-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, AnueWCCJrFYE6/tvaKOAxW/6r7MHCRX9k6vIRYQKRoQxVaXGP/Uwy2PbE5zhwSES w2ubdZgmzBGzyOgCmfujzQ== 0001193125-10-253997.txt : 20101109 0001193125-10-253997.hdr.sgml : 20101109 20101109151711 ACCESSION NUMBER: 0001193125-10-253997 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20100930 FILED AS OF DATE: 20101109 DATE AS OF CHANGE: 20101109 FILER: COMPANY DATA: COMPANY CONFORMED NAME: KENSEY NASH CORP CENTRAL INDEX KEY: 0001002811 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 363316412 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-34388 FILM NUMBER: 101175961 BUSINESS ADDRESS: STREET 1: 735 PENNSYLVANIA DRIVE CITY: EXTON STATE: PA ZIP: 19341 BUSINESS PHONE: 6105947156 MAIL ADDRESS: STREET 1: 735 PENNSYLVANIA DRIVE CITY: EXTON STATE: PA ZIP: 19341 10-Q 1 d10q.htm FORM 10-Q Form 10-Q
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

 

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

For the Quarterly Period Ended: September 30, 2010

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: 001-34388

 

 

Kensey Nash Corporation

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   36-3316412
(State or other jurisdiction of
incorporation or organization)
  (IRS Employer
Identification No.)
735 Pennsylvania Drive Exton, Pennsylvania   19341
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (484) 713-2100

 

 

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 Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ¨    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 definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

  Large accelerated filer   ¨    Accelerated filer   x
  Non-accelerated filer   ¨    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

As of October 31, 2010, there were 8,497,891 outstanding shares of Common Stock, par value $.001, of the registrant.

 

 

 


Table of Contents

 

KENSEY NASH CORPORATION

QUARTER ENDED SEPTEMBER 30, 2010

INDEX

 

         PAGE  

PART I - FINANCIAL INFORMATION

  
  Item 1.   Condensed Consolidated Financial Statements (Unaudited)   
    Balance Sheets as of September 30, 2010 and June 30, 2010      3   
    Statements of Income for the three months ended September 30, 2010 and 2009      4   
    Statement of Stockholders’ Equity for the three months ended September 30, 2010      5   
    Statements of Cash Flows for the three months ended September 30, 2010 and 2009      6   
    Notes to Condensed Consolidated Financial Statements      7   
  Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations      20   
 

Item 3.

  Quantitative and Qualitative Disclosures about Market Risk      31   
 

Item 4.

  Controls and Procedures      32   

PART II - OTHER INFORMATION

  
 

Item 2.

  Unregistered Sales of Equity Securities and Use of Proceeds      33   
 

Item 6.

  Exhibits      33   

SIGNATURES

     34   

EXHIBITS

     35   

 

2


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PART I - FINANCIAL INFORMATION

 

Item 1. Condensed Consolidated Financial Statements

KENSEY NASH CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)

 

 

     September 30,
2010
    June 30,
2010
 

ASSETS:

    

CURRENT ASSETS:

    

Cash and cash equivalents

   $ 21,454,383      $ 23,102,362   

Investments

     28,095,011        42,571,544   

Trade receivables, net of allowances for doubtful accounts of $5,867 and $13,513 as of September 30, 2010 and June 30, 2010 respectively

     3,984,040        5,307,563   

Royalties receivable

     5,638,486        5,818,310   

Other receivables (including $16,659 and $2,582 at September 30, 2010 and June 30, 2010, respectively, due from non-executive employees)

     338,969        1,119,703   

Inventory

     10,403,102        8,885,875   

Deferred tax asset, current portion

     2,668,376        2,857,262   

Prepaid expenses and other

     1,194,532        1,091,760   
                

Total current assets

     73,776,899        90,754,379   
                

PROPERTY, PLANT AND EQUIPMENT, AT COST:

    

Land

     4,883,591        4,883,591   

Building

     46,632,773        46,489,239   

Machinery, furniture and equipment

     32,880,047        32,728,301   

Construction in progress

     167,233        63,322   
                

Total property, plant and equipment

     84,563,644        84,164,453   

Accumulated depreciation

     (30,302,419     (29,179,563
                

Net property, plant and equipment

     54,261,225        54,984,890   
                

OTHER ASSETS:

    

Deferred tax asset, non-current portion

     1,964,601        1,872,619   

Acquired patents and other intangibles, net of accumulated amortization of $6,867,867 and $6,628,605 at September 30, 2010 and June 30, 2010 respectively

     1,809,332        2,048,595   

Goodwill

     4,366,273        4,366,273   

Other non-current assets

     73,646        93,973   
                

Total other assets

     8,213,852        8,381,460   
                

TOTAL

   $ 136,251,976      $ 154,120,729   
                

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

CURRENT LIABILITIES:

    

Accounts payable

   $ 3,385,653      $ 2,460,740   

Accrued expenses

     4,487,307        5,494,910   

Other current liabilities

     300,584        131,836   

Current portion of debt

     1,399,997        1,399,997   

Deferred revenue

     1,008,257        947,378   
                

Total current liabilities

     10,581,798        10,434,861   
                

OTHER LIABILITIES:

    

Long term debt

     29,633,333        29,983,333   

Deferred revenue, non-current

     3,113,011        3,336,780   

Other non-current liabilities

     6,210,119        5,542,509   
                

Total liabilities

     49,538,261        49,297,483   
                

COMMITMENTS AND CONTINGENCIES (Note 11)

     —          —     

STOCKHOLDERS’ EQUITY:

    

Preferred stock, $.001 par value, 100,000 shares authorized, of which 25,000 shares are designated as Series A junior participating preferred stock, $.001 par value, no shares issued or outstanding at September 30, 2010 and June 30, 2010

     —          —     

Common stock, $.001 par value, 25,000,000 shares authorized, 8,625,460 and

    

9,437,236 shares issued and outstanding at September 30, 2010 and June 30, 2010 respectively

     8,572        9,403   

Capital in excess of par value

     5,990,948        27,528,282   

Retained earnings

     84,406,720        80,561,830   

Accumulated other comprehensive loss

     (3,692,525     (3,276,269
                

Total stockholders’ equity

     86,713,715        104,823,246   
                

TOTAL

   $ 136,251,976      $ 154,120,729   
                

See notes to Condensed Consolidated Financial Statements.

 

3


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KENSEY NASH CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF INCOME (Unaudited)

 

 

     Three Months Ended
September 30, 2010
 
     2010     2009  

REVENUES:

    

Net sales

    

Biomaterial sales

   $ 10,421,456      $ 12,575,046   

Endovascular sales

     458,499        857,656   
                

Total net sales

     10,879,955        13,432,702   

Royalty income

     6,084,644        6,309,116   
                

Total revenues

     16,964,599        19,741,818   
                

OPERATING COSTS AND EXPENSES:

    

Cost of products sold

     4,220,125        5,538,400   

Research and development

     4,277,383        4,275,571   

Selling, general and administrative

     2,297,875        2,179,931   
                

Total operating costs and expenses

     10,795,383        11,993,902   
                

INCOME FROM OPERATIONS

     6,169,216        7,747,916   
                

OTHER INCOME (EXPENSE):

    

Interest income

     154,939        174,148   

Interest expense

     (514,404     (537,268

Other income (expense)

     3,512        (17,540
                

Total other expense - net

     (355,953     (380,660
                

INCOME BEFORE INCOME TAX

     5,813,263        7,367,256   

Income tax expense

     (1,968,373     (2,486,447
                

NET INCOME

   $ 3,844,890      $ 4,880,809   
                

BASIC EARNINGS PER SHARE

   $ 0.43      $ 0.44   
                

DILUTED EARNINGS PER SHARE

   $ 0.41      $ 0.43   
                

WEIGHTED AVERAGE COMMON SHARES OUTSTANDING

     9,037,623        11,121,389   
                

DILUTED WEIGHTED AVERAGE COMMON SHARES OUTSTANDING

     9,300,323        11,476,756   
                

See notes to consolidated financial statements.

 

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KENSEY NASH CORPORATION

CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY (Unaudited)

 

 

     Common Stock     Capital in
Excess of
Par

Value
    Retained
Earnings
     Accumulated
Other
Comprehensive

(Loss)/Income
    Comprehensive
Income
    Total  
     Shares     Amount             

BALANCE, JUNE 30, 2010

     9,402,836      $ 9,403      $ 27,528,282      $ 80,561,830       $ (3,276,269     $ 104,823,246   

Exercise of:

               

Stock options

     223,993        224        3,421,696               3,421,920   

Stock repurchase

     (1,054,702     (1,055     (26,645,181            (26,646,236

Tax benefit from exercise of:

               

Stock options

         690,723               690,723   

Employee share-based compensation:

               

Stock options

         855,991               855,991   

Nonvested stock awards

         139,437               139,437   

Net income

           3,844,890         $ 3,844,890        3,844,890   

Change in unrealized gain on investments (net of tax)

              17,690        17,690        17,690   

Change in interest rate swap unrealized loss (net of tax)

              (433,946     (433,946     (433,946
                     

Comprehensive income

              $ 3,428,634     
                                                         

BALANCE, SEPTEMBER 30, 2010

     8,572,127      $ 8,572      $ 5,990,948      $ 84,406,720       $ (3,692,525     $ 86,713,715   
                                                   

See notes to the Condensed Consolidated Financial Statements.

 

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KENSEY NASH CORPORATION

CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)

 

 

     Three Months Ended
September 30,
 
     2010     2009  

OPERATING ACTIVITIES:

    

Net income

   $ 3,844,890      $ 4,880,809   

Adjustments to reconcile net income to net cash provided by operating activities:

    

Depreciation and amortization

     1,757,173        1,676,022   

Share-based compensation:

    

Stock options

     855,991        458,446   

Nonvested stock awards

     139,437        124,992   

Cash-settled stock appreciation rights

     168,748        100,466   

Tax benefit/(deficiency) from exercise/issuance of:

    

Stock options

     690,723        56,599   

Nonvested stock awards

     —          (602

Excess tax benefits from share-based payment arrangements

     (295,356     (37,105

Deferred income taxes

     321,044        (337,784

Gain on disposal/retirement of property, plant and equipment

     (14,646     —     

Changes in assets and liabilities which provided/(used) cash:

    

Accounts receivable

     2,298,643        298,592   

Prepaid expenses and other current assets

     (85,741     (132,914

Inventory

     (1,517,227     (211,980

Accounts payable and accrued expenses

     (813,564     1,748,070   

Deferred revenue, current

     60,879        (20,000

Deferred revenue, non-current

     (223,769     40,714   
                

Net cash provided by operating activities

     7,187,225        8,644,325   
                

INVESTING ACTIVITIES:

    

Additions to property, plant and equipment

     (638,532     (435,755

Purchases of intangible assets

     —          (230,833

Proceeds from maturity of investments

     14,330,000        315,000   
                

Net cash provided by/(used in) investing activities

     13,691,468        (351,588
                

FINANCING ACTIVITIES:

    

Repayments of long term debt

     (350,000     (350,000

Stock repurchase

     (25,879,386     (891,007

Excess tax benefits from share-based payment arrangements

     295,356        37,105   

Proceeds from exercise of stock options

     3,407,358        182,018   
                

Net cash used in financing activities

     (22,526,672     (1,021,884
                

(DECREASE)/INCREASE IN CASH

     (1,647,979     7,270,853   

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

     23,102,362        49,474,255   
                

CASH AND CASH EQUIVALENTS, END OF PERIOD

   $ 21,454,383      $ 56,745,108   
                

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:

    

Cash paid for interest

   $ 525,725      $ 537,642   
                

Cash paid for income taxes

   $ 1,742,500      $ 800,000   
                

Retirement of fully depreciated property, plant and equipment

   $ 186,013      $ —     
                

See notes to the Condensed Consolidated Financial Statements.

