IMI announces first quarter financial results and provides
operational update - Lead cardiovascular test, PREVU(x) POC, made
available for sale - Significant new PREVU(x) study in life
insurance testing industry - Pivotal study for breast cancer test
underway - Positioned to receive milestone payments later this year
TORONTO, May 11 /PRNewswire-FirstCall/ -- Predictive medicine
company IMI International Medical Innovations Inc. (TSX: IMI; Amex:
IME) today announced financial results for the first quarter of
fiscal 2005 ended March 31, 2005. "The first few months of 2005
have been highly successful, with a number of achievements that
will contribute to the long-term success of our cardiovascular
product family," said Dr. Brent Norton, President and Chief
Executive Officer. "Our first product, PREVU(x) Point of Care (POC)
Skin Sterol Test, was made available for sale to medical
professionals in the United States, Canada and select European
markets. In addition, new data on PREVU(x) presented in
high-profile scientific and medical forums heightened the
visibility of our unique approach. Furthermore, we have realized a
key strategic objective with the start of the PREPARE (PREVU(x)
Predicts Atherosclerosis Risk and Events) clinical trial, a
25,000-patient study in the life insurance testing industry using
PREVU(x) LT Skin Sterol Test, the lab- processed format of our
technology. This study will generate valuable new data on PREVU(x)
LT, with interim results expected by early fall." Dr. Norton
continued, "Over the next few months, McNeil will continue to
invest in building the PREVU(x) brand. With supportive clinical
data from the insurance study, they expect to be in a position to
launch PREVU(x) LT this year, which will fulfill a central element
of the strategy to have multiple products available in different
market segments at the same time. It also positions us to receive
other milestone payments from McNeil." Dr. Norton also noted that
IMI's cancer program is advancing with the start of a pivotal study
for the company's breast cancer screening test at the University of
Louisville. "The successful completion of this study will provide
the data needed to design a larger trial aimed at regulatory
approval," he said. "We are continuing to work towards finalizing a
major study for our colorectal cancer screening test,
ColorectAlert(TM), and expect to have new data on our lung cancer
test, LungAlert(TM), later this summer." Operational Review
Advancing commercialization of PREVU(x) Skin Sterol Test During the
first quarter McNeil made PREVU(x) POC Skin Sterol Test available
for sale to medical professionals in the U.S., Canada and select
European markets. McNeil is actively promoting PREVU(x) POC through
a number of innovative marketing programs, including eight medical
conferences in major world markets, where they are targeting
cardiologists, and directly to specific health care programs and
providers. Additionally, McNeil continues to meet with life
insurance companies to prepare for the upcoming launch of PREVU(x)
LT later this year. Increased visibility of PREVU(x) POC with
presentation of new clinical data In March, new data was presented
at the American College of Cardiology annual meeting, showing the
relationship between skin sterol and increased carotid intima-media
thickness (CIMT) in patients with no symptoms of disease. CIMT is a
marker of atherosclerosis and an independent predictor of heart
attack and stroke. This strong association with increased CIMT
suggests that skin sterol testing may help to identify asymptomatic
patients who could benefit from more intensive interventions.
Subsequent to quarter end, new data presented at the 6th Annual
Arteriosclerosis, Thrombosis and Vascular Biology conference,
sponsored by the American Heart Association, showed that patients
with elevated skin sterol and a high Framingham global risk score
have a significantly higher risk of multivessel disease. To date,
an additional three scientific papers have been accepted for
publication in 2005. Expanded patent protection for all products
IMI's market reach was broadened when a new patent related to the
company's process for quantifying color-change reactions in the
presence of disease in humans was granted by the Australian Patent
Office. This color- reading system, used throughout IMI's product
line, is patent pending in key regions globally. Additionally, IMI
filed a new patent for an alternative format of the PREVU(x) test,
in keeping with its strategy to control and develop all relevant
technologies that could be applied to the company's tests.
Continuing to pursue re-instatement of two U.S. skin sterol patents
The U.S. Patent and Trademark Office (U.S. PTO) granted an
extension for the submission of IMI's request for consideration to
accept unavoidably delayed payments of maintenance fees for two
U.S. patents related to IMI's skin sterol technology. As disclosed
in February, the U.S. PTO has asked for more information regarding
the credentials and procedures of IMI's patent agents and their
performance of clerical functions related to the payment of the
maintenance fees. Business Outlook "We have already achieved a
number of important strategic objectives in the year to date and
have a positive outlook for the remainder of 2005," said Dr.
