|
November 12, 2003
Neurochem Announces First Quarter Results for Fiscal 2004.
Successfully completes U.S. Initial Public Offering and raises $85.0 million, lists
on Nasdaq, advances clinical trials, changes fiscal year-end.
- Neurochem, Inc. (NASDAQ: NRMX, TSX: NRM) - today announced its results for the first quarter of
fiscal 2004, ended September 30, 2003. Milestones for the period included the successful
completion of an initial public offering in the United States and a share offering in Canada, in
total, of 5,75 million common shares (including the over-allotment) for gross proceeds of $85.0
million (U.S. $62.5 million). The Company concurrently listed its shares on NASDAQ and continued
progress in clinical trials for its three lead product candidates.
The Company today also announced that it intends to change the date of its fiscal year-end from
June 30 to December 31.
For the quarter, Neurochem reported a net loss of $6.8 million or $0.28 per share, compared to a
net loss of $4.0 million or $0.20 per share for the same quarter last year.
Following the close of the quarter, Neurochem also announced interim results of an open-label
Phase II extension study on its product candidate, Alzhemed™, reporting promising cognitive
benefits in patients with Alzheimer's Disease.
"Neurochem has made significant progress during this quarter," stated Dr. Francesco
Bellini, Chairman and CEO. "Our successful financing provides us with the resources to fund
our drug development activities as well as to expand the business and commercial capabilities of
the Company. Interim findings on how Alzhemed™ improves the cognitive function of patients
with Alzheimer's Disease, especially in the milder population, are also very encouraging," he
added.
Update on Scientific Progress
Progress on Neurochem's drug development programs was significant during the quarter.
-
Alzhemed™
Following promising results from the Phase II clinical trial reported at the close of the
fourth quarter of fiscal 2003, Neurochem has received additional positive interim results
on cognitive function (as measured by ADAS-cog)1 of patients suffering from
mild-to-moderate Alzheimer's Disease (AD) in an open-label Phase II extension
study1. These results are from the first 10 patients out of the 33 enrolled in
the ongoing study who have now completed 9 months of treatment on the highest dose (300 mg
daily) of Alzhemed™.
Overall, after 9 months of follow-up, the combined cohort of mild-to-moderate patients on
Alzhemed™ performed 59% better in their cognitive function scores (ADAS-cog) when
compared to historical, untreated control patient groups.
The data has revealed that patients with mild AD3 (n=6) showed the greatest
benefits (-3.5 points on average) from Alzhemed™ as compared to historical control
data from a longitudinal study with mild AD patients who showed an average decline in
their cognitive function of approximately +4.6 points over the same period of
time4.
As the results from other groups of patients on this extension study become available,
Neurochem expects to release additional interim data, with a full report of the study
planned for the first quarter of calendar 2004.
Neurochem intends to initiate Phase III trials on Alzhemed™ in North America, in the
spring of 2004.
-
Fibrillex™
Neurochem's Phase II/III clinical trial for Fibrillex™, the Company's most advanced
drug candidate, is slated for completion in January 2005 with commercialization planned by
the end of that year. To date, more than 50% of the 183 patients enrolled have been
participating for a year or more. Some have completed the study and have entered the
open-label extension study. Neurochem's Data Safety Monitoring Board (DSMB), composed of
leading authorities in the field, meets every eight months to evaluate the safety of
Fibrillex™, and has unanimously recommended on two occasions that the Company proceed
with the trial. The next DSMB report is expected in December 2003.
-
Cerebril™
Cerebril™, the same compound as Alzhemed&153;, is currently being studied in a
12-week, Phase II clinical trial at five centers in the United States. This product
candidate is for the treatment of Hemorrhagic Stroke due to Cerebral Amyloid Angiopathy
(CAA), a syndrome of recurrent strokes. The aim is primarily to establish the safety,
tolerability and optimal dosage of the product candidate. Patient enrollment has been
completed and this study in expected to end in January 2004.
1 - Alzheimer's Disease Assessment Scale, cognitive subpart (ADAS-cog).
2 - In an open-label extension study, in contrast to a blind study, all patients are treated with
an investigational drug candidate, and no patients receive a placebo.
3 - Mini Mental State Exam (MMSE): 19-25
4 - Stern, R.G., et al. Am.J.Psychiatry 151:3, March 1994.
Financial Results Highlights
The following information should be read in conjunction with the unaudited interim consolidated
financial statements for the quarter ended September 30, 2003, as well as the audited
consolidated financial statements for the fiscal year ended June 30, 2003.
For the quarter ended September 30, 2003, net loss amounted to $6,787,000 ($0.28 per share)
compared to $3,962,000 ($0.20 per share) for the same quarter last year.