 

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Table of Contents

 

KENSEY NASH CORPORATION

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Note 1 – Condensed Consolidated Financial Statements

Principles of Consolidation and Basis of Presentation

The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP) for interim financial information and with the instructions of Form 10-Q and Article 10 of Regulation S-X and, therefore, do not include all of the information and notes required by U.S. GAAP for complete annual financial statements. The accompanying financial information reflects all adjustments which are, in the opinion of management, necessary for a fair presentation of the results for the interim periods. The results of operations for the three months ended September 30, 2010 are not necessarily indicative of the results to be expected for the full year. These Condensed Consolidated Financial Statements should be read in conjunction with the consolidated statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2010 (fiscal 2010).

The Condensed Consolidated Financial Statements include the accounts of Kensey Nash Corporation and its wholly-owned subsidiaries (the Company). All intercompany transactions and balances have been eliminated.

The preparation of the financial statements in conformity with U.S. GAAP and the notes to the financial statements requires management to make estimates and assumptions. These estimates and assumptions, which may differ from actual results, will affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of revenues, expenses and cash flows for the periods presented.

Revenue Recognition

Sales Revenue

The Company recognizes revenue in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Subtopic 605-10-S99, “Revenue Recognition” (ASC 605-10-S99). In addition, the Company accounts for certain customer arrangements containing multiple revenue elements, which were entered into, or materially amended, after June 30, 2003, in accordance with FASB ASC Subtopic 605-25, “Multiple Element Arrangements” (ASC 605-25).

Sales revenue is generally recognized when the products are shipped or the services are completed. Advance payments received for products or services are recorded as deferred revenue and are generally recognized when the product is shipped or services are performed. The Company reduces sales revenue for estimated customer returns and other allowances. The Company recorded $30,064 and $0 for net sales returns provisions respectively, for the three months ended September 30, 2010 and 2009.

Royalty Income

The Company generally recognizes its royalty revenue at the end of each month, when the relevant net total end-user product sales dollars are reported by customers to the Company for the month. Royalty payments are generally received within 45 days after the end of each calendar quarter.

Geographic Information

The Company’s total revenues are attributed to a country based on the location of the customer. The Company’s business is not directly dependent on foreign operations, as the Company’s sales to customers outside the U.S. are not significant. However, a portion of the Company’s total revenues, including sales and royalties, are dependent on U.S. based customers selling to end-users outside the U.S. No one country where the Company sells its products, other than the U.S., represented more than 10% of the Company’s revenues. In addition, all of the Company’s long-lived tangible assets are located in the U.S.

 

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KENSEY NASH CORPORATION

Notes to Condensed Consolidated Financial Statements—(Continued)

(Unaudited)

 

 

Earnings Per Share

Earnings per share are calculated in accordance with FASB ASC Topic 260, “Earnings Per Share” (ASC 260). Basic and diluted EPS are computed using the weighted average number of shares of Common Stock outstanding, with common equivalent shares from options and nonvested stock awards included in the diluted computation when their effect is dilutive. There were no nonvested stock awards included for the three months ended September 30, 2010 and 2009 that were antidilutive. Options to purchase shares of the Company’s Common Stock that were outstanding for the three months ended September 30, 2010 and 2009, but were not included in the computation of diluted EPS because the options would have been antidilutive, are shown in the table below:

 

     Three months ended September 30,  
     2010      2009  

Number of shares from options

     1,235,292         1,001,479   
                 

Option exercise price range

   $ 23.45 - $35.71       $ 27.80 - $35.71   
                 

Goodwill

The Company accounts for goodwill under the provisions of FASB ASC Topic 350, “Intangibles – Goodwill and Other” (ASC 350). Goodwill is not amortized, but is subject to impairment tests on an annual basis or at an interim date if certain events or circumstances indicate that the asset might be impaired. The most recent annual test as of June 30, 2010 indicated that goodwill was not impaired. There were no indicators of impairment as of September 30, 2010.

New Accounting Standards

Adopted:

In October 2009, the FASB issued ASU 2009-13, “Revenue Recognition for Multiple-Deliverable Revenue Arrangements of FASB ASC Topic 605,” which amends ASC Subtopic 605-25, and will be effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010, which for the Company was July 1, 2010 (fiscal 2011). Alternatively, adoption may be on a retrospective basis, and early application is permitted. This statement provides principles for allocation of consideration among its multiple-elements based on an element’s estimated selling price if vendor-specific (VSOE) or other third-party evidence (TPE) of value is not available. This statement allows more flexibility in identifying and accounting for separate deliverables under an arrangement, introduces an estimated selling price method for valuing the elements of a bundled arrangement if VSOE or TPE of selling price is not available, and significantly expands related disclosure requirements. The Company’s prospective adoption of this new accounting update on July 1, 2010 did not have a significant impact on the Company’s consolidated financial position, results of operations or cash flows; however, the Company will continue to assess the impact of any future arrangements entered into or materially modified after the Company’s adoption.

In April 2010, the FASB issued ASU 2010-17, “Milestone Method of Revenue Recognition of FASB ASC Topic 605,” which will be effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010, which for the Company is its fiscal 2011. This statement provides criteria for recognizing the achievement of a milestone in its entirety as revenue in the period in which the milestone is achieved, only if the milestone meets all criteria considered substantive made at the inception of the arrangement. The Company’s prospective adoption of this new accounting update on July 1, 2010 did not have a significant impact on the Company’s consolidated financial position, results of operations or cash flows; however, the Company will continue to assess the impact of any future arrangements entered into or materially modified after the Company’s adoption.

 

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KENSEY NASH CORPORATION

Notes to Condensed Consolidated Financial Statements—(Continued)

(Unaudited)

 

 

Note 2 – Investments

Investments as of September 30, 2010 consist of non-taxable high quality municipal obligations and taxable U.S. government securities. In accordance with FASB ASC Topic 320, “Investments – Debt and Equity Securities” (ASC 320), the Company has classified its entire investment portfolio as available-for-sale securities with secondary or resale markets, and, as such, its portfolio is reported at fair value with unrealized gains and losses included in Comprehensive Income in stockholders’ equity (see Note 9) and realized gains and losses included in Other income/expense. The following is a summary of available-for-sale securities as of September 30, 2010 and June 30, 2010:

 

     September 30, 2010  

Description

   Amortized
Cost
     Gross Unrealized     Estimated
Fair Value
 
      Gain      Loss    

Municipal Obligations

   $ 23,696,973       $ 529,418       $ —        $ 24,226,391   

U.S. Government Securities

     3,868,727         84         (191     3,868,620   
                                  

Total Investments

   $ 27,565,700       $ 529,502       $ (191   $ 28,095,011   
                                  

 

     June 30, 2010  

Description

   Amortized
Cost
     Gross Unrealized        
      Gain      Loss     Fair Value  

Municipal Obligations

   $ 33,693,441       $ 509,300       $ (9,683   $ 34,193,058   

U.S. Government Securities

     8,376,007         2,479         —          8,378,486   
                                  

Total Investments

   $ 42,069,448       $ 511,779       $ (9,683   $ 42,571,544   
                                  

The Company’s U.S. government securities are comprised of U.S. government agency debt instruments. As of September 30, 2010, the Company’s investments had maturities ranging from less than one year to approximately three years. The fair values of the Company’s municipal obligations and U.S. government agency debt instruments are obtained from broker quotes using pricing matrices based on inputs that may include quoted prices for identical or similar assets in the municipal and U.S. government bond market and based on other various inputs that are directly or indirectly observable.

Certain investment securities shown below as of September 30, 2010 had fair values less than their amortized costs and, therefore, contained unrealized losses. The Company has evaluated these investments and has determined that the decline in value was not related to any Company or industry specific event. As of September 30, 2010, there were 2 out of 42 investments with unrealized losses. The gross unrealized losses related to these investments were due to either changes in interest rates or investments having been obtained at a premium. Given that the Company has no intent to sell any of these investments until a recovery of its fair value, which may be at maturity, and there is no current requirement to sell any of these investments, the Company did not consider these investments to be other-than-temporarily impaired as of September 30, 2010. The Company anticipates full recovery of amortized costs with respect to these investments at maturity or sooner in the event of a more favorable market interest rate environment. The duration of time the investments had been in a continuous unrealized loss position as of September 30, 2010 were as follows:

 

Description

   Loss < 12 months     Loss > or equal to 12 months      Total  
     Fair Value      Gross
Unrealized
Losses
    Fair Value      Gross
Unrealized
Losses
     Fair Value      Gross
Unrealized
Losses
 

Municipal Obligations

   $ —         $ —        $ —         $ —         $ —         $ —     

U.S. Government Securities

     2,616,931         (191     —           —           2,616,931         (191
                                                    

Total Investments

   $ 2,616,931       $ (191   $ —         $ —         $ 2,616,931       $ (191
                                                    

 

9


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KENSEY NASH CORPORATION

Notes to Condensed Consolidated Financial Statements—(Continued)

(Unaudited)

 

 

Note 3 – Inventory

Inventory is stated at the lower of cost (determined by the average cost method, which approximates first-in, first-out) or market value. Inventory primarily includes the cost of material utilized in the processing of the Company’s products and was as follows as of September 30, 2010 and June 30, 2010:

 

     September 30,
2010
    June 30,
2010
 

Raw materials

   $ 7,882,324      $ 7,550,043   

Work in process

     1,613,087        1,425,174   

Finished goods

     1,852,837        2,018,512   
                

Gross inventory

     11,348,249        10,993,729   

Provision for inventory obsolescence

     (945,147     (2,107,854
                

Inventory

   $ 10,403,102      $ 8,885,875   
                

The provision for inventory obsolescence decreased approximately $1.2 million during the quarter ended September 30, 2010, primarily due to the disposal of the fully reserved inventory in September 2010. Adjustments to inventory are made at the individual part level for estimated excess, obsolescence or impaired balances, to reflect inventory at the lower of cost or market. Factors influencing these adjustments include changes in demand, rapid technological changes, product life cycle and development plans, component cost trends, product pricing, physical deterioration and quality concerns. Revisions to these adjustments would be required if any of these factors differ from the Company’s estimates.

Note 4 – Select Customer Agreements

St. Jude Medical, Inc.

The License Agreements – Under license agreements with St. Jude Medical, St. Jude Medical has exclusive worldwide rights to manufacture and market the Angio-SealTM Vascular Closure Device (the Angio-Seal), for which the Company receives an approximate 6% royalty on end-user product sales by St. Jude Medical.

Existing Component Supply Contract – Under a supply agreement executed with St. Jude Medical in 2005, the Company is the exclusive supplier of 100% of the collagen plug and at least 30% of the bioresorbable polymer anchor components for the Angio-Seal over the term of the agreement, which expires in December 2010. As part of the agreement, the Company received a $1.0 million origination fee upon execution, as consideration for the Company’s ongoing investments in collagen research and development. As of September 30, 2010 the Company had recognized $979,230 of this origination fee and the remaining $20,770 had been recorded as deferred revenue to be recognized over the remaining period of the contract.

New Collagen Supply Agreement – On June 23, 2010, the Company entered into a new two-year supply agreement with St. Jude Medical, effective for the period from January 1, 2011 to December 31, 2012. Under this new supply agreement, the Company will be the exclusive outside supplier of collagen plugs to St. Jude Medical. The new supply agreement provides for calendar year 2011 minimum order levels equivalent to approximately 25% of fiscal year 2010 annual collagen plug sales and calendar year 2012 minimum order levels equivalent to approximately 20% of fiscal year 2010 collagen plug sales. The new supply agreement does not call for the Company to supply polymer anchors to St. Jude Medical.

Orthovita, Inc.

The Company has a development, manufacturing and supply agreement with Orthovita under which the Company develops and commercializes products based on Orthovita’s proprietary Vitoss™ Bone Graft Substitute Material in combination with the Company’s proprietary biomaterials (the Orthovita Agreement). Under the Orthovita Agreement, the Company manufactures the products, while Orthovita markets and sells the products worldwide. Under the Orthovita Agreement, the Company receives royalty payments on co-developed Vitoss™, Vitoss™ Foam and VitossBioactive Foam products based upon Orthovita’s net total end-user sales of such products.

