SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 ----- X QUARTERLY REPORT ----- FOR THE QUARTERLY PERIOD ENDED JUNE 30, 1998 -- or -- ----- TRANSITION REPORT ----- FOR THE TRANSITION PERIOD FROM TO ------------------------ OSTEX INTERNATIONAL, INC. Name of Registrant as Specified in Its Charter 0-25250 Commission File Number STATE OF WASHINGTON State or Other Jurisdiction of Incorporation or Organization 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 [N/A] Former name, address and fiscal year, if changed since last report ------------------------ 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 AUGUST 1, 1998 WAS 12,696,250. OSTEX INTERNATIONAL, INC. INDEX TO FORM 10-Q PART I - FINANCIAL INFORMATION Page ----- ITEM 1 - FINANCIAL STATEMENTS Condensed Balance Sheets .....................................F-1 Condensed Statements of Operations ..........................F-2 Condensed Statements of Cash Flow ...........................F-3 Notes to Condensed Financial Statements .................F-4 ITEM 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS ........2 ITEM 3 - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK ......................................6 PART II -- OTHER INFORMATION ITEM 1 - LEGAL PROCEEDINGS ...........................................6 ITEM 2 - CHANGES IN SECURITIES........................................6 ITEM 4 - SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.............................7 ITEM 6 - EXHIBITS AND REPORTS ON FORM 8-K ..........................7 PART I -- FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS Attached hereto are Ostex International, Inc.'s (the 'Company's or Ostex' ') unaudited condensed balance sheet as of June 30, 1998, and audited condensed balance sheet as of December 31, 1997, the unaudited condensed statements of operations for the quarters ended June 30, 1998 and 1997, and for the six months ended June 30, 1998 and 1997, and the statements of cash flow for the six months ended June 30, 1998 and 1997. Notes follow the unaudited financial statements and are an integral part thereof. 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, 1997, 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-registered trademark- test, incorporates breakthrough technology in the area of bone resorption measurement. Osteoporosis is a significant health problem. According to the National Osteoporosis Foundation (the 'NOF'), osteoporosis afflicts approximately 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 direct healthcare and indirect lost productivity costs of osteoporosis 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 therapeutic market for osteoporosis will increase significantly. The Company also believes new therapeutic products are under development for osteoporosis, some of which are in late-stage clinical trials, and that the Osteomark test can be used to effectively predict a patient's response to osteoporosis therapy and monitor existing therapies and other therapies which may be developed. The Company is the exclusive licensee of the Osteomark technology, known clinically as the NTx assay, which is a urine test that can aid in healthcare decision-making at early menopause and beyond. The Osteomark assay is a non-invasive diagnostic test which 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. The Company believes that early identification of high levels of bone resorption allows physicians the opportunity to prescribe antiresorptive therapy in cases where prescriptions may not have been made otherwise, thereby avoiding the onset of osteoporosis. The Company also believes that the Osteomark assay aids clinicians in monitoring the effects of antiresorptive therapies in postmenopausal women, as well as in older patients who have already lost significant bone mass. On May 8, 1995, the Company's Osteomark assay became commercially available in the United States as a urinary assay 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, and in July 1996 the Company received expanded claims from the Food and Drug Administration (the 'FDA') for the assay. 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 response to that therapy, in terms of its effect on bone mineral density. Additionally, the claims allow that the test can be used for therapeutic monitoring of antiresorptive therapies in postmenopausal women, as well as individuals diagnosed with osteoporosis and Paget's disease, and for therapeutic monitoring of estrogen-suppressing therapies. 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. The Company is manufacturing and marketing the Osteomark assay initially in an Enzyme-linked Immunosorbent Assay ('ELISA') microtiter plate format for testing urine samples and is in the latter stages of adapting the Osteomark assay to a serum format. 