UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
For the month of: February, 2004
Commission File Number: 000-50393
NEUROCHEM INC.
7220 Frederick-Banting, Suite 100
Saint-Laurent, Quebec
H4S 2A1
Indicate by check mark whether the registrant files or will file annual reports
under cover of Form 20-F or Form 40-F. Form 20-F [ ] Form 40-F [X]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1):
Yes [ ] No [X]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7):
Yes [ ] No [X]
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g-3 under the Securities Exchange Act of 1934.
Yes [ ] No [X]
If "Yes" is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b):
SIGNATURES:
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
NEUROCHEM INC.
February 23, 2004
By: /s/ David Skinner
-----------------------------------------
David Skinner
Director, Legal Affairs,
General Counsel and Corporate Secretary
NEUROCHEM INC.
7220 Frederick-Banting, Suite 100
Saint-Laurent, Quebec H4S 2A1
[NEUROCHEM ("LOGO")]
________________________________________________________________________________
NEUROCHEM REPORTS RESULTS
FOR ITS QUARTER AND
TRANSITIONAL FINANCIAL YEAR ENDED DECEMBER 31, 2003
NEUROCHEM WILL HOST A CONFERENCE CALL TODAY AT 4:30 P.M. EST
------------------------------------------------------------
MONTREAL, FEBRUARY 23, 2004 - Neurochem Inc. (NASDAQ: NRMX, TSX: NRM) today
announced results for its quarter and six-month transitional financial year
ended December 31, 2003. As previously announced, Neurochem changed the date of
its fiscal year-end from June 30 to December 31. This step was taken in
consideration of the Company approaching commercialization and to align its
fiscal period with the fiscal year of most companies in its industry. All
amounts are in Canadian dollars unless