UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
[X] Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the quarterly period ended March 31, 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.
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 offices) |
(Zip Code) |
Registrants 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 registrants Common Stock, $.01 par value, as of April 30, 2003 was 12,885,417 shares.
1
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
FORM 10-Q
INDEX
Page | ||||
Part I | Financial Information | |||
Item 1. | Financial Statements | |||
Condensed Consolidated Balance Sheets at March 31, 2003 and June 30, 2002 |
3 | |||
Condensed Consolidated Statements of Operations for Three Months and Nine Months Ended March 31, 2003 and 2002 |
4 | |||
Condensed Consolidated Statements of Cash Flows for Nine Months Ended March 31, 2003 and 2002 |
5 | |||
Notes to Condensed Consolidated Financial Statements | 6-10 | |||
Item 2. |
Managements Discussion and Analysis of Results of Operations and Financial Condition |
11-15 | ||
Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 16 | ||
Item 4. | Controls and Procedures | 16 | ||
Part II | Other Information | |||
Item 6. | Exhibits and Reports on Form 8-K | |||
a. Exhibit Index | 17 | |||
b. Reports on Form 8-K | 17 | |||
Signatures | 18 | |||
Certifications | 19-20 |
2
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
March 31, | June 30, | |||||||||
2003 | 2002 | |||||||||
ASSETS |
||||||||||
Current Assets |
||||||||||
Cash and cash equivalents |
$ | 3,277,000 | $ | 2,528,000 | ||||||
Accounts receivable, less allowances |
7,253,000 | 7,882,000 | ||||||||
Inventories |
12,695,000 | 11,810,000 | ||||||||
Prepaid expenses |
950,000 | 997,000 | ||||||||
Total current assets |
24,175,000 | 23,217,000 | ||||||||
Property, plant and equipment |
||||||||||
Land, building and equipment |
44,619,000 | 43,988,000 | ||||||||
Less accumulated depreciation |
(19,188,000 | ) | (17,194,000 | ) | ||||||
25,431,000 | 26,794,000 | |||||||||
Other Assets |
||||||||||
Intangibles |
4,685,000 | 4,850,000 | ||||||||
Security deposits |
835,000 | 845,000 | ||||||||
Inventories |
2,873,000 | 3,316,000 | ||||||||
Other |
891,000 | 1,074,000 | ||||||||
9,284,000 | 10,085,000 | |||||||||
$ | 58,890,000 | $ | 60,096,000 | |||||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||||
Current Liabilities |
||||||||||
Current maturities of long-term obligations |
$ | 139,000 | $ | 139,000 | ||||||
Accounts payable |
1,763,000 | 3,500,000 | ||||||||
Accrued compensation |
1,258,000 | 1,053,000 | ||||||||
Accrued expenses |
833,000 | 742,000 | ||||||||
Total current liabilities |
3,993,000 | 5,434,000 | ||||||||
Long-term obligations |
6,024,000 | 6,114,000 | ||||||||
Shareholders equity |
48,873,000 | 48,548,000 | ||||||||
$ | 58,890,000 | $ | 60,096,000 | |||||||
See accompanying notes to condensed consolidated financial statements.
