10-Q
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2014

or

 

¨ 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   41-1356149

(State of

incorporation)

 

(I.R.S. Employer

Identification No.)

9924 West 74th Street

Eden Prairie, Minnesota 55344

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (952) 500-7000

 

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨

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  x    No  ¨

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   ¨    Accelerated filer   x
Non-accelerated filer   ¨  (Do not check if a smaller reporting company)    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  ¨    No  x

The number of shares of the registrant’s Common Stock, $.05 par value per share, outstanding as of July 31, 2014 was 13,596,744.

 

 

 


Table of Contents

TABLE OF CONTENTS

 

PART I. FINANCIAL INFORMATION      3   

Item 1.

  Financial Statements      3   

Item 2.

  Management’s Discussion and Analysis of Financial Condition and Results of Operations      21   

Item 3.

  Quantitative and Qualitative Disclosures About Market Risk      29   

Item 4.

  Controls and Procedures      29   
PART II. OTHER INFORMATION      30   

Item 1.

  Legal Proceedings      30   

Item 1A.

  Risk Factors      30   

Item 2.

  Unregistered Sales of Equity Securities and Use of Proceeds      30   

Item 3.

  Defaults Upon Senior Securities      30   

Item 4.

  Mine Safety Disclosures      30   

Item 5.

  Other Information      30   

Item 6.

  Exhibits      31   
SIGNATURES   

EX-12

  

EX-31.1

  

EX-31.2

  

EX-32.1

  

EX-32.2

  

EX-101 INSTANCE DOCUMENT

  

EX-101 SCHEMA DOCUMENT

  

EX-101 CALCULATION LINKBASE DOCUMENT

  

EX-101 DEFINITION LINKBASE DOCUMENT

  

EX-101 LABEL LINKBASE DOCUMENT

  

EX-101 PRESENTATION LINKBASE DOCUMENT

  

 

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

SurModics, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

 

     June 30,
2014
     September
30, 2013
 
(in thousands, except share and per share data)    (Unaudited)  

ASSETS

     

Current Assets:

     

Cash and cash equivalents

   $ 39,729       $ 15,495   

Available-for-sale securities

     882         10,212   

Accounts receivable, net of allowance for doubtful accounts of $53 and $26 as of June 30, 2014 and September 30, 2013, respectively

     5,176         5,332   

Inventories

     2,900         3,328   

Deferred tax assets

     321         506   

Prepaids and other

     1,718         860   

Current assets of discontinued operations

     85         46   
  

 

 

    

 

 

 

Total Current Assets

     50,811         35,779   

Property and equipment, net

     12,710         12,845   

Available-for-sale securities

     16,497         32,397   

Deferred tax assets

     6,392         6,038   

Intangible assets, net

     3,131         3,688   

Goodwill

     8,010         8,010   

Other assets, net

     3,166         3,166   
  

 

 

    

 

 

 

Total Assets

   $ 100,717       $ 101,923   
  

 

 

    

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

     

Current Liabilities:

     

Accounts payable

   $ 1,400       $ 954   

Accrued liabilities:

     

Compensation

     1,756         2,271   

Accrued other

     844         1,149   

Share repurchase accrual

     —           1,004   

Deferred revenue

     41         43   

Restructuring and other current liabilities

     2         416   

Current liabilities of discontinued operations

     75         139   
  

 

 

    

 

 

 

Total Current Liabilities

     4,118         5,976   

Deferred revenue, less current portion

     149         160   

Other long-term liabilities

     1,779         1,970   
  

 

 

    

 

 

 

Total Liabilities

     6,046         8,106   
  

 

 

    

 

 

 

Commitments and Contingencies (Note 17)

     

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; 13,594,564 and 13,891,402 shares issued and outstanding, respectively

     680         695   

Additional paid-in capital

     2,419         2,028   

Accumulated other comprehensive income

     36         58   

Retained earnings

     91,536         91,036   
  

 

 

    

 

 

 

Total Stockholders’ Equity

     94,671         93,817   
  

 

 

    

 

 

 

Total Liabilities and Stockholders’ Equity

   $ 100,717       $ 101,923   
  

 

 

    

 

 

 

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 Income

 

     Three Months Ended
June 30,
    Nine Months Ended
June 30,
 
     2014     2013     2014     2013  
(In thousands, except per share data)    (Unaudited)     (Unaudited)  

Revenue:

        

Royalties and license fees

   $ 7,385      $ 7,827      $ 22,179      $ 22,294   

Product sales

     6,067        5,577        16,632        16,688   

Research and development

     1,164        885        3,292        2,853   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     14,616        14,289        42,103        41,835   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating costs and expenses:

        

Product costs

     2,037        1,990        5,737        5,894   

Research and development

     3,655        4,009        11,488        11,145   

Selling, general and administrative

     3,591        4,052        11,736        11,552   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating costs and expenses

     9,283        10,051        28,961        28,591   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating income from continuing operations

     5,333        4,238        13,142        13,244   
  

 

 

   

 

 

   

 

 

   

 

 

 

Other income (loss):

        

Investment income, net

     42        60        194        187   

Impairment loss on strategic investment

     —          —          —          (129

Gain on sales of strategic investments

     28        —          709        119   

Other income, net

     —          2        125        1,341   
  

 

 

   

 

 

   

 

 

   

 

 

 

Other income, net

     70        62        1,028        1,518   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income from continuing operations before income taxes

     5,403        4,300        14,170        14,762   

Income tax provision

     (1,729     (1,122     (4,407     (3,916
  

 

 

   

 

 

   

 

 

   

 

 

 

Income from continuing operations

     3,674        3,178        9,763        10,846   

(Loss) income from discontinued operations, net of income taxes

     (76     (47     (76     635   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income

   $ 3,598      $ 3,131      $ 9,687      $ 11,481   
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic income (loss) per share:

        

Continuing operations

   $ 0.27      $ 0.22      $ 0.72      $ 0.74   

Discontinued operations

     (0.01     0.00        (0.01     0.04   

Net income

   $ 0.26      $ 0.22      $ 0.71      $ 0.79   

Diluted income (loss) per share:

        

Continuing operations

   $ 0.27      $ 0.22      $ 0.70      $ 0.73   

Discontinued operations

     (0.01     0.00        (0.01     0.04   

Net income

   $ 0.26      $ 0.21      $ 0.70      $ 0.77   

Weighted average number of shares outstanding:

        

Basic

     13,585        14,413        13,639        14,563   

Diluted

     13,813        14,739        13,891        14,823   

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 Comprehensive Income

 

     Three Months Ended
June 30,
    Nine Months Ended
June 30,
 
     2014      2013     2014     2013  
(In thousands)    (Unaudited)     (Unaudited)  

Net income

   $ 3,598       $ 3,131      $ 9,687      $ 11,481   

Other comprehensive income (loss), net of tax:

         

Unrealized holding gains (losses) on available-for-sale securities arising during the period

     46         (158     62        158   

Reclassification adjustment for realized gains included in net income

     —           (1     (84     (230
  

 

 

    

 

 

   

 

 

   

 

 

 

Other comprehensive income (loss)

     46         (159     (22     (72
  

 

 

    

 

 

   

 

 

   

 

 

 

Comprehensive income

   $ 3,644       $ 2,972      $ 9,665      $ 11,409   
  

 

 

    

 

 

   

 

 

   

 

 

 

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

 

     Nine Months Ended
June 30,
 
     2014     2013  
(in thousands)    (Unaudited)  

Operating Activities:

    

Net income

   $ 9,687      $ 11,481   

Adjustments to reconcile net income to net cash provided by operating activities from continuing operations:

    

Loss (income) from discontinued operations

     76        (635

Depreciation and amortization

     2,054        2,174   

Stock-based compensation

     3,043        1,983   

Deferred taxes

     (98     34   

Gain on sales of available-for-sale securities and strategic investments

     (835     (1,460

Impairment loss on investments

     —          129   

Excess tax (benefit) deficiency from stock-based compensation plans

     (452     252   

Change in operating assets and liabilities, excluding the impact from discontinued operations:

    

Accounts receivable

     156        333   

Inventories

     428        314   

Prepaids and other

     (114     (305

Accounts payable and accrued liabilities

     (919     (876

Income taxes

     (560     (1,520
  

 

 

   

 

 

 

Net cash provided by operating activities from continuing operations

     12,466        11,904   
  

 

 

   

 

 

 

Investing Activities:

    

Purchases of property and equipment

     (1,165     (1,448

Purchases of available-for-sale securities

     (132,648     (34,599

Sales and maturities of available-for-sale securities

     157,970        34,487   

Cash received from sales of strategic investments

     708        2,286   

Cash transferred to discontinued operations

     (239     (118
  

 

 

   

 

 

 

Net cash provided by investing activities from continuing operations

     24,626        608   
  

 

 

   

 

 

 

Financing Activities:

    

Excess tax benefit (deficiency) from stock-based compensation plans

     452        (252

Issuance of common stock

     348        273   

Repurchase of common stock

     (12,544     (10,323

Purchase of common stock to pay employee taxes

     (1,114     (39
  

 

 

   

 

 

 

Net cash used in financing activities from continuing operations

     (12,858     (10,341
  

 

 

   

 

 

 

Net cash provided by continuing operations

     24,234        2,171   
  

 

 

   

 

 

 

Discontinued Operations:

    

Net cash used in operating activities

     (239     (118

Net cash provided by financing activities

     239        118   
  

 

 

   

 

 

 

Net cash provided by discontinued operations

     —          —     
  

 

 

   

 

 

 

Net change in cash and cash equivalents

     24,234        2,171   

Cash and Cash Equivalents:

    

Beginning of period

     15,495        15,540   
  

 

 

   

 

 

 

End of period

   $ 39,729      $ 17,711   
  

 

 

   

 

 

 

Supplemental Information:

    

Cash paid for income taxes

   $ 4,860      $ 5,257   

Noncash transactions – acquisition of property and equipment on account

   $ 224      $ 19   

Noncash transactions – issuance of performance shares, restricted and deferred stock units

   $ 3,007      $ —     

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 June 30, 2014

(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 (“U.S.”) (“GAAP”) and, in the opinion of management, reflect all adjustments, consisting solely of normal recurring adjustments, needed to fairly present the financial results of SurModics, Inc. and subsidiaries (“SurModics” or the “Company”) for the periods presented. These financial statements include some amounts that are based on management’s best estimates and judgments. These estimates may be adjusted as more information becomes available, and any adjustment could be significant. The impact of any change in estimates is included in the determination of earnings in the period in which the change in estimate is identified. The results of operations for the three and nine months ended June 30, 2014 are not necessarily indicative of the results that may be expected for the entire 2014 fiscal year.

In accordance with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”), 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 fiscal year ended September 30, 2013, and footnotes thereto included in the Company’s Form 10-K as filed with the SEC on December 11, 2013.

2. Key Accounting Policies

Revenue recognition

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. Under revenue arrangements with multiple deliverables, the Company recognizes each separable deliverable as it is earned.

The Company derives its revenue from three primary sources: (1) royalties and license fees from licensing its proprietary drug delivery and surface modification technologies and in vitro diagnostic formats to customers; (2) the sale of reagent chemicals to licensees and the sale of stabilization products, antigens, substrates and surface coatings to the diagnostic and biomedical research markets; and (3) research and commercial development fees generated on customer projects.

Royalties and license fees. The Company licenses technology to third parties and collects royalties. Royalty revenue is generated when a customer sells products incorporating the Company’s licensed technologies. Royalty revenue is recognized as licensees report it to the Company, and payment is typically submitted concurrently with the report. For stand-alone license agreements, up-front license fees are recognized over the term of the related licensing agreement. Minimum royalty fees are recognized in the period earned.

