SURMODICS INC - Quarter Report: 2010 March (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2010
or
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 0-23837
SurModics, Inc.
(Exact name of registrant as specified in its charter)
MINNESOTA (State of incorporation) |
41-1356149 (I.R.S. Employer Identification No.) |
9924 West 74th Street
Eden Prairie, Minnesota 55344
(Address of principal executive offices) (Zip Code)
Eden Prairie, Minnesota 55344
(Address of principal executive offices) (Zip Code)
Registrants telephone number, including area code: (952) 829-2700
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes
o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
Large accelerated filer o | Accelerated filer þ | Non-accelerated filer o | Smaller reporting company o | |||
(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 number of shares of the registrants Common Stock, $.05 par value per share, outstanding as of
May 3, 2010 was 17,409,835.
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EXHIBIT INDEX TO FORM 10-Q |
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Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
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Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
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Certification of Chief Executive Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
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Certification of Chief Financial Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002 |
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EX-10.1 | ||||||||
EX-10.2 | ||||||||
EX-31.1 | ||||||||
EX-31.2 | ||||||||
EX-32.1 | ||||||||
EX-32.2 |
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PART I. FINANCIAL INFORMATION
Item 1. | Financial Statements |
SurModics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
Condensed Consolidated Balance Sheets
March 31, | September 30, | |||||||
2010 | 2009 | |||||||
(In thousands, except share data) | (Unaudited) | |||||||
ASSETS |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
$ | 11,174 | $ | 11,636 | ||||
Short-term investments |
8,170 | 8,932 | ||||||
Accounts receivable, net of allowance for doubtful
accounts of $195 and $82 as of March 31, 2010 and
September 30, 2009, respectively |
12,805 | 11,320 | ||||||
Inventories |
3,312 | 3,330 | ||||||
Deferred tax asset |
721 | 353 | ||||||
Prepaids and other |
2,514 | 1,443 | ||||||
Total current assets |
38,696 | 37,014 | ||||||
Property and equipment, net |
64,249 | 66,915 | ||||||
Long-term investments |
32,467 | 27,300 | ||||||
Deferred tax asset |
1,752 | 2,548 | ||||||
Intangible assets , net |
16,644 | 17,458 | ||||||
Goodwill |
21,820 | 21,070 | ||||||
Other assets, net |
14,886 | 13,257 | ||||||
Total assets |
$ | 190,514 | $ | 185,562 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities |
||||||||
Accounts payable |
$ | 2,004 | $ | 3,468 | ||||
Accrued liabilities |
2,219 | 2,563 | ||||||
Accrued income taxes payable |
| 186 | ||||||
Deferred revenue |
1,054 | 905 | ||||||
Other current liabilities |
1,797 | 862 | ||||||
Total current liabilities |
7,074 | 7,984 | ||||||
Deferred revenue, less current portion |
4,047 | 623 | ||||||
Other long-term liabilities |
4,811 | 4,583 | ||||||
Total liabilities |
15,932 | 13,190 | ||||||
Commitments and contingencies |
||||||||
Stockholders Equity |
||||||||
Series A Preferred stock- $.05 par value, 450,000
shares authorized; no shares issued and
outstanding |
| | ||||||
Common stock- $.05 par value, 45,000,000 shares
authorized; 17,416,335 and 17,471,472 shares
issued and outstanding |
871 | 874 | ||||||
Additional paid-in capital |
67,341 | 66,005 | ||||||
Accumulated other comprehensive income |
890 | 1,504 | ||||||
Retained earnings |
105,480 | 103,989 | ||||||
Total stockholders equity |
174,582 | 172,372 | ||||||
Total liabilities and stockholders equity |
$ | 190,514 | $ | 185,562 | ||||
The accompanying notes are an integral part of these unaudited condensed consolidated
financial statements.
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SurModics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
Condensed Consolidated Statements of Operations
Three Months Ended | Six Months Ended | |||||||||||||||
March 31, | March 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
(In thousands, except per share data) | (unaudited) | (unaudited) | ||||||||||||||
Revenue |
||||||||||||||||
Royalties and license fees |
$ | 7,779 | $ | 10,052 | $ | 16,977 | $ | 57,799 | ||||||||
Product sales |
5,269 | 4,776 | 9,817 | 8,632 | ||||||||||||
Research and development |
5,312 | 6,097 | 8,947 | 17,710 | ||||||||||||
Total revenue |
18,360 | 20,925 | 35,741 | 84,141 | ||||||||||||
Operating costs and expenses |
||||||||||||||||
Product costs |
2,475 | 1,838 | 4,432 | 3,353 | ||||||||||||
Customer research and development |
4,783 | 3,368 | 8,106 | 7,073 | ||||||||||||
Other research and development |
4,565 | 5,116 | 9,284 | 10,764 | ||||||||||||
Selling, general and administrative |
4,109 | 4,403 | 8,723 | 9,086 | ||||||||||||
Purchased in-process research and development |
| | | 3,200 | ||||||||||||
Restructuring charges |
1,306 | | 1,306 | 1,798 | ||||||||||||
Asset impairment charge |
2,074 | | 2,074 | | ||||||||||||
Total operating costs and expenses |
19,312 | 14,725 | 33,925 | 35,274 | ||||||||||||
(Loss) income from operations |
(952 | ) | 6,200 | 1,816 | 48,867 | |||||||||||
Other income |
||||||||||||||||
Investment income |
281 | 397 | 578 | 1,131 | ||||||||||||
Other income (loss), net |
3 | 20 | 3 | (129 | ) | |||||||||||
Other income |
284 | 417 | 581 | 1,002 | ||||||||||||
(Loss) income before income taxes |
(668 | ) | 6,617 | 2,397 | 49,869 | |||||||||||
Income tax benefit (provision) |
241 | (2,401 | ) | (907 | ) | (18,568 | ) | |||||||||
Net (loss) income |
$ | (427 | ) | $ | 4,216 | $ | 1,490 | $ | 31,301 | |||||||
Basic net (loss) income per share |
$ | (0.02 | ) | $ | 0.24 | $ | 0.09 | $ | 1.79 | |||||||
Diluted net (loss) income per share |
$ | (0.02 | ) | $ | 0.24 | $ | 0.09 | $ | 1.78 | |||||||
Weighted average shares outstanding |
||||||||||||||||
Basic |
17,369 | 17,320 | 17,378 | 17,509 | ||||||||||||
Dilutive effect of outstanding stock options
and nonvested stock |
| 29 | 23 | 45 | ||||||||||||
Diluted |
17,369 | 17,349 | 17,401 | 17,554 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial
statements.
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SurModics, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
Six Months Ended | ||||||||
March 31, | ||||||||
2010 | 2009 | |||||||
(In thousands) | (unaudited) | |||||||
Operating Activities: |
||||||||
Net income |
$ | 1,490 | $ | 31,301 | ||||
Adjustments to reconcile net income to net cash provided by operating activities: |
||||||||
Depreciation and amortization |
3,852 | 2,999 | ||||||
Loss (gain) on equity method investment and sales of investments |
(3 | ) | 221 | |||||
Amortization of premium on investments |
68 | 69 | ||||||
Stock-based compensation |
2,760 | 3,632 | ||||||
Purchased in-process research and development |
| 3,200 | ||||||
Restructuring charges |
1,306 | 1,798 | ||||||
Asset impairment charge |
2,074 | | ||||||
Deferred taxes |
856 | 9,203 | ||||||
Tax benefits from exercise of stock options |
(90 | ) | 273 | |||||
Change in operating assets and liabilities: |
||||||||
Accounts receivable |
(1,485 | ) | 1,721 | |||||
Inventories |
18 | (454 | ) | |||||
Accounts payable and accrued liabilities |
(956 | ) | (2,529 | ) | ||||
Income taxes |
(1,129 | ) | 1,427 | |||||
Deferred revenue |
3,573 | (36,118 | ) | |||||
Prepaids and other |
19 | 119 | ||||||
Net cash provided by operating activities |
12,353 | 16,862 | ||||||
Investing Activities: |
||||||||
Purchases of property and equipment |
(5,614 | ) | (11,269 | ) | ||||
Purchases of available-for-sale investments |
(10,696 | ) | (12,280 | ) | ||||
Sales/maturities of investments |
6,172 | 16,373 | ||||||
Business acquisition |
(750 | ) | (4,040 | ) | ||||
Other investing activities |
(501 | ) | (202 | ) | ||||
Net cash used in investing activities |
(11,389 | ) | (11,418 | ) | ||||
Financing Activities: |
||||||||
Tax benefit from exercise of stock options |
90 | (273 | ) | |||||
Issuance of common stock |
892 | 655 | ||||||
Repurchase of common stock |
(2,032 | ) | (14,998 | ) | ||||
Purchase of common stock to pay employee taxes |
(376 | ) | (436 | ) | ||||
Repayment of notes payable |
| (236 | ) | |||||
Net cash used in financing activities |
(1,426 | ) | (15,288 | ) | ||||
Net change in cash and cash equivalents |
(462 | ) | (9,844 | ) | ||||
Cash and Cash equivalents |
||||||||
Beginning of period |
11,636 | 15,376 | ||||||
End of period |
$ | 11,174 | $ | 5,532 | ||||
Supplemental Information |
||||||||
Cash paid for income taxes |
$ | 1,180 | $ | 7,869 | ||||
Noncash transaction accrued contingent consideration or accrued earnout
payments in connection with business acquisitions |
$ | | $ | 4,530 | ||||
Noncash transaction acquisition of property, plant, and equipment on account |
$ | 195 | $ | 3,977 | ||||
Noncash transaction acquisition of intangible assets on account |
$ | 210 | $ | 631 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial
statements.
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SurModics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
Period Ended March 31, 2010
(Unaudited)
(1) Basis of Presentation
The accompanying unaudited interim condensed consolidated financial statements have been
prepared in accordance with accounting principles generally accepted in the United States of
America (GAAP) and reflect all adjustments, consisting solely of normal recurring adjustments,
needed to fairly present the financial results for the periods presented. These financial
statements include some amounts that are based on managements best estimates and judgments. These
estimates may be adjusted as more information becomes available, and any adjustment could be
significant. The impact of any change in estimates is included in the determination of earnings in
the period in which the change is identified. The results of operations for the three-month and
six-month periods ended March 31, 2010 are not necessarily indicative of the results that may be
expected for the entire 2010 fiscal year.
In accordance with the rules and regulations of the United States Securities and Exchange
Commission, the Company has omitted footnote disclosures that would substantially duplicate the
disclosures contained in the audited financial statements of the Company. These unaudited condensed
consolidated financial statements should be read together with the audited consolidated financial
statements for the year ended September 30, 2009, and footnotes thereto included in the Companys
Form 10-K/A as filed with the United States Securities and Exchange Commission on December 14,
2009.
In September 2008, following a strategic review of Merck & Co., Inc.s (Merck) business and
product development portfolio, Merck gave notice to SurModics of Mercks intent to terminate a
collaborative research and license agreement (Merck Agreement) and separate supply agreement
entered into in June 2007. The termination was effective December 16, 2008. The Company recognized
revenue of approximately $45 million in the first six months of fiscal 2009 principally from
amounts that previously had been deferred and amortized under the then existing accounting
treatment required for revenue arrangements with multiple deliverables and a $9 million milestone
payment associated with the termination of the triamcinolone acetonide development program under
the Merck Agreement. The fiscal 2009 six month revenue associated with the Merck Agreement is
reflected in royalties and license fees ($37.6 million) and in research and development fees ($7.5
million).
Subsequent events have been evaluated through the date the financial statements were issued.
(2) Key Accounting Policies and Recent Accounting Pronouncements
Revenue recognition
This revenue recognition section includes the Companys historical policies as well as
adoption of any applicable accounting guidance that has been issued during fiscal 2010.
