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Previous: BARING ASSET MANAGEMENT INC /MA/, 13F-HR/A, 2000-11-14 |
Next: OSTEX INTERNATIONAL INC /WA/, 10-Q, EX-27.1, 2000-11-14 |
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 | |
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For the quarterly period ended September 30, 2000 |
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— or — |
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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 0-25250
OSTEX INTERNATIONAL, INC.
Name of Registrant as Specified in Its Charter
| State of Washington State or Other Jurisdiction of Incorporation or Organization |
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91-1450247 I.R.S. Employer Identification Number |
| 2203 Airport Way South, Suite 400, Seattle, Washington 98134 206-292-8082 Address and Telephone Number of Principal Executive Offices |
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| [n/a] Former name, address and fiscal year, if changed since last report |
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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 of the Registrant's common stock outstanding as of November 3, 2000 was 12,527,847.
OSTEX INTERNATIONAL, INC.
INDEX TO FORM 10-Q
PART I—FINANCIAL INFORMATION
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Page |
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| ITEM 1— | FINANCIAL STATEMENTS | ||
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Condensed Balance Sheets |
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F-1 |
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Condensed Statements of Operations |
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F-2 |
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Condensed Statements of Cash Flows |
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F-3 |
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Notes to Condensed Financial Statements |
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F-4 |
| ITEM 2— |
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
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1 |
| ITEM 3— |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
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4 |
| PART II—OTHER INFORMATION |
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| ITEM 1— |
LEGAL PROCEEDINGS |
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5 |
| ITEM 5— |
OTHER INFORMATION |
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5 |
| ITEM 6— |
EXHIBITS AND REPORTS ON FORM 8-K |
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5 |
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OSTEX INTERNATIONAL, INC.
CONDENSED BALANCE SHEETS
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September 30, 2000 |
December 31, 1999 |
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(Unaudited) |
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| ASSETS | |||||||||
| Current Assets: |
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| Cash and cash equivalents | $ | 620,000 | $ | 1,562,000 | |||||
| Short-term investments | 6,556,000 | 6,838,000 | |||||||
| Trade receivables and other current assets, net | 1,056,000 | 1,142,000 | |||||||
| Inventory, at cost | 409,000 | 251,000 | |||||||
| Total current assets | 8,641,000 | 9,793,000 | |||||||
| Property, Plant and Equipment, net | 1,885,000 | 1,905,000 | |||||||
| Other Assets | 599,000 | 599,000 | |||||||
| Total assets | $ | 11,125,000 | $ | 12,297,000 | |||||
| LIABILITIES AND SHAREHOLDERS' EQUITY |
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| Current Liabilities: |
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| Accounts payable | $ | 478,000 | $ | 278,000 | |||||
| Accrued expenses | 233,000 | 195,000 | |||||||
| Current portion of note payable | — | 115,000 | |||||||
| Total current liabilities | 711,000 | 588,000 | |||||||
| Noncurrent Liabilities | |||||||||
| Note payable, net of current portion | — | — | |||||||
| Commitments and Contingencies | |||||||||
| Shareholders' Equity: |
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| Common stock, $.01 par value, 50,000,000 authorized; 12,529,139 and 12,469,050 issued and outstanding at September 30, 2000 and December 31, 1999 respectively | 125,000 | 125,000 | |||||||
| Additional paid-in capital | 45,642,000 | 45,494,000 | |||||||
| Accumulated items of comprehensive loss | (109,000 | ) | (117,000 | ) | |||||
| Accumulated deficit | (35,244,000 | ) | (33,793,000 | ) | |||||
| Total shareholders' equity | 10,414,000 | 11,709,000 | |||||||
| Total liabilities and shareholders' equity | $ | 11,125,000 | $ | 12,297,000 | |||||
The accompanying notes are an integral part of these condensed financial statements.