 

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KENSEY NASH CORPORATION

Notes to Condensed Consolidated Financial Statements—(Continued)

(Unaudited)

 

 

In a separate transaction in August 2004, the Company entered into an agreement (the Assignment Agreement) whereby the Company acquired the intellectual property rights of a third party having rights in the Vitoss™ technology, as an inventor of the Vitoss™ technology (the Inventor), for $2,600,000. Under the Assignment Agreement, the Company received all intellectual property rights of the Inventor that had not previously been assigned to Orthovita. Also under the Assignment Agreement, the Company generally receives a royalty on the sale of all Orthovita products containing the Vitoss™ technology, up to a total to be received of $4,035,782. The entire cost of these proprietary rights is expected to be amortized over an approximate 83 month period. As of September 30, 2010, the Company had recognized cumulative royalty income of $3,596,235 under the Assignment Agreement and $439,547 was yet to be received. The Company currently anticipates receiving the remaining economic benefit in relation to these proprietary rights during fiscal 2011.

Note 5 – Acquired Patents and Other Intangibles

The costs of internally developed patents are expensed when incurred due to the long development cycle for products and the Company’s inability to measure the recoverability of these costs when incurred. From time to time, the Company has acquired portfolios of patents and other intangibles that it believes are beneficial and complementary to the Company’s existing intellectual property and material processing knowledge platform. These acquisitions have included a portfolio of puncture closure patents acquired in November 1997, patents acquired in the asset purchase of THM Biomedical, Inc. (THM) in 2000, certain intellectual property and other rights related to the Vitoss™ product line acquired from a third party inventor in 2004 and certain assets of MacroPore Biosurgery, Inc. (MacroPore) acquired in 2007, as well as other smaller purchases.

The Company amortizes the entire cost of acquired patents and intangible assets over their respective remaining periods of economic benefit, ranging from approximately 1 to 6 years as of September 30, 2010. The gross carrying amount of such patents and intangible assets as of September 30, 2010 was $8,677,199, with accumulated amortization of $6,867,867.

Amortization expense on these patents and intangible assets was $239,262 and $225,518 for the three months ended September 30, 2010 and 2009, respectively. The table below details the estimated amortization expense as of September 30, 2010 for the next five fiscal years on the patents and intangible assets previously acquired by the Company:

 

Fiscal year ending June 30,

   Amortization
Expense
 

2011

   $ 960,031   

2012

     629,181   

2013

     242,444   

2014

     198,504   

Thereafter

     18,434   

Note 6 – Accrued Expenses

As of September 30, 2010 and June 30, 2010, accrued expenses consisted of the following:

 

     September 30,
2010
     June 30,
2010
 

Accrued payroll and related compensation

   $ 2,930,088       $ 2,987,702   

Income taxes payable

     886,718         1,627,630   

Other

     670,501         879,578   
                 

Total

   $ 4,487,307       $ 5,494,910   
                 

 

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KENSEY NASH CORPORATION

Notes to Condensed Consolidated Financial Statements—(Continued)

(Unaudited)

 

 

Note 7 – Debt

Secured Commercial Mortgage – On May 25, 2006, the Company entered into an agreement for a $35 million Secured Commercial Mortgage (the “Mortgage”) with Citibank, F.S.B. The Mortgage is secured by the Company’s facility and land in Exton, Pennsylvania and bears interest at one-month LIBOR plus an 0.82% Loan Credit Spread. At September 30, 2010, the outstanding Mortgage balance, net of principal payments, was $31.0 million.

The Mortgage contains various conditions to borrowing, including affirmative, restrictive and financial maintenance covenants. Certain of the more significant covenants require the Company to maintain a Minimum Fixed Charge Coverage Ratio of EBITDA (as defined in the Mortgage) to debt service equal to or greater than 1.50–to–1.0 and an interest rate hedge of at least 50 percent of the outstanding principal balance of the Mortgage through an interest rate protection product reasonably acceptable to Citibank, F.S.B.

Interest Rate Swap Agreement In order to hedge its interest rate risk under the Mortgage, the Company entered into a $35 million aggregate 10-year fixed interest rate swap agreement (the Swap) with Citibank, N.A. in May 2006. The Swap is secured by the Company’s facility and land in Exton, Pennsylvania. The Company is using the Swap as a cash flow hedge of the Company’s interest payments under the Mortgage. The Swap converts the variable LIBOR portion of the Mortgage payments to a fixed rate of 6.44% (5.62% fixed interest rate plus a 0.82% Loan Credit Spread).

The Company follows the provisions of FASB ASC Topic 815, “Derivatives and Hedging,” to account for the Swap as a cash flow hedge due to the hedging of forecasted interest rate payments and to record the Swap at its fair value on the Consolidated Balance Sheets. This value represents the estimated amount the Company would receive or pay to terminate the Swap. As such, the Company records a mark-to-market adjustment at the end of each period. In establishing the fair value, the Company includes and evaluates dealer quotes, the counterparty’s ability to settle the asset or liability and the counterparty’s creditworthiness. Additionally, the Company considers current interest rates, collateralization of the Mortgage and the Swap by the land and building and any adverse Company or industry specific events that would impact the fair value measurement.

The Company utilizes the Hypothetical Derivative Method in determining hedge effectiveness each period. Transactions that would cause ineffectiveness would include the prepayment of the Mortgage or an adverse Company or industry specific event that would impact the fair value measurement, which would result in the Company reclassifying the ineffective portion into current earnings and an impact to the Condensed Consolidated Statements of Cash Flows. If the conditions underlying the Swap or the hedge item do not change, the Swap will be considered to be highly effective. The effective portion of the Swap’s gain or loss, due to a change in the fair value, is reported as a component of Accumulated other comprehensive loss and has no impact on the Condensed Consolidated Statements of Income or Cash Flows.

As of September 30, 2010 and June 30, 2010, the fair value of the Swap was in an unrealized loss position of $6,210,118 ($4,036,577, net of tax) and $5,542,509 ($3,602,631, net of tax), respectively, with the gross unrealized loss position included in Other non-current liabilities and the net of tax position included in Accumulated other comprehensive loss on the Condensed Consolidated Balance Sheets. Interest expense under the Swap is recorded in earnings at the fixed rate set forth in the Swap.

For the three months ended September 30, 2010 and 2009, no amounts were recognized in current earnings due to ineffectiveness or amounts excluded from the assessment of hedge effectiveness. The Company does not currently anticipate any material unrealized losses to be recognized within the subsequent 12 months as the anticipated transactions under the Mortgage and Swap occur, unless the Mortgage, or a portion thereof, is prepaid.

 

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KENSEY NASH CORPORATION

Notes to Condensed Consolidated Financial Statements—(Continued)

(Unaudited)

 

 

The following table summarizes the fair value of the Swap as of September 30, 2010 and June 30, 2010 on the Condensed Consolidated Balance Sheet:

 

Derivative Designed as a
Hedging Instrument

   Location in the Condensed
Consolidated Balance Sheet
     Fair Value as of
September 30, 2010
     Fair Value as of
June 30, 2010
 

Interest Rate Swap Contract

     Other non-current liabilities       $ 6,210,118       $ 5,542,509   
                    

Total Derivative

      $ 6,210,118       $ 5,542,509   
                    

The following table summarizes the Swap’s impact on Accumulated other comprehensive loss and earnings for the three months ended September 30, 2010:

 

      Amount of Gain/(Loss)
Recognized in Other Comprehensive Loss on
Derivative

(Effective Portion)
 

Derivative in Cash Flow Hedging Relationship

   For the Three Months Ended September,  
         2010                 2009        

Interest Rate Swap Contract

   $ (1,100,914   $ (897,209
                

Total

   $ (1,100,914   $ (897,209
                
     Amount of Gain/(Loss) Reclassed From
Accumulated Other Comprehensive  Loss Into Income
(Effective Portion)
 
     For the Three Months Ended  

Location of Loss Reclassed From Accumulated
Other Comprehensive Loss Into Income

   September 30, 2010     September 30, 2009  

Interest expense

   $ (433,305   $ (445,096
                

Total

   $ (433,305   $ (445,096
                
     Amount of Gain / (Loss) Recognized in Income on
Derivative

(Ineffective Portion)
 
     For the Three Months Ended  

Location of Loss Reclassed From Accumulated
Other Comprehensive Loss Into Income

   September 30, 2010     September 30, 2009  

Interest expense

   $  —       $ —     
                

Total

   $ —        $ —     
                

 

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KENSEY NASH CORPORATION

Notes to Condensed Consolidated Financial Statements—(Continued)

(Unaudited)

 

 

Note 8 – Fair Value of Financial Instruments

The Company follows the provisions of FASB ASC Topic 820, “Fair Value Measurements and Disclosures,” for fair value measurement recognition and disclosure purposes for its financial assets and financial liabilities that are remeasured and reported at fair value each reporting period. The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents, available-for-sale securities and the Swap. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of financial assets and financial liabilities and their placement within the fair value hierarchy. Categorization is based on a three-tier valuation hierarchy, which prioritizes the inputs used in measuring fair value, as follows

 

   

Level 1 - Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities;

 

   

Level 2 - Inputs that are other than quoted prices in active markets for identical assets and liabilities, inputs that are quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are either directly or indirectly observable; and

 

   

Level 3 - Unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.

The following table presents the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2010 and June 30, 2010:

 

     Fair Value Measurements as of
September 30, 2010
 
     Level 1      Level 2      Level 3  

Assets

        

Money market funds (a)

   $ 20,409,450       $ —         $ —     

Available-for-sale securities:

        

Municipal Obligations and U.S. Government

        

Securities (See Note 2)

     —           28,095,011         —     
                          

Total Assets Measured at Fair Value

   $ 20,409,450       $ 28,095,011       $ —     
                          

Liabilities

        

Interest rate swap (See Note 7)

   $ —         $ 6,210,118       $ —     
                          

Total Liabilities Measured at Fair Value

   $ —         $ 6,210,118       $ —     
                          
     Fair Value Measurements as of
June 30, 2010
 
     Level 1      Level 2      Level 3  

Assets

        

Money market funds (a)

   $ 21,813,659       $ —         $ —     

Available-for-sale marketable securities:

        

Municipal Obligations and

        

U.S. Government Securities (See Note 2)

     —           42,571,544         —     
                          

Total Assets

   $ 21,813,659       $ 42,571,544       $ —     
                          

Liabilities

        

Interest rate swap (See Note 7)

   $ —         $ 5,542,509       $ —     
                          

Total Liabilities

   $ —         $ 5,542,509       $ —     
                          

 

a) The Company’s money market funds are classified along with the Company’s cash balances as Cash and cash equivalents within the Consolidated Balance Sheets. Money market funds are valued at quoted prices in active markets.

 

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KENSEY NASH CORPORATION

Notes to Condensed Consolidated Financial Statements—(Continued)

(Unaudited)

 

 

The Company follows the disclosure provisions of FASB ASC Topic 825, “Financial Instruments” (ASC 825), for disclosure purposes for financial assets and financial liabilities that are not measured at fair value. As of September 30, 2010, the financial assets and liabilities recorded on the Consolidated Balance Sheets that are not measured at fair value on a recurring basis include accounts receivable, net; accounts payable and debt obligations. The carrying values of accounts receivable, net; accounts payable and current debt obligations approximate fair value due to the short-term nature of these instruments. The fair value of long-term debt, where a quoted market price was not available, is evaluated based on, among other factors, interest rates currently available to the Company for debt with similar terms, remaining payments and considerations of the Company’s creditworthiness. The Company determined that the recorded book value of long-term debt approximates fair value at September 30, 2010 due to the variable LIBOR portion of the Mortgage payments.

