SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q [X] Quarterly Report Pursuant to Section 13 or 12(g) of the Securities Exchange Act of 1934 For the Quarterly Period Ended September 30, 1997 OR [ ] Transition Report Pursuant to Section 13 or 12(g) of the Securities Exchange Act of 1934 For the Transition Period from _____ to _____ Commission File Number 0-26144 International Murex Technologies Corporation - ------------------------------------------------------------------------ (Exact name of registrant as specified in its charter) Province of British Columbia, Canada N/A - ------------------------------------ --------------------- (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 2255 B. Queen Street, East, Suite 828, Toronto, Ontario, Canada M4E 1G3 - ------------------------------------------------------------------------ (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (519) 836-8016 --------------- Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 12(g) of the Securities Exchange Act of 1934 during the preceding 12 months and (2) has been subject to such filing requirements for the past 90 days. Yes X No ------ ------ The number of common shares outstanding as of November 10, 1997 was 16,628,413, excluding treasury shares. INTERNATIONAL MUREX TECHNOLOGIES CORPORATION Quarterly Report on Form 10-Q For the Nine Months Ended September 30, 1997 Table of Contents ----------------- Item Page Number PART I -- FINANCIAL INFORMATION Number - ------ ------ 1 Financial Statements Consolidated Balance Sheets at September 30, 1997 and December 31, 1996 3 Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 1997 and 1996 5 Consolidated Statements of Changes in Shareholders' Equity for the Period January 1, 1996 to September 30, 1997 6 Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 1997 and 1996 7 Notes to Consolidated Financial Statements 9 2 Management's Discussion and Analysis of Financial Condition and Results of Operations 12 PART II -- OTHER INFORMATION 1 Legal Proceedings 19 6 Exhibits and Reports on Form 8-K 19 SIGNATURES 20 -2- INTERNATIONAL MUREX TECHNOLOGIES CORPORATION CONSOLIDATED BALANCE SHEETS (In thousands of U. S. Dollars) September 30, December 31, ---------------------------------- 1997 1996 - -------------------------------------------------------------------------------- ASSETS CURRENT ASSETS Cash and cash equivalents $ 6,101 $ 9,723 Accounts receivable, net of allowance for doubtful accounts of $2,999 and $3,174, respectively 39,737 33,718 Inventories 21,734 21,534 Amounts due from affiliate 2,589 4,415 Prepaid and other 2,942 1,207 ----------------------------- Total current assets 73,103 70,597 - ------------------------------------------------------------------------------- PROPERTY, PLANT AND EQUIPMENT- at cost less accumulated depreciation and amortization 13,309 10,091 PATENTS, TRADEMARKS AND LICENSES- at cost less accumulated amortization 6,862 5,738 OTHER ASSETS 8,907 8,687 ------------------------------ TOTAL $ 102,181 $ 95,113 =============================================================================== See notes to consolidated financial statements. -3- September 30, December 31, -------------------------------- 1997 1996 - -------------------------------------------------------------------------------- LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES: Trade accounts payable $ 11,579 $ 9,757 Accrued expenses: Professional fees 1,828 2,222 Royalty payments 2,225 1,978 Employee related 5,291 5,985 Income taxes payable 1,600 1,508 Litigation settlements 347 3,310 Restructuring 99 1,402 Other 4,299 2,809 Current portion of capitalized lease obligations 114 151 ------------------------------ Total current liabilities 27,382 29,122 - ------------------------------------------------------------------------------- DEFERRED RENT 65 77 LINE OF CREDIT AND NOTE PAYABLE 13,846 9,638 CAPITALIZED LEASE OBLIGATIONS 93 COMMITMENTS AND CONTINGENCIES SHAREHOLDERS' EQUITY Common shares, without par value, 200,000,000 shares authorized; 16,627,745 and 16,578,853 shares issued, respectively 84,611 84,460 Additional paid-in capital 14,521 13,906 Accumulated deficit (35,342) (41,655) Less cost of 101,043 and 286,929 common shares held in treasury, respectively (5) (1,085) Unrealized gain on marketable securities 5,328 4,405 Accumulated currency translation adjustment (8,225) (3,848) ------------------------------ Shareholders' equity 60,888 56,183 - ------------------------------------------------------------------------------- TOTAL $ 102,181 $ 95,113 =============================================================================== See notes to consolidated financial statements. -4- INTERNATIONAL MUREX TECHNOLOGIES CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands of U.S. Dollars, except per share data) Three Months Nine Months Ended September 30, Ended September 30, --------------------- --------------------- 1997 1996 1997 1996 - -------------------------------------------------------------------------------------- REVENUES: Product sales $ 23,760 $ 