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SECURITIES AND EXCHANGE COMMISSION

Washington, DC

 


 

Form 10-Q

 


 

(Mark One)

x Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the quarterly period ended March 31, 2004

 

or

 

¨ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the transition period from              to             

 

Commission File Number: 0-28748

 


 

CLOSURE MEDICAL CORPORATION

(Exact name of registrant as specified in its charter)

 


 

Delaware   56-1959623

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

5250 Greens Dairy Road, Raleigh, North Carolina   27616
(Address of principal executive offices)   (Zip Code)

 

(919) 876-7800

(Registrant’s telephone number, including area code)

 


 

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 is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).    Yes  x    No  ¨

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

 

Class


 

Outstanding at May 6, 2004


Common Stock, par value $0.01 per share   14,260,936

 



Table of Contents

CLOSURE MEDICAL CORPORATION

 

INDEX

 

     Page Number

PART I: FINANCIAL INFORMATION     
    Item 1. Condensed Financial Statements     
        Balance Sheets as of March 31, 2004 (unaudited) and December 31, 2003    3
        Statements of Operations (unaudited) for the three months ended March 31, 2004 and 2003    4
        Statements of Cash Flows (unaudited) for the three months ended March 31, 2004 and 2003    5
        Notes to Condensed Financial Statements (unaudited)    6
    Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations    9
    Item 3. Quantitative and Qualitative Disclosure about Market Risk    14
    Item 4. Controls and Procedures    14
PART II: OTHER INFORMATION     
    Item 6. Exhibits and Reports on Form 8-K    15

 

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PART I- FINANCIAL INFORMATION

 

ITEM 1. CONDENSED FINANCIAL STATEMENTS

 

CLOSURE MEDICAL CORPORATION

BALANCE SHEETS

(In thousands, except per share data)

 

    

MARCH 31,
2004

(unaudited)


    DECEMBER 31,
2003


 

Assets

                

Cash and cash equivalents

   $ 3,083     $ 1,403  

Short-term investments

     27,343       23,614  

Accounts receivable

     5,981       2,976  

Inventories

     2,044       1,795  

Prepaid expenses

     647       698  

Deferred income taxes

     5,417       5,470  
    


 


Total current assets

     44,515       35,956  

Furniture, fixtures and equipment, net

     6,245       5,980  

Intangible assets, net

     3,076       3,049  

Long-term investments

     4,778       8,410  

Deferred income taxes

     —         373  
    


 


Total assets

   $ 58,614     $ 53,768  
    


 


Liabilities and Stockholders’ Equity

                

Accounts payable

   $ 2,445     $ 1,889  

Accrued expenses

     1,445       2,546  

Deferred revenue

     235       547  
    


 


Total current liabilities

     4,125       4,982  

Other accrued liabilities

     114       171  

Deferred revenue

     1,128       1,187  

Deferred income taxes

     493       —    
    


 


Total liabilities

     5,860       6,340  
    


 


Commitments and contingencies

     —         —    

Preferred Stock, $.01 par value. Authorized 2,000 shares; none issued or outstanding

     —         —    

Common Stock, $.01 par value. Authorized 35,000 shares; 14,247 and 14,127 shares issued and outstanding, respectively

     143       141  

Additional paid-in capital

     63,564       60,762  

Accumulated deficit

     (10,945 )     (13,475 )

Other comprehensive income (loss)

     (8 )     —    
    


 


Total stockholders’ equity

     52,754       47,428  
    


 


Total liabilities and stockholders’ equity

   $ 58,614     $ 53,768  
    


 


 

The accompanying notes are an integral part of these condensed financial statements.