F-1
OSTEX INTERNATIONAL, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
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Quarter Ended |
Year to Date |
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September 30, 2000 |
September 30, 1999 |
September 30, 2000 |
September 30, 1999 |
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| Revenues: | |||||||||||||||
| Product sales and research testing services | $ | 1,619,000 | $ | 1,335,000 | $ | 4,073,000 | $ | 3,363,000 | |||||||
| Cost of products sold |
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628,000 |
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287,000 |
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1,349,000 |
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807,000 |
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| Gross Profit |
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991,000 |
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1,048,000 |
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2,724,000 |
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2,556,000 |
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| Operating Expenses: |
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| Research and development | 399,000 | 386,000 | 1,176,000 | 1,335,000 | |||||||||||
| Selling, general and administrative | 1,076,000 | 961,000 | 3,469,000 | 2,904,000 | |||||||||||
| Total operating expenses | 1,475,000 | 1,347,000 | 4,645,000 | 4,239,000 | |||||||||||
| Loss from operations |
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(484,000 |
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(299,000 |
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(1,921,000 |
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(1,683,000 |
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| Other Income, net |
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281,000 |
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78,000 |
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470,000 |
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325,000 |
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| Net loss |
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$ |
(203,000 |
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$ |
(221,000 |
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$ |
(1,451,000 |
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$ |
(1,358,000 |
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| Basic and diluted net loss per common share |
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$ |
(0.02 |
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$ |
(0.02 |
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$ |
(0.12 |
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$ |
(0.11 |
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| Weighted average shares used in calculation of net loss per share |
12,529,000 | 12,503,000 | 12,502,000 | 12,589,000 | |||||||||||
The accompanying notes are an integral part of these condensed financial statements.
F-2
OSTEX INTERNATIONAL, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
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Year to Date |
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September 30, 2000 |
September 30, 1999 |
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| CASH FLOWS FROM OPERATING ACTIVITIES | $ | (873,000 | ) | $ | (1,570,000 | ) | |||
| CASH FLOWS FROM INVESTING ACTIVITIES: |
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| Purchases of short-term investments | (4,608,000 | ) | (6,379,000 | ) | |||||
| Proceeds from sales and maturities of short-term investments | 4,898,000 | 7,171,000 | |||||||
| Proceeds from sale of property, plant and equipment | — | 15,000 | |||||||
| Purchases of property, plant and equipment | (369,000 | ) | (53,000 | ) | |||||
| Net cash from investing activities | (79,000 | ) | 754,000 | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES: |
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| Net proceeds from the exercise of stock options | 125,000 | 1,000 | |||||||
| Repurchase of common stock | — | (240,000 | ) | ||||||
| Payments on note payable | (115,000 | ) | (155,000 | ) | |||||
| Net cash from financing activities | 10,000 | (394,000 | ) | ||||||
| NET DECREASE IN CASH AND EQUIVALENTS |
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(942,000 |
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(1,210,000 |
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| CASH AND CASH EQUIVALENTS, beginning of period |
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1,562,000 |
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2,744,000 |
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| CASH AND CASH EQUIVALENTS, end of period |
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$ |
620,000 |
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$ |
1,534,000 |
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The accompanying notes are an integral part of these condensed financial statements.
F-3
OSTEX INTERNATIONAL, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
1. Basis of Presentation
The unaudited condensed financial statements include the accounts of Ostex International, Inc., a Washington corporation (the "Company"). These financial statements have been prepared in accordance with generally accepted accounting principles for interim financial reporting and pursuant to the rules and regulations of the Securities and Exchange Commission. While these statements reflect all normal recurring adjustments which are, in the opinion of management, necessary for fair presentation of the results of the interim periods, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. For further information, refer to the financial statements and footnotes thereto included in the Company's Annual Report filed on Form 10-K for the year ended December 31, 1999.