24,917 $ 74,870 $ 75,291 License fees and other 2,223 5,445 -------------------- -------------------- Total revenues 25,983 24,917 80,315 75,291 COSTS AND EXPENSES: Cost of products sold 10,326 8,556 28,314 26,911 Research and development 2,136 1,504 5,863 4,918 General and administrative 3,421 10,147 13,882 20,452 Sales and marketing 6,750 7,164 21,088 21,892 Foreign exchange (gain) loss (43) 227 (68) 951 Royalty expense 1,378 (5,916) 4,784 (3,124) Restructuring expense 2,100 2,100 -------------------- -------------------- Total costs and expenses 23,968 23,782 73,863 74,100 -------------------- -------------------- Income From Operations 2,015 1,135 6,452 1,191 Interest income 15 138 104 447 Interest expense (321) (92) (933) (1,058) Loss (gain) on asset disposals (17) 74 (30) 78 Gain (loss) on liquidation of investee 444 (43) Other income 962 21 987 125 -------------------- -------------------- Income (loss) before income taxes 2,654 1,720 6,580 740 Income tax expense 89 428 267 731 -------------------- -------------------- NET INCOME $ 2,565 $ 1,292 $ 6,313 $ 9 ==================== ==================== Net income per common share $ 0.14 $ 0.08 $ 0.36 $ 0.00 ==================== ==================== Weighted average shares outstanding (in thousands) 17,779 16,447 17,681 16,257 ==================== ==================== See notes to consolidated financial statements. -5- INTERNATIONAL MUREX TECHNOLOGIES CORPORATION CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY (In thousands of U.S. Dollars, except share data) Common Stock Additional ---------------------------- Paid-In Accumulated Shares Amount Capital Deficit - ----------------------------------------------------------------------------------------------- December 31, 1995 16,688,931 $84,136 $13,906 ($43,504) Issued pursuant to employee stock purchase plan 23,297 91 Exercise of employee stock options 15,900 50 Issued as stock compensation 281,925 1,692 Shares tendered to treasury Retirement of treasury shares (431,200) (1,509) Unrealized gain on marketable securities Net income 1,849 Foreign currency translation ------------------------------------------------------------ December 31, 1996 16,578,853 84,460 13,906 (41,655) Issued pursuant to employee stock purchase plan 16,806 116 Exercise of employee stock options 171,500 845 Retirement of treasury shares (185,886) (1,080) Issued pursuant to class action settlement 46,472 270 Reversion of settlement shares 615 Unrealized gain on marketable securities Net income 6,313 Foreign currency translation ------------------------------------------------------------ September 30, 1997 16,627,745 $84,611 $14,521 ($35,342) ============================================================ Unrealized Accumulated Gain On Currency Total Treasury Marketable Translation Shareholders' Shares Securities Adjustment Equity - --------------------------------------------------------------------------------------------------- December 31, 1995 ($1,514) ($3,493) $49,531 Issued pursuant to employee stock purchase plan 91 Exercise of employee stock options 50 Issued as stock compensation 1,692 Shares tendered to treasury (1,080) (1,080) Retirement of treasury shares 1,509 Unrealized gain on marketable securities $4,405 4,405 Net income 1,849 Foreign currency translation (355) (355) ------------------------------------------------------------- December 31, 1996 (1,085) 4,405 (3,848) 56,183 Issued pursuant to employee stock purchase plan 116 Exercise of employee stock options 845 Retirement of treasury shares 1,080 Issued pursuant to class action settlement 270 Reversion of settlement shares 615 Unrealized gain on marketable securities 923 923 Net income 6,313 Foreign currency translation (4,377) (4,377) ------------------------------------------------------------- September 30, 1997 ($5) $5,328 ($8,225) $60,888 ============================================================= See notes to consolidated financial statements. -6- INTERNATIONAL MUREX TECHNOLOGIES CORPORATION CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands of U.S. Dollars) Nine Months Ended September 30, -------------------- 1997 1996 - ------------------------------------------------------------------------------- Operating Activities: Net income $ 6,313 $ 9 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation 2,964 2,974 Amortization 602 269 Loss (gain) on sale of property and equipment 30 (78) Changes in working capital: Accounts receivable (4,247) 2,196 Inventories (200) (3,557) Prepaid expenses and other assets (2,401) (108) Trade accounts payable 1,822 2,770 Accrued expenses (2,619) (2,871) -------------------- Net cash provided by operating activities 2,264 1,604 - ------------------------------------------------------------------------------- Investing Activities: Additions to property and equipment (6,300) (3,537) Additions to patents and licenses (1,726) (5,154) Proceeds from sale of marketable securities 1,254 Proceeds from sale of property and equipment 88 154 --------------------- Net cash (used in) investing activities (6,684) (8,537) - ------------------------------------------------------------------------------- Financing Activities: Increase in borrowings 4,208 Reduction of other long-term liabilities (142) (152) Proceeds from issuance of common shares 961 41 --------------------- Net cash provided by (used in) financing activities 5,027 (111) - ------------------------------------------------------------------------------- Effect of Exchange Rate Changes (4,229) (953) Net (Decrease) in Cash and Cash Equivalents (3,622) (7,997) Cash and Cash Equivalents at Beginning of Period 9,723 15,771 --------------------- Cash and Cash Equivalents at End of Period $ 6,101 $ 7,774 =============================================================================== Supplemental Disclosure of Cash Flow Information: Cash paid for interest $933 $447 Cash paid for income taxes $475 $1,127 -7- INTERNATIONAL MUREX TECHNOLOGIES CORPORATION Consolidated Statements of Cash Flows (Continued) (In thousands of U.S. Dollars) - ------------------------------------------------------------------------------- SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING AND FINANCING ACTIVITIES During the nine months ending September 30, 1997 and 1996, IMTC retired $1,080 and $1,509, respectively, of shares held in treasury. During the nine months ended September 30, 1996, a subsidiary of the Company, Specialist Diagnostics Limited ("SDL"), entered voluntary liquidation. Therefore, its financial statements were deconsolidated. During the three months ended September 30, 1997, approximately $1,700 in cash was returned to the Company, consequently, as of September 30, 1997, the Company has an amount due from SDL of $2,589. See notes to consolidated financial statements. -8- INTERNATIONAL MUREX TECHNOLOGIES CORPORATION Notes to Consolidated Financial Statements (In thousands of U.S. Dollars, except per share data) - ------------------------------------------------------------------------------ 1. NATURE OF THE COMPANY AND BASIS OF PRESENTATION: International Murex Technologies Corporation ("IMTC") operates through many incorporated subsidiaries throughout the world under the Murex name (the "Murex Group"). The Murex Group develops, manufactures and markets medical diagnostic products, licenses its technology and provides medical services for the screening, diagnosis and monitoring of infectious diseases and other medical conditions. (IMTC and the Murex Group are collectively referred to herein for consolidated financial purposes only as the "Company"). Effective January 1, 1996, IMTC's United Kingdom ("UK") operating business was restructured into two companies, Murex Diagnostics Limited ("MDL") and Murex Biotech Limited ("MBL"). MDL subsequently changed its name to Specialist Diagnostics Limited ("SDL") and entered voluntary liquidation. As of September 30, 1997 and December 31, 1996, IMTC and its subsidiaries represented predominantly all of the creditors of SDL; therefore, in the consolidated financial statements, the subsidiary is assumed to be fully liquidated. During the three months ended September 30, 1997, approximately $1,700 in cash was returned to the Company from the SDL liquidator. Management expects to ultimately receive additional net proceeds of $2,589 from the SDL liquidator after settlement of all liquidation costs, which is reflected as of September 30, 1997 as amounts due from affiliates. 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-Q and Article 10 of Regulation S-X promulgated by the Securities and Exchange Commission. Such financial statements do not include all disclosures required by generally accepted accounting principles for annual financial statement reporting purposes. However, there has been no material change in the information disclosed in the Company's annual consolidated financial statements dated December 31, 1996, except as disclosed herein. Accordingly, the information contained herein should be read in conjunction with such annual consolidated financial statements and related disclosures. The accompanying financial statements reflect, in the opinion of management, all adjustments (consisting of normal recurring adjustments) necessary for a fair presentation of the results for the interim periods presented. Results of operations for the quarter and nine months ended September 30, 1997 are not necessarily indicative of results expected for an entire year. -9- 2. INVENTORIES: September 30, December 31, 1997 1996 ------------------------------------------------------------------------- Raw materials and supplies.......... $ 5,605 $ 5,911 Work in process..................... 5,312 5,244 Finished goods...................... 