The Companys revenue is derived from three primary
sources: (1) royalties and license fees from licensing its
patented drug delivery and surface modification technologies and
in vitro diagnostic formats to customers;
(2) the sale of polymers and reagent chemicals to
licensees; substrates, antigens and stabilization products to
the diagnostics industry; microarray slides to the diagnostic
and biomedical research markets; and (3) research and
development fees generated on projects for customers.
Basis
of Presentation
The consolidated financial statements include all accounts and
wholly owned subsidiaries, and have been prepared in accordance
with accounting principles generally accepted in the United
States of America (GAAP). All significant inter-company
transactions have been eliminated.
Subsequent
Events
Subsequent events have been evaluated through December 11,
2009, the date the financial statements were issued.
On October 5, 2009, the Company 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), associated with the
Companys proprietary biodegradable microparticles drug
delivery system. SurModics received an up front licensing fee of
$3.5 million, could be eligible to receive up to
approximately $200 million in fees and milestone payments
in the event of the successful development and commercialization
of multiple products, and will be paid 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, the Company will also receive
royalties on sales of such products.
|
|
2.
|
Summary
of Significant Accounting Policies
|
Cash
and Cash Equivalents
Cash and cash equivalents consist of financial instruments with
original maturities of three months or less and are stated at
cost which approximates fair value.
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 September 30, 2009 and 2008.
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 that 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
F-6
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
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 September 30 were as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
|
Original Cost
|
|
|
Unrealized Gains
|
|
|
Unrealized Losses
|
|
|
Fair Value
|
|
|
U.S. government obligations
|
|
$
|
10,837
|
|
|
$
|
253
|
|
|
$
|
|
|
|
$
|
11,090
|
|
Mortgage-backed securities
|
|
|
7,938
|
|
|
|
177
|
|
|
|
(106
|
)
|
|
|
8,009
|
|
Municipal bonds
|
|
|
7,210
|
|
|
|
232
|
|
|
|
|
|
|
|
7,442
|
|
Asset-backed securities
|
|
|
2,334
|
|
|
|
65
|
|
|
|
(143
|
)
|
|
|
2,256
|
|
Corporate bonds
|
|
|
1,181
|
|
|
|
3
|
|
|
|
|
|
|
|
1,184
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
29,500
|
|
|
$
|
730
|
|
|
$
|
(249
|
)
|
|
$
|
29,981
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
|
Original Cost
|
|
|
Unrealized Gains
|
|
|
Unrealized Losses
|
|
|
Fair Value
|
|
|
U.S. government obligations
|
|
$
|
18,440
|
|
|
$
|
91
|
|
|
$
|
(87
|
)
|
|
$
|
18,444
|
|
Mortgage-backed securities
|
|
|
10,147
|
|
|
|
46
|
|
|
|
(179
|
)
|
|
|
10,014
|
|
Municipal bonds
|
|
|
11,022
|
|
|
|
153
|
|
|
|
(3
|
)
|
|
|
11,172
|
|
Asset-backed securities
|
|
|
6,193
|
|
|
|
2
|
|
|
|
(171
|
)
|
|
|
6,024
|
|
Corporate bonds
|
|
|
4,582
|
|
|
|
8
|
|
|
|
(33
|
)
|
|
|
4,557
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
50,384
|
|
|
$
|
300
|
|
|
$
|
(473
|
)
|
|
$
|
50,211
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The original cost and fair value of investments by contractual
maturity at September 30, 2009 were as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Original Cost
|
|
|
Fair Value
|
|
|
Debt securities due within:
|
|
|
|
|
|
|
|
|
One year
|
|
$
|
6,830
|
|
|
$
|
6,911
|
|
One to five years
|
|
|
14,297
|
|
|
|
14,749
|
|
Five years or more
|
|
|
8,373
|
|
|
|
8,321
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
29,500
|
|
|
$
|
29,981
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes sales of
available-for-sale
securities for the years ended September 30, 2009, 2008 and
2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
Proceeds from sales
|
|
$
|
55,263
|
|
|
$
|
29,258
|
|
|
$
|
185,075
|
|
Gross realized gains
|
|
$
|
823
|
|
|
$
|
454
|
|
|
$
|
7
|
|
Gross realized losses
|
|
$
|
(12
|
)
|
|
$
|
(26
|
)
|
|
$
|
(34
|
)
|
At September 30, 2009, the amortized cost and fair market
value of
held-to-maturity
debt securities were $6.3 million and $6.4 million,
respectively. Investments in securities designated as
held-to-maturity
consist of tax-exempt municipal bonds and have maturity dates
ranging between three months and three years from
September 30, 2009. At September 30, 2008, the
amortized cost and fair market value of
held-to-maturity
debt securities were $6.4 million and $6.3 million,
respectively.
F-7
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
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 as of September 30 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
Raw materials
|
|
$
|
1,287
|
|
|
$
|
1,308
|
|
Finished products
|
|
|
2,043
|
|
|
|
1,343
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
3,330
|
|
|
$
|
2,651
|
|
|
|
|
|
|
|
|
|
|
Property
and Equipment
Property and equipment are stated at cost and are depreciated
using the straight-line method over 1 to 32 years, the
estimated useful lives of the assets. The Company recorded
depreciation expense of $3.8 million, $3.1 million and
$2.2 million for the years ended September 30, 2009,
2008 and 2007, respectively.
The September 30, 2009 and 2008 balances in
construction-in-progress
include the cost of enhancing the capabilities of the
Companys Eden Prairie, Minnesota and Birmingham, Alabama
facilities. As assets are placed in service,
construction-in-progress
is transferred to the specific property and equipment categories
and depreciated over the estimated useful lives of the assets.
In April 2008, the Company acquired a 286,000 square foot
facility situated on 42 acres in Birmingham, Alabama for
$12.2 million. The Company has been renovating the existing
facility to accommodate research and development, clinical
manufacturing and commercial manufacturing of drug delivery
products for pharmaceutical and biotechnology customers. The
building is currently classified as
construction-in-progress
until renovation and remodeling is completed. The value of the
land associated with the purchase is classified as part of the
total land carrying value.
In August 2008, the Company acquired approximately five acres of
undeveloped land adjacent to its headquarters in Eden Prairie,
Minnesota for $3.6 million. The value of the land purchase
is classified as part of the total land carrying value.
Property and equipment consisted of the following components as
of September 30 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Useful Life
|
|
|
2009
|
|
|
2008
|
|
|
|
(In years)
|
|
|
|
|
|
|
|
|
Land
|
|
|
|
|
|
$
|
7,409
|
|
|
$
|
7,409
|
|
Laboratory fixtures and equipment
|
|
|
3 to 12
|
|
|
|
19,549
|
|
|
|
15,767
|
|
Building and improvements
|
|
|
1 to 32
|
|
|
|
15,911
|
|
|
|
15,025
|
|
Office furniture and equipment
|
|
|
3 to 10
|
|
|
|
4,550
|
|
|
|
4,156
|
|
Construction-in-progress
|
|
|
|
|
|
|
40,210
|
|
|
|
16,931
|
|
Less accumulated depreciation
|
|
|
|
|
|
|
(20,714
|
)
|
|
|
(17,391
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
|
|
|
$
|
66,915
|
|
|
$
|
41,897
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Assets
Other assets consist principally of strategic investments. In
fiscal 2009, the balance in other assets increased primarily as
a result of an investment in a medical technology company and an
increase in the value of the Companys investment in
OctoPlus N.V. (OctoPlus).
F-8
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
In January 2005, the Company made an initial equity investment
of approximately $3.9 million in OctoPlus, a company based
in the Netherlands active in the development of pharmaceutical
formulations incorporating novel biodegradable polymers.