 

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CLOSURE MEDICAL CORPORATION

STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except per share data)

 

     THREE MONTHS ENDED
MARCH 31,


     2004

   2003

Product sales

   $ 10,204    $ 7,899

License and product development revenues

     264      262
    

  

Total revenues

     10,468      8,161

Cost of products sold

     2,667      1,893
    

  

Gross profit

     7,801      6,268
    

  

Research, development and regulatory affairs expenses

     2,308      1,830

General and administrative expenses

     1,662      1,527
    

  

Total operating expenses

     3,970      3,357
    

  

Income from operations

     3,831      2,911

Interest income, net

     109      78
    

  

Income before income taxes

     3,940      2,989

Provision for income taxes

     1,410      1,070
    

  

Net income

   $ 2,530    $ 1,919
    

  

Shares used in computation of net income per common share:

             

Basic

     14,217      13,604
    

  

Diluted

     16,042      13,751
    

  

Net income per common share:

             

Basic

   $ 0.18    $ 0.14
    

  

Diluted

   $ 0.16    $ 0.14
    

  

 

The accompanying notes are an integral part of these condensed financial statements.

 

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CLOSURE MEDICAL CORPORATION

STATEMENTS OF CASH FLOWS

(Unaudited)

(In thousands)

 

     THREE MONTHS ENDED
MARCH 31,


 
     2004

    2003

 

Cash flows from operating activities:

                

Net income

   $ 2,530     $ 1,919  

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

                

Depreciation and amortization expense

     323       292  

Loss on disposals of intangible assets

     40       100  

Change in accounts receivable

     (3,005 )     (658 )

Change in inventories

     (249 )     (97 )

Change in prepaid expenses

     51       37  

Change in accounts payable and accrued expenses

     (602 )     (1,200 )

Change in deferred revenue

     (371 )     (349 )

Change in deferred income taxes

     919       777  

Tax benefits associated with stock options

     438       217  
    


 


Net cash provided by operating activities

     74       1,038  
    


 


Cash flows from investing activities:

                

Purchases of furniture, fixtures and equipment

     (553 )     (236 )

Investment in intangible assets

     (102 )     (159 )

Purchases of investments

     (5,398 )     (4,294 )

Proceeds from the sale of investments

     5,293       3,171  
    


 


Net cash used by investing activities

     (760 )     (1,518 )
    


 


Cash flows from financing activities:

                

Repayment of debt

     —         (150 )

Net proceeds from the issuance of shares under the stock option and stock purchase plans

     2,366       513  
    


 


Net cash provided by financing activities

     2,366       363  
    


 


Increase (decrease) in cash and cash equivalents

     1,680       (117 )

Cash and cash equivalents at beginning of period

     1,403       666  
    


 


Cash and cash equivalents at end of period

   $ 3,083     $ 549  
    


 


 

The accompanying notes are an integral part of these condensed financial statements.

 

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Closure Medical Corporation

Notes to Condensed Financial Statements

(Unaudited)

 

1. Organization

 

Closure Medical Corporation (the “Company” or “Closure”) develops and manufactures innovative biomaterial-based medical devices that fulfill the needs of healthcare practitioners, patients and consumers. From May 10, 1990 to February 29, 1996, the business of the Company was conducted by its predecessor, Tri-Point Medical L.P. The Company was incorporated in Delaware on February 20, 1996.

 

2. Significant Accounting Policies

 

The significant accounting policies followed by the Company for interim financial reporting are consistent with the accounting policies followed for annual financial reporting. These unaudited financial statements have been prepared in accordance with Rule 10-01 of Regulation S-X, and in management’s opinion, all adjustments of a normal recurring nature necessary for a fair presentation have been included. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements and should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2003 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2003.

 

The results of operations for the three month period ended March 31, 2004 are not necessarily indicative of the results to be expected for the entire fiscal year ending December 31, 2004.

 

Recent Accounting Pronouncements

 

Financial Accounting Standards Board Interpretation No. 46 (“FIN 46”), “Consolidation of Variable Interest Entities,” was effective for calendar year companies as of January 1, 2004. Because the Company does not have interests in variable interest entities, the adoption of FIN 46 did not have a material effect on the Company’s financial position or results of operations.

