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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, 2003

[  ] 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 O-4136

Lifecore Biomedical, Inc.


(Exact name of Registrant as specified in its charter)
     
Minnesota   41-0948334

 
(State or other jurisdiction of
incorporation or organization)
  (IRS Employer Identification No.)
     
3515 Lyman Boulevard    
Chaska, Minnesota   55318

 
(Address of principal executive   (Zip Code)
offices)    

Registrant’s telephone number, including area code: 952-368-4300

Indicate by checkmark 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 checkmark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).

Yes  [X]   No  [  ]

The number of shares outstanding of the registrant’s Common Stock, $.01 par value, as of October 30, 2003 was 12,890,917 shares.

1


TABLE OF CONTENTS

PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CONDENSED CONSOLIDATED BALANCE SHEETS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
ITEM 4. CONTROLS AND PROCEDURES
PART II – OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K
Exhibit Index
Reports on Form 8-K
SIGNATURES
EX-10.1 Employment Agreement - James W. Bracke
EX-31.1 Certification of CEO - Section 302
EX-31.2 Certification of CFO - Section 302
EX-32.1 Certification of CEO - Section 906
EX-32.2 Certification of CFO - Section 906


Table of Contents

LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES

FORM 10-Q

INDEX

                 
            Page
Part I.  
Financial Information
       
Item 1.  
Financial Statements
       
       
Condensed Consolidated Balance Sheets at September 30, 2003 and June 30, 2003
    3  
       
Condensed Consolidated Statements of Operations for Three Months Ended September 30, 2003 and 2002
    4  
       
Condensed Consolidated Statements of Cash Flows for Three Months Ended September 30, 2003 and 2002
    5  
       
Notes to Condensed Consolidated Financial Statements
    6-10  
Item 2.  
Management’s Discussion and Analysis of Results of Operations and Financial Condition
    11-14  
Item 3.  
Quantitative and Qualitative Disclosures About Market Risk
    15  
Item 4.  
Controls and Procedures
    15  
Part II.  
Other Information
       
Item 6.  
Exhibits and Reports on Form 8-K
       
       
a.     Exhibit Index
    16  
       
b.     Reports on Form 8-K
    16  
Signatures  
 
    17  

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Table of Contents

LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

                     
        September 30,   June 30,
        2003   2003
       
 
ASSETS
               
Current Assets
               
 
Cash and cash equivalents
  $ 5,081,000     $ 4,211,000  
 
Accounts receivable, less allowances
    7,004,000       7,795,000  
 
Inventories
    9,773,000       9,728,000  
 
Prepaid expenses
    644,000       766,000  
 
 
   
     
 
   
Total current assets
    22,502,000       22,500,000  
     
Property, plant and equipment
               
 
Land, building and equipment
    44,834,000       44,732,000  
 
Less accumulated depreciation
    (20,431,000 )     (19,820,000 )
 
 
   
     
 
 
    24,403,000       24,912,000  
Other Assets
               
 
Intangibles
    4,601,000       4,643,000  
 
Security deposits
    845,000       843,000  
 
Inventories
    4,639,000       4,639,000  
 
Other
    703,000       815,000  
 
 
   
     
 
 
    10,788,000       10,940,000  
 
 
   
     
 
 
  $ 57,693,000     $ 58,352,000  
 
 
   
     
 
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
Current Liabilities
               
 
Current maturities of long-term obligations
  $ 145,000     $ 156,000  
 
Accounts payable
    2,147,000       1,880,000  
 
Accrued compensation
    1,305,000       1,113,000  
 
Accrued expenses
    867,000       840,000  
 
 
   
     
 
   
Total current liabilities
    4,464,000       3,989,000  
     
Long-term obligations
    5,938,000       5,969,000  
     
Shareholders’ equity
    47,291,000       48,394,000  
 
 
   
     
 
 
  $ 57,693,000     $ 58,352,000  
 
 
   
     
 

See accompanying notes to condensed consolidated financial statements.