Research and development expenses, before research tax credits and grants, amounted to $3,840,000
this quarter, compared to $3,963,000 for the same quarter last year. Research and development
expenses were incurred to support the on-going Fibrillex™ Phase II/III clinical trials, the
Alzhemed™ open-label Phase II extension study and advancements towards its Phase III clinical
trial, as well as the Cerebril™ on-going Phase II clinical trial. As at September 30, 2003,
246 patients were enrolled in clinical trials compared to approximately 80 patients a year
earlier.
Research tax credits amounted to $315,000 for this first quarter of our 2004 fiscal year compared
to $213,000 for the same period last year. The increase is due to higher eligible expenses this
quarter compared to the same quarter last year.
Research grants amounted to $101,000 this quarter, compared to $573,000 for last year's first
quarter. This quarter's research grants essentially represent the amount received from the FDA for
the Fibrillex™ Phase II/III trial; whereas, in last year's first quarter, in addition to
receiving a similar amount from the FDA for the Fibrillex™ program, the Company received
$460,000 from the Technology Partnerships Canada Program for the development of
Alzhemed™.
General and administrative expenses for the quarter totaled $3,018,000, compared to $717,000 for
the same quarter last year. The increase is mainly due to the hiring of new employees in the
accounting, legal, marketing and business development functions of the organization, increased
awareness and educational activities related to AA Amyloidosis, Fibrillex™'s target
indication, increased legal and other professional expenses as well as an increase in the overall
activity level at the Company.
Depreciation and amortization for the current quarter increased to $323,000 from $250,000 for the
comparable quarter last year. The increase reflects the depreciation and amortization associated
with the acquisition, during the past year, of additional property and equipment, as well as
additions to patent costs.
Interest income amounted to $127,000 this quarter, compared to $253,000 for last year's first
quarterly results. The decrease in interest income quarter over quarter is the result of lower
average cash balance in the quarter ended September 30, 2003, compared to the same period last
year, as well as lower yield on US dollar denominated investments.
LIQUIDITY AND CAPITAL RESOURCES
As at September 30, 2003, the Company had cash, cash equivalents and marketable securities of
$89,843,000 compared to $16,334,000 as at June 30, 2003. The increase is due to proceeds received
from the issue of additional share capital during the quarter, net of funds used in operations and
in investing activities.
In September 2003, the Company completed the initial public offering of its common shares in the
United States and a new issue of shares in Canada. The Company issued 5.75 million common shares,
including the over-allotment, at a price of US$10.87 per share. Total proceeds from the offering
were $84,956,000 (U.S. $62,502,500) and the issue costs totaled $6,813,000. Net proceeds will be
used to fund clinical trials of the Company's product candidates, other research and development
programs, capital expenditures, working capital and general corporate purposes.
As at October 31, 2003, the Company had outstanding 29,591,781 common shares, 2,247,872 options
granted under the employee stock option plan and 4,000,000 warrants.
CHANGE IN DATE OF FISCAL YEAR-END
The Company announced that it has applied for regulatory approval to change its fiscal year end
from June 30 to December 31, effective as of December 31, 2003. This step is being taken to allow
the Company to change its fiscal period to end on the same date as most companies in its
sector.
The last day of the Company's most recent financial year was June 30, 2003 and the last day of the
Company's transitional financial year will be December 31, 2003.
Neurochem Inc.
Selected Financial Highlights ($'000CDN)1
|
|
1 Condensed from the Company's unaudited consolidated financial statements.
About Neurochem
Neurochem is focused on the development and commercialization of innovative therapeutics for
neurological disorders. The Company's staged pipeline of proprietary, disease-modifying, oral
products addresses critical unmet medical needs. Fibrillex™, designated an orphan drug, is in
a Phase II/III clinical trial for AA amyloidosis. Alzhemed™ has completed a Phase II clinical
trial. Cerebril™ is in a Phase II trial for the prevention of hemorrhagic stroke caused by
cerebral amyloid angiopathy. Neurochem is also developing a product for the potential treatment of
epileptic seizures induced by traumatic brain injury. For additional information on Neurochem,
please visit our website at: (www.neurochem.com).
Certain statements contained in this news release, other than statements of fact that are
independently verifiable at the date hereof, may constitute forward-looking statements. Such
statements, based as they are on the current expectations of management, inherently involve
numerous risks and uncertainties, known and unknown, many of which are beyond Neurochem's control.
Such risks include but are not limited to: 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 as well as other risks included in
public filings of Neurochem. Consequently, actual future results may differ materially from the
anticipated results expressed in the forward-looking statements. The reader should not place
undue reliance on the forward-looking statements included in this news release.
These statements speak only as of the date made and Neurochem is under no obligation and disavows
any intention to update or revise such statements as a result of any event, circumstances or
otherwise.
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
|
|