3
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three months ended March 31, | Nine months ended March 31, | ||||||||||||||||
2003 | 2002 | 2003 | 2002 | ||||||||||||||
Net sales |
$ | 11,833,000 | $ | 10,254,000 | $ | 31,067,000 | $ | 27,072,000 | |||||||||
Cost of goods sold |
5,413,000 | 5,653,000 | 14,487,000 | 15,911,000 | |||||||||||||
Gross profit |
6,420,000 | 4,601,000 | 16,580,000 | 11,161,000 | |||||||||||||
Operating expenses |
|||||||||||||||||
Research and development |
890,000 | 1,057,000 | 2,858,000 | 3,820,000 | |||||||||||||
Marketing and sales |
3,154,000 | 2,778,000 | 9,059,000 | 7,913,000 | |||||||||||||
General and administrative |
1,404,000 | 1,217,000 | 4,108,000 | 3,566,000 | |||||||||||||
5,448,000 | 5,052,000 | 16,025,000 | 15,299,000 | ||||||||||||||
Operating income (loss) |
972,000 | (451,000 | ) | 555,000 | (4,138,000 | ) | |||||||||||
Other income (expense) |
|||||||||||||||||
Interest income |
3,000 | (26,000 | ) | 38,000 | 52,000 | ||||||||||||
Interest expense |
(163,000 | ) | (178,000 | ) | (591,000 | ) | (571,000 | ) | |||||||||
Other |
135,000 | (2,000 | ) | 211,000 | (12,000 | ) | |||||||||||
(25,000 | ) | (206,000 | ) | (342,000 | ) | (531,000 | ) | ||||||||||
Net income (loss) |
$ | 947,000 | $ | (657,000 | ) | $ | 213,000 | $ | (4,669,000 | ) | |||||||
Net income (loss) per share |
|||||||||||||||||
Basic |
$ | 0.07 | $ | (0.05 | ) | $ | 0.02 | $ | (0.37 | ) | |||||||
Diluted |
$ | 0.07 | $ | (0.05 | ) | $ | 0.02 | $ | (0.37 | ) | |||||||
Weighted average shares outstanding |
|||||||||||||||||
Basic |
12,885,206 | 12,806,177 | 12,880,683 | 12,785,059 | |||||||||||||
Diluted |
12,962,378 | 12,806,177 | 12,965,972 | 12,785,059 | |||||||||||||
See accompanying notes to condensed consolidated financial statements.
4
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine months ended March 31, | |||||||||||
2003 | 2002 | ||||||||||
Cash flows from operating activities: |
|||||||||||
Net income (loss) |
$ | 213,000 | $ | (4,669,000 | ) | ||||||
Adjustments to reconcile net income (loss) to net cash used in
operating activities: |
|||||||||||
Depreciation and amortization |
2,248,000 | 2,274,000 | |||||||||
Allowance for doubtful accounts |
63,000 | 126,000 | |||||||||
Changes in operating assets and liabilities
Accounts receivable |
566,000 | (336,000 | ) | ||||||||
Inventories |
(442,000 | ) | 1,916,000 | ||||||||
Prepaid expenses |
47,000 | (257,000 | ) | ||||||||
Accounts payable |
(1,738,000 | ) | (553,000 | ) | |||||||
Accrued liabilities |
295,000 | 343,000 | |||||||||
Net cash provided by (used in) operating activities |
1,252,000 | (1,156,000 | ) | ||||||||
Cash flows from investing activities: |
|||||||||||
Purchases of property, plant and equipment |
(631,000 | ) | (643,000 | ) | |||||||
Purchases of intangibles |
(80,000 | ) | (60,000 | ) | |||||||
Decrease in security deposits |
9,000 | | |||||||||
Decrease (increase) in other assets |
176,000 | (223,000 | ) | ||||||||
Net cash used in investing activities |
(526,000 | ) | (926,000 | ) | |||||||
Cash flows from financing activities: |
|||||||||||
Payments on long-term obligations |
(90,000 | ) | (193,000 | ) | |||||||
Proceeds from stock issuance |
113,000 | 443,000 | |||||||||
Net cash provided by financing activities |
23,000 | 250,000 | |||||||||
Net increase (decrease) in cash and cash equivalents |
749,000 | (1,832,000 | ) | ||||||||
Cash and cash equivalents at beginning of period |
2,528,000 | 2,310,000 | |||||||||
Cash and cash equivalents at end of period |
$ | 3,277,000 | $ | 478,000 | |||||||
Supplemental disclosure of cash flow information: |
|||||||||||
Cash paid during the period for: |
|||||||||||
Interest |
$ | 541,000 | $ | 582,000 |
See accompanying notes to condensed consolidated financial statements.