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Table of Contents

LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

                   
      Three months ended September 30,
     
      2003   2002
     
 
Net sales
  $ 9,947,000     $ 8,972,000  
Cost of goods sold
    4,769,000       4,909,000  
 
   
     
 
Gross profit
    5,178,000       4,063,000  
     
Operating expenses
               
 
Research and development
    1,259,000       957,000  
 
Marketing and sales
    3,173,000       2,848,000  
 
General and administrative
    1,561,000       1,159,000  
 
   
     
 
 
    5,993,000       4,964,000  
 
   
     
 
Operating loss
    (815,000 )     (901,000 )
     
Other income (expense)
               
 
Interest income
    6,000       29,000  
 
Interest expense
    (155,000 )     (166,000 )
 
Other
    121,000       (8,000 )
 
   
     
 
 
    (28,000 )     (145,000 )
 
   
     
 
Net loss
  $ (843,000 )   $ (1,046,000 )
 
   
     
 
Net loss per share
               
 
Basic and diluted
  $ (0.07 )   $ (0.08 )
 
   
     
 
Weighted average shares outstanding
               
 
Basic and diluted
    12,889,113       12,874,628  
 
   
     
 

See accompanying notes to condensed consolidated financial statements.

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Table of Contents

LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

                     
        Three months ended September 30,
       
        2003   2002
       
 
Cash flows from operating activities:
               
Net loss
  $ (843,000 )   $ (1,046,000 )
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
               
 
Depreciation and amortization
    654,000       738,000  
 
Allowance for doubtful accounts
    29,000       (40,000 )
 
Accumulated currency translation adjustment
    (279,000 )      
     
 
Changes in operating assets and liabilities:
               
   
Accounts receivable
    762,000       371,000  
   
Inventories
    (45,000 )     (145,000 )
   
Prepaid expenses
    122,000       (396,000 )
   
Accounts payable
    267,000       (1,150,000 )
   
Accrued liabilities
    219,000       (17,000 )
 
   
     
 
Net cash provided by (used in) operating activities
    886,000       (1,685,000 )
     
Cash flows from investing activities:
               
 
Purchases of property, plant and equipment
    (101,000 )     (182,000 )
 
Increase in security deposits
    (2,000 )     (5,000 )
 
Decrease in other assets
    110,000       84,000  
 
   
     
 
Net cash provided by (used in) investing activities
    7,000       (103,000 )
     
Cash flows from financing activities:
               
 
Payments on long-term obligations
    (42,000 )     (22,000 )
 
Proceeds from stock issuance
    19,000       55,000  
 
   
     
 
Net cash provided by (used in) financing activities
    (23,000 )     33,000  
 
   
     
 
Net increase (decrease) in cash and cash equivalents
    870,000       (1,755,000 )
Cash and cash equivalents at beginning of period
    4,211,000       2,528,000  
 
   
     
 
Cash and cash equivalents at end of period
  $ 5,081,000     $ 773,000  
 
   
     
 
Supplemental disclosure of cash flow information:
               
 
Cash paid during the period for:
               
   
Interest
  $ 208,000     $ 123,000  

See accompanying notes to condensed consolidated financial statements.

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Table of Contents

LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2003

NOTE A - FINANCIAL INFORMATION

Lifecore Biomedical, Inc. (the “Company”) develops, manufactures and markets biomaterials and medical devices for use in various surgical markets through two divisions, the Hyaluronan Division and the Oral Restorative Division. The Company’s manufacturing facility is located in Chaska, Minnesota. The Hyaluronan Division conducts its business through OEM and contract manufacturing alliances in the gynecologic, ophthalmic, orthopedic and veterinary surgery fields. The Oral Restorative Division conducts its dental surgery business through direct sales and marketing in the United States, Germany, Italy and Sweden and through 22 distributors in 35 countries.

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with Regulation S-X pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to such rules and regulations, although management believes that the disclosures are adequate to make the information presented not misleading.