Revenue related to a performance milestone is recognized upon the achievement of the milestone, as defined in the respective agreements and provided the following conditions have been met:

 

    The milestone payment is non-refundable;

 

    The milestone involved a significant degree of risk, and was not reasonably assured at the inception of the arrangement;

 

    Accomplishment of the milestone involved substantial effort;

 

    The amount of the milestone payment is commensurate with the related effort and risk; and

 

    A reasonable amount of time passed between the initial license payment and the first and subsequent milestone payments.

If these conditions have not been met, the milestone payment is deferred and recognized over the term of the agreement.

Product sales. Product sales to third parties consist of direct and distributor sales and are recognized at the time of shipment. The Company’s 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.

 

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Arrangements with multiple deliverables. Revenue arrangements with multiple deliverables require the Company to:

(i) disclose whether multiple deliverables exist, how the deliverables in an arrangement should be separated, and how the consideration should be allocated;

(ii) 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) allocate revenue using the relative selling price method.

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 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 Company’s 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 is required to evaluate each deliverable in a multiple element arrangement for separability. The Company is then required to allocate revenue to each separate deliverable using a hierarchy of VSOE, TPE, or ESP. In many instances, the Company is not able to establish VSOE for all deliverables in an arrangement with multiple elements. This may be a result of the Company infrequently selling each element separately or having a limited history with multiple element arrangements. When VSOE cannot be established, the Company attempts to establish 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 features. The determination of ESP is made through consultation with the Company’s management, taking into consideration the marketing strategies for each business unit.

New Accounting Pronouncements

Accounting Standards to be Adopted

In July 2013, the Financial Accounting Standards Board (“FASB”) issued amended guidance on the financial statement presentation of an unrecognized tax benefit when a net operating loss carryforward, similar to a tax loss, or tax credit carryforward exits. The guidance requires an unrecognized tax benefit, or a portion of an unrecognized tax benefit, be presented as a reduction of a deferred tax asset when a net operating loss carryforward, or similar tax loss, or tax credit carryforward exits, with certain exceptions. This accounting guidance is effective prospectively for the Company beginning in the first quarter of fiscal 2015. The adoption is not expected to have a material impact on the Company’s results of operations, cash flows and financial position.

In May 2014, the FASB issued new revenue recognition guidance for recognizing revenue from contracts with customers that provides a five-step analysis of transactions to determine when and how revenue is recognized. The guidance states that a Company should recognize revenue which depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to receive in exchange for those goods or services. The new standard will also result in enhanced disclosures about revenue related to the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. The standard also requires quantitative and qualitative disclosures about customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. Additionally it has provided

 

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guidance for transactions that were not previously addressed comprehensively, and improved guidance for multiple-element arrangements. This pronouncement is effective for the Company beginning in fiscal 2018 (October 1, 2017), early adoption is not permitted, and can be adopted by the Company either retrospectively (October 1, 2015) or as a cumulative-effect adjustment as of the date of adoption. The Company is currently evaluating the impact of adopting this new accounting guidance will have on the Company’s results of operations, cash flows and financial position.

No other new accounting pronouncement issued or effective has had, or is expected to have, a material impact on the Company’s consolidated financial statements.

3. Discontinued Operations

Beginning with the first quarter of fiscal 2012, the results of operations, cash flows, assets and liabilities of SurModics SMP, LLC (“SurModics Pharmaceuticals”), which were previously reported in the Pharmaceuticals segment as a separate operating segment, are classified as discontinued operations.

On November 1, 2011, the Company entered into a definitive agreement (the “Purchase Agreement”) to sell substantially all of the assets of its wholly-owned subsidiary, SurModics Pharmaceuticals, to Evonik Degussa Corporation (“Evonik”). Under the terms of the Purchase Agreement, the entire portfolio of products and services of SurModics Pharmaceuticals, including the Company’s Current Good Manufacturing Practices (“cGMP”) development and manufacturing facility located in Birmingham, Alabama, were sold. The Company retained all accounts receivable and the majority of liabilities associated with SurModics Pharmaceuticals incurred prior to closing. The sale (the “Pharma Sale”) closed on November 17, 2011. The total consideration received from the Pharma Sale was $30.0 million in cash. As part of the Pharma Sale, SurModics agreed not to compete in the restricted business (as defined in the Purchase Agreement) for a period of five years and to indemnify Evonik against specified losses in connection with SurModics Pharmaceuticals, including certain contingent consideration obligations related to the acquisition by SurModics Pharmaceuticals of the portfolio of intellectual property and drug delivery projects from PR Pharmaceuticals, Inc. (“PR Pharma”) and other specified excluded liabilities, including the litigation matter with Southern Research Institute (“SRI”) described below. SurModics retained responsibility for repayment obligations related to an agreement with various governmental authorities associated with creation of jobs in Alabama. These repayment obligations were settled or terminated in the second and third quarters of fiscal 2013 with payments totaling $325,000 repaid to the governmental authorities and a gain of $1.3 million recognized in the nine months ended June 30, 2013.

The following is a summary of the operating results of SurModics Pharmaceuticals discontinued operations for the three and nine months ended June 30, 2014 and 2013:

 

     Three Months Ended     Nine Months Ended  
     June 30,     June 30,  
(Dollars in thousands)    2014     2013     2014     2013  

(Loss) income from discontinued operations

   $ (117   $ 136      $ (117   $ 1,151   

Income tax benefit (provision)

     41        (183     41        (516
  

 

 

   

 

 

   

 

 

   

 

 

 

(Loss) income from discontinued operations, net of income taxes

   $ (76   $ (47   $ (76   $ 635   
  

 

 

   

 

 

   

 

 

   

 

 

 

The major classes of assets and liabilities of discontinued operations as of June 30, 2014 and September 30, 2013 were as follows:

 

     June 30,      September 30,  
(Dollars in thousands)    2014      2013  

Other current assets

   $ 85       $ 46   
  

 

 

    

 

 

 

Current assets of discontinued operations

     85         46   
  

 

 

    

 

 

 

Total assets of discontinued operations

   $ 85       $ 46   
  

 

 

    

 

 

 

Other current liabilities payable

   $ 75       $ 139   
  

 

 

    

 

 

 

Current liabilities of discontinued operations

     75         139   
  

 

 

    

 

 

 

Total liabilities of discontinued operations

   $ 75       $ 139   
  

 

 

    

 

 

 

In June 2014, the Company resolved the previously disclosed litigation involving SRI, two of SRI’s former employees and SurModics Pharmaceuticals. In connection with the resolution of the litigation, the Company recorded an additional expense, within discontinued operations, of $0.1 million in the three and nine months ended June 30, 2014. The assets and liabilities of discontinued operations as of June 30, 2014 represent amounts associated with the resolution of this litigation and the related deferred taxes. See Note 17 for additional discussion of the SRI litigation matter.

 

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4. Fair Value Measurements

The accounting guidance on fair value measurements defines fair value, establishes a framework for measuring fair value under GAAP, and expands disclosures about fair value measurements. The guidance is applicable for all financial assets and financial liabilities and for all nonfinancial assets and nonfinancial liabilities recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually). Fair value is defined as the exchange price that would be received from selling an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities required or permitted to be recorded at fair value, the Company considers the principal or most advantageous market in which it would transact and also considers assumptions that market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions and risk of nonperformance.

Fair Value Hierarchy

Accounting guidance on fair value measurements requires that assets and liabilities carried at fair value be classified and disclosed in one of the following three categories:

Level 1 — Quoted (unadjusted) prices in active markets for identical assets or liabilities.

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 Company’s Level 2 assets consist of money market funds, U.S. Treasury securities, corporate bonds, municipal bonds, U.S. government agency securities, government agency and municipal securities and certain asset-backed 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. The Company performs limited tests of the quoted vendor prices based on available U.S. Treasury security pricing on government websites as a means of validating the third party pricing. To ensure the accuracy of quoted vendor prices and broker pricing, the Company performs regular reviews of investment returns to industry benchmarks and sample tests of individual securities to validate quoted vendor prices with other available market data.

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.

There were no Level 3 assets at June 30, 2014, March 31, 2014, September 30, 2013, June 30, 2013 or March 31, 2013 and there was no Level 3 activity during the first nine months of fiscal 2014 or fiscal 2013.

In valuing assets and liabilities, the Company is required to maximize the use of quoted market prices and minimize the use of unobservable inputs. The Company did not significantly change its valuation techniques from prior periods.

Assets and Liabilities Measured at Fair Value on a Recurring Basis

In instances where the inputs used to measure fair value fall into different levels of the fair value hierarchy, the fair value measurement has been determined based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s 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 Company’s assets and liabilities measured at fair value on a recurring basis as of June 30, 2014:

 

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(Dollars in thousands)    Quoted Prices in
Active Markets
for Identical
Instruments
(Level 1)
     Significant
Other
Observable
Inputs

(Level 2)
     Significant
Unobservable
Inputs

(Level 3)
     Total Fair
Value as of
June 30,
2014
 

Assets:

           

Cash equivalents

   $ —         $ 36,861       $ —         $ 36,861   

Available-for-sale debt securities:

           

U.S. government and government agency obligations

     —           2,864         —           2,864   

Mortgage-backed securities

     —           5,106         —           5,106   

Municipal bonds

     —           1,564         —           1,564   

Asset-backed securities

     —           6,000         —           6,000   

Corporate bonds

     —           1,845         —           1,845   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets measured at fair value

   $ —         $ 54,240       $ —         $ 54,240   
  

 

 

    

 

 

    

 

 

    

 

 

 

The following table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis as of September 30, 2013:

 

(Dollars in thousands)    Quoted Prices in
Active Markets
for Identical
Instruments
(Level 1)
     Significant
Other
Observable
Inputs

(Level 2)
     Significant
Unobservable
Inputs

(Level 3)
     Total Fair
Value as of
September 30,
2013
 

Assets:

           

Cash equivalents

   $ —         $ 4,402       $ —         $ 4,402   

Available-for-sale debt securities:

           

U.S. government and government agency obligations

     —           22,890         —           22,890   

Mortgage-backed securities

     —           8,216         —           8,216   

Municipal bonds

     —           3,059         —           3,059   

Asset-backed securities

     —           3,537         —           3,537   

Corporate bonds

     —           4,907         —           4,907   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets measured at fair value

   $ —         $ 47,011       $ —         $ 47,011   
  

 

 

    

 

 

    

 

 

    

 

 

 

Valuation Techniques

The valuation techniques used to measure the fair value of assets are as follows:

Cash equivalents — These assets are classified as Level 2 and are carried at historical cost which is a reasonable estimate of fair value because of the relatively short time between origination of the instrument and its expected realization.

Available-for-sale debt securities — These securities are classified as Level 2 and include various types of debt securities. These securities are valued based on quoted vendor prices in active markets underlying the securities.