5
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 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 Companys 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 business through direct sales and marketing in the United States, Germany, Italy and Sweden and through 22 distributors in 35 foreign 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 March 31, 2003, and the results of operations for the three and nine month periods ended March 31, 2003 and 2002 and cash flows for the nine month periods ended March 31, 2003 and 2002. The results of operations for the nine months ended March 31, 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, 2002 has been derived from audited financial statements as of that date.
In preparation of the Companys 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. Inventories not expected to be consumed within one year are classified as a long-term asset. Finished good inventories include hyaluronan, packaged aseptic, and oral restorative products. Inventories consist of the following:
March 31, | June 30, | |||||||
2003 | 2002 | |||||||
Raw materials |
$ | 2,993,000 | $ | 2,902,000 | ||||
Work in progress |
306,000 | 272,000 | ||||||
Finished goods |
12,269,000 | 11,952,000 | ||||||
$ | 15,568,000 | $ | 15,126,000 | |||||
6
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)
March 31, 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, there was no impairment recorded for the three month period ended March 31, 2003 and a $40,000 impairment was recorded for the nine month period ended March 31, 2003.
Intangibles consisted of the following:
March 31, | June 30, | |||||||
2003 | 2002 | |||||||
Goodwill |
$ | 8,245,000 | $ | 8,245,000 | ||||
Customer list |
725,000 | 725,000 | ||||||
Patents |
387,000 | 387,000 | ||||||
Accumulated amortization |
(4,672,000 | ) | (4,507,000 | ) | ||||
$ | 4,685,000 | $ | 4,850,000 | |||||
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 Companys sodium hyaluronan material. The technology transferred to Lifecore includes written technical documents related to ETHICONs 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 GYNECARE 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 such review will be conducted expeditiously and that the product will return to the market following completion of the review and implementation of any appropriate action. As a result of GYNECARES voluntary withdrawal of INTERGEL Solution from the market, the Company expects to reduce production levels beginning the quarter ending June 30, 2003, which will result in increased unused manufacturing capacity charges. Further, the Company expects increased expenditures related to the process for assessment of information obtained from postmarketing experience with the device. Management does not believe there has been an impairment of assets as of March 31, 2003.
* | Trademark of ETHICON, INC. |
7
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)
March 31, 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 and inventories, subject to a borrowing base certificate. Interest is accrued at the prime rate at March 31, 2003, which was 4.25% and at the prime rate plus 1%, or 5.75%, as of June 30, 2002 under a previous credit facility agreement. At March 31, 2003 and June 30, 2002, 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 March 31, 2003 and June 30, 2002, 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 Companys 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 Companys pro-forma net income (loss), and basic and diluted income (loss) per common share would have been as follows:
Three months ended March 31, | Nine months ended March 31, | ||||||||||||||||
2003 | 2002 | 2003 | 2002 | ||||||||||||||
Net income (loss), as reported |
$ | 947,000 | $ | (657,000 | ) | $ | 213,000 | $ | (4,669,000 | ) | |||||||
Deduct: Total stock-based employee compensation
expense determined under fair value method for
awards, net of related tax effects |
(6,000 | ) | (12,000 | ) | (73,000 | ) | (521,000 | ) | |||||||||
Pro forma net income (loss) |
$ | 941,000 | $ | (669,000 | ) | $ | 140,000 | $ | (5,190,000 | ) | |||||||
Net income (loss) per common equivalent share: |
|||||||||||||||||
Basic as reported |
$ | 0.07 | $ | (0.05 | ) | $ | 0.02 | $ | (0.37 | ) | |||||||
Basic pro-forma |
$ | 0.07 | $ | (0.05 | ) | $ | 0.01 | $ | (0.41 | ) | |||||||
Diluted as reported |
$ | 0.07 | $ | (0.05 | ) | $ | 0.02 | $ | (0.37 | ) | |||||||
Diluted pro-forma |
$ | 0.07 | $ | (0.05 | ) | $ | 0.01 | $ | (0.41 | ) |
8
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)
March 31, 2003
NOTE G NET LOSS PER SHARE
The Companys 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 Companys 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 and nine month periods ended March 31, 2003 the Company reported net income and as a result, 77,172 and 85,289 common share equivalents, respectively, were included in the computation of diluted net income per share. For the three and nine month periods ended March 31, 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 and nine month periods ended March 31, 2002, 351,278 and 279,865 common share equivalents, respectfully, would have been included in the computation of diluted net income per share.
