UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ---------------------- FORM 10-Q [X] Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 1996 ------------------ [ ] Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from ____________ to _____________ Commission File Number O-4136 ------ Lifecore Biomedical, Inc. -------------------------------------------------- (Exact name of Registrant as specified in its charter) Minnesota 41-0948334 - -------------------------------- ------------------------ (State or other jurisdiction of (IRS Employer incorporation or organization) Identification No.) 3515 Lyman Boulevard Chaska, Minnesota 55318 - -------------------------------- ------------------------ (Address of principal executive (Zip Code) offices) Registrant's telephone number, including area code: 612-368-4300 ------------ 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 ----- ----- The number of shares outstanding of the registrant's Common Stock, $.01 per value, as of October 18, 1996 was 12,148,815 shares. 1 LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES FORM 10-Q INDEX Page PART I. Financial Information Item 1. Financial Statements Consolidated Condensed Balance Sheets at September 30, 1996 and June 30, 1996 3 Consolidated Condensed Statements of Operations for Three Months Ended September 30, 1996 and 1995 4 Consolidated Condensed Statements of Cash Flows for Three Months Ended September 30, 1996 and 1995 5 Notes to Consolidated Condensed Financial Statements 6-9 Item 2. Management's Discussion and Analysis of Results of Operations and Financial Condition 10-12 PART II. Other Information Item 6. a. Exhibit Index 13 b. Reports on Form 8-K 13 SIGNATURES 14 2 LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES CONSOLIDATED CONDENSED BALANCE SHEETS (Unaudited) September 30, June 30, 1996 1996 ------------- ------------ ASSETS Current assets Cash and cash equivalents $ 931,000 $ 3,264,000 Short-term investments 19,044,000 14,947,000 Accounts receivable 2,338,000 2,326,000 Inventories 6,261,000 5,954,000 Prepaid expenses 1,047,000 800,000 ------------ ------------ 29,621,000 27,291,000 Property, plant and equipment Land, building and equipment 13,488,000 13,670,000 Less accumulated depreciation (4,751,000) (5,009,000) ------------ ------------ 8,737,000 8,661,000 Other assets Intangibles 4,177,000 4,268,000 Long-term investments 16,042,000 20,137,000 Security deposits 798,000 788,000 Inventory 2,313,000 2,014,000 Other 1,094,000 1,270,000 ------------ ------------ 24,424,000 28,477,000 ------------ ------------ $ 62,782,000 $ 64,429,000 ------------ ------------ ------------ ------------ LIABILITIES AND SHAREHOLDERS' EQUITY Current Liabilities Current maturities of long-term obligations $ 698,000 $ 698,000 Accounts payable 849,000 1,156,000 Accrued compensation 350,000 548,000 Accrued expenses 777,000 730,000 Customers' deposits 1,347,000 1,952,000 ------------ ------------ 4,021,000 5,084,000 Long-term obligations 7,142,000 7,193,000 Shareholders' equity 51,619,000 52,152,000 ------------ ------------ $ 62,782,000 $ 64,429,000 ------------ ------------ ------------ ------------ See accompanying notes to consolidated condensed financial statements. 3 LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS (Unaudited) Three months ended September 30, ---------------------------- 1996 1995 ------------ ------------ Net sales $ 3,568,000 $ 2,729,000 Cost of goods sold 2,098,000 1,990,000 ------------ ------------ Gross profit 1,470,000 739,000 Operating expenses Research and development 686,000 382,000 Marketing and sales 1,112,000 932,000 General and administrative 725,000 564,000 ------------ ------------ 2,523,000 1,878,000 ------------ ------------ Loss from operations (1,053,000) (1,139,000) Other income (expense) Interest income 555,000 68,000 Interest expense (156,000) (207,000) ------------ ------------ 399,000 (139,000) ------------ ------------ Net loss $ (654,000) $ (1,278,000) ------------ ------------ ------------ ------------ Net loss per common share $ (.05) $ (.16) ------------ ------------ ------------ ------------ Weighted average number of common shares outstanding 12,131,046 7,982,218 ------------ ------------ ------------ ------------ See accompanying notes to consolidated condensed financial statements. 