5. Investments

Investments consist principally of U.S. government and government agency obligations, mortgage-backed securities and corporate and municipal debt securities and are classified as available-for-sale at June 30, 2014 and September 30, 2013. Available-for-sale securities are reported at fair value with unrealized gains and losses, net of tax, excluded from the condensed consolidated statements of income and reported in the condensed consolidated statements of comprehensive income as well as a separate component of stockholders’ equity in the condensed consolidated balance sheets, except for other-than-temporary impairments, which are reported as a charge to current earnings. 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. Interest earned 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 amortized cost, unrealized holding gains and losses, and fair value of available-for-sale securities as of June 30, 2014 and September 30, 2013 were as follows:

 

     June 30, 2014  
(Dollars in thousands)    Amortized
Cost
     Unrealized
Gains
     Unrealized
Losses
    Fair Value  

U.S. government and government agency obligations

   $ 2,846       $ 21       $ (3   $ 2,864   

Mortgage-backed securities

     5,096         56         (46     5,106   

Municipal bonds

     1,558         9         (3     1,564   

Asset-backed securities

     5,990         14         (4     6,000   

Corporate bonds

     1,835         12         (2     1,845   
  

 

 

    

 

 

    

 

 

   

 

 

 

Total

   $ 17,325       $ 112       $ (58   $ 17,379   
  

 

 

    

 

 

    

 

 

   

 

 

 

 

     September 30, 2013  
(Dollars in thousands)    Amortized
Cost
     Unrealized
Gains
     Unrealized
Losses
    Fair Value  

U.S. government and government agency obligations

   $ 22,889       $ 28       $ (27   $ 22,890   

Mortgage-backed securities

     8,149         118         (51     8,216   

Municipal bonds

     3,049         15         (5     3,059   

Asset-backed securities

     3,539         6         (8     3,537   

Corporate bonds

     4,896         17         (6     4,907   
  

 

 

    

 

 

    

 

 

   

 

 

 

Total

   $ 42,522       $ 184       $ (97   $ 42,609   
  

 

 

    

 

 

    

 

 

   

 

 

 

As of June 30, 2014 and September 30, 2013, the Company concluded that the unrealized losses related to the available-for-sale securities shown above were not other-than-temporary as the Company does not have the intent to sell, nor is it more likely than not that the Company will be required to sell, before recovery of their amortized cost.

The amortized cost and fair value of investments by contractual maturity at June 30, 2014 were as follows:

 

(Dollars in thousands)    Amortized Cost      Fair Value  

Debt securities due within:

     

One year

   $ 875       $ 882   

One to five years

     10,784         10,823   

Five years or more

     5,666         5,674   
  

 

 

    

 

 

 

Total

   $ 17,325       $ 17,379   
  

 

 

    

 

 

 

The following table summarizes sales of available-for-sale securities:

 

     Three Months Ended     Nine Months Ended  
     June 30,     June 30,  
(Dollars in thousands)    2014      2013     2014     2013  

Proceeds from sales

   $ 65,455       $ 8,507      $ 157,970      $ 34,487   

Gross realized gains

   $ —         $ 6      $ 126      $ 171   

Gross realized losses

   $ —         $ (4   $ (1   $ (4

 

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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:

 

     June 30,      September 30,  
(Dollars in thousands)    2014      2013  

Raw materials

   $ 976       $ 1,378   

Finished products

     1,924         1,950   
  

 

 

    

 

 

 

Total

   $ 2,900       $ 3,328   
  

 

 

    

 

 

 

7. Other Assets

Other assets consist principally of strategic investments as follows:

 

     June 30,      September 30,  
(Dollars in thousands)    2014      2013  

CeloNova BioSciences, Inc.

   $ 1,500       $ 1,500   

ThermopeutiX, Inc.

     1,185         1,185   

ViaCyte, Inc.

     479         479   

Other

     2         2   
  

 

 

    

 

 

 

Other assets, net

   $ 3,166       $ 3,166   
  

 

 

    

 

 

 

In February 2011, the stent technology of Nexeon MedSystems, Inc. (“Nexeon”) was acquired by CeloNova BioSciences, Inc. (“CeloNova”). Prior to the acquisition by CeloNova, Nexeon created a wholly-owned subsidiary, Nexeon Stent, to hold the company’s stent-related assets. Nexeon distributed to its stockholders the Nexeon Stent stock which was exchanged for Series B-1 preferred shares of CeloNova. CeloNova is a privately-held Texas-based medical technology company that is marketing a variety of medical products. The Company’s investment in CeloNova, which is accounted for under the cost method, represents less than a 2% ownership interest. The Company does not exert significant influence over CeloNova’s operating or financial activities.

The Company has invested a total of $1.2 million in ThermopeutiX, Inc. (“ThermopeutiX”), a California-based early stage company developing novel medical devices for the treatment of vascular and neurovascular diseases. In addition to the investment, SurModics has licensed its hydrophilic and hemocompatible coating technologies to ThermopeutiX for use with its devices. The Company’s investment in ThermopeutiX, which is accounted for under the cost method, represents an ownership interest of less than 20%. The Company does not exert significant influence over ThermopeutiX’s operating or financial activities.

The Company has invested a total of $5.3 million in ViaCyte, Inc. (“ViaCyte”), a privately-held California-based biotechnology firm that is developing a unique treatment for diabetes using coated islet cells, the cells that produce insulin in the human body. In fiscal 2006, the Company determined that its investment in ViaCyte was impaired and that the impairment was other than temporary. Accordingly, the Company recorded an impairment loss of $4.7 million. In the second quarter of fiscal 2013, the Company recorded an additional other-than-temporary impairment loss on this investment totaling $0.1 million based on a current financing round and market valuations. The balance of the investment of $0.5 million, which is accounted for under the cost method, represents less than a 1% ownership interest. The Company does not exert significant influence over ViaCyte’s operating or financial activities.

The Company had invested a total of $2.5 million in Vessix Vascular, Inc. (“Vessix”) and recognized an other-than-temporary impairment loss on this investment totaling $2.4 million in fiscal 2010, based on market valuations and a pending financing round for Vessix. Vessix was purchased by Boston Scientific Corporation in November 2012. The Company recorded a gain of approximately $1.2 million in the condensed consolidated statements of income gains on sale of strategic investments line, on the sale of this investment in the first quarter of fiscal 2013. In the first nine months of fiscal 2014, the Company recorded a $0.7 million gain upon achievement by Vessix of a clinical milestone and a sales milestone for calendar 2013. Total remaining potential maximum additional proceeds of $3.4 million may be received in fiscal 2015 through fiscal 2017 depending on Vessix’s achievement of future sales milestones. No amounts have been recorded associated with these future milestones given the level of uncertainty that exists. Any potential additional income will be recognized once the milestones are achieved.

The total carrying value of cost method investments is reviewed quarterly for changes in circumstances or the occurrence of events that suggest the Company’s investment may not be recoverable. The fair value of cost method investments is not adjusted if there are no identified events or changes in circumstances that may have a material adverse effect on the fair value of the investment.

The Company recognized no revenue for the three months ended June 30, 2014 and revenue of less than $0.1 million for the three months ended June 30, 2013, respectively, from activity with companies in which it had a strategic investment. The Company recognized revenue of less than $0.1 million and approximately $0.1 million for the nine months ended June 30, 2014 and 2013, respectively, from activity with companies in which it had a strategic investment.

 

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8. Intangible Assets

Intangible assets consist principally of acquired patents and technology, customer relationships, licenses and trademarks. For the three months ended June 30, 2014 and 2013, the Company recorded amortization expense of $0.2 million for each period. For the nine months ended June 30, 2014 and 2013, the Company recorded amortization expense of $0.6 million for each period.

Intangible assets consisted of the following:

 

     June 30, 2014  
(Dollars in thousands)    Weighted Average
Original Life (Years)
     Gross Carrying
Amount
     Accumulated
Amortization
    Net  

Definite-lived intangible assets:

          

Customer lists

     9.0       $ 4,857       $ (3,679   $ 1,178   

Core technology

     8.0         530         (458     72   

Patents and other

     16.8         2,256         (955     1,301   
     

 

 

    

 

 

   

 

 

 

Subtotal

        7,643         (5,092     2,551   

Unamortized intangible assets:

          

Trademarks

        580         —          580   
     

 

 

    

 

 

   

 

 

 

Total

      $ 8,223       $ (5,092   $ 3,131   
     

 

 

    

 

 

   

 

 

 

 

     September 30, 2013  
(Dollars in thousands)    Weighted Average
Original Life (Years)
     Gross Carrying
Amount
     Accumulated
Amortization
    Net  

Definite-lived intangible assets:

          

Customer lists

     9.0       $ 4,857       $ (3,274   $ 1,583   

Core technology

     8.0         530         (409     121   

Patents and other

     16.8         2,256         (852     1,404   
     

 

 

    

 

 

   

 

 

 

Subtotal

        7,643         (4,535     3,108   

Unamortized intangible assets:

          

Trademarks

        580         —          580   
     

 

 

    

 

 

   

 

 

 

Total

      $ 8,223       $ (4,535   $ 3,688   
     

 

 

    

 

 

   

 

 

 

Based on the intangible assets in service as of June 30, 2014, estimated amortization expense for the remainder of fiscal 2014 and each of the next five fiscal years is as follows:

 

(Dollars in thousands)

  

Remainder of 2014

   $ 186   

2015

     731   

2016

     594   

2017

     183   

2018

     137   

2019

     137   

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 an acquired entity over the fair value assigned to the assets purchased and liabilities assumed in connection with a company’s acquisition. Goodwill is not amortized but is subject, at a minimum, to annual tests for impairment in accordance with accounting guidance for goodwill. The carrying amount of goodwill is evaluated annually, and between annual evaluations if events occur or circumstances change indicating that it is more likely than not that the fair value of a reporting unit is less than its carrying amount.

The $8.0 million of goodwill at June 30, 2014 and September 30, 2013 is related to the In Vitro Diagnostics reporting unit and represents the gross value from the acquisition of BioFX Laboratories, Inc. (“BioFX”) in 2007. The goodwill was not impaired based on the outcome of the fiscal 2013 annual impairment test, and there have been no events or circumstances that have occurred in the first nine months of fiscal 2014 associated with the In Vitro Diagnostics reporting unit to indicate that the goodwill may be impaired.

 

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10. Stock-based Compensation

The Company has stock-based compensation plans under which it grants stock options, restricted stock awards, performance share awards and restricted stock units. 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 Company’s stock-based compensation expenses were allocated to the following expense categories:

 

     Three Months Ended      Nine Months Ended  
     June 30,      June 30,  
(Dollars in thousands)    2014      2013      2014      2013  

Product costs

   $ 4       $ 7       $ 13       $ 17   

Research and development

     38         54         136         141   

Selling, general and administrative

     538         684         2,894         1,825   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 580       $ 745       $ 3,043       $ 1,983   
  

 

 

    

 

 

    

 

 

    

 

 

 

As of June 30, 2014, approximately $3.2 million of total unrecognized compensation costs related to non-vested awards is expected to be recognized over a weighted average period of approximately 1.6 years. Such costs include $1.1 million based on payout levels associated with performance share awards that are currently anticipated to be fully expensed because the performance conditions are expected to be met at or near target levels.

Stock Option Awards

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 values of stock options granted during the three months ended June 30, 2014 was $8.69. No stock options were granted during the three months ended June 30, 2013. The weighted average per share fair values of stock options granted during the nine months ended June 30, 2014 and 2013 were $8.72 and $8.69, respectively. The assumptions used as inputs in the model were as follows:

 

     Three Months Ended
June 30,
     Nine Months Ended
June 30,
 
     2014     2013      2014     2013  

Risk-free interest rates

     1.6     N/A         1.2     0.6

Expected life (years)

     4.8        N/A         4.6        4.8   

Expected volatility

     43.9     N/A         44.5     49.2

Dividend yield

     0.0     N/A         0.0     0.0

The risk-free interest rate assumption was based on the U.S. Treasury’s 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 Company’s experience. Expected volatility is based on the Company’s stock price movement over a period approximating the expected term. Based on management’s 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.

Non-qualified stock options are granted at fair market value on the date of grant. Non-qualified stock options expire in seven to ten years or upon termination of employment or service as a Board member. Non-qualified stock options granted to the Company’s employees generally become exercisable with respect to 25% of the shares on each of the first four anniversaries following the grant date. Non-qualified stock options granted to the Company’s non-employee directors vest on a prorated basis within the one-year period following the grant date.