Options to purchase 2,510,494 and 2,501,494 shares of common stock with a weighted average exercise price of $12.69 and $12.71 for the three-month and nine-month periods ended March 31, 2003 and options to purchase 1,411,168 and 1,549,918 shares of common stock with a weighted average exercise price of $16.07 and $15.47 for the three-month and nine-month periods ended March 31, 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 Companys 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 Companys 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 Companys 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, 2002. Segment information for sales and income (loss) from operations are as follows:
Three months ended March 31, | Nine months ended March 31, | ||||||||||||||||
2003 | 2002 | 2003 | 2002 | ||||||||||||||
Net sales |
|||||||||||||||||
Hyaluronan products |
$ | 4,547,000 | $ | 4,717,000 | $ | 11,656,000 | $ | 10,270,000 | |||||||||
Oral restorative products |
7,286,000 | 5,537,000 | 19,411,000 | 16,802,000 | |||||||||||||
$ | 11,833,000 | $ | 10,254,000 | $ | 31,067,000 | $ | 27,072,000 | ||||||||||
Income (loss) from operations |
|||||||||||||||||
Hyaluronan products |
$ | 595,000 | $ | 93,000 | $ | 732,000 | $ | (3,239,000 | ) | ||||||||
Oral restorative products |
377,000 | (544,000 | ) | (177,000 | ) | (899,000 | ) | ||||||||||
$ | 972,000 | $ | (451,000 | ) | $ | 555,000 | $ | (4,138,000 | ) | ||||||||
9
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)
March 31, 2003
NOTE I NEW ACCOUNTING PRONOUNCEMENTS
In June 2002, FASB issued SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities, which addresses accounting and processing for costs associated with exit or disposal activities. SFAS No. 146 requires the recognition of a liability for a cost associated with an exit or disposal activity when the liability is incurred versus the date the Company commits to an exit plan. In addition, SFAS No. 146 states the liability should be initially measured at fair value. The requirements of SFAS No. 146 are effective for exit or disposal activities that are initiated after December 31, 2002. This pronouncement is not expected to have a material impact on our consolidated financial position or results of operation.
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 Companys consolidated financial statements. The Companys interim disclosures are presented in Note F.
In November 2002, FASB issued FASB Interpretation No. 45 (FIN 45), Guarantors Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others. FIN 45 addresses the disclosure requirements of a guarantor in its interim and annual financial statements about its obligations under certain guarantees that it has issued. FIN 45 also requires a guarantor to recognize, at the inception of a guarantee, a liability for the fair value of the obligation undertaken in issuing the guarantee. The disclosure requirements of FIN 45 are effective for the Company for its quarter ended December 31, 2002. The liability recognition requirements will be applicable prospectively to all guarantees issued or modified after December 31, 2002. Other than the additional disclosure requirements, this pronouncement is not expected to have a material impact on our consolidated financial position or results of operation.
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 June 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 our consolidated financial position or results of operation.
10
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 2. MANAGEMENTS 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 our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America (US GAAP). 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 our 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 Companys revenues are recognized when products are shipped to or otherwise accepted by unaffiliated customers. The Securities and Exchange Commissions Staff Accounting Bulletin (SAB) No. 101, Revenue Recognition provides guidance on the application of US GAAP to selected revenue recognition issues. The Company has concluded that its revenue recognition policy is appropriate and in accordance with US GAAP 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 by an allowance for obsolete, excess or unmarketable inventory. The estimated allowance is based on managements 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 managements 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 dates.
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 Companys financial statements from these pronouncements are not expected to be material.
11
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF RESULTS OF
OPERATIONS AND FINANCIAL CONDITION (cont.)