Norton. "Bringing a new product to market is a complex process in
which several variables come into play. McNeil has a proven track
record of successfully launching new products and dominating its
chosen markets." Dr. Norton continued, "Acceptance and excitement
about PREVU(x) is growing. While we expect to see sales build
through late 2005 and 2006, McNeil will determine the timing and
volume of those sales. IMI's focus is on enhancing our current
technologies, further developing our cancer franchise and expanding
our product offering, all with a view to building the value of our
business." Primary objectives for 2005 include: - Starting a major
U.S. colorectal cancer study with ColorectAlert(TM) led by a U.S.
government-sponsored institution; - Initiating a clinical trial
directed at expanding PREVU(x)'s regulatory claims to screening for
risk of heart attack; - Developing an additional test format for
PREVU(x); - Seeking regulatory approval of PREVU(x) LT in Canada
and Europe later this year; and - Achieving milestone payments from
McNeil. First Quarter Financial Review (in Canadian dollars) Total
product sales to McNeil were $12,000 for Q1 2005 compared with nil
in Q1 2004. Subsequent to quarter end, in April 2005 product sales
of $179,000 were recorded that had been committed to by McNeil for
Q1 2005. The invoice was issued in Q1 and title had passed to
McNeil in accordance with the license agreements but delivery was
deferred until April. As a result, the amount was included in
accounts receivable and deferred revenue on the balance sheet.
License revenue for Q1 2005 was $77,000 compared with $2,000 for Q1
2004. The net loss for the quarter was $1,302,000 or $0.06 per
share compared with a loss of $1,083,000 or $0.05 per share for the
quarter ended March 31, 2004 (Q1 2004). Research and development
expenditures for the quarter increased to $642,000 from $571,000 in
Q1 2004. This variance reflects: - an increase in stock-based
compensation (a non-cash expense) of $30,000 compared with $20,000
for Q1 2004; - an increase of $82,000 in spending on clinical
trials for skin sterol and lung cancer; and - a decrease of $47,000
in sub-contracted research expenses compared with Q1 2004. General
and administration expenses amounted to $764,000 compared with
$521,000 in Q1 2004, an increase of $243,000. This variance
reflects: - an increase in stock-based compensation (a non-cash
expense) of $65,000 to $99,000 compared with $34,000 for Q1 2004; -
an increase of $90,000 in professional fees for legal, audit and
human resources, some of which related to legal expenses associated
with IMI's petition to reinstate two U.S. skin sterol patents; and
- an increase of $60,000, reflecting additional consulting expenses
for investor relations. Amortization expenses for equipment and
acquired technology amounted to $52,000 compared with $57,000 for
Q1 2004. Purchases of equipment to support clinical trials amounted
to $82,000 during Q1 2005 compared with $73,000 in Q1 2004.
Interest income amounted to $29,000 compared with $28,000 for Q1
2004. Refundable scientific investment tax credits accrued for Q1
2005 amounted to $50,000 versus $37,000 for Q1 2004. As at March
31, 2005 IMI had cash, cash equivalents and short-term investments
totaling $3,630,000 ($5,200,000 as at December 31, 2004). Cash used
to fund operating activities during Q1 2005 amounted to $1,730,000
compared to $834,000 in Q1 2004, which was affected by the
reduction in accounts payable and accrued liabilities by $466,000
during Q1 2005. To date, IMI has financed its activities through
product sales, license revenues, the issuance of shares and the
recovery of scientific research tax credits (ITCs). Management
believes that, based on historic cash expenditures and the current
expectation of further revenues from partnering activities, product
sales and royalties, its existing cash resources together with the
ITCs receivable of $439,000 will be sufficient to meet its current
operating and capital requirements until at least the second
quarter of 2006.
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Conference Call and Webcast IMI will hold a conference call and
webcast tomorrow, May 12, 2005, at 10 a.m. ET. To access the
conference call, please dial (416) 640-4127 in Toronto, or 1 (800)
814-4862 elsewhere in North America. A live audio webcast will be
available at http://www.imimedical.com/, and will be subsequently
archived for three months. To access the replay via telephone,
which will be available until May 19, 2005, please dial (416)
640-1917 or (877) 289-8525 and enter the passcode 21124554 followed
by the number sign.
