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May 12, 2005
At Annual and Special Meeting of Shareholders Fibrillex - Results to be Presented to FDA
Neurochem completed the Fibrillex Phase II/III clinical trial in December 2004. Fibrillex is being developed
for the treatment of Amyloid A (AA) Amyloidosis, a serious consequence of chronic inflammatory and infectious
diseases, such as Rheumatoid Arthritis. It is estimated that there are approximately 40,000 people in Europe and the
U.S. diagnosed with the disease. Alzhemed - North American Phase III Clinical Trial on Track
Progress throughout 2004 and into the first quarter of 2005 on the development of the investigational product
candidate, Alzhemed, for the treatment of Alzheimer's Disease (AD) is on-track and encouraging. This first-in-class
product candidate has a unique mechanism of action, which may be capable of stopping the disease in its early stages
by interfering with the formation of the toxic beta-amyloid complex and has been shown by many scientists to be
neurotoxic. Data from a Phase II clinical trial and interim results from a follow-on open-label extension study
over a 28-month period indicate that this orally administered investigational product candidate is safe and appears
to stop the progression of the disease, particularly in milder AD patients. Cerebril - A Phase IIb Clinical Trial Under Preparation
Cerebril, Neurochem's lead product candidate for the treatment of Hemorrhagic Stroke due to Cerebral Amyloid
Angiopathy (HS-CAA), has successfully completed a Phase IIa clinical trial to assess safety conducted at five
centers in the U.S.. There were no concerns regarding safety, and the pharmacokinetic profile of the product
candidate was well characterized. Senior Management Team - Additions and Reassignment of Responsibilities
Neurochem also announced senior management appointments and reassignment of responsibilities: Francesco Bellini,
Chairman, President and CEO, committed to remain with the Company in an executive capacity for at least three
more years. Andreas Orfanos, M.B.B.Ch, MBA, was named Executive Vice President - Strategic Planning and
Scientific Affairs, Shona McDiarmid, PhD, LLB, was appointed Vice President - Intellectual Property, Daniel
Delorme, PhD, was named Vice President - Research, Mariano Rodriguez was appointed Vice President, Finance
and Chief Financial Officer, Christine Lennon was named Vice President, Business Development and Judith Paquin
was appointed Vice President, Human Resources. Philippe Calais, Pharm. D., became President - Global Business
and Denis Garceau, PhD, was appointed Senior Vice President - Drug Development. Recent Developments
Neurochem announced in March 2005 that it had completed a public offering of 4 million common shares. The common
shares issued from treasury were sold in the United States and Canada and resulted in total gross proceeds to the
Company of approximately US$61.2 million. Neurochem Inc. and its subsidiaries intend to use the net proceeds from
the offering to fund the clinical trials of their investigational product candidates, primarily Alzhemed, to
advance Fibrillex, to further complete pre-clinical and research and development programs and for working
capital and general corporate purposes. First Quarter Results - Consolidated Financial Results Highlights
The following information should be read in conjunction with the unaudited consolidated financial statements for the
three-month period ended March 31, 2005, as well as the audited consolidated financial statements for the year ended
December 31, 2004. For discussion regarding related-party transactions, contractual obligations and commercial
commitments, critical accounting policies, recent accounting pronouncements, and risks and uncertainties, refer to
the Management's Discussion and Analysis of Consolidated Financial Condition and Results of Operations for the year
ended December 31, 2004. All dollar figures are Canadian dollars, unless specified otherwise. Liquidity and capital resources
As at March 31, 2005, the Company had cash, cash equivalents and marketable securities of $89,703,000, compared to
$29,173,000 at December 31, 2004. The increase is primarily due to proceeds received from the issue of additional
share capital during the quarter (as described below), net of funds used in operations and in investing activities. Consolidated Financial Information1 ($'000 CDN, except per share data) |
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Three-month period |
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Consolidated Statements |
2005 |
2004 |
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Revenues: |
|
|
|
|
Collaboration agreement |
1,205 |
- |
|
|
Reimbursable costs |
444 |
- |
|
|
|
1,649 |
- |
|
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Expenses: |
|
|
|
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Research |
11,965 |
5,577 |
|
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Research tax credits |
(409) |
(312) |
|
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Research grants |
(9) |
(119) |
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General |
5,165 |
3,965 |
|
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Reimbursable costs |