The Company recognizes revenue when all of the following criteria are met: (1) persuasive
evidence of an arrangement exists; (2) shipment has occurred or delivery has occurred if the terms
specify destination; (3) the sales price is fixed or determinable; and (4) collectability is
reasonably assured. When there are additional performance requirements, revenue is recognized when
all such requirements have been satisfied.
The Companys revenue is derived from three primary sources: (1) royalties and license fees
from licensing its proprietary drug delivery and surface modification technologies to customers;
(2) the sale of polymers and reagent chemicals, stabilization products, antigens, substrates and
microarray slides to the diagnostics and biomedical research industries; and (3) research and
development fees generated on customer projects.
Royalties and licenses fees. The Company licenses technology to third parties and collects
royalties. Royalty revenue is generated when a customer sells products incorporating the Companys
licensed technologies. Royalty revenue is recognized as licensees report it to the Company, and
payment is typically submitted concurrently with the report. This revenue recognition model is
similar to usage fee accounting. Minimum royalty fees are recognized in the period earned, provided
that collectability is reasonably assured. For stand-alone license agreements, up-front license
fees are recognized over the term of the related licensing agreement.
Milestone payments. Revenue related to a performance milestone is recognized based upon the
achievement of the milestone, as defined in the respective agreements and provided the following
conditions have been met:
| The milestone payment is non-refundable; |
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| The milestone involved a significant degree of risk, and was not reasonably assured at the inception of the arrangement; | ||
| Accomplishment of the milestone involved substantial past effort/performance; | ||
| The amount of the milestone payment is commensurate with the related effort and risk; | ||
| The milestone payment is reasonable in comparison to all of the deliverables and payment terms in the arrangement; and | ||
| A reasonable amount of time passed between the initial license payment and the first and subsequent milestone payments. |
If these conditions have not been met, the milestone payment is deferred and recognized over
the 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. Prior to October 1, 2009, arrangements such as
license and development agreements were analyzed to determine whether the deliverables, which often
include a license and performance obligations such as research and development, could be separated,
or whether they must be accounted for as a single unit of accounting in accordance with accounting
guidance. If the fair value of the undelivered performance obligations could be determined, such
obligations would then be accounted for separately. If the license was considered to either (i) not
have stand-alone value or (ii) have stand-alone value but the fair value of any of the undelivered
performance obligations could not be determined, the arrangement would then be accounted for as a
single unit of accounting, and the license payments and payments for performance obligations would
be recognized as revenue over the estimated period of when the performance obligations are
performed, or the economic life of the technology licensed to the customer. When the Company
determined that an arrangement should be accounted for as a single unit of accounting, it
recognized the related revenue on a time-based accounting model.
The Company had one significant multiple element arrangement prior to October 1, 2009 that was
accounted for as a single unit of accounting resulting in deferral and recognition of all related
payments received for license and research and development activities using a time-based model.
This arrangement was terminated during the first quarter of fiscal 2009 as described in Note 1
above.
In October 2009, the Financial Accounting Standards Board (FASB) amended the accounting
standards for multiple deliverable revenue arrangements to:
(i) | provide updated guidance on whether multiple deliverables exist, how the deliverables in an arrangement should be separated, and how the consideration should be allocated; | ||
(ii) | require an entity to allocate revenue in an arrangement using estimated selling prices (ESP) of deliverables if a vendor does not have vendor-specific objective evidence of selling price (VSOE) or third-party evidence of selling price (TPE); and | ||
(iii) | eliminate the use of the residual method and require an entity to allocate revenue using the relative selling price method. |
The Company elected to early adopt this accounting guidance at the beginning of its first
quarter of fiscal 2010, on a prospective basis, for applicable transactions originating or
materially modified after October 1, 2009. In connection with the adoption of the amended
accounting standard the Company also changed its policy prospectively for multiple element
arrangements, whereby the Company accounts for revenue using a multiple attribution model in which
consideration allocated to research and development activities is recognized as performed, and
milestone payments are recognized when the milestone events are achieved, when such activities and
milestones are deemed substantive. Accordingly, in situations where a unit of accounting includes
both a license and research and development activities, and when a license does not have stand
alone value, the Company applies a multiple attribution model in which consideration allocated to
the license is recognized ratably, consideration allocated to research and development activities
is recognized as performed and milestone payments are recognized when the milestone events are
achieved, when such activities and milestones are deemed substantive.
The Company enters into license and development arrangements that may consist of multiple
deliverables which could include a license(s) to SurModics technology, research and development
activities, manufacturing services, and product sales based on the needs of its customers. For
example, a customer may enter into an arrangement to obtain a license to SurModics intellectual
property which may also include research and development activities, and supply of products
manufactured by SurModics. For these services
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provided, SurModics could receive upfront license
fees upon signing of an agreement and granting the license, fees for research and
development activities as such activities are performed, milestone payments contingent upon
advancement of the product through development and clinical stages to successful commercialization,
fees for manufacturing services and supply of product, and royalty payments based on customer sales
of product incorporating SurModics technology. The Companys license and development arrangements
generally do not have refund provisions if the customer cancels or terminates the agreement.
Typically all payments made are non-refundable.
The Company evaluates each deliverable in a multiple element arrangement for separability. The
Company is then required to allocate revenue to each separate deliverable using a hierarchy of
VSOE, TPE, or ESP. In certain instances, the Company is not able to establish VSOE for all
deliverables in an arrangement with multiple elements which may be a result of the Company
infrequently selling each element separately. When VSOE cannot be established, the Company
establishes a selling price of each element based on TPE. TPE is determined based on competitor
prices for similar deliverables when sold separately.
When the Company is unable to establish a selling price using VSOE or TPE, the Company uses
ESP in its allocation of arrangement consideration. The objective of ESP is to determine the price
at which the Company would transact a sale if the product or service were sold on a stand-alone
basis. ESP is generally used for highly customized offerings.
The Company determines ESP for undelivered elements by considering multiple factors including,
but not limited to, market conditions, competitive landscape and past pricing arrangements with
similar characteristics.
Net sales as reported and pro forma net sales that would have been reported for the
three-month and six-month periods ended March 31, 2010, if the transactions entered into or
materially modified after September 30, 2009 were subject to the Companys accounting policies
under the previous accounting guidance, are shown in the following table (in thousands):
Three months ended | Six months ended | |||||||||||||||
March 31, 2010 | March 31, 2010 | |||||||||||||||
Pro Forma | Pro Forma | |||||||||||||||
Basis as if the | Basis as if the | |||||||||||||||
Previous | Previous | |||||||||||||||
Accounting | Accounting | |||||||||||||||
Guidance | Guidance | |||||||||||||||
As | Were in | As | Were in | |||||||||||||
Reported | Effect | Reported | Effect | |||||||||||||
Total multiple element arrangement revenue |
$ | 2,355 | $ | 114 | $ | 3,377 | $ | 170 | ||||||||
The impact to revenue for the three-month and six-month periods ended March 31, 2010
associated with adoption of the new accounting guidance was primarily related to research and
development activities. The Companys accounting policies under the previous accounting guidance
would have resulted in partial recognition of the research and development revenue in the current
periods with the remainder deferred and recognized over the economic life of the technology. Under
the new accounting guidance, the Company is recognizing research and development revenue as the
activities are performed. The Company notes that this new accounting guidance will result in
current revenue recognition of research and development activities in the period the activities are
performed with the revenue generated changing from period to period based on the stage of project
development. The amount of revenue that is recognized could be material in any reporting period.
In April 2010, the FASB issued updated authoritative accounting guidance which provides a
consistent framework for applying the milestone method of revenue recognition in arrangements that
include research or development deliverables. The amendments are effective on a prospective basis
for milestones achieved in fiscal years, and interim periods within those years, beginning on or
after June 15, 2010 with early adoption permitted. The Company is evaluating the guidance and does
not expect the adoption to have a material impact on the Companys consolidated financial
statements.
Other accounting areas
In April 2008, the FASB issued authoritative accounting guidance which amends the factors that
should be considered in developing renewal or extension assumptions used to determine the useful
life of intangible assets under goodwill and other intangible asset accounting. The authoritative
guidance is intended to improve the consistency between the useful life of a recognized intangible
asset under goodwill and intangible asset accounting and the period of the expected cash flows used
to measure the fair value of the asset under business combination accounting and other GAAP. The
adoption of the authoritative guidance did not have a material impact on the Companys consolidated
financial statements.
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In September 2006, the FASB issued authoritative accounting guidance associated with fair
value measurements. This guidance
defines fair value, establishes a consistent framework for measuring fair value, gives
guidance regarding methods used for measuring fair value and expands disclosures about fair value
measurements. These provisions were implemented in fiscal 2009. See Note 3 for additional
information regarding fair value measurements. However, in February 2008, the FASB issued guidance
that delayed the effective date from fiscal 2009 to fiscal 2010 for all nonfinancial assets and
liabilities, except those that are recognized or disclosed at fair value in the financial
statements on a recurring basis (at least annually). The adoption of the authoritative guidance did
not have a material impact on the Companys consolidated financial statements.
No other new accounting pronouncement issued or effective has had, or is expected to have, a
material impact on the Companys consolidated financial statements.
(3) Fair Value Measurements
Effective October 1, 2008, the Company adopted the new accounting guidance on fair value
measurements. The new guidance defines fair value, establishes a framework for measuring fair value
under GAAP, and expands disclosures about fair value measurements. The guidance is applicable for
all financial assets and financial liabilities and for all nonfinancial assets and nonfinancial
liabilities recognized or disclosed at fair value in the financial statements on a recurring basis
(at least annually). Fair value is defined as the exchange price that would be received from
selling an asset or paid to transfer a liability (an exit price) in an orderly transaction between
market participants at the measurement date. When determining the fair value measurements for
assets and liabilities required or permitted to be recorded at fair value, the Company considers
the principal or most advantageous market in which it would transact and also considers assumptions
that market participants would use when pricing the asset or liability, such as inherent risk,
transfer restrictions and risk of nonperformance.
Fair Value Hierarchy
Accounting guidance on fair value measurements requires that assets and liabilities carried at
fair value be classified and disclosed in one of the following three categories:
Level 1 Quoted (unadjusted) prices in active markets for identical assets or liabilities.
The Companys Level 1 asset consists of its investment in OctoPlus, N.V. (see Note 7 for
further information). The fair market value of this investment is based on the quoted price of
OctoPlus shares traded on the Amsterdam Stock Exchange.
Level 2 Observable inputs other than quoted prices included in Level 1, such as quoted prices for
similar assets or liabilities in active markets; quoted prices for identical or similar assets or
liabilities in markets that are not active; or other inputs that are observable or can be
corroborated by observable market data for substantially the full term of the asset or liability.
The Companys Level 2 assets consist of money market funds, U.S. Treasury securities,
corporate bonds, municipal bonds, U.S. agency securities, agency and municipal securities, certain
asset-backed securities and mortgage-backed securities. Fair market values for these assets are
based on quoted vendor prices and broker pricing where all significant inputs are observable.
Level 3 Unobservable inputs to the valuation methodology that are supported by little or no
market activity and that are significant to the measurement of the fair value of the assets or
liabilities. Level 3 assets and liabilities include those whose fair value measurements are
determined using pricing models, discounted cash flow methodologies or similar valuation
techniques, as well as significant management judgment or estimation.
The Companys Level 3 assets include other U.S. government agency securities 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. The Company did not significantly change
its valuation techniques from prior periods.
Transfers of assets from Level 2 to Level 3 classifications are made when there is a lack of
observable market data resulting from a decrease in market activity for the affected securities.
The Companys policy is to recognize transfers in and out of Level 3 using the value at the
beginning of the reporting period.
