UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Form 10-Q
þ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the quarterly period ended September 30, 2004
o Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the transition period from to
Commission File Number 0-4136
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
Not Applicable
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
Yes þ No o
The number of shares outstanding of the registrants Common Stock, $.01 par value, as of November 1, 2004 was 12,943,808 shares.
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
FORM 10-Q
TABLE OF CONTENTS
1
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
ITEM 1. FINANCIAL STATEMENTS
(Unaudited)
September 30, | June 30, | |||||||
2004 |
2004 |
|||||||
ASSETS |
||||||||
Current Assets |
||||||||
Cash and cash equivalents |
$ | 9,126,000 | $ | 8,553,000 | ||||
Accounts receivable, less allowances |
8,408,000 | 8,626,000 | ||||||
Inventories |
10,436,000 | 9,491,000 | ||||||
Prepaid expenses |
923,000 | 705,000 | ||||||
Total current assets |
28,893,000 | 27,375,000 | ||||||
Property, plant and equipment |
||||||||
Land, building and equipment |
45,892,000 | 45,398,000 | ||||||
Less accumulated depreciation |
(22,715,000 | ) | (22,200,000 | ) | ||||
23,177,000 | 23,198,000 | |||||||
Other Assets |
||||||||
Intangibles |
4,508,000 | 4,513,000 | ||||||
Security deposits |
7,000 | 837,000 | ||||||
Inventories |
3,300,000 | 3,891,000 | ||||||
Other |
582,000 | 504,000 | ||||||
8,397,000 | 9,745,000 | |||||||
$ | 60,467,000 | $ | 60,318,000 | |||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Current Liabilities |
||||||||
Current maturities of long-term obligations |
$ | 277,000 | $ | 177,000 | ||||
Accounts payable |
1,893,000 | 2,467,000 | ||||||
Accrued compensation |
1,064,000 | 1,362,000 | ||||||
Accrued expenses |
1,700,000 | 1,677,000 | ||||||
Total current liabilities |
4,934,000 | 5,683,000 | ||||||
Long-term obligations |
5,330,000 | 5,809,000 | ||||||
Shareholders equity |
50,203,000 | 48,826,000 | ||||||
$ | 60,467,000 | $ | 60,318,000 | |||||
See accompanying notes to condensed consolidated financial statements.
2
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
(Unaudited)
Three months ended September 30, |
||||||||
2004 |
2003 |
|||||||
Net sales |
$ | 12,195,000 | $ | 9,947,000 | ||||
Cost of goods sold |
4,986,000 | 4,769,000 | ||||||
Gross profit |
7,209,000 | 5,178,000 | ||||||
Operating expenses |
||||||||
Research and development |
848,000 | 1,259,000 | ||||||
Marketing and sales |
3,215,000 | 3,173,000 | ||||||
General and administrative |
1,467,000 | 1,561,000 | ||||||
5,530,000 | 5,993,000 | |||||||
Operating income (loss) |
1,679,000 | (815,000 | ) | |||||
Other income (expense) |
||||||||
Interest, net |
(103,000 | ) | (149,000 | ) | ||||
Bond retirement expense |
(290,000 | ) | | |||||
Currency transaction gains |
85,000 | 125,000 | ||||||
Other |
2,000 | (4,000 | ) | |||||
(306,000 | ) | (28,000 | ) | |||||
Income (loss) before income taxes |
1,373,000 | (843,000 | ) | |||||
Provision for income taxes |
94,000 | | ||||||
Net income (loss) |
$ | 1,279,000 | $ | (843,000 | ) | |||
Net income (loss) per share |
||||||||
Basic |
$ | 0.10 | $ | (0.07 | ) | |||
Diluted |
$ | 0.10 | $ | (0.07 | ) | |||
Weighted average shares outstanding |
||||||||
Basic |
12,932,606 | 12,889,113 | ||||||
Diluted |
12,965,549 | 12,889,113 | ||||||
See accompanying notes to condensed consolidated financial statements.