2. Comprehensive Income
SFAS No. 130, "Reporting Comprehensive Income", which was effective for the Company beginning January 1, 1998, establishes standards for reporting and disclosure of comprehensive income. The components of comprehensive income for the nine months ended September 30, 2000 and September 30, 1999, are as follows:
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September 30, 2000 |
September 30, 1999 |
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| Net Loss | $ | (1,451,000 | ) | $ | (1,358,000 | ) | ||
| Unrealized loss on short-term investments | 8,000 | (44,000 | ) | |||||
| Total comprehensive loss | $ | (1,443,000 | ) | $ | (1,402,000 | ) | ||
F-4
PART I—FINANCIAL INFORMATION (Continued)
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
This Quarterly Report on Form 10-Q contains forward-looking statements which reflect the Company's current views with respect to future events and financial performance. These forward-looking statements are subject to certain risks and uncertainties, including those discussed below, that could cause actual results or the timing of certain events to differ materially from historical results or those anticipated. Words used herein such as "believes," "anticipates," "expects," "intends," and similar expressions are intended to identify forward-looking statements but are not the exclusive means of identifying such statements. In addition, the disclosures in this Item 2 under the caption "Other Factors that May Affect Operating Results" consist principally of a brief discussion of risks which may affect future results and are thus, in their entirety, forward-looking in nature. Readers are urged to carefully review and consider the various disclosures made by the Company in this report and in the Company's other reports previously filed with the Securities and Exchange Commission (the "Commission"), including the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1999, that attempt to advise interested parties of the risks and factors that may affect the Company's business.
Overview
Ostex was incorporated in the State of Washington in 1989. The Company is engaged in the discovery and commercialization of products associated with osteoporosis and other collagen-related diseases. The Company believes that its lead product, the OSTEOMARK® test, now available in multiple test formats, incorporates breakthrough and patented technology in the area of bone resorption measurement. As of September 30, 2000, the Company had 40 employees.
Osteoporosis is a significant health problem. According to the National Osteoporosis Foundation (the "NOF"), osteoporosis afflicts over 28 million people in the U.S. alone. Additionally millions of people are at risk of skeletal degradation associated with Paget's disease of bone, cancer that metastasizes to bone, hyperparathyroidism (overactivity of the parathyroid gland, characterized by a reduction of bone mass) and renal osteodystrophy. In spite of the serious human and economic consequences of these diseases (according to the NOF, the national direct expenditures for osteoporosis and associated fractures exceed $14 billion annually in the U.S. alone), medical intervention usually commences only after pain, immobility, fractures, or other symptoms have appeared. The Company expects the osteoporosis therapeutic market will continue to increase as the population ages.
The Company is the exclusive licensee of the Osteomark technology, known clinically as the NTx test, which is available in multiple formats that can aid in healthcare decision-making at early menopause and beyond. The Osteomark test is a non-invasive test that quantitatively indicates the level of bone resorption. Individuals who are losing bone collagen at accelerated rates may progress to low bone mass, a major cause of osteoporosis. Identification of high levels of bone resorption provides the opportunity to predict skeletal response (bone mineral density) to hormonal antiresorptive therapy in postmenopausal women, which are intended to prevent the onset of osteoporosis. The Company's Osteomark test can be used to effectively predict a patient's response to osteoporosis therapy. In addition, the Company's Osteomark test aids clinicians in monitoring the effects of antiresorptive therapies in postmenopausal women, as well as patients who have already lost bone mass in a matter of three months versus one to two years with conventional technology.
In May 1995, the Company's Osteomark test became commercially available in the United States as a urinary test that provides a quantitative measure of the excretion of cross-linked N-telopeptides of Type I collagen (NTx) as an indicator of human bone resorption. In July 1996, the Company received expanded claims for the urine test. The 1996 claims allow that an Osteomark test measurement, if taken prior to the initiation of hormonal antiresorptive therapy, can be utilized to predict a patient's
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response to that therapy, in terms of its effect on bone mineral density. Additionally, the claims allow that the test can be used to measure the effect of antiresorptive therapies in postmenopausal women, as well as individuals diagnosed with osteoporosis and Paget's disease. In March 1998 the claims were further expanded by allowing that, in addition to the 1996 claims, an Osteomark test measurement can identify the probability of a decrease in bone mineral density in postmenopausal women taking calcium supplements relative to those treated with hormonal antiresorptive therapy.