Note 9 – Comprehensive Income

The Company’s comprehensive income is shown on the Condensed Consolidated Statement of Stockholders’ Equity as of September 30, 2010 and June 30, 2010, and is comprised of net unrealized gains and losses on the Company’s available-for-sale securities and the Swap. The net tax benefit for the three months ended September 30, 2010 and for the fiscal year ended June 30, 2010 of other comprehensive loss was $224,138 and $218,826, respectively.

Note 10 – Stockholders’ Equity

Stock Repurchase Program

From time to time, the Company has made repurchases of its stock, as authorized by the various stock repurchase programs established by the Company’s Board of Directors, and through equity incentive plan transactions. On June 16, 2010, the Company announced that its Board of Directors approved a stock repurchase program allowing the Company to repurchase up to a total of $30 million of its issued and outstanding shares of Common Stock. As of September 30, 2010, there was approximately $4.2 million remaining to repurchase shares of Common Stock under the current stock repurchase program.

The Company repurchased and retired 1,035,769 shares of its Common Stock, at an average price per share of $24.96, during the three months ended September 30, 2010. These shares were settled at a total cost of $25,848,312, using available cash. Included in these totals were 34,400 shares that were repurchased in June 2010, but settled in July 2010, at a cost of $811,054, or an average price per share of $23.58. An additional 53,333 shares were repurchased in September 2010, but settled in October 2010, at a cost of $1,577,336, or an average price per share of $29.58. During the quarter ended September 30, 2009, the Company repurchased and retired a total of 35,642 shares of Common Stock that were settled at a cost of $889,582, or an average price per share of $24.96, using available cash. Included in these totals were 3,500 shares that were repurchased in June 2009, but settled in July 2009, at a cost of $87,279, or an average price per share of $24.94.

Share-Based Compensation

The Company accounts for its share-based compensation plans in accordance with FASB ASC Topic 718, “Compensation – Stock Compensation” (ASC 718). Compensation expense related to share-based awards is classified on the Consolidated Statements of Income within the same line items as salary or consulting expense with respect to the award recipients, and is recorded over the awards’ relevant vesting periods. Compensation expense related to share-based awards granted to the members of the Board of Directors is recorded as a component of Selling, general and administrative expense on the Consolidated Statements of Income.

 

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Table of Contents

KENSEY NASH CORPORATION

Notes to Condensed Consolidated Financial Statements—(Continued)

(Unaudited)

 

 

The following table provides additional information related to the Company’s share-based compensation:

 

     Three Months Ended
September 30,
     Estimated
Unrecognized
Share-based
Compensation
as of
September 30,

2010
     Weighted Average
Period Remaining
of Share-based
Compensation as
of September 30,

2010
 
     2010      2009        

Stock options

   $ 855,991       $ 458,446       $ 7,583,910         2.20   

Non-vested stock awards

     139,437         124,992         755,000         1.73   

SARs

     168,748         100,466         —           1.04   
                             

Total share-based compensation

   $ 1,164,176       $ 683,904       $ 8,338,910      
                             

Stock Options

Stock options have been granted to officers and other employees and members of the Board of Directors of the Company, as well as non-employee outside consultants, under the Company’s Seventh Amended and Restated Kensey Nash Corporation Employee Incentive Compensation Plan and prior versions of this incentive compensation plan (collectively, the Employee Plan). The Company also has a Non-employee Directors’ Stock Option Plan (the Directors’ Plan). No shares are available for new awards under this plan and any awards of the type granted previously under the Directors’ Plan are now granted under the Employee Plan. The fair value of each option grant was estimated on the date of grant using the Black-Scholes option-pricing model.

The Board of Directors has approved and proposes that the Company’s stockholders approve, at the Annual Meeting to be held on December 1, 2010, amending and restating the Employee Plan as the Eighth Amended and Restated Employee Incentive Compensation Plan (the Amended Plan). The Amended Plan, if approved, would provide for among other things an increase in the number of shares of Common Stock authorized for issuance by 300,000 shares (raising the total number provided under the plan to 5,700,000), only 40,000 shares of which may be issued as nonvested stock, bonus stock or stock-based awards other than stock options or SARs.

During the three months ended September 30, 2010, the Company granted options to employees of the Company under the Employee Plan, with exercise prices equal to the fair market values of the Company’s Common Stock on the respective grant date, to purchase an aggregate of 383,625 shares of the Company’s Common Stock. The total options granted were valued at a weighted average value of $11.25 per share on the grant date under the Black-Scholes option-pricing model, using the fair value assumptions noted in the table below and will be expensed over the three-year vesting period applicable to all of these options.

During the three months ended September 30, 2009, the Company granted options to employees of the Company under the Employee Plan, with exercise prices equal to the fair market value of the Company’s Common Stock on the respective grant date, to purchase 335,240 shares of the Company’s Common Stock. These options were valued at a weighted average value of $11.88 per share on the grant date under the Black-Scholes option-pricing model using the fair value assumptions noted in the following table and will be expensed over a three-year vesting period.

 

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Table of Contents

KENSEY NASH CORPORATION

Notes to Condensed Consolidated Financial Statements—(Continued)

(Unaudited)

 

 

     Three Months Ended September 30,
     2010   2009

Dividend yield

   0%   0%

Expected volatility

   37% - 39%   38% - 41%

Weighted average volatility

   37.61%   39.02%

Risk-free interest rate

   1.514% - 2.255%   2.504% - 3.160%

Expected term (years)

   5.25 - 7.75   5.17 - 7.57

Options are exercisable over a maximum term of 10 years from the date of grant and typically vest over periods of zero to four years from the grant date. Expected volatilities are based on historical volatility of the Company’s Common Stock, and other factors. The Company uses historical data to estimate option exercise and employee termination within the valuation model; separate groups of employees that have similar historical exercise behavior are considered separately for valuation purposes. The expected terms of options are derived from historical exercise behavior and represent the periods of time that options granted are expected to be outstanding.

A summary of the stock option activity under the Employee Plan for the three months ended September 30, 2010 is as follows:

 

     Employee Plan      Directors’ Plan  
     Shares     Weighted
Avg

Exercise
Price
     Aggregate
Intrinsic  Value
     Shares     Weighted
Avg

Exercise
Price
     Aggregate
Intrinsic  Value
 

Balance at June 30, 2010

     1,840,484      $ 24.46       $ 5,966,212         210,500      $ 21.98       $ 736,218   

Granted

     383,625      $ 28.98            —        $ —        

Cancelled

     (17,975   $ 29.47            —        $ —        

Exercised

     (172,493   $ 15.33            (51,500   $ 15.11      
                           

Balance at September 30, 2010

     2,033,641      $ 26.04       $ 7,657,227         159,000      $ 24.21       $ 883,680   
                           

Shares vested + expected to vest

     1,998,676      $ 25.99       $ 7,641,216         159,000      $ 24.21       $ 883,680   
                           

Exercisable portion

     1,262,116      $ 24.37       $ 7,226,039         159,000      $ 24.21       $ 883,680   
                           

Available for future grant

     196,476              —          
                           

Nonvested Stock Awards

Nonvested stock awards have been granted to the non-employee members of the Board of Directors, executive officers, certain other management of the Company and a non-employee outside consultant, pursuant to the Employee Plan, and generally vest in three equal annual installments based solely on continued employment or service, as applicable, with the Company. Nonvested stock awards granted to executive officers, management, non-employee members of the Board of Directors and non-employee consultants usually are referred to as restricted stock, but ASC 718 reserves that term for fully vested and outstanding shares, the sale of which is contractually or governmentally prohibited for a specified period of time. Fair value is based upon the closing price of the Company’s Common Stock on the date of grant. The following table outlines the nonvested stock awards activity for the three months ended September 30, 2010.

 

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Table of Contents

KENSEY NASH CORPORATION

Notes to Condensed Consolidated Financial Statements—(Continued)

(Unaudited)

 

 

     Nonvested Stock Awarded Under
the Employee Plan
 
     Shares      Weighted
Average Price
Per Share
 

Balance at June 30, 2010

     56,434       $ 21.05   

Granted:

     

Non-employee Directors

     —           —     

Issued:

     

Executive officers & management

     —           —     

Non-employee Directors

     —           —     

Forfeited:

     

Non-employee Directors

     —           —     
                 

Balance at September 30, 2010

     56,434       $ 21.05   
                 

Cash-Settled Stock Appreciation Rights (SARs)

Cash-settled stock appreciation rights (SARs) awards were granted to eligible employees during the fiscal year ended June 30, 2007, and provided each participant with the right to receive payment in cash, upon exercise, for the appreciation in market value of a specified number of shares of the Company’s Common Stock over the award’s exercise price. No SARs awards were granted during the three months ended September 30, 2010. The per-share exercise price of a SAR is equal to the closing market price of a share of the Company’s Common Stock on the date of grant.

As of September 30, 2010, the average fair market value of each of the remaining SARs was $3.17 and the related liability for all remaining SARs was $300,584. These SARs will continue to be remeasured at each reporting period until all awards are settled and are classified as liability awards as a component of Other current liabilities on the Condensed Consolidated Balance Sheets, with fluctuations in the fair market value recorded as increases or decreases in compensation cost.

The fair value of each SAR award is remeasured at each reporting period using the Black-Scholes option-pricing model that uses the assumptions noted in the following table.

 

     Three Months  Ended
September 30,
     2010    2009

Dividend yield

   0%    0%

Expected volatility

   35%    35%

Risk-free interest rate

   0.269% - 0.333%    0.702% - .820%

Expected term (years)

   1.04 - 1.13    1.54 - 1.63

SARs are exercisable over a maximum term of five years from the date of grant and originally were to vest over a period of three years from the grant date. All SARs automatically became fully vested and exercisable on August 30, 2007 as a result of the acquisition by Ramius Capital Group, L.L.C. and its affiliates, of more than 20 percent of the Company’s then outstanding Common Stock, which constituted a “Change in Control” as defined under the Employee Plan as it then existed. Expected volatilities are based on historical volatility of the Company’s Common Stock and other factors. The Company uses historical data to estimate SAR employee termination behavior within the valuation model; separate groups of employees that have similar historical exercise behavior are considered separately for valuation purposes. The risk-free rate for periods within the contractual life of the SAR is based on U.S. treasuries with constant maturities in effect at the time of grant.

 

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Table of Contents

KENSEY NASH CORPORATION

Notes to Condensed Consolidated Financial Statements—(Continued)

(Unaudited)

 

 

Note 11 – Commitment and Contingencies

Certain Compensation and Employment Agreements

The Company has entered into employment agreements with certain of its named executive officers. As of September 30, 2010, these employment agreements provided for, among other things, annual base salaries in an aggregate amount of not less than $1,354,565, from that date through fiscal 2012. This amount does not reflect the extensions to January 1, 2012 of the terms of employment agreements for two of these named executive officers, to be effective January 1, 2011, each pursuant to a Mutual Consent to Extend Employment Terms between the Company and such named executive officers, as disclosed by the Company in a Form 8-K filed with the Securities and Exchange Commission on October 21, 2010.

Purchase Commitments

As of September 30, 2010, the Company had outstanding non-cancelable and cancelable purchase commitments in the amount of $1,946,688 related to inventory, capital expenditures and other goods and services.

Research and Development Contractual Obligations

Under the Development and Regulatory Services Agreement with Spectranetics, as amended, the Company’s contributions are limited to a maximum amount of $2,750,000 toward the expenses associated with clinical studies to obtain approval from the FDA for certain next-generation endovascular products, which is reduced by the total cumulative expenses incurred through September 30, 2010 of approximately $30,000.

Note 12 – Income Taxes

The Company accounts for taxes under the provisions of ASC Subtopic 740, “Income Taxes.” The amount of unrecognized tax benefits at September 30, 2010 was $107,139, of which $105,281 would impact the Company’s tax rate, if recognized.

Interest and penalties are included in Interest expense and Other income/expense respectively on the Condensed Consolidated Statements of Income. No material interest and penalty changes were recorded for the three months ended September 30, 2010.