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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 March 31, 2010 (in thousands):
Quoted Prices | ||||||||||||||||
in Active | Significant | |||||||||||||||
Markets for | Other | Significant | Total Fair | |||||||||||||
Identical | Observable | Unobservable | Value as of | |||||||||||||
Instruments | Inputs | Inputs | March 31, | |||||||||||||
(Level 1) | (Level 2) | (Level 3) | 2010 | |||||||||||||
Assets: |
||||||||||||||||
Cash equivalents |
$ | | $ | 8,092 | $ | | $ | 8,092 | ||||||||
Available for sale debt securities |
||||||||||||||||
US government obligations |
| 19,233 | 924 | 20,157 | ||||||||||||
Mortgage backed securities |
| 6,356 | 145 | 6,501 | ||||||||||||
Municipal bonds |
| 5,153 | | 5,153 | ||||||||||||
Asset back securities |
| 1,862 | | 1,862 | ||||||||||||
Corporate bonds |
| 1,780 | | 1,780 | ||||||||||||
Other assets |
2,714 | | | 2,714 | ||||||||||||
Total assets measured at fair value |
$ | 2,714 | $ | 42,476 | $ | 1,069 | $ | 46,259 | ||||||||
Short-term and long-term investments disclosed in the condensed consolidated balance sheets
include held-to-maturity investments totaling $5.2 million as of March 31, 2010. Held-to-maturity
investments are carried at an amortized cost.
Changes in Level 3 Instruments Measured at Fair Value on a Recurring Basis
The following tables provide a reconciliation of fiscal 2010 financial assets and liabilities
measured at fair value on a recurring basis using significant unobservable inputs (Level 3) based
on accounting guidance that is applicable for periods ended March 31, 2010 (in thousands):
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) | ||||||||||||
For the three months ended March 31, 2010 | ||||||||||||
Available -for-Sale Debt Securities | ||||||||||||
U.S. government obligations | Mortgage Backed | Total | ||||||||||
Balance, December 31, 2009 |
$ | 1,002 | $ | 75 | $ | 1,077 | ||||||
Transfers into Level 3 |
| 70 | 70 | |||||||||
Total realized and unrealized gains (losses): |
||||||||||||
Included in
other comprehensive (loss) income |
(6 | ) | 3 | (3 | ) | |||||||
Purchases, issuances, sales and settlements, net |
(72 | ) | (3 | ) | (75 | ) | ||||||
Balance, March 31, 2010 |
$ | 924 | $ | 145 | $ | 1,069 | ||||||
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) | ||||||||||||
For the six months ended March 31, 2010 | ||||||||||||
Available -for-Sale Debt Securities | ||||||||||||
U.S. government obligations | Mortgage Backed | Total | ||||||||||
Balance, September 30, 2009 |
$ | 1,130 | $ | 73 | $ | 1,203 | ||||||
Transfers into Level 3 |
| 148 | 148 | |||||||||
Transfers out of Level 3 |
(36 | ) | (73 | ) | (109 | ) | ||||||
Total realized and unrealized gains (losses): |
||||||||||||
Included in
other comprehensive (loss) income |
(6 | ) | 3 | (3 | ) | |||||||
Purchases, issuances, sales and settlements, net: |
(164 | ) | (6 | ) | (170 | ) | ||||||
Balance, March 31, 2010 |
$ | 924 | $ | 145 | $ | 1,069 | ||||||
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As of March 31, 2010, marketable securities measured at fair value using Level 3 inputs were
comprised of $0.9 million of U.S. government agency securities and $0.1 million of mortgage-backed
securities within the Companys available-for-sale investment portfolio. These securities were
measured using observable market data and Level 3 inputs as a result of the lack of market activity
and liquidity. The fair value of these securities was based on the Companys assessment of the
underlying collateral and the creditworthiness of the particular issuer of the securities.
The following tables provide a reconciliation of fiscal 2009 financial assets and liabilities
measured at fair value on a recurring basis using significant unobservable inputs (Level 3) (in
thousands):
Three Months | Six Months | |||||||
Ended | Ended | |||||||
March 31, | March 31, | |||||||
2009 | 2009 | |||||||
Balance, beginning of period |
$ | 838 | $ | 264 | ||||
Total realized and unrealized gains: |
||||||||
Included in
other comprehensive (loss) income |
| 25 | ||||||
Purchases, issuances and settlements, net |
(13 | ) | 536 | |||||
Transfer in (out) of Level 3 |
(778 | ) | (778 | ) | ||||
Balance, end of period |
$ | 47 | $ | 47 | ||||
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 need for
possible additional funding at a lower valuation. The valuation methodology for determining the
decline in value of non-marketable equity securities is based on inputs that require management
judgment and are Level 3 inputs.
(4) Investments
Investments consist principally of U.S. government and government agency obligations and
mortgage-backed securities and are classified as available-for-sale or held-to-maturity at March
31, 2010 and September 30, 2009. Available-for-sale investments are reported at fair value with
unrealized gains and losses net of tax excluded from operations and reported as a separate
component of stockholders equity, except for other-than-temporary impairments, which are reported
as a charge to current operations. A loss would be recognized when there is an other-than-temporary
impairment in the fair value of any individual security classified as available-for-sale with the
associated net unrealized loss reclassified out of accumulated other comprehensive income with a
corresponding adjustment to other income (loss). This adjustment results in a new cost basis for
the investment. Investments which management has the intent and ability to hold to maturity are
classified as held-to-maturity and reported at amortized cost. If there is an other-than-temporary
impairment in the fair value of any individual security classified as held-to-maturity, the Company
will write down the security to fair value, with a corresponding adjustment to other income (loss).
Interest on debt securities, including amortization of premiums and accretion of discounts, is
included in other income (loss). Realized gains and losses from the sales of debt securities, which
are included in other income (loss), are determined using the specific identification method.
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The original cost, unrealized holding gains and losses, and fair value of available-for-sale
investments as of March 31, 2010 and September 30, 2009 were as follows (in thousands):
March 31, 2010 | ||||||||||||||||
Original Cost | Unrealized Gains | Unrealized Losses | Fair Value | |||||||||||||
U.S. government obligations |
$ | 19,921 | $ | 249 | $ | (13 | ) | $ | 20,157 | |||||||
Mortgage-backed securities |
6,421 | 155 | (74 | ) | 6,502 | |||||||||||
Municipal bonds |
4,983 | 171 | (2 | ) | 5,152 | |||||||||||
Asset-backed securities |
1,925 | 38 | (101 | ) | 1,862 | |||||||||||
Corporate bonds |
1,778 | 3 | (1 | ) | 1,780 | |||||||||||
Total |
$ | 35,028 | $ | 616 | $ | (191 | ) | $ | 35,453 | |||||||
September 30, 2009 | ||||||||||||||||
Original Cost | Unrealized Gains | Unrealized Losses | Fair Value | |||||||||||||
U.S. government obligations |
$ | 10,837 | $ | 253 | $ | | $ | 11,090 | ||||||||
Mortgage-backed securities |
7,938 | 177 | (106 | ) | 8,009 | |||||||||||
Municipal bonds |
7,210 | 232 | | 7,442 | ||||||||||||
Asset-backed securities |
2,334 | 65 | (143 | ) | 2,256 | |||||||||||
Corporate bonds |
1,181 | 3 | | 1,184 | ||||||||||||
Total |
$ | 29,500 | $ | 730 | $ | (249 | ) | $ | 29,981 | |||||||
The original cost and fair value of investments by contractual maturity at March 31, 2010 were
as follows (in thousands):
Amortized | ||||||||
Cost | Fair Value | |||||||
Debt securities due within: |
||||||||
One year |
$ | 5,984 | $ | 6,022 | ||||
One to five years |
21,991 | 22,411 | ||||||
Five years or more |
7,053 | 7,020 | ||||||
Total |
$ | 35,028 | $ | 35,453 | ||||
The following table summarizes sales of available-for-sale securities for the three-month and
six-month periods ended March 31, 2010 (in thousands):
Three Months | ||||||||
Ended | Six Months Ended | |||||||
March 31, | March 31, | |||||||
2010 | 2010 | |||||||
Proceeds from sales |
$ | 2,202 | $ | 5,172 | ||||
Gross realized gains |
$ | 3 | $ | 3 | ||||
Gross realized losses |
$ | | $ | |
At March 31, 2010, the amortized cost and fair market value of held-to-maturity debt
securities was $5.2 million and $5.3 million, respectively. Investments in securities designated as
held-to-maturity consist of tax-exempt municipal bonds and have maturity dates ranging between one
and two years from March 31, 2010. At September 30, 2009, the amortized cost and fair market value
of held-to-maturity debt securities were $6.3 million and $6.4 million, respectively. A
held-to-maturity security with an amortized cost of $1.0 million matured in the six-month period
ended March 31, 2010.
(5) Acquisitions
PR Pharmaceuticals, Inc. On November 4, 2008, the Companys SurModics Pharmaceuticals, Inc.
subsidiary entered into an asset purchase agreement with PR Pharmaceuticals, Inc. (PR Pharma)
whereby it acquired certain contracts and assets of PR Pharma for $5.6 million consisting of $2.9
million in cash on the closing date, additional consideration of $2.4 million upon successful
achievement of specified milestones, and $0.3 million in transaction costs. $3.7 million of the
total consideration was paid in the six-month period ended March 31, 2009. PR Pharma is eligible to
receive up to an additional $3.6 million in cash upon the successful achievement of milestones for
contract signing and invoicing, successful patent issuances and product development. Management
believes this acquisition strengthens the Companys portfolio of drug delivery technologies for the
pharmaceutical and biotechnology industries. As part of the acquisition, the Company recognized
fair value associated with in-process research and development
12
Table of Contents
(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.
(6) Inventories
Inventories are principally stated at the lower of cost or market using the specific
identification method and include direct labor, materials and overhead. Inventories consisted of
the following components (in thousands):
March 31, | September 30, | |||||||
2010 | 2009 | |||||||
Raw materials |
$ | 1,386 | $ | 1,287 | ||||
Finished products |
1,926 | 2,043 | ||||||
Total |
$ | 3,312 | $ | 3,330 | ||||
(7) Other Assets
Other assets consist principally of strategic investments. The Company accounts for its
strategic investments under the cost method. The Company accounts for its investment in OctoPlus
N.V. common stock as an available-for-sale investment rather than a cost method investment
following an initial public offering of OctoPlus N.V. common stock in October 2006.
Available-for-sale investments are reported at fair value with unrealized gains and losses reported
as a separate component of stockholders equity, except for other-than-temporary impairments, which
are reported as a charge to current operations, recorded in the other income (loss) section of the
condensed consolidated statements of operations. The cost basis in the Companys investment in
OctoPlus N.V. was adjusted to $1.7 million in fiscal 2008 based on a significant decline in the
stock price of OctoPlus N.V. that was determined to be an other-than-temporary impairment.
The Company has made equity investments in Paragon Intellectual Properties, LLC (Paragon)
and a Paragon subsidiary, Apollo Therapeutics, LLC (Apollo). In October 2008, Paragon announced
that it had restructured, along with its subsidiaries, including Apollo, moving from a limited
liability company with seven subsidiaries to a single C-corporation named Nexeon MedSystems, Inc.
(Nexeon). The Company accounted for the investments in Paragon and Apollo under the equity method
in the first quarter of fiscal 2009, as both entities reported results to us on a one-quarter lag.
Commencing in the second quarter of fiscal 2009, the Company 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 $0.5 million in Nexeon in fiscal 2009.
In August 2009, the Company invested $2.0 million in a medical technology company and made a
follow-on investment of $0.5 million in March 2010. The 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.
In March 2010, the Company recorded a $2.1 million asset impairment charge associated with its
facilities in Alabama as the Company works to consolidate its multiple facilities in Birmingham,
Alabama into its newly opened cGMP manufacturing and development facility. The Company intends to
sell a facility within the next twelve months. The remaining asset value, totaling $2.1
million, has been reclassified from property, plant and equipment to assets held for sale and is
included in the category titled Other in the table below.
