10QSB 1 0001.txt U.S. SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-QSB [X] Quarterly report under Section 13 of 15(d) of the Securities Exchange Act of 1934. For the quarterly period ended NOVEMBER 30, 2000 or ----------------- [ ] Transition report under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from to . ---------------- -------------- Commission file number 0-19866 ---------------------------- CELOX LABORATORIES, INC. (Exact name of small business issuer as specified in its charter) MINNESOTA 36-3384240 ------------------------------- ------------------------------ (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification Number) 1311 HELMO AVENUE, SAINT PAUL, MINNESOTA 55128 ------------------------------------------ ------- (Address of principal executive offices) (Zip Code) Issuers telephone number, including area code: (651) 730-1500 Check whether the issuer (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Act of 1934 during the past 12 months (or for such shorter periods that the issuer was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes _X_ No ___ State the number of shares outstanding of each the issuer's classes of common equity, as of the latest practicable date. THE NUMBER OF SHARES OF COMMON STOCK, PAR VALUE $.01 PER SHARE, OUTSTANDING ON DECEMBER 31, 2000 WAS 3,683,169. Transitional small business format disclosure: Yes ___ No _X_ 1 Table of Contents CELOX LABORATORIES, INC. Report on Form 10-QSB for fiscal quarter ended November 30, 2000 PART I-- FINANCIAL INFORMATION Page ---- ITEM 1. Financial Statements Balance Sheet as of August 31, 2000 and November 30, 2000 3 Statement of Operations -- Three months ended November 30, 2000 and November 30, 1999 5 Statement of Changes in Shareholders' Equity for the year ended August 31, 2000 and the three months ended November 30, 2000 6 Statement of Cash Flows -- Three months ended November 30, 2000 and November 30, 1999 7 Notes to Financial Statements 8 ITEM 2. Management's Discussion and Analysis of Financial Conditions and Results of Operations 9 PART II-- OTHER INFORMATION 14 2 PART I -- FINANCIAL INFORMATION ITEM 1 -- FINANCIAL STATEMENTS CELOX LABORATORIES, INC. BALANCE SHEET November 30, August 31, ASSETS 2000 2000 ------------ ------------ (Unaudited) CURRENT ASSETS Cash and cash equivalents $ 128,704 $ 63,935 Certificates of deposit 435,867 560,867 Trade receivables 36,061 33,816 Related-party receivable 6,633 6,633 Accrued interest receivable 12,988 11,901 Inventories 60,285 53,191 Prepaid expenses 2,631 1,460 ------------- ------------ Total current assets 683,169 731,803 ------------- ------------ EQUIPMENT AND LEASEHOLD IMPROVEMENTS Laboratory and production equipment 226,937 226,937 Office furniture and equipment 94,822 94,822 Leasehold improvements 138,426 138,426 ------------- ------------ 460,185 460,185 Less accumulated depreciation (361,797) (354,522) ------------- ------------ 98,388 105,663 OTHER ASSETS Patents, net 50,974 51,852 ------------- ------------ TOTAL ASSETS $ 832,531 $ 889,318 ============= ============ See Notes to Financial Statements. 3 CELOX LABORATORIES, INC. BALANCE SHEET November 30, August 31, LIABILITIES AND SHAREHOLDERS' EQUITY 2000 2000 ------------ ------------ (Unaudited) CURRENT LIABILITIES Accounts payable $ 27,339 $7,277 Accrued liabilities 30,817 36,923 Bank note payable - current 73,463 73,926 ------------ -------------- Total current liabilities 131,619 118,126 ------------ -------------- SHAREHOLDERS' EQUITY Common stock 36,832 36,832 Additional paid-in capital 5,691,646 5,691,646 ------------ -------------- 5,728,478 5,728,478 Accumulated deficit (5,027,566) (4,957,286) ------------ -------------- Total shareholders' equity 700,912 771,192 ------------ -------------- TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $832,531 $889,318 ============ ============== See Notes to Financial Statements. 4 CELOX LABORATORIES, INC. STATEMENT OF OPERATIONS (Unaudited) -------------------------------------------------------------------------------- Three months ended November 30, 2000 1999 -------------------------------------------------------------------------------- REVENUES Net sales $48,719 $52,375 Cost of products sold 20,883 19,393 -------------------------------------------------------------------------------- GROSS MARGIN 27,836 32,982 -------------------------------------------------------------------------------- OPERATING EXPENSES Research and development 35,391 35,855 Marketing and sales 24,933 23,931 Administration 64,716 68,711 -------------------------------------------------------------------------------- Total operating expenses 125,040 128,497 OPERATING LOSS (97,204) (95,515) OTHER INCOME (EXPENSE) Interest and investment income 7,422 4,998 Other income 20,539 350 Interest expense (1,037) (958) -------------------------------------------------------------------------------- Total other income, net 26,924 4,390 NET LOSS ($70,280) ($91,125) ================================================================================ BASIC AND DILUTED LOSS PER COMMON SHARE ($0.02) ($0.03) -------------------------------------------------------------------------------- 3,683,169 2,909,169 WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING ================================================================================ See Notes to Financial Statements. 5 CELOX LABORATORIES, INC. STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY (Unaudited) --------------------------------------------------------------------------------