3
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
(Unaudited)
Three months ended September 30, |
||||||||
2004 |
2003 |
|||||||
Cash flows from operating activities: |
||||||||
Net income (loss) |
$ | 1,279,000 | $ | (843,000 | ) | |||
Adjustments to reconcile net income (loss) to net cash provided by
(used in) operating activities: |
||||||||
Depreciation and amortization |
523,000 | 654,000 | ||||||
Allowance for doubtful accounts |
139,000 | 29,000 | ||||||
Accumulated currency translation adjustment |
92,000 | (279,000 | ) | |||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable |
78,000 | 762,000 | ||||||
Inventories |
(354,000 | ) | (45,000 | ) | ||||
Prepaid expenses |
(219,000 | ) | 122,000 | |||||
Accounts payable |
(573,000 | ) | 267,000 | |||||
Accrued liabilities |
(275,000 | ) | 219,000 | |||||
Net cash provided by operating activities |
690,000 | 886,000 | ||||||
Cash flows from investing activities: |
||||||||
Purchases of property, plant and equipment |
(493,000 | ) | (101,000 | ) | ||||
Decrease (increase) in security deposits |
830,000 | (2,000 | ) | |||||
Decrease (increase) in other assets |
(81,000 | ) | 110,000 | |||||
Net cash provided by investing activities |
256,000 | 7,000 | ||||||
Cash flows from financing activities: |
||||||||
Payments on long-term obligations |
(23,000 | ) | (42,000 | ) | ||||
Issuance of industrial revenue bonds |
5,630,000 | | ||||||
Retirement of industrial revenue bonds |
(5,986,000 | ) | | |||||
Proceeds from stock issuance |
6,000 | 19,000 | ||||||
Net cash used in financing activities |
(373,000 | ) | (23,000 | ) | ||||
Net increase in cash and cash equivalents |
573,000 | 870,000 | ||||||
Cash and cash equivalents at beginning of period |
8,553,000 | 4,211,000 | ||||||
Cash and cash equivalents at end of period |
$ | 9,126,000 | $ | 5,081,000 | ||||
Supplemental disclosure of cash flow information: |
||||||||
Cash paid during the period for: |
||||||||
Interest |
$ | 156,000 | $ | 208,000 | ||||
Taxes |
68,000 | 10,000 |
See accompanying notes to condensed consolidated financial statements.
4
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
September 30, 2004
NOTE A FINANCIAL INFORMATION
Lifecore Biomedical, Inc. (referred to in this report as Lifecore or the Company) manufactures biomaterials and surgical devices for use in various surgical markets and provides specialized contract aseptic manufacturing services through its two divisions, the Hyaluronan Division and the Oral Restorative Division. The Companys manufacturing facility is located in Chaska, Minnesota. The Hyaluronan Division markets its products through original equipment manufacturers and contract manufacturing alliances in ophthalmologic, orthopedic surgery, veterinary medicine and gynecologic fields. The Oral Restorative Division markets its products through direct sales in the United States, Italy, Germany and Sweden and through distributors in other 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 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 of the Company as of September 30, 2004, the results of operations for the three month periods ended September 30, 2004 and 2003; and cash flows for the three month periods ended September 30, 2004 and 2003. The results of operations for the three months ended September 30, 2004 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, 2004 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. 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, | |||||||
2004 |
2004 |
|||||||
Raw materials |
$ | 3,385,000 | $ | 2,756,000 | ||||
Work in progress |
490,000 | 416,000 | ||||||
Finished goods |
9,861,000 | 10,210,000 | ||||||
$ | 13,736,000 | $ | 13,382,000 | |||||
5
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
September 30, 2004
NOTE C INTANGIBLE ASSETS
The Company does not amortize goodwill. The Companys customer list was fully amortized as of June 30, 2004 and patents are amortized over their useful lives. 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, 2004.
Intangibles consisted of the following at:
September 30, | June 30, | |||||||
2004 |
2004 |
|||||||
Goodwill |
$ | 8,245,000 | $ | 8,245,000 | ||||
Customer list |
725,000 | 725,000 | ||||||
Patents |
387,000 | 387,000 | ||||||
Accumulated amortization |
(4,849,000 | ) | (4,844,000 | ) | ||||
$ | 4,508,000 | $ | 4,513,000 | |||||
NOTE D 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 credit facility agreement allows for advances against eligible accounts receivable, subject to a borrowing base certificate. Interest is accrued at the prime rate, which was 4.75% at September 30, 2004. At September 30, 2004 and June 30, 2004, there were no balances outstanding under the line of credit. The terms of the credit facility 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, 2004 and June 30, 2004, the Company was in compliance with all covenants.
