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November 4, 2004
Neurochem reports results for third quarter of fiscal 2004. Alzhemed
Following the June 2004 launch of its 18-month double-blind, placebo-controlled, randomized Phase III clinical trial
of Alzhemed for the treatment of AD in North America, Neurochem has 337 mild-to-moderate AD patients who have been
screened to date. Of these, 163 patients are now randomized and are receiving study medication, either placebo or one
of the two doses of Alzhemed. The primary endpoints of this study include the evaluation of cognitive and
functional abilities with the Alzheimer's Disease Assessment Scale, cognitive subpart (ADAS-cog) and Clinical Dementia
Rating Scale-Sum of Boxes (CDR-SB). Fibrillex
The Company is approaching the completion of its Phase II/III clinical trial of Fibrillex, which is planned to end
in January 2005. To date, 68 patients have completed the two-year study. Of these, 66 (97%) have enrolled in the
open-label Phase II/III extension study that will run for two years. Cerebril
For Cerebril, Neurochem's investigational product candidate for the treatment of Hemorrhagic Stroke due to
Cerebral Amyloid Angiopathy (HS-CAA), the Company continues to work towards the preparation of the Phase IIb protocol
in collaboration with the principal investigator and Clinical Advisory Board member for this product candidate, Steven
M. Greenberg, M.D., Co-Director of the Neurology Clinical Unit of the Massachusetts General Hospital. The trial
is expected to test the safety and efficacy of Cerebril for the prevention of recurrence of HS-CAA. Conference Call
Neurochem will host a conference call Thursday, Nov. 4, 2004, at 5:00 P.M. ET. The telephone number to access the
conference call is 416 695-5252 or 1 877 461-2815. A replay of the call will be available until Nov. 11, 2004. The
telephone number to access the replay of the call is 1 866 518-1010. Please mention that you are calling for the Dr.
Bellini or Neurochem conference replay. Financial Results Highlights
The following information should be read in conjunction with the selected financial information contained
herein. Results of operations
For the three-month period ended September 30, 2004, net loss amounted to $13,775,000 ($0.45 per share), compared to
$6,787,000 ($0.28 per share) for the same period last year. For the nine-month period ended September 30, 2004, net
loss amounted to $37,011,000 ($1.23 per share), compared to $15,866,000 ($0.55 per share) for the same period last
year. |
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Neurochem Inc. |
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Three-month period ended September 30 |
Nine-month period ended September 30 |
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Consolidated Statements of Operations |
2004 |
2003 |
2004 |
2003 |
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Expenses (Income): |
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Research and |
7,760 |
3,840 |
20,260 |
13,172 |
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Research tax credits |
(399) |
(416) |
(1,249) |
(2,148) |
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General and |
4,913 |
3,018 |
13,502 |
7,733 |
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Stock based |
666 |
- |
3,329 |
- |
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Special charges |
- |
- |
2,085 |
- |
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Depreciation and |
587 |
323 |
1,454 |
964 |
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Interest and |
103 |
22 |
151 |
76 |
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13,630 |
6,787 |
39,532 |
19,797 |
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Interest income |
247 |
127 |
822 |
445 |
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Foreign exchange |
(392) |
(127) |
1,699 |
2 |
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Gain on disposal of |
- |
- |
- |
3,484 |
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Net loss |
(13,775) |
(6,787) |
(37,011) |
(15,866) |
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Loss per share: |
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Basic |
$ (0.45) |
$ (0.28) |
$ (1.23) |
$ (0.68) |
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Diluted |
$ (0.45) |
$ (0.28) |
$ (1.23) |
$ (0.68) |
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Weighted average number of common shares outstanding: |
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Basic |
30,281,440 |
24,034,052 |
30,103,171 |
23,328,076 |
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Diluted |
34,045,804 |
28,300,178 |
34,350,786 |
27,054,582 |
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Consolidated |
At September 30 2004 |
At December 31 2003 |
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Cash, cash equivalents |
44,219 |
77,594 |
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Other current assets |
4,977 |
4,503 |
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Total current assets |
49,196 |
82,097 |
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Long-term investment |
4,421 |
4,421 |
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Capital assets |
20,629 |
7,481 |
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Other long term assets |
1,172 |
226 |
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Total assets |
75,418 |
94,225 |
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Current liabilities |
9,978 |
6,244 |
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Long term debt |
9,625 |
- |
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Obligations under |
78 |
416 |
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Long term |
568 |
- |
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Shareholders' equity |
55,169 |
87,565 |
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Total liabilities and |
75,418 |
94,225 |
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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.
Fibrillex, designated as an orphan drug and as a Fast Track Product candidate, is also part of a Continuous
Marketing Applications Pilot 2 program and is currently in a Phase II/III clinical trial for the treatment of Amyloid A
Amyloidosis. Alzhemed, for the treatment of Alzheimer's Disease, is in a Phase III clinical trial and
Cerebril, for the prevention of Hemorrhagic Stroke caused by Cerebral Amyloid Angiopathy, has completed a Phase II
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 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 disclosed 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, if any, 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: |
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