In the opinion of management, the unaudited condensed consolidated financial statements contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the financial position as of September 30, 2003, and the results of operations for the three month periods ended September 30, 2003 and 2002 and cash flows for the three month periods ended September 30, 2003 and 2002. The results of operations for the three months ended September 30, 2003 are not necessarily indicative of the results for the full year or of the results for any future periods. The unaudited condensed consolidated balance sheet as of June 30, 2003 has been derived from audited financial statements as of that date.

In preparation of the Company’s consolidated financial statements, management is required to make estimates and assumptions that affect reported amounts of assets and liabilities and related revenues and expenses during the reporting periods. Actual results could differ from the estimates used by management.

NOTE B - INVENTORIES

Inventories are stated at the lower of cost (first-in, first-out method) or market. The portion of finished hyaluronan powder inventory not expected to be consumed within the next twelve months is classified as a long-term asset. Finished good inventories include hyaluronan, packaged aseptic, and oral restorative products. Inventories consist of the following:

                 
    September 30,   June 30,
    2003   2003
   
 
Raw materials
  $ 3,077,000     $ 2,756,000  
Work in progress
    393,000       344,000  
Finished goods
    10,942,000       11,267,000  
 
   
     
 
 
  $ 14,412,000     $ 14,367,000  
 
   
     
 

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LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)

September 30, 2003

NOTE C – INTANGIBLE ASSETS

Effective July 1, 2001, the Company adopted Financial Accounting Standards Board (FASB) Statement of Financial Accounting Standard (SFAS) No. 142, “Goodwill and Other Intangible Assets.” Under the provisions of SFAS No. 142 the Company ceased amortization of goodwill and technology and regulatory rights effective July 1, 2001, while the customer list continues to be amortized on the straight-line method over 5 years. On an ongoing basis the Company reviews the valuation of intangibles to determine possible impairment by comparing the carrying value to projected undiscounted future cash flows of the related assets. As a result of such review, there was no impairment recorded for the three month period ended September 30, 2003.

     Intangibles consisted of the following at:

                 
    September 30,   June 30,
    2003   2003
   
 
Goodwill
  $ 4,301,000     $ 4,301,000  
Customer list
    725,000       725,000  
Patents
    387,000       387,000  
Accumulated amortization
    (812,000 )     (770,000 )
 
   
     
 
 
  $ 4,601,000     $ 4,643,000  
 
   
     
 

NOTE D - AGREEMENTS

Lifecore and ETHICON have entered into a Conveyance, License, Development and Supply Agreement (the “ETHICON Agreement”) whereby ETHICON transferred to Lifecore its ownership in certain technology related to research and development previously conducted on the Company’s sodium hyaluronan material. The technology transferred to Lifecore includes written technical documents related to ETHICON’s research and development of a product to inhibit the formation of postsurgical adhesions. These documents include product specifications, methods and techniques, technology, know-how and certain patents. Lifecore assumed responsibility for continuing the anti-adhesion development project including conducting a human gynecology clinical trial on GYNECARE INTERGEL * Adhesion Prevention Solution (“INTERGEL Solution”), a second-generation ferric hyaluronan-based product. Lifecore has granted ETHICON exclusive worldwide marketing rights through 2008 to the products developed by Lifecore within defined fields of use. On March 27, 2003, the Company announced that ETHICON voluntarily suspended global marketing and sales of INTERGEL Solution and has voluntarily withdrawn the product from the market in order to assess information obtained from postmarketing experience with the device. The assessment will include a review of technical issues, surgical techniques and circumstances associated with the postmarketing events, including reports from off-label use. Since the launch of the product in August of 1998 to February 2003, the worldwide complaint rate has been 0.29 percent of units sold. The contribution of the device to these events is unknown. The Company currently expects that the product will return to the market following completion of the review and implementation of any appropriate action. Management does not believe there has been an impairment of assets as of September 30, 2003.

*Trademark of ETHICON, INC.