The total pre-tax intrinsic value of options exercised during the three months and nine months ended June 30, 2014 was $0.2 million and $1.3 million, respectively. The total pre-tax intrinsic value of options exercised during the three months and nine months ended June 30, 2013 was less than $0.1 million in each period. The intrinsic value represents the difference between the exercise price and the fair market value of the Company’s common stock on the last day of the respective fiscal period end.

The Company modified stock option awards granted to Board members in February 2014, which resulted in acceleration of the stock option vesting period. The modification changed the vesting period to pro-rata over a 12-month service period and resulted in an increase to stock option related expense of $0.6 million in the nine months ended June 30, 2014.

 

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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 is released to the key employees if they are employed by the Company at the end of the vesting period. Compensation has been recognized for the estimated fair value of the common shares and is being charged to income over the vesting term. The stock-based compensation table above includes Restricted Stock expenses recognized related to these awards, which totaled less than $0.1 million during the three months ended June 30, 2014 and $0.2 million during the nine months ended June 30, 2014 and less than $0.1 million during the three and nine months ended June 30, 2013, respectively. In February 2014, the Company granted an award of $0.2 million to the former Chairman of its Board of Directors in connection with his retirement from the Board and in recognition of his contributions to the Company during his years of service.

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. The Performance Shares are not issued and outstanding until the performance objectives are met. Performance objectives selected by the Organization and Compensation Committee of the Board of Directors (the “Committee”) were cumulative earnings per share and cumulative revenue for the three-year performance periods for fiscal 2011 (2011 – 2013), fiscal 2012 (2012 – 2014), fiscal 2013 (2013 – 2015) and fiscal 2014 (2014 – 2016). Assuming that the minimum performance level is attained, the number of shares that may actually vest will vary based on performance from 20% (minimum) to 200% (maximum). Shares will be issued to participants as soon as practicable following the end of the performance periods subject to Committee approval and verification of results. The fiscal 2011 awards were finalized in the three months ended December 31, 2013 and resulted in issuance of 122,053 shares (maximum was 137,066 shares) based on the performance objective results. The compensation cost related to the number of shares to be granted under each performance period is fixed on the grant date, which is the date the performance period begins. Compensation is recognized in each period based on management’s best estimate of the achievement level of the specified performance objectives for Performance Shares. For the three and nine months ended June 30, 2014, the Company recognized expenses of $0.2 million and $0.7 million, respectively, in each period. For the three and nine months ended June 30, 2013, the Company recognized expenses of $0.3 million and $0.9 million, respectively. The stock-based compensation table above includes the Performance Shares expenses.

The fair values of the Performance Shares, at target, were $0.9 million, $0.9 million and $0.8 million for grants awarded in fiscal 2014, 2013 and 2012, respectively.

The aggregate number of shares that could be awarded to key employees if the minimum, target and maximum performance goals are met, based upon the fair value at the date of grant is as follows:

 

Performance Period

   Minimum Shares      Target Shares      Maximum Shares  

Fiscal 2012—2014

     12,499         62,497         124,994   

Fiscal 2013—2015

     8,551         42,753         85,506   

Fiscal 2014—2016

     7,861         39,303         78,606   

1999 Employee Stock Purchase Plan

Under the 1999 Employee Stock Purchase Plan (“Stock Purchase Plan”), the Company is authorized to issue up to 400,000 shares of common stock. All full-time and part-time employees can choose to have up to 10% of their annual compensation withheld, with a limit of $25,000, to purchase the Company’s common stock at purchase prices defined within the provisions of the Stock Purchase Plan. As of June 30, 2014 and 2013, there was less than $0.1 million and $0.1 million, respectively, of employee contributions in each period included in accrued liabilities in the condensed consolidated balance sheets. Stock compensation expense recognized related to the Stock Purchase Plan for the three and nine months ended June 30, 2014 and 2013 totaled less than $0.1 million and $0.1 million, respectively, in each period. The stock-based compensation table above includes the Stock Purchase Plan expenses.

Restricted Stock Units

The Company has awarded 24,834 restricted stock units (“RSU”) in fiscal 2014 and 2013 under the 2009 Equity Incentive Plan to non-employee directors with forfeiture of 3,417 RSU’s in the nine months ended June 30, 2014. The RSU awards were modified in the second quarter of fiscal 2014 to vest pro-rata over a 12-month service period. This modification resulted in a total expense of $0.2 million in the nine months ended June 30, 2014. RSU awards are not considered issued or outstanding common stock of the Company until they vest. The estimated fair value of the RSU awards was calculated based on the closing market price of SurModics’ common stock on the date of grant. Compensation has been recognized for the estimated fair value of the common shares and is being charged to income over the vesting term. Directors can also elect to receive their cash retainers for services to the Board of Directors and its

 

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committees in the form of deferred stock units (“DSU”). Certain directors elected this option beginning on January 1, 2013 which has resulted in 10,952 DSUs issued with a total value of $0.3 million. The DSUs are fully vested. The stock-based compensation table above includes RSU and DSU expenses recognized related to these awards, which totaled $0.1 million and $0.4 million during the three months and nine months ended June 30, 2014, respectively, and less than $0.1 million and $0.1 million during the three and nine months ended June 30, 2013, respectively.

11. Restructuring Charges

The Company did not incur any restructuring charges during the three and nine months ended June 30, 2014 and 2013.

In September 2013 (fiscal 2013), the Company announced a realignment of its business to enhance focus on key growth initiatives. As a result of the organizational change, the Company eliminated approximately 6% of its workforce. These employee terminations occurred across various functions, and the reorganization plan was completed by the end of fiscal 2013. The Company recorded total pre-tax restructuring charges of $0.5 million in the fourth quarter of fiscal 2013, which consisted of severance pay and benefits expenses.

The following table summarizes the restructuring accrual activity:

 

(Dollars in thousands)    Employee
Severance
and Benefits
    Facility-
Related
Costs
    Total  

Balance at September 30, 2013

   $ 399      $ 17      $ 416   

Cash payments

     (399     (15     (414
  

 

 

   

 

 

   

 

 

 

Balance at June 30, 2014

   $ —        $ 2      $ 2   
  

 

 

   

 

 

   

 

 

 

The remaining restructuring accrual balance is expected to be paid within the next 12 months and is recorded as a current liability within other current liabilities on the consolidated balance sheet as of June 30, 2014.

12. Revolving Credit Facility

On November 4, 2013, the Company entered into a three-year $20.0 million secured revolving credit facility. The Company’s obligations under the credit facility are secured by substantially all of its and its subsidiaries’ assets, other than intellectual property and real estate. Borrowings under the credit facility, if any, will bear interest at a benchmark rate plus a margin ranging from 1.375% to 2.00% based on the Company’s leverage ratio. A facility fee is payable on unused commitments at a rate of 0.20% per annum. In connection with the credit facility, the Company is required to maintain financial covenants related to a maximum leverage ratio and a minimum EBITDA amount and to comply with nonfinancial covenants. As of June 30, 2014, the Company has no debt outstanding and was in compliance with all financial covenants.

13. Income Per Share Data

Basic income per common share is calculated based on the weighted average number of common shares outstanding during the period. Diluted income per common share is computed by dividing income by the weighted average number of common and common equivalent shares outstanding during the period. The Company’s only potentially dilutive common shares are those that result from dilutive common stock options, non-vested stock relating to restricted stock awards, restricted stock units and performance shares.

The following table sets forth the denominator for the computation of basic and diluted income per share (in thousands):

 

    Three Months Ended
June 30,
    Nine Months Ended
June 30,
 
    2014     2013     2014     2013  

Net income from continuing operations available to common shareholders

  $ 3,674      $ 3,178      $ 9,763      $ 10,846   
 

 

 

   

 

 

   

 

 

   

 

 

 

Basic weighted average shares outstanding

    13,585        14,413        13,639        14,563   

Dilutive effect of outstanding stock options, non-vested restricted stock, restricted stock units and performance shares

    228        326        252        260   
 

 

 

   

 

 

   

 

 

   

 

 

 

Diluted weighted average shares outstanding

    13,813        14,739        13,891        14,823   
 

 

 

   

 

 

   

 

 

   

 

 

 

The calculation of weighted average diluted shares outstanding excludes outstanding stock options associated with the right to purchase 0.6 million and 0.3 million shares of common stock for the three months ended June 30, 2014 and 2013, respectively, and 0.4 million and 0.5 million for the nine months ended June 30, 2014 and 2013, respectively, as their inclusion would have had an antidilutive effect on diluted income per share.

 

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During the first nine months of fiscal 2014, the Company repurchased 485,577 shares of common stock for a total of $11.5 million under the then-existing share repurchase authorization of the Board. The entire authorized amount has been used as of June 30, 2014.

14. Income Taxes

The Company recorded income tax provisions associated with income from continuing operations of $1.7 million and $1.1 million for the three months ended June 30, 2014 and 2013, respectively, representing effective tax rates of 32.0% and 26.1%, respectively. The Company recorded income tax provisions associated with income from continuing operations of $4.4 million and $3.9 million for the nine months ended June 30, 2014 and 2013, respectively, representing effective tax rates of 31.1% and 26.5%, respectively. The difference between the U.S. federal statutory tax rate of 35.0% and the Company’s effective tax rate for the three and nine months ended June 30, 2014 and 2013 reflects the impact of state income taxes, permanent tax items such as valuation allowance releases associated with gains from our strategic investments and our available-for-sale investment portfolio and discrete tax benefits. Discrete tax benefits aggregated less than $0.1 million and $0.3 million for the three and nine months ended June 30, 2014, respectively, and $0.2 million and $0.8 million for the three and nine months ended June 30, 2013, respectively. The discrete tax items in the fiscal 2013 nine-month period includes a one-time capital gain carryback benefit and retroactive federal R&D tax credits that aggregated $0.4 million. The nine months ended June 30, 2014 reflects the impact of gains related to two Vessix contingent consideration payments totaling $0.7 million and gains related to certain debt securities in our available-for-sale investment portfolio of $0.1 million. The nine months ended June 30, 2013 reflects the impact of gains on the sale of Vessix, OctoPlus N.V of $1.3 million and certain debt securities in our available-for-sale investment portfolio of $0.2 million. Each of these gains has had a tax expense recognized which has been offset by the reversal of capital loss valuation allowances.

The Company recorded an income tax benefit from discontinued operations of less than $0.1 million in each of the three and nine months ended June 30, 2014 which resulted in an effective tax rate associated with discontinued operations of 34.8% in each period. The Company recorded an income tax expense from discontinued operations of $0.2 million and $0.5 million for the three and nine months ended June 30, 2013, respectively, with a resulting effective tax rate for discontinued operations of 134.6% and 44.8% for the three and nine months ended June 30, 2013, respectively.

The total amount of unrecognized tax benefits including interest and penalties that, if recognized, would affect the effective tax rate as of June 30, 2014 and September 30, 2013, respectively, are $0.9 million and $1.0 million. Currently, the Company does not expect the liability for unrecognized tax benefits to change significantly in the next 12 months with the above balances classified on the condensed consolidated balance sheets in other long-term liabilities. Interest and penalties related to unrecognized tax benefits are recorded in income tax expense.

The Company files income tax returns, including returns for its subsidiaries, in the U.S. federal jurisdiction and in various state jurisdictions. Uncertain tax positions are related to tax years that remain subject to examination. In the first quarter of fiscal 2014 the Internal Revenue Service commenced an examination of the Company’s U.S. income tax return for fiscal 2012 and the examination has not been completed as of June 30, 2014. U.S. income tax returns for years prior to fiscal 2010 are no longer subject to examination by federal tax authorities. For tax returns for state and local jurisdictions, the Company is no longer subject to examination for tax years generally before fiscal 2003.