Subsequent investments brought the Companys total
investment to $6.0 million. In October 2006, OctoPlus
common stock began trading on an international exchange
following an initial public offering of its common stock. With a
readily determinable fair market value, the Company now treats
the investment in OctoPlus as an
available-for-sale
investment rather than a cost method 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
consolidated statements of income, and result in a new cost
basis for the investment. As of September 30, 2009, the
investment in OctoPlus represented an ownership interest of less
than 10%. The Company recorded no realized gain or loss related
to this investment in fiscal 2009. The Company recognized an
impairment loss on the investment totaling $4.3 million in
fiscal 2008 based on a significant decline in the stock price of
OctoPlus as a result of market conditions. The cost basis in the
Companys investment in OctoPlus is $1.7 million.
Beginning in May 2005, the Company has invested
$1.2 million in ThermopeutiX, Inc.
(ThermopeutiX), a California-based early stage
company developing novel medical devices for the treatment of
vascular and neurovascular diseases. In addition to the
investment, SurModics has licensed its hydrophilic and
hemocompatible coating technologies to ThermopeutiX for use with
its devices. The Companys investment in ThermopeutiX,
which is accounted for under the cost method, represents an
ownership interest of less than 20%.
The Company has invested a total of $5.2 million in
Novocell, Inc. (Novocell), a privately-held
California-based biotechnology firm that is developing a unique
treatment for diabetes using coated islet cells, the cells that
produce insulin in the human body. In fiscal 2006, the Company
determined its investment in Novocell was impaired and that the
impairment was
other-than-temporary.
Accordingly, the Company recorded an impairment loss of
$4.7 million. The balance of the investment, $559,000,
which is accounted for under the cost method, represents less
than a 5% ownership interest.
In July 2007, the Company made equity investments in Paragon
Intellectual Properties, LLC (Paragon) and Apollo
Therapeutics, LLC (Apollo), a Paragon subsidiary,
totaling $3.5 million. SurModics made an additional equity
investment in fiscal 2008 totaling $2.5 million, based upon
successful completion of specified development milestones. In
addition to the investments, the Company has licensed its
Finaletm
prohealing coating technology and provides development services
on a time and materials basis to Apollo. In October 2008,
Paragon announced that it had restructured, moving from a
limited liability company with seven subsidiaries to a single
C-corporation named Nexeon MedSystems, Inc.
(Nexeon). SurModics continued to account for the
investments in Paragon and Apollo under the equity method in the
first quarter of fiscal 2009, as both entities report results to
us on a one-quarter lag. Commencing with the second quarter of
fiscal 2009, SurModics accounted for the investment in Nexeon
under the cost method as the Companys ownership level is
less than 20%. The Company made an additional investment of
$500,000 in Nexeon in fiscal 2009.
In August 2009, the Company invested $2.0 million in a
medical technology company. The Companys investment is
accounted for under the cost method, as the Companys
ownership interest is less than 20%. This investment is included
in the category titled Other in the table below.
F-9
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
Other assets consisted of the following components as of
September 30 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
Investment in OctoPlus
|
|
$
|
3,700
|
|
|
$
|
1,714
|
|
Investment in Nexeon MedSystems
|
|
|
5,651
|
|
|
|
5,388
|
|
Investment in ThermopeutiX
|
|
|
1,185
|
|
|
|
1,185
|
|
Investment in Novocell
|
|
|
559
|
|
|
|
559
|
|
Other
|
|
|
2,162
|
|
|
|
455
|
|
|
|
|
|
|
|
|
|
|
Other assets, net
|
|
$
|
13,257
|
|
|
$
|
9,301
|
|
|
|
|
|
|
|
|
|
|
In the years ended September 30, 2009, 2008 and 2007, the
Company recognized revenue of $1.4 million,
$4.1 million and $909,000, respectively, from activity with
companies in which it had a strategic investment.
Intangible
Assets
Intangible assets consist principally of acquired patents and
technology, customer relationships, licenses, and trademarks.
The Company recorded amortization expense of $2.1 million,
$3.0 million, and $2.0 million for the years ended
September 30, 2009, 2008 and 2007, respectively.
In fiscal 2009, the Company acquired certain assets of PR
Pharmaceuticals, Inc., which resulted in an increase to
intangible assets. See Note 4 for further information
regarding the acquisition.
Intangible assets consisted of the following as of September 30
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Useful Life
|
|
|
2009
|
|
|
2008
|
|
|
|
(In years)
|
|
|
|
|
|
|
|
|
Customer lists
|
|
|
9-11
|
|
|
$
|
8,657
|
|
|
$
|
7,340
|
|
Abbott license
|
|
|
4
|
|
|
|
|
|
|
|
7,037
|
|
Core technology
|
|
|
8-18
|
|
|
|
8,330
|
|
|
|
6,930
|
|
Patents and other
|
|
|
2-20
|
|
|
|
3,076
|
|
|
|
3,398
|
|
Trademarks
|
|
|
|
|
|
|
600
|
|
|
|
580
|
|
Less accumulated amortization
|
|
|
|
|
|
|
(3,205
|
)
|
|
|
(8,415
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets, net
|
|
|
|
|
|
$
|
17,458
|
|
|
$
|
16,870
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Abbott license was fully amortized as of September 30,
2009 and the original cost and accumulated amortization have
been removed from the 2009 amounts presented. Based on the
intangible assets in service as of September 30, 2009,
estimated amortization expense for the next five fiscal years is
as follows (in thousands):
|
|
|
|
|
2010
|
|
$
|
1,627
|
|
2011
|
|
|
1,604
|
|
2012
|
|
|
1,602
|
|
2013
|
|
|
1,602
|
|
2014
|
|
|
1,602
|
|
Goodwill
Goodwill represents the excess of the cost of the acquired
entities over the fair value assigned to the assets purchased
and liabilities assumed in connection with the Companys
acquisitions (see Note 4 for further information). 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.
F-10
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
In fiscal 2009 a milestone was achieved associated with the July
2007 acquisition of SurModics Pharmaceuticals, and
$3 million of additional purchase price was recorded as an
increase to goodwill.
Impairment
of Long-Lived Assets
The Company periodically evaluates whether events and
circumstances have occurred that may affect the estimated useful
life or the recoverability of the remaining balance of
long-lived assets, such as property and equipment and
investments. If such events or circumstances were to indicate
that the carrying amount of these assets would not be
recoverable, the Company would estimate the future cash flows
expected to result from the use of the assets and their eventual
disposition. If the sum of the expected future cash flows
(undiscounted and without interest charges) or other measure of
fair value were less than the carrying amount of the assets, the
Company would recognize an impairment loss reducing the carrying
value to fair market value.
Revenue
Recognition
In accordance with Securities and Exchange Commission (SEC)
guidance, 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. However, 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
patented drug delivery and surface modification technologies and
in vitro diagnostic formats 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.
Taxes collected from customers and remitted to governmental
authorities are excluded from revenue and amounted to $187,000,
$309,000 and $170,000 for the years ended September 30,
2009, 2008 and 2007, respectively.
Royalties & License 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. Generally, license fees are recognized as revenue
when the Company receives payment and the contract price is
fixed or determinable. 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.
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, involves a significant degree of
risk, and was not reasonably assured at the inception of the
arrangement.
|
|
|
|
Accomplishment of the milestone involves substantial effort.
|
|
|
|
The amount of the milestone payment is commensurate with the
related effort and risk.
|
|
|
|
A reasonable amount of time passes between the initial license
payment and the first and subsequent milestone payments.
|
F-11
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
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.