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LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)

September 30, 2003

NOTE E - LINE OF CREDIT

The Company has a $5,000,000 credit facility with a bank which has a maturity date of December 31, 2005. The agreement allows for advances against eligible accounts receivable, subject to a borrowing base certificate. Interest is accrued at the prime rate which was 4.00% at September 30, 2003. At September 30, 2003 and June 30, 2003, there were no balances outstanding under the line of credit. The terms of the agreement require the Company to comply with various financial covenants including minimum tangible net worth, liabilities to tangible net worth ratio and profitability. At September 30, 2003 and June 30, 2003, the Company was in compliance with all covenants.

NOTE F - STOCK PLAN INFORMATION

The Company has various stock option plans that provide for the granting of stock options to officers, key employees and directors. The Company accounts for stock-based compensation using the intrinsic value method prescribed in APB No. 25, “Accounting for Stock Issued to Employees,” whereby the options are granted at market price, and therefore no compensation costs are recognized. The Company has elected to retain its current method of accounting as described above and has adopted the disclosure requirements of SFAS Nos. 123 and 148. If compensation expense for the Company’s various stock option plans had been determined based upon the projected fair values at the grant dates for awards under those plans in accordance with SFAS No. 123, the Company’s pro-forma net loss, and basic and diluted loss per common share would have been as follows:

                   
      Three months ended September 30,
     
      2003   2002
     
 
Net loss, as reported
  $ (843,000 )   $ (1,046,000 )
Deduct: Total stock-based employee compensation expense determined under fair value method for awards, net of related tax effects
    (90,000 )     (33,000 )
 
   
     
 
Pro forma net loss
  $ (933,000 )   $ (1,079,000 )
 
   
     
 
Net loss per common equivalent share:
               
 
Basic and diluted - as reported
  $ (0.07 )   $ (0.08 )
 
Basic and diluted - pro-forma
  $ (0.07 )   $ (0.08 )

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LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)

September 30, 2003

NOTE G – NET LOSS PER SHARE

The Company’s basic net income (loss) per share amounts have been computed by dividing net income (loss) by the weighted average number of outstanding common shares. The Company’s diluted net income (loss) per share is computed by dividing net income (loss) by the weighted average number of outstanding common shares and common share equivalents relating to stock options, when dilutive. For the three month periods ended September 30, 2003 and 2002 the Company reported a net loss and as such, no common share equivalents were included in the computation of diluted net loss per share. However, if the Company would have reported net income in the three month periods ended September 30, 2003 and 2002, 32,614 and 158,830 common share equivalents, respectfully, would have been included in the computation of diluted net income per share.

Options to purchase 2,606,332 shares of common stock with a weighted average exercise price of $12.34 for the three-month period ended September 30, 2003 and options to purchase 1,887,168 shares of common stock with a weighted average exercise price of $14.30 for the three-month period ended September 30, 2002, respectively, were outstanding but were not included in the calculation of diluted net loss per share because the options’ exercise prices were greater than the average market price of the Company’s common stock during those periods. Although these options were antidilutive for the periods presented, they may be dilutive in future period calculations.

NOTE H – SEGMENT INFORMATION

The Company operates two business segments. The Hyaluronan Division develops, manufactures, and markets products containing hyaluronan. The Oral Restorative Division develops, manufactures and/or markets various oral restorative products to the area of implant dentistry. Currently, products containing hyaluronan are sold primarily to customers pursuant to ongoing supply agreements. The Company’s Oral Restorative Division markets products directly to clinicians and dental laboratories in the United States, Germany, Italy and Sweden and primarily through distributorship arrangements in other foreign locations. The operations of the Company’s subsidiaries, Lifecore Biomedical GmbH, Lifecore Biomedical SpA, and Lifecore Biomedical AB have not been material to the consolidated financial statements.