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 and to ultimately perform NTx testing on random access, automated analyzers. The Company initiated clinical studies of its serum NTx test in an ELISA format in June of 1998. These studies are scheduled for completion in the third quarter of 1998. Worldwide promotion of the Osteomark test kits is 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, Ostex sells Johnson & Johnson the Osteomark assay in the existing microtiter plate format for distribution in the United States and certain foreign countries and Johnson & Johnson is adapting the urine assay for use with its automated analyzer. Ostex will receive royalties on Johnson & Johnson's automated analyzer sales of products incorporating licensed Ostex technology. Ostex has also 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 assay in Japan. Under the research and development agreement, Mochida has an option to license the NTx serum assay upon completion of certain milestones. Under the license agreement, Ostex granted Mochida exclusive marketing and distribution rights to certain Ostex products in Japan, and Ostex sells to Mochida the critical reagents necessary for Mochida to assemble Osteomark kits. In January 1998 Mochida launched the Osteomark assay in Japan for the management of patients with hyperparathyroidism and for patients with metastatic bone tumors. The Company also plans to develop the Osteomark assay in other formats, including formats suitable for use in the physician's office. The Company has entered into agreements with Hologic, Inc. ('Hologic'), a worldwide leader in X-ray and ultrasound bone sonometers used to measure and/or estimate bone density to assist in the diagnosis and monitoring of osteoporosis and other bone diseases, and Metrika, Inc. ('Metrika'), a diagnostic device company, to develop physician office 'point-of-care' Osteomark assay devices. RESULTS OF OPERATIONS FOR THE THREE MONTHS ENDED JUNE 30, 1998 AND JUNE 30, 1997 The Company had revenues from product sales of $1,011,000 for the quarter ended June 30, 1998, compared to $949,000 for the quarter ended June 30, 1997. Revenue in the 1998 quarter increased 7% compared to the 1997 due to a slightly higher number of Osteomark kits sold to domestic distributors and laboratories and an increase in research testing services. The Company recorded approximately $16,000 of revenue from research testing services during the second quarter 1998 compared to zero in the same quarter of 1997. The Company's gross margin has remained constant in the quarter ended June 30, 1998, compared to the gross margin in the second quarter of 1997. In the 1998 quarter, revenue increased despite a slight decrease in average pricing levels as sales to distributors increased as a percentage of total sales over direct customers as well as a decrease in unit production for the Osteomark urine assay. Cost of products sold primarily include labor costs, material management, equipment and facility costs. In addition, the Company incurred startup costs associated with the introduction of the serum NTx assay to the production process. The gross margin is expected to continue to fluctuate depending on the volume and timing of customer orders and the production levels needed to fill customer demand. The Company's research and development expenditures totaled $686,000 for the quarter ended June 30, 1998, compared to $1,354,000 for the quarter ended June 30, 1997. The $668,000 decrease resulted primarily from completion of contract development payments pursuant to NTx point-of-care co-development programs during the first quarter of 1998. The Company incurred higher costs in the second quarter of 1997 while initiating these programs. The decreased research and development expenses were also attributable to the completion of clinical studies that were ongoing during the 1997 quarter. The Company's clinical study expenses during the 1997 quarter included a study for the determination of the NTx reference range in males, a study to complement physician interpretation of NTx results in postmenopausal women, and preliminary studies for the use of the Osteomark test in helping to identify bone metastases. The Company anticipates research and development expenses to increase in future quarters as it continues its clinical studies of its serum NTx test in an ELISA format. Selling, general and administrative expenses totaled $1,774,000 for the quarter ended June 30, 1998, compared to $1,862,000 for the period ended June 30, 1997. The decrease was due to restructuring within the administrative areas of the Company which reduced the number of personnel, the completion of litigation in connection with the arbitration against Boehringer Mannheim Diagnostics, and the resignation of certain executive management during the fourth quarter of 1997 who were not replaced. The decrease was offset by an increase in expenses associated with the promotion and advertising of the Osteomark test and higher costs associated with patent prosecution, litigation costs in connection with the Company's legal action against Osteometer A/S ('Osteometer'), and defense costs associated with litigation initiated by C.R. Bard Inc. ('Bard')(see 'Legal Proceedings' in Part II, Item 1 of this Form 10-Q). Selling, general and administrative expenses are expected to increase in future quarters as the Company implements new marketing programs to elevate physician and consumer awareness of the Osteomark test. Interest income totaled $202,000 for the quarter ended June 30, 1998, compared to $230,000 for the quarter ended June 30, 1997. The decrease is due to lower invested balances resulting from using cash to fund the Company's operating losses. RESULTS OF OPERATIONS FOR THE SIX MONTHS ENDED JUNE 30, 1998 AND JUNE 30, 1997 The Company recorded revenues of $1,592,000 for the six month period ended June 