6
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
September 30, 2004
NOTE E STOCK PLAN INFORMATION
The Company has various stock option plans that provide for the granting of stock options to officers, employees and directors. The Company accounts for stock-based compensation using the intrinsic value method whereby the options are granted at market price, and therefore no compensation costs are recognized. 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, the Companys pro-forma net income (loss), and basic and diluted net income (loss) per common share would have been as follows:
Three months ended September 30, |
||||||||
2004 |
2003 |
|||||||
Net income (loss), as reported |
$ | 1,279,000 | $ | (843,000 | ) | |||
Deduct: Total stock-based employee compensation expense
determined under fair value method for awards, net of
related tax effects (no tax effect in 2004 and 2003) |
(200,000 | ) | (90,000 | ) | ||||
Pro forma net income (loss) |
$ | 1,079,000 | $ | (933,000 | ) | |||
Net income (loss) per common equivalent share: |
||||||||
Basic as reported |
$ | 0.10 | $ | (0.07 | ) | |||
Diluted as reported |
$ | 0.10 | $ | (0.07 | ) | |||
Basic pro-forma |
$ | 0.08 | $ | (0.07 | ) | |||
Diluted pro-forma |
$ | 0.08 | $ | (0.07 | ) |
7
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
September 30, 2004
NOTE F NET INCOME (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 month period ended September 30, 2004, 32,943 shares of common stock equivalents were included in the computation of diluted net income per share. For the three month period ended September 30, 2003, the common share equivalents that would have been included in the computation of diluted net income per share were 32,614 had net income been achieved.
Options to purchase 1,343,978 shares of common stock with a weighted average exercise price of $11.20 for the three-month period ended September 30, 2004 and 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 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 G SEGMENT INFORMATION
The Company operates two business segments. The Hyaluronan Division manufactures, markets and sells products containing hyaluronan and provides contract aseptic packaging services. The Oral Restorative Division produces and 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.
Segment assets and the basis of segmentation are consistent with that reported at June 30, 2004. Segment information for sales and income (loss) from operations are as follows:
Three months ended September 30, |
||||||||
2004 |
2003 |
|||||||
Net sales |
||||||||
Hyaluronan products |
$ | 4,637,000 | $ | 3,558,000 | ||||
Oral restorative products |
7,558,000 | 6,389,000 | ||||||
$ | 12,195,000 | $ | 9,947,000 | |||||
Income (loss) from operations |
||||||||
Hyaluronan products |
$ | 1,319,000 | $ | (574,000 | ) | |||
Oral restorative products |
360,000 | (241,000 | ) | |||||
$ | 1,679,000 | $ | (815,000 | ) | ||||
8
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (continued)
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)
September 30, 2004
NOTE H AGREEMENTS
On September 20, 2004, the Company secured worldwide marketing rights to its ferric hyaluronan adhesion prevention product from Ethicon, Inc. Lifecores product, which was previously marketed by Gynecare, a division of Ethicon, Inc. (Gynecare), under the trademark GYNECARE INTERGEL Adhesion Prevention Solution, was voluntarily withdrawn from the market by Gynecare on March 27, 2003 to assess information obtained from its usage in the treatment of patients. Under the agreement, Gynecare will have no responsibility for any aspect of the future manufacture, marketing, sale or distribution of the product nor will it derive any financial benefit therefrom.
NOTE I LEGAL PROCEEDINGS
Lifecore is a party in 47 pending lawsuits filed by 43 different plaintiffs, all of which allege that the plaintiffs suffered injuries due to the defective nature of INTERGEL Solution manufactured by Lifecore and marketed by ETHICON. ETHICON is currently defending Lifecore in each of these lawsuits. Lifecore also has products liability insurance that it believes will cover these claims.