Segment assets and the basis of segmentation are consistent with that reported at June 30, 2003. Segment information for sales and loss from operations are as follows:

                   
      Three months ended September 30,
     
      2003   2002
     
 
Net sales
               
 
Hyaluronan products
  $ 3,558,000     $ 3,698,000  
 
Oral restorative products
    6,389,000       5,274,000  
 
   
     
 
 
  $ 9,947,000     $ 8,972,000  
 
   
     
 
Loss from operations
               
 
Hyaluronan products
  $ (574,000 )   $ (435,000 )
 
Oral restorative products
    (241,000 )     (466,000 )
 
   
     
 
 
  $ (815,000 )   $ (901,000 )
 
   
     
 

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LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)

September 30, 2003

NOTE I – NEW ACCOUNTING PRONOUNCEMENTS

In December 2002, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standard (“SFAS”) No. 148, “Accounting for Stock-Based Compensation— Transition and Disclosure.” SFAS No. 148 amends SFAS No. 123, “Accounting for Stock-Based Compensation,” to provide alternative methods of transition for a voluntary change to the fair value based method of accounting for stock-based employee compensation. In addition, SFAS No. 148 amends the disclosure requirements of Accounting Principles Board (“APB”) Opinion No. 28, Interim Financial Reporting, to require pro-forma disclosure in interim financial statements by companies that elect to account for stock-based compensation using the intrinsic value method prescribed in APB Opinion No. 25. The Company continues to use the intrinsic value method of accounting for stock-based compensation. As a result, the transition provisions will not have an effect on the Company’s consolidated financial statements.

In January 2003, FASB issued FASB Interpretation No. 46 (FIN 46), “Consolidation of Variable Interest Entities”. FIN 46 is an interpretation of Accounting Research Bulletin No. 51, “Consolidated Financial Statements”, and addresses consolidation by business enterprises of variable interest entities. FIN 46 applies immediately to variable interest entities created or obtained after January 31, 2003 and it applies in the first fiscal year or interim period beginning after December 15, 2003, to variable interest entities in which an enterprise holds a variable interest that it acquired before February 1, 2003. This pronouncement is not expected to have a material impact on the Company’s consolidated financial position or results of operation.

In May 2003, the FASB issued Statement No. 150, “Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity”. SFAS No. 150 changes the classifications in the statement of financial position of certain common financial instruments from either equity or mezzanine presentation to liabilities and requires an issuer of those financial statements to recognize changes in fair value or redemption amount, as applicable, in earnings. SFAS No. 150 is effective for financial instruments entered into or modified after May 31, 2003, and otherwise is effective at the beginning of the first interim period beginning after June 15, 2003. Adoption of SFAS No. 150 is not anticipated to have an impact on the Company’s consolidated financial position or results of operations.

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LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I - FINANCIAL INFORMATION
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF RESULTS OF
OPERATIONS AND FINANCIAL CONDITION

Critical Accounting Policies:

The discussion and analysis of our financial condition and results of operations are based upon the Company’s consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires management to make estimates and assumptions in certain circumstances that affect the reported amount of assets and liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities at the date of the Company’s financial statements. Management bases its estimates and judgments on historical experience, observance of trends in the industry, information provided by customers and other outside sources and on various other factors that are believed to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions.

Revenue Recognition:

The Company’s revenues are recognized when products are shipped to or otherwise accepted by unaffiliated customers. The Securities and Exchange Commission’s Staff Accounting Bulletin (SAB) No. 101, “Revenue Recognition” provides guidance on the application of generally accepted accounting principles to selected revenue recognition issues. The Company has concluded that its revenue recognition policy is appropriate and in accordance with generally accepted accounting principles and SAB No. 101.

Allowance for Uncollectible Accounts Receivable:

Accounts receivable are reduced by an allowance for amounts that may become uncollectible in the future. The Company extends credit to customers in the normal course of business, but generally does not require collateral or any other security to support amounts due. Management performs on-going credit evaluations of its customers and bases the estimated allowance on these evaluations.

Inventories:

Inventories are stated at the lower of cost (first-in, first-out method) or market and have been reduced to lower of cost or market for obsolete, excess or unmarketable inventory. The lower of cost or market adjustment is based on management’s review of inventories on hand compared to estimated future usage and sales.