10,817 10,379 ------ ------ Total inventories................... $ 21,734 $21,534 ======== ======= ------------------------------------------------------------------------ 3. CONTINGENCIES: Four class action lawsuits were instituted on behalf of all persons who had purchased IMTC's securities between May 21, 1992 and August 19, 1992 against IMTC, two executive officers of IMTC, and two shareholders. Although the defendants denied the allegations in the complaints, the parties agreed to settle all outstanding claims for $5.4 million during 1996. In accordance with the Stipulation Settlement Agreement, the shareholders transferred 185,886 common shares of the Company's stock to the Company to be used as their portion of the settlement. During the third quarter of 1997, the claims administrator finished qualifying claimants and submitted a motion to the U.S. District Court setting out the final distribution of the settlement fund, which was approved by the Court during October 1997. The sum of damages claimed and expenses incurred by the claims administrator and Plaintiffs' counsel is less than the total settlement fund, consequently, the Company is entitled to the remaining cash of approximately $1,500, net of employment costs and 105,766 common shares of the Company's stock. These shares are valued at $615 ($5.81 per share), as defined by the settlement agreement. The reversion of the settlement fund has been reflected in the accompanying financial statements as an offset to general and administrative costs for the cash portion and an increase to additional paid-in capital for the stock portion. During 1995, the UK Inland Revenue questioned the tax basis of inventory, accounts receivable and property, plant and equipment related to the 1992 purchase of assets from The Wellcome Foundation Limited ("Wellcome"). If Inland Revenue is successful in its argument, a tax charge of up to $4.2 million could arise. Management believes it has meritorious defenses against the claims of Inland Revenue and that the Company has sufficient tax loss carryforwards to offset any tax charges. Therefore, the Company has not recorded a provision for losses related to this matter. 4. RESTRUCTURING: During September 1996, the Company recorded a restructuring charge of $2,100. The restructuring was driven by the need to reposition the Company for its movement into the patient monitoring business. The worldwide plan resulted in personnel reductions of approximately 50 people from various functions. The restructuring provision consisted predominantly of estimated costs for employee severance and other benefits. As of December 31, 1996, 35 employees left the Company -10- related to the restructuring plan, resulting in actual payments of $698. As such, the remaining accrual at December 31, 1996 was $1,402. The Company substantially completed the restructuring during the nine months ended September 30, 1997, and $99 remained accrued at September 30, 1997 for payments to former employees. 5. RECONCILIATION OF CANADIAN AND U.S. GENERALLY ACCEPTED ACCOUNTING PRINCIPLES ("CANADIAN GAAP" AND U.S. GAAP"): There were no differences between Canadian GAAP and U.S. GAAP during the year ended December 31, 1996 and the quarter and nine months ended September 30, 1997. -11- INTERNATIONAL MUREX TECHNOLOGIES CORPORATION Form 10-Q for the Nine Months Ended September 30, 1997 Part I - Financial Information - ------------------------------------------------------------------------------ ITEM 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (Amounts expressed in U.S. Dollars) This report contains or refers to forward-looking information including future revenues, products, and income and is based upon current expectations that involve a number of business risks and uncertainties. Among the factors that could cause actual results to differ materially from any forward-looking statement include, but are not limited to, technological innovations of competitors, delays in product introductions, changes in health care regulations and reimbursements, litigation claims, changes in foreign economic conditions or currency translation, product acceptance or changes in government regulation of the Company's products, as well as other factors discussed in other Securities and Exchange Commission filings for the Company. FINANCIAL CONDITION During the quarter and nine months ended September 30, 1997, the Company continued its profitability, generated cash from operations and maintained positive working capital. Litigation and Technology Disputes The Murex Group's business utilizes newly-developed technologies that include patents on processes and devices. These types of technologies are the focal point for the biotechnology industry. The ownership and patentability of such processes or devices have become increasingly complex, resulting in competitive claims of ownership within the industry. IMTC and several subsidiaries of the Murex Group were involved in several lawsuits, including technology patent issues, which were settled during 1996. The Company is not presently the defendant in any material judicial proceeding. The Company is vigorously pursuing its patent infringement suit in which the Company is the plaintiff against Abbott Laboratories ("Abbott"), and continues to defend one UK Inland Revenue Claim, both of which are discussed below. On July 2, 1996, a subsidiary of IMTC, Murex Diagnostics Corporation ("MDC"), filed a patent infringement suit