Arrangements with multiple
deliverables. Arrangements such as license and
development agreements are analyzed to determine whether the
deliverables, which often include a license and performance
obligations such as research and development, can be separated
or whether they must be accounted for as a single unit of
accounting in accordance with accounting guidance. The Company
recognizes up-front license payments under these agreements over
the economic life of the technology licensed. If the fair value
of the undelivered performance obligations can be determined,
such obligations would then be accounted for separately. If the
license is considered to either (i) not have stand-alone
value or (ii) have stand-alone value but the fair value of
any of the undelivered performance obligations cannot be
determined, the arrangement would then be accounted for as a
single unit of accounting, and the license payments and payments
for performance obligations would be recognized as revenue over
the estimated period of when the performance obligations are
performed, or the economic life of the technology licensed to
the customer. When the Company determines that an arrangement
should be accounted for as a single unit of accounting, it
recognizes the related revenue based on a time-based accounting
model. Revenue associated with arrangements with multiple
deliverables totaled $45.3 million, $4.2 million and
$0.3 million in fiscal 2009, 2008 and 2007, respectively.
The fiscal 2009 revenue associated with multiple deliverable
arrangements is reflected in royalties and license fees revenue
($37.6 million) and in research and development revenue
($7.7 million) in the consolidated statements of income.
Merck Agreement. On June 27, 2007 the
Company announced a license and research collaboration agreement
with Merck & Co., Inc. (Merck). The
agreement called for SurModics and Merck to pursue the joint
development and commercialization of SurModics I-vation
sustained drug delivery system with TA (triamcinolone
acetonide), and other products combining certain of Mercks
proprietary drug compounds and the I-vation system for the
treatment of serious retinal diseases. Under the terms of the
agreement, Merck led and funded development and
commercialization activities. SurModics received an up-front
license fee of $20 million in fiscal 2007 and additional
license fees totaling $11 million in fiscal 2008. In
addition, the Company was paid for its activities in researching
and developing the combination products. Research and
development fees totaling $5.8 million were billed in
fiscal 2008. The Company recognized
out-of-pocket
reimbursements, totaling $1.6 million in fiscal 2008, as
revenue in the period since the related costs were incurred when
commensurate value was transferred to Merck in exchange for the
reimbursement received.
The Company recognized revenue from the up-front license fee,
additional license fees and research and development fees over
the economic life of the technology licensed to Merck, which was
16 years.
In September 2008, following a strategic review of Mercks
business and product development portfolio, Merck gave notice to
SurModics of its intent to terminate the collaborative research
and license agreement as well as the supply agreement entered
into in June 2007. The termination was effective December 2008.
The Company recognized all remaining deferred revenue related to
the Merck agreement, totaling $34.8 million, as revenue in
fiscal 2009. The Company also recognized a $9 million
milestone payment from Merck associated with the termination of
the triamcinolone acetonide development program in fiscal 2009.
As of September 30, 2009, there were no deferred revenue
amounts from Merck, compared with $34.8 million of license
fees and research and development fees in deferred revenue as of
September 30, 2008.
F-12
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
Deferred
Revenue
Amounts received prior to satisfying the above revenue
recognition criteria are recorded as deferred revenue in the
accompanying consolidated balance sheets, with deferred revenue
to be recognized beyond one year being classified as non-current
deferred revenue. As of September 30, 2009 and 2008, the
Company had deferred revenue of $1.5 million and
$37.6 million, respectively.
Costs related to products and services delivered are recognized
in the period revenue is recognized except for services related
to the Merck agreement, which were recognized as incurred.
Customer advances are accounted for as a liability until all
criteria for revenue recognition have been met.
Research
and Development Costs
Research and development costs are expensed as incurred. Some
research and development costs are related to third party
contracts, and the related revenue is recognized as described in
Revenue Recognition above. The research and
development costs are presented in the consolidated statements
of income in two categories; those associated with customer
related projects and those associated with other research and
development costs.
Costs associated with customer related research and development
include specific project direct labor costs and material
expenses as well as an allocation of overhead costs based on
direct labor dollars.
Use of
Estimates
The preparation of financial statements in conformity with GAAP
requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities, the
disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenue and
expenses during the reporting period. Ultimate results could
differ from those estimates.
New
Accounting Pronouncements
In October 2009, the Financial Accounting Standards Board (FASB)
issued an update to authoritative accounting guidance to address
the accounting for multiple-deliverable arrangements. This
accounting update enables vendors to account for products and
services (deliverables) separately rather than as a combined
unit. This authoritative guidance establishes the accounting and
reporting for arrangements under which the vendor will perform
multiple revenue-generating activities. The amendments to the
authoritative guidance establish a selling price hierarchy for
determining the selling price of a deliverable. The selling
price used for each deliverable will be based on vendor-specific
objective evidence if available, third-party evidence if
vendor-specific objective evidence is not available, or
estimated selling price if neither vendor-specific objective
evidence nor third-party evidence is available. The
authoritative guidance also expands the disclosures related to
multiple-deliverable revenue arrangements and in the year of
adoption requires additional disclosures following previous
authoritative guidance. The authoritative guidance is effective
for the Company beginning in fiscal 2011 with early adoption
permitted. The Company expects to early adopt this authoritative
guidance in the first quarter of fiscal 2010 and is currently
evaluating the impact on the consolidated financial statements.
In June 2009, the FASB issued authoritative guidance to
eliminate the historical GAAP hierarchy and establish only two
levels of GAAP, authoritative and nonauthoritative. When
launched on July 1, 2009, the FASB Accounting Standards
Codification (ASC) became the single source of authoritative,
nongovernmental GAAP, except for rules and interpretive releases
of the Securities and Exchange Commission (SEC), which are
sources of authoritative GAAP for SEC registrants. All other
nongrandfathered, non-SEC accounting literature not included in
the ASC became nonauthoritative. The subsequent issuances of new
standards will be in the form of Accounting Standards Updates
that will be included in the ASC. This authoritative guidance
was effective for financial statements for interim or annual
reporting periods ended after September 15, 2009. The
Company adopted the new codification in
F-13
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
the fourth quarter of fiscal 2009. As the codification was not
intended to change or alter existing GAAP, it did not have any
impact on the Companys consolidated financial statements.
In April 2008, the FASB issued authoritative accounting guidance
which amends the factors that should be considered in developing
renewal or extension assumptions used to determine the useful
life of intangible assets under goodwill and other intangible
asset accounting. The authoritative guidance is intended to
improve the consistency between the useful life of a recognized
intangible asset under goodwill and intangible asset accounting
and the period of the expected cash flows used to measure the
fair value of the asset under business combination accounting
and other GAAP. The authoritative guidance is effective for the
Company in fiscal 2010, with early adoption prohibited. The
Company does not expect the adoption of the authoritative
guidance to have a material impact on its consolidated financial
statements.
In December 2007, the FASB issued authoritative accounting
guidance which establishes principles and requirements for how
an acquirer recognizes and measures in its financial statements
the identifiable assets acquired, the liabilities assumed, and
any noncontrolling interest in an acquiree, including the
recognition and measurement of goodwill acquired in a business
combination. The authoritative guidance is effective for the
Company in fiscal 2010 and once adopted will impact recognition
and measurement of future business combinations.
In September 2006, the FASB issued authoritative accounting
guidance associated with fair value measurements. This guidance
defines fair value, establishes a consistent framework for
measuring fair value, gives guidance regarding methods used for
measuring fair value and expands disclosures about fair value
measurements. These provisions were implemented in fiscal 2009.
See Note 3 for additional information regarding fair value
measurements. However, in February 2008, the FASB issued
guidance which delayed the effective date from fiscal 2009 to
fiscal 2010 for all nonfinancial assets and liabilities, except
those that are recognized or disclosed at fair value in the
financial statements on a recurring basis (at least annually).
The Company is currently evaluating the potential impact of the
authoritative guidance for which the effective date was delayed
until fiscal 2010 on its consolidated financial statements.