9
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Critical Accounting Policies
The discussion and analysis of our financial condition and results of operations is based upon the Companys 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 Companys 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 recognizes revenue when the product is shipped, or otherwise accepted by unaffiliated customers, pursuant to customers orders, the price is fixed and collection is reasonably assured. The Securities and Exchange Commissions 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 the Companys 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 the lower of cost or market for obsolete, excess or unmarketable inventory. The lower of cost or market adjustment 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.
The Company 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.
10
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (continued)
Overview
The Company manufactures biomaterials and medical devices for use in various surgical markets and provides related specialized contract aseptic manufacturing services. The Company operates through two business divisions, the Hyaluronan Division and the Oral Restorative Division.
The Companys performance continues to be positively affected by revenue growth in both the Oral Restorative Division and the Hyaluronan Division. Continued unused manufacturing capacity charges resulting from reduced hyaluronan production levels have negatively impacted the Hyaluronan Division operating results. Further, the financial leverage gained by the reduction of regulatory consulting expenses and the workforce reduction in fiscal 2004 has had a positive impact on operating results. The above factors are applicable to the three month period ended September 30, 2004.
Results of Operations
Three Months Ended September 30, 2004 Compared to Three Months Ended September 30, 2003:
Hyaluronan | Oral Restorative | |||||||||||||||||||||||
Division |
Division |
Consolidated |
||||||||||||||||||||||
2004 |
2003 |
2004 |
2003 |
2004 |
2003 |
|||||||||||||||||||
Net sales |
$ | 4,637,000 | $ | 3,558,000 | $ | 7,558,000 | $ | 6,389,000 | $ | 12,195,000 | $ | 9,947,000 | ||||||||||||
Cost of goods sold |
2,086,000 | 2,369,000 | 2,900,000 | 2,400,000 | 4,986,000 | 4,769,000 | ||||||||||||||||||
Gross profit |
2,551,000 | 1,189,000 | 4,658,000 | 3,989,000 | 7,209,000 | 5,178,000 | ||||||||||||||||||
Operating expenses
Research and
development |
604,000 | 1,019,000 | 244,000 | 240,000 | 848,000 | 1,259,000 | ||||||||||||||||||
Marketing and sales |
92,000 | 127,000 | 3,123,000 | 3,046,000 | 3,215,000 | 3,173,000 | ||||||||||||||||||
General and
administrative |
536,000 | 617,000 | 931,000 | 944,000 | 1,467,000 | 1,561,000 | ||||||||||||||||||
1,232,000 | 1,763,000 | 4,298,000 | 4,230,000 | 5,530,000 | 5,993,000 | |||||||||||||||||||
Operating income
(loss) |
$ | 1,319,000 | $ | (574,000 | ) | $ | 360,000 | $ | (241,000 | ) | $ | 1,679,000 | $ | (815,000 | ) | |||||||||
Net sales for the quarter ended September 30, 2004 increased $2,248,000 or 23% as compared to the same quarter of last fiscal year. Hyaluronan product sales for the current quarter increased $1,079,000 or 30% as compared to the same quarter of last fiscal year due to increased ophthalmic and orthopedic sales. Oral restorative product sales for the current quarter increased $1,169,000 or 18% compared to the same quarter of last fiscal year. Domestic sales increased 24% and international sales increased 12% as compared to the same quarter of last fiscal year. Favorable foreign currency comparisons increased international sales by $132,000 over the same quarter of last fiscal year.
Consolidated gross margin increased to 59% for the current quarter from 52% for the same quarter of last fiscal year. The gross margin for the Hyaluronan Division increased to 55%, from a gross margin of 33%, due to a favorable product mix and decreased unused manufacturing capacity charges associated with increased production. The gross margin for the Oral Restorative Division was 62% for the current quarter, which is comparable to the same quarter of last fiscal year.
11
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (continued)
Research and development expenses decreased $411,000 or 33% in the current quarter as compared to the same quarter of last fis cal year. The decrease is due to the decline in regulatory consulting and professional fees associated with the market withdrawal of INTERGEL Solution in March 2003.