4 LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) Three months ended September 30, ---------------------------- 1996 1995 ------------ ------------ Net cash used in operating activities $ (2,280,000) $ (1,830,000) Cash flows from investing activities: Purchases of property, plant and equipment (279,000) (320,000) Purchases of investments (3,953,000) -- Maturities of investments 3,912,000 -- Purchases of intangibles (4,000) (5,000) Other 202,000 35,000 ------------ ------------ Net cash (used in) provided from investing activities (122,000) (290,000) Cash flows form financing activities: Payments of long-term obligations (51,000) (95,000) Proceeds from stock issuance 120,000 191,000 ------------ ------------ Net cash (used in) provided from financing activities 69,000 96,000 ------------ ------------ Net increase (decrease) in cash and cash equivalents (2,333,000) (2,024,000) Cash and cash equivalents at beginning of period 3,264,000 2,726,000 ------------ ------------ Cash and cash equivalents at end of period $ 931,000 $ 702,000 ------------ ------------ ------------ ------------ Supplemental disclosure of cash flow information: Cash paid during the period: Interest $ 175,000 $ 207,000 See accompanying notes to consolidated condensed financial statements. 5 LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS September 30, 1996 NOTE A - FINANCIAL INFORMATION Lifecore Biomedical, Inc. ("the Company"), develops, manufactures, and markets surgically implantable materials and devices through its two divisions, the Hyaluronate Division and the Oral Restorative Division. The Hyaluronate Division's manufacturing facility is located in Chaska, Minnesota and markets its products through OEM and contract manufacturing alliances in the fields of ophthalmology, veterinary and wound care management. The Oral Restorative Division markets its products through direct sales in the United States and Italy and through distributors in other foreign countries. In April 1995, the Company began direct sales operations in Italy through a newly formed subsidiary, Lifecore Biomedical SpA, in Verona, Italy. The accompanying unaudited consolidated condensed 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 generally accepted accounting principles 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 consolidated condensed financial statements contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the financial position as of September 30, 1996, and the results of operations and cash flows for the three month periods ended September 30, 1996 and 1995. The results of operations for the three months ended September 30, 1996 are not necessarily indicative of the results for the full year or of the results for any future periods. In preparation of the Company's consolidated financial statements, management is required to make estimates and assumptions that effect reported amounts of assets and liabilities and related revenues and expenses. Actual results could differ from the estimates used by management. 6 LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (CONT.) September 30, 1996 NOTE B - INVESTMENTS The Company has invested its excess cash from the public offering completed in the second quarter of fiscal 1996 and the offshore stock offering in April 1996 in commercial paper, government agencies and medium term corporate notes. These investments are classified as held-to-maturity given the Company's intent and ability to hold the securities to maturity and are carried at amortized cost. Investments that have maturities of less than one year have been classified as short-term investments. September 30, June 30, 1996 1996 ------------- ------------- (Unaudited) Short-term investments: Commercial paper (maturing October 1996 through August 1997) $ 14,312,000 $ 12,447,000 U.S. Government Agencies (maturing November 1996 through August 1997) 4,732,000 2,500,000 ------------- ------------- 19,044,000 14,947,000 Long-term investments: U.S. Government Agencies (maturing July 1997) -- 1,242,000 Medium term corporate notes (maturing November 1997 through October 1998) 16,042,000 18,895,000 ------------- ------------- 16,042,000 20,137,000 ------------- ------------- $ 35,086,000 $ 35,084,000 ------------- ------------- ------------- ------------- NOTE C - INVENTORIES Inventories are stated at the lower of cost (first-in, first-out method) or market. Inventory not expected to be consumed within one year is classified as a long-term asset. Inventories consist of the following: September 30, June 30, 1996 1996 ------------- ------------- (Unaudited) Raw materials $ 2,724,000 $ 2,632,000 Work in progress 140,000 82,000 Finished goods 5,710,000 5,254,000 ------------- ------------- $ 8,574,000 $ 7,968,000 ------------- ------------- ------------- ------------- 7 LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (CONT.) September 30, 1996 NOTE D - CUSTOMERS' DEPOSITS In November 1994, Lifecore renewed its current supply contract with Alcon Laboratories, Inc., an indirect subsidiary of Nestle S.A. ("Alcon"), through December 1998. The agreement contains minimum annual purchase requirements totaling $10,400,000 for calendar years 1995 