PreMD Previews Fiscal 2005 Results and Provides Outlook for 2006
March 14 2006 - 5:52PM
PR Newswire (US)
- Definitive heart attack data for PREVU(x) anticipated - Major
milestones expected in 2006, including second product approval
(PREVU(x) LT) and additional regulatory claims for PREVU(x) POC -
Conclude strategic partnership for cancer products - Potential to
break even by end of 2006 TORONTO, March 14 /PRNewswire-FirstCall/
-- Predictive medicine company PreMD Inc. (TSX: PMD; Amex: PME)
today previewed financial results for the fourth quarter and fiscal
year ended December 31, 2005 (unaudited) and provided investors
with an operating update and outlook for fiscal 2006. "Last year we
advanced our business significantly on a number of fronts," said
Dr. Brent Norton, President and Chief Executive Officer. "We
focused on expanding the market opportunity for PREVU(x), launching
two major clinical trials to broaden PREVU(x)'s regulatory claims.
The first trial is examining PREVU(x)'s ability to assess risk of
heart attack. The second is evaluating the efficacy of PREVU(x) LT
in the life insurance industry. Additionally, we showcased PREVU(x)
to scientific thought leaders through eight peer-reviewed
scientific presentations and publications, and McNeil Consumer
Healthcare completed its first sales of PREVU(x) in the U.S. and
Canada. Likewise, we took important strides with our cancer
portfolio, including the start of new studies with
ColorectAlert(TM) and our breast cancer test." "On the financial
front, we are pleased to report that we achieved nearly $1 million
in revenue in the fourth quarter ---- the highest in the company's
history --- and $1.6 million in revenue for the year, also a record
high," said Dr. Norton. "We expect fiscal 2006 to be a very
productive year as we conclude several of our clinical and
development initiatives for our skin sterol technology and cancer
portfolio. At the same time, we expect additional revenues and
milestone payments related to the successful completion of our
strategic objectives. As these goals are achieved, we expect to
move towards breaking even, possibly by the end of 2006." Fiscal
2006 Objectives (1) Achieve regulatory clearance for PREVU(x) LT to
enable marketing launch - Complete the life insurance industry
study (PREPARE) with PREVU(x) LT Skin Sterol Test, the
lab-processed format of the technology, during the second quarter;
and - Seek regulatory clearance for PREVU(x) LT in the U.S., Canada
and Europe; (2) Achieve new regulatory claim for PREVU(x) in U.S.
as a tool to predict risk of heart attack - Complete the
600-patient PASA study; and - Seek new regulatory claim for
PREVU(x) POC and PREVU(x) LT for risk assessment of heart attacks
and strokes, which would create exciting new opportunities for the
technology and position PREVU(x) as the only cost-effective tool to
predict who is going to have a heart attack, something that simple
blood cholesterol tests cannot do. (3) Complete analysis of new
LungAlert(TM) data - Complete analysis of data from 1,000 patients
in the International Early Lung Cancer Action Program (I-ELCAP)
clinical trial and submit for publication; and - Expand
participation in I-ELCAP to additional sites to enhance data for a
future FDA submission. (4) Drive cancer clinical program - Complete
pivotal study for the breast cancer test at the University of
Louisville; and - Initiate an additional clinical trial for
ColorectAlert(TM). (5) Conclude a strategic partnership for PreMD's
cancer products PREVU(x) Commercialization Update McNeil completed
its first sales of PREVU(x) in 2005 and is continuing to advance
initiatives in targeted segments of the risk assessment market as
well as the life insurance industry. Throughout 2006, McNeil will
continue to showcase PREVU(x) POC to cardiologists and other
medical professionals through conferences in major world markets,
including the recent American College of Cardiology annual meeting,
as well as the annual conferences of the European Society of
Cardiology and Canadian Cardiovascular Society later this year.