Results of Operations
Three Months Ended March 31, 2003 Compared to Three Months Ended March 31, 2002:
Hyaluronan | Oral Restorative | ||||||||||||||||||||||||
Division | Division | Consolidated | |||||||||||||||||||||||
2003 | 2002 | 2003 | 2002 | 2003 | 2002 | ||||||||||||||||||||
Net sales |
$ | 4,547,000 | $ | 4,717,000 | $ | 7,286,000 | $ | 5,537,000 | $ | 11,833,000 | $ | 10,254,000 | |||||||||||||
Cost of goods sold |
2,619,000 | 3,278,000 | 2,794,000 | 2,375,000 | 5,413,000 | 5,653,000 | |||||||||||||||||||
Gross profit |
1,928,000 | 1,439,000 | 4,492,000 | 3,162,000 | 6,420,000 | 4,601,000 | |||||||||||||||||||
Operating expenses |
|||||||||||||||||||||||||
Research and development |
668,000 | 815,000 | 222,000 | 242,000 | 890,000 | 1,057,000 | |||||||||||||||||||
Marketing and sales |
164,000 | 54,000 | 2,990,000 | 2,724,000 | 3,154,000 | 2,778,000 | |||||||||||||||||||
General and administrative |
501,000 | 477,000 | 903,000 | 740,000 | 1,404,000 | 1,217,000 | |||||||||||||||||||
1,333,000 | 1,346,000 | 4,115,000 | 3,706,000 | 5,448,000 | 5,052,000 | ||||||||||||||||||||
Operating income (loss) |
$ | 595,000 | $ | 93,000 | $ | 377,000 | $ | (544,000 | ) | $ | 972,000 | $ | (451,000 | ) | |||||||||||
Net sales for the quarter ended March 31, 2003 increased $1,579,000 or 15% as compared to the same quarter of last fiscal year. Hyaluronan product sales for the current quarter decreased $170,000 or 4% as compared to the same quarter of last fiscal year. The sales decrease was due to lower veterinary and gynecologic hyaluronan shipments. Oral restorative product sales for the current quarter increased $1,749,000 or 32% compared to the same quarter of last fiscal year. International sales of oral restorative products increased 50% and domestic sales increased 17% as compared to the same quarter of last fiscal year.
Consolidated gross margin increased to 54% for the current quarter from 45% for the same quarter of last fiscal year. The gross margin for the Hyaluronan Division increased to 42% from a gross margin of 31% due to absorption of unused manufacturing capacity charges associated with increased hyaluronan production and product mix. The gross margin for the Oral Restorative Division increased to 62% for the current quarter from 57% 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 decreased $167,000 or 16% in the current quarter as compared to the same quarter of last fiscal year. The decrease is due to the decline in consulting and professional fees related to the regulatory review process of INTERGEL Solution. The Company received FDA approval to market this product in the United States in November 2001.
Marketing and sales expenses increased $376,000 or 14% in the current quarter as compared to the same quarter of last fiscal year due to increased costs associated with oral restoratives international expansion.
General and administrative expenses increased $187,000 or 15% for the current quarter as compared to the same quarter of last fiscal year. The increase resulted from higher personnel related expenses primarily associated with oral restoratives international expansion.
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LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF RESULTS OF
OPERATIONS AND FINANCIAL CONDITION (cont.)
Net other expense decreased $181,000 or 88% for the current quarter as compared to the same quarter of last fiscal year. The decrease is primarily due to the $137,000 increase in other income from currency gains realized on Euro denominated intercompany transactions.