No other new accounting pronouncement issued or effective has
had, or is expected to have, a material impact on the
Companys consolidated financial statements.
|
|
3.
|
Fair
Value Measurements
|
Effective October 1, 2008, the Company adopted new
accounting guidance on fair value measurements. The new guidance
defines fair value, establishes a framework for measuring fair
value under GAAP, and expands disclosures about fair value
measurements. The guidance is applicable for all financial
assets and liabilities and for all nonfinancial assets and
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
New 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.
F-14
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
The Companys Level 1 asset consists of its investment
in OctoPlus (see Note 2 for further information). The fair
market value of this investment is based on the quoted price of
OctoPlus shares as traded on the Amsterdam Stock Exchange.
Level 2 Observable inputs other than quoted
prices included in Level 1, such as quoted prices for
similar assets or liabilities in active markets; quoted prices
for identical or similar assets or liabilities in markets that
are not active; or other inputs that are observable or can be
corroborated by observable market data for substantially the
full term of the asset or liability.
The Companys Level 2 assets consist of money market
funds, U.S. Treasury securities, corporate bonds, municipal
bonds, U.S. agency securities, agency and municipal
securities and 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 a
U.S. government agency security and certain asset-backed
and 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.
We did not significantly change our 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
September 30, 2009 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Prices
|
|
|
|
|
|
|
|
|
|
|
|
|
in Active
|
|
|
Significant
|
|
|
|
|
|
|
|
|
|
Markets for
|
|
|
Other
|
|
|
Significant
|
|
|
Total Fair
|
|
|
|
Identical
|
|
|
Observable
|
|
|
Unobservable
|
|
|
Value as of
|
|
|
|
Instruments
|
|
|
Inputs
|
|
|
Inputs
|
|
|
September 30,
|
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
|
2009
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents
|
|
$
|
|
|
|
$
|
9,108
|
|
|
$
|
|
|
|
$
|
9,108
|
|
Short-term investments
|
|
|
|
|
|
|
6,911
|
|
|
|
|
|
|
|
6,911
|
|
Long-term investments
|
|
|
|
|
|
|
21,867
|
|
|
|
1,203
|
|
|
|
23,070
|
|
Other assets
|
|
|
3,700
|
|
|
|
|
|
|
|
|
|
|
|
3,700
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured at fair value
|
|
$
|
3,700
|
|
|
$
|
37,886
|
|
|
$
|
1,203
|
|
|
$
|
42,789
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term and long-term investments disclosed in the
consolidated balance sheets include
held-to-maturity
investments totaling $6.3 million as of September 30,
2009 and 2008.
Held-to-maturity
investments are carried at an amortized cost.
F-15
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
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):
|
|
|
|
|
|
|
2009
|
|
|
Balance, beginning of year
|
|
$
|
264
|
|
Total realized and unrealized gains included in other
comprehensive income
|
|
|
25
|
|
Purchases, sales and maturities, net
|
|
|
339
|
|
Transfer in (out) of Level 3
|
|
|
575
|
|
|
|
|
|
|
Balance, end of year
|
|
$
|
1,203
|
|
|
|
|
|
|
As of September 30, 2009, marketable securities measured at
fair value using Level 3 inputs was comprised of $36,000 of
a U.S. government agency security, $73,000 of a
mortgage-backed security and $1,094,000 of asset-backed
securities within the Companys
available-for-sale
investment portfolio. These securities were measured using
observable market data and Level 3 inputs as a result of
the lack of market activity and liquidity. The fair value of
these securities was based on the Companys assessment of
the underlying collateral and the creditworthiness of the 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 or equity
method. 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 potential
need for additional funding at a possibly 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.
PR Pharmaceuticals, Inc. On November 4,
2008, the Companys SurModics Pharmaceuticals, Inc.
(formerly known as Brookwood Pharmaceuticals, Inc.) subsidiary
entered into an asset purchase agreement with PR
Pharmaceuticals, Inc. (PR Pharma), whereby it
acquired certain contracts and assets of PR Pharma for
$5.6 million consisting of $2.9 million in cash on the
closing date, additional consideration of $2.4 million upon
successful achievement of specified milestones and
$0.3 million in transaction costs. PR Pharma is eligible to
receive up to an additional $3.6 million in cash upon the
successful achievement of milestones for contract signing and
invoicing, successful patent issuances and product development.
Management believes this acquisition strengthens the
Companys portfolio of drug delivery technologies for the
pharmaceutical and biotechnology industries. The purchase price
was allocated as follows as of November 4, 2008 (in
thousands):
|
|
|
|
|
Core technology
|
|
$
|
1,400
|
|
Customer relationships
|
|
|
900
|
|
In-process research and development
|
|
|
3,200
|
|
Trade names
|
|
|
20
|
|
Non-compete agreements
|
|
|
50
|
|
|
|
|
|
|
Total purchase price
|
|
$
|
5,570
|
|
|
|
|
|
|
F-16
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
The acquired developed technology is being amortized on a
straight-line basis over 18 years, customer relationships
are being amortized over 9 years, and non-compete
agreements are being amortized over 2 years. The trade
names have a life of less than one year and were fully amortized
in fiscal 2009. As part of the acquisition, the Company
recognized fair value associated with in-process research and
development (IPR&D) of $3.2 million. The IPR&D
was expensed on the date of acquisition and relates to
polymer-based drug delivery systems. The value assigned to
IPR&D is related to projects for which the related products
have not achieved commercial feasibility and have no future
alternative use. The amount of purchase price allocated to
IPR&D was based on estimating the future cash flows of each
project and discounting the net cash flows back to their present
values. The discount rate used was determined at the time of
acquisition in accordance with accepted valuation methods. These
methodologies include consideration of the risk of the project
not achieving commercial feasibility. The research efforts
ranged from 5% to 50% complete at the date of acquisition. The
Company used the Relief from Royalty valuation method to assess
the fair value of the projects with a risk-adjusted discount
rate of 25%. The Company determined the method was appropriate
based on the nature of the projects and future cash flow
streams. The research and development work performed is billed
to customers, in most cases, using standard commercial billing
rates which include a reasonable markup. Accordingly, the
Company has no fixed cost obligations to carry projects forward.
There have been no significant changes to the development plans
for the acquired incomplete projects. Significant net cash
inflows would commence with the commercial launch of customer
products that are covered by the intellectual property rights
and related agreements acquired from PR Pharma.
SurModics Pharmaceuticals, Inc. On
July 31, 2007, the Company entered into a stock purchase
agreement with Southern Research Institute (SRI)
whereby it acquired 100% of the capital stock of SurModics
Pharmaceuticals, Inc. (formerly Brookwood Pharmaceuticals, Inc.)
(SurModics Pharmaceuticals) held by SRI for
$42.3 million consisting of $40 million in cash on the
closing date and $2.3 million in transaction costs. SRI
could receive up to an additional $22 million in cash upon
the successful achievement of specified milestones. In fiscal
2009, a milestone was achieved and $3 million of additional
purchase price was recorded as an increase to goodwill. In
fiscal 2008, a milestone was achieved and $2 million of
additional purchase price was recorded as an increase to
goodwill. SurModics Pharmaceuticals is a drug delivery company
based in Birmingham, Alabama that provides proprietary
polymer-based technologies to companies developing
pharmaceutical products. SurModics Pharmaceuticals, a wholly
owned subsidiary of SurModics, operates as a separate business
unit. Management believes this acquisition strengthens
SurModics portfolio of drug delivery technologies for the
pharmaceutical and biotechnology industries in particular.
Operating results of SurModics Pharmaceuticals have been
included in the Companys consolidated financial statements
since August 1, 2007.