444 |
- |
|
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Stock-based |
770 |
424 |
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Depreciation |
570 |
368 |
|
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Interest and bank charges |
121 |
24 |
|
|
|
18,617 |
9,927 |
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Net loss before |
(16,968) |
(9,927) |
|
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Interest income |
251 |
322 |
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Foreign exchange gain |
226 |
441 |
|
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Other income |
51 |
- |
|
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Share of loss in a |
(755) |
- |
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Non-controlling interest |
225 |
- |
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Net loss |
(16,970) |
(9,164) |
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Net loss per share: |
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Basic |
(0.54) |
(0.31) |
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Diluted |
(0.54) |
(0.31) |
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Weighted average number |
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|
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Basic |
31,401,858 |
29,863,793 |
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Diluted |
34,568,931 |
34,817,965 |
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Consolidated |
At March 31 |
At December 31 |
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Cash, cash equivalents |
89,703 |
29,173 |
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Other current assets |
6,363 |
20,410 |
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Total current assets |
96,066 |
49.583 |
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Restricted cash |
7,258 |
- |
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Long-term prepaid |
1,815 |
1,361 |
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Long-term investment |
2,604 |
4,421 |
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Capital assets |
20,711 |
21,083 |
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Total assets |
128,454 |
76,448 |
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Current liabilities |
15,297 |
16,406 |
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Deferred revenue |
10,101 |
9,772 |
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Long-term |
121 |
126 |
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Long-term debt |
9,275 |
9,450 |
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Non-controlling interest |
1,214 |
- |
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Shareholders' equity |
92,446 |
40,694 |
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Total liabilities and |
128,454 |
76,448 |
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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 pipeline of proprietary, disease-modifying oral products addresses critical unmet medical needs.
1,3-propanedisulfonate (1,3PDS; Fibrillex) is designated as an orphan drug and a Fast Track Product candidate
and is also part of an FDA Continuous Marketing Applications Pilot 2 program. The Phase II/III clinical trial of
Fibrillex for the treatment of AA Amyloidosis was recently concluded and preliminary results were disclosed
in April 2005. 3-amino-1-propanesulfonic acid (3APS; Alzhemed), for the treatment of Alzheimer's Disease, is
in a Phase III clinical trial and 3APS (Cerebril), for the prevention of Hemorrhagic Stroke caused by Cerebral
Amyloid Angiopathy, has completed a Phase IIa clinical trial. To Contact Neurochem
For additional information on Neurochem and its drug development programs, please call the North American toll-free number
1 877 680-4500 or visit our Web Site at: www.neurochem.com.
Certain statements contained in this presentation, other than statements of fact that are independently verifiable
at the date hereof, may constitute forward-looking statements. Examples of such forward-looking statements include
those regarding Fibrillex, as well those regarding continuing and further development efforts. Such statements,
based as they are on the current analysis and 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. In the case of forward-looking statements
regarding Fibrillex and continuing and further development efforts, specific risks which could cause actual results
to differ materially from Neurochem's current analysis and expectations include: failure to demonstrate the safety,
tolerability and efficacy of our product, the expense and uncertainty of obtaining regulatory approval, including
from the FDA, and the possibility of having to conduct additional clinical trials. Additionally, even if regulatory
approval is obtained, therapeutic products are generally subject to: stringent on-going governmental regulation,
challenges in gaining market acceptance, and competition. The reader should not place undue reliance on the
forward-looking statements included in this presentation. 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: |
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