through 1998. Lifecore received a $6,300,000 cash advance from Alcon against future contract purchases. The remaining cash advance is classified as short-term as it is expected to be realized during the fiscal year ended June 30, 1997. As security for the cash advance, Lifecore granted Alcon a right to accelerate delivery of certain finished hyaluronate inventory. The amount of inventory that is subject to acceleration is limited to the amount purchasable by the outstanding cash advance based upon the contract price. NOTE E - OFFERINGS OF COMMON STOCK On October 18, 1995, the Company received net proceeds of approximately $19,852,000 from the sale of 2,200,000 shares of its common stock through a public offering. On November 16, 1995, the Company received net proceeds of approximately $3,010,000 when the underwriters purchased an additional 330,000 shares of common stock related to the over-allotment option. On April 11, 1996, the Company completed the sale of 1,500,000 shares of its common stock and received net proceeds of approximately $22,443,000 through a Regulation S offering to qualified investors outside the United States. NOTE F - AGREEMENTS In 1994, Lifecore and Ethicon, Inc. ("Ethicon"), a subsidiary of Johnson & Johnson, entered into a Conveyance, License, Development and Supply Agreement (the "Ethicon Agreement"). Under the terms of the Ethicon Agreement, Ethicon transferred to Lifecore its ownership in certain technology related to research and development previously conducted on the Company's sodium hyaluronate material. The technology transferred to Lifecore includes written technical documents related to Ethicon's research and development of a product to inhibit the formation of surgical adhesions. These documents include product specifications, methods and techniques, 8 LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (CONT.) September 30, 1996 technology, know-how and certain patent applications. Lifecore has assumed responsibility for continuing the anti-adhesion development project including conducting human clinical trials on LUBRICOAT Gel, a second generation hyaluronate-based product. Lifecore has granted Ethicon exclusive worldwide marketing rights through 2008 to the products developed by Lifecore within defined fields of use. The Company has made and continues to make a significant investment in the development and testing of LUBRICOAT Gel, a product designed to reduce the incidence of postsurgical adhesions. The product is currently undergoing human clinical trials to develop the data necessary to apply to the United States Food and Drug Administration ("FDA") for clearance to market the product for commercial application. However, even if the product is successfully developed and the Company receives clearance from the FDA, there can be no assurance that it will receive market acceptance. Failure to achieve significant sales of the product could have a material adverse effect on future prospects for the Company's operations. 9 LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONAL AND FINANCIAL CONDITION RESULTS OF OPERATIONS THREE MONTHS ENDED SEPTEMBER 30, 1996 COMPARED TO THREE MONTHS ENDED SEPTEMBER 30, 1995 Net sales for the quarter ended September 30, 1996 increased $839,000 or 31% as compared to the same quarter of last fiscal year. Hyaluronate product sales for the current quarter decreased 10% as compared to the same quarter of last fiscal year. The decrease resulted from two main factors. First, sales to Alcon for the quarter ended September 30, 1996 were at contract minimums, which were lower than the contract minimums for the same quarter of last fiscal year. Second, revenues from products in development were lower during the quarter ended September 30, 1996 as compared to the same quarter of last fiscal year. These decreases were partially offset by product revenues from Chiron Vision in the quarter ended September 30, 1996 compared to no revenues from Chiron Vision in the same quarter of last fiscal year. Product shipments to Chiron Vision commenced in December 1995. Oral restorative product sales for the current quarter increased 71% as compared to the same quarter of last fiscal year. The increase in oral restorative product sales is a result of increased marketing and sales activities in the domestic market and expanded distribution networks in international markets, including Italy, where the Company's subsidiary, Lifecore Biomedical SpA is located. Cost of goods sold, as a percentage of net sales, decreased to 59% for the current quarter from 73% for the same quarter of last fiscal year. The decrease resulted principally from spreading fixed expenses over increased product sales and to a lesser extent, lower direct charges for idle capacity related to hyaluronate products resulting from a higher utilization of the Company's manufacturing facility. Research and development expenses increased $304,000 or 80% for the current quarter as compared to the same quarter of last fiscal year. The increase resulted principally from increased costs associated with human clinical trials on LUBRICOAT Gel. Human clinical trials began in late fiscal 1995 and continued throughout the current quarter. Activity on other products in development was higher in the current quarter compared to the same quarter of last fiscal year which accounted for the remainder of the increase. 