Changes in the Company’s uncertain tax positions for the three months ended September 30, 2010 were as follows:

 

Balance at June 30, 2010

   $ 117,216   

Increases related to prior year tax positions

     —     

Reduction due to lapse in statute of limitations

     (10,077
        

Balance at September 30, 2010

   $ 107,139   
        

The Company and its subsidiaries file U.S. federal and various state income tax returns. The Company is no longer subject to U.S. federal income tax examination for years prior to fiscal 2005 due to the expiration of applicable statutes of limitation. The Company does not expect the total amount of unrecognized tax benefits to change significantly in the next 12 months.

For the period ended September 30, 2010, the Company’s estimated effective tax rate was approximately 34%. In the course of estimating the Company’s annual effective tax rate and recording its quarterly income tax provision, the Company considers many factors, including its expected earnings, state income tax apportionment, estimated manufacturing deduction, non-taxable interest income and other estimates. Material changes in, or differences from, these estimates, including an extension of the research and development tax credit, could have a significant impact on the Company’s effective tax rate.

 

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

The following discussion and analysis should be read in conjunction with our Condensed Consolidated Financial Statements and the related notes included in this report and our audited consolidated financial statements and the related notes contained in our Annual Report on Form 10-K for the fiscal year ended June 30, 2010 (fiscal 2010), as filed with the Securities and Exchange Commission. As used herein, the terms “the Company,” “we,” “us” and “our” refer to Kensey Nash Corporation and its consolidated subsidiaries, collectively.

This discussion and analysis below contains forward-looking statements relating to future events or our future financial performance. These statements are only predictions and actual events or results may differ materially. In evaluating such statements, you should carefully consider the various factors identified in this report which could cause actual results to differ materially from those expressed in, or implied by, any forward-looking statements, including those factors set forth under the heading “CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS” at the end of this Item 2 in this Quarterly Report on Form 10-Q.

OVERVIEW

Kensey Nash Corporation is a medical device company primarily focused in the field of regenerative medicine, which is the application of devices, materials and other therapies to help repair damaged or diseased tissues. We are recognized as a leader for innovative product development, as well as for our broad portfolio of resorbable biomaterials products. We have an extensive range of products, which are sold through strategic partners in multiple large medical markets: cardiovascular, general surgery, dental, wound care, endovascular and orthopaedic devices, including those used in sports medicine, spine, trauma, cranial-maxillofacial and other procedures. We also have an ongoing development and manufacturing program for products in the endovascular market. We sell our products through strategic partners and do not sell direct to the end-user. Our revenues consist of two components: net sales, which include biomaterials sales and endovascular sales, and royalty income.

Net Sales

Biomaterials Sales

During the past 25 years, we have established ourselves as a leader in designing, developing, manufacturing and processing proprietary medical devices, which include resorbable biomaterials products such as synthetic polymers and collagen. We have expanded our base of technology, which has enabled us to develop multiple resorbable product platforms that can be used in a wide variety of applications. We have developed extensive expertise in tissue regeneration and tissue repair, and the ability to commercialize and produce products with these capabilities. We sell our biomaterials products to over 30 companies that sell them into the end-user marketplace. Our largest biomaterials customers include St. Jude Medical, to which we supply Angio-Seal™ Vascular Closure Device (Angio-Seal device) components; Arthrex, Inc., to which we supply a broad range of sports medicine and trauma products; and Orthovita, Inc., to which we supply products for use in repair of the spine and orthopaedic trauma injuries. Our other key customers include Johnson & Johnson, Inc. and its subsidiaries (Johnson & Johnson), Medtronic, Inc. (Medtronic), Stryker, Inc. (Stryker), Synthes, Inc. (Synthes) and Zimmer, Inc. (Zimmer). We continue to seek to expand relationships with companies, targeting new markets, including general, pelvic and urological surgery.

Our customer relationships are generally long-term and contractual in nature, with contracts specifying development and regulatory responsibilities, the specifications of the product to be supplied and pricing. We often work with existing and potential customers at very early stages of feasibility and provide significant input into product development programs. Once a product is approved for sale, we generally provide our customers fully packaged and sterilized products ready for their further distribution or, as in the case with Angio-Seal components, provide a bioresorbable product that is ready to be incorporated into a finished device. Our products often represent a key strategic source for these customers and partners. In many cases, our proprietary technology is incorporated into the product and cannot be replicated by other companies.

Sales of biomaterial orthopaedic products, including products with applications primarily in sports medicine and spine, and cardiovascular products, consisting primarily of Angio-Seal components sold to St. Jude Medical, continue to be our primary source of revenue. The table below shows our orthopaedic product, cardiovascular

 

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product and general surgery product sales for the three months ended September 30, 2010 and September 30, 2009, including as a percentage of our total biomaterials sales:

 

Net Sales of    Three months
ended
9/30/10
     % of
Biomaterials
Sales
    Three months
ended
9/30/09
     % of
Biomaterials
Sales
    % Change Prior
Period to
Current Period
 

Orthopaedic Products

   $ 5,283,591         51   $ 6,421,454         51     (18 %) 

Cardiovascular Products

     4,258,053         41     4,930,668         39     (14 %) 

General Surgery Products

     605,390         6     1,166,392         9     (48 %) 

Other Products

     274,422         2     56,532         1     385
                                          

Total Net Sales - Biomaterials

   $ 10,421,456         100   $ 12,575,046         100     (17 %) 
                                          

Our orthopaedic product sales decreased 18% in the first three months of fiscal 2011 over the comparable prior fiscal year three month period. The ongoing negative economic climate has continued to impact the medical device industry. High unemployment and a challenging health insurance environment appear to have reduced procedures in our markets. The current quarter was soft and our outlook for the second quarter is for continued weakness in our sales, primarily in sales of spine and sports medicine products, which are often used in elective procedures.

In addition to the macroeconomic and health insurance environment factors discussed above, our net sales in the orthopaedic portion of our business are dependent on our partners’ management of their inventory levels, as well as risk factors disclosed in our Annual Report on Form 10-K under “Item 1A Risk Factors”. Due to these dependencies and other factors, sales to our orthopaedic customers can vary significantly from quarter to quarter.

Our cardiovascular sales consist primarily of Angio-Seal components sold to St. Jude Medical. Specifically, we currently supply 100% of their requirements for the collagen plug and at least 30% of their requirements for the polymer anchors under a supply agreement that expires in December 2010. Sales to St. Jude Medical are highly dependent on ordering patterns of components used in the manufacturing of the Angio-Seal device by St. Jude Medical and can vary significantly from quarter to quarter. In June 2010, we entered into a new two-year supply agreement with St. Jude Medical effective for the period from January 1, 2011 to December 31, 2012. Under the new supply agreement, we will be the exclusive outside supplier to St. Jude Medical of collagen plugs, and does not call for us to supply any polymer anchors to St. Jude Medical. The new supply agreement provides for calendar year 2011 minimum order levels equivalent to approximately 25% of our fiscal 2010 collagen plug sales, and calendar year 2012 minimum order levels equivalent to approximately 20% of our fiscal 2010 collagen plug sales. As a result, if St. Jude Medical’s purchase levels are at the minimum levels under this new supply agreement, our related product sales in fiscal 2011 will be substantially lower than in fiscal 2010. Royalties under our license agreement with St. Jude Medical for the Angio-Seal device are not affected by this new supply agreement.

We also have developed and manufactured products used in the general surgery markets. These products primarily include products from our extracellular matrix (ECM) program, as well as a resorbable collagen product for use in breast biopsies. In our fiscal 2010, we announced two strategic agreements involving our Medeor™ Matrix porcine dermis ECM, one with Synthes, and the other with Arthrex. Synthes launched the XCM Biologic™ Tissue Matrix, the first commercial Medeor™ Matrix product, initially focused on ventral hernia repair and breast reconstruction, in the U.S. in May 2010. European launch is expected in our fiscal year ending June 30, 2011 (fiscal 2011). Arthrex is expected to launch our rotator cuff repair product, Medeor™ Matrix, later in fiscal 2011. We are currently evaluating partnering opportunities for the Meso BioMatrix products, as well as other fields of use for the Medeor™ Matrix products. We plan to continue to expand our relationships with our current customers and build relationships with new customers, by targeting new markets, including general, pelvic and urological surgery.

The other key product in our development pipeline, not currently contributing to sales, is our cartilage repair device, which consists of a proprietary bi-phasic, resorbable biomaterials implant designed to repair focal (primary) defects of articular cartilage in joints. The device received CE Mark approval in February 2010. We have engaged in discussions with potential European distributors and we believe that European commercialization will begin in fiscal 2011. We recently received FDA approval to initiate our U.S. pilot trial for the cartilage repair device and expect trial enrollment to begin in fiscal 2011. Commercialization of our cartilage repair device in the U.S. is at least several years away.

 

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While not currently a large part of our business, we also develop, manufacture and sell a variety of biomaterials-based products designed for other market applications. These products include dental barrier membranes and resorbable materials used in ophthalmology and oncology applications.

Royalty Income

We also derive a significant portion of our revenue and profitability from royalty income from proprietary products that we have developed or co-developed.

Angio-SealTM Royalty Income. We are the inventor and original developer of the Angio-Seal device, a vascular closure device that reduces recovery time and enhances patient comfort following both diagnostic and therapeutic cardiovascular catheterizations. St. Jude Medical has the exclusive worldwide rights for the development, manufacturing and sales and marketing of the Angio-Seal device. We receive an approximate 6% royalty on end-user product sales by St. Jude Medical. Royalty income under the Angio-Seal device license agreement is not affected by our new supply agreement with St. Jude Medical. We believe the vascular closure device market is a mature market and anticipate that sales of the Angio-Seal device by St. Jude Medical are expected to be relatively flat or decline slightly in upcoming years.

Vitoss™ Foam, Vitoss™, and Vitoss™ Bioactive Foam Royalty Income. Since 2003, we have partnered with Orthovita to co-develop and commercialize a series of unique and proprietary bone void filler products, branded VitossTM Foam, the first of which was launched in March 2004, and the most recent, VitossTM Bioactive Foam, which was launched during the fourth quarter of fiscal 2008. We receive a royalty on Orthovita’s end-user sales of VitossTM Foam and VitossTM Bioactive Foam products. In addition, in August 2004, we entered into an agreement to acquire the proprietary rights of a third party inventor of the VitossTM technology for $2.6 million (the Assignment Agreement). Under the Assignment Agreement, we receive an additional royalty from Orthovita on the end-user sales of all Orthovita products containing the VitossTM technology, up to a total royalty to be received of $4.0 million, with approximately $144,000 received in the first quarter of fiscal 2011 and $440,000 remaining to be received as of September 30, 2010. We expect to earn the balance of the royalty income under the Assignment Agreement during fiscal 2011. We believe the unique technology associated with the VitossTM Foam and VitossTM Bioactive Foam products, including product extensions, will result in the Orthovita component of our royalty income continuing to grow over the next fiscal year.

We have other royalty generating relationships, none of which materially contributes to revenue at this time, but which we expect to provide increased revenue as the related products gain market acceptance and additional products are commercialized.

Share-Based Compensation

The following table summarizes share-based compensation expense within each operating expense category of our Condensed Consolidated Statements of Income for the three months ended September 30, 2010 and 2009:

 

     Three Months Ended
September 30,
 
     2010      2009  

Cost of products sold

   $ 236,653       $ 149,211   

Research and development

     454,875         316,065   

Selling, general and administrative

     472,648         218,628   
                 

Total share-based compensation expense

   $ 1,164,176       $ 683,904   
                 

Share-based compensation expense consists of (a) stock options granted to employees and executive officers, (b) nonvested stock awards (i.e., restricted stock) granted to non-employee members of our Board of Directors and an executive officer and (c) cash-settled stock appreciation rights (SARs) granted to executive officers and other non-executive employees of our Company. We cannot predict the market value of our Common Stock at the

 

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time of exercise for these grants, nor the magnitude of exercises at any particular time over the terms of these grants. Our cash-settled SARs, which are classified as liability awards, have been, and will continue to be, remeasured at each reporting period until all awards are settled. Fluctuations in the fair value of a liability award are recorded as increases or decreases in compensation cost, either immediately or over the remaining service period, depending on the vesting status of the award.