 

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Closure Medical Corporation

Notes to Condensed Financial Statements

(Unaudited)

 

Accounting for Stock-Based Compensation

 

The Company accounts for stock-based compensation based on the provisions of Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees”. In December 2002, the FASB issued Statement No. 148, “Accounting for Stock-Based Compensation – Transition and Disclosure – an amendment of FASB Statement No. 123” (“SFAS 148”). This amendment of Statement No. 123, “Accounting for Stock-Based Compensation” (“SFAS 123”) provides alternative methods of transition for a voluntary change to the fair value based method of accounting for stock-based employee compensation. In addition, this statement amends the disclosure requirements of SFAS 123 to require prominent disclosures in both annual and interim financial statements about the method of accounting for stock-based employee compensation and the effect of the method used on reported results. The Company has adopted the disclosure requirements of SFAS 123 and SFAS 148.

 

Had compensation expense, assuming it was recognized on a straight-line basis over the vesting period for awards under the Company’s Equity Compensation Plan and in the period of purchase for benefits received under the Employee Stock Purchase Plan, been determined based on the fair value at the grant date, consistent with the provisions of SFAS 123 and SFAS 148, the Company’s results of operations would have been reduced to the pro forma amounts indicated below (in thousands, except per share data):

 

     Three Months Ended
March 31,


 
     2004

    2003

 

Net income –as reported

   $ 2,530     $ 1,919  

Less: Pro forma adjustment for stock- based compensation expense

     (2,043 )     (1,228 )
    


 


Net income –pro forma

   $ 487     $ 691  
    


 


Basic net income per common share:

                

As reported

   $ 0.18     $ 0.14  

Effect of pro forma adjustment

     (0.14 )     (0.09 )
    


 


Pro forma

   $ 0.04     $ 0.05  
    


 


Diluted net income per common share:

                

As reported

   $ 0.16     $ 0.14  

Effect of pro forma adjustment

     (0.13 )     (0.09 )
    


 


Pro forma

   $ 0.03     $ 0.05  
    


 


 

The assumptions used to calculate the fair value of options granted are evaluated and revised, as necessary, to reflect market conditions and experience at the grant date.

 

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Closure Medical Corporation

Notes to Condensed Financial Statements

(Unaudited)

 

3. Income Taxes

 

The Company estimated that its effective tax rate for the quarters ended March 31, 2004 and 2003 was approximately 36%. The effective tax provision rate differed from the statutory federal income tax rate primarily due to the impact of state taxes and the estimated effect of research and development credits.

 

4. Inventories

 

Inventories included the following (in thousands):

 

     March 31,
2004


   December 31,
2003


Packaging

   $ 880    $ 995

Raw materials

     147      236

Work–in–process

     933      547

Finished goods

     84      17
    

  

     $ 2,044    $ 1,795
    

  

 

5. Net Income Per Common Share

 

Basic net income per common share is computed using the weighted-average number of shares of common stock outstanding during the period.

 

Diluted net income per common share is computed using the weighted-average number of shares of common and common equivalent shares outstanding during the period. Common equivalent shares consist of stock options using the treasury stock method and are excluded from the computation if their effect is antidilutive.

 

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ITEM 2.   MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

CAUTIONARY STATEMENT PURSUANT TO SAFE HARBOR PROVISIONS OF THE PRIVATE SECURITIES LITIGATION ACT OF 1995

 

The following discussion should be read in conjunction with the unaudited, condensed financial statements and notes thereto included in Part I—Item 1 of this Form 10-Q and the audited financial statements and notes thereto and Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in our Annual Report on Form 10-K for the year ended December 31, 2003.

 

This report and the documents incorporated by reference herein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this report and the documents incorporated herein by reference, the words “expect,” “anticipate,” “believe,” “estimate,” and similar expressions are generally intended to identify forward-looking statements. These forward-looking statements are based on a number of factors concerning future events, and are subject to a number of uncertainties and other factors, many of which are outside of our control. These statements include, among others, the statements in Management’s Discussion and Analysis about the following:

 

our expectations with respect to increases in operating expenses;

 

expectations with respect to increases in research and development and general and administrative expenses in order to develop new products, manufacture commercial quantities of products and fund additional clinical studies;

 

expectations with respect to the development, manufacturing and approval of new products and line extensions of our existing products;

 

expectations with respect to incurring additional capital expenditures to expand our manufacturing capabilities;

 

expectations with respect to generating revenue or maintaining profitability;

 

our ability to maintain our existing marketing agreements and to enter into additiona