As part of the acquisition, the Company recognized IPR&D of
$15.6 million. The IPR&D was expensed on the date of
acquisition and relates to polymer-based drug delivery systems.
The value assigned to IPR&D is related to projects for
which the related products have not received commercial
feasibility and have no future alternative use. The amount of
purchase price allocated to IPR&D was based on estimating
the future cash flows of each project and discounting the net
cash flows back to their present values.
BioFX Laboratories, Inc. On August 13,
2007, the Company acquired 100% of the capital stock of BioFX
Laboratories, Inc. (BioFX), a provider of substrates
to the in vitro diagnostics industry, for
$11.6 million, $11.3 million of which was in cash paid
to the sellers and $300,000 in transaction costs. The Company is
also required to pay up to an additional $11.4 million in
cash upon the successful achievement of specified revenue
targets. In fiscal 2008, a milestone was achieved and
$1.1 million of additional purchase price was recorded as
an increase to goodwill. The sellers are still eligible to
receive up to $7.6 million in additional consideration.
BioFX is a wholly owned subsidiary of SurModics, and operates
within the In Vitro Technologies business unit. Management
believes the acquisition enhances the Companys
technological position in the in vitro diagnostics
market. Operating results of BioFX have been included in the
Companys consolidated financial statements since
August 14, 2007.
F-17
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
The following pro forma consolidated condensed financial
results of operations for the 2007 fiscal year, are presented as
if the SurModics Pharmaceuticals and BioFX acquisitions had been
completed at the beginning of fiscal 2007 (in thousands).
|
|
|
|
|
Pro forma revenue
|
|
$
|
89,708
|
|
Pro forma income from operations
|
|
$
|
28,034
|
|
Pro forma net income
|
|
$
|
17,735
|
|
Pro forma basic earnings per share
|
|
$
|
0.98
|
|
Pro forma diluted earnings per shares
|
|
$
|
0.98
|
|
|
|
5.
|
Revolving
Credit Facility
|
In February 2009, the Company entered into a two-year
$25.0 million unsecured revolving credit facility.
Borrowings under the credit facility, if any, will bear interest
at a benchmark rate plus an applicable margin based upon the
Companys funded debt to EBITDA ratio. In connection with
the credit facility, the Company is required to maintain certain
financial and nonfinancial covenants. As of September 30,
2009, the Company had no debt outstanding under this credit
facility and was in compliance with all covenants.
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 for the years ended September 30 were
allocated as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
Product
|
|
$
|
87
|
|
|
$
|
161
|
|
|
$
|
96
|
|
Research and development
|
|
|
3,621
|
|
|
|
3,793
|
|
|
|
5,188
|
|
Selling, general and administrative
|
|
|
3,145
|
|
|
|
5,698
|
|
|
|
5,028
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
6,853
|
|
|
$
|
9,652
|
|
|
$
|
10,312
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2009, approximately $8.7 million
of total unrecognized compensation costs related to non-vested
awards is expected to be recognized over a weighted average
period of approximately 2.6 years. The unrecognized
compensation costs include $2.8 million associated with
performance share awards that are currently not anticipated to
be fully expensed because the performance conditions are not
expected to be met.
Stock
Option Plans
The Company uses the Black-Scholes option pricing model to
determine the weighted average grant date fair value of stock
options granted. The weighted average per share fair value of
stock options granted during fiscal 2009, 2008 and 2007 was
$8.95, $14.85, and $17.42, respectively. The assumptions used as
inputs in the model for the years ended September 30 were as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
2007
|
|
Risk-free interest rates
|
|
|
2.30
|
%
|
|
|
2.80
|
%
|
|
|
4.50
|
%
|
Expected life
|
|
|
4.8 years
|
|
|
|
4.6 years
|
|
|
|
5.4 years
|
|
Expected volatility
|
|
|
40
|
%
|
|
|
37
|
%
|
|
|
45
|
%
|
Dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
The risk-free interest rate assumption was based on the
U.S. Treasurys rates for U.S. Treasury
zero-coupon bonds with maturities similar to those of the
expected term of the award. The expected life of options granted
is
F-18
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
determined based on the Companys experience. Expected
volatility is based on the Companys stock price movement.
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 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 options expire in 7 to 10 years or upon
termination of employment or service as a Board member.
Nonqualified 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 such that the
entire option is fully vested five years after date of grant,
and nonqualified options granted subsequent to May 2008
generally become exercisable with respect to 25% on each of the
first four anniversaries following the grant date such that the
entire option is fully vested four years after the grant date.
The Company has authorized 2,400,000 shares for grant under
the 2003 Equity Incentive Plan of which 51,000 remain available
for future awards. In September 2009, the Company granted 29,066
performance share awards to officers under the 2003 Equity
Incentive Plan and 229,552 stock options to officers under the
2009 Equity Incentive Plan. The 2009 Equity Incentive Plan is
subject to shareholder approval at the February 2010 Annual
Meeting of Shareholders. As of September 30, 2009, the
aggregate intrinsic value of the option shares outstanding and
option shares exercisable was $0.7 million and
$0.6 million, respectively. At September 30, 2009, the
average remaining contractual life of options outstanding and
options exercisable was 4.3 and 3.2 years, respectively.
The intrinsic value of options exercised during fiscal 2009,
2008 and 2007 was $235,000, $2.9 million and
$4.4 million, respectively.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
Number of
|
|
|
Average
|
|
|
|
Shares
|
|
|
Exercise Price
|
|
|
Outstanding at September 30, 2006
|
|
|
1,510,780
|
|
|
$
|
29.69
|
|
Granted
|
|
|
166,400
|
|
|
|
37.85
|
|
Exercised
|
|
|
(253,060
|
)
|
|
|
25.82
|
|
Forfeited
|
|
|
(22,700
|
)
|
|
|
33.71
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2007
|
|
|
1,401,420
|
|
|
|
31.29
|
|
Granted
|
|
|
392,917
|
|
|
|
41.86
|
|
Exercised
|
|
|
(163,297
|
)
|
|
|
27.45
|
|
Forfeited
|
|
|
(108,250
|
)
|
|
|
33.59
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2008
|
|
|
1,522,790
|
|
|
|
34.26
|
|
Granted
|
|
|
268,700
|
|
|
|
24.06
|
|
Exercised
|
|
|
(17,600
|
)
|
|
|
8.82
|
|
Forfeited
|
|
|
(104,320
|
)
|
|
|
35.33
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2009
|
|
|
1,669,570
|
|
|
$
|
32.82
|
|
Exercisable at September 30, 2009
|
|
|
902,589
|
|
|
$
|
32.07
|
|
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. Compensation has been
recognized for the estimated fair value of the 100,895 common
shares awarded and is being charged to income over the vesting
term. The stock-based compensation table includes the
F-19
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
Restricted Stock expenses recognized related to these awards,
which totaled $1.8 million, $2.2 million and
$1.2 million during fiscal 2009, 2008 and 2007,
respectively.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
Number of
|
|
|
Average
|
|
|
|
Shares
|
|
|
Grant Price
|
|
|
Balance at September 30, 2006
|
|
|
153,000
|
|
|
$
|
32.14
|
|
Granted
|
|
|
83,027
|
|
|
|
42.07
|
|
Vested
|
|
|
(24,836
|
)
|
|
|
37.87
|
|
Forfeited
|
|
|
(5,000
|
)
|
|
|
34.56
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2007
|
|
|
206,191
|
|
|
|
35.89
|
|
Granted
|
|
|
12,383
|
|
|
|
42.18
|
|
Vested
|
|
|
(40,336
|
)
|
|
|
38.76
|
|
Forfeited
|
|
|
(21,109
|
)
|
|
|
32.83
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2008
|
|
|
157,129
|
|
|
|
36.06
|
|
Granted
|
|
|
7,700
|
|
|
|
23.93
|
|
Vested
|
|
|
(59,047
|
)
|
|
|
34.44
|
|
Forfeited
|
|
|
(4,887
|
)
|
|
|
41.91
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2009
|
|
|
100,895
|
|
|
$
|
35.80
|
|
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. In fiscal 2009 the Company reversed expenses
previously recognized of $207,000 relating to three-year
Performance Shares awarded in May 2008 and one-year Performance
Shares awarded in September 2008, which was partially offset by
an expense of $164,000 related to the estimated value of
Performance Shares awarded to individuals based on likely
achievement of specific performance objectives. The Company
recorded compensation expense of $1.9 million in fiscal
2008 related to 30,552 one-year Performance Shares and 30,552
three-year Performance Shares awarded in May 2008 and 7,600
Performance Shares that vested for certain individuals that met
various specific performance objectives. The Company recorded
compensation expense of $4.8 million in fiscal 2007 related
to 132,375 Performance Shares. The stock-based compensation
table includes the Performance Shares expenses.