Total share-based compensation expense for the three months ended September 30, 2010 increased in relation to the corresponding period of the prior year, primarily due to the amortized expense related to three years of equity grants versus two years in the prior year period (as a result of the acceleration of stock awards in fiscal 2008), as well as adjustments in the fair value of our cash-settled SARs, which were remeasured based on, among other factors, our closing stock price on September 30, 2010.

The following table summarizes our share-based compensation expense by each fiscal year grant for the three month periods ended September, 2010 and 2009.

 

     Three Months Ended
September 30,
 
     2010      2009  

SARS

   $ 168,748       $ 100,466   
                 

Stock Options

     

Fiscal Year 2008 Grant

   $ 216,063       $ 144,955   

Fiscal Year 2009 Grant

     301,198         308,082   

Fiscal Year 2010 Grant

     300,486         28,223   

Fiscal Year 2011 Grant

     38,244         —     

Share-Based Compensation Adjustment

     —           (22,814
                 
   $ 855,991       $ 458,446   
                 

Nonvested Stock Awards

     

Fiscal Year 2008 Grant

   $ 40,420       $ 64,367   

Fiscal Year 2009 Grant

     51,041         60,625   

Fiscal Year 2010 Grant

     47,976         —     
                 
   $ 139,437       $ 124,992   
                 

Total share-based compensation expense

   $ 1,164,176       $ 683,904   
                 

In fiscal 2011, we expect an increase of approximately $1.0 million in share-based compensation expense over the $3.4 million recorded in fiscal 2010. This expected increase will be primarily a result of our fiscal 2011 stock option expense reflecting amortized expense related to 36 months of equity grants, whereas fiscal 2010 amortized expense related to 33 months of equity grants as a result of the acceleration of stock awards in fiscal 2008 triggered by a third party’s significant open market purchase of our Common Stock. We also expect additional expense relating to unfavorable mark-to-market adjustments on cash-settled SARs. Our share-based compensation expense is derived using the Black-Scholes option-pricing valuation model, which is dependent on several factors, such as weighted average assumptions, stock volatilities, employee termination behavior and other factors that differ each fiscal year. The expense may vary significantly if there is a change in any one of these valuation assumptions.

See Note 10 to the Condensed Consolidated Financial Statements included in this Form 10-Q for additional information concerning our share-based compensation.

 

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CRITICAL ACCOUNTING POLICIES

Our critical accounting policies are those that require application of management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about matters that are inherently uncertain and may change in future periods. We have identified the following as our critical accounting policies: revenue recognition, accounting for share-based compensation, accounting for investments in debt and equity securities, valuation of financial instruments, inventory valuation and income taxes.

Revenue Recognition. We recognize revenue in accordance with FASB ASC Topic 605, “Revenue Recognition” (ASC 605-10-S99). We also follow FASB ASC Subtopic 605-25, “Multiple Element Arrangements” (ASC 605-25) for customer arrangements containing multiple revenue elements that were entered into, or materially amended, after June 30, 2003.

Sales Revenue. Sales revenue is generally recognized when the related product is shipped or the service is completed. Advance payments received for products or services are generally recorded as deferred revenue and are recognized when the product is shipped or services are performed; the timing of the performance of such services could be subjective. We reduce sales for estimated customer returns and other allowances, if applicable. Our products are primarily manufactured according to our customers’ specifications and are subject to return only for failure to meet those specifications.

Royalty Revenue. Royalty revenue is recognized as the related product is sold by our customers to end-users. We recognize substantially all of our royalty revenue at the end of each month, in accordance with our customer agreements. See Note 1 to the Consolidated Financial Statements included in this Form 10-Q for additional information concerning our royalty revenue recognition.

Accounting for Share-Based Compensation. We use various forms of equity compensation, including stock options and nonvested stock awards as a major part of our compensation programs to retain and provide incentives to our top management team members and other employees. In the past, we have also issued cash-settled SARs to employees. We account for equity compensation in accordance with FASB ASC Topic 718, “Compensation — Stock Compensation.” Revisions to any of our estimates or methodologies could have a material impact on our financial statements.

 

   

Fair value of option grants is estimated on the date of grant using the Black-Scholes option-pricing model, which uses weighted average assumptions. Expected volatilities are based on historical volatility of our Common Stock and other factors. We use historical data to estimate option exercise and employee termination behavior within the valuation model. We separate groups of employees that have similar historical exercise behavior and consider them separately for valuation purposes. The expected terms of options are derived from historical exercise behavior and represent the periods of time that options granted are expected to be outstanding. The risk-free rate for periods within the contractual life of an option is based on U.S. treasuries with constant maturities in effect at the time of grant.

 

   

Nonvested stock awards (i.e. restricted stock) granted to non-employee members of our Board of Directors and executive officers are accounted for using the fair value method. Fair value for nonvested stock awards is based upon the closing price of our Common Stock on the date of the grant.

 

   

Cash-settled SARs awarded in share-based payment transactions are classified as liability awards; accordingly, we record these awards as a component of Other current liabilities on our Consolidated Balance Sheets. The fair value of each SAR is estimated using the Black-Scholes option-pricing model, which uses weighted average assumptions. Expected volatilities are based on the historical volatility of our Common Stock, as well as other factors. For liability awards, the fair value of the award, which determines the measurement of the liability on our Consolidated Balance Sheet, is remeasured at each reporting period until the award is settled. Fluctuations in the fair value of the liability award are recorded as increases or decreases in compensation cost, either immediately or over the remaining service period, depending on the vested status of the award. We use historical data to estimate employee termination within the valuation model; employees that have similar historical exercise behavior are considered separately for valuation purposes. The expected term of cash-settled SARs has been determined using the simplified method in accordance with ASC 718-10-S99.

 

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Accounting for Investments in Debt Securities. We account for our investment portfolio in accordance with FASB ASC Topic 320, “Investments — Debt and Equity Securities.” We have classified our entire investment portfolio as available-for-sale securities with secondary or resale markets and report the portfolio at fair value, with unrealized gains and losses included in Stockholders’ equity and realized gains and losses in Other income. We currently have various investment securities with fair values that are less than their amortized costs and, therefore, contain unrealized losses. The unrealized losses related to these investments were due to either changes in interest rates or investments obtained at a premium. We have evaluated these securities and have determined that the decline in value is not related to any Company or industry specific event. We have no intent to sell any of these investments until there is a recovery of the fair value, and there is no current requirement that we sell any of these investments. We anticipate full recovery of amortized costs with respect to these securities at maturity or sooner in the event of a more favorable market interest rate environment. Revisions to our classification of these investments, and/or a determination other than the anticipation of a full recovery of the amortized costs at maturity or sooner, could result in our realizing gains and losses on these investments and, therefore, have a material impact on our financial statements.

Valuation of Financial Instruments. We adopted the provisions of FASB ASC Topic 820, “Fair Value Measurements and Disclosures,” (ASC 820) for financial assets and liabilities, which provides guidance for using fair value to measure financial assets and liabilities by defining fair value as the exit price, or the amount that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants as of the measurement date. Categorization is based on a three-tier valuation hierarchy, which prioritizes the inputs used in measuring fair value. Our assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of financial assets and financial liabilities and their placement within the fair value hierarchy. See Note 8 to the Consolidated Financial Statements included in this Form 10-Q for further discussion regarding the fair value of financial assets and liabilities.

Inventory Valuation. Our inventory is stated at the lower of cost or market. Adjustments to inventory are made at the individual part level for estimated excess, obsolescence or impaired balances, to reflect inventory at the lower of cost or market. Factors influencing these adjustments include changes in demand, technological changes, product life cycle and development plans, component cost trends, product pricing, physical deterioration and quality concerns. Revisions to these adjustments would be required if any of these factors differ from our estimates.

Income Taxes. In the course of estimating our estimated annual effective tax rate and recording our quarterly income tax provisions, we consider many factors, including our expected earnings, state income tax apportionment, estimated manufacturing deduction, non-taxable interest income and other estimates. Material changes in, or differences from, these estimates, including an extension of the research and development tax credit, could have a significant impact on our effective tax rate.

RESULTS OF OPERATIONS

Comparison of Three Months Ended September 30, 2010 and 2009

Total Revenues. Total revenues of $17.0 million for the three months ended September 30, 2010 decreased 14% from total revenues of $19.7 million for the three months ended September 30, 2009.

Total Net Sales. Net sales of products decreased 19% to $10.9 million in the three months ended September 30, 2010, compared to net sales of $13.4 million in the three months ended September 30, 2009. We had a $2.2 million, or a 17%, decrease in our biomaterials sales, and a $400,000, or a 47%, decrease in our endovascular sales.

Biomaterials Sales. Biomaterials sales were $10.4 million in the three months ended September 30, 2010, a 17% decrease compared to $12.6 million in the same period of the prior fiscal year. Biomaterials sales include revenue recognized from products shipped, as well as revenue generated from product development programs with, and milestone revenue earned from, biomaterials customers. Biomaterials sales for the three months ended September 30, 2010 were primarily composed of sales of orthopaedic products, consisting primarily of sports medicine and spine products, of $5.3 million, a decrease of $1.1 million, or 18%, from $6.4 million for the three months ended September 30, 2009. Sales of sports medicine product sales decreased $929,000, or 26%, to $2.7 million in the three months ended September 30, 2010 from $3.6 million in the same period of the prior fiscal year due primarily to variations in customer ordering patterns

 

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in the quarter as well as the ongoing negative economic climate causing reduced procedures in these markets. Sales of spine products decreased $212,000, or 8%, to $2.5 million in the three months ended September 30, 2010 from $2.7 million in the same period of the prior fiscal year, reflecting a continued overall weakness in the spine market.

Additionally, cardiovascular product sales, consisting principally of sales of vascular closure product components to St. Jude Medical, decreased approximately $673,000, or 14%, to $4.3 million in the three months ended September 30, 2010 from $4.9 million in the same period of the prior fiscal year. The decrease in sales of Angio-Seal components to St. Jude Medical was primarily attributable to variations in ordering patterns of components used in the manufacture of the Angio-Seal device by St. Jude Medical. The fluctuation in Angio-Seal component sales in any given period is not always indicative of the change in end-user sales of the Angio-Seal device by St. Jude Medical in the same period, due to variations in ordering patterns of the components used in the manufacturing of the Angio-Seal device by St. Jude Medical, inventory stocking and supplements to St. Jude Medical’s production, as well as the impact of foreign currency exchange on end-user sales.

General surgery product sales were approximately $605,000 for the three months ended September 30, 2010, a decrease of approximately $561,000, or 48%, from $1.2 million in the same period of the prior fiscal year. First quarter fiscal 2011 general surgery sales consisted primarily of initial shipments to Synthes related to the US launch of our new ECM product, XCM BiologicTM Tissue Matrix, however, these product sales were more than offset by unfavorable variations in ordering patterns from another customer.

Endovascular Sales. Endovascular sales were $458,000 in the three months ended September 30, 2010, a 47% decrease compared to sales of $858,000 in the same period of the prior fiscal year. Endovascular sales include revenue recognized from products shipped, as well as milestone revenue recognized from product development programs with Spectranetics. The endovascular sales decrease was primarily due to a decrease in Safe-Cross and QuickCat product sales. In the quarters ended September 30, 2010 and 2009, we recognized revenue of $144,000 for two milestones achieved in the fiscal year ended June 30, 2009 under our Development and Regulatory Service Agreement with Spectranetics.

Royalty Income. Royalty income of $6.1 million in the three months ended September 30, 2010 decreased 4% from $6.3 million in the three months ended September 30, 2009.

