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IME Imi International Medical Innovations

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Share Name Share Symbol Market Type
Imi International Medical Innovations AMEX:IME AMEX Ordinary Share
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IMI announces third quarter results

11/11/2004 11:24pm

PR Newswire (US)


Imi Medical Innovations (AMEX:IME)
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IMI announces third quarter results TORONTO, Nov. 11 /PRNewswire-FirstCall/ -- IMI International Medical Innovations Inc. (TSX:IMI; Amex: IME), a leader in predictive medicine, today announced financial results for the third quarter of fiscal 2004 ended September 30, 2004 (Q3 2004). "IMI is making solid progress on all of our business plan objectives," said Dr. Brent Norton, President and Chief Executive Officer. "We are continuing to publish and present key findings, most recently at the Canadian Cardiovascular Congress, which strengthens the scientific credibility of our products while raising our profile with the medical community. Additionally, a new paper on our skin sterol technology has just been accepted by the Journal of Clinical Chemistry for publication in January 2005." Dr. Norton continued, "During the quarter we worked closely with McNeil to brand our cardiovascular products as PREVU(x) Skin Sterol Test, a complex process that ranged from software enhancements to extended dating on the test kits. Moreover, we shipped additional product to McNeil subsequent to quarter end." "IMI is building a world class portfolio of predictive medicine technologies," Dr. Norton said. "Our recent bid to acquire IBEX Technologies Inc. reflects our growth focus and will help position IMI to be a significant force in the North American biotech industry and globally, with products that address urgent health needs. We believe our offer, which enables IBEX shareholders to unlock the full value of their company's assets, will result in an even stronger, more dynamic predictive medicine company and increased shareholder value." Recent Highlights ----------------- Publications and Presentations New findings presented at the Canadian Cardiovascular Congress on October 25, 2004 confirmed that skin sterol provides new information about heart disease risk in patients on statin drug therapy independent of traditional risk factors. Additionally, this trial provided important new data about skin sterol levels, which were higher in patients with a history of stroke, angina and diabetes. Conversely, blood markers did not positively correlate with prior stroke, angina or diabetes. During the quarter positive study results for IMI's breast cancer test were published in the prestigious journal Cancer. The data showed that IMI's test demonstrated a statistically significant difference between early-stage breast cancer and non-cancerous samples, which demonstrates the test's effectiveness in identifying early-stage disease. PREVU(x) Skin Sterol Test McNeil Consumer Healthcare continues its commercialization process, forming plans for the international build-out of PREVU(x) as well as ongoing marketing and sales initiatives this fall and through 2005. McNeil has exhibited at several major medical conferences, including the Canadian Cardiovascular Congress and the American Heart Association annual conference as the planned rollout of the product begins to the professional medical community. McNeil's educational newsletter, titled Prediction and Prevention: New Perspectives in Cardiovascular Disease Risk, has recently been made available on IMI's website. Patents In August 2004, IMI learned that two of its U.S. skin sterol patents had been listed as abandoned by the United States Patent and Trademark Office (PTO) for failure to pay maintenance fees. The failure to pay these fees appears to have occurred while management of the files was being transferred between two separate patent agents. IMI and its agents have filed a petition with the PTO for reinstatement of the patents, which is a process that could take several months. Investor Relations Activities IMI is continuing to broaden its relationships with the professional investment community in Canada as well as the United States, where the company has engaged The Investor Relations Group (IRG). IRG is increasing investor awareness of IMI by individually and personally introducing IMI and its management to pre-qualified fund managers and analysts. IRG is also working to increase public awareness of IMI through media placement in television, radio, magazine, newspaper and trade media outlets. Financial Review ---------------- For the three months ended September 30, 2004 (Q3 2004), IMI reported a net loss of $1,203,000 or $0.06 per share compared with a loss of $992,174 or $0.05 per share for the quarter ended September 30, 2003 (Q3 2003). For the nine months ended September 30, 2004, IMI reported a net loss of $3,765,000 or $0.18 per