Goodwill, Intangible and Other Long-Lived Assets:

Intangible and certain other long-lived assets with a definite life are amortized over their useful lives. Useful lives are based on management’s estimates of the period that the assets will generate revenue.

In July 2001, the Financial Accounting Standards Board issued SFAS No. 142 which deals with, among other things, amortization of goodwill. The Company adopted this new standard effective July 1, 2001 and ceased amortization of goodwill at that date and reviews goodwill for impairment on a regular basis, at least annually.

Management has reviewed goodwill and other intangibles for impairment and has concluded that such assets are appropriately valued at the financial statement date.

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LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I - FINANCIAL INFORMATION
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF RESULTS OF
OPERATIONS AND FINANCIAL CONDITION (cont.)

Recently Issued Accounting Pronouncements:

The notes to the consolidated financial statements included in this Form 10-Q include a discussion regarding recently issued accounting pronouncements. The effects on the Company’s financial statements from these pronouncements are not expected to be material.

Results of Operations

Three Months Ended September 30, 2003 Compared to Three Months Ended September 30, 2002:

                                                   
      Hyaluronan   Oral Restorative                
      Division   Division   Consolidated
     
 
 
      2003   2002   2003   2002   2003   2002
     
 
 
 
 
 
Net sales
  $ 3,558,000     $ 3,698,000     $ 6,389,000     $ 5,274,000     $ 9,947,000     $ 8,972,000  
Cost of goods sold
    2,369,000       2,799,000       2,400,000       2,110,000       4,769,000       4,909,000  
 
   
     
     
     
     
     
 
Gross profit
    1,189,000       899,000       3,989,000       3,164,000       5,178,000       4,063,000  
Operating expenses
                                               
 
Research and development
    1,019,000       709,000       240,000       248,000       1,259,000       957,000  
 
Marketing and sales
    127,000       174,000       3,046,000       2,674,000       3,173,000       2,848,000  
 
General and administrative
    617,000       451,000       944,000       708,000       1,561,000       1,159,000  
 
   
     
     
     
     
     
 
 
    1,763,000       1,334,000       4,230,000       3,630,000       5,993,000       4,964,000  
 
   
     
     
     
     
     
 
Operating loss
  $ (574,000 )   $ (435,000 )   $ (241,000 )   $ (466,000 )   $ (815,000 )   $ (901,000 )
 
   
     
     
     
     
     
 

Net sales for the quarter ended September 30, 2003 increased $975,000 or 11% as compared to the same quarter of last fiscal year. Hyaluronan product sales for the current quarter decreased $140,000 or 4% as compared to the same quarter of last fiscal year. The sales decrease was due to lower gynecologic hyaluronan shipments resulting from the withdrawal of INTERGEL Solution from the market, offset by increased ophthalmic and veterinary sales. Oral restorative product sales for the current quarter increased $1,115,000 or 21% compared to the same quarter of last fiscal year. International sales of oral restorative products increased 28% and domestic sales increased 16% as compared to the same quarter of last fiscal year.

Consolidated gross margin increased to 52% for the current quarter from 45% for the same quarter of last fiscal year. The gross margin for the Hyaluronan Division increased to 33% from a gross margin of 24% due to product mix. The gross margin for the Oral Restorative Division increased to 62% for the current quarter from 60% for the same quarter of last fiscal year. The gross margin increase is due to sales mix and reduced material costs.

Research and development expenses increased $302,000 or 32% in the current quarter as compared to the same quarter of last fiscal year. The increase is due to consulting and professional fees associated with the market withdrawal of INTERGEL Solution.

Marketing and sales expenses increased $325,000 or 11% in the current quarter as compared to the same quarter of last fiscal year due to increased costs associated with expansion of oral restorative’s domestic sales force and international operations.

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LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I - FINANCIAL INFORMATION
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF RESULTS OF
OPERATIONS AND FINANCIAL CONDITION (cont.)