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Other assets consisted of the following components (in thousands):
March 31, | September 30, | |||||||
2010 | 2009 | |||||||
Investment in OctoPlus N.V. |
$ | 2,713 | $ | 3,700 | ||||
Investment in Nexeon MedSystems |
5,651 | 5,651 | ||||||
Investment in ThermopeutiX |
1,185 | 1,185 | ||||||
Investment in Novocell |
559 | 559 | ||||||
Other |
4,778 | 2,162 | ||||||
Other assets |
$ | 14,886 | $ | 13,257 | ||||
The Company recognized revenue of $0.1 million and $0.2 million for the three-month period
ended March 31, 2010 and 2009, respectively, and recognized revenue of $0.2 million and $0.5
million for the six-month period ended March 31, 2010 and 2009, respectively, from activity with
companies in which it had a strategic investment.
(8) Intangible Assets
Intangible assets consist principally of acquired patents and technology, customer
relationships, licenses, and trademarks. The Company recorded amortization expense of $0.4 million
for the three-month periods ended March 31, 2010 and 2009, respectively. The Company recorded
amortization expense of $0.8 million and $1.2 million for the six-month periods ended March 31,
2010 and 2009, respectively.
Intangible assets consisted of the following (in thousands):
Useful life | March 31, | September 30, | ||||||||||
(in years) | 2010 | 2009 | ||||||||||
Customer list |
9 11 | $ | 8,657 | $ | 8,657 | |||||||
Core technology |
8 18 | 8,330 | 8,330 | |||||||||
Patents and other |
2 20 | 3,076 | 3,076 | |||||||||
Trademarks |
600 | 600 | ||||||||||
Less accumulated amortization of intangible assets |
(4,019 | ) | (3,205 | ) | ||||||||
Intangible assets, net |
$ | 16,644 | $ | 17,458 | ||||||||
Based on the intangible assets in service as of March 31, 2010, estimated amortization expense
for each of the next five fiscal years is as follows (in thousands):
Remainder of 2010 |
$ | 814 | ||
2011 |
1,604 | |||
2012 |
1,602 | |||
2013 |
1,602 | |||
2014 |
1,602 | |||
2015 |
1,591 |
Future amortization amounts presented above are estimates. Actual future amortization expense
may be different, as a result of future acquisitions, impairments, changes in amortization periods,
or other factors.
(9) Goodwill
Goodwill represents the excess of the cost of the acquired entities over the fair value
assigned to the assets purchased and liabilities assumed in connection with the Companys
acquisitions. The carrying amount of goodwill is evaluated annually, and between annual evaluations
if events occur or circumstances change indicating that the carrying amount of goodwill may be
impaired.
In the six months of fiscal 2010 a milestone was achieved associated with the July 2007
acquisition of SurModics Pharmaceuticals, Inc. and $0.8 million of additional purchase price was
recorded as an increase to goodwill.
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(10) Revolving Credit Facility
In February 2009, the Company entered into a two-year $25.0 million unsecured revolving credit
facility. Borrowings under the credit facility, if any, will bear interest at a benchmark rate plus
an applicable margin based upon the Companys funded debt to EBITDA ratio. In connection with the
credit facility, the Company is required to maintain certain financial and nonfinancial covenants.
As of March 31, 2010, the Company had no debt outstanding under this credit facility and was in
compliance with all covenants.
(11) Stock-based Compensation
The Company has stock-based compensation plans under which it grants stock options and
restricted stock awards. Accounting guidance requires all share-based payments to be recognized as
an operating expense, based on their fair values, over the requisite service period. The Companys
stock-based compensation expenses were allocated as follows (in thousands):
Three months ended | Six months ended | |||||||||||||||
March 31, | March 31, 2010 | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Product costs |
$ | 31 | $ | 22 | 66 | $ | 46 | |||||||||
Customer research and development |
150 | 200 | 303 | 366 | ||||||||||||
Other research and development |
444 | 710 | 1,059 | 1,453 | ||||||||||||
Selling, general and administrative |
600 | 789 | 1,332 | 1,767 | ||||||||||||
Total |
$ | 1,225 | $ | 1,721 | $ | 2,760 | $ | 3,632 | ||||||||
As of March 31, 2010, approximately $10.6 million of total unrecognized compensation costs
related to non-vested awards could be recognized over the remaining weighted average period of
approximately 2.2 years. The $10.6 million of total unrecognized compensation costs include $3.5
million associated with performance share awards that are currently not anticipated to be fully
expensed because the performance conditions are not expected to be met.
Stock Option Plans
The Company uses the Black-Scholes option pricing model to determine the weighted average
grant date fair value of stock options granted. The weighted average per share fair value of stock
options granted during the three-month periods ended March 31, 2010 and 2009 was $6.44 and $7.12,
respectively. The weighted average per share fair value of stock options granted during the
six-month periods ended March 31, 2010 and 2009 was $6.91 and $8.41, respectively. The assumptions
used as inputs in the model were as follows:
Three months ended | Six months ended | |||||||||||||||
March 31, | March 31, 2010 | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Risk-free interest rates |
2.1 | % | 1.7 | % | 2.0 | % | 2.2 | % | ||||||||
Expected life (years) |
4.8 | 4.9 | 4.8 | 4.8 | ||||||||||||
Expected volatility |
41.4 | % | 39.8 | % | 41.4 | % | 38.1 | % | ||||||||
Dividend yield |
0 | % | 0 | % | 0 | % | 0 | % |
The risk-free interest rate assumption was based on the U.S. Treasurys rates for U.S.
Treasury zero-coupon bonds with maturities similar to those of the expected term of the award. The
expected life of options granted is determined based on the Companys experience. Expected
volatility is based on the Companys stock price movement over a period approximating the expected
term. Based on managements judgment, dividend rates are expected to be zero for the expected life
of the options. The Company also estimates forfeitures of options granted, which are based on
historical experience.
The Companys Incentive Stock Options (ISO) are granted at a price of at least 100% of the
fair market value of the common stock of the Company on the date of the grant or 110% with respect
to optionees who own more than 10% of the total combined voting power of all classes of stock. ISOs
generally expire in seven years or upon termination of employment and generally are exercisable at
a rate of 20% per year commencing one year after the date of grant. Nonqualified stock options are
granted at fair market value on the date of grant. Nonqualified stock options generally expire in 7
to 10 years or upon termination of employment or service as a Board member. Nonqualified stock
options granted prior to May 2008 generally become exercisable with respect to 20% of the shares on
each of the first five anniversaries following the grant date such that the entire option is fully
vested five years after date of grant, and nonqualified stock options granted subsequent to May
2008 generally become exercisable with respect to 25% on
each of the first four anniversaries
following the grant date such that the entire option is fully vested four years after the grant
date.
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The total pre-tax intrinsic value of options exercised during the three-month periods ended
March 31, 2010 and 2009 was $69,000 and $70,000, respectively. During the six-month periods ended
March 31, 2010 and 2009, the total pre-tax intrinsic value of options exercised was $4,000 and
$65,000, respectively. The intrinsic value represents the difference between the exercise price and
the fair market value of the Companys common stock on the last day of the respective fiscal period
end.
Restricted Stock Awards
The Company has entered into restricted stock agreements with certain key employees, covering
the issuance of common stock (Restricted Stock). Under accounting guidance these shares are
considered to be non-vested shares. The Restricted Stock will be released to the key employees if
they are employed by the Company at the end of the vesting period. The stock-based compensation
table above includes Restricted Stock expenses of $0.2 million, and $0.5 million during three-month
and six-month periods ended March 31, 2010, respectively, and $0.5 million and $1.1 million for the
three-month and six-month periods ended March 31, 2009, respectively.
Performance Share Awards
The Company has entered into performance share agreements with certain key employees, covering
the issuance of common stock (Performance Shares). The Performance Shares vest upon the
achievement of all or a portion of certain performance objectives, which must be achieved during
the performance period. Compensation is recognized in each period based on managements best
estimate of the achievement level of the grants specified performance objectives and the resulting
vesting amounts. The Company did not recognize an expense in the three-month period ended March 31,
2010 and recognized expense of $32,000 for the six-month period ended March 31, 2010 related to the
Performance Shares granted. For the three-month and six-month periods ended March 31, 2009, the
Company recognized expenses of $10,000 and reduced expenses by $29,000, respectively, associated
with the Performance Shares granted. The stock-based compensation table above includes the
Performance Shares expenses and expense reversal.
1999 Employee Stock Purchase Plan
Under the 1999 Employee Stock Purchase Plan (Stock Purchase Plan), the Company is authorized
to issue up to 400,000 shares of common stock. The number of authorized shares was increased by
200,000 effective with shareholder approval at the February 8, 2010 Annual Meeting. All full-time
and part-time employees can choose to have up to 10% of their annual compensation withheld, with a
limit of $25,000, to purchase the Companys common stock at purchase prices defined within the
provisions of the Stock Purchase Plan. As of March 31, 2010 and 2009, there were $0.1 million of
employee contributions, respectively, included in accrued liabilities in the accompanying condensed
consolidated balance sheets. Stock compensation expense recognized related to the Stock Purchase
Plan for the three-month periods ended March 31, 2010 and 2009 totaled $0.1 million in each period.
Stock compensation expense for the six-month periods ended March 31, 2010 and 2009 totaled $0.1
million in each period. The stock-based compensation table above includes the Stock Purchase Plan
expenses.
(12) Restructuring Charges
In March 2010, the Company announced an organizational change designed to support future
growth by better meeting customer needs, leveraging its multiple competencies across the
organization, and building on its pharmaceutical industry experience. As a result of the
reorganization, the Company eliminated 11 positions, or approximately 4% of the Companys
workforce. These employee terminations occurred across various functions and the reorganization
plan was completed by the end of the second quarter of fiscal 2010. The Company also announced that
it was vacating its leased sales office in Irvine, California and a leased warehouse in Birmingham,
Alabama, as part of the reorganization plan. The leased space was vacated by March 31, 2010.
The Company recorded total restructuring charges of approximately $1.3 million in connection
with the fiscal 2010 reorganization. These pre-tax charges consisted of $0.8 million of severance
pay and benefits expenses and $0.5 million of facility-related costs. The restructuring is expected
to result in approximately $0.5 million to $1.0 million in annualized cost savings. Cash payments
totaled $0.1 million as of March 31, 2010, resulting in a balance of $1.2 million.
In November 2008, the Company announced a functional reorganization to better serve its
customers and improve its operating performance. As a result of the reorganization, the Company
eliminated 15 positions, or approximately 5% of the Companys workforce. These employee
terminations occurred across various functions and the reorganization plan was completed by the end
of the first quarter of fiscal 2009. The Company also vacated a leased facility in Eden Prairie,
Minnesota, consolidating into its owned office and research facility also in Eden Prairie, as part
of the reorganization plan.
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The Company recorded total restructuring charges of approximately $1.8 million in
connection with the fiscal 2009 reorganization. These pre-tax charges consisted of $0.5 million of
severance pay and benefits expenses and $1.3 million of facility-related costs. The restructuring
was expected to result in approximately $2.2 million in annualized cost savings. Cash payments
totaled $0.9 million as of March 31, 2010 resulting in a balance of $0.9 million.
The charges above for fiscal 2010 have been presented separately as restructuring charges in
the condensed consolidated statements of operations. The remaining balance is expected to be paid
within the next 45 months. As such, the current portion totaling $1.8 million is recorded as a
current liability within other accrued liabilities and the long-term portion totaling $0.3 million
is recorded as a long-term liability within other long-term liabilities on the condensed
consolidated balance sheets.