1999
Employee Stock Purchase Plan
Under the 1999 Employee Stock Purchase Plan (Stock Purchase
Plan), the Company is authorized to issue up to
200,000 shares of Common Stock. All full-time and part-time
employees can choose to have up to 10% of their annual
compensation withheld to purchase the Companys Common
Stock at purchase prices defined within the provisions of the
Stock Purchase Plan. As of September 30, 2009 and 2008,
there were $276,000 and $355,000 of employee contributions,
respectively, included in accrued liabilities in the
accompanying consolidated balance sheets. Stock compensation
expense recognized related to the Stock Purchase Plan totaled
$265,000, $199,000 and $156,000 during fiscal 2009, 2008 and
2007, respectively. The stock-based compensation table includes
the Stock Purchase Plan expenses.
F-20
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
In November 2008, the Company announced a functional
reorganization to allow the Company to better serve its
customers and improve its operating performance. As a result of
the reorganization, the Company eliminated 15 positions, or
approximately five percent of the Companys workforce.
These employee terminations occurred across various functions
and the reorganization plan was completed by the end of the
first quarter of fiscal 2009. The Company also vacated a leased
facility in Eden Prairie, Minnesota, consolidating into its
owned office and research facility also in Eden Prairie, as part
of the reorganization plan.
The Company recorded total restructuring charges of
approximately $1.8 million in connection with the
reorganization. These pre-tax charges consisted of
$0.5 million of severance pay and benefits expenses and
$1.3 million of facility-related costs which were recorded
in fiscal 2009. The restructuring is expected to result in
approximately $2.0 million in annualized cost savings.
The following table summarizes the restructuring accrual
activity for fiscal 2009 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee
|
|
|
Facility-
|
|
|
|
|
|
|
Severance
|
|
|
Related
|
|
|
|
|
|
|
and Benefits
|
|
|
Costs
|
|
|
Total
|
|
|
Balance at September 30, 2008
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Accruals during the year
|
|
|
513
|
|
|
|
1,250
|
|
|
|
1,763
|
|
Cash Payments
|
|
|
(513
|
)
|
|
|
(295
|
)
|
|
|
(808
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2009
|
|
$
|
|
|
|
$
|
955
|
|
|
$
|
955
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The charges above have been shown separately as restructuring
charges on the consolidated statements of income. The remaining
accrual as of September 30, 2009 relates to
facility-related costs that are expected to be paid within the
next 15 months. As such, the current portion totaling
$0.9 million is recorded as a current liability within
other accrued liabilities and the long-term portion totaling
$0.1 million is recorded as a long-term liability within
other long-term liabilities on the consolidated balance sheets.
The Company accounts for income taxes under the asset and
liability method prescribed in accounting guidance. Deferred tax
assets and liabilities are recognized for the future tax
consequences attributable to differences between the financial
statement carrying amounts of existing assets and liabilities
and their respective tax bases. A valuation allowance is
provided when it is more likely than not that some portion or
all of a deferred tax asset will not be realized. The ultimate
realization of deferred tax assets depends on the generation of
future taxable income during the period in which related
temporary differences become deductible. Management considers
the scheduled reversal of deferred tax liabilities, projected
future taxable income and tax planning strategies in this
assessment. Deferred tax assets and liabilities are measured
using the enacted tax rates expected to apply to taxable income
in the years in which those temporary differences are expected
to be recovered or settled. The effect on deferred tax assets
and liabilities of a change in tax rates is recognized in income
in the period that includes the enactment date of such change.
F-21
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
Income taxes in the accompanying consolidated statements of
income for the years ended September 30 are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
Current provision:
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
$
|
12,257
|
|
|
$
|
13,534
|
|
|
$
|
19,069
|
|
State and foreign
|
|
|
1,362
|
|
|
|
1,516
|
|
|
|
1,732
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current provision
|
|
|
13,619
|
|
|
|
15,050
|
|
|
|
20,801
|
|
Deferred provision (benefit):
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
|
7,483
|
|
|
|
(2,832
|
)
|
|
|
(8,573
|
)
|
State
|
|
|
872
|
|
|
|
(65
|
)
|
|
|
(907
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total deferred provision (benefit)
|
|
|
8,355
|
|
|
|
(2,897
|
)
|
|
|
(9,480
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total provision
|
|
$
|
21,974
|
|
|
$
|
12,153
|
|
|
$
|
11,321
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The reconciliation of the difference between amounts calculated
at the statutory federal tax rate for the fiscal years ended
September 30 and the Companys effective tax rate is as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
Amount at statutory federal income tax rate
|
|
$
|
20,833
|
|
|
$
|
9,387
|
|
|
$
|
5,067
|
|
Change because of the following items:
|
|
|
|
|
|
|
|
|
|
|
|
|
State taxes
|
|
|
1,206
|
|
|
|
715
|
|
|
|
736
|
|
Other
|
|
|
(481
|
)
|
|
|
223
|
|
|
|
(241
|
)
|
Stock-based compensation
|
|
|
416
|
|
|
|
239
|
|
|
|
262
|
|
Valuation allowance
|
|
|
|
|
|
|
1,589
|
|
|
|
|
|
Write-off of in-process research and development
|
|
|
|
|
|
|
|
|
|
|
5,497
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision
|
|
$
|
21,974
|
|
|
$
|
12,153
|
|
|
$
|
11,321
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The components of deferred income taxes consisted of the
following as of September 30 and result from differences in the
recognition of transactions for income tax and financial
reporting purposes (in thousands):
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
Depreciable assets
|
|
$
|
(2,951
|
)
|
|
$
|
(4,325
|
)
|
Deferred revenue
|
|
|
261
|
|
|
|
11,005
|
|
Accruals and reserves
|
|
|
526
|
|
|
|
523
|
|
Stock options
|
|
|
5,258
|
|
|
|
4,397
|
|
Impaired asset
|
|
|
3,264
|
|
|
|
3,318
|
|
Unrealized (losses) gains on investments
|
|
|
(962
|
)
|
|
|
66
|
|
Other
|
|
|
844
|
|
|
|
571
|
|
Valuation allowance
|
|
|
(3,339
|
)
|
|
|
(3,398
|
)
|
|
|
|
|
|
|
|
|
|
Total deferred tax asset
|
|
|
2,901
|
|
|
|
12,157
|
|
Less current deferred tax asset
|
|
|
(353
|
)
|
|
|
(1,058
|
)
|
|
|
|
|
|
|
|
|
|
Noncurrent deferred tax asset
|
|
$
|
2,548
|
|
|
$
|
11,099
|
|
|
|
|
|
|
|
|
|
|
In fiscal 2008, the Company recorded a $1.6 million
valuation allowance against the potential capital loss created
by the impairment of the Companys investment in OctoPlus
(see Note 2 for further information). The valuation
allowance was recorded because the Company does not currently
foresee future capital gains within the
F-22
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
allowable carry forward and carry back periods to offset this
capital loss when it was recognized. As such, no tax benefit has
been recorded in the consolidated statements of operations.