Common Stock Additional ------------------- Paid-in Accumulated Shares Amount Capital Deficit Total -------------------------------------------------------------------------------------------------------- BALANCE AT AUGUST 31, 1999 2,909,169 $29,092 $5,312,486 ($4,649,940) $691,638 Shares issued in private placement 774,000 7,740 379,160 386,900 Net loss for the year (307,346) (307,346) -------------------------------------------------------------------------------------------------------- BALANCE AT AUGUST 31, 2000 3,683,169 $36,832 $5,691,646 ($4,957,286) $771,192 Net loss for the period (70,280) (70,280) -------------------------------------------------------------------------------------------------------- BALANCE AT NOVEMBER 30, 2000 3,683,169 $36,832 $5,691,646 ($5,027,566) $700,912
See Notes to Financial Statements. 6 CELOX LABORATORIES, INC. STATEMENT OF CASH FLOWS (Unaudited)
--------------------------------------------------------------------------------------------------------------- Three months ended November 30, --------------------------- 2000 1999 --------------------------------------------------------------------------------------------------------------- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss for the period (70,280) ($91,125) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 8,153 8,976 Changes in assets and liabilities: (Increase) decrease in: Accounts receivable (2,245) (4,838) Accrued interest receivable (1,087) (2,761) Inventories (7,094) 3,768 Prepaid expenses (1,171) (773) Increase (decrease) in: Accounts payable 20,062 19,868 Accrued liabilities (6,106) 3,782 --------------------------------------------------------------------------------------------------------------- Net cash used in operating activities (59,768) (63,103) --------------------------------------------------------------------------------------------------------------- CASH FLOWS FROM INVESTING ACTIVITIES: Maturity (Purchase) of bank certificates of deposit, net 125,000 0 Capital expenditures 0 (5,518) --------------------------------------------------------------------------------------------------------------- Net cash from (used in) investing activities 125,000 (5,518) --------------------------------------------------------------------------------------------------------------- CASH FLOWS FROM FINANCING: Principal payments on bank note payable (463) (821) --------------------------------------------------------------------------------------------------------------- Net cash used in financing activities (463) (821) Net decrease in cash and cash equivalents 64,769 (69,442) CASH AND CASH EQUIVALENTS: Beginning of period 63,935 150,824 --------------------------------------------------------------------------------------------------------------- End of period $128,704 $81,382 ===============================================================================================================
See Notes to Financial Statements. 7 CELOX LABORATORIES, INC. NOTES TO FINANCIAL STATEMENTS -- NOVEMBER 30, 2000 NOTE A - BASIS OF PRESENTATION The accompanying financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-QSB and Item 310 of Regulation S-B. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation have been included. The organization and business of the Company, accounting policies followed by the Company and other information are contained in the notes to the Company's financial statements filed as part of the Company's August 31, 2000 Form 10-KSB. This quarterly report should be read in connection with such annual report. NOTE B - CASH AND CASH EQUIVALENTS For purposes of reporting the statements of cash flows, the Company considers all highly liquid debt instruments purchased with a maturity of three months or less to be cash equivalents. NOTE C - SHORT-TERM INVESTMENTS As of November 30, 2000 the Company had investments of $435,867 in certificates of deposit. Certificates of deposit are made only with the highest rated banks. The Company also utilizes a money market fund, which is restricted by its charter to Tier 1 instruments, for a portion of its investments. At times throughout the year, the Company's cash, cash equivalents and certificates of deposit in financial institutions may exceed FDIC insurance limits. The Company has not experienced any losses in such accounts. NOTE D - NOTES PAYABLE BANK During April, 1997 the Company borrowed $100,000 from a local bank with the proceeds used for financing a portion of the tenant improvements in the Company's new facility. In February, 2000 the loan was renegotiated with a different Bank. The new loan is secured by a certificate of deposit at this bank. The interest rate for this loan, currently 5.5%, is tied to the certificate of deposit rate. NOTE E - LOSS PER COMMON SHARE Basic loss per share is computed based upon the weighted average number of common shares outstanding during the period. Stock options for 292,000 shares were not included in the computation of diluted loss per share as the results were antidilutive. 