WINNIPEG, MANITOBA (AMEX: MCU), a cardiovascular focused
biopharmaceutical company, today reported the results of operations
for the three and six month periods ended November 30, 2007. All
amounts referenced herein are in Canadian dollars unless otherwise
noted. At the close of business on November 30, 2007, the exchange
rate was CAD$1.00 = US$1.00.
"The second quarter of fiscal 2008 brought us closer to the
results from our Phase 3 MEND-CABG II trial," stated Medicure's
President and CEO, Albert D. Friesen, PhD. "The results of more
than a decade of hard work are on the horizon and the anticipation
at Medicure and within the cardiology community is increasing."
Clinical Update
In September, Medicure announced it completed enrollment for its
MEND-CABG II trial two months earlier than it had forecast. The
Company believes MC-1 represents a significant improvement in the
care of CABG surgery patients, and could become the first
cardioprotective therapy approved to reduce mortality and morbidity
in this patient population. This pivotal registration study is
evaluating the Company's FDA Fast Tracked product MC-1's safety and
cardioprotective efficacy in patients undergoing coronary artery
bypass graft (CABG) surgery, with top-line results expected in the
third quarter of fiscal 2008.
Corporate Update
During its second quarter of fiscal 2008, Medicure strengthened
its cash position through the completion of two financings totaling
US$41 million.
Under the terms of the first agreement, Birmingham Associates
Ltd., an affiliate of Elliott Associates, L.P., provided Medicure
with an upfront cash payment of US$25 million. Birmingham will
receive an escalating minimum annual return starting at US$2.5
million based on AGGRASTAT� revenue or MC-1 until May 31, 2020.
Birmingham will also receive the option to convert its rights based
on AGGRASTAT� to MC-1 within six months after MC-1's
commercialization, if achieved.
In a separate transaction, Medicure raised total gross proceeds
of US$16 million. Under terms of the private placement, Medicure
issued approximately 13.9 million common shares at a price of
US$1.15, together with warrants, to purchase approximately 4.37
million additional common shares. The warrants have a five-year
term and an exercise price of US$1.50.
Subsequent to quarter end, Medicure announced that David Banks
joined its Board of Directors. Mr. Banks brings to the Board more
than 35 years of international investment banking and private
equity investing experience, and possesses extensive investment
banking knowledge that will be important as Medicure looks to build
greater shareholder value.
AGGRASTAT� Update
During the first half of fiscal 2008, sales of AGGRASTAT�
continued to decline as compared to the same period in fiscal 2007.
The Company recognized that the initial commercial structure, which
consisted of a contract sales organization (CSO) was not optimal as
the Company was not able to maintain sufficient control and
direction of the sales organization. The Company believes it has
taken the corrective steps to address this issue with the recent
hiring of Mr. Brian Best as Vice President, Marketing and the
transition to an internally managed and more cost effective
operation under Brian's leadership. Brian has 16 years of
pharmaceutical industry experience including six years with
Millennium Pharmaceuticals Inc. and Cor Therapeutics Inc. where he
held senior positions including Director of Medical Affairs and
Director of Marketing, Cardiovascular. Brian will play a critical
role in the stabilization and long-term expansion of the Company's
commercial operations in the United States.
"While revenues slightly declined from the previous quarter, we
believe the change in strategic direction is beginning to show
progress," stated Dr. Friesen. "We are building a dynamic and
entrepreneurial team with extensive acute cardiovascular experience
and are optimistic that it will translate into revenue growth for
AGGRASTAT� in the coming year."
Financial Results:
Total product revenue for the three-month period ending November
30, 2007 was $324,000 compared to $1,419,000 for the same period in
fiscal 2007. Revenues for the six month period to date were
$803,000 compared to $1,699,000 in the same period last year.
AGGRASTAT� revenues were lower for the three and six month
periods ended November 30, 2007 as compared to the same periods in
fiscal 2007 for several reasons including the reconfiguring of the
Company's commercial operations during the first quarter of fiscal
2008. While the Company's focus has been on stabilizing revenues,
it was recognized that the initial commercial structure, which
consisted of a contract sales organization (CSO) was not optimal as
the Company was not able to maintain sufficient control and
direction of the sales organization and has since transitioned to
an internally managed and more cost effective operation.
This transition will require additional time to fully implement
and establish customer relationships in order to stabilize and
eventually increase product revenues. The Company also reduced the
wholesaler inventory levels during the first half of fiscal 2008,
and will continue to make adjustments as required. Finally, the
Company's estimate for customer chargebacks increased during the
quarter which resulted in an additional decrease in net product
sales.