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Financial statements are attached to this press release. IMI's
Annual and Special Meeting of Shareholders will be held at 10:30
a.m. (ET) on May 25, 2005 at the Toronto Stock Exchange Conference
Centre, 130 King Street West, in Toronto, Ontario. The event will
also be webcast live at http://www.imimedical.com/. About IMI IMI
(http://www.imimedical.com/) 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, are
marketed and distributed worldwide by McNeil Consumer Healthcare,
Canada. 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
information regarding PREVU(x), please go visit
http://www.prevu.com/. This press release contains forward-looking
statements. These statements involve known and unknown risks and
uncertainties, which could cause the Company'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 the Company's
products, reliance on third-party manufacturers, the
competitiveness of the Company's products if successfully
commercialized, the ability of the Company to take advantage of
business opportunities, uncertainties related to the regulatory
process, and general changes in economic conditions. In addition,
while the Company 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. Investors should consult the Company'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.
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IMI International Medical Innovations Inc. Incorporated under the
laws of Canada
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Consolidated Balance Sheets (in Canadian Dollars) As at March 31,
2005 and December 31, 2004
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March 31 December 31 2005 2004
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ASSETS Current Cash and cash equivalents $ 308,642 $ 239,458
Short-term investments 3,321,215 4,956,945 Accounts receivable
228,407 222,348 Inventory 273,702 267,500 Prepaid expenses and
other receivables 273,074 137,015 Investment tax credits receivable
439,000 389,000
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Total current assets 4,844,040 6,212,266
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Capital assets, net of accumulated amortization of $615,318 (2004 -
$581,155) 468,440 420,955 Acquired technology, net of accumulated
amortization of $802,542 (2004 -$784,399) 344,715 362,858
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$ 5,657,195 $ 6,996,079
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LIABILITIES AND SHAREHOLDERS' EQUITY Current Accounts payable $
844,780 $ 1,021,086 Accrued liabilities 276,964 566,951 Current
portion of deferred revenue 485,675 306,900
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Total current liabilities 1,607,419 1,894,937
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Deferred revenue 2,527,575 2,604,300
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Total liabilities 4,134,994 4,499,237
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Shareholders' equity Capital stock 24,404,722 24,192,321
Contributed surplus 1,443,057 1,328,187 Warrants 200,000 200,000
Deficit (24,525,578) (23,223,666)
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Total shareholders' equity 1,522,201 2,496,842
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$ 5,657,195 $ 6,996,079
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IMI International Medical Innovations Inc.
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Consolidated Statements of Loss and Deficit Three months ended
---------------------------- March 31 March 31 2005 2004
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REVENUE Product sales $ 12,359 $ - License revenue 76,725 1,725
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89,084 1,725 Cost of product sales 11,229 -
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Gross Profit 77,855 1,725
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EXPENSES Research and development $ 642,486 $ 571,110 General and
administration 763,865 520,554 Amortization 52,306 57,268
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1,458,657 1,148,932
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RECOVERIES AND OTHER INCOME Investment tax credits 50,000 37,000
Interest 28,890 27,507
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78,890 64,507
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Net loss for the period (1,301,912) (1,082,700) Deficit, beginning
of period (23,223,666) (17,654,767)
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Deficit, end of period $(24,525,578) $(18,737,467)
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Basic and diluted loss per share $ (0.06) $ (0.05)
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Weighted average number of common shares outstanding 21,276,497
21,262,979
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IMI International Medical Innovations Inc. Consolidated Statements
of Cash Flows Three months ended ---------------------------- March
31 March 31 2005 2004
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OPERATING ACTIVITIES Net loss for the period $ (1,301,912) $
(1,082,700) Add item not involving cash Amortization 52,306 57,268
Stock compensation costs included in: Research and development
expense 30,321 20,182 General and administrative expense 98,550
34,181 Net change in non-cash working capital balances related to
operations (532,221) 138,744 Decrease in deferred revenue (76,725)
(1,725)
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Cash used in operating activities (1,729,681) (834,050)
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INVESTING ACTIVITIES Short term investments 1,635,730 1,074,416
Purchase of capital assets (35,265) (73,004)
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Cash provided by investing activities 1,600,465 1,001,412
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FINANCING ACTIVITIES Issuance of capital stock, net 198,400 10,868
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Cash provided by financing activities 198,400 10,868
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Net increase in cash and cash equivalents during the period 69,184
(178,230) Cash and cash equivalents - Beginning of period 239,458
61,625
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- End of period $ 308,642 $ 239,855
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Represented by Cash $ 308,642 $ 239,855 Cash equivalents - -
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$ 308,642 $ 239,855
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DATASOURCE: IMI International Medical Innovations Inc. CONTACT:
Company Contact: Sarah Borg-Olivier, Director, Communications, Ron
Hosking, Chief Financial Officer, T: (416) 222-3449, , ; U.S.
Investor Contact: John Nesbett/Andrea Faville, The Investor
Relations Group, T: (212) 825-3210, ,
Copyright