10 LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONAL AND FINANCIAL CONDITION (CONT.) Marketing and sales expenses increased $180,000 or 19% for the current quarter as compared to the same quarter of last fiscal year. The increase reflects increased advertising, sales literature costs and expenses from the expanded direct sales force at Lifecore Biomedical SpA. General and Administrative expenses increased $161,000 or 29% for the current quarter as compared to the same quarter of last fiscal year. The increase reflects higher personnel related costs. Other income (expense) increased $538,000 for the current quarter as compared to the same quarter of last fiscal year. The increase in interest income of $487,000 reflected the effect of having additional cash available to invest as a result of the proceeds received from the public stock offering completed in fall 1995 and the offshore stock offering in April 1996. Interest expense decreased for the current quarter as compared to the same quarter of last fiscal year due to lower average debt outstanding as a result of the October 1995 payment on the note payable to Implant Support, Systems, Inc. (ISS). LIQUIDITY AND CAPITAL RESOURCES The Company's Annual Report on Form 10-K for the year ended June 30, 1996 contains a detailed discussion of Lifecore's liquidity and capital resources. In conjunction with this Quarterly Report on Form 10-Q, investors should read the 1996 Form 10-K. The Company has had significant operating cash flow deficits for the last three fiscal years. As the Hyaluronate Division's production increases, the Company's direct charges associated with excess plant capacity will decrease; however, research and development costs for LUBRICOAT Gel, marketing and sales expenses for the oral restorative products, and personnel costs are increasing. Approximately $1.9 million of product shipments due to Alcon in fiscal 1997 will not generate additional cash as the customer deposit from November 1994 is reduced to zero. In addition, the Company will have significant fixed obligations in future periods associated with the equipment lease, the industrial development revenue bonds and the ISS note, which total $2,518,000 for fiscal 1997 and $2,073,000 for fiscal 1998. In the second quarter of fiscal 1996, the Company completed a public offering of its Common Stock, providing net proceeds of approximately $23 million. In the fourth quarter of fiscal 1996, the Company completed a Regulation S offering to qualified investors outside the United States providing net proceeds of approximately $22 11 LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONAL AND FINANCIAL CONDITION (CONT.) million. The Company intends to use the net proceeds of these offerings to expand its warehouse and distribution capabilities, to accelerate the scale-up of aseptic-packaging facilities in anticipation of significant commercial demand for finished hyaluronate products, for working capital, and for possible future redemption of all or a portion of the outstanding industrial development revenue bonds. The Company believes these capital resources are sufficient to meet the Company's needs through fiscal 1998, including its fixed obligations and anticipated operating cash flow deficits. Please refer to the Management's Discussion and Analysis section of the Annual Report on Form 10-K for the year ended June 30, 1996 for a cautionary statement on important factors to consider in evaluating the forward-looking statements included in this Form 10-Q. 12 LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES PART II OTHER INFORMATION Item 6. Exhibits and Reports on Form 8-K a. Exhibits and Exhibit Index None Required b. Reports on Form 8-K None 13 LIFECORE BIOMEDICAL, INC. AND SUBSIDIARIES 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: October 28, 1996 /s/ James W. Bracke -------------------------- James W. Bracke President & Chief Executive Officer Dated: October 28, 1996 /s/ Dennis J. Allingham -------------------------- Dennis J. Allingham Vice President & Chief Financial Officer (Principal Financial Officer) 14