Marketing and sales expenses increased $42,000 or 1% in the current quarter as compared to the same quarter of last fiscal year due to increased costs associated with expansion of the Oral Restorative Divisions domestic sales force and international operations.
General and administrative expenses decreased $94,000 or 6% for the current quarter as compared to the same quarter of last fiscal year. The decrease resulted from the workforce reduction in the third quarter of fiscal 2004.
Other income (expense), as shown on the Condensed Consolidated Statements of Operations, increased $278,000 for the current quarter as compared to the same quarter of last fiscal year. The increase is due to bond retirement expense of $290,000, which resulted from the refinancing of industrial revenue bonds.
Liquidity and Capital Resources
The Companys Annual Report on Form 10-K for the year ended June 30, 2004 contains a detailed discussion of Lifecores liquidity and capital resources. Investors should read the 2004 Form 10-K in conjunction with this Quarterly Report on Form 10-Q.
For the three month period ended September 30, 2004, the Company had positive cash flow from operations of $690,000. Cash flow from operations was positive in fiscal years 2004, 2003 and 2002. Charges for unused manufacturing capacity associated with the Companys hyaluronan production have negatively impacted operating results in the current fiscal year. Also, marketing and sales expenses for the oral restorative products are expected to continue at a high level due to continued international expansion and increased personnel costs.
The Company has a $5,000,000 credit facility with a bank which has a maturity date of December 31, 2005. The credit facility agreement allows for advances against eligible accounts receivable, subject to a borrowing base certificate. Interest is accrued at the prime rate which was 4.75% at September 30, 2004. At September 30, 2004 and June 30, 2004, 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, 2004 and June 30, 2004, the Company was in compliance with all covenants.
On August 19, 2004, the Company issued variable rate industrial revenue bonds. The proceeds from these bonds were used to retire the existing 10.25% fixed rate industrial revenue bonds on September 1, 2004. The aggregate principal amount of the new bonds is $5,630,000, and the bonds will bear interest at a variable rate set weekly by the bond remarketing agent (1.69% as of September 30, 2004). In addition, the Company will pay an annual remarketing fee equal to .125% and an annual letter of credit fee of 1.0%. The bonds are collateralized by a bank letter of credit which is secured by a first mortgage on the facility. The Company is required to make monthly principal and interest payments to a sinking fund. 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 net income (loss). As of September 30, 2004, the Company was in compliance with all covenants.
12
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART I FINANCIAL INFORMATION
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (continued)
The Companys 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 complex governmental regulatory environment for new medical products, the early stage of certain of these markets and the uncertainty associated with the future market status of the Companys adhesion prevention product. 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. The Company expects its cash generated from anticipated operations and the available funds 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 Companys 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 material off-balance sheet financing activities.
Cautionary Statement
Statements included in this Managements Discussion and Analysis of Financial Condition and Results of Operations and elsewhere in this Form 10-Q, in future filings by the Company with the Securities and Exchange Commission and in the Companys press releases and oral statements made with the approval of authorized executive officers, that are not historical or current facts, should be considered forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to market acceptance and demand for the Companys products, future product development plans and timing, the results of clinical trials, FDA clearances and the related timing of such, the potential size of the markets for the Companys products, future product introductions, future revenues, expense levels and capital needs and the Companys ability to successfully negotiate acceptable agreements with its corporate partners. These statements are subject to certain risks and uncertainties that could cause actual results to differ materially from historical earnings and those presently anticipated or projected. The Company wishes to caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made. The following important factors, among others, in some cases have affected or in the future could affect the Companys actual results and could cause its actual financial performance to differ materially from that expressed in any forward-looking statement: (i) obtaining the necessary regulatory approvals for new hyaluronan and oral restorative products; (ii) the Companys reliance on corporate partners to develop new products on a timely basis and to market the Companys existing and new hyaluronan products effectively; (iii) intense competition in the markets for the Companys principal products; and (iv) the uncertainty associated with the future market status of the Companys adhesion prevention product. Investors are referred to a more detailed discussion of the risks presented in Exhibit 99.1 to the Companys Annual Report on Form 10-K.
