|
February 14, 2001
Neurochem Announces Second Quarter Financial Results
Quarter highlighted by completed proof of concept study of a compound to treat
Alzheimer's Disease
Neurochem Inc. (TSX : NRM) today announced second quarter 2001 financial results for the
three-month period ended December 31, 2000. The Company reported net income of $1,184,000 or
$0.06 per share on a fully-diluted basis for the quarter, compared to a net loss of $1,702,000
or ($0.14) per share for the same quarter last year. The net income for the current quarter was
primarily due to a $3.8 million milestone payment received from H. Lundbeck A/S ("Lundbeck")
for the successful completion of a proof of concept study for an anti-amyloid compound to treat
Alzheimer's Disease. The achievement of this milestone also triggered research support payments
for a three-year period from Lundbeck, and an equity purchase of U.S. $2.5 million. The milestone
payment reduced the cumulative net loss for the six months ended December 31st, 2000 to $418,000 or
($0.02) per share compared to a net loss of $3,263,000 or ($0.26) per share for the same period last
year.
"During the last quarter, Neurochem made solid progress in the clinical development of the
Company's Alzheimer and Secondary Amyloidosis Programs. We are particularly proud to note that our
successful proof of concept study provided strong scientific support for our approach to treating
Alzheimer's Disease," said Dr. Louis R. Lamontagne, Neurochem's President and Chief Executive
Officer. "The advancement of the international Phase II/III clinical trial for
Fibrillex™ to treat Secondary Amyloidosis was also noteworthy event this quarter.
This trial marks the first time an anti-amyloid compound has arrived to such a late clinical
stage and articulates our leadership status in the field of amyloid research."
Highlights of the second quarter of 2001 include:
-
Completed Proof of Concept Study for an anti-amyloid compound to treat Alzheimer's Disease
Using an aggressive transgenic mice model of Alzheimer's Disease, an anti-amyloid compound was
shown to significantly reduce the number and size of brain amyloid plaques, to decrease the
inflammatory reaction in the brain and to maintain a higher survival rate in treated mice. In
accordance with the ongoing collaboration agreement with H. Lunbeck A/S ("Lundbeck"),
the achievement of this milestone triggered a number of milestone and research support payments
from Lundbeck, as well as an equity purchase of US $2.5 million;
-
Received approval in the United Kingdom to conduct a pivotal Phase II/III trial for
Fibrillex™ Neurochem received approval from the Clinical Trials Unit of the
Medicines Control Agency in the United Kingdom for the initiation of the pivotal
Phase II/III clinical study for Fibrillex™. Coupled with
the previously granted Investigational New Drug application by the Food and Drug
Administration in the United States, this important event marks the initiation of the
international study to reconfirm the drug's safety, tolerability and pharmacokinetic
profile prior to commercialisation. The Company is actively working towards other
approbations in Finland, France, Israel, Italy, the Netherlands and Spain;
-
Filed for Orphan Medicinal Product Designation in Europe for Fibrillex™
Neurochem has filed for "Orphan Medicinal Product" (OMP) designation with the
European Agency for the Evaluation of Medicinal Products (EMEA) for Fibrillex™.
The OMP designation in Europe typically allows for a ten-year market exclusivity in the
15 Member States of the European Community; and
-
Organized First International Conference on Cerebral Amyloid Angiopathy (CAA)
Neurochem supported the First International Conference on Cerebral Amyloid Angiopathy (CAA)
associated with Hemorrhagic Stroke which was hosted by the Massachusetts General Hospital in
Boston in October 2000. World-renowned scientists and leaders in their field presented and
discussed possible therapeutic preventative trials for Hemorrhagic Stroke due to CAA, for which
there is presently no present cure. At this meeting, Neurochem's research and drug development
teams developed plans with key scientific and clinical groups in CAA for participation in its
clinical advancement.
Financial Highlights
Revenues for the second fiscal quarter ended December 31st, 2000 increased $4.1 million
over the comparable 1999 period, as a result of the first major milestone payment of $3.8
million from Lundbeck, and $380,000 more in interest income as a result of significantly
higher average cash balances for the current period.
Research and development expenditures, before the application of research tax credits and
grants, increased to $2,222,000 as compared to $1,730,000 for the comparable quarter last
year. Research tax credits, federal grants and investment contributions amounted to $466,000
as compared to $510,000 for the quarter ended December 31st, 1999, which included $323,000
in research tax credits from prior years.
General and administrative expenses increased to $1,347,000 for the quarter ended December
31st, 2000, as compared to $582,000 for the comparable
quarter last year. The key expense components of the $765,000 quarter-to-quarter increase
were as follows; salary of additional support personnel and annual salary increases of
existing staff ($113,000), success fees to consultants related to the Lundbeck agreement
($240,000) and increased costs associated with being a public company ($260,000), which
includes investor relations as a new area of focus and cost for the company.
As at December 31st, 2000, the Company had cash and short-term
investments of $40.3 million, representing an increase of $7.4 million over the last quarter ended
June 30, 2000. The increase in cash resources over the prior quarter is solely due to the various
payments received from Lundbeck including US $2.5 million equity purchase.
About Neurochem
Neurochem is a leader in the development of novel, proprietary compounds that inhibit
the formation, deposition and toxic effects of amyloid fibrils within the body.
Neurochem's research team has been working with international amyloid experts on the
development of therapeutic cures to amyloid-related diseases, including Alzheimer's
Disease, Secondary Amyloidosis, Diabetes Type II and Hemorrhagic Stroke due to Cerebral
Amyloid Angiopathy. Neurochem has advanced three drug candidates to clinical trials for
Alzheimer's Disease, Secondary Amyloidosis and Hemorrhagic Stroke.
At present, the Company employs over 66 people and is located in Saint-Laurent, Canada
(www.neurochem.com).
All of the statements contained in this news release, other than statements of fact which
are independently verifiable at the date hereof, are forward-looking statements. Such
statements, based as they are on the current expectations of management, inherently involve
numerous risks and uncertainties, known and unknown. Some examples of known risks are: the
impact of general economic conditions, general conditions in the pharmaceutical industry, changes
in the regulatory environment in the jurisdictions in which Neurochem does business, stock
market volatility, fluctuations in costs, and changes to the competitive environment due to
consolidation or otherwise. Consequently, actual future results may differ materially from
the anticipated results expressed in the forward-looking statements.
For further Information, please contact:
Dr. Lise Hébert
Vice President, Corporate Communications
lhebert@neurochem.com
275 Armand-Frappier
Laval (Quebec)
H7V 4A7
Tel: (450) 680-4500
Fax: (450) 680-4501
|