8 ITEM 2--MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS INTRODUCTION A. BACKGROUND AND PRODUCTS Celox Laboratories, Inc. ("Celox" or the "Company") is a cell technology company formed in 1985 that researches, develops, manufactures and markets cell biology products used in the propagation of cells derived from mammals, including humans, and other species. These specialized cell growth products are used primarily in academic, pharmaceutical, diagnostic and other commercial laboratories to improve the growth condition, productivity and quality of cell-derived medical and other biological products such as vaccines, monoclonal antibodies, interferons and human growth factor. The Company focuses primarily on solving the fundamental problems associated in culturing cells with the use of serum, which is derived from the whole blood of animals and humans. One of these fundamental problems is the possibility of the "mad cow disease" (Bovine Spongiform Encephalopathy) to exist in the serum derived from the whole blood of animals. The Company's research activities have resulted in proprietary technology which has been used to commercialize its non-serum growth media, cell freezing solutions and other cell biology products. The Company markets over 25 different products. The Company's proprietary products consist of six different serum-free supplements: TCMT(M), TM-235(TM), TCH(TM), Nephrigen(TM), HemaPro(TM) and VaxMax(TM)and two cell freezing solutions, Cellvation(TM) and pZerve(TM). VaxMax(TM), introduced in September of 1993, was developed specifically for use in the production of veterinary vaccines. Nephrigen(TM) was introduced in fiscal 1998 and is a serum-free growth medium developed specifically for the culturing of Human Embryonic Kidney (293) cells. As part of the Nephrigen(TM) system, the Company also introduced a non-enzymatic dissociation solution that is used instead of an enzyme such as trypsin. HemaPro(TM) was also introduced in fiscal 1998 and is a low protein, serum-free medium for clonogenic assays or EX VIVO expansion of human progenitor cells. The Company intends to obtain IN VITRO diagnostic status for HemaPro(TM). pZerve(TM) was introduced in 1999 and is used primarily for cryopreserving human cells. pZerve(TM) is used as a research product only, it is not for human use. An additional proposed clinical product, ViaStem(TM), has completed preclinical testing. This product was developed to improve the preservation of critical cells (e.g., stem cells), which are required for bone marrow transplantation. During the first quarter of fiscal 2001 the Company introduced the new product STEMSOL(TM). STEMSOL(TM) is a sterile filtered, USP Grade Dimethyl Sulfoxide (DMSO) used in a cryopreservation solution for, among other things, peripheral-blood stem cells and cord blood preservations. The Company has received a Drug Master File classification from the Food and Drug Administration (FDA) for TCM(TM). This classification will expedite the FDA approval process for customers who want to use the Company's TCM(TM) product for manufacturing purposes. The Company also manufactures eleven basal media formulations, a series of buffered saline solutions, other cell biology reagents, and a variety of custom formulations. During the third quarter of fiscal 2000, the Company entered into an agreement to manufacture specialized solutions for the processing of pancreatic islet cells for transplants. In February, 1999 the Company announced the formation of Protide Pharmaceuticals, Inc., (Protide), a wholly owned subsidiary. Celox owns four million shares of Protide. Protide was formed in connection with the further development of ViaStem(TM) and other clinically related cell therapy and transfusion products. 9 b. VIASTEM(TM) In March 1995, the Company filed a patent application for ViaStem(TM) with the U.S. Patent and Trademark Office. The Company received the U.S. Patent in early December 1996. This patent provides protection of the Company's ViaStem(TM) technology through March of 2015. A second U.S. Patent was received in August, 1998. This second patent broadened the patented uses of ViaStem(TM) in bone marrow transplantation and related therapies. The Company has also filed the documents needed for an International Patent Application as required by the Patent Cooperation Treaty. In October, 1998 the Company received notice from the New Zealand and Australia Patent Office that a patent on ViaStem(TM) had been granted by each of the respective countries. In May, 2000 the Company received notice from the Russian Patent Office of the official issue date for the Russian patent. In March, 2000 notice was received from the Patent Office in Canada that a patent had been issued for ViaStem(TM). Initial reports from other countries that have reviewed the International Patent Application have been positive. Due to the unique nature of ViaStem(TM)and its applications, the Company pursued the patent process for this product. On March 31, 2000, Protide Pharmaceuticals, Inc. (the wholly owned subsidiary of Celox) entered into an agreement with Fairview-University Medical Center (FUMC), Minneapolis, MN. FUMC will provide collecting, processing and assaying of human peripheral blood stem cells as part of Protide's clinical investigation of ViaStem(TM). During May, 2000 the Company submitted an application to the Food and Drug Administration (FDA) to initiate human clinical trials for ViaStem(TM). This was the first submission ever made by the Company to the FDA for testing in human subjects. In August, 2000 the Company announced that it had received notice from the FDA