13
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 short-term 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 is exposed to foreign currency exchange rate risk arising from transactions in the normal course of business from sales to its foreign subsidiaries. Because the Companys products are manufactured or sourced primarily from the United States, a stronger U.S. dollar generally has a negative impact on results from operations outside the United States while a weaker dollar generally has a positive effect. The Company does not use derivative financial instruments to manage foreign currency fluctuation risk.
On August 19, 2004, the Company issued variable rate industrial revenue bonds. The proceeds from these bonds were used to retire the existing 10.25% fixed rate industrial revenue bonds on September 1, 2004. The aggregate principal amount of the new bonds is $5,630,000, and the bonds will bear interest at a variable rate set weekly by the bond remarketing agent (1.69% as of September 30, 2004). A ten percent change in this variable rate would be approximately $10,000 annually.
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation of disclosure controls and procedures.
Under the supervision and with the participation of the Companys management, including the Companys Chief Executive Officer and Chief Financial Officer, the Company evaluated the effectiveness of the design and operation of the Companys disclosure controls and procedures (as defined in Rule 13a 15(e) under the Securities Exchange Act of 1934, as amended, (the Exchange Act)). 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, the Companys disclosure controls and procedures were adequately designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in applicable rules and forms.
(b) Changes in internal control over financial reporting.
During the fiscal period covered by this report, there has been no change in the Companys internal control over financial reporting (as defined in Rule 13a 15(f) under the Exchange Act) that has materially affected, or is reasonably likely to materially affect, the Companys internal control over financial reporting.
14
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
ITEM 1. LEGAL PROCEEDINGS
Lifecore has been named as a defendant in 47 product liability lawsuits filed by 43 different plaintiffs (four plaintiffs have filed more than one case) alleging that the plaintiffs suffered injuries due to the defective nature of INTERGEL Solution manufactured by Lifecore and marketed by ETHICON. Lifecore has been served in the following cases as of November 8, 2004:
1. | Linda Authement and Michael Ray Lavergne v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); served 8/20/04 | |||
2. | Susan Bethers v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); served 11/3/04 | |||
3. | Barbara Black v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); served 8/16/04 | |||
4. | Renee Contratto v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Northern District of California); served 9/15/03 | |||
5. | Renee Contratto v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Superior Court of the State of California, County of Alameda); served 2/4/04 | |||
6. | Nancy Susan Drinkwitz v. Lifecore Biomedical, Inc., Johnson & Johnson, Ethicon, Inc. and Gynecare Worldwide (Carver County District Court, State of Minnesota); served 8/20/04 | |||
7. | April Ferrell and Michael Ferrell, Jr. v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc., (Florida); served 8/20/04 | |||
8. | Michelle Frosh Bernard v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); served 8/20/04 | |||
9. | Pamela Gregory and Darrell Gregory v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida);served 8/20/04 | |||
10. | Misty Langfitt v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); served 11/3/04 | |||
11. | Kristin Manning v. Johnson & Johnson, Ethicon, Inc., d/b/a Gynecare Worldwide and Lifecore Biomedical, Inc. (D. Kansas); served 1/29/04 | |||
12. | Elizabeth M. Manning v. Lifecore Biomedical, Inc., Johnson & Johnson, Ethicon, Inc. and Gynecare Worldwide (Carver County District Court, State of Minnesota) this case was settled in June 2004 | |||
13. | Marie McCabe and Scott McCabe v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); 10/29/04 (A. Complaint) | |||
14. | Antoinette McNeil v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); served 11/3/04 | |||
15. | Lauria Nuccio and Dominic Nuccio Sr. v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); served 11/3/04 |
15
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART II OTHER INFORMATION
16. | Tammy Philibert and Rudolph Philibert v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); served 11/3/04 | |||
17. | Melissa Powers v. Gynecare Through Ethicon, Inc., Johnson & Johnson, Lifecore Biomedical, Inc. and George B. Morris, IV, M.D. (Civil District Court for the Parish of Orleans, State of Louisiana); served 6/3/04 | |||
18. | Rebecca J. Rezendes v. Lifecore Biomedical, Inc., Johnson &Johnson, Ethicon, Inc. and Gynecare Worldwide; served 6/4/04 | |||
19. | Natalie M. Sanders v. Johnson & Johnson, Inc., Gynecare Worldwide, Ethicon, Inc., and Lifecore Biomedical, Inc. (District of New Jersey); served 5/21/04 | |||
20. | Monika Shumbo-Poissant v. Lifecore Biomedical, Inc., et al. (Superior Court of Connecticut); served 7/19/04 | |||
21. | Siobhan Sprecace and David Sprecace v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); served 8/20/04 | |||
22. | Heather Strauch v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); served 11/3/04 | |||
23. | Charmaine Wickwire and Michael Steven Wickwire, Sr. v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); served 11/3/04 | |||
24. | Marisol Suarez Saiz v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); served 11/8/04 | |||
25. | Dianna Shirley v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); served 11/8/04 | |||
26. | Stephanie Succar v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); served 11/8/04 | |||
27. | Joanne Thorpe v. Ethicon, Inc., d/b/a Gynecare Worldwide, Johnson & Johnson, Lifecore Biomedical, Inc. and Vital Pharma, Inc. (Florida); served 11/8/04 |
ETHICON is defending Lifecore in the above-listed lawsuits.