The following table summarizes the restructuring accrual activity for the first six months of
fiscal 2010 (in thousands):
Employee | Facility- | |||||||||||
severance and | related | |||||||||||
Benefits | costs | Total | ||||||||||
Balance at September 30, 2009 |
$ | | $ | 955 | $ | 955 | ||||||
Accruals during the period |
818 | 488 | 1,306 | |||||||||
Cash payments |
(89 | ) | (74 | ) | (163 | ) | ||||||
Balance at March 31, 2010 |
$ | 729 | $ | 1,369 | $ | 2,098 | ||||||
(13) Asset impairment charge
In the second quarter ended March 31, 2010, the Company recorded a $2.1 million asset
impairment charge associated with its facilities in Alabama as the Company works to consolidate its
multiple facilities in Birmingham, Alabama into its newly opened cGMP manufacturing and development
facility. The Company intends to sell a facility within the next twelve months. Long-lived
assets are measured at fair value on a non-recurring basis. Long-lived assets are not measured at
fair value on an ongoing basis but are subject to fair value adjustments only in certain
circumstances. These circumstances include assets that are written down to fair value when they are
held for sale or are determined to be impaired. The assets that are held for sale were written down
to their fair value of $2.3 million, less selling costs of $0.2 million, and the net amount has
been reclassified from property, plant and equipment and included within other assets on the
condensed consolidated balance sheets.
(14) Comprehensive Income
The components of comprehensive income are as follows (in thousands):
Three months ended | Six months ended | |||||||||||||||
March 31, | March 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Net (loss) income |
$ | (427 | ) | $ | 4,216 | $ | 1,490 | $ | 31,301 | |||||||
Other
comprehensive (loss) income: |
||||||||||||||||
Unrealized holding gains
(losses) on available-for-sale
securities arising during the
period, net of tax |
(100 | ) | 79 | (612 | ) | 613 | ||||||||||
Less reclassification adjustment
for realized gains included in
net income, net of tax |
(2 | ) | | (2 | ) | (201 | ) | |||||||||
Other
comprehensive (loss) income |
(102 | ) | 79 | (614 | ) | 412 | ||||||||||
Comprehensive (loss) income |
$ | (529 | ) | $ | 4,295 | $ | 876 | $ | 31,713 | |||||||
(15) Income Taxes
The Company recorded an income tax benefit of $0.2 million and an income tax provision of $2.4
million for the three-month periods ended March 31, 2010 and 2009, respectively, representing
effective tax rates of 36.1% and 36.3%, respectively. The Company recorded income tax provisions of
$0.9 million and $18.6 million for the six-month periods ended March 31, 2010 and 2009,
respectively, representing effective tax rates of 37.8% and 37.2%, respectively. The difference
between the U.S. federal statutory tax rate of 35% and the Companys effective tax rate reflects
state taxes and other permanent items.
The October 2008 adoption of the Emergency Economic Stabilization Act of 2008 retroactively
extended the term of the federal tax credit for research activities through calendar 2009. The tax
credit for research activities for the six-month period ended
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March 31, 2010 was $39,000, unchanged from the amount recognized in the three-month period
ended December 31, 2009. During the six-month period ended March 31, 2009, the Company recognized a
discrete benefit of approximately $120,000 related to the nine-month period ended September 30,
2008.
The total amount of unrecognized tax benefits including interest and penalties that, if
recognized, would affect the effective tax rate as of March 31, 2010 and September 30, 2009,
respectively, are $2.1 million and $2.0 million. Currently, the Company does not expect the
liability for unrecognized tax benefits to change significantly in the next twelve months. Interest
and penalties related to the unrecognized tax benefits are recorded in income tax expense.
The Company files income tax returns, including returns for its subsidiaries, in the United
States (U.S.) federal jurisdiction and in various state jurisdictions. Uncertain tax positions are
related to tax years that remain subject to examination. U.S. tax returns for fiscal years ended
September 30, 2006, 2007, 2008 and 2009 remain subject to examination by federal tax authorities.
Tax returns for state and local jurisdictions for fiscal years ended September 30, 2003 through
2009 remain subject to examination by state and local tax authorities.
(16) Operating Segments
Operating segments are defined as components of an enterprise about which separate financial
information is available that is evaluated regularly by the chief operating decision maker, or
decision making group, in deciding how to allocate resources and in assessing performance.
In March 2010, the Company announced it changed its operational structure to better align
functional expertise, which also resulted in the elimination of the Companys business units. The
Company evaluates revenue results and opportunities on the basis of the clinical market areas in
which the Companys customers participate as noted in the table below. The Therapeutic market
includes revenue from: (1) Cardiovascular, which provides drug delivery and surface modification
technologies to customers in the cardiovascular market; (2) Ophthalmology, which is focused on the
advancement of treatments for eye diseases, such as age-related macular degeneration (AMD) and
diabetic macular edema (DME), two of the leading causes of blindness; and (3) Other Markets, which
is focused on a variety of clinical markets principally in the pharmaceutical and biotechnology
industries. The Diagnostic market includes revenue from the Companys microarray slide
technologies, stabilization products, antigens and substrates for immunoassay diagnostics tests,
and its in vitro diagnostic format technology.
The Company has one reportable segment as its sales and marketing efforts and its expenses are
managed on a company-wide basis. The table below presents revenue from the markets, with
Therapeutic broken out further by focus area, for the three-month and six-month periods in fiscal
2010 and 2009, (in thousands):
Three months ended | Six months ended | |||||||||||||||
March 31, | March 31, 2010 | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Therapeutic |
||||||||||||||||
Cardiovascular |
$ | 9,244 | $ | 9,570 | $ | 19,958 | $ | 19,973 | ||||||||
Ophthalmology |
3,405 | 3,710 | 5,902 | 48,842 | ||||||||||||
Other Markets |
2,889 | 2,925 | 4,772 | 6,697 | ||||||||||||
Total Therapeutic |
15,538 | 16,205 | 30,632 | 75,152 | ||||||||||||
Diagnostic |
2,822 | 4,720 | 5,109 | 8,989 | ||||||||||||
Total revenue |
$ | 18,360 | $ | 20,925 | $ | 35,741 | $ | 84,141 | ||||||||
(17) Commitments and Contingencies
Litigation. From time to time, the Company has been, and may become, involved in various legal
actions involving its operations, products and technologies, including intellectual property and
employment disputes. The outcomes of these legal actions are not within the Companys complete
control and may not be known for prolonged periods of time. In some actions, the claimants seek
damages, as well as other relief, including injunctions barring the sale of products that are the
subject of the lawsuit, which, if granted, could require significant expenditures or result in lost
revenues. The Company records a liability in the consolidated financial statements for these
actions when a loss is known or considered probable and the amount can be reasonably estimated. If
the reasonable estimate of a known or probable loss is a range, and no amount within the range is a
better estimate, the minimum amount of the range is accrued. If a loss is possible but not known or
probable, and can be reasonably estimated, the estimated loss or range of loss is disclosed. In
most cases, significant judgment is required to estimate the amount and timing of a loss to be
recorded.
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InnoRx, Inc. In January 2005, the Company entered into a merger agreement whereby SurModics
acquired all of the assets of
InnoRx, Inc. (InnoRx), an early stage company developing drug delivery devices and therapies
for the ophthalmology market. SurModics will be required to issue up to approximately 480,059
additional shares of its common stock to the stockholders of InnoRx upon the successful completion
of the remaining development and commercial milestones involving InnoRx technology acquired in the
transaction.
BioFX Laboratories, Inc. In August 2007, the Company acquired 100% of the capital stock of
BioFX Laboratories, Inc. (BioFX), a provider of substrates to the in vitro diagnostics industry.
The sellers of BioFX are still eligible to receive up to $3.5 million in additional consideration
based on specific revenue targets through calendar 2011.
SurModics Pharmaceuticals, Inc. In July 2007, the Company acquired 100% of the capital stock
of Brookwood Pharmaceuticals Inc. (now known as SurModics Pharmaceuticals, Inc.) (SurModics
Pharmaceuticals), a drug delivery company that provides proprietary polymer-based technologies to
companies developing pharmaceutical products. The sellers of SurModics Pharmaceuticals are still
eligible to receive up to $15.5 million in additional consideration based on successful achievement
of specific milestones through calendar 2011.
Alabama Jobs Commitment. In April 2008, the Company purchased a 286,000 square foot
office and warehouse facility to support Current Good Manufacturing Practices manufacturing needs
of customers and the anticipated growth of the SurModics Pharmaceuticals business. At the same
time, SurModics Pharmaceuticals entered into an agreement with various governmental authorities to
obtain financial incentives associated with creation of jobs in Alabama. Some of the governmental
agencies have recapture rights in connection with the financial incentives if a specific number of
full-time employees are not hired by June 2012, with an extension to June 2013 if circumstances or
events occur that are beyond the control of SurModics Pharmaceuticals or could not have been
reasonably anticipated by SurModics Pharmaceuticals. As of March 31, 2010, SurModics
Pharmaceuticals has received $1.7 million in connection with the agreement, and the Company has
recorded the payment in other long-term liabilities. If the additional jobs are created, the
Company will recognize the $1.7 million as an offset to operating expenses in the period the
contingency is resolved.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition, results of operations and
trends for the future should be read together with our unaudited condensed consolidated financial
statements and related notes appearing elsewhere in this report. Any discussion and analysis
regarding trends in our future financial condition and results of operations are forward-looking
statements that involve risks, uncertainties and assumptions, as more fully identified in
Forward-Looking Statements. Our actual future financial condition and results of operations may
differ materially from those anticipated in the forward-looking statements.
Overview
SurModics is a leading provider of drug delivery and surface modification technologies to the
healthcare industry. In March 2010 we announced a change in our operational structure to better
align functional expertise, which resulted in the elimination of the Companys business units. This
new structure is designed to support future growth by better meeting customer needs, leveraging our
multiple competencies across our organization, and building on our pharmaceutical industry
experience.
The organization change did not impact the Companys continued market focus. The
Therapeutic market includes revenue from: (1) Cardiovascular, which provides drug delivery and
surface modification technologies to customers in the cardiovascular market; (2) Ophthalmology,
which is focused on the advancement of treatments for eye diseases, such as age-related macular
degeneration (AMD) and diabetic macular edema (DME), two of the leading causes of blindness; and
(3) Other Markets, which is focused on a variety of clinical markets principally in the
pharmaceutical and biotechnology industries. The Diagnostic market includes revenue from the
Companys microarray slide technologies, our stabilization products, antigens and substrates for
immunoassay diagnostic tests, and our in vitro diagnostic format technology.
The Companys revenue is derived from three primary sources: (1) royalties and license
fees from licensing our proprietary drug delivery and surface modification technologies to
customers; the vast majority (typically in excess of 90%) of revenue in the royalties and license
fees category is in the form of royalties; (2) the sale of polymers and reagent chemicals,
stabilization products, antigens, substrates and microarray slides to the diagnostics and
biomedical research industry; and (3) research and development fees generated on customer projects.
Revenue fluctuates from quarter to quarter depending on, among other factors: our customers
success in selling products incorporating our technologies; the timing of introductions of licensed
products by customers; the timing of introductions of products that compete with our customers
products; the number and activity level associated with customer development projects; the number
and terms of new license agreements that are finalized; the value of reagent chemicals and other
products sold to customers; and the timing of future acquisitions we complete, if any.
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For financial accounting and reporting purposes, we report our results in one reportable
segment. We made this determination because we manage our sales and marketing efforts and our
expenses on a company-wide basis. In addition, a significant percentage of our employees provide
support services (including research and development) to a variety of customers; and technology and
products are marketed to the same or similar customers.
In June 2007, we signed a collaborative research and license agreement with Merck & Co.,
Inc. (Merck) to pursue the joint development and commercialization of the I-vationTM
sustained drug delivery system with triamcinolone acetonide and other products that combine Merck
proprietary drug compounds with the I-vation system for the treatment of serious retinal diseases.
Under the terms of our agreement with Merck, we received an up-front license fee of $20 million and
had the potential to receive up to an additional $288 million in fees and development milestones
associated with the successful product development and attainment of appropriate U.S. and EU
regulatory approvals for these new combination products.
In September 2008, Merck gave notice that it was terminating the collaborative research
and license agreement, as well as the supply agreement entered into in June 2007, following a
strategic review of Mercks business and product development portfolio. The termination was
effective December 16, 2008. SurModics recognized revenue previously deferred, totaling $34.8
million, under the accounting treatment required for revenue arrangements with multiple
deliverables. In addition, we received and recognized a $9 million milestone payment from Merck
associated with the termination of the triamcinolone acetonide development program in the first
quarter of fiscal 2009.