Royalty income of $4.6 million from St. Jude Medical’s Angio-Seal net end-user sales in the quarter ended September 30, 2010 decreased 5% from $4.9 million in the same period of the prior fiscal year. Royalty income of $1.4 million from Orthovita’s net end-user sales of Vitoss™, Vitoss™ Foam and Vitoss™ Bioactive Foam products was relatively flat in the quarter ended September 30, 2010, compared to the same period of the prior fiscal year.

Cost of Products Sold.

 

     Three
Months
Ended
9/30/10
    Three
Months
Ended
9/30/09
    % Change
Prior Period to
Current
Period
 

Cost of products sold

   $ 4,220,125      $ 5,538,400        (24 %) 

Gross Margin on Net Sales

     61     59  

Cost of products sold was $4.2 million in the three months ended September 30, 2010, a $1.3 million, or 24%, decrease from $5.5 million in the three months ended September 30, 2009. Gross margin on net sales was 61% for the three months ended September 30, 2010 and 59% for the same period of the prior fiscal year. Contributing to the reduction of cost of products sold was the $2.6 million decrease in net sales, excluding net milestone revenue recognized of $245,000 in the three months ended September 30, 2010 and $185,000 in the three months ended September 30, 2009. The increase in gross margin over the comparable quarter was primarily due to favorable changes in product mix to more higher margin products compared to the prior year period. In particular, a lower percentage of sales consisted of our sports medicine products, which typically are lower margin products.

 

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Research and Development Expense.

 

     Three
Months
Ended
9/30/10
    Three
Months
Ended
9/30/09
    % Change
Prior Period to
Current Period
 

Research & Development

   $ 4,277,383      $ 4,275,571        0

Research & Development as a % of Revenue

     25     22  

Research and development expense was $4.3 million in the three months ended September 30, 2010 consistent with research and development expense in the three months ended September 30, 2009. Research and development expense in the three months ended September 30, 2010 compared to the prior year period reflects an increase in clinical trial expense related to the start-up of our U.S. pilot cartilage clinical study of approximately $159,000, largely offset by a decrease of $138,000 in personnel expenses primarily due to reduced headcount in the current quarter compared to the prior year comparable quarter. Research and development expense was 25% of our total revenue for the three month periods ended September 30, 2010 and 22% of revenue in the three months ended September 30, 2009.

Selling, General and Administrative Expense.

 

     Three
Months
Ended
9/30/10
    Three
Months
Ended
9/30/09
    % Change
Prior Period to
Current Period
 

Selling, General and Administrative

   $ 2,297,875      $ 2,179,931        5

Selling, General and Administrative as a % of Revenue

     14     11  

Selling, general and administrative expense was $2.3 million in the three months ended September 30, 2010, a $118,000, or 5%, increase from $2.2 million in the three months ended September 30, 2009. The increase in selling, general and administrative expense over the prior comparable period was primarily due to an increase is share-based compensation expense of approximately $268,000, partially offset by a decrease in professional services fees of approximately $106,000.

Interest Income. Interest income decreased by 11% to $155,000 in the three months ended September 30, 2010 from $174,000 in the same period of the prior fiscal year. This decrease was due to a decrease in our average cash and investment balances over the same period of the prior fiscal year due to our stock repurchases of $25.9 million, principally under our stock repurchase programs. See “Stock Repurchase Programs” below.

Interest Expense. Interest expense in the three months ended September 30, 2010 was $514,000, a decrease of 4% from $537,000 in the same period of the prior fiscal year. We have borrowed $35.0 million under our Secured Commercial Mortgage (the Mortgage) with Citibank, F.S.B. The Mortgage is hedged by a fixed interest rate swap agreement (the Swap) bearing interest of 6.44%. The Mortgage balance was $31.0 million as of September 30, 2010. See Note 7 to the Condensed Consolidated Financial Statements included in this Form 10-Q for additional information concerning the Mortgage and the Swap.

Income Tax Expense. Our income tax expense for the three months ended September 30, 2010 was approximately $2.0 million, resulting in an effective tax rate of approximately 34%. Our income tax expense for the three months ended September 30, 2009 was approximately $2.5 million, also resulting in an effective tax rate of approximately 34%. See Note 12 to the Condensed Consolidated Financial Statements included in this Form 10-Q for additional information concerning our effective tax rate.

 

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LIQUIDITY AND CAPITAL RESOURCES

Our cash, cash equivalents and investments were $49.5 million as of September 30, 2010, a decrease of $16.1 million from our balance of $65.7 million at June 30, 2010, the end of our prior fiscal year. Our working capital was $63.2 million as of September 30, 2010, a decrease of $17.1 million from our working capital of $80.3 million at June 30, 2010. The decrease in cash and working capital was primarily due to our stock repurchases of $25.9 million, principally under our stock repurchase programs. See “Stock Repurchase Programs” below.

Operating Activities

Net cash provided by our operating activities was $7.2 million in the three months ended September 30, 2010. For the three months ended September 30, 2010, we had net income of $3.8 million, non-cash depreciation and amortization of $1.8 million, a net effect of non-cash employee share-based compensation and related tax events of $1.2 million and a change in deferred income taxes of $321,000, which was primarily the result of the change in our non-current deferred tax assets.

Cash used in operations as a result of changes in asset and liability balances was $281,000. This use of cash was primarily a result of an increase in our inventory balance of $1.5 million, a decrease in accounts payable and accrued expenses of $814,000, primarily due a decrease in our federal income tax liability as a result of estimated federal tax payments made during the period, a decrease in our deferred revenue balance of $163,000, and an increase in our prepaid expenses balance of $86,000. Offsetting these uses of cash was cash provided by a decrease in our receivable balances of $2.3 million, primarily due to the decrease in sales.

Investing Activities

Cash provided by investing activities was $13.7 million for the three months ended September 30, 2010. This increase in cash was primarily the result of $14.3 million of maturities within our investment portfolio offset by cash used for capital expenditures of $639,000 to continue to expand our research and development and manufacturing capabilities and improve our information technology systems.

Financing Activities

Cash used in financing activities was $22.5 million for the three months ended September 30, 2010. This amount was primarily the result of $25.9 million in Common Stock repurchases and $350,000 in repayments of long-term debt, offset by $3.7 million in cash proceeds from the net effect of the exercise of stock options.

Stock Repurchase Programs

From time to time, we have made repurchases of our Common Stock, executed under various stock repurchase programs established by our Board of Directors, as well as equity incentive plan transactions.

On December 10, 2009, we announced that our Board of Directors approved a stock repurchase program which allowed us to repurchase up to a total of 400,000 of our issued and outstanding shares of Common Stock. On February 9, 2010, we announced that our Board of Directors approved a new stock repurchase program allowing us to repurchase up to an additional total of $30 million of our issued and outstanding shares of Common Stock. On June 16, 2010, we announced that our Board of Directors approved another new stock repurchase program allowing us to repurchase up to an additional $30 million of our issued and outstanding shares of Common Stock.

During the three months ended September 30, 2010, we repurchased and retired a total of 1,035,769 shares of Common Stock that were settled at a total cost of $25.8 million, or an average price per share of $24.96, using available cash. Commissions and other related costs associated with these stock repurchases totaled $31,073. An additional 53,333 shares were repurchased in September 2010, but settled in October 2010 at a cost of $1,577,336, or an average price per share of $29.58. We financed these repurchases using available cash, liquid investments and cash from operations. See Note 10 to the Condensed Consolidated Financial Statements included in this Form 10-Q for additional information on our stock repurchase programs. See Part II. Item 2 (Unregistered Sales of Equity Securities and Use of Proceeds) in this Form 10-Q.

 

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General

We plan to continue to increase our research and development spending for our biomaterials products as we expand our clinical activities relating to our ECM and cartilage technologies both in the U.S. and Europe.

We believe our current cash and investment balances and expected future cash generated from operations will be sufficient to meet our operating, financing, and capital requirements for the next 12 months. Although we believe our cash and investment balances will also be sufficient on a longer term basis, that will depend on numerous factors, including the following: continuation of our existing customer relationships and royalty streams; market acceptance of our existing and future products; the successful commercialization of products in development; the costs associated with that commercialization; progress in our product development efforts; the magnitude and scope of such efforts; progress with pre-clinical studies, future clinical trials and product clearance by the FDA and other agencies; the cost and timing of our efforts to expand our manufacturing, sales, and marketing capabilities; the cost of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights; competing technological and market developments; and the development of strategic alliances for the marketing of certain of our products.

The terms of any future equity financing we undertake may be dilutive to our stockholders and the terms of any debt financing may contain restrictive covenants that limit our ability to pursue desired courses of action. Our ability to obtain financing is dependent on the status of our future business prospects, as well as conditions prevailing in the relevant capital markets. No assurance can be given that any additional financing will be available to us, or will be available to us on acceptable terms, should such a need arise.

Contractual Obligations and Other Contingent Commitments

Presented below is a summary of our approximate aggregate contractual obligations and other contingent commitments at September 30, 2010, for future payments under contracts and other contingent commitments, for fiscal 2011 and beyond:

 

     Payments Due by Period  
Contractual Obligations    Total      Less than
1 year
     1-3 years      3-5 years      More than
5 years
 

Long-Term Debt Obligations (1):

              

Secured Commercial Mortgage

   $ 31,033,330       $ 1,399,997       $ 2,800,000       $ 2,800,000       $ 24,033,333   

Interest on mortgage

     22,548,201         1,978,615         3,694,515         3,328,991         13,546,080   

Purchase Obligations (2):

     1,946,688         1,946,688         —           —           —     

Other Obligations:

              

Research and Development

              

Contractual Obligations (3)

     2,720,157         —           —           —           —     

Employment Agreements (4)

     1,354,565         868,508         486,057         —           —     

FIN 48 Tax Obligations (5)

     —           —           —           —           —     

Other Long-Term Liabilities

              

Deferred Revenue Non-Current (6)

     3,113,011         —           1,213,235         636,312         1,263,464   

Other Non-Current Liabilities (7)

     6,210,118         —           —           —           —     
                                            

Total Contractual Obligations

   $ 68,926,070       $ 6,193,808       $ 8,193,807       $ 6,765,303       $ 38,842,877   
                                            

These obligations are related to the Mortgage and other agreements that are legally binding and enforceable against us.

 

(1) The long-term debt obligations consist of principal and interest on the Mortgage outstanding principal balance of $31.0 million as of September 30, 2010. In accordance with accounting principles generally accepted in the United States of America (U.S. GAAP), the future interest obligations are not recorded on our Condensed Consolidated Balance Sheet. See Note 7 to the Condensed Consolidated Financial Statements included in this Form 10-Q.
(2) These obligations consist of cancelable and non-cancelable purchase commitments related to inventory, capital expenditures and other goods or services. In accordance with U.S. GAAP, these obligations are not recorded on our Condensed Consolidated Balance Sheets. See Note 11 to the Condensed Consolidated Financial Statements included in this Form 10-Q.
(3)

Under the Development and Regulatory Services Agreement with Spectranetics, as amended, our contributions are capped at a maximum amount of $2,750,000 toward the expenses associated with clinical studies to obtain approval from the FDA for certain next-generation endovascular products, which is reduced by the total cumulative expenses incurred through September 30, 2010 of approximately $30,000. We are unable to reliably estimate the amount and timing of these contributions because they are dependent on the type and complexity of the clinical studies and intended uses of the products,

 

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which have not been established. In accordance with U.S. GAAP, these obligations are not recorded on our Condensed Consolidated Balance Sheets.