Nine Months Ended March 31, 2003 Compared to Nine Months Ended March 31, 2002:
Hyaluronan | Oral Restorative | ||||||||||||||||||||||||
Division | Division | Consolidated | |||||||||||||||||||||||
2003 | 2002 | 2003 | 2002 | 2003 | 2002 | ||||||||||||||||||||
Net sales |
$ | 11,656,000 | $ | 10,270,000 | $ | 19,411,000 | $ | 16,802,000 | $ | 31,067,000 | $ | 27,072,000 | |||||||||||||
Cost of goods sold |
6,707,000 | 8,901,000 | 7,780,000 | 7,010,000 | 14,487,000 | 15,911,000 | |||||||||||||||||||
Gross profit |
4,949,000 | 1,369,000 | 11,631,000 | 9,792,000 | 16,580,000 | 11,161,000 | |||||||||||||||||||
Operating expenses |
|||||||||||||||||||||||||
Research and development |
2,171,000 | 3,132,000 | 687,000 | 688,000 | 2,858,000 | 3,820,000 | |||||||||||||||||||
Marketing and sales |
517,000 | 183,000 | 8,542,000 | 7,730,000 | 9,059,000 | 7,913,000 | |||||||||||||||||||
General and administrative |
1,529,000 | 1,293,000 | 2,579,000 | 2,273,000 | 4,108,000 | 3,566,000 | |||||||||||||||||||
4,217,000 | 4,608,000 | 11,808,000 | 10,691,000 | 16,025,000 | 15,299,000 | ||||||||||||||||||||
Operating income (loss) |
$ | 732,000 | $ | (3,239,000 | ) | $ | (177,000 | ) | $ | (899,000 | ) | $ | 555,000 | $ | (4,138,000 | ) | |||||||||
Net sales for the nine months ended March 31, 2003 increased $3,995,000 or 15% as compared to the same period of last fiscal year. Hyaluronan product sales for the current period increased $1,386,000 or 13% as compared to the same period of last fiscal year. The sales increase was due to higher ophthalmic and orthopedic hyaluronan shipments. Oral restorative product sales for the current period increased $2,609,000 or 16% compared to the same period of last fiscal year. International sales of oral restorative products increased 30% and domestic sales increased 5% compared to the same period of last fiscal year.
Consolidated gross margin increased to 53% for the current period from 41% for the same period of last fiscal year. The gross margin for the Hyaluronan Division increased to 42% from a gross margin of 13% due to absorption of unused manufacturing capacity charges associated with increased hyaluronan production and product mix. The gross margin for the Oral Restorative Division increased to 60% for the current period from 58% 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 decreased $962,000 or 25% in the current period as compared to the same period of last fiscal year. The decrease is due to the decline in consulting and professional fees related to the regulatory review process of INTERGEL Solution. The Company received FDA approval to market this product in the United States in November 2001.
Marketing and sales expenses increased $1,146,000 or 14% in the current period as compared to the same period of last fiscal year due to an increased costs associated with oral restoratives international expansion.
General and administrative expenses increased $542,000 or 15% for the current period as compared to the same period of last fiscal year. The increase resulted from higher personnel related expenses primarily associated with oral restoratives international expansion.
13
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF RESULTS OF
OPERATIONS AND FINANCIAL CONDITION (cont.)
Net other expense decreased $189,000 for the current period as compared to the same period of last fiscal year. The decrease is primarily due to the $223,000 increase in other income from currency gains realized on Euro denominated intercompany transactions.
Liquidity and Capital Resources
The Companys Annual Report on Form 10-K for the year ended June 30, 2002 contains a detailed discussion of Lifecores liquidity and capital resources. In conjunction with this Quarterly Report on Form 10-Q, investors should read the 2002 Form 10-K.
For the nine month period ended March 31, 2003, the Company had positive cash flow from operations of $1,252,000. Cash flow from operations was positive in fiscal years 2002, 2001 and 2000. Although decreasing significantly in the last two quarters, charges for unused manufacturing capacity associated with the Companys hyaluronan production and additional costs associated with the regulatory review process for INTERGEL Solution have negatively impacted operating results in the current fiscal year, as well as in fiscal 2002, 2001 and 2000. 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. As a result of GYNECARES voluntary withdrawal of INTERGEL Solution from the market (see NOTE D), the Company expects to reduce production levels beginning the quarter ending June 30, 2003, which will result in increased unused manufacturing capacity charges. Further, the Company expects increased 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 Companys Chaska, Minnesota facility was amended in June 2002 to waive the fixed charge coverage ratio and the cash flow coverage ratio through June 30, 2003. With respect to certain of these covenants, the Company may be required to obtain further waivers for fiscal 2004. 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 and inventories, subject to a borrowing base certificate. Interest is accrued at the prime rate at March 31, 2003, which was 4.25% and at the prime rate plus 1%, or 5.75%, as of June 30, 2002 under a previous credit facility agreement. At March 31, 2003 and June 30, 2002, 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 March 31, 2003 and June 30, 2002, the Company was in compliance with all covenants.