On October 1, 2007, the Company adopted new accounting
guidance on the accounting for uncertainty in income taxes. The
adoption of the new guidance resulted in an increase to retained
earnings as of October 1, 2007, of $80,000, which was
reflected as a cumulative effect of a change in accounting
principle, with a corresponding decrease to the net liability
for unrecognized tax expenses. Unrecognized tax benefits are the
differences between a tax position taken, or expected to be
taken in a tax return, and the benefit recognized for accounting
purposes pursuant to accounting guidance. A reconciliation of
the beginning and ending amount of unrecognized tax benefits is
as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
Beginning of fiscal year
|
|
$
|
1,540
|
|
|
$
|
1,120
|
|
Increases in tax positions for prior years
|
|
|
273
|
|
|
|
194
|
|
Increases in tax positions for current year
|
|
|
260
|
|
|
|
237
|
|
Settlements with taxing authorities
|
|
|
|
|
|
|
|
|
Lapse of the statute of limitations
|
|
|
(31
|
)
|
|
|
(11
|
)
|
|
|
|
|
|
|
|
|
|
End of fiscal year
|
|
$
|
2,042
|
|
|
$
|
1,540
|
|
|
|
|
|
|
|
|
|
|
The total amount of unrecognized tax benefits including interest
and penalties that, if recognized, would affect the effective
tax rate as of September 30, 2009 and 2008, respectively,
are $2.0 million and $1.3 million. Currently, the
Company does not expect the liability for unrecognized tax
benefits to change significantly in the next twelve months with
the above balances classified on the consolidated balance sheets
as a part of long-term liabilities. Interest and penalties
related to unrecognized tax benefits are recorded in income tax
expense. As of September 30, 2009 and 2008, a gross balance
of $605,000 and $397,000, respectively, has been accrued related
to the unrecognized tax benefits balance for interest and
penalties.
The Company files tax returns, including returns for its
subsidiaries, in the United States (U.S.) federal jurisdiction
and in various state jurisdictions. Uncertain tax positions are
related to tax years that remain subject to examination.
U.S. tax returns for fiscal years ended September 30,
2006, 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 2008
remain subject to examination by state and local tax authorities.
|
|
9.
|
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.
F-23
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
Alabama Jobs Commitment. In April 2008, the
Company purchased a 286,000 square foot facility to support
Current Good Manufacturing Practices manufacturing needs of
customers and the anticipated growth of the SurModics
Pharmaceuticals business. At the same time, SurModics
Pharmaceuticals entered into an agreement with various
governmental authorities to obtain financial incentives
associated with creation of jobs in Alabama. Some of the
governmental agencies have recapture rights in connection with
the financial incentives if the number of full-time employees
are not hired by June 2012, with an extension to June 2013 if
circumstances or events occur that are beyond the control of
SurModics Pharmaceuticals or could not have been reasonably
anticipated by SurModics Pharmaceuticals. As of
September 30, 2009, SurModics Pharmaceuticals has received
$1.7 million in connection with the agreement, and the
Company has recorded the payment in other long-term liabilities.
SRI Litigation. On July 31, 2009, the
Companys SurModics Pharmaceuticals business unit was named
as a defendant in litigation pending in the circuit court of
Jefferson County, Alabama, between SRI and two of SRIs
former employees (the Plaintiffs). In the
litigation, the Plaintiffs allege that they contributed to or
invented certain intellectual property while they were employed
at SRI, and pursuant to SRIs policies then in effect, they
are entitled to, among other things, a portion of the purchase
price consideration paid by the Company to SRI as part the
Companys acquisition of Brookwood Pharmaceuticals, Inc.,
pursuant to a stock purchase agreement made effective on
July 31, 2007 (the Stock Purchase Agreement). A
trial has not yet been scheduled. Pursuant to the Stock Purchase
Agreement, the Company has certain rights of indemnification
against losses (including without limitation, damages, expenses
and costs) incurred as a result of the litigation. The
Companys consolidated financial statements do not include
any expenses or liabilities related to the above litigation as
the probability of the outcome is currently not determinable and
any potential loss is not estimable. The Company believes that
it has meritorious defenses to the Plaintiffs claims and
will vigorously defend and prosecute this matter.
Operating Leases. The Company leases certain
facilities under noncancelable operating lease agreements. Rent
expense for the years ended September 30, 2009, 2008 and
2007 was $994,000, $773,000 and $140,000, respectively. Annual
commitments pursuant to operating lease agreements are as
follows:
|
|
|
|
|
Year Ended September 30,
|
|
|
|
|
2010
|
|
$
|
422,000
|
|
2011
|
|
|
177,000
|
|
2012
|
|
|
126,000
|
|
2013
|
|
|
131,000
|
|
2014
|
|
|
33,000
|
|
Thereafter
|
|
|
|
|
|
|
|
|
|
Total minimum lease payments
|
|
$
|
889,000
|
|
|
|
|
|
|
|
|
10.
|
Defined
Contribution Plans
|
The Company has a 401(k) retirement and savings plan for the
benefit of qualifying employees. The Company has matched 50% of
each dollar of the first 6% of the tax deferral elected by each
employee. Effective April 1, 2009, the Company changed its
matching contribution to a discretionary approach and the
Company ceased matching contributions. Company contributions
totaling $243,000, $539,000 and $356,000 have been expensed for
the years ended September 30, 2009, 2008 and 2007,
respectively. The expense increase in fiscal 2008 principally
reflects the addition of employees eligible for this benefit as
a result of the SurModics Pharmaceuticals acquisition.
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
F-24
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
how to allocate resources and in assessing performance. In
November 2008, the Company announced it changed its operational
structure so that the Company is now organized into four
clinically and market focused business units: Cardiovascular,
Ophthalmology, SurModics Pharmaceuticals, and In Vitro
Technologies. The Company believes that this structure will
improve the visibility, marketing and adoption of the
Companys broad array of technologies within specific
markets and help its customers in the medical device,
pharmaceutical and life science industries solve unmet clinical
needs. In addition, a new centralized research and development
function has been formed to serve the needs of the
Companys clinically and market focused business units,
other than the SurModics Pharmaceuticals business unit, which
continues to maintain certain R&D operations.
The Company manages its business on the basis of the markets
noted in the table below, which are comprised of the
Companys four business units. Therapeutic
contains: (1) the Cardiovascular business unit, which
provides drug delivery and surface modification technologies to
customers in the cardiovascular market; (2) the
Ophthalmology business unit, which is currently focused on the
advancement of treatments for eye diseases, such as age-related
macular degeneration (AMD) and diabetic macular edema (DME), two
of the leading causes of blindness; and (3) the SurModics
Pharmaceuticals business unit, which provides proprietary
polymer-based drug delivery technologies to companies developing
improved pharmaceutical products in cardiovascular,
ophthalmology and other clinical markets. Revenue results in
Therapeutic are presented below by the clinical market areas in
which the Companys customers participate (Cardiovascular,
Ophthalmology and Other Markets). Diagnostic
contains the In Vitro Technologies business unit, which includes
the Companys microarray slide technologies, stabilization
products, antigens and substrates for immunoassay diagnostics
tests, and its in vitro diagnostic format technology.