Lifecore has also received claim letters alleging claims similar to the complaints listed above as follows:
1. | Heather Dunne, letter dated October 9, 2003 | |||
2. | Margery LeRoux, letter dated September 9, 2003 | |||
3. | Kenna Schaller, letter dated July 10, 2003 | |||
4. | Julia Smith, letter dated May 10, 2004 |
ETHICON is responding to the above-listed claim letters on behalf of Lifecore. In addition to the above-listed claim letters, Lifecore has received a claim letter on behalf of Melody Whitfield, dated October 2, 2003, relating to injuries unrelated to INTERGEL Solution suffered in a second-look surgery as part of a clinical trial. Whitfield is seeking $195,000 in damages. Lifecore has not received any response to its letter dated February 19, 2003 disputing her claim. ETHICON has denied Lifecores tender of defense of Whitfields claim.
16
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART II OTHER INFORMATION
ITEM 6. EXHIBITS
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]) | |
10.1
|
Form of Option Agreement for employees under the Lifecore Biomedical, Inc. 1996 Stock Plan | |
10.2
|
Form of Option Agreement for directors under the Lifecore Biomedical, Inc. 1996 Stock Plan | |
10.3
|
Form of Change of Control Agreement between the Company and certain executive officers | |
10.4
|
Change of Control Agreement, dated as of June 17, 2004, between the Company and Dennis J. Allingham | |
10.5
|
Form of Noncompetition Agreement between the Company and certain executive officers | |
10.6
|
Loan Agreement, dated as of August 1, 2004, between City of Chaska, Minnesota and the Company (incorporated by reference to Exhibit 10.9 to Form 10-k for the year ended June 30, 2004) | |
10.7
|
Remarketing Agreement, dated as of August 1, 2004, between the Company and Northland Securities, Inc. (incorporated by reference to Exhibit 10.10 to Form 10-k for the year ended June 30, 2004) | |
10.8
|
Tax Exemption Agreement, dated as of August 1, 2004, between City of Chaska, Minnesota, the Company and Wells Fargo Bank, National Association (incorporated by reference to Exhibit 10.11 to Form 10-k for the year ended June 30, 2004) | |
10.9
|
Irrevocable Letter of Credit, dated as of August 19, 2004, from M&I Marshall & Ilsley Bank to Wells Fargo Bank, National Association (incorporated by reference to Exhibit 10.12 to Form 10-k for the year ended June 30, 2004) | |
10.10
|
Reimbursement Agreement, dated as of August 1, 2004, between the Company and M&I Marshall & Ilsley Bank (incorporated by reference to Exhibit 10.13 to Form 10-k for the year ended June 30, 2004) | |
10.11
|
Mortgage, Security Agreement, Assignment of Leases and Rents and Fixture Financing Statement, dated as of August 1, 2004, from the Company to M&I Marshall & Ilsley Bank (incorporated by reference to Exhibit 10.14 to Form 10-k for the year ended June 30, 2004) | |
10.12
|
Security Agreement, dated as of August 1, 2004, from the Company to M&I Marshall & Ilsley Bank (incorporated by reference to Exhibit 10.15 to Form 10-k for the year ended June 30, 2004) |
17
LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES
PART II OTHER INFORMATION
10.13
|
Pledge and Security Agreement, dated as of August 1, 2004, between the Company, M&I Marshall & Ilsley Bank and Wells Fargo Bank, National Association (incorporated by reference to Exhibit 10.16 to Form 10-k for the year ended June 30, 2004) | |