15. Amounts Reclassified Out of Accumulated Other Comprehensive Income

There were no amounts reclassified out of accumulated other comprehensive income (“AOCI”) for the three months ended June 30, 2014 or 2013. The amounts reclassified out of AOCI for the nine months ended June 30, 2014 and 2013 totaled $0.1 million and $0.2 million, respectively, on a pre-tax basis. The amounts reclassified out of AOCI are associated with unrealized gains on available-for-sale securities that were realized on the sale of the securities and are presented in other income, net in the condensed consolidated statements of income.

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, who is the Company’s Chief Executive Officer, in deciding how to allocate resources and in assessing performance. For financial accounting and reporting purposes, the Company reports its results for the two reportable segments as follows: (1) the Medical Device unit, which is comprised of surface modification coating technologies to improve access, deliverability, and predictable deployment of medical devices, as well as drug delivery coating technologies to provide site-specific drug delivery from the surface of a medical device, with end markets that include coronary, peripheral, and neuro-vascular, and urology, among others, and (2) the In Vitro Diagnostics unit, which consists of component products and technologies for diagnostic test kits and biomedical research applications, with products that include protein stabilization reagents, substrates, antigens and surface coatings.

 

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The tables below present segment revenue, operating income and depreciation and amortization, as follows:

 

    Three Months Ended
June 30,
    Nine Months Ended
June 30,
 
(Dollars in thousands)   2014     2013     2014     2013  

Revenue:

       

Medical Device

  $ 10,821      $ 10,591      $ 31,852      $ 30,857   

In Vitro Diagnostics

    3,795        3,698        10,251        10,978   
 

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

  $ 14,616      $ 14,289      $ 42,103      $ 41,835   
 

 

 

   

 

 

   

 

 

   

 

 

 

Operating income:

       

Medical Device

  $ 5,855      $ 5,223      $ 16,466      $ 15,848   

In Vitro Diagnostics

    974        915        2,277        2,933   
 

 

 

   

 

 

   

 

 

   

 

 

 

Total segment operating income

    6,829        6,138        18,743        18,781   

Corporate

    (1,496     (1,900     (5,601     (5,537
 

 

 

   

 

 

   

 

 

   

 

 

 

Total operating income

  $ 5,333      $ 4,238      $ 13,142      $ 13,244   
 

 

 

   

 

 

   

 

 

   

 

 

 

Depreciation and amortization:

       

Medical Device

  $ 281      $ 319      $ 862      $ 947   

In Vitro Diagnostics

    214        216        641        649   

Corporate

    179        193        551        578   
 

 

 

   

 

 

   

 

 

   

 

 

 

Total depreciation and amortization

  $ 674      $ 728      $ 2,054      $ 2,174   
 

 

 

   

 

 

   

 

 

   

 

 

 

The Corporate category includes expenses for administrative corporate functions, such as executive, corporate accounting, legal, human resources and Board of Directors related, that have not been fully allocated to the Medical Device and In Vitro Diagnostics segments. Corporate also includes expenses, such as litigation, which are not specific to a segment and thus not allocated to the operating segments.

Asset information by segment is not presented because the Company does not provide its chief operating decision maker assets by segment, as the data is not readily available.

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 Company’s 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 revenue. 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.

Southern Research Institute (“SRI”) Litigation. On July 31, 2009, SurModics Pharmaceuticals was named as a defendant in litigation pending in the circuit court of Jefferson County, Alabama, between SRI and two of SRI’s former employees (the “Plaintiffs”). In the litigation, the Plaintiffs alleged that they contributed to or invented certain intellectual property while they were employed at SRI, and pursuant to SRI’s policies then in effect, they were entitled to, among other things, a portion of the purchase price consideration paid by the Company to SRI as part of the Company’s acquisition of SurModics Pharmaceuticals (the “purchase price claim”) pursuant to a stock purchase agreement made effective on July 31, 2007 (the “Stock Purchase Agreement”). The Plaintiffs also alleged that they were entitled to a portion of the intellectual property income derived from license agreements with certain customers of SurModics Pharmaceuticals that make use of patents to which the Plaintiffs invented or contributed (the “royalty claim”). In April 2014, the Alabama Court granted summary judgment in favor of the Company and SRI dismissing (a) all of the claims of one of the Plaintiffs, and (b) the claims of the remaining Plaintiff relating to the purchase price claim. In connection with the royalty claim, the Alabama Court concluded that two license agreements that were entered into with certain customers of SurModics Pharmaceuticals resulted in intellectual property income and that the remaining Plaintiff is entitled to a portion of such income. In June 2014, the Company entered into agreements with the Plaintiffs resolving the litigation. In connection with the resolution of the litigation, the Company recorded an additional expense, within discontinued operations, of $0.1 million in the three and nine months ended June 30, 2014.

 

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Pursuant to the Stock Purchase Agreement, the Company has certain rights of indemnification against losses (including without limitation, damages, expenses and costs) incurred as a result of the litigation described above. The Company had recorded cumulative unreimbursed legal expenses totaling $1.3 million as of June 30, 2013, related to this litigation, within selling, general and administrative expenses from continuing operations in the condensed consolidated statements of income. In June 2011, the Company sued SRI in United States District Court for the District of Minnesota seeking a judicial declaration regarding the scope of the Company’s indemnification rights under the Stock Purchase Agreement. In April 2013, the District Court entered a judgment in the Company’s favor requiring SRI to indemnify the Company for prior and future legal expenditures related to this matter. On July 30, 2013, the Company and SRI entered into a settlement and release agreement resolving the litigation relating to indemnification rights. The settlement and release agreement does not relate to claims for indemnification under the Stock Purchase Agreement for any substantive liability, judgment, or settlement in or related to the ongoing litigation in Alabama discussed above. The Company received payment of $1.0 million associated with the historical cumulative unreimbursed legal expenses and recognized the receipt as an expense offset in the fourth quarter ended September 30, 2013. This settlement included $0.6 million of legal expenses incurred prior to fiscal 2013.

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. The Company has not recorded any accrual for this contingency as of June 30, 2014 as the milestones have not been achieved and the probability of achievement is low.

InnoCore Technologies BV. In March 2006, the Company entered into a license agreement whereby SurModics obtained an exclusive license to a drug delivery coating for licensed products within the vascular field which included peripheral, coronary and neurovascular biodurable stent product. The license requires an annual minimum payment of 200,000 euros (equivalent to $273,000 using a euro to US $ exchange rate of 1.36452 as of June 30, 2014) until the last patent expires which is currently estimated to be September 2027. The total minimum future payments associated with this license are approximately $3.6 million. The license is currently utilized with one of SurModics’ drug delivery customers.

PR Pharmaceuticals, Inc. In November 2008, SurModics Pharmaceuticals acquired certain contracts and assets of PR Pharma to enhance its portfolio of drug delivery technologies for the pharmaceutical and biotechnology industries. The Company agreed to indemnify Evonik, for a period of five years, for up to $2.5 million of contingent consideration obligations to the sellers of PR Pharma related to a future patent issuance milestone when it sold substantially all of the SurModics Pharmaceuticals assets to Evonik on November 17, 2011. The Company has not recorded any accrual for this contingency as of June 30, 2014 as the milestone has not been achieved and the probability of achievement is low.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis provides information that we believe is useful in understanding our operating results, cash flows and financial condition. The discussion should be read in conjunction with both the unaudited condensed consolidated financial statements and related notes included in this Form 10-Q, and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the fiscal year ended September 30, 2013. This discussion contains various “Forward-Looking Statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We refer readers to the statement entitled “Forward-Looking Statements” located at the end of this Item 2.

Overview

SurModics is a leading provider of surface modification and in vitro diagnostic technologies to the healthcare industry. In fiscal 2014, our business performance continued to be driven by growth from our Medical Device hydrophilic coatings royalty revenue, product sales and contract coating services included in research and development revenue. Our In Vitro Diagnostics segment realized decreased demand in the first nine months of fiscal 2014 driven primarily by a shift in order patterns in the second quarter of fiscal 2014 by a few key customers who initiated inventory rebalancing programs, a slowdown in European sales, which continued throughout the third quarter, and recent increased competition related to our BioFx product offerings.

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. For financial accounting and reporting purposes, we report our results for the two reportable segments as follows: (1) the Medical Device unit, which is comprised of surface modification coating technologies to improve access, deliverability, and predictable deployment of medical devices, as well as drug delivery coating technologies to provide site-specific drug delivery from the surface of a medical device, with end markets that include coronary, peripheral, and neurovascular, and urology, among others, and (2) the In Vitro Diagnostics unit, which consists of component products and technologies for diagnostic immunoassay and molecular tests and biomedical research applications, with products that include protein stabilization reagents, substrates, antigens and surface coatings. We made this determination based on how we manage our operations and the information provided to our chief operating decision maker who is our Chief Executive Officer.

We derive our revenue from three primary sources: (1) royalties and license fees from licensing our proprietary surface modification and device drug delivery technologies and in vitro diagnostic formats 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 reagent chemicals to licensees and the sale of stabilization products, antigens, substrates and surface coatings to the diagnostic and biomedical research markets; and (3) research and commercial 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 our 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; and the value of reagent chemicals and other products sold to customers.

In our Medical Device business unit, we have licensed our Photolink® hydrophilic technology to a number of our customers for use in a variety of medical device surface applications. We have several U.S. and international issued patents and pending international patent applications protecting various aspects of these technologies, including compositions, methods of manufacture and methods of coating devices. The expiration dates for these patents and the anticipated expiration dates of the patent applications range from 2015 to 2033. These patents and patent applications represent distinct families, with each family generally covering a successive generation of the technology, including improvements that enhance coating performance, manufacturability, or other important features desired by our customers. Among these, an early generation of our Photolink® hydrophilic technology is protected by a family of patents that are expected to expire in November 2015 (in the U.S.) and October 2016 (in certain other countries).

We estimate the royalty revenue associated with this early generation technology that has not yet converted, or that is not in the process of converting, to one of our advanced generation technologies will comprise approximately 18% of our anticipated fiscal 2014 revenue. A majority of the customer products utilizing this early generation technology (representing approximately 13% of our anticipated fiscal 2014 revenue) will continue to generate royalty revenue at a reduced royalty rate beyond the expiration of these patents. The royalty obligation for these customer products extends beyond the expiration of these patents because the license also includes rights to our know-how or other proprietary rights. Under these circumstances, the royalty obligation will continue at a reduced royalty rate for a specified number of years, as determined based on the specific terms and conditions of the applicable customer agreement, the date on which the customer’s product was first sold, and other factors.

In recent years, we have successfully converted a number of our customer’s products utilizing this early generation technology to one of our advanced generation technologies. While we are actively seeking to convert our customers to one of our advanced generations of our hydrophilic coating technology, there can be no assurance that we will be successful in doing so, or that those customers that have converted, or will convert, will sell products utilizing our technology which will generate earned royalty revenue for us.

 

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Overview of Research and Development Activities

We manage our customer-sponsored research and development (“R&D”) programs based largely on the requirements of our customers. In this regard, our customers typically establish the various measures and metrics that are used to monitor a program’s progress, including key deliverables, milestones, timelines, and an overall program budget. The customer is ultimately responsible for deciding whether to continue or terminate a program, and does so based on research results (relative to the above measures and metrics) and other factors, including their own strategic and/or business priorities. Customer R&D programs are mainly in our Medical Device segment.

Our internal R&D activities are engaged in the exploration, discovery and application of technologies that solve meaningful problems in the diagnosis and treatment of disease. Our key R&D activities include efforts that support and expand our core offerings. These efforts include activities that support the development of our coating technologies that enhance drug-coated balloons. In the second quarter of fiscal 2013, we completed development activities and launched our next generation hydrophilic coating platform which is now commercially available under the tradename SereneTM (formerly referred to as Gen 5). We also launched in July 2013 a new in vitro diagnostic product, StabliZyme ® Protein-Free Stabilizer, which focuses on stabilizing biomolecule activity in assay tests. Additional planned activities include initiation of surface modification experiments that improve medical device performance and developing chemistries to support molecular diagnostic applications.