The Company expects to finance its future business operations with cash generated from anticipated operations and the availability of the line of credit. No assurance can be given that the Company will sustain positive cash flow from operations. The Companys ability to generate positive cash flow from operations and achieve 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 complex governmental regulatory environment for new medical products and to the uncertainty of product acceptance within the medical community. Similarly, expansion of the Companys 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. While the Companys capital resources appear adequate today, the Company may need 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.
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LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 2. MANAGEMENTS 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 potential 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 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 Managements Discussion and Analysis of Financial Condition and Results of Operations section in the Companys Annual Report on Form 10-K for the year ended June 30, 2002 as well as Exhibit 99.1 to such Form 10-K.
15
LIFE 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 Companys 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 Companys outstanding long-term debt carries interest at a fixed rate. There is no material market risk relating to the Companys 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 Companys 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-14(c) under the Exchange Act) as of a date (the Evaluation Date) within 90 days prior to the filing date of this report. Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that, as of the Evaluation Date, our disclosure controls and procedures are effective in timely alerting them to the material information relating to us (or our consolidated subsidiaries) required to be included in our periodic SEC filings.
(b) Changes in internal controls.
There were no significant changes made in our internal controls during the period covered by this report or, to our knowledge, in other factors that could significantly affect these controls subsequent to the date of their evaluation.
16
LIFE BIOMEDICAL, INC. AND SUBSIDIARIES
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 Companys 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]) | ||
99.1 | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002 | ||
99.2 | Certification pursuant to 18 U.S.C. Section 1350, as adopted 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 April 17, 2003 (dated April 15, 2003) to report under Item 9 the Companys third quarter financial results. | |||
A report on Form 8-K was filed on March 31, 2003 (dated March 27, 2003) to report under Item 9 that Gynecare voluntarily suspends marketing and sales of anti-adhesion product pending evaluation of postmarketing events. |
17
LIFE BIOMEDICAL, INC. AND SUBSIDIARIES
PART II FINANCIAL 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: May 12, 2003 |
/s/ James W. Bracke James W. Bracke President & Chief Executive Officer |
||
Dated: May 12, 2003 |
/s/ Dennis J. Allingham Dennis J. Allingham Executive Vice President & Chief Financial Officer (Principal Financial Officer) |
18
CERTIFICATION
Chief Executive Officer
I, James W. Bracke, Ph.D., certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Lifecore Biomedical, Inc.; | ||
2. | Based on my knowledge, this quarterly 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 quarterly report; | ||
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly report; | ||
4. | The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: |
| designed such disclosure controls and procedures 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 quarterly report is being prepared; | ||
| evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and | ||
| presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; |
5. | The registrants other certifying officer and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent function): |
| all significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and | ||
| any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and |
6. | The registrants other certifying officer and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. |
Dated: May 12, 2003 |
By /s/ James W. Bracke James W. Bracke, Ph.D. President, Chief Executive Officer (principal executive officer), Secretary and Director |
19
CERTIFICATION
Chief Financial Officer
I, Dennis J. Allingham, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Lifecore Biomedical, Inc.; | ||
2. | Based on my knowledge, this quarterly 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 quarterly report; | ||
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly report; | ||
4. | The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: |
| designed such disclosure controls and procedures 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 quarterly report is being prepared; | ||
| evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and | ||
| presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; |
5. | The registrants other certifying officer and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent function): |
| all significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and | ||
| any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and |
6. | The registrants other certifying officer and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. |
Dated: May 12, 2003 |
By /s/ Dennis J. Allingham Dennis J. Allingham Executive Vice President and Chief Financial Officer (principal financial officer) |
20