On October 5, 2009, we entered into a License and Development Agreement with F.
Hoffmann-La Roche, Ltd. (Roche) and Genentech, Inc., a wholly owned member of the Roche Group
(Genentech). Under the terms of the agreement, Roche and Genentech will have an exclusive license
to develop and commercialize a sustained drug delivery formulation of Lucentis® (ranibizumab
injection) utilizing SurModics proprietary biodegradable microparticles drug delivery system. We
received an up-front licensing fee of $3.5 million and are eligible to receive potential payments
of up to approximately $200 million in fees and milestone payments in the event of the successful
development and commercialization of multiple products, as well as payment for development work
done on these products. In addition, Roche and Genentech could request that SurModics provide
manufacturing services. In the event a commercial product is developed, we will also receive
royalties on sales of such product.
Critical Accounting Policies
Critical accounting policies are those policies that require the application of managements
most challenging subjective or complex judgment, often as a result of the need to make estimates
about the effect of matters that are inherently uncertain and may change in subsequent periods.
Critical accounting policies involve judgments and uncertainties that are sufficiently sensitive to
result in materially different results under different assumptions and conditions. See Note 2 to
the condensed consolidated financial statements for disclosures related to key accounting policies
and recently adopted accounting pronouncements.
Our revenue recognition accounting policy regarding arrangements with multiple deliverables
was changed effective October 1, 2009, as a direct effect of the early adoption of the new
accounting guidance regarding multiple element arrangements. We have applied the new accounting
guidance on a prospective basis for applicable transactions that originated or were materially
modified after October 1, 2009.
For a detailed description of our other critical accounting policies, see the notes to the
consolidated financial statements included in our Annual Report on Form 10-K for the year ended
September 30, 2009.
Results of Operations Three Months Ended March 31
Three Months Ended March 31, | Increase | |||||||||||||||
(Dollars in thousands) | 2010 | 2009 | (Decrease) | Change % | ||||||||||||
Revenue: |
||||||||||||||||
Therapeutic |
||||||||||||||||
Cardiovascular |
$ | 9,244 | $ | 9,570 | $ | (326 | ) | (3) | % | |||||||
Ophthalmology |
3,405 | 3,710 | (305 | ) | (8) | % | ||||||||||
Other Markets |
2,889 | 2,925 | (36 | ) | (1) | % | ||||||||||
Total Therapeutic |
15,538 | 16,205 | (667 | ) | (4) | % | ||||||||||
Diagnostic |
2,822 | 4,720 | (1,898 | ) | (40) | % | ||||||||||
Total revenue |
$ | 18,360 | $ | 20,925 | $ | (2,565 | ) | (12) | % | |||||||
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Revenue. Revenue during the second quarter of fiscal 2010 was $18.4 million, a decrease
of $2.6 million or 12%, compared
with the second quarter of fiscal 2009. The decreases in Therapeutic and Diagnostic revenue,
as detailed in the table above, are further explained in the narrative below.
Therapeutic. Revenue in Therapeutic was $15.5 million in the second quarter of fiscal 2010, a
decrease of 4% compared with $16.2 million in the second quarter of fiscal 2009. The decrease in
total revenue was driven by lower research and development (R&D) revenue as well as lower royalties
and license fees. Therapeutic revenue is further characterized by the market-focused areas detailed
above.
Cardiovascular derives a substantial amount of revenue from royalties and license fees and
product sales attributable to Cordis Corporation, a Johnson & Johnson company, on its
CYPHER® Sirolimus-eluting Coronary Stent. The CYPHER® stent
incorporates a proprietary SurModics polymer coating that delivers a therapeutic drug designed to
reduce the occurrence of restenosis in coronary artery lesions. The CYPHER®
stent faces continuing competition from Boston Scientific, Medtronic and Abbott Laboratories.
Stents from these companies compete directly with the CYPHER® stent both
domestically and internationally. Future royalty and reagent sales revenue could decrease as a
result of lower CYPHER® stent sales from ongoing and expected future
competition. We anticipate that royalty revenue from the CYPHER® stent may be
volatile throughout fiscal 2010 and beyond as the various marketers of drug-eluting stents compete
in the marketplace and as other companies enter the marketplace. We also receive a royalty on the
Medtronic Endeavor® drug-eluting stent delivery system incorporating our
hydrophilic technology, which is sold in the United States and internationally and commenced sales
in Japan in May 2009.
Cardiovascular revenue decreased $0.3 million, or 3%, in the second quarter of fiscal 2010,
compared with the second quarter of fiscal 2009 with the decrease principally from R&D revenue. Our
royalty and license fee revenue declined slightly as our broad portfolio of royalty paying
customers offset the decrease in royalty revenue from Cordis as a result of 24% lower Cordis
CYPHER® stent sales.
Ophthalmology revenue decreased $0.3 million, or 8%, in the second quarter of fiscal 2010,
compared with the second quarter of fiscal 2009. The decrease principally reflects a milestone
event that occurred in the second quarter of fiscal 2009. There were no such events in the second
quarter of fiscal 2010.
Other Markets revenue decreased 1% in the second quarter of fiscal 2010, compared with the
second quarter of fiscal 2009. Lower R&D revenue and royalties and license fees were offset by
higher product sales. Other Markets revenue is derived
from more than 50 customers.
Diagnostic. Revenue in Diagnostic was $2.8 million in the second quarter of fiscal 2010, a
decrease of 40% compared with $4.7 million in the prior-year period. This decrease was attributable
to lower royalties and license fees. In past quarters, Diagnostic derived a significant percentage
of revenue from Abbott Laboratories. Our diagnostic format patent license agreement with Abbott
Laboratories ceased following the expiration of licensed patents, which occurred in December 2008.
Royalty payments are typically recognized on a quarter lag, thus there was royalty revenue in the
second quarter of fiscal 2009. Product sales decreased 5% compared with fiscal 2009, principally
reflecting lower microarray slide sales in the second quarter of fiscal 2010.
Product costs. Product costs were $2.5 million in the second quarter of fiscal 2010, compared
with $1.8 million in the prior-year period. The $0.7 million increase principally reflects higher
product costs associated with reagent and antigen products, as well as the impact of overall
product sales increases. Overall product margins averaged 53%, compared with 62% reported last
year.
Customer research and development expenses. Customer research and development (Customer R&D)
expenses were $4.8 million, an increase of 42% compared with the first quarter of fiscal 2009. The
increase principally reflects the impact of higher fixed overhead costs attributable to our Alabama
research and development operations. The margins on R&D revenue were 10% in the second quarter of
fiscal 2010 compared with 31% for the second quarter of fiscal 2009, after adjusting for final
Merck payments. Expenses associated with our cGMP manufacturing facility were previously recorded
in selling, general and administrative expenses prior to the facility being placed in service in
December 2009.
Other research and development expenses. Other research and development (Other R&D) expenses
were $4.6 million for the second quarter of fiscal 2010, a decrease of 11% compared with the second
quarter of fiscal 2009. The decrease principally reflects lower labor costs as a result of more
employees dedicated to customer related activities, as well as a decrease in our overall R&D
headcount.
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Selling, general and administrative expenses. Selling, general and administrative expenses
were $4.1 million for the three months ended March 31, 2010, which were $0.3 million, or 7% lower,
compared with expenses of $4.4 million in the prior-year period. Lower incentive and stock-based
compensation costs were the principal contributors to the decrease.
Restructuring charges. In March 2010, we announced an organizational change designed to
support future growth by better meeting customer needs, leveraging our multiple competencies across
the organization, and building on our pharmaceutical industry experience. As a result of the
reorganization, we eliminated 11 positions, or approximately 4% of our workforce. These employee
terminations occurred across various functions, and the reorganization plan was completed by the
end of the second quarter of fiscal 2010. The Company also announced that it was vacating its
leased sales office in Irvine, California and a leased warehouse in Birmingham, Alabama, as part of
the reorganization plan. The leased space was vacated by March 31, 2010.
The Company recorded total restructuring charges of $1.3 million in connection with the fiscal
2010 reorganization. These pre-tax charges consisted of $0.8 million of severance pay and benefits
expenses and $0.5 million of facility-related costs. The restructuring is expected to result in
approximately $0.5 million to $1.0 million in annualized cost savings.
Asset impairment charge. In the second quarter ended March 31, 2010, we recorded a $2.1
million asset impairment charge associated with our facilities in Alabama as we work to consolidate
our multiple facilities in Birmingham, Alabama into our newly opened cGMP manufacturing and
development facility.
Other income, net. Other income was $0.3 million in the second quarter of fiscal 2010,
compared with $0.4 million in the second quarter of fiscal 2010. The decrease primarily reflects
lower investment balances.
Income tax expense. The Company recorded an income tax benefit of $0.2 million in the second
quarter of fiscal 2010, compared with an income tax provision of $2.4 million in the prior-year
period. The effective tax rate was 36.1%, compared with 36.3% in the prior-year period.
Results of Operations Six Months Ended March 31
Six Months Ended March 31, | Increase | |||||||||||||||
(Dollars in thousands) | 2010 | 2009 | (Decrease) | Change % | ||||||||||||
Revenue: |
||||||||||||||||
Therapeutic |
||||||||||||||||
Cardiovascular |
$ | 19,958 | $ | 19,973 | $ | (15 | ) | | % | |||||||
Ophthalmology |
5,902 | 48,482 | (42,580 | ) | (88 | )% | ||||||||||
Other Markets |
4,772 | 6,697 | (1,925 | ) | (29 | )% | ||||||||||
Total Therapeutic |
30,632 | 75,152 | (44,520 | ) | (59 | )% | ||||||||||
Diagnostic |
5,109 | 8,989 | (3,880 | ) | (43 | )% | ||||||||||
Total revenue |
$ | 35,741 | $ | 84,141 | $ | (48,400 | ) | (58 | )% | |||||||
Revenue. Revenue for the first six months of fiscal 2010 was $35.7 million, a decrease of
$48.4 million or 58% compared with the first six months of fiscal 2009. The decreases in
Therapeutic and Diagnostic revenue, as detailed in the table above, are further explained in the
narrative below.
Therapeutic. Revenue in Therapeutic was $30.6 million in the first six months of fiscal 2010,
a decrease of 59% compared with $75.1 million in the first six months of fiscal 2009. The decrease
in total revenue reflects the recognition of revenue of approximately $45 million associated with
the terminated Merck collaborative research and license agreement, which was terminated effective
in the first quarter of fiscal 2009. Excluding this significant event-specific item in fiscal 2009,
revenue increased $0.5 million in the first six months of fiscal 2010 compared with the comparable
prior period. Therapeutic revenue is further characterized by the market-focused areas detailed
above.
Cardiovascular
revenue was comparable in the first six months of fiscal 2010 with the
first six months of fiscal 2009. Increased royalties and license fees and product sales were offset
by a decrease in R&D revenue. Our royalty revenue from Cordis decreased as a result of 21% lower
Cordis CYPHER® stent sales.
Ophthalmology revenue decreased $42.6 million, or 88%, in the first six months of fiscal 2010,
compared with the first six months of fiscal 2009. The significant decrease relates to the
recognition of previously deferred revenue associated with the terminated collaborative research
and license
agreement with Merck. In September 2008, following a strategic review of Mercks
business and product development portfolio, Merck gave notice that it was terminating the
collaborative research and license
22
Table of Contents
agreement as well as the supply agreement entered into in June
2007. The termination became effective in December 2008. In the first six months of fiscal 2009, we
recognized the revenue previously deferred totaling $34.8 million, and we received and recognized a
$9 million milestone payment from Merck associated with the termination of the triamcinolone
acetonide development program.
Ophthalmology revenue, when excluding the Merck event-specific items in the first six months
of fiscal 2009, increased by approximately $2.4 million, or 69%, principally as a result of higher
R&D revenue.