In February 1999, Osteomark NTx Serum became the first and only commercially available test in the United States that measures specific bone breakdown by osteoclasts using a blood sample. The Company believes that the use of a serum NTx test provides a number of advantages to testing laboratories, including the elimination of the requirement to normalize NTx values to creatinine concentration. The Company is manufacturing and marketing the Osteomark test in an Enzyme-linked Immunosorbent Assay ("ELISA") format for testing urine or serum samples.
Worldwide promotion of the Osteomark urine test kits is also supported by Johnson & Johnson Clinical Diagnostics, Inc. ("Johnson & Johnson"). In 1995 the Company entered into research, development, license and supply agreements with Johnson & Johnson. These agreements grant Johnson & Johnson a license to manufacture, sell and distribute certain products using Ostex's bone resorption technology. Currently, Johnson & Johnson distributes in the United States and certain foreign countries the Osteomark test in the existing microtiter plate format and beginning in March 1999 it offered the NTx test on its Vitros® automated analyzer. Ostex receives material transfer payments and royalties on Johnson & Johnson's sales of products incorporating the Ostex technology. Under the Johnson & Johnson license agreement, the Company has the right to license its technology for use on automated instruments to one other company in addition to Johnson & Johnson.
In 1992, Ostex entered into a research and development agreement and a license agreement with Mochida Pharmaceutical Co., Ltd. ("Mochida"), a Japanese pharmaceutical company, for the commercialization of the Osteomark test in Japan. Under the research and development agreement, Mochida has an option to license the NTx serum test and has paid Ostex $3,350,000 in development fees to date. Future payments of $750,000 under the agreement are contingent upon Mochida's decision to exercise its option. Under the license agreement, Ostex granted Mochida exclusive marketing and distribution rights to certain Ostex products in Japan. Since 1992, Mochida has paid Ostex $2,500,000 in licensing fees for the Osteomark test. In January 1998, Mochida launched the Osteomark test in Japan for the management of patients with hyperparathyroidism and for patients with metastatic bone tumors. In December 1999, Mochida received an additional regulatory indication from the Japanese Ministry of Health and Welfare for the Osteomark test for selecting suitable drugs for the treatment of osteoporosis and monitoring efficacy of drug therapy for osteoporosis. During 1999, Ostex sold Mochida the critical reagents to be assembled into finished products in Japan by Mochida. In first quarter 2000, Ostex began selling the finished product to Mochida.
The Company has, through an agreement with Metrika, Inc. ("Metrika") a diagnostic device company, developed a physician's office "point-of-care" Osteomark test device. The Company and Metrika developed the fully disposable point-of-care NTx test as an indicator of bone resorption that computes a NTx value and displays it digitally. In October 1999, the Osteomark NTx Point-of-Care device became commercially available. At the same time, the Company signed an agreement with PSS World Medical, Inc. as its exclusive U.S. distribution partner of the NTx Point-of-Care device. On May 10, 2000, the Company announced it had acquired the exclusive right from Metrika to manufacture the Osteomark NTx Point-of-Care device as well as exclusive worldwide license to manufacture, market and sell this device for the measurement of other connective tissue markers, including those associated with arthritis.
2
Results of Operations for the Three Months Ended September 30, 2000 and September 30, 1999
Total revenues were $1,619,000 for the quarter ended September 30, 2000, compared to $1,335,000 for the quarter ended September 30, 1999. The $284,000 increase was due primarily to shipments of the NTx Point-of-Care device to a large multinational company, increased shipments of NTx urine kits to the Company's Japanese partner, and the current year portion of the Osteometer Biotech A/S (Osteometer) royalty payment which resulted from settlement of the outstanding lawsuit (see "Legal Proceedings" in Part II, Item 1 of this 10-Q).