For our internal R&D programs in our segments, we prioritize these programs based on a number of factors, including a program’s strategic fit, commercial impact, potential competitive advantage, technical feasibility, and the amount of investment required. The measures and metrics used to monitor a program’s progress vary based on the program, and typically include many of the same factors discussed above with respect to our customer R&D programs. We typically make decisions to continue or terminate a program based on research results (relative to the above measures and metrics) and other factors, including our own strategic and/or business priorities, and the amount of additional investment required.

With respect to cost components, R&D expenses consist of labor, materials and overhead costs (for example, utilities, depreciation, and indirect labor) for both customer R&D and internal R&D programs. We manage our R&D organization in a flexible manner, balancing workloads/resources between customer R&D and internal R&D programs primarily based on the level of customer program activity. Therefore, costs incurred for customer R&D and internal R&D can shift as customer activity increases or decreases.

Critical Accounting Policies

Critical accounting policies are those policies that require the application of management’s most challenging subjective or complex judgment, often as a result of the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods. Critical accounting policies involve judgments and uncertainties that are sufficiently likely to result in materially different results under different assumptions and conditions. For a detailed description of our critical accounting policies, see the notes to the consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended September 30, 2013.

Results of Operations – Three and Nine Months Ended June 30

Revenue. Revenue during the third quarter of fiscal 2014 was $14.6 million, an increase of $0.4 million, or 2%, compared with the third quarter of fiscal 2013. Revenue during the first nine months of fiscal 2014 was $42.1 million, an increase of $0.3 million, compared with the same period of fiscal 2013. The increase in revenue, as detailed in the table below, is further explained in the narrative below.

 

    Three Months Ended June 30,     %     Nine Months Ended June 30,     %  

(Dollars in thousands)

  2014     2013     Change     2014     2013     Change  

Revenue

           

Medical Device

  $ 10,821      $ 10,591        2   $ 31,852      $ 30,857        3

In Vitro Diagnostics

    3,795        3,698        3     10,251        10,978        (7 )% 
 

 

 

   

 

 

     

 

 

   

 

 

   

Total Revenue

  $ 14,616      $ 14,289        2   $ 42,103      $ 41,835        1
 

 

 

   

 

 

     

 

 

   

 

 

   

Medical Device. Medical Device revenue was $10.8 million in the quarter ended June 30, 2014, an increase of 2% compared with $10.6 million for the same prior-year quarter. Medical Device revenue was $31.9 million in the first nine months of fiscal 2014, an increase of 3% compared with $30.9 million for the same prior-year period. The increase in the total revenue for both the three and nine months ended June 30, 2014 was attributable to higher royalty revenue ($0.1 million and $0.3 million, respectively), product

 

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sales ($0.4 million and $0.6 million, respectively) and R&D revenue ($0.3 million and $0.6 million, respectively). The increase in royalty revenue and product sales revenue resulted from continued growth in our hydrophilic coatings and drug delivery offerings. R&D revenue increased from increased hydrophilic contract coating services and customer development activities. Fiscal year 2013 third quarter and nine month results included license fee revenue of $0.5 million based on a customer achieving a milestone event in the third quarter. In addition, fiscal 2013 nine-month revenue included a $0.6 million one-time royalty catch-up payment.

In Vitro Diagnostics. In Vitro Diagnostics revenue was $3.8 million in the quarter ended June 30, 2014, an increase of 3% compared with $3.7 million for the same prior-year quarter. In Vitro Diagnostics revenue was $10.3 million in the first nine months of fiscal 2014, a decrease of 7% compared with $11.0 million for the prior-year period. The $0.1 million increase for the third quarter was attributable to higher sales of micro-array slides ($0.3 million), antigens ($0.2 million) and BioFX branded products ($0.1 million) offset substantially by lower stabilization sales which declined $0.5 million. The $0.7 million decrease for the nine months was attributable to lower sales of stabilization products ($0.7 million), antigens ($0.3 million) and commercial R&D revenue ($0.1 million) offset partially by increases in micro-array slides ($0.4 million). The decline in the current year revenue was primarily driven by a shift in order patterns by a few key customers who initiated inventory rebalancing programs in the second fiscal quarter related to our stabilization and antigen product lines combined with a slowdown in sales in Europe, which continued throughout the third quarter, and recent increased competition related to our BioFx product offerings.

The following is a summary of major costs and expenses as a percent of total revenue:

 

    Three Months Ended June 30,     Nine Months Ended June 30,  
    2014     2013     2014     2013  

(Dollars in thousands)

  Amount     % Total
Revenue
    Amount     % Total
Revenue
    Amount     % Total
Revenue
    Amount     % Total
Revenue
 

Product costs

  $ 2,037        14   $ 1,990       14   $ 5,737        14   $ 5,894        14

Research and development

    3,655        25        4,009        28        11,488        27        11,145        27   

Selling, general and administrative

    3,591        25        4,052       28        11,736        28        11,552        28   

Product costs. Product costs were $2.0 million and $5.7 million or 14% of total revenue in both the three and nine months ended June 30, 2014 compared with $2.0 million and $5.9 million or 14% in each of the respective prior-year periods. Product gross margins were 66% in both the three and nine months ended June 30, 2014 compared with 64% and 65% in the prior-year periods. The increase in product gross margins in the current year three-month and nine-month periods primarily reflected improved manufacturing leverage from higher production levels.

Research and development expenses. R&D expenses were $3.7 million and $11.5 million in the third quarter and first nine months of fiscal 2014, respectively, or 25% and 27% of total revenue, respectively, compared with $4.0 million and $11.1 million or 28% and 27% in the respective prior-year periods. The fiscal 2014 third quarter decrease from fiscal 2013 was primarily the result of $0.3 million of lower compensation costs resulting from our September 2013 restructuring. The increase in expense in the fiscal 2014 nine-month period compared with fiscal 2013 was primarily a result of $1.2 million of higher spending for our drug-coated balloon development activities, offset partially by $0.5 million of lower compensation costs and $0.3 million of lower patent-related legal expenses. We expect R&D expenses to increase 2% to 5% for fiscal 2014 compared with fiscal 2013 as we continue to invest in our drug-coated balloon development program. This overall increase has declined from previous disclosures as the timing of certain expected drug coated balloon expenditures estimated for fiscal 2014 will not be incurred until fiscal 2015.

Selling, general and administrative (SG&A) expenses. SG&A expenses were $3.6 million and $11.7 million in the third quarter and first nine months of fiscal 2014, respectively, or 25% and 28% of total revenue, compared with $4.1 million and $11.6 million or 28% of total revenue in both of the respective prior-year periods. The SG&A expense decrease of $0.5 million in the third quarter of fiscal 2014 resulted from $0.2 million in lower compensation costs and $0.1 million of lower professional services expenses covering legal, financial and strategic matters as well as $0.1 million of lower marketing expenses. The increase of $0.1 million for the nine months of fiscal 2014 included $1.4 million of higher compensation expense principally from $0.9 million in higher stock-based compensation expense as a result of accelerated vesting of Board of Director stock awards and the granting of a restricted stock award to the former Chairman of the Company’s Board in recognition of his contributions to the Company during his years of service on the Board. A substantial amount of this increase was offset by $0.5 million in lower legal expenses as the prior-year period included higher SRI litigation costs, $0.3 million in lower consulting expenses as the prior-year period included higher costs associated with Medical Device and In Vitro Diagnostic business unit strategic activities and $0.2 million in lower professional services expenses.

 

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Other income, net. Major classifications of other income are as follows:

 

     Three Months Ended
June 30,
     Nine Months Ended
June 30,
 

(Dollars in thousands)

   2014      2013      2014      2013  

Investment income, net

   $ 42       $ 60       $ 194       $ 187   

Gain on sale of strategic investments

     28         —           709         1,293   

Other-than-temporary impairment of strategic investments

     —           —           —           (129

Other investment capital gains

     —           2         125         167   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total other income

   $ 70       $ 62       $ 1,028       $ 1,518   
  

 

 

    

 

 

    

 

 

    

 

 

 

Other income was $0.1 million and $1.0 million in the three and nine months ended June 30, 2014, respectively, compared with $0.1 million and $1.5 million for the respective prior-year periods.

Income from investments in fiscal 2014 remained relatively unchanged at approximately $0.1 million and $0.2 million, respectively, compared with the prior-year periods primarily from higher yields on our investments which were offset by lower investment balances as the result of our share repurchase activities in fiscal 2013 and 2014.

We recorded a gain of $0.7 million in the nine months ended June 30, 2014 associated with contingent clinical and sales milestone payments resulting from the fiscal 2013 sale of our ownership interest in Vessix Vascular, Inc. (“Vessix”).

We recorded a gain of $1.3 million in the nine months ended June 30, 2013 associated with both the sale of our investment position in OctoPlus N.V. (“OctoPlus”) and the sale of our ownership interest in Vessix.

In the nine months ended June 30, 2013, we recorded a $0.1 million other-than-temporary impairment loss related to our investment in ViaCyte, Inc.

In addition, in the nine months ended June 30, 2014 and 2013, we recognized $0.1 million and $0.2 million, respectively, in realized investment gains associated with our investment portfolio.

Income tax provision. The reconciliation of the statutory U.S. federal tax rate of 35.0% and the Company’s effective tax rate from continuing operations for the three and nine months ended June 30, 2014 and 2013 is as follows:

 

     Three Months Ended
June 30,
    Nine Months Ended
June 30,
 
     2014     2013     2014     2013  

Statutory U.S. federal income tax rate

     35.0     35.0     35.0     35.0

State income taxes, net of federal benefit

     0.6        1.3        0.6        1.3   

Gain on strategic investments

     —          (2.2     (1.3     (1.7

Discrete item – capital loss carryback

     —          —          —          (1.8

Discrete item – 2012 retroactive R&D federal tax credit

     —          —          —          (1.0

Discrete item – state tax reserve release

     —          —          (1.7     (1.2

Discrete items – other

     (0.7     (5.7     —          (1.4

Strategic investment

     (2.9     (2.3     (1.5     (2.7
  

 

 

   

 

 

   

 

 

   

 

 

 

Effective tax rate from continuing operations

     32.0     26.1     31.1     26.5
  

 

 

   

 

 

   

 

 

   

 

 

 

The difference between the U.S. federal statutory tax rate of 35.0% and the Company’s effective tax rate reflects the impact of state income taxes, permanent tax items, valuation allowance changes for utilization of capital losses and discrete tax items. The income tax provision associated with continuing operations was $1.7 million and $4.4 million, respectively, for the three and nine months ended June 30, 2014 resulting in respective effective tax rates of 32.0% and 31.1%. The income tax provision associated with continuing operations was $1.1 million and $3.9 million for the three and nine months ended June 30, 2013, respectively, resulting in respective effective tax rates of 26.1% and 26.5%.

The most significant variability in our effective tax rate is the result of changes in capital loss valuation allowances resulting from both gains on the sales of strategic investments or contingent milestone consideration payment and other-than-temporary impairment losses associated with certain strategic investments. We have historically recorded other-than-temporary impairment losses with no income tax effect as it has not been more likely than not that we would generate sufficient capital gains to realize these benefits. Consequently, the OctoPlus, Vessix and available-for-sale securities gains realized during fiscal 2014 or 2013 resulted in a reduction in capital loss carryforward valuation allowances resulting in no financial statement income tax effects associated with these capital gains.