share, compared with $2,636,000 or $0.13 per share for the nine months ended September 30, 2003. In Q2 2004, IMI made its first sales of product to its marketing partner, McNeil Consumer Healthcare. IMI reported no product sales of its skin sterol tests during Q3 2004, however additional product was shipped to McNeil subsequent to quarter end. As reported in Q2 2004, IMI completed a worldwide licensing agreement with McNeil to sell the company's cardiovascular products, which have been branded as PREVU(x) Skin Sterol Test. The upfront cash payments from both the original Canadian agreement and the worldwide agreement have been deferred and are being recognized into income on a straight-line basis over the relative terms of the agreements. Therefore, $76,725 has been reported as license revenue for Q3 2004 compared with $1,725 in Q3 2003. At September 30, 2004 IMI had cash, cash equivalents and short-term investments totaling $6,116,000 ($6,697,000 as at December 31, 2003). Management believes that, based on historic burn rates and the current expectation of revenues from partnering activities and product sales, the company's cash resources, together with investment tax credits receivable, are sufficient to meet current operating and capital requirements through at least 2005. Research and development expenditures for the quarter increased by $68,000 to $525,000 from $457,000 in Q3 2003. The variance for the quarter reflects: - A $33,000 increase in spending on clinical trials for skin sterol and cancer to $107,000 from $74,000 during fiscal 2003. This increase is related to a lung cancer trial that commenced in the latter part of 2003. IMI currently has 17 clinical trials ongoing. - Increased filing fees on intellectual property, which amounted to $74,000 compared with $17,000 in fiscal 2003. During the quarter IMI filed new patents on skin sterol in numerous European countries. - Subcontract research increased by $11,000 as IMI continued to develop new prototypes of the skin sterol technology. - Stock-based compensation, which was prospectively adopted in 2003, resulted in non-cash expenses for research of $23,000 in Q3 2004 compared with $22,000 for Q3 2003. Other development costs remained at fairly constant levels during the period. Total research expenditures for the nine months ended September 30, 2004 and 2003 amounted to $1,872,000 and $1,154,000, respectively. General and administration expenses for the quarter increased by $267,000 to $791,000 from $524,000 in Q3 2003. The variance for the quarter reflects: - Stock-based compensation for options granted for administration resulted in a non-cash expense of $286,000 for the quarter compared with $3,000 for Q3 2003. This increase was primarily for options granted in Q3 that vest over 12 months pursuant to a consulting contract. It also reflects the cashless exercise of options that were granted prior to the January 1, 2003 adoption of the policy for expensing the fair value of options. - A $21,000 increase in professional fees, primarily due to legal fees related to finalizing the global licensing agreement. - A $21,000 increase in insurance over Q3 2003. This primarily reflects IMI's decision to increase its liability insurance coverage following the September 2003 U.S. listing on the American Stock Exchange. However, Q3 2004 U.S. listing costs were nil compared with $61,000 in Q3 2003. - Annual report, annual meeting and investor relations expenses were higher by $40,000 as a result of additional expenses to improve shareholder communications. - Directors' fees were lower by $17,000 during the quarter compared with Q3 2003 but were comparable for the nine-month periods. The difference is due to the timing of the meetings in 2003. Total general and administration expenses for the nine months ended September 30, 2004 and 2003 amounted to $2,078,000 and $1,637,000, respectively. Amortization expenses for equipment and acquired technology for the three months and nine months ended September 30, 2004 amounted to $51,000 and $177,000, respectively. (The nine-month amount comprises $6,000 that was included as an overhead allocation in cost of sales.) This is a decrease of $68,000 and $35,000, respectively, over the corresponding periods in 2003. In Q3 2003, there was a large purchase of equipment that resulted in the extraordinary amortization charge for that quarter. Purchases of equipment to support clinical trials and manufacturing amounted to $16,000 and $167,000 for the three and nine months ended September 30, 2004, respectively. Interest income amounted to $32,000 for the quarter, compared with $48,000 for Q3 2003, reflecting lower interest rates on invested cash and lower cash balances through most of the quarter. Conference Call and Webcast --------------------------- IMI will hold a conference call and webcast to discuss third quarter results on Friday, November 12, 2004 at 10 a.m. ET. To listen to the call, please dial 416-640-4127 or 1-800-814-4853, or visit