Other Markets revenue decreased $1.9 million, or 29%, in the first six months of fiscal 2010,
compared with the first six months of fiscal 2009. Lower R&D revenue was the main contributor to
the decrease. Select customers have delayed, slowed or canceled development projects as a result of
various factors, including current economic conditions.
Diagnostic. Revenue in Diagnostic was $5.1 million in the first six months of fiscal 2010, a
decrease of 43% compared with $9.0 million in the prior-year period. This decrease was attributable
to lower royalties and license fees. In past periods, Diagnostic derived a significant percentage
of revenue from royalties generated under our diagnostic format patent license agreement with
Abbott Laboratories. Our agreement with Abbott Laboratories ceased following the expiration of
licensed patents, which occurred in December 2008. Product sales were at similar levels for both
periods.
Product costs. Product costs were $4.4 million in the first six months of fiscal 2010,
compared with $3.4 million in the prior-year period. The $1.0 million increase in product costs
principally reflects higher product sales. Overall product margins averaged 55%, compared with 61%
reported in the first six months of fiscal 2009. The decrease in product margins reflects a shift
in the mix of products sold and some modest cost increases related to our reagents and antigen
products.
Customer research and development expenses. Customer R&D expenses were $8.1 million, an
increase of 15% compared with the first six months of fiscal 2009. The increase principally
reflects the impact of higher R&D revenue, adjusted for Merck event-specific items. Customer R&D
margins were 9%, compared with 60% in the first six months of fiscal 2009. The margin was 31% for
the first six months of fiscal 2009, after adjusting for Merck event-specific items. The margin
decrease in the first six months of fiscal 2010 reflects increased fixed overhead costs
attributable to our Alabama research and development operations.
Other research and development expenses. Other R&D expenses were $9.3 million for the first
six months of fiscal 2010, a decrease of 14% compared with the first six months of fiscal 2009. The
decrease principally reflects lower labor costs as a result of more employees dedicated to customer
related activities, a decrease in our overall R&D headcount and lower overhead costs being
allocated to Other R&D.
Selling, general and administrative expenses. Selling, general and administrative expenses
were $8.7 million for the six months ended March 31, 2010, which was a 4% decrease compared to
expenses of $9.1 million in the prior-year period. Lower incentive and stock-based compensation
costs were offset by higher facility expenses.
Purchased in-process research and development. In November 2008, we acquired certain assets
comprised of intellectual property and collaborative programs from PR Pharmaceuticals, Inc. The
fair value of $3.2 million associated with the in-process research and development intangible asset
was determined by management and recognized as an expense in the six months ended March 31, 2009.
Restructuring charges. In March 2010, we announced an organizational change designed to
support future growth by better meeting customer needs, leveraging our multiple competencies across
the organization, and building on our pharmaceutical industry experience.
SurModics recorded total restructuring charges of approximately $1.3 million in connection
with the fiscal 2010 reorganization. These pre-tax charges consisted of $0.8 million of severance
pay and benefits expenses and $0.5 million of facility-related costs.
In November 2008, we announced a functional reorganization to better serve our customers and
improve our operating performance and recorded total restructuring charges of approximately $1.8
million in connection with the 2009 reorganization. These pre-tax charges consisted of $0.5 million
of severance pay and benefits expenses and $1.3 million of facility-related costs.
Asset impairment charge. In the six months ended March 31, 2010, we recorded a $2.1 million
asset impairment charge associated with our facilities in Alabama as we work to consolidate our
multiple facilities.
Other income, net. Other income was $0.6 million in the first six months of fiscal 2010,
compared with $1.0 million in the first six months of fiscal 2010. Income from investments was $0.6
million, compared with $1.1 million in the prior-year period. The
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decrease primarily reflects lower
investment balances. In the six months of fiscal 2009, our pro rata net loss on our equity method
investments was partially offset by $0.3 million of gains from our investment portfolio.
Income tax expense. The income tax provision was $0.9 million in the first six months of
fiscal 2010, compared with $18.6 million in the prior-year period. The effective tax rate was
37.8%, compared with 37.2% in the prior-year period. The increase over the federal statutory rate
of 35% is primarily related to incentive stock options and state taxes.
Liquidity and Capital Resources
As of March 31, 2010, the Company had working capital of $33.7 million, of which $19.3 million
consisted of cash, cash equivalents and short-term investments. Working capital increased $4.7
million from September 30, 2009, driven principally by higher accounts receivable and prepaid
balances and lower accounts payable balances. Our cash, cash equivalents and short-term and
long-term investments totaled $51.8 million at March 31, 2010, an increase of $3.9 million from
$47.9 million at September 30, 2009. The Companys investments principally consist of U.S.
government and government agency obligations and investment grade, interest-bearing corporate debt
securities with varying maturity dates, the majority of which are five years or less. The Companys
policy requires that no more than 5% of investments be held in any one credit issue, excluding U.S.
government and government agency obligations. The primary investment objective of the portfolio is
to provide for the safety of principal and appropriate liquidity, while meeting or exceeding a
benchmark (Merrill Lynch 1-3 Year Government-Corporate Index) total rate of return. Management
plans to continue to direct its investment advisors to manage the Companys investments primarily
for the safety of principal for the foreseeable future, as it assesses other investment
opportunities and uses of its investments.
We had cash flows from operating activities of approximately $12.4 million in the first six
months of fiscal 2010, compared with $16.9 million in the first six months of fiscal 2009. The
decrease compared with prior-year results primarily reflects receipt of a $9 million contract
termination payment from Merck in fiscal 2009, while in fiscal 2010 we received a $3.5 million
upfront license fee from Genentech.
In November 2007, our Board of Directors authorized the repurchase of $35.0 million of the
Companys common stock in open-market transactions, private transactions, tender offers, or other
transactions. The repurchase authorization does not have a fixed expiration date. During the six
months ended March 31, 2010, the Company repurchased 102,533 shares for $2.0 million at an average
price of $19.81 per share, leaving $5.3 million remaining available for future share repurchases
under the repurchase program.
As of March 31, 2010, we had no debt under our $25 million unsecured revolving credit
facility. As of March 31, 2010, the Company was in compliance with all covenants.
We do not have any other credit agreements and believe that our existing cash, cash
equivalents and investments, together with cash flow from operations, will provide liquidity
sufficient to meet the below stated needs and fund our operations for the next twelve months. There
can be no assurance, however, that SurModics business will continue to generate cash flows at
current levels, and disruptions in financial markets may negatively impact the Companys ability to
access capital in a timely manner and on attractive terms, if at all. Our anticipated liquidity
needs for the remainder of fiscal 2010 include, but are not limited to, the following: capital
expenditures related to the Alabama cGMP facility in the range of $4.5 million to $5.5 million;
general capital expenditures in the range of $3 million to $4 million; contingent consideration
payments, if any, related to our acquisitions of SurModics Pharmaceuticals, BioFX Laboratories,
Inc., as well as the purchase of certain assets from PR Pharmaceuticals, Inc.; and any amounts
associated with the repurchase of common stock under the authorization discussed above.
Off-Balance Sheet Arrangements
As of March 31, 2010, the Company did not have any off-balance sheet arrangements with any
unconsolidated entities.
Forward-Looking Statements
Certain statements contained in this report, or in other reports of the Company and other
written and oral statements made from time to time by the Company, do not relate strictly to
historical or current facts. As such, they are considered forward-looking statements that provide
current expectations or forecasts of future events. These forward-looking statements are made
pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Such statements can be identified by the use of terminology such as anticipate, believe,
could, estimate, expect, forecast, intend, may, plan, possible, project, will
and similar words or expressions. Any statement that is not a historical fact, including estimates,
projections, future trends and the outcome of events that have not yet occurred, are
forward-looking statements. The Companys forward-looking statements generally relate to its growth
strategy, financial prospects, product development programs, sales efforts, revenue expectations
and the impact of the Cordis and Genentech agreements, as well as other significant customer
agreements, and capital and liquidity expectations and needs. You should carefully consider
forward-looking statements and understand that such statements involve a
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variety of risks and uncertainties, known and unknown, and may be affected by inaccurate
assumptions. Consequently, no forward-looking statement can be guaranteed and actual results may
vary materially. The Company undertakes no obligation to update any forward-looking statement.
Although it is not possible to create a comprehensive list of all factors that may cause
actual results to differ from the Companys forward-looking statements, such factors include, among
others:
| the Companys reliance on a small number of significant customers, which causes our financial results and stock price to be subject to factors affecting those significant customers and their products, the timing of market introduction of their or competing products, product safety or efficacy concerns and intellectual property litigation, the outcome of which could adversely affect the royalty revenue we derive based on the sales of licensed products; | ||
| general economic conditions which are beyond our control, including the impact of recession, business investment and changes in consumer confidence; | ||
| frequent intellectual property litigation in the medical device and pharmaceutical industries that may directly or indirectly adversely affect our customers ability to market their products incorporating our technologies; | ||
| our ability to protect our own intellectual property; | ||
| healthcare reform efforts, including reduced reimbursement rates and new taxes on medical devices and pharmaceutical products that may adversely affect our customers ability to cost-effectively market and sell devices incorporating our technologies or affect the prices they receive for such products thereby affecting the Companys revenue; | ||
| the Companys ability to attract new licensees and to enter into agreements for additional product applications with existing licensees, the willingness of potential licensees to sign license agreements under the terms offered by the Company, changes in the development and marketing priorities of our licensees and development partners and the Companys ability to maintain satisfactory relationships with its licensees; | ||
| the Companys ability to increase the number of market segments and applications that use its technologies through its sales and marketing and research and development efforts; | ||
| the decrease in available financing for the Companys customers and for new ventures which could potentially become customers can reduce the Companys potential opportunities; | ||
| market acceptance of products sold by customers incorporating our technologies and the timing of new product introductions by licensees; | ||
| market acceptance of products sold by customers competitors and the timing and pricing of new product introductions by customers competitors; | ||
| the difficulties and uncertainties associated with the lengthy and costly new product development and foreign and domestic regulatory approval processes, such as delays, difficulties or failures in achieving acceptable clinical results or obtaining foreign or FDA marketing clearances or approvals, which may result in lost market opportunities or postpone or preclude product commercialization by licensees; | ||
| efficacy or safety concerns with respect to products marketed by us and our licensees, whether scientifically justified or not, that may lead to product recalls, withdrawals or declining sales; | ||
| the ability to secure raw materials for reagents the Company sells; | ||
| the Companys ability to successfully manage clinical trials and related foreign and domestic regulatory processes for the I-vation intravitreal implant or other products under development by the Company, whether delays, difficulties or failures in achieving acceptable clinical results or obtaining foreign or FDA marketing clearances or approvals postpone or preclude product commercialization of the intravitreal implant or other products, and whether the intravitreal implant and any other products remain viable commercial prospects; | ||
| product liability claims against which we are not indemnified or that are not covered by insurance; | ||
| the development of new products or technologies by competitors, technological obsolescence and other changes in competitive factors; | ||
| the trend of consolidation in the medical device and pharmaceutical industries, resulting in more significant, complex and long term contracts than in the past and potentially greater pricing pressures; | ||
| the Companys ability to identify suitable businesses to acquire or with whom to form strategic relationships to expand its technology development and commercialization, its ability to successfully integrate the operations of companies it may acquire from time to time and its ability to create synergies from acquisitions and other strategic relationships; |
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| the Companys ability to successfully internally perform certain product development activities and governmental and regulatory compliance activities which the Company has not previously undertaken in any significant manner; | ||
| acts of God or terrorism which impact the Companys personnel or facilities; and | ||
| other factors described below in Risk Factors and other sections of SurModics Annual Report on Form 10-K, which you are encouraged to read carefully. |
Many of these factors are outside the control and knowledge of the Company, and could result
in increased volatility in period-to-period results. Investors are advised not to place undue
reliance upon the Companys forward-looking statements and to consult any further disclosures by
the Company on this subject in its filings with the Securities and Exchange Commission.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
The Companys investment policy requires the Company to invest in high credit quality issuers
and limits the amount of credit exposure to any one issuer. The Companys investments principally
consist of U.S. government and government agency obligations and investment-grade, interest-bearing
corporate debt securities with varying maturity dates, the majority of which are five years or
less. Because of the credit criteria of the Companys investment policies, the primary market risk
associated with these investments is interest rate risk. The Company does not use derivative
financial instruments to manage interest rate risk or to speculate on future changes in interest
rates. A one percentage point increase in interest rates would result in an approximate $0.7
million decrease in the fair value of the Companys available-for-sale and held-to-maturity
securities as of March 31, 2010, but no material impact on the results of operations or cash flows.