The gross profit as a percentage of sales was 61% for the quarter ended September 30, 2000, compared to 79% for the quarter ended September 30, 1999. The decrease was primarily due to shared start-up and production costs related to acquiring the manufacturing rights for the NTx Point-of-Care device. The gross profit percentage can also fluctuate depending on the average sales price per unit and sales mix for both urine and serum products.
The Company's research and development expenditures totaled $399,000 for the quarter ended September 30, 2000, compared to $386,000 for the quarter ended September 30, 1999. Selling, general and administrative expenses totaled $1,076,000 for the quarter ended September 30, 2000, compared to $961,000 for the quarter ended September 30, 1999. The $115,000 increase was due primarily to higher marketing related expenditures related to launching the NTx Point-of-Care device as well as increased legal fees.
Net other income totaled $281,000 for the quarter ended September 30, 2000, compared to $78,000 for the quarter ended September 30, 1999. The increase is due to a one-time settlement fee and prior year royalties paid by Osteometer related to the settlement of the lawsuit between Osteometer and the Company (see "Legal Proceedings" in Part II, Item 1 of this 10-Q).
Results of Operations for the Nine Months Ended September 30, 2000 and September 30, 1999
Total revenues were $4,073,000 for the nine-month period ended September 30, 2000, compared to $3,363,000 for the nine-month period ended September 30, 1999. The $710,000 increase was due primarily to growth in serum sales, the launch of the NTx Point-of-Care device and increased shipments of NTx urine kits to the Company's Japanese partner.
The gross profit as a percentage of sales was 67% for the nine-month period ended September 30, 2000, compared to 76% for the nine-month period ended September 30, 1999. The decrease was primarily due to shared start-up and production costs related to acquiring the manufacturing rights for the NTx Point-of-Care device. The gross profit percentage can also fluctuate depending on the average sales price per unit and sales mix for both urine and serum.
The Company's research and development expenditures totaled $1,176,000 for the nine-month period ended September 30, 2000, compared to $1,335,000 for the nine-month period ended September 30, 1999. The $159,000 decrease was attributable primarily to a reduction in outside services and lower labor and related expenses.
Selling, general and administrative expenses totaled $3,469,000 for the nine-month period ended September 30, 2000, compared to $2,904,000 for the nine-month period ended September 30, 1999. The $565,000 increase was due primarily to higher professional service fees, marketing related expenditures related to launching the NTx Point-of-Care device, and increased legal fees.
Net other income totaled $470,000 for the nine-month period ended September 30, 2000, compared to $325,000 for the period ended September 30, 1999. The increase is due to a one-time settlement fee and prior year royalties paid by Osteometer related to the settlement of the lawsuit between Osteometer and the Company (see "Legal Proceedings" in Part II, Item 1 of this 10-Q).
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Liquidity and Capital Resources
As of September 30, 2000, the Company had cash and cash equivalents and short-term investments of $7,176,000, working capital of $7,930,000 and total shareholders' equity of $10,414,000. As a result of funding operating losses during the nine months ended September 30, 2000, cash, cash equivalents and short-term investments decreased by $1,224,000, working capital decreased by $1,275,000 and shareholders' equity decreased by $1,295,000. During the nine-month period ended September 30, 2000, the Company purchased $369,000 in property, plant and equipment, received net proceeds from the exercise of stock options of $125,000 and reduced notes payable by $115,000.