http://www.imimedical.com/. A rebroadcast of the call will be available until November 19, 2004. Please dial 416-640-1917 or 1-877-289-8525 and enter the passcode 21101081 followed by the number sign. About IMI --------- IMI is a world leader in predictive medicine, dedicated to developing rapid, non-invasive tests for the early detection of life-threatening diseases. IMI's cardiovascular products, which are branded as PREVU(x) Skin Sterol Test, will be marketed and distributed worldwide by McNeil Consumer Healthcare. The company's cancer tests include ColorectAlert(TM), LungAlert(TM) and a breast cancer test. IMI's head office is located in Toronto, and its research and product development facility is at McMaster University in Hamilton, Ontario. For further information, please visit http://www.imimedical.com/. This press release contains forward-looking statements. These statements involve known and unknown risks and uncertainties, which could cause IMI's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the lack of operating profit and availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the successful development or marketing of IMI's products, reliance on third-party manufacturers, the competitiveness of IMI's products if successfully commercialized, the ability of IMI to take advantage of business opportunities, uncertainties related to the regulatory process, and general changes in economic conditions. In addition, while IMI routinely obtains patents for its products and technology, the protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. The following factors related to the business combination of IMI and IBEX could cause actual results to differ materially from the forward-looking statements: lack of Shareholder support for the Offer; the timing of the closing of the transaction, if approved by Shareholders; dilution; the businesses of IMI and IBEX may suffer due to uncertainty prior to completion of the transaction; the business of IMI and IBEX may not be integrated successfully or such integration may be more difficult, time-consuming or costly than expected; changes in management and organizational structure; and the expected combination benefits from the IMI/IBEX transaction may not be fully realized nor realized within the expected time frame. Investors should consult IMI's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. IMI is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. Financial statements are attached to this release. The company's complete third quarter report is available on IMI's website. ------------------------------------------------------------------------- IMI International Medical Innovations Inc. Incorporated under the laws of Canada ------------------------------------------------------------------------- Consolidated Balance Sheets (in Canadian Dollars) (Unaudited) As at September 30, 2004 and December 31, 2003 September 30 December 31 2004 2003 ------------------------------------------------------------------------- ASSETS Current Cash and cash equivalents $ 1,169,612 $ 61,625 Short-term investments 4,946,356 6,635,135 Prepaid expenses and other receivables 186,873 340,489 Investment tax credits receivable 335,000 180,000 ------------------------------------------------------------------------- Total current assets 6,637,841 7,217,249 ------------------------------------------------------------------------- Capital assets, net of accumulated amortization of $557,781 (2003 - $448,182) 460,158 403,205 Acquired technology, net of accumulated amortization of $761,719 (2003 - $693,684) 385,538 453,573 ------------------------------------------------------------------------- $ 7,483,537 $ 8,074,027 ------------------------------------------------------------------------- ------------------------------------------------------------------------- LIABILITIES AND SHAREHOLDERS' EQUITY Current Accounts payable $ 73,340 $ 139,435 Accrued liabilities 253,270 403,213 ------------------------------------------------------------------------- Total current liabilities 326,610 542,648 ------------------------------------------------------------------------- Deferred revenue 2,987,925 93,100 ------------------------------------------------------------------------- Total liabilities 3,314,535 635,748 ------------------------------------------------------------------------- Shareholders' equity Capital stock 25,384,843 24,780,846 Warrants 204,200 312,200 Deficit (21,420,041) (17,654,767) ------------------------------------------------------------------------- Total shareholders' equity 4,169,002 7,438,279 ------------------------------------------------------------------------- $ 7,483,537 $ 8,074,027 ------------------------------------------------------------------------- ------------------------------------------------------------------------- ------------------------------------------------------------------------- IMI International Medical Innovations