against Abbott seeking injunctive relief against Abbott and damages for infringement of a patent held by MDC for a particle-bound binding component immunoassay. The suit alleges that two Abbott systems, the Abbott IMx(TM)Immunoassay and the Abbott AxSYM(TM) System, infringe one or more claims of MDC's patent. A motion for Summary Judgement filed by Abbott was subsequently denied, in all aspects, by the US District Court. Murex is anticipating to go to trial in mid-1998, unless an out of court settlement can be reached. The 1998 legal costs to be incurred by the Company for this litigation will not exceed the 1997 legal costs incurred to date. During 1995, the UK Inland Revenue questioned the tax basis of inventory, accounts receivable and property, plant and equipment related to the 1992 purchase of assets from Wellcome. If the Inland -12- Revenue is successful in its argument, a tax charge of up to $4.2 million could arise. Management believes it has meritorious defenses against the claims of the Inland Revenue and that the Company has sufficient tax loss carryforwards to offset any tax charges. Therefore, the Company has not recorded a provision for losses related to this matter. Liquidity and Capital Resources The Company has sufficient cash resources and adequate working capital to carry on its current business and meet existing capital requirements over the next twelve months and beyond. Cash and working capital totaled $6.1 million and $45.7 million, respectively at September 30, 1997. For the nine months ended September 30, 1997, the Company generated cash from operations of $2.3 million. On November 12, 1996, the Company entered into a three year, $15 million line of credit facility with Bank of America, which is collateralized by the accounts receivable and inventory of its United States ("US"), UK and Barbados subsidiaries. Based on the value of the collateral, the borrowings outstanding of $12,378,000 and a letter of credit outstanding of $809,000, there were $2,053,000 unused and available under this credit facility as of September 30, 1997. The credit facility was drawn upon for, among other things, payments associated with the Innogenetics alliance, working capital and ongoing business activities. The Company has an interest rate swap agreement with the lender that fixed the interest rate at 8.9% for a notional principal amount of $8.0 million. The Company's working capital and capital requirements will depend upon numerous factors including: the results of research and development, the levels of resources devoted to the establishment and expansion of marketing and manufacturing, technological developments, and the timing and costs of obtaining approvals for new products. Depending on the outcome of these factors, the Company may need to raise additional funds in the future for use to fund acquisitions, complete products in development, and for general purposes. There are no assurances that such funds will be available on favorable terms, if at all. The Company anticipates that its current capital resources, availability under its line of credit facility, and anticipated profitability will enable it to maintain planned operations over the next twelve months and beyond. Management Outlook The key to the Company's growth is the ability to identify new needs in the marketplace, and to expeditiously meet these needs through access to appropriate innovations and technologies, and to rapidly incorporate them into the Murex Group's product line. However, there can be no assurance that the Murex Group will successfully add a significant number of new products to its product line. Management believes that strategic ventures and licensing arrangements position the Company for the future and play an important role in the achievement of management's corporate objectives. The strategic ventures, licensing transactions and Murex Group product innovations discussed below are examples of the Company's recent successes in capitalizing on the Company's world-wide distribution network and product technologies. -13- During February 1996, MDC entered into an exclusive distribution, development and license agreement with Innogenetics N.V. ("Innogenetics") to develop and market gene probe products for the monitoring of patients and the classification of viral diseases. Under the terms of the agreement, MDC paid $5.9 million during 1996 and $1.6 million during 1997 to Innogenetics for the exclusive rights to distribute Innogenetics' LiPA(R) products, excluding HCV, for 15 years. MDC will also pay Innogenetics a royalty of 10% of the Murex Group's net sales of Innogenetics' products. This strategic alliance with Innogenetics has provided the Murex Group with exclusive rights to the Murex/Innogenetics LiPA(R) HIV-1 Reverse Transcriptase ("HIV-1 RT") monitoring test. This test simultaneously detects wild-type and HIV mutations associated with the reverse transcriptase drugs AZT, ddI, ddC and 3TC. The Company launched the test world-wide, except in the US and France where the product is distributed for research use