 

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During the nine months ended June 30, 2013, we realized a 1.8% reduction in our effective tax rate as we recognized capital loss carrybacks as a result of the tax capital losses generated by the sale of certain of our strategic investments. During the nine months ended June 30, 2014 and 2013, the effective tax rate was reduced by 1.3% and 1.7% for net capital gains including the impact of a gain related to Vessix milestone contingent consideration payments and a gain on sale of our ownership interest in Vessix stock, respectively, for which there is tax expense recognized which has been offset by the reversal of a capital loss valuation allowance. We may receive an additional maximum of $3.4 million of future contingent payments through fiscal 2017 based on sales of Vessix products. These proceeds, if any, will generate capital gains which will result in reduction of the existing capital loss carryforward valuation allowance.

Discontinued operations. The following is a summary of the operating results of SurModics Pharmaceuticals discontinued operations for the three and nine months ended June 30, 2014 and 2013:

 

     Three Months
Ended June 30,
    Nine Months
Ended June 30,
 

(Dollars in thousands)

   2014     2013     2014     2013  

(Loss) income from discontinued operations

   $ (117   $ 136      $ (117   $ 1,151   

Income tax benefit (provision)

     41        (183     41        (516
  

 

 

   

 

 

   

 

 

   

 

 

 

(Loss) income from discontinued operations, net of income taxes

   $ (76   $ (47   $ (76   $ 635   
  

 

 

   

 

 

   

 

 

   

 

 

 

(Loss) income from discontinued operations. The Company’s discontinued operations gains and losses are recorded net of the income tax impact of these transactions. The Company recorded discontinued operations loss of $0.1 million in each of the three and nine-month periods ended June 30, 2014 associated with the resolution of the SRI litigation matter discussed in Footnote 17 to the financial statements included in this report. The Company recorded discontinued operations loss of less than $0.1 million and income of $0.6 million for the three and nine months ended June 30, 2013 related to this litigation matter. The loss in the three months ended June 30, 2013 reflects a $0.2 million pre-tax gain from the termination of recapturable job creation financial incentives provided by the State of Alabama offset by an income tax provision resulting from finalization of the fiscal 2012 federal and state income tax returns and adjustment of the recorded fiscal 2012 tax provision. The discontinued operations income of $0.6 million for the nine months ended June 30, 2013 is principally from a $1.2 million pre-tax gain from the settlement of recapturable job creation financial incentives provided by the City of Birmingham, Alabama. In this settlement, the Company paid $325,000 of $1.5 million of the recapturable financial incentives which were previously fully accrued by the Company as a discontinued operations liability.

Segment Operating Results

Operating income for each of our reportable segments was as follows:

 

     Three Months Ended
June 30,
    Nine Months Ended
June 30,
 

(Dollars in thousands)

   2014     2013     %Change     2014     2013     %
Change
 

Operating income:

            

Medical Device

   $ 5,855      $ 5,223        12   $ 16,466      $ 15,848        4

In Vitro Diagnostics

     974        915        6     2,277        2,933        (22 )% 
  

 

 

   

 

 

     

 

 

   

 

 

   

Total segment operating income

     6,829        6,138          18,743        18,781     

Corporate

     (1,496     (1,900     (21 )%      (5,601     (5,537     1
  

 

 

   

 

 

     

 

 

   

 

 

   

Total operating income from continuing operations

   $ 5,333      $ 4,238        26   $ 13,142      $ 13,244        (1 )% 
  

 

 

   

 

 

     

 

 

   

 

 

   

Medical Device. Operating income was $5.9 million in the third quarter of fiscal 2014, compared with $5.2 million in the third quarter of fiscal 2013. Operating income was $16.5 million in the first nine months of fiscal 2014, compared with $15.8 million in the same period of fiscal 2013.

The increase in operating income of $0.6 million in the three months ended June 30, 2014, compared with the prior-year period, resulted from the gross margin impact of $0.4 million of higher reagent product sales and $0.3 million of higher R&D revenue offset substantially by $0.5 million in lower royalty and license fee as the prior-year period included license fee revenue associated with a customer’s milestone event. Direct operating expenses decreased $0.4 million in the three months ended June 30, 2014, compared with the prior-year period, with the majority of the decrease from $0.2 million in lower compensation costs following the September 2013 organizational changes and $0.1 million decrease in spending with the drug coated-balloon development program based on timing of activities in the program. Allocated corporate costs decreased $0.1 million in the three months ended June 30, 2014 when compared with the prior-year period.

 

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The increase in operating income of $0.6 million for the nine months ended June 30, 2014, compared with the prior-year period, resulted from the gross margin impact from $0.6 million of higher reagent product sales and $0.6 million of higher R&D revenue offset partially by $0.2 million of lower royalty and license fee revenue as the prior-year period included the customer milestone event referenced previously. Offsetting the increased revenue was higher direct operating expenses of $0.4 million principally from $1.2 million of additional expenses associated with the drug-coated balloon development program offset by $0.4 million of lower compensation costs. Allocated corporate costs were $4.0 million and $4.1 million in the nine months ended June 30, 2014 and 2013, respectively.

In Vitro Diagnostics. Operating income was $1.0 million in the third quarter of fiscal 2014, compared with $0.9 million in the third quarter of fiscal 2013. Operating income was $2.3 million in the first nine months of fiscal 2014, compared with $2.9 million in the same period of fiscal 2013.

The increase in operating income of $0.1 million in the three months ended June 30, 2014 was a result of the gross margin impact from $0.6 million of higher microarray slides, antigen and BioFX branded product sales offset by $0.5 million of lower stabilization product sales. Product gross margins were 62.2% and 60.1% for the three months ended June 30, 2014 and 2013, respectively. Direct operating expenses increased $0.1 million in the three months ended June 30, 2014 compared with the prior-year period resulting from $0.2 million in fees for professional services offset by lower spending in several other expenses. Allocated corporate costs remained relatively unchanged in both periods.

The decrease in operating income of $0.7 million in the nine months ended June 30, 2014 was a result of the gross margin impact of $1.1 million of lower stabilization, antigens, reagents and BioFX branded product sales offset partially by $0.4 million in higher revenue from microarray slides. Product gross margins were 61.9% and 61.2% for the nine months ended June 30, 2014 and 2013, respectively. Direct operating expenses increased $0.3 million in the nine months ended June 30, 2014 compared with the prior-year period principally from $0.3 million in increased fees for professional services. Allocated corporate costs decreased by $0.1 million in the nine months ended June 30, 2014, compared with the comparable prior-year period.

Corporate. The Corporate category includes expenses for administrative corporate functions, such as executive, corporate accounting, legal, human resources and Board of Directors related fees and expenses, which have not been fully allocated to the Medical Device and In Vitro Diagnostics segments. Corporate also includes expenses, such as litigation, which are not specific to a segment and thus not allocated to our operating segments. The unallocated Corporate expense operating loss was $1.5 million and $1.9 million in the three months ended June 30, 2014 and 2013, respectively, and $5.6 million and $5.5 million in the nine months ended June 30, 2014 and 2013, respectively. Share-based compensation expenses decreased $0.1 million and increased $1.0 million in the three and nine months ended June 30, 2014, compared with the comparable prior-year periods. The increase in the nine-month expense was primarily from $0.9 million in additional expense related to the accelerated vesting of Board of Director stock awards and granting of an award to the former Chairman of the Company’s Board in recognition of his contributions to the Company during his years of service on the Board. Other compensation costs increased $0.2 million in the nine months ended June 30, 2014 resulting from increased headcount, annual salaries effective October 1, 2013 and our insurance premiums. Legal expenses decreased $0.4 million in the nine months ended June 30, 2014 as the prior-year period included higher expenses related to the SRI litigation. In fiscal 2014 we were reimbursed by SRI for a substantial portion of our legal expenses pursuant to an agreement reached in the fourth quarter of fiscal 2013.

Liquidity and Capital Resources

As of June 30, 2014, we had working capital of $46.7 million, an increase of $16.9 million from September 30, 2013. Our cash, cash equivalents and available-for-sale securities totaled $57.1 million at June 30, 2014, a decrease of $1.0 million from $58.1 million at September 30, 2013, principally resulting from share repurchases of $12.5 million and capital expenditures of $1.2 million in the first nine months of fiscal 2014 offset by cash generated by continuing operations of $12.5 million.

Our investments consist principally of U.S. government and government agency obligations, asset-backed securities, mortgage-backed securities and investment grade, interest-bearing corporate and municipal debt securities with varying maturity dates, the majority of which are five years or less. The Company’s investment policy excludes ownership of collateralized mortgage obligations, mortgage-backed derivatives and other derivative securities without prior written approval of the Board of Directors. The Company’s investment policy requires that no more than 5% of investments be held in any one credit or issue, excluding U.S. government and government agency obligations. The primary investment objective of the portfolio is to provide for the safety of principal and appropriate liquidity while generating an above benchmark (“Merrill Lynch 1-3 Year Government-Corporate Index”) total rate of return on a pre-tax basis. Management plans to continue to direct its investment advisors to manage the Company’s securities investments primarily for the safety of principal for the foreseeable future as it continues to assess other investment opportunities and uses of its cash and securities investments, including those described below.

 

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On November 4, 2013, we entered into a three-year $20.0 million secured revolving credit facility. Borrowings under the credit facility, if any, will bear interest at a benchmark rate plus an applicable margin based on the Company’s leverage ratio. No borrowings have been made on the credit facility and the Company is in compliance with all covenants, including a maximum leverage ratio and a minimum EBITDA amount.

The following table depicts our cash flows provided by operating activities from continuing operations:

 

     Nine Months Ended  
     June 30,  

(Dollars in thousands)

   2014     2013  

Net income

   $ 9,687      $ 11,481   

Loss (income) from discontinued operations

     76        (635

Depreciation and amortization

     2,054        2,174   

Stock-based compensation

     3,043        1,983   

Deferred tax

     (98     34   

Net other operating activities

     (1,287     (1,079

Net change in other operating assets and liabilities

     (1,009     (2,054
  

 

 

   

 

 

 

Net cash provided by operating activities from continuing operations

   $ 12,466      $ 11,904   
  

 

 

   

 

 

 

Operating Activities. We generated cash flows from operating activities from continuing operations of $12.5 million and $11.9 million for the first nine months ended June 30, 2014 and 2013, respectively. The fiscal 2014 nine-month period increase compared with fiscal year 2013 reflected incremental cash generation of $0.9 million from accrued income taxes, accounts payable and accrued liability balances, $0.2 million from a reduction in prepaids and other assets and $0.1 million from a decrease in inventory partially offset by usage of cash flow of $0.2 million from accounts receivable and $0.5 million from adjustments to net income as noted in the table above.

Investing Activities. We invested $1.2 million in property and equipment in the first nine months of fiscal 2014, compared with $1.4 million in the prior-year period, primarily as a result of higher spending on building improvements in the 2013 period. We have invested $0.6 million in building improvements and $0.6 million in laboratory and production equipment in the nine months of fiscal 2014. We anticipate spending an additional $1.0 million to $1.3 million on building improvements and equipment purchases for the remainder of fiscal 2014 which would result in a full year increase when compared with our fiscal 2013 investment of $1.9 million. Our sales of available-for-sale securities less the amounts reinvested in securities also provided cash of $25.3 million. We received cash of $0.7 million (contingent milestone payments associated with the sale of our ownership interest in Vessix Vascular) and $2.3 million (sale of shares of Vessix Vascular and OctoPlus) in the first nine months of fiscal 2014 and 2013, respectively. In the first nine months of fiscal 2014 and 2013, we invested cash associated with our discontinued operations of $0.2 million and $0.1 million, respectively.