Inc. ------------------------------------------------------------------------- Consolidated Statements of Loss and Deficit (Unaudited) Three months ended Nine months ended September 30 September 30 2004 2003 2004 2003 ------------------------------------------------------------------------- REVENUE Product sales $ - $ - $ 100,000 $ - License revenue 76,725 1,725 105,175 5,175 ------------------------------------------------------------------------- 76,725 1,725 205,175 5,175 Cost of sales - - 93,464 - ------------------------------------------------------------------------- Gross profit 76,725 1,725 111,711 5,175 ------------------------------------------------------------------------- EXPENSES Research and development 524,634 456,633 1,872,136 1,154,112 General and administration 790,805 524,109 2,077,508 1,636,957 Amortization 50,743 118,174 171,034 205,575 ------------------------------------------------------------------------- 1,366,182 1,098,916 4,120,678 2,996,644 ------------------------------------------------------------------------- RECOVERIES AND OTHER INCOME Investment tax credits 55,000 56,634 155,000 172,217 Interest 31,549 48,383 88,693 183,342 ------------------------------------------------------------------------- 86,549 105,017 243,693 355,559 ------------------------------------------------------------------------- Net loss for the period (1,202,908) (992,174) (3,765,274) (2,635,910) Deficit, beginning of period (20,217,133) (15,235,792) (17,654,767) (13,592,056) ------------------------------------------------------------------------- Deficit, end of period $(21,420,041) $(16,227,966) $(21,420,041) $(16,227,966) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Basic and diluted loss per share $ (0.06) $ (0.05) $ (0.18) $ (0.13) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Weighted average number of common shares outstanding 21,270,199 20,924,582 21,265,760 20,884,113 ------------------------------------------------------------------------- ------------------------------------------------------------------------- IMI International Medical Innovations Inc. ------------------------------------------------------------------------- Consolidated Statements of Cash Flows (Unaudited) Three months ended Nine months ended September 30 September 30 2004 2003 2004 2003 ------------------------------------------------------------------------- OPERATING ACTIVITIES Net loss for the period $ (1,202,908) $ (992,174) $ (3,765,274) $ (2,635,910) Add items not involving cash Amortization 50,743 118,174 177,634 205,575 Stock compensation costs included in: Research and development expense 23,391 21,507 99,460 25,673 General and administrative expense 293,425 3,424 378,569 24,694 Loss on sale of capital asset - - - 5,230 ------------------------------------------------------------------------- (835,349) (849,069) (3,109,611) (2,374,738) Net change in non-cash working capital balances related to operations (150,007) 93,403 (222,822) 876 Increase (decrease) in deferred revenue (76,725) (1,725) 2,894,825 (5,175) ------------------------------------------------------------------------- Cash used in operating activities (1,062,081) (757,391) (437,608) (2,379,037) ------------------------------------------------------------------------- INVESTING ACTIVITIES Short term investments (9,587) 704,168 1,688,779 2,156,933 Purchase of capital assets (15,895) (102,412) (166,552) (133,844) ------------------------------------------------------------------------- Cash provided by (used in) investing activities (25,482) 601,756 1,522,227 2,023,089 ------------------------------------------------------------------------- FINANCING ACTIVITIES Issuance of capital stock, net - 73,437 23,368 216,437 ------------------------------------------------------------------------- Cash provided by financing activities - 73,437 23,368 216,437 ------------------------------------------------------------------------- Net increase (decrease) in cash and cash equivalents during the period (1,087,563) (82,198) 1,107,987 (139,511) Cash and cash equivalents - Beginning of period 2,257,175 93,138 61,625 150,451 ------------------------------------------------------------------------- - End of period $ 1,169,612 $ 10,940 $ 1,169,612 $ 10,940 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Represented by Cash $ 76,962 $ 10,940 $ 76,962 $ 10,940 Cash equivalents 1,092,650 - 1,092,650 - ------------------------------------------------------------------------- $ 1,169,612 $ 10,940 $ 1,169,612 $ 10,940 ------------------------------------------------------------------------- ------------------------------------------------------------------------- DATASOURCE: IMI International Medical Innovations Inc. CONTACT: Company Contacts: Sarah Borg-Olivier, Director, Communications, (416) 222-3449, ; Ron Hosking, Vice President, Finance and CFO, (416) 222-3449, ; U.S. Investor Contact: John Nesbett, The Investor Relations Group, (212) 825-3210,

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