General and administrative expenses increased $402,000 or 35% for the current quarter as compared to the same quarter of last fiscal year. The increase resulted from increased legal expenses, insurance premiums and higher personnel related expenses.

Other expense, net, decreased $117,000 or 81% for the current quarter as compared to the same quarter of last fiscal year. The decrease is primarily due to the $129,000 increase in other income from currency gains realized on Euro denominated intercompany transactions.

Liquidity and Capital Resources

The Company’s Annual Report on Form 10-K for the year ended June 30, 2003 contains a detailed discussion of Lifecore’s liquidity and capital resources. In conjunction with this Quarterly Report on Form 10-Q, investors should read the 2003 Form 10-K.

For the three month period ended September 30, 2003, the Company had positive cash flow from operations of $886,000. Cash flow from operations was positive in fiscal years 2003, 2002 and 2001. Charges for unused manufacturing capacity associated with the Company’s hyaluronan production and additional costs associated with the withdrawal of INTERGEL Solution from the market have negatively impacted operating results in the current fiscal year. Prior to the current fiscal year, charges for unused capacity were due to an unanticipated delay in receiving INTERGEL Solution marketing approval in the U.S. from the FDA. Further, the Company expects ongoing expenditures related to the process for assessment of information obtained from postmarketing experience with the device. Also, marketing and sales expenses for the oral restorative products are expected to continue at a high level with continued international expansion and increased personnel costs.

The loan agreement between the Company and the holder of the industrial development revenue bonds issued to finance the Company’s Chaska, Minnesota facility was amended in May 2003 to waive the fixed charge coverage ratio and the cash flow coverage ratio through June 30, 2004. With respect to certain of these covenants, the Company may be required to obtain further waivers for fiscal 2005. There can be no assurance that future waivers will be granted to the Company.

The Company has a $5,000,000 credit facility with a bank which has a maturity date of December 31, 2005. The agreement allows for advances against eligible accounts receivable, subject to a borrowing base certificate. Interest is accrued at the prime rate at September 30, 2003, which was 4.00%. At September 30, 2003 and June 30, 2003, there were no balances outstanding under the line of credit. The terms of the agreement require the Company to comply with various financial covenants including minimum tangible net worth, liabilities to tangible net worth ratio and profitability. At September 30, 2003 and June 30, 2003, the Company was in compliance with all covenants.

The Company’s ability to generate positive cash flow from operations and achieve ongoing profitability is dependent upon the continued expansion of revenue from its hyaluronan and oral restorative businesses. Growth in the Hyaluronan Division is unpredictable due to the uncertainty associated with the future market status of INTERGEL Solution, the complex governmental regulatory environment for new medical products and the early stage of certain of these markets. Similarly, expansion of the Company’s Oral Restorative Division sales is also dependent upon increased revenue from new and existing customers, as well as successfully competing in a more mature market. The Company expects its cash generated from anticipated operations and the availability under the line of credit to satisfy cash flow needs in the near term. No assurance can be given that the Company will maintain positive cash flow from operations. While the Company’s capital resources appear adequate today, the Company may seek additional financing in the future. If additional financing is necessary, no assurance can be given that such financing will be available and, if available, will be on terms favorable to the Company and its shareholders.

The Company does not have any “off-balance sheet” financing activities.

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LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I - FINANCIAL INFORMATION
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF RESULTS OF
OPERATIONS AND FINANCIAL CONDITION (cont.)