Financing Activities. We used cash related to our financing activities of $12.9 million and $10.3 million in the first nine months of fiscal 2014 and 2013, respectively. In July 2013, our Board of Directors authorized the repurchase of up to $20.0 million of the Company’s outstanding common stock through open-market purchases, private transactions, block trades, accelerated share repurchase transactions, tender offers, or by any combination of such methods. During the first nine months of fiscal 2014, we repurchased 485,577 shares of common stock for $11.5 million at an average price of $23.77 per share. As of June 30, 2014, there was no remaining amount available for future share repurchases under the July 2013 repurchase authorization. We also used cash of $1.1 million in the first nine months of fiscal 2014 to purchase common stock to pay employee taxes resulting principally from issuance of common shares associated with our fiscal year 2011-2013 performance share program. In fiscal 2013, we used cash totaling $10.3 million to repurchase 405,290 shares at an average price of $25.47 under a repurchase authorization approved by our board of directors in January 2013.

We believe that our existing cash, cash equivalents and available-for-sale securities, which totaled $57.1 million as of June 30, 2014, together with cash flow from operations and our credit facility, will provide liquidity sufficient to meet the below-stated needs and fund our operations for the remainder of fiscal 2014. There can be no assurance, however, that SurModics’ business will continue to generate cash flows at current levels, and disruptions in financial markets may negatively impact our ability to access capital in a timely manner and on attractive terms. Our anticipated liquidity needs for the remainder of fiscal 2014 may include, but are not limited to, the following: general capital expenditures in the range of $1.0 million to $1.3 million and obligations remaining after the Pharma Sale, including indemnification obligations of $2.5 million to Evonik related to contingent consideration payments from the acquisition of assets from PR Pharmaceuticals in November 2008.

Discontinued Operations. Our Pharmaceuticals discontinued operation used cash in operating activities of $0.2 million and $0.1 million in the first nine months of fiscal 2014 and 2013, respectively. Cash used in discontinued operations in fiscal 2014 related to payments made in connection with the resolution of the SRI litigation matter discussed in Footnote 17 to the financial statements included in this report, and payments of certain accounts payable

 

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balances. Cash used in discontinued operations in fiscal 2013 related to payments to settle the City of Birmingham job incentive obligation and other accrued liability payments partially offset by cash received from remaining accounts receivable balances. Cash generated by financing activities of $0.2 million and $0.1 million in the first nine months of fiscal 2014 and 2013, respectively, related to transfers of cash from the continuing operations of SurModics and consisted of cash used for the matters previously mentioned.

Customer Concentrations. Our licensed technologies provide royalty revenue, which represents the largest revenue stream to the Company. We have licenses with a diverse base of customers and certain customers have multiple products using our technology. Medtronic, Inc. (“Medtronic”) was our largest customer comprising 19% of total revenue for fiscal 2013 and remains at this level for the first nine months of fiscal 2014. Medtronic has several separately licensed products that generate royalty revenue for SurModics, none of which represented more than 7% of SurModics’ total revenue. No other individual customer using licensed technology constitutes more than 10% of SurModics’ total revenue.

Off-Balance Sheet Arrangements

As of June 30, 2014, the Company did not have any off-balance sheet arrangements with any unconsolidated entities.

Forward-Looking Statements

This Quarterly Report on Form 10-Q, including “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Item 2, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include expectations concerning our growth strategy, including our ability to sign new license agreements, broaden our hydrophilic coatings royalty revenue and convert our customers using early generation technology to one of our advanced generation technologies, product development programs, various milestone achievements, research and development expenses, increased legal expenses within selling, general and administrative expenses, future cash flow and sources of funding, short-term liquidity requirements, future property and equipment investment levels, the impact of potential lawsuits or claims, and the impact of Medtronic, as well as other significant customers, including new diagnostic kit customers. Without limiting the foregoing, words or phrases such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “project,” “will” and similar terminology, generally identify forward-looking statements. Forward-looking statements may also represent challenging goals for us. These statements, which represent the Company’s expectations or beliefs concerning various future events, are based on current expectations that involve a number of risks and uncertainties that could cause actual results to differ materially from those of such forward-looking statements. We caution that undue reliance should not be placed on such forward-looking statements, which speak only as of the date made. Some of the factors which could cause results to differ from those expressed in any forward-looking statement are set forth under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2013. We disclaim any intent or obligation to update publicly these forward-looking statements, whether because of new information, future events or otherwise.

Although it is not possible to create a comprehensive list of all factors that may cause actual results to differ from our forward-looking statements, such factors include, among others:

 

    our reliance on a small number of significant customers, which causes our financial results and stock price to be subject to factors affecting those significant customers and their products, the timing of market introduction of their or competing products, product safety or efficacy concerns and intellectual property litigation could adversely affect our growth strategy and the royalty revenue we derive;

 

    general economic conditions which are beyond our control, such as the impact of recession, business investment and changes in consumer confidence;

 

    a decrease in our available cash or the value of our investment holdings could impact short-term liquidity requirements and expected capital and other expenditures;

 

    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 U.S. Food and Drug Administration marketing clearances or approvals, which may result in lost market opportunities or postpone or preclude product commercialization by licensees;

 

    the development of new products or technologies by competitors, technological obsolescence and other changes in competitive factors as well as our ability to perform successfully certain product development activities, the related R&D expense impact and governmental and regulatory compliance activities which we have not previously undertaken in any significant manner;

 

    our ability to successfully convert our customers from an early generation of our Photolink® hydrophilic technology protected by a family of patents expected to expire in November 2015 (in the U.S.) and October 2016 (in certain other countries) to one of our advanced generation technologies; and

 

    other factors described in “Risk Factors” and other sections of SurModics’ Annual Report on Form 10-K for the fiscal year ended September 30, 2013, which you are encouraged to read carefully.

 

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Many of these factors are outside the control and knowledge of us, and could result in increased volatility in period-to-period results. Investors are advised not to place undue reliance upon our forward-looking statements and to consult any further disclosures by us on this subject in its filings with the SEC.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our investment policy requires investments with high credit quality issuers and limits the amount of credit exposure to any one issuer. Our investments consist principally of U.S. government and government agency obligations, agency and commercial mortgage-backed securities and investment-grade, interest-bearing corporate and municipal debt securities with varying maturity dates, the majority of which are five years or less. Because of the credit criteria of our investment policies, the primary market risk associated with these investments is interest rate risk. SurModics does not use derivative financial instruments to manage interest rate risk or to speculate on future changes in interest rates. A one percentage point increase in interest rates would result in an approximate $0.3 million decrease in the fair value of our available-for-sale securities as of June 30, 2014, but would have 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 Company’s inventory exposure is not material.

Although we conduct business in foreign countries, our international operations consist primarily of sales of reagent and stabilization chemicals. Additionally, all sales transactions are denominated in U.S. dollars. We generate royalty revenue from the sale of customer products in foreign jurisdictions. Royalties generated in foreign jurisdictions by customers are converted and paid in U.S. dollars per contractual terms. Given the diverse nature of our customers’ products and international operations, changes in foreign currencies are not expected to materially impact our operating results. A limited number of our purchasing transactions are denominated in foreign currencies and they are converted to U.S. dollars. These purchasing transactions are not material to our operating results. 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

Our Chief Executive Officer and Chief Financial Officer, referred to collectively herein as the Certifying Officers, are responsible for establishing and maintaining our disclosure controls and procedures. The Certifying Officers have reviewed and evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934 (the “Exchange Act”)) as of June 30, 2014. Based on that review and evaluation, which included inquiries made to certain other employees of the Company, the Certifying Officers have concluded that, as of the end of the period covered by this report, the Company’s disclosure controls and procedures, as designed and implemented, 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 Company’s management, including its Certifying Officers, as appropriate, to allow timely decisions regarding required disclosures.

Changes in Internal Controls over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) during the three months ended June 30, 2014 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II — OTHER INFORMATION

Item 1. Legal Proceedings

Except as described in Footnote 17 to the financial statements included in this report, there were no material developments in the legal proceedings previously disclosed in the Company’s Form 10-K for the fiscal year ended September 30, 2013.

Item 1A. Risk Factors

In our report on Form 10-K for the fiscal year ended September 30, 2013, filed with the SEC on December 11, 2013, we identify under “Part 1, Item 1A. Risk Factors.” important factors which could affect our financial performance and could cause our actual results for future periods to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statements made in this Form 10-Q.

There have been no material changes in our risk factors subsequent to the filing of our Form 10-K for the fiscal year ended September 30, 2013.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

(c) Issuer Purchases of Equity Securities

The following table presents information with respect to purchases of common stock of the Company made during the three months ended June 30, 2014, 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.

 

Period

   Total Number
of Shares
Purchased(1)
     Average
Price Paid
per Share
     Total Number
of Shares
Purchased
as Part of
Publicly
Announced
Plans or
Programs
     Approximate Dollar
Value of
Shares That
May Yet Be
Purchased
Under the
Plans or
Programs(2)
 

4/1/14 — 4/30/14

     19,436       $ 22.74         0       $ 8   

5/1/14 — 5/31/14

     0         N/A         0       $ 8   

6/1/14 — 6/30/14

     0         N/A         0       $ 8   
  

 

 

       

 

 

    

Total

     19,436       $ 22.74         0       $ 8   
  

 

 

       

 

 

    

 

(1) The purchases in this column were repurchased by the Company to pay the exercise price and/or to satisfy tax withholding obligations in connection with so-called “stock swap exercises” related to the exercise of employee stock options.
(2) On July 29, 2013, our Board of Directors authorized the repurchase of up to $20.0 million of our outstanding common stock. Through June 30, 2014, we have repurchased 875,930 shares at an average price of $22.83 under the July 2013 authorization. As of June 30, 2014, no amounts were available for repurchases under the July 2013 authorization.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not Applicable.

Item 5. Other Information

None.

 

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Item 6. Exhibits

 

Exhibit

  

Description

3.1    Restated Articles of Incorporation, as amended—incorporated by reference to Exhibit 4.1 of the Company’s Registration Statement on Form S-3 filed on July 31, 2014, SEC File No. 333-197757.
3.2    Restated Bylaws of SurModics, Inc., as amended November 30, 2009 – incorporated by reference to Exhibit 3.2 of the Company’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2009, SEC File No. 0-23837.
12*    Computation of Ratio of Earnings to Fixed Charges.
31.1*    Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*    Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*    Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2*    Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101*
   Financial statements from the Quarterly Report on Form 10-Q for SurModics, Inc. for the quarterly period ended June 30, 2014, filed on August 1, 2014, formatted in Extensible Business Reporting Language (XBRL): (i) Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated Statements of Income, (iii) Condensed Consolidated Statements of Comprehensive Income, (iv) Condensed Consolidated Statements of Cash Flows, and (v) Notes to Condensed Consolidated Financial Statements.

 

* 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.

 

August 1, 2014    SurModics, Inc.
   By:  

/s/ Andrew D.C. LaFrence

     Andrew D.C. LaFrence
     Vice President of Finance and Chief Financial Officer
     (duly authorized signatory and principal financial officer)

 

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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

EXHIBIT INDEX TO FORM 10-Q

For the Quarter Ended June 30, 2014

SURMODICS, INC.

 

Exhibit

  

Description

3.1    Restated Articles of Incorporation, as amended—incorporated by reference to Exhibit 4.1 of the Company’s Registration Statement on Form S-3 filed on July 31, 2014, SEC File No. 333-197757.
3.2    Restated Bylaws of SurModics, Inc., as amended November 30, 2009 – incorporated by reference to Exhibit 3.2 of the Company’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2009, SEC File No. 0-23837.
12*    Computation of Ratio of Earnings to Fixed Charges.
31.1*    Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*    Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*    Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2*    Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS*    XBRL Instance Document
101.SCH*    XBRL Taxonomy Extension Schema Document
101.CAL*    XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*    XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*    XBRL Taxonomy Extension Label Linkbase Document
101.PRE*    XBRL Taxonomy Extension Presentation Linkbase Document

 

* Filed herewith

 

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