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August 13, 2004
Neurochem reports results for second quarter of fiscal 2004 and closing of $10.5 million bank
financing. Highlights of the Quarter
Alzhemed
Neurochem launched patient recruitment for its North American Phase III clinical trial of Alzhemed
in June at an investigators' meeting attended by more than 200 clinicians and study coordinators, with
each of the 50 U.S. sites and 20 Canadian sites represented. This launch followed a meeting of the
Company with its clinical advisory board for this product candidate in July 2003 and a meeting
between Neurochem and the FDA at the end of the Phase II trials in December 2003 for
Alzhemed. Fibrillex
Fibrillex is Neurochem's investigational product candidate for the treatment of AA Amyloidosis, a serious
consequence of chronic inflammatory and infectious diseases, such as Rheumatoid Arthritis.
Subsequent to the end of the quarter, the Cardio-Renal Drug Product Division of the FDA selected
Fibrillex to be part of the Continuous Marketing Applications Pilot 2 program aimed at
further accelerating the development and eventual marketing of this product candidate. As a result
of the Pilot 2 program, in August, Neurochem will begin a series of frequent discussions with the
FDA based on a pre-approved schedule to agree on the new drug approval package to be submitted.
Fibrillex has already been designated as a Fast Track Product and received orphan drug status
designation by the FDA, as well as being designated as an Orphan Medicinal Product in Europe. Neurochem
anticipates completing the Phase II/III clinical trial of Fibrillex in January 2005, and, assuming
positive clinical outcomes, would expect to receive regulatory approvals by the end of 2005. Cerebril
The Company continues to work towards a Phase IIb trial to determine whether Cerebril can prevent
recurrence of stroke in patients suffering from Hemorrhagic Stroke due to Cerebral Amyloid Angiopathy,
a form of stroke for which there is currently no effective therapy. Conference Call
Neurochem will host a conference call Monday, Aug. 16, 2004 at 8:30 A.M. EDT. The telephone number
to access the conference call is 514 985-7038 or 1 800 208-6587. A replay of the call will be
available until Aug. 23, 2004. The telephone number to access the replay of the call is 416 626-4100
or 1 800 558-5253. The access code for the call and the replay is 21205603. Financial Results Highlights
The following information should be read in conjunction with the selected financial information
contained herein. |
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Neurochem Inc. |
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Three-month period ended June 30 |
Six-month period ended June 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 |
6,923 |
4,676 |
12,500 |
9,332 |
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Research tax credits |
(419) |
(843) |
(850) |
(1,732) |
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General and |
4,624 |
2,997 |
8,589 |
4,715 |
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Stock based compensation |
2,239 |
- |
2,663 |
- |
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Special charges |
2,085 |
- |
2,085 |
- |
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Depreciation and amortization |
499 |
320 |
867 |
641 |
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Interest and bank charges |
24 |
23 |
48 |
54 |
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15,975 |
7,173 |
25,902 |
13,010 |
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Interest income |
253 |
157 |
575 |
318 |
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Foreign exchange gain |
1,650 |
62 |
2,091 |
129 |
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Gain on disposal of intellectual property |
- |
3,484 |
- |
3,484 |
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Net loss |
(14,072) |
(3,470) |
(23,236) |
(9,079) |
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Loss per share: |
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Basic |
$ (0.47) |
$ (0.15) |
$ (0.77) |
$ (0.40) |
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Diluted |
$ (0.47) |
$ (0.15) |
$ (0.77) |
$ (0.40) |
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Weighted average number of common shares outstanding: |
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Basic |
30,162,322 |
23,294,432 |
30,013,058 |
22,798,005 |
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Diluted |
34,907,357 |
27,086,468 |
34,736,983 |
26,321,577 |
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Consolidated |
At June 30 2004 |
At Dec. 31 2003 |
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Cash, cash equivalents and marketable securities |
49,574 |
77,594 |
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Other current assets |
5,025 |
4,503 |
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Total current assets |
54,599 |
82,097 |
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Long-term investment |
4,421 |
4,421 |
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Capital assets |
19,919 |
7,481 |
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Other long term assets |
475 |
226 |
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Total assets |
79,414 |
94,225 |
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Current liabilities |
10,358 |
6,244 |
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Obligations under |
192 |
416 |
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Long term |
590 |
- |
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Shareholders' equity |
68,274 |
87,565 |
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Total liabilities and |
79,414 |
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 AA 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 s
tatements, 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 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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