30, 1998, compared to $1,603,000 for the six month period ended June 30, 1997. The decreased revenues were due to lower volumes of Osteomark kits sold to research and industrial laboratories during the six months ended June 30, 1998, compared to the same period of 1997. Cost of products sold increased 2% as a percentage of sales for the quarter ended June 30, 1998, compared to the same quarter in 1997. The increase in cost of products sold as a percentage of sales during the first six months of 1998 compared to the same period of 1997 resulted from a lower unit production volume and a slight decrease in the average price due to an increased level of shipments to distributors over direct customers during the 1998 period. Additionally, costs in the 1998 period increased within manufacturing due to startup costs associated with the introduction of the NTx assay to the production process. The gross margin is expected to continue to fluctuate depending on the volume and timing of customer orders and the production levels needed to fill customer demand. The Company's research and development expenditures totaled $1,521,000 for the six month period ended June 30, 1998, compared to $2,432,000 for the six months ended June 30, 1997. The decrease of $911,000 was primarily due to lower expenses in connection with the Company's point-of-care programs. Reduced obligations for contract development payments for the NTx point-of-care development program in the first quarter of 1998 contributed approximately $445,000 to the decrease for the six months ended June 30, 1998, compared to the same period of 1997. The Company anticipates development to continue for a NTx point-of-care product in future quarters. The completion of clinical studies and the closing of a laboratory in Portland also contributed to the decrease in research and development expenses for the six months ended June 30, 1998, compared to the same period of 1997. Clinical study expenses decreased approximately $218,000 in the 1998 period compared to 1997. Included in the Company's clinical study expenses during the 1997 quarter was a study for the determination of the NTx reference range in males, a study to complement physician interpretation of NTx results in postmenopausal women, and preliminary studies for the use of the Osteomark test in helping to identify bone metastases. These studies were completed in 1997. Additionally, research and development decreased in the 1998 period because of a consolidation of research from its laboratory located in Portland, Oregon, into the Seattle laboratory in July 1997. Selling, general and administrative expenses totaled $4,025,000 for the six month period ended June 30, 1998, compared to $3,785,000 for the six months ended June 30, 1997. The higher expense level was due to an increase in expenses associated with the promotion and advertising of the Osteomark test and higher costs associated with patent prosecution, litigation costs in connection with the Company's legal action against Osteometer, and defense costs associated with litigation initiated by Bard (see 'Legal Proceedings' in Part II, Item 1 of this Form 10-Q) despite lower expenses from restructuring of administrative areas, the completion of certain litigation and the resignation of certain executive management. Selling, general and administrative expenses are expected to increase as the Company implements new marketing programs to elevate physician and consumer awareness of the Osteomark test. Interest income totaled $420,000 for the six month period ended June 30, 1998, compared to $479,000 for the same period ended June 30, 1997. The decrease is due to lower invested balances resulting from using cash to fund the Company's operating losses. LIQUIDITY AND CAPITAL RESOURCES As of June 30, 1998, the Company had $14,215,000 in cash and cash equivalents and short-term investments, working capital of $14,496,000 and total shareholders' equity of $17,593,000. As a result of funding operating losses during the six months ended June 30, 1998, cash, cash equivalents and short-term investments decreased by $4,750,000, working capital decreased by $3,872,000 and shareholders equity decreased by $4,051,000. During the six month period ended June 30, 1998, the Company purchased $71,000 in property, plant and equipment and reduced notes payable by $89,000. The Company's future capital requirements depend upon many factors, including the timing and effectiveness of commercialization activities and collaborative arrangements; continued scientific progress in its research and development programs; the costs involved in filing, prosecuting and enforcing patent claims; the costs involved in legal efforts to enforce patent rights; and the time and costs involved in obtaining regulatory approvals. The Company is likely to require additional funds from equity or debt financing and there can be no assurance that such additional funds will be available on favorable terms, if at all. Due to the Company's significant long-term cash requirements, it may seek to raise additional capital if conditions in the public equity markets are favorable, even if the Company does not have an immediate need for additional cash at that time. If additional financing is not available, the Company anticipates that its existing available cash, its future license and research revenues from existing collaboration agreements, product sales and interest income from short-term investments will be adequate to satisfy its capital requirements and to fund operations through 1999. No assurance can be given, however, that such funds will in fact be adequate until that time, since the Company's prediction is subject to a number of risks and uncertainties, including those discussed in the following paragraph. 