For fiscal years ended September 30, 2009, 2008 and 2007,
the Companys results are aggregated into one reportable
segment, as each business unit has similar economic
characteristics, technology, manufacturing processes, customers,
regulatory environments, and shared infrastructures. The Company
manages its expenses on a company-wide basis, as many costs and
activities are shared among the business units. 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 markets, for the years
ended September 30 as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
Therapeutic
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular
|
|
$
|
39,841
|
|
|
$
|
47,675
|
|
|
$
|
46,487
|
|
Ophthalmology
|
|
|
52,102
|
|
|
|
10,252
|
|
|
|
2,453
|
|
Other Markets
|
|
|
13,114
|
|
|
|
17,875
|
|
|
|
4,041
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Therapeutic
|
|
|
105,057
|
|
|
|
75,802
|
|
|
|
52,981
|
|
Diagnostic
|
|
|
16,477
|
|
|
|
21,249
|
|
|
|
20,183
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
121,534
|
|
|
$
|
97,051
|
|
|
$
|
73,164
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Major
Customers
Revenue from customers that equaled or exceeded 10% of total
revenue was as follows for the years ended September 30:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
2007
|
|
Merck & Company
|
|
|
37
|
%
|
|
|
<10
|
%
|
|
|
**
|
|
Johnson & Johnson
|
|
|
11
|
%
|
|
|
20
|
%
|
|
|
33
|
%
|
Abbott Laboratories
|
|
|
<10
|
%
|
|
|
10
|
%
|
|
|
16
|
%
|
|
|
|
** |
|
- less than one percent |
F-25
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
The revenue from the customers listed is derived from all three
primary sources: royalties and license fees, product sales, and
research and development fees.
Geographic
Revenue
Geographic revenue was as follows for the years ended September
30:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
2007
|
|
Domestic
|
|
|
84
|
%
|
|
|
79
|
%
|
|
|
81
|
%
|
Foreign
|
|
|
16
|
%
|
|
|
21
|
%
|
|
|
19
|
%
|
|
|
12.
|
Quarterly
Financial Data (Unaudited)
|
The following is a summary of the unaudited quarterly results
for the years ended September 30, 2009, 2008 and 2007
(in thousands, except per share data).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First
|
|
|
Second
|
|
|
Third
|
|
|
Fourth
|
|
|
|
Quarter
|
|
|
Quarter
|
|
|
Quarter
|
|
|
Quarter
|
|
|
Fiscal 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
63,216
|
|
|
$
|
20,925
|
|
|
$
|
18,186
|
|
|
$
|
19,207
|
|
Income from operations
|
|
|
42,667
|
|
|
|
6,200
|
|
|
|
4,661
|
|
|
|
3,973
|
|
Net income
|
|
|
27,085
|
|
|
|
4,216
|
|
|
|
3,539
|
|
|
|
2,710
|
|
Net income per share(1):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
1.53
|
|
|
|
0.24
|
|
|
|
0.20
|
|
|
|
0.16
|
|
Diluted
|
|
|
1.53
|
|
|
|
0.24
|
|
|
|
0.20
|
|
|
|
0.16
|
|
Fiscal 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
23,829
|
|
|
$
|
25,707
|
|
|
$
|
24,276
|
|
|
$
|
23,239
|
|
Income from operations
|
|
|
7,571
|
|
|
|
7,181
|
|
|
|
7,184
|
|
|
|
5,325
|
|
Net income (loss)
|
|
|
5,646
|
|
|
|
5,107
|
|
|
|
4,800
|
|
|
|
(814
|
)
|
Net income (loss) per share(1):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
0.31
|
|
|
|
0.28
|
|
|
|
0.27
|
|
|
|
(0.05
|
)
|
Diluted
|
|
|
0.31
|
|
|
|
0.28
|
|
|
|
0.26
|
|
|
|
(0.05
|
)
|
Fiscal 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
16,740
|
|
|
$
|
17,362
|
|
|
$
|
17,762
|
|
|
$
|
21,300
|
|
Income (loss) from operations
|
|
|
8,109
|
|
|
|
8,085
|
|
|
|
7,518
|
|
|
|
(13,813
|
)
|
Net income (loss)
|
|
|
5,992
|
|
|
|
5,675
|
|
|
|
5,587
|
|
|
|
(13,907
|
)
|
Net income (loss) per share(1):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
0.32
|
|
|
|
0.31
|
|
|
|
0.31
|
|
|
|
(0.78
|
)
|
Diluted
|
|
|
0.32
|
|
|
|
0.31
|
|
|
|
0.31
|
|
|
|
(0.78
|
)
|
|
|
|
(1) |
|
The sum of the quarterly earnings per share may not equal the
annual earnings per share because of changes in the average
shares outstanding. |
F-26
SurModics,
Inc. and Subsidiaries
Notes to
Consolidated Financial
Statements (Continued)
In the first quarter of fiscal 2009, the Company recorded income
that had previously been deferred of $34.8 million
associated with the Merck contract termination, a
$9 million milestone payment from Merck associated with the
termination of the triamcinolone acetonide development program,
a $3.2 million charge for in-process research and
development acquired in connection with the purchase of certain
contracts and assets of PR Pharma, as well as a
$1.8 million restructuring charge associated with a
functional reorganization.
In the fourth quarter of fiscal 2009, the Company recorded
$1.3 million in royalty income in connection with the
settlement of previously disclosed litigation involving Abbott
Laboratories and Church & Dwight Co, Inc.
In the fourth quarter of fiscal 2008, the Company recorded a
$4.3 million non-cash impairment loss on its investment in
OctoPlus.
In the fourth quarter of fiscal 2007, the Company recorded a
$15.6 million charge for in-process research and
development acquired in connection with the purchase of
SurModics Pharmaceuticals, Inc.
F-27
exv23
Exhibit 23
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in Registration Statement No. 333-123524 on Form S-3
and Registration Statement Nos. 333-104258, 333-64171, 333-64173, 333-79741, 333-54266 and
333-123521 on Form S-8 of our report dated December 11, 2009, relating to the consolidated
financial statements and financial statement schedule of SurModics, Inc., which report expresses an
unqualified opinion and includes an explanatory paragraph relating to SurModics, Inc.s adoption of
new accounting guidance on the accounting for uncertainty in income
taxes, appearing in the Annual Report on Form
10-K/A of SurModics, Inc. for the year ended September 30, 2009.
DELOITTE & TOUCHE LLP
Minneapolis, Minnesota
December 11, 2009
exv31w1
Exhibit 31.1
CERTIFICATIONS
I, Bruce J Barclay, certify that:
1. |
|
I have reviewed this Annual Report on Form 10-K/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 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.
Date: December 14, 2009
|
|
|
|
|
|
|
|
|
/s/ Bruce J Barclay
|
|
|
Bruce J Barclay |
|
|
President and Chief Executive Officer |
|
|
exv31w2
Exhibit 31.2
CERTIFICATIONS
I, Philip D. Ankeny, certify that:
1. |
|
I have reviewed this Annual Report on Form 10-K/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 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.
Date: December 14, 2009
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/s/ Philip D. Ankeny
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Philip D. Ankeny |
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Senior Vice President and
Chief Financial Officer |
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exv32w1
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report of SurModics, Inc. (the Company) on Form 10-K/A for the
year ended September 30, 2009 as filed with the Securities and Exchange Commission (the Report),
I, Bruce J Barclay, 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, as amended; and
(2) The information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
Date: December 14, 2009
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/s/ Bruce J Barclay
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Bruce J Barclay |
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President and Chief Executive Officer |
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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 Annual Report of SurModics, Inc. (the Company) on Form 10-K/A for
the year ended September 30, 2009 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, as amended; and
(2) The information contained in the Report fairly presents, in all material respects,
the financial condition and results of operations of the Company.
Date: December 14, 2009
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/s/ Philip D. Ankeny
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Philip D. Ankeny |
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Senior Vice President and
Chief Financial Officer |
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