only, late in the second quarter of 1997. In the US, Murex Diagnostics, Inc. ("MDI") has had discussions with the Food and Drug Administration but has not yet filed an application for the clearance of the test. The reverse transcriptase drugs AZT, ddI, ddC and 3TC are currently being utilized, separately and in combination, to treat HIV patients. Resistance to the drugs occurs as virus mutations develop that may eventually cause the drug, or combination of drugs, to become ineffective against the virus. The Murex/Innogenetics LiPA HIV-1 RT test is the first rapid assay to identify HIV mutant strains. Resistant mutations occur with all the approved HIV therapies. Therefore, it is critical to monitor the development of mutations so therapies can be appropriately combined and adjusted. The new HIV-1 RT test provides crucial information relating to the development of resistance to individual and combination therapy. By obtaining resistance information, physicians can avoid using drugs that may not be effective, thereby improving patient care and eliminating the expense of unnecessary and ineffective therapy. In addition, a physician may utilize resistance information prior to starting or changing therapy by screening a patient for the presence of existing drug resistant mutations. The broadening of the Company's focus into the world-wide emerging diagnostics monitoring market, which management expects to exceed $1 billion by the year 2000, should support revenue growth in the coming years. The Innogenetics distribution, developing and licensing agreement gives the Murex Group access to the rapidly growing gene probe market for monitoring patients and the classification of viral diseases. The monitoring market directly complements the Company's existing markets of screening and diagnosis and also leverages its worldwide marketing and distribution network. The diagnostic monitoring market includes tests that, among other applications, assess a patient through the course of a disease or infection, monitor various forms of anti-viral therapies and monitor conditions associated with transplants. In contrast, screening and diagnosis tests are used to indicate whether a patient is, or is not, carrying a disease or infection. In patient use, screening and diagnosis tests are usually only required to be administered once while monitoring tests are usually administered numerous times. Patient monitoring has become an important and critical element of patient care and treatment. The Murex Group believes it can capture a significant portion of this emerging market by strategically -14- positioning itself in key segments of the market including AIDS therapy, organ transplantation and other immune compromised conditions. In addition to the agreement above, during May 1997, the Company licensed its trademarked Sample Addition Monitor (SAM(TM)) technology to Innogenetics. The color-coded SAM technology will be utilized in Innogenetics' enzyme immunoassay products (EIA) with the first being Innogenetics' HIV Ag assay. Developed by Murex's internal research and development, SAM's color-coded reagents change color in each testing step of an assay. The technology assists clinicians in ensuring that samples have been added and the testing procedure has been conducted correctly. The Company's SAM technology is utilized in selected Murex products and it has been licensed to a number of large healthcare companies, including Chiron Corporation. Effective June 1997, Genelabs Diagnostics SA of Geneva, Switzerland, ("Genelabs") appointed MDC to handle distribution of its diagnostics products in Europe and South America. The move is expected to benefit hospitals and laboratories in terms of product availability and technical support, and expand the supply of Genelabs' specialty tests for the diagnosis of infectious diseases and immunological disorders to new areas of need. Agreements made between the two companies, which are exclusive or co-exclusive depending on the country, provide for the sale of viral confirmatory tests including, Western Blots for Human TCell Lymphotropic Virus ("HTLV"), Human Immunodeficiency Virus ("HIV"), EpsteinBarr Virus ("EBV") and cytomegalovirus ("CMV"), Autoblot 36 and Western Blot instrumentation, as well as Hepatitis E Elisa. Effective February 1997, the Murex Group and Digene Corporation ("Digene") entered into a five year agreement to work together to create a direct European sales operation for Digene's sexually transmitted disease diagnostics business. Digene will sell its Hybrid Capture(R) human papilloma virus ("HPV") DNA test directly in selected European markets using the Company's existing distribution infrastructure in exchange for selling service fees and a percentage of Digene HPV sales. All other Digene products exclusively sold by Murex in Europe will not be affected by this transaction. In August 1997, the Company further extended the strategic alliance with Digene by obtaining exclusive rights to market Digene's new Hybrid Capture(R) II HIV RNA, CMV and Hepatitis B ("HBV") tests in