The Company's future capital requirements depend upon many factors, including the effectiveness of Osteomark NTx Serum and Urine tests and the new point-of-care device's commercialization activities and arrangements; continued scientific progress in its research and development programs; the costs involved in filing, prosecuting and enforcing patent claims; and the time and costs involved in obtaining regulatory approvals. In October 2000, the Company received a commitment from Transamerica Technology Finance to provide up to $2.8 million in debt financing to help fund the expansion of it's manufacturing facility in Seattle, Washington Company (see "Other Information" in Part II, Item 5 of this 10-Q). The new facility was needed as a result of acquiring the manufacturing rights of the NTx Point-of-Care device.
Depending on sales growth realization and expenses associated with this activity, additional funds from equity or debt financing may be required in the future. There can be no assurance that such additional funds will be available on favorable terms, if at all. If additional funds become necessary, the Company may seek to raise additional capital if conditions in the public equity markets are favorable or through private placements, even if the Company does not have an immediate need for additional cash at that time. If additional financing is not available, the Company believes that its existing available cash, its future license and research revenues from existing collaboration agreements, its current level of product sales and interest income from short-term investments, and the impact of current cost reduction activities, will be adequate to fund operations into the foreseeable future.
Other Factors that May Affect Operating Results
The Company's operating results may fluctuate due to a number of factors including, but not limited to: volume and timing of product sales, pricing, market acceptance of the Company's products, changing economic conditions in the healthcare industry, activities of competitors, delays and increased costs of product and technology development, increased production costs and manufacturing capacity related to the new point-of-care device, the Company's ability to develop and maintain collaborative arrangements, the outcome of litigation, and the effect of the Company's accounting policies and other risk factors detailed in the Company's 1999 Form 10-K and other Commission filings. All of the foregoing factors are difficult for the Company to predict and can materially adversely affect the Company's business and operating results.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not Applicable
4
Effective August 1, 2000, the Company, Osteometer, Diagnostics Systems Laboratories (DSL), and the Washington Research Foundation (Foundation), entered into an agreement settling a lawsuit brought against Osteometer and DSL for infringements of patents exclusively licensed by the Foundation to the Company and directed to C-telopeptide markers of bone resorption. The Company filed the initial action in June 1996 in the United States District Court for the Western District of Washington against Osteometer and DSL for patent infringement of United States Patent No. 5,455,179. In September 1996, the defendants filed a response denying infringement and counterclaimed that Ostex' patent is invalid and unenforceable. By order dated July 7, 1997, the Court granted Ostex' motion to file a supplemental complaint, to add a second cause of action based upon United States Patent No. 5,641,837, which issued on September 24, 1997. On October 24, 1997, Ostex filed a second supplemental complaint to add third and fourth causes of action based upon U.S. Patent No. 5,652,112, which issued on July 29, 1997, and U.S. Patent No. 5,656,439, which issued on August 12, 1997.
Under the settlement agreement, Osteometer may sell the CrossLaps™ ELISA urine kits in the United States for two years, paid the Company a settlement fee for past sales and will pay royalties on future sales.
On October 2, 2000, the Company and Transamerica Business Credit Corporation (Transamerica) signed a letter of commitment whereby Transamerica will provide up to $2.8 million in debt financing for the Company's manufacturing expansion plan. Each drawdown on the commitment will be on a separate loan schedule and repaid over a 36-month period. The Company expects to close loan documents and begin drawing down the commitment before the end of the year.
On October 4, 2000, the Company announced a share repurchase program whereby the Company may purchase 1,000,000 shares of its outstanding common stock. Such stock repurchases will be executed in open market transactions on NASDAQ, subject to regulatory and market considerations, and at such prices and times as the Company determines are in the best interest of the Company's shareholders.
Item 6. Exhibits and Reports on Form 8-K
The following exhibit is filed herewith:
None
5
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.
| OSTEX INTERNATIONAL, INC. | ||||
| DATED: November 14, 2000 |
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By |
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/s/ THOMAS A. BOLOGNA Thomas A. Bologna Chairman, President and Chief Executive Officer (Principal financial and principal accounting officer) |
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