10.14
|
Bond Purchase Agreement, dated as of August 19, 2004, by and between City of Chaska, Minnesota, the Company and Northland Securities, Inc. (incorporated by reference to Exhibit 10.17 to Form 10-k for the year ended June 30, 2004) | |
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 |
18
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. |
||||
By: | ||||
Dated: November 9, 2004 | /s/ Dennis J. Allingham | |||
Dennis J. Allingham | ||||
President, Chief Executive Officer, Secretary and Director (duly authorized officer) | ||||
Dated: November 9, 2004 | /s/ David M. Noel | |||
David M. Noel | ||||
Vice President of Finance and Chief Financial Officer (principal financial and accounting officer) | ||||
19
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]) | |
10.1
|
Form of Option Agreement for employees under the Lifecore Biomedical, Inc. 1996 Stock Plan | |
10.2
|
Form of Option Agreement for directors under the Lifecore Biomedical, Inc. 1996 Stock Plan | |
10.3
|
Form of Change of Control Agreement between the Company and certain executive officers | |
10.4
|
Change of Control Agreement, dated as of June 17, 2004, between the Company and Dennis J. Allingham | |
10.5
|
Form of Noncompetition Agreement between the Company and certain executive officers | |
10.6
|
Loan Agreement, dated as of August 1, 2004, between City of Chaska, Minnesota and the Company (incorporated by reference to Exhibit 10.9 to Form 10-k for the year ended June 30, 2004) | |
10.7
|
Remarketing Agreement, dated as of August 1, 2004, between the Company and Northland Securities, Inc. (incorporated by reference to Exhibit 10.10 to Form 10-k for the year ended June 30, 2004) | |
10.8
|
Tax Exemption Agreement, dated as of August 1, 2004, between City of Chaska, Minnesota, the Company and Wells Fargo Bank, National Association (incorporated by reference to Exhibit 10.11 to Form 10-k for the year ended June 30, 2004) | |
10.9
|
Irrevocable Letter of Credit, dated as of August 19, 2004, from M&I Marshall & Ilsley Bank to Wells Fargo Bank, National Association (incorporated by reference to Exhibit 10.12 to Form 10-k for the year ended June 30, 2004) | |
10.10
|
Reimbursement Agreement, dated as of August 1, 2004, between the Company and M&I Marshall & Ilsley Bank (incorporated by reference to Exhibit 10.13 to Form 10-k for the year ended June 30, 2004) | |
10.11
|
Mortgage, Security Agreement, Assignment of Leases and Rents and Fixture Financing Statement, dated as of August 1, 2004, from the Company to M&I Marshall & Ilsley Bank (incorporated by reference to Exhibit 10.14 to Form 10-k for the year ended June 30, 2004) | |
10.12
|
Security Agreement, dated as of August 1, 2004, from the Company to M&I Marshall & Ilsley Bank (incorporated by reference to Exhibit 10.15 to Form 10-k for the year ended June 30, 2004) | |
10.13
|
Pledge and Security Agreement, dated as of August 1, 2004, between the Company, M&I Marshall & Ilsley Bank and Wells Fargo Bank, National Association (incorporated by reference to Exhibit 10.16 to Form 10-k for the year ended June 30, 2004) |
20
10.14
|
Bond Purchase Agreement, dated as of August 19, 2004, by and between City of Chaska, Minnesota, the Company and Northland Securities, Inc. (incorporated by reference to Exhibit 10.17 to Form 10-k for the year ended June 30, 2004) | |
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 |
21