that the clinical trial on had been placed on clinical hold pending further information. The Company intends to submit the additional requested information to the FDA in the near future. C. DISTRIBUTION/MARKETING The Company continues to sell its products on a direct basis to customers around the world. In addition the Company has formed the following distribution avenues: The Company has a non-exclusive world-wide distribution agreement with ICN Pharmaceuticals, Inc. (NYSE:ICN), Costa Mesa, CA. Under the agreement, ICN is marketing Celox' TCM(TM), TCH(TM), TM-235(TM) serum replacement products as well as Cellvation(TM). The Company has also entered into an agreement with ICN to custom manufacture certain of the Company's basal media and balanced salt solutions to ICN for worldwide distribution. ICN manufactures and markets a broad range of prescription and over-the-counter pharmaceuticals, medical diagnostic products and biotechnology research products in North and Latin America, Eastern and Western Europe and the Pacific Rim countries. In 1997, the Company began providing its proprietary products to Sigma Chemical Company (NASDAQ:SIAL), St. Louis, MO. under a private label distribution agreement for worldwide distribution. 10 In 1997, the Company entered into a non-exclusive distribution agreement with TaKaRa Shuzo Co., Ltd., Biomedical Group, Kyoto, Japan. Under the agreement, TaKaRa will initially market Celox' proprietary product Cellvation(TM). TaKaRa's Biomedical Group leads the industry in several areas owing to the international scope of its research operations which span from the People's Republic of China to North America and Europe. TaKaRa will market Cellvation(TM) in Japan, Taiwan, Korea and People's Republic of China. The Company also has distribution of its products in Japan through Funakoshi Co., LTD, a well established Japanese distributor. In March, 2000, the Company entered into an agreement with SciQuest.com, Inc. (NASDAQ:SQST) to sell its products online. SciQuest.com, Inc. is a leading business-to-business e-marketplace for scientific products used by pharmaceutical, clinical, biotechnology, chemical, industrial and educational organizations worldwide. RESULTS OF OPERATIONS During the quarter ended November 30, 2000, the Company had net sales of $48,719 which was a decrease of $3,656 or 7% from $52,375 reported in the same quarter for the prior year. The decrease between years results primarily from the amount and timing of custom orders as well as orders received from distributors and customers. The Company has also discontinued some products. In addition, the Company has been expending substantial efforts relating to the advancement of ViaStemTM. The Company had a net loss of $70,280 for the quarter ended November 30, 2000 compared to a net loss of $91,125 for the same period in the previous year. The decrease results primarily from the receipt of a check in the amount of $20,539 from the KPMG Litigation Settlement Fund. This check was the result of a settlement with the Piper Jaffray Institutional Government Fund's auditors, KPMG. The check was recognized as other income in the first quarter of fiscal 2001. On a per share basis, the loss for the current quarter equaled 2 cents versus a 3 cent loss in the comparable period in fiscal 1999. The cost of products sold was 43% of net sales for the three months ended November 30, 2000, as compared to 37%$ of net sales for the three months ended November 30, 1999. The increase for the current quarter results from reduced sales levels which results in a higher percentage of fixed manufacturing costs as compared to sales. The mix of products sold also impacts the cost of sales comparisons. An operating loss of $125,040 was generated for the quarter ended November 30, 2000 compared to an operating loss of $128,497 for the same period in the previous year. The decrease between years for the three month reporting period resulted from decreases in administrative expenses with relatively flat expenses in the marketing and sales and research and development areas. The Company received interest and investment income of $7,422 during the quarter ended November 30, 2000 as compared to $4,998 in the prior year. Investment income is derived primarily from the investment of the proceeds of the Company's March 1992 initial public offering as well as from subsequent private placements. The increase in investment income during the quarter as compared to the previous year results from investing the proceeds of the private placements in bank certificates of deposit. 11 Operating expenses decreased $3,457 (3%) to $125,040 from $128,497 for the quarter ended November 30, 2000 as compared to the prior year. The decrease for the three month reporting period as compared to the prior fiscal year results from lower administrative expenses along with a small increase in marketing and sales costs, which fluctuate based on timing of promotional activities, and flat research and development expenses. Research and development costs decreased by $464 (1%) to $35,391 from $35,855 in the current quarter as compared to the previous fiscal year. The small decrease for the current quarter reflects similar expenditures in the areas of salaries and wages and professional fees as compared to the prior year. The Company expects the costs of research and development to fluctuate based on the status of