the UK, Western and Eastern Europe, Africa, the Middle East and Singapore, following receipt of appropriate import and export authorizations from the FDA and relevant foreign authorities. During January 1997, MDC entered into a 10 year, worldwide Original Equipment Manufacturer ("OEM") distribution agreement with Eurogenetics N.V. ("Eurogenetics"). Pursuant to the terms of the agreement, the Murex Group will distribute Eurogenetics' mircotitre plate EIA kits for rubella, toxoplasmosis, CMV, chlamydia, herpes and beta-2 microglobulin. The Company's worldwide marketing and distribution capabilities motivate companies such as Innogenetics, Genelabs, Digene and Eurogenetics to partner with the Company in licensing agreements and product development and thereby contribute to the flow of new and creative products. The Company's alliances provide the Murex Group with access to technology, strengthen and extend the Company's monitoring market strategy and allow the Company to further penetrate its existing markets in blood screening and clinical diagnostics. Throughout 1997 and beyond, the Company will actively seek out -15- acquisitions, strategic business alliances and other opportunities that will support the Company's future. During June 1997, the Company sold TTP Corporation ("TTP"), a wholly-owned subsidiary of MDC, to Shield Diagnostics Group plc. ("Shield"). TTP owned the intellectual property and other rights to ten products used for the diagnosis of thyroid dysfunction and the measurement of cardiovascular/blood coagulation degradation products. TTP's assays are targeted to a specific segment of the diagnostics industry that is not a part of the Company's long-term strategy of focusing on the screening, diagnosis and monitoring of infectious diseases. Therefore, the divestiture of TTP is an element of the Murex Group's overall plan that will allow the Company to focus its resources on the infectious disease diagnostics monitoring market. The Company will continue to manufacture and sell the TTP product line acquired by Shield for a period of three years, pursuant to a purchase commitment. This will provide Shield security regarding availability of the products while they are being integrated into Shield's business as well as permit Shield to utilize the Murex Group's worldwide distribution network. MDC completed a non-exclusive, out-licensing transaction during the second quarter of 1994 by licensing to Abbott certain technology acquired as part of the 1992 acquisition of the diagnostics division of Wellcome. For the nine months ended September 30, 1997, MDC accrued $940,000 of pro-rata excess minimum royalty revenue for 1997. The underlying revenue stream associated with this licensing agreement has been growing at approximately 40% per year. It continues to remain strong and growing and the Company expects the minimum royalty levels to continue to be exceeded until the expiration of the patent in the year 2004. Therefore, beginning in 1998, the Company anticipates receiving at least $3 million per year from this licensing arrangement. Recent Murex Group product innovations, such as SAM(TM), and tests for HTLV, syphilis and E-Coli, should contribute to future sales growth. These new and enhanced products, created through the Company's in-house research and development endeavors, strengthened the Company's broad line of well-established virology and bacteriology products and allowed the Company to enter new markets in targeted areas around the world. In addition to relying on research and development and licensing of core technologies, management's operation strategy also focuses on quality, customer service, reducing costs and improving cash flows. -16- - ---------------------------------------------------------------------------- RESULTS OF OPERATIONS Total revenues for the quarter and nine months ended September 30, 1997 increased $1,066,000 and $5,024,000 to $25,983,000 and $80,315,000, respectively, from $24,917,000 and $75,291,000 for the prior year periods. These increases are primarily attributable to the ongoing royalty revenue generated from licensing certain technology to Abbott, the fixed payments made by Digene in accordance with the February 1997 agreement and the sale of certain technologies to Shield. The technologies sold to Shield are targeted to a specific segment of the diagnostics industry that is not part of the Company's long term strategy. The strength of the US Dollar against most major currencies during the quarter and nine months ended September 30, 1997 relative to the prior year periods caused a decrease in the Dollar equivalent product sales revenue. Murex operates a worldwide distribution network; consequently, approximately 70% of the Company's product sales are denominated in currencies other than the US Dollar, the reporting currency of the Company. The changes in product sales represent actual increases using a constant currency basis of $271,000 and $3,554,000, offset by negative foreign exchange impacts of $1,377,000 and $3,830,000 for the three and nine month