Cautionary Statement

Certain statements in this Form 10-Q are forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements, which refer to the likelihood of return of INTERGEL Solution to the market and the timing of such return; the extent of the impact on Hyaluronan Division margins from increased unused manufacturing capacity charges; the level of expenditures related to the process associated with the assessment of information obtained from postmarketing experience with the device; the likelihood of adequate cash flow and access to financial markets; expected production levels; and the future marketing and sales success of Oral Restorative Division products, are subject to change. These statements are subject to certain risks and uncertainties that could cause actual results to differ materially from historical results and those presently anticipated or projected, such as, unforeseen difficulties or delays in assessing information obtained from postmarketing experience with INTERGEL Solution, unforeseen difficulties or delays in interactions with the FDA, and lack of cooperation or marketing success from marketing partners for the hyaluronan products. Investors are referred to a more detailed discussion of those risks presented in Management’s Discussion and Analysis of Financial Condition and Results of Operations section in the Company’s Annual Report on Form 10-K for the year ended June 30, 2003 as well as Exhibit 99.1 to such Form 10-K.

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LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I – FINANCIAL INFORMATION

               ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

The Company invests its excess cash in money market mutual funds and highly rated corporate debt securities. All investments are held-to-maturity. The market risk on such investments is minimal.

Receivables from sales to foreign customers are denominated in U.S. Dollars. Transactions at the Company’s foreign subsidiaries are denominated in European Euros at Lifecore Biomedical SpA and Lifecore Biomedical GmbH and are denominated in Swedish Krona at Lifecore Biomedical AB. The Company has historically had minimal exposure to changes in foreign currency exchange rates, and as such, has not used derivative financial instruments to manage foreign currency fluctuation risk.

The Company’s outstanding long-term debt carries interest at a fixed rate. There is no material market risk relating to the Company’s long-term debt.

               ITEM 4. CONTROLS AND PROCEDURES

(a)  Evaluation of disclosure controls and procedures.

Under the supervision and with the participation of our management, including the Company’s Chief Executive Officer and Chief Financial Officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a – 15(e) under the Exchange Act) as of the end of the period covered by this report. Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures are adequately designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Securities and Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in applicable rules and forms.

(b)  Changes in internal controls.

During the fiscal quarter covered by this report, there have not been any significant changes in the Company’s internal control over financial reporting (as defined in Rule 13a - 15(f) under the Exchange Act) that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART II – OTHER INFORMATION

Item 6. Exhibits and Reports on Form 8-K

         
  a.     Exhibits and Exhibit Index
         
    3.1   Restated Articles of Incorporation, as amended (incorporated by reference to Exhibit 19(a) to Amendment No. 1 on Form 8, dated July 13, 1988, to Form 10-Q for the quarter ended December 31, 1987), as amended by Amendment No. 2, (incorporated by reference to Exhibit 3.1 to Form 10-K for the year ended June 30, 1997)
         
    3.2   Amended Bylaws, (incorporated by reference to Exhibit 3.2 to Form 10-K/A for the year ended June 30, 1995)
         
    3.3   Form of Rights Agreement, dated as of May 23, 1996, between the Company and Norwest Bank Minnesota, National Association (incorporated by reference to Exhibit 1 to the Company’s Form 8-A Registration Statement dated May 31, 1996)
         
    4.1   Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to 1987 S-2 Registration Statement [File No. 33-12970])
         
    10.1   Employment agreement between the Company and James W. Bracke, dated October 16, 2003
         
    31.1   Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
         
    31.2   Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
         
    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
         
  b.     Reports on Form 8-K
         
        A report on Form 8-K was filed on August 12, 2003 to report under item 12 the Company’s Fiscal 2003 fourth quarter and year end financial results.
         
        A report on Form 8-K was filed on September 10, 2003 (dated September 9, 2003) to report under Item 9 the dismissal of The Straumann Company’s lawsuit against the Company.
         
        A report on Form 8-K was filed on October 15, 2003 (dated October 14, 2003) to report under Item 12 the Company’s Fiscal 2004 first quarter financial results.

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LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART II – OTHER INFORMATION

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.

     
    LIFECORE BIOMEDICAL, INC.
     
Dated: November 10, 2003   /s/ James W. Bracke
   
         James W. Bracke
     President & Chief Executive Officer
     
Dated: November 10, 2003   /s/ Dennis J. Allingham
   
         Dennis J. Allingham
     Executive Vice President
     & Chief Financial Officer
     (Principal Financial Officer)

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