preclinical and clinical trials for ViaStem(TM) . Marketing expenses increased by $1,002 (4%) to $24,933 from $23,931 for the quarter ended November 30, 2000 as compared to the previous year. The increase for the current quarter as compared to the previous year results primarily from brochures and other marketing materials developed in connection with the introduction of STEMSOL(TM) during the quarter. The Company expects that marketing and sales expenses will fluctuate based on introduction of new products, new studies, and as new advertising materials are developed. Administrative expenses decreased by 3,995 (6%) for the quarter ended November 30, 2000 compared to the previous fiscal year to $64,716 from $68,711 The decrease for the three month reporting period is due to the timing of legal and professional fees expended in connection with the introduction of new products and certain matters related to ViaStem(TM). LIQUIDITY AND CAPITAL RESOURCES Capital resources on hand at November 30, 2000 include cash and short-term investments of $564,571 and net working capital of $551,550 This represents a decrease of $60,231 (10%) in cash and short-term investments and a decrease of $62,127 (10%) in net working capital as compared to August 31, 2000. The Company is leasing approximately 9,500 square feet of office, laboratory and warehouse space in St. Paul, MN under a seven year lease. The Company moved into the new facility during March, 1997. As partial payment for tenant improvements in the new facility, the Company borrowed $100,000 from a local bank. In February, 2000 the loan was renegotiated with a different bank. The new loan is secured by a certificate of deposit at this bank. The interest rate for this loan, currently 5.5%, is tied to the certificate of deposit rate. The loan is for a one year term with a maturity in February, 2001. The balance of the tenant improvements over this amount was paid with Company funds. During fiscal 1999 the Company raised $59,400 in additional capital by selling 55,000 units at $1.00 per unit to five accredited investors through a private placement. Each unit consisted of one share of common stock and a warrant to purchase an additional two shares of common stock at an exercise price of $0.04 per share. The units were sold at a premium to the share price on the OTC Bulletin Board at the time of the placement. 12 During the second quarter of fiscal 2000 the Company raised $175,150 in additional capital by selling 145,000 units at $1.15 per unit to five investors through a private placement. Each unit consisted of one share of common stock and a warrant to purchase an additional two shares of common stock at an exercise price of $0.10 per share. During the third quarter of fiscal 2000 additional funds in the amount of $211,750 were raised by selling units at $1.15 per unit and common stock at $1.40 per share to other investors in a private placement. The additional funds raised will be primarily used for advancing ViaStem(TM) through the necessary testing before FDA approval can be obtained. The Company intends to pursue additional financing, subject to prevailing market conditions. There is no guarantee however, that the Company will be able to successfully raise an adequate amount of additional funds. In addition, there can be no assurance that the Company will be able to obtain the necessary FDA approvals for ViaStem(TM). The Company anticipates spending approximately $50,000 during fiscal 2001 on capital expenditures. Through November, 2000 the Company has made no capital expenditures. The majority of the planned expenditures will be used to fund new products, research and development and manufacturing growth. The Company believes that its capital resources on hand at November 30, 2000 together with revenues from product sales, will be sufficient to meet its cash requirements for the fiscal year. FORWARD LOOKING INFORMATION Information contained in this Form 10-QSB contains " forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, which can be identified by the use of forward-looking terminology such as "may", "will", "expect", "plan", "anticipate", "estimate" or "continue" or the negative thereof or other variations thereon or comparable terminology. There are certain important factors that could cause results to differ materially from those anticipated by some of these forward-looking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainty. The factors, among others, that could cause actual results to differ materially include the Company's ability to obtain FDA approval for its clinical products, the ability of the Company to raise additional capital and the ability to execute its business plan. 13 PART II -- OTHER INFORMATION ITEM I. -- LEGAL PROCEEDINGS The Company is not presently involved in any material legal proceedings. ITEM 2. -- CHANGES IN SECURITIES None ITEM 3. -- DEFAULTS UPON SENIOR SECURITIES None ITEM 4. -- SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS None ITEM 5. -- OTHER INFORMATION None ITEM 6. -- (A) EXHIBITS 27 Financial Data Schedule (B) REPORTS ON FORM 8-K None SIGNATURES In accordance with the requirements of the Exchange Act, the Registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. CELOX LABORATORIES, INC. Dated: January 10, 2001 By: /S/ Milo R. Polovina ---------------------------------- Milo R. Polovina, President & CEO (Principal Financial Officer) 14