Management believes that a reasonable change in raw material prices would not have a material
impact on future earnings or cash flows because the Companys inventory exposure is not material.
Although we conduct business in foreign countries, all sales transactions are denominated in
U.S. dollars. Accordingly, we do not expect to be subject to material foreign currency risk with
respect to future costs or cash flows from our foreign sales. To date, we have not entered into any
foreign currency forward exchange contracts or other derivative financial instruments to hedge the
effects of adverse fluctuations in foreign currency exchange.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this report, the Company conducted an evaluation under
the supervision and with the participation of the Companys management, including the Companys
Chief Executive Officer and Chief Financial Officer regarding the effectiveness of the design and
operation of the Companys disclosure controls and procedures pursuant to Rule 13a-15(b) of the
Securities Exchange Act of 1934 (the Exchange Act). Based upon that evaluation, the Chief
Executive Officer and Chief Financial Officer concluded that the Companys disclosure controls and
procedures are effective to ensure that information required to be disclosed by the Company in
reports that it files under the Exchange Act is recorded, processed, summarized and reported within
the time period specified in the Securities Exchange Commission rules and forms, and to ensure that
information required to be disclosed by the Company in the reports the Company files or submits
under the Exchange Act is accumulated and communicated to the Companys management, including its
principal executive and principal financial officers, as appropriate, to allow timely decisions
regarding required disclosures.
Changes in Internal Controls
There was no change in the Companys internal control over financial reporting that occurred
during the period covered by this report that has materially affected, or is reasonably likely to
materially affect, the Companys internal control over financial reporting.
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PART II OTHER INFORMATION
Item 1. Legal Proceedings.
There have been no material developments in the legal proceedings previously disclosed in the
Companys Form 10-K for the fiscal year ended September 30, 2009.
Item 1A. Risk Factors.
There have been no material changes from risk factors as previously disclosed in the Companys
Form 10-K for the fiscal year ended September 30, 2009 in response to Item 1A to Part I of Form
10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
(c) Issuer Purchases of Equity Securities
The following table presents information with respect to purchases of common stock of the
Company made during the three months ended March 31, 2010, by the Company or on behalf of the
Company or any affiliated purchaser of the Company, as defined in Rule 10b-18(a)(3) under the
Exchange Act.
(c) | (d) | |||||||||||||||
Total Number | Dollar | |||||||||||||||
of Shares | Value of | |||||||||||||||
Purchased | Shares that | |||||||||||||||
as Part of | May Yet Be | |||||||||||||||
(a) | (b) | Publicly | Purchased | |||||||||||||
Total Number | Average | Announced | Under the | |||||||||||||
of Shares | Price Paid | Plans or | Plans or | |||||||||||||
Period | Purchased(1) | Per Share | Programs | Programs(2) | ||||||||||||
1/01/10 1/31/10 |
32,141 | $ | 19.88 | 31,558 | $ | 6,706,269 | ||||||||||
2/01/10 2/28/10 |
70,975 | $ | 19.78 | 70,975 | $ | 5,302,113 | ||||||||||
3/01/10 3/31/10 |
6,773 | $ | 20.76 | 0 | $ | 5,302,113 | ||||||||||
Total |
109,889 | $ | 19.87 | 102,533 | $ | 5,302,113 | ||||||||||
(1) | The purchases in this column included shares repurchased as part of our publicly announced program and in addition include 7,356 shares repurchased by the Company to satisfy tax withholding obligations in connection with so-called stock swap exercises related to the vesting of restricted stock awards or to satisfy payment associated with exercise of non-qualified stock options. | |
(2) | On November 15, 2007, our Board of Directors announced the authorization of the repurchase of $35 million of outstanding common stock. As of March 31, 2010, we have repurchased a cumulative 1,024,181 shares at an average price of $29.00 per share. Under the current authorization the Company has $5.3 million available for authorized share repurchases as of March 31, 2010. The repurchase authorization does not have an expiration date. |
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Removed and Reserved.
Item 5. Other Information.
Submission of matters to a vote of security holders
Set forth below is information concerning matters submitted to a vote of the Companys
security holders at the recent annual meeting of shareholders during the period covered by this
Report on Form 10-Q:
(a) | The Company held its Annual Meeting of Shareholders on February 8, 2010. |
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(b) | Proxies were solicited pursuant to Regulation 14A under the Securities Act of 1934. The shareholders voted on five matters: (i) to elect Class II directors; (ii) to set the number of directors at nine (9); (iii) to ratify the appointment of Deloitte & Touche LLP as SurModics independent registered public accounting firm for fiscal year 2010; (iv) to approve the SurModics, Inc. 2009 Equity Incentive Plan; and (v) to approve certain amendments to the SurModics, Inc. 1999 Employee Stock Purchase Plan. The shareholders approved all matters by the following votes: |
Votes | ||||||||
Votes For | Withheld | |||||||
(i) Elect Class II directors (elected by plurality voting) | ||||||||
John W. Benson |
8,370,695 | 3,216,518 | ||||||
Mary K. Brainerd |
5,608,782 | 5,978,431 | ||||||
Gerald B. Fischer |
8,402,661 | 3,184,552 |
Votes | Votes | Broker | ||||||||||||||
Votes For | Against | Abstained | Non-Votes | |||||||||||||
(ii) Set the number of directors at nine (9) |
14,645,656 | 62,727 | 21,162 | |
(iii) Ratify the appointment of Deloitte & Touche LLP as SurModics independent registered public accounting firm for fiscal year 2010
Votes | Votes | Broker | ||||||||||||||
Votes For | Against | Abstained | Non-Votes | |||||||||||||
14,537,500 | 182,256 | 9,790 | |
(iv) Approve the SurModics, Inc. 2009 Equity Incentive Plan
Votes | Votes | Broker | ||||||||||||||
Votes For | Against | Abstained | Non-Votes | |||||||||||||
10,798,074 | 761,081 | 28,058 | 3,142,333 |
(v) Approve certain amendments to the SurModics, Inc. 1999 Employee Stock Purchase Plan
Votes | Votes | Broker | ||||||||||||||
Votes For | Against | Abstained | Non-Votes | |||||||||||||
11,376,233 | 159,838 | 51,142 | 3,142,333 |
Asset impairment charge
In second quarter ended March 31, 2010, the Company recorded a $2.1 million asset impairment
charge associated with its facilities in Alabama as the Company works to consolidate its multiple
facilities in Birmingham, Alabama into the Companys newly opened cGMP manufacturing and
development facility.
Item 6. Exhibits.
Exhibit | Description | |
3.1
|
Restated Articles of Incorporation, as amended incorporated by reference to Exhibit 3.1 of the Companys Quarterly Report on Form 10-QSB for the quarter ended December 31, 1999, SEC File No. 0-23837. | |
3.2
|
Restated Bylaws of SurModics, Inc., as amended November 30, 2009 incorporated by reference to Exhibit 3.2 of the Companys Quarterly Report on Form 10-Q for the quarter ended December 31, 2009, SEC File No. 0-23837. | |
10.1*
|
SurModics, Inc. 2009 Equity Incentive Plan. | |
10.2*
|
SurModics, Inc. 1999 Employee Stock Purchase Plan (as amended and restated November 30, 2009). | |
10.3
|
SurModics, Inc. 2009 Equity Incentive Plan incorporated by reference from Appendix A to SurModics Definitive Proxy Statement filed with the SEC on December 18, 2009. | |
10.4
|
Form of Incentive Stock Option Agreement for the SurModics, Inc. 2009 Equity Incentive Plan incorporated by reference to Exhibit 10.2 to the Companys 8-K filed February 12, 2010, SEC File No. 0-23837. | |
10.5
|
Form of Non-Statutory Stock Option Agreement for the SurModics, Inc. 2009 Equity Incentive Plan incorporated by reference to Exhibit 10.3 to the Companys 8-K filed February 12, 2010, SEC File No. 0-23837. | |
10.6
|
Form of Performance Share Agreement for the SurModics, Inc. 2009 Equity Incentive Plan incorporated by reference to Exhibit 10.4 to the Companys 8-K filed February 12, 2010, SEC File No. 0-23837. | |
10.7
|
Form of Restricted Stock Agreement for the SurModics, Inc. 2009 Equity Incentive Plan incorporated by reference to Exhibit 10.5 to the Companys 8-K filed February 12, 2010, SEC File No. 0-23837. | |
31.1*
|
Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002. | |
31.2*
|
Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002. | |
32.1*
|
Certification of Chief Executive Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002. | |
32.2*
|
Certification of Chief Financial Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002. |
* | Filed herewith. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
May 7, 2010 | SurModics, Inc. |
|||
By: | /s/ Philip D. Ankeny | |||
Philip D. Ankeny | ||||
Senior Vice President and Chief Financial Officer |
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
EXHIBIT INDEX TO FORM 10-Q
For the Quarter Ended March 31, 2010
SURMODICS, INC.
WASHINGTON, D.C. 20549
EXHIBIT INDEX TO FORM 10-Q
For the Quarter Ended March 31, 2010
SURMODICS, INC.
Exhibit | Description | |
3.1
|
Restated Articles of Incorporation, as amended incorporated by reference to Exhibit 3.1 of the Companys Quarterly Report on Form 10-QSB for the quarter ended December 31, 1999, SEC File No. 0-23837. | |
3.2
|
Restated Bylaws of SurModics, Inc., as amended November 30, 2009 incorporated by reference to Exhibit 3.2 of the Companys Quarterly Report on Form 10-Q for the quarter ended December 31, 2009, SEC File No. 0-23837. | |
10.1*
|
SurModics, Inc. 2009 Equity Incentive Plan. | |
10.2*
|
SurModics, Inc. 1999 Employee Stock Purchase Plan (as amended and restated November 30, 2009). | |
10.3
|
SurModics, Inc. 2009 Equity Incentive Plan incorporated by reference from Appendix A to SurModics Definitive Proxy Statement filed with the SEC on December 18, 2009. | |
10.4
|
Form of Incentive Stock Option Agreement for the SurModics, Inc. 2009 Equity Incentive Plan incorporated by reference to Exhibit 10.2 to the Companys 8-K filed February 12, 2010, SEC File No. 0-23837. | |
10.5
|
Form of Non-Statutory Stock Option Agreement for the SurModics, Inc. 2009 Equity Incentive Plan incorporated by reference to Exhibit 10.3 to the Companys 8-K filed February 12, 2010, SEC File No. 0-23837. | |
10.6
|
Form of Performance Share Agreement for the SurModics, Inc. 2009 Equity Incentive Plan incorporated by reference to Exhibit 10.4 to the Companys 8-K filed February 12, 2010, SEC File No. 0-23837. | |
10.7
|
Form of Restricted Stock Agreement for the SurModics, Inc. 2009 Equity Incentive Plan incorporated by reference to Exhibit 10.5 to the Companys 8-K filed February 12, 2010, SEC File No. 0-23837. | |
31.1*
|
Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002. | |
31.2*
|
Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002. | |
32.1*
|
Certification of Chief Executive Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002. | |
32.2*
|
Certification of Chief Financial Officer Pursuant to Section 906 of Sarbanes-Oxley Act of 2002. |
* | Filed herewith. |
30