McNeil will also continue to promote PREVU(x) directly to specific
health care programs and providers, including screening clinics
where cardiovascular risk assessment is conducted. Additionally,
McNeil has implemented a strategy for reimbursement in the U.S. and
expects to make a formal reimbursement application in 2006. McNeil
is also evaluating its reimbursement strategy in each of the
various provinces of Canada. In spring 2006, McNeil plans to extend
the previously announced pilot program in Quebec targeting
customers of a major North American retail chain. If successful, it
is currently anticipated that the program, which is being conducted
in on-site pharmacies or clinics, will be extended to additional
locations. McNeil will launch a similar program with another
retailer in the United States this month. Another important focus
for McNeil in 2006 is the occupational health market, which
includes employee health fairs and programs. McNeil is also
evaluating opportunities in the alternative health market, which
includes natural health clinics. In the life insurance testing
market, McNeil is continuing to meet with life insurance companies
to prepare for the launch of PREVU(x) LT. McNeil has established an
industry Advisory Board to help guide marketing activities and will
be once again exhibiting the product in October at the annual
Association of Home Office Underwriters (AHOU) meeting.
Additionally, McNeil plans to initiate a pilot program in Ireland
with a tele-underwriting firm that conducts interviews by phone
with candidates for life insurance. When required, candidates are
referred to a pharmacy to undergo select tests, including PREVU(x)
POC. Patent Update In February 2006, PreMD filed a request for
reconsideration with the U.S. Patent and Trademark Office (U.S.
PTO) regarding its decision in December 2005 not to reinstate two
U.S. skin sterol patents. PreMD has authorized legal action against
its former law firm, which was responsible for managing its patent
portfolio at the time when the maintenance fees for the two patents
in question should have been paid. Fiscal 2005 Overview For the
year ended December 31, 2005, PreMD recorded revenue of $1,579,000,
consisting of $426,000 in product sales to McNeil and $1,153,000 in
license revenue. Expenses for the year increased marginally from
fiscal 2004, reflecting higher research and development costs
related to clinical trials and product development as well as the
interest expense related to the convertible debentures issued in
August 2005. However, general and administration expenses in the
fourth quarter of fiscal 2005 decreased approximately 30% from
recurring expenses in the fourth quarter of fiscal 2004. As at
December 31, 2005 PreMD had cash, cash equivalents and short-term
investments totaling $8,679,000 ($5,196,000 as at December 31,
2004). Management believes that, based on historic cash
expenditures and the current expectation of further revenues from
product sales, royalties and license revenues, PreMD's existing
cash resources together with the investment tax credits receivable
of $200,000 will be sufficient to meet our current operating and
capital requirements through at least 2008. PreMD will file
complete audited financial results on March 31, 2006.
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Conference Call and Webcast PreMD will hold a conference call and
webcast tomorrow, March 15, 2006, at 10 a.m. ET. To access the
conference call, please dial 416-644-3425 or 1-800-814-3911. A live
audio webcast will be available at http://www.premdinc.com/, and
will be subsequently archived for three months. To access the
replay via telephone, which will be available until March 24, 2006,
please dial (416) 640-1917 or (877) 289-8525 and enter the passcode
21180267 followed by the number sign.
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About PreMD Inc. PreMD Inc. is a world leader in predictive
medicine, dedicated to developing rapid, non-invasive tests for the
early detection of life-threatening diseases. PreMD's
cardiovascular products, which are branded as PREVU(x) Skin Sterol
Test, are licensed worldwide to McNeil Consumer Healthcare. The
company's cancer tests include ColorectAlert(TM), LungAlert(TM) and
a breast cancer test. PreMD'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.premdinc.com/. For more information about
PREVU(x), please visit http://www.prevu.com/ or call 1-866-283-8328
(North America) or 00-800-8283-8328 (Europe), or email . 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 successful development or marketing of
the Company's products, the competitiveness of the Company's
products if successfully commercialized, the lack of operating
profit and availability of funds and resources to pursue R&D
projects, the successful and timely completion of clinical studies,
product liability, reliance on third-party manufacturers, 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. PreMD 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. DATASOURCE: PreMD Inc. CONTACT: Sarah Borg-Olivier,
Director, Communications, T: (416) 222-3449, ; Ron Hosking, Chief
Financial Officer, T : (416) 222-3449,
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