(4) We have entered into employment agreements with certain of our named executive officers. As of September 30, 2010, these employment agreements provided for, among other things, annual base salaries in an aggregate amount of not less than $1,354,565, from that date through fiscal 2012. In accordance with U.S. GAAP, these obligations are not recorded on our Condensed Consolidated Balance Sheets. This amount does not reflect the extensions of the terms to January 1, 2012 of employment agreements for two of these named executive officers, to be effective January 1, 2011, each pursuant to a Mutual Consent to Extend Employment Terms between the Company and such named executive officers, as disclosed by the Company in a Form 8-K filed with the Securities and Exchange Commission on October 21, 2010. See Note 11 to the Condensed Consolidated Financial Statements included in this Form 10-Q.
(5) Liabilities for uncertain tax positions in the aggregate amount of $109,036 have been omitted from the table above due to an inability to reliably estimate the period of cash settlement of these liabilities. See Note 12 to the Condensed Consolidated Financial Statements included in this Form 10-Q.
(6) Non-current deferred revenue includes milestone payments received by us pursuant to customer agreements, as well as advance payments from customers for future services. Several of these deferred milestone revenues are non-refundable and may not require future performance from our Company. These liabilities are recorded in accordance with U.S. GAAP, and are recorded on our Condensed Consolidated Balance Sheets.
(7) This value represents the estimated amount we would pay to terminate the Swap if we were to prepay the Mortgage. We currently do not intend to prepay the Mortgage and, therefore, are unable to reliably estimate the period of cash settlement of the Swap, if any. In accordance with U.S. GAAP, this liability is recorded on our Condensed Consolidated Balance Sheets. See Note 7 to the Condensed Consolidated Financial Statements included in this Form 10-Q.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This report includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934 and Section 27A of the Securities Act of 1933. We have based these forward-looking statements largely on our current expectations and projections about future events and trends affecting our business. In this report, the words “believe,” “may,” “will,” “should,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “project,” “plan” and similar expressions, as they relate to us, our business or our management, are intended to identify forward-looking statements, but they are not the exclusive means of identifying them.

A number of risks, uncertainties and other factors could cause our actual results, performance, financial condition, cash flows, prospects and opportunities to differ materially from those expressed in, or implied by, the forward-looking statements. These risks, uncertainties and other factors, most of which have been described in greater detail in Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended June 30, 2010, include but are not limited to the following:

 

   

our reliance on revenues, including both royalty income and product sales, from the Angio-Seal product line;

 

   

our reliance on three customers (St. Jude Medical, Arthrex, Inc. and Orthovita, Inc.) for a majority of our revenues;

 

   

the performance of St. Jude Medical as the manufacturer, marketer and distributor of the Angio-Seal product;

 

   

the risk that St. Jude Medical changes the source of its collagen supply from us to its internal manufacturing and the uncertainty of the future performance of the Angio-Seal device in the marketplace;

 

   

the performance of Spectranetics as the marketer and distributor and, in the future, the manufacturer of the ThromCat products;

 

   

future success of our research and development efforts with respect to the endovascular products, including the risk that those efforts will not be successful and that some of the associated milestone payments will not be received from Spectranetics;

 

   

our dependence on the continued growth and success of our biomaterials products and customers;

 

   

future success of our research and development efforts with respect to biomaterials products, including our cartilage repair and extracellular matrix technologies, Synthes’ success in selling our extracellular matrix products, and future market acceptance of our biomaterials products;

 

   

the competitive markets for our products and our ability to respond more quickly than our competitors to new or emerging technologies and changes in customer requirements;

 

   

the acceptance of our products by the medical community or new technology introduced replacing our products;

 

   

the loss of, or interruption of supply from, key vendors;

 

   

the successful initiation and completion of clinical trials in both the U.S. and Europe to support regulatory approval of future generations of our products;

 

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our ability to scale up the manufacturing of our products to accommodate sales volumes;

 

   

our dependence on our customers for planning their inventories, marketing and obtaining regulatory approval for their products;

 

   

our dependence on key vendors and personnel;

 

   

our use of hazardous materials, which could expose us to future environmental liabilities;

 

   

international market risks that could harm future international sales of our products and our customers;

 

   

the unpredictability of our future operating results and trading price of our stock from quarter to quarter;

 

   

risks related to product recalls of, and other manufacturing issues relating to, our partners’ biomaterials or endovascular products;

 

   

risks related to our intellectual property, including patent and proprietary rights and trademarks;

 

   

risks related to our industry, including potential for litigation, product liability claims, ability to obtain reimbursement for our products, changes in applicable laws or regulations (including in particular, healthcare and tax laws and regulations), and our products’ exposure to extensive government regulation;

 

   

risks related to reform of the U.S. healthcare system;

 

   

adherence and compliance with corporate governance laws, regulations and other obligations affecting our business; and

 

   

general economic and business conditions, nationally, internationally and within our markets.

Except as expressly required by the federal securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. Our results of operations in any past period should not be considered indicative of the results to be expected for future periods. Fluctuations in operating results may also result in fluctuations in the price of our Common Stock.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

Our interest income and expense are sensitive to changes in the general level of interest rates. In this regard, changes in interest rates affect the interest earned on our cash, cash equivalents and investments, as well as the fair value of the Swap.

Investment Portfolio

Our investment portfolio consists of high quality municipal securities and U.S. Government securities. The majority of these investments have maturities ranging from less than one year to approximately three years. We mitigate default risk by investing in what we believe are safe and high credit quality securities and by monitoring the credit rating of investment issuers. Our portfolio includes only securities with secondary or resale markets. We have an audit committee-approved investment strategy, which currently limits the duration and types of our investments. These available-for-sale securities are subject to interest rate risk and decreases in market value if interest rates increase. As of September 30, 2010, our total investment portfolio consisted of approximately $28.1 million of investments. While our investments generally may be sold at any time because the portfolio includes available-for-sale securities with secondary or resale markets, we generally hold securities until the earlier of their call date or their maturity. We do not expect our results of operations or cash flows to be materially impacted due to a sudden change in interest rates. We review our investments to identify and evaluate investments that have an indication of possible impairment. We have no intent to sell any of these investments until a recovery of their respective fair values, which may be at maturity, and we have no current requirement to sell any of these investments. Additional information regarding our investments is located in Note 2 to the Condensed Consolidated Financial Statements included herein in this Form 10-Q.

Debt

On May 25, 2006, we entered into a $35.0 million aggregate ten-year fixed interest rate Swap, with Citibank, N.A., to manage the market risk from changes in interest rates under the Mortgage. On May 25, 2006 and November 23, 2007, the Company took $8 million and $27 million advances, respectively, under the Mortgage (see Note 7 to the Condensed Consolidated Financial Statements included in this Form 10-Q). Our objective and strategy for undertaking the Swap was to hedge our exposure to variability in cash flows and interest expense associated with the future interest rate payments under the Mortgage and to reduce our interest rate risk in the event of an unfavorable interest rate environment. We currently utilize the Hypothetical Derivative Method in determining the hedge effectiveness of the hedged item each period. We do not expect our results of operations or cash flows to be materially impacted due to a sudden change in interest rates. If the conditions underlying the Swap or the hedge item change, there is a risk that our hedged item would be deemed an ineffective hedge, and therefore, we would

 

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record changes in the fair value of the Swap within our Condensed Consolidated Statements of Income, as well as our Condensed Consolidated Statements of Cash Flows. Additional information regarding the Swap is located in Note 7 – under the heading “Interest Rate Swap Agreement” to the Condensed Consolidated Financial Statements included in this Form 10-Q.

Foreign Currency Exchange Rate Risk

The Company’s business is not directly dependent on foreign operations as the Company’s sales to customers outside the U.S. are not significant. However, a portion of the Company’s total revenues, including sales and royalties, are dependent on U.S. based customers selling to end-users outside the U.S. There is a risk related to the changes in foreign currency exchange rates as it relates to royalties paid to us in U.S. dollars for which royalties are received on end-user sales within foreign countries. We are currently not taking any affirmative steps to hedge the risk of fluctuations in foreign currency exchange rates. We do not expect our financial position, results of operations or cash flows to be materially impacted due to a sudden change in foreign currency exchange rates fluctuations relative to the U.S. Dollar.

 

Item 4. Controls and Procedures

Disclosure Controls and Procedures

We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act)) as of the end of the period covered by this report. Our disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported accurately and within the time frames specified in the SEC’s rules and forms and that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of September 30, 2010 at the reasonable assurance level.

Changes In Internal Control Over Financial Reporting

There were not any changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended September 30, 2010 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations on the Effectiveness of Controls

Our management does not expect that our disclosure controls and procedures or our internal controls will prevent or detect all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in a cost-effective control system, no controls can provide absolute assurance that misstatements due to error or fraud will not occur, and no evaluation of any such controls can provide absolute assurance that control issues and instances of fraud, if any, within our company have been detected.

These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of controls effectiveness to future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies and procedures.

 

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Part II – OTHER INFORMATION

 

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

The following table contains information about our purchases of our equity securities during July, August and September 2010:

 

Period

   Total number of
shares purchased*
     Average price
paid per share (1)
     Maximum number
(or approximate dollar value)
of shares that may yet be
repurchased under
the plans or programs (2)
 

July 1-31, 2010

     393,800       $ 23.26       $ 20,839,809   

August 1-31, 2010

     319,888         23.65       $ 13,273,084   

September 1-30, 2010

     322,081         28.32       $ 4,151,688   
                    

Total

     1,035,769       $ 24.96      
                    

 

* All shares purchased under a publicly announced plan on the purchase date (i.e., settlement date).
(1) Average price paid per share is calculated on the purchase date and excludes commissions paid to brokers.
(2) Represents the remaining approximate dollar amount of our issued and outstanding Common Stock that may yet be repurchased under the $30,000,000 repurchase program, which was announced on June 16, 2010, and has no scheduled expiration date. This table includes the repurchase of 34,400 shares, at a cost of approximately $811,000, of our Common Stock for which the trade date was on or prior to June 30, 2010, but for which the settlement date was after June 30, 2010. This table excludes the repurchase of 53,333 shares, at a cost of approximately $1.6 million, of our Common Stock for which the trade date was on or prior to September 30, 2010, but for which the settlement date was after September 30, 2010.

 

Item 6. Exhibits.

 

Exhibit

  

Description

31.1    Certification of the Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a).
31.2    Certification of the Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a).
32.1    Certification of the Chief Executive Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002.
32.2    Certification of the Chief Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002.

 

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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.

 

  KENSEY NASH CORPORATION
Date: November 9, 2010   By:  

/s/    MICHAEL CELANO        

    Michael Celano
    Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

34

EX-31.1 2 dex311.htm SECTION 302 CEO CERTIFICATION Section 302 CEO Certification

 

Exhibit 31.1

CERTIFICATION

I, Joseph W. Kaufmann, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Kensey Nash Corporation;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s Board of Directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: November 9, 2010   

/s/ Joseph W. Kaufmann

  
   Joseph W. Kaufmann   
   Chief Executive Officer   
EX-31.2 3 dex312.htm SECTION 302 CFO CERTIFICATION Section 302 CFO Certification

 

Exhibit 31.2

CERTIFICATION

I, Michael Celano, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Kensey Nash Corporation;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s Board of Directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: November 9, 2010   

/s/ Michael Celano

  
   Michael Celano   
   Chief Financial Officer   
EX-32.1 4 dex321.htm SECTION 906 CEO CERTIFICATION Section 906 CEO Certification

 

Exhibit 32.1

CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Kensey Nash Corporation (the “Company”) on Form 10-Q for the quarter ended September 30, 2010, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Joseph W. Kaufmann, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. 1350, as adopted pursuant to 906 of the Sarbanes-Oxley Act of 2002, that:

1. The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: November 9, 2010

  

/s/ Joseph W. Kaufmann

  
   Joseph W. Kaufmann   
   Chief Executive Officer   
EX-32.2 5 dex322.htm SECTION 906 CFO CERTIFICATION Section 906 CFO Certification

 

Exhibit 32.2

CERTIFICATION OF THE PRINCIPAL FINANCIAL AND ACCOUNTING OFFICER PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Kensey Nash Corporation (the “Company”) on Form 10-Q for the quarter ended September 30, 2010, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Michael Celano, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. 1350, as adopted pursuant to 906 of the Sarbanes-Oxley Act of 2002, that:

1. The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: November 9, 2010

  

/s/ Michael Celano

  
   Michael Celano   
   Chief Financial Officer   
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