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, product pricing, market acceptance of the Company's products, changing economic conditions in the healthcare industry, delays and increased costs of product and technology development, the Company's ability to develop and maintain collaborative arrangements, the timing of payments under those arrangements, the outcome of litigation, and the effect of the Company's accounting policies, as well as other risk factors detailed in the Company's 1997 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. The Company is currently in the process of evaluating its information technology infrastructure for the Year 2000 compliance. The Company does not expect that the cost to modify its information technology infrastructure to be Year 2000 compliant will be material to its financial condition or results of operations. The Company does not anticipate any material disruption in its operations as a result of any failure by the Company to be in compliance. The Company does not currently have any information concerning the Year 2000 compliance status of its suppliers and customers. In the event that any of the Company's significant suppliers or customers do not successfully and timely achieve Year 2000 compliance, the Company's business or operations could be adversely affected. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Not Applicable PART II -- OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS In June 1996, the Company filed an action in the United States District Court for the Western District of Washington against Osteometer Biotech A/S, a medical technology company based in Denmark, and Diagnostic Systems Laboratories Inc. for patent infringement of United States Patent No. 5,455,179. The Company believes Osteometer's bone resorption immunoassay incorporates technology which infringes patented Ostex technology. 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's 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 June 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. The lawsuit is currently scheduled for trial commencing February 23, 1999. Management intends to continue to vigorously assert its position in the lawsuit. On April 9, 1997, the Company was served with a lawsuit filed in the United States District Court, Central District of California by C.R. Bard, Inc. The complaint alleged that Ostex' Osteomark product infringed U.S. Patent No. 4,628,027 assigned to Bard in 1993. On April 22, 1998, the Court issued an order granting Ostex' motion for summary judgment and dismissed Bard's lawsuit with prejudice. On June 8, 1998, the Court denied Bard's motion for reconsideration. On June 29, 1998, the parties filed a joint stipulation of dismissal without prejudice of Ostex' counterclaim for declaratory judgment of invalidity and unenforceability. In that filing, Bard indicated that it was presently considering whether to appeal the Court's judgment that the `027 patent is not infringed. ITEM 2. CHANGES IN SECURITIES None ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS On May 18, 1998, the Company held its 1998 Annual Meeting of Shareholders (the 'Annual Meeting'), at which the following members were elected to the Board of Directors: Affirmative Votes Votes Withheld ----- -------- Thomas A. Bologna 11,155,024 63,631 Elisabeth L. Evans, M.D. 11,152,217 66,438 Gregory D. Phelps 11,156,074 62,581 John H. Trimmer 11,152,074 66,581 The following members continued their terms on the Board of Directors: Thomas J. Cable David R. Eyre, Ph.D. Fredric J. Feldman, Ph.D. The following proposals were also approved at the Annual Meeting: Affirmative Votes Votes Votes Against Withheld ----- -------- -------- Ratification of Arthur Andersen LLP 11,134,144 38,659 45,852 as the Company's independent auditors for the fiscal year ending December 31, 1998 ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K (A) EXHIBITS The following exhibit is filed herewith: (1) 10.32 Development and Distribution Agreement dated June 8, 1998, with Metrika, Inc. 27.1 Financial Data Schedule (1) Confidential treatment requested. Exhibit omits information that has been filed separately with the Commission. (B) REPORTS ON FORM 8-K None SIGNATURE 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. DATE: August 12, 1998 By /S/ JOHN M. BRENNEMAN ---------------------------------- John M. Brenneman Director of Finance and Operations (principal financial and principal accounting officer) OSTEX INTERNATIONAL, INC. CONDENSED BALANCE SHEETS (In thousands, except share amounts) June 30, December 31, 1998 1997 --------------- -------------- (unaudited) CURRENT ASSETS: Cash and cash equivalents $ 1,851 $ 2,201 Short-term investments 12,364 16,764 Trade receivables and other current assets, net 1,431 1,344 Inventory, at cost 183 201 --------------- -------------- Total current assets 15,829 20,510 PROPERTY, PLANT AND EQUIPMENT, net of accumulated 2,695 2,965 depreciation OTHER ASSETS 599 637 =============== ============== Total assets $ 19,123 $ 24,112 =============== ============== CURRENT LIABILITIES: Accounts payable and accrued expenses $ 1,333 $ 2,142 NONCURRENT LIABILITIES: Note payable, net of current portion 197 326 --------------- -------------- Total liabilities 1,530 2,468 --------------- -------------- SHAREHOLDERS' EQUITY: Common stock, $.01 par value, 50,000,000 authorized; 12,696,250 and 12,696,250 issued and outstanding, respectively 127 127 Additional paid-in capital 45,642 45,642 Accumulated other comprehensive income - unrealized (loss)/gain on short-term investments (32) 3 Accumulated deficit (28,144) (24,128) --------------- --------------- Total shareholders' equity 17,593 21,644 --------------- --------------- Total liabilities and shareholders' equity $ 19,123 $ 24,112 =============== =============== The accompanying notes are an integral part of these condensed balance sheets. OSTEX INTERNATIONAL, INC. CONDENSED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (unaudited) Quarter Ended Year to Date ------------------------------------ ---------------------------------- June 30, June 30, June 30, June 30, 1998 1997 1998 1997 ----------------- ----------------- ---------------- ----------------- REVENUE: Product sales and research testing services $ 1,011 $ 949 $ 1,592 $ 1,603 ----------------- ----------------- ---------------- ----------------- Total revenues 1,011 949 1,592 1,603 OPERATING EXPENSES: Cost of products sold 263 261 452 412 Research and development 686 1,354 1,521 2,432 Selling, general and administrative 1,774 1,862 4,025 3,785 ----------------- ----------------- ---------------- ----------------- Total operating expenses 2,723 3,477 5,998 6,629 ----------------- ----------------- ---------------- ----------------- Loss from operations (1,712) (2,528) (4,406) (5,026) OTHER INCOME (EXPENSE): Interest income 202 230 420 479 Interest expense (15) (19) (30) (39) ----------------- ----------------- ---------------- ----------------- Net loss $ (1,525) $ (2,317) $ (4,016) $ (4,586) ================= ================= ================ ================= Basic and diluted net loss per common and common equivalent share $ (0.12) $ (0.18) $ (0.32) $ (0.37) Shares used in calculation 12,696 12,557 12,696 12,502 The accompanying notes are an integral part of these condensed financial statements. OSTEX INTERNATIONAL, INC. CONDENSED STATEMENTS OF CASH FLOWS (In thousands) (unaudited) Year to Date -------------------------------------------- June 30, June 30, 1998 1997 --------------------- --------------------- CASH FLOWS FROM OPERATING ACTIVITIES $ (4,555) $ (5,000) --------------------- --------------------- CASH FLOWS FROM INVESTING ACTIVITIES: Purchases of short-term investments (29,809) (3,592) Proceeds from sales of short-term investments 34,174 8,791 Purchase of property, plant and equipment (71) (763) --------------------- --------------------- Net cash provided by investing activities 4,294 4,436 --------------------- --------------------- CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from exercise of common stock options 0 118 Payments on note payable (89) (79) --------------------- --------------------- Net cash provided by financing activities (89) 39 --------------------- --------------------- NET INCREASE IN CASH AND CASH EQUIVALENTS (350) (525) CASH AND CASH EQUIVALENTS, beginning of period 2,201 1,289 --------------------- --------------------- CASH AND CASH EQUIVALENTS, end of period $ 1,851 $ 764 ===================== ===================== The accompanying notes are an integral part of these condensed financial statements. OSTEX INTERNATIONAL, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES 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, 1997. NET LOSS PER COMMON AND COMMON EQUIVALENT SHARE The Company adopted SFAS No. 128, 'Earnings per Share,' effective December 15, 1997. Basic net loss per share is the net loss divided by the average number of shares outstanding during the year. Diluted net loss per share is calculated as the net loss divided by the sum of the average number of shares outstanding during the year plus the net additional shares that would have been issued had all dilutive options been exercised, less shares that would be repurchased with the proceeds from such exercise (Treasury Stock Method). During all years presented, the effect of including outstanding options is antidilutive, therefore, no options are considered in the calculation of diluted net loss per share. There is no difference between the previously reported net loss per share and the basic and diluted net loss per share. 2. CONTINGENCIES LEGAL PROCEEDINGS Refer to Part II, Item 1 of this Form 10-Q. 3. NEW ACCOUNTING PRONOUNCEMENTS The Company has adopted SFAS No. 130, 'Reporting Comprehensive Income', which establishes standards for reporting and disclosure of comprehensive income. The components of comprehensive income for the six months ended June 30, 1998 and June 30, 1997, are as follows (in thousands) : June 30, June 30, 1998 1997 ------------ ------------ Net loss $ (4,016) $ (4,586) Unrealized gain/(loss) on short-term investments (35) (105) ------------ ------------ Total comprehensive loss $ (4,051) $ (4,691) ============ ============