periods, respectively. The gross profit on total revenues increased to 64.7% from 64.3% for the nine months ended September 30, 1997 compared to the same period in 1996. The cost of products sold was $10,326,000 and $28,314,000 for the quarter and nine months ended September 30, 1997, respectively, compared to $8,556,000 and $26,911,000 for the prior year periods. The increase in cost of goods sold is primarily due to the strength of the Pound since the majority of manufacturing is done in the UK. Total costs and expenses, excluding cost of products sold, of $13,642,000 and $45,549,000 for the quarter and nine months ended September 30, 1997, respectively, reflect net decreases of $1,584,000 and $1,640,000 from the quarter and nine months ended September 30, 1996. Research and development cost for the quarter and nine months ended September 30, 1997 increased by $632,000 and $945,000 to $2,136,000 and $5,863,000, respectively. The increase in research and development expenditures is a result of the Company's strategy of developing innovative products for its distribution network and continuously improving its existing products. The Company has also been improving its HCV test design and manufacturing process to meet the changing requirements of this considerable market. General and administrative expenses of $3,421,000 and $13,882,000 for the quarter and nine months ended September 30, 1997 reflect decreases of $6,726,000 and $6,570,000 compared to the prior year. As discussed in Note 3 of the accompanying financial statements, the Company is entitled to the reversion of the class action settlement fund, of which the net cash portion is considered as a reduction to general and administrative expenses. The previous year's general and administrative expenses of $10,147,000 and $20,452,000 for the three and nine month periods included legal, employee compensation, and other expenses associated with settling the Company's HCV patent litigation during the third quarter of last year. Sales and marketing expenses of $6,750,000 and $21,088,000 reflect decreases of $414,000 -17- and $804,000 compared to the quarter and nine months ended September 30, 1996. Foreign exchange gains were $43,000 and $68,000 for the quarter and nine months ended September 30, 1997, respectively, versus losses of $227,000 and $951,000 reported for the comparable prior year periods. The 1996 foreign exchange losses were caused predominantly by the strengthening of the British Pound in relation to the US and German currencies, as well as the weakening of the South African Rand. The royalty expense was $1,378,000 and $4,784,000 for the quarter and nine months ended September 30, 1997, respectively, compared to credits of $5,916,000 and $3,124,000 for the prior year periods. As a result of the settlement of the HCV litigation during the third quarter of 1996, a reversal was made to royalty accruals made in previous years, which produced a $5.9 million net credit to royalty expense. During September 1996, the Company recorded a restructuring charge of $2.1 million before tax. The restructuring was driven by the need to reposition the Company for its movement into the patient monitoring business, and consisted predominantly of estimated costs for employee severance and other benefits. Net interest expense (income) was $306,000 and $829,000 compared to $(46,000) and $611,000 for the quarter and nine months ended September 30, 1997 and 1996, respectively. The Company currently has access to capital at favorable rates via the line of credit with Bank of America. However, during the nine months ended September 30, 1997, the Company increased the amount borrowed. In the prior year, the Company factored its Italian receivables to fund the agreement with Innogenetics. Other income was $962,000 and $987,000 for the three and nine months ended September 30, 1997, primarily from realized gains on marketable securities. The equity in loss of investee represents SDL's net loss for the quarter and nine months ended September 30, 1996. -18- INTERNATIONAL MUREX TECHNOLOGIES CORPORATION Form 10-Q for the Nine Months Ended September 30, 1997 Part II - Other Information - ----------------------------------------------------------------------------- ITEM 1 - LEGAL PROCEEDINGS See Note 3 to the financial statements for information regarding current legal proceedings. ITEM 6 - EXHIBITS AND REPORTS ON FORM 8-K 1. Exhibits Exhibit 11 Statement Regarding Computation of Per Share Earnings 2. Reports on Form 8-K None -18- 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. INTERNATIONAL MUREX TECHNOLOGIES CORPORATION (Registrant) Date: November 11, 1997 By: /s/ C. Robert Cusick -------------------- ------------------------------------- C. Robert Cusick, Vice Chairman President & CEO Date: November 11, 1997 By: /s/ Steve Ramsey -------------------- ------------------------------------- Steve Ramsey, Vice President & CFO -20- EXHIBIT INDEX Exhibit Description ------- ----------- 11 Statement Regarding Computation of Per Share Earnings 27 Financial Data Schedule