Research and development expenditures were $11,231,000 in the
second quarter of fiscal 2008 as compared to $3,816,000 in the same
period of fiscal 2007. As expected, research and development
expenditures were significantly higher as compared to the same
period in fiscal 2007 due to the ongoing Phase 3 MEND-CABG II
clinical trial that commenced in the second quarter of fiscal 2007.
Research and development for the six month period to date were
$22,468,000 compared to $6,602,000 for the same period last
year.
Selling, general and administrative expenditures increased by
$1,214,000 to $3,872,000 during the three-month period ended
November 30, 2007 as compared $2,658,000 in the same period in
fiscal 2007 primarily due to costs associated with the Company's
AGGRASTAT� operations. The Company acquired the US rights to
AGGRASTAT� near the end of the first quarter of fiscal 2007 and did
not have a sales force in place until partially through the second
quarter of fiscal 2007. In addition, other selling, general and
administrative expenses were higher during the quarter due to
higher salaries and professional fees. Selling, general and
administrative expenditures for the six month period to date
totaled $7,096,000 compared to $3,818,000 for the same period in
fiscal 2007.
Interest and other income for the second quarter of fiscal 2008
was $297,000 compared to $287,000 for the same quarter in fiscal
2007. Interest and other income for the six month period to date
totaled $603,000 compared to $676,000 for the same period in fiscal
2007.
As a result of the above noted items, the financial results for
the three-month period ended November 30, 2007 include a
consolidated net loss from operations of $16,940,000 or $0.14 per
share, compared to $6,093,000 or $0.06 per share for the
three-month period ended November 30, 2006. The six month
year-to-date loss for fiscal 2008 was $32,023,000 or $0.27 per
share, compared to $9,339,000 or $0.10 per share for the six month
period ended November 30, 2006.
At November 30, 2007, the Company had cash and cash equivalents
totaling $38,751,000 as compared to $31,770,000 as of May 31,
2007.
An expanded version of Management's Discussion and Analysis and
the financial statements for the three-month period ended November
30, 2007 is accessible on Medicure's website at
www.medicure.com.
Notification of Conference Call:
Medicure has scheduled a conference call and webcast to review its results
of operations for the quarter ended November 30, 2007.
Date: January 14, 2008
Time: 8:30 AM Eastern Time
Telephone: 1-416-695-6371 or 1-866-223-7781
Webcast: Available at the Medicure website at www.medicure.com
Archive of Conference Call:
Telephone: 1-416-695-5800 or 1-800-408-3053
Passcode: 3247700
Webcast: Available at the Medicure website at www.medicure.com
Expires: January 18, 2008
About Medicure Inc.
Medicure is a biopharmaceutical company focused on the research,
development and commercialization of novel compounds to treat
cardiovascular disorders. The Company's solid position in this
field is highlighted by the following:
- Lead compound MC-1 in pivotal Phase 3 study for FDA
approval
- Four positive Phase 2 trials completed with MC-1
- FDA Fast Track designation for MC-1
- U.S. rights to AGGRASTAT� Injection (tirofiban
hydrochloride)
- Combination of MC-1 and lisinopril (MC-4232) completed Phase
2
- Dual action antithrombotic, MC-45308, with positive
preclinical results
Medicure also has a medicinal chemistry based Drug Discovery
program focused on discovery and advancement of novel small
molecule anti-ischemics and antithrombotics towards human clinical
studies.
This press release contains forward-looking statements, as
defined under applicable securities legislation, that involve
risks, which may cause actual results to differ materially from the
statements made, and accordingly may be deemed to be
forward-looking statements made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
The forward-looking statements are made as of the date hereof, and
the Company disclaims any intention and has no obligation or
responsibility to update or revise any forward-looking statements,
whether as a result of new information, future events, or otherwise
except as required by law. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors that may
cause the actual results, events or developments to be materially
different from any future results, events or developments expressed
or implied by such forward-looking statements. Such factors
include, among others, the Company's stage of development, lack of
product revenues, additional capital requirements, risks associated
with the completion of clinical trials and obtaining regulatory
approval to market the Company's products, the ability to protect
its intellectual property, dependence on collaborative partners and
the ability to meet its debt obligations. These factors should be
considered carefully and readers are cautioned not to place undue
reliance on such forward-looking statements. Additional risks and
uncertainties relating to the Company and its business can be found
in the "Risk Factors" section of its Form 20F for the year ended
May 31, 2007.
Contacts: Medicure Inc. Derek Reimer Chief Financial Officer
1-888-435-2220 (204) 488-9823 (FAX) Medicure Inc. Adam Peeler
Manager of Investor & Public Relations 1-888-435-2220 (204)
488-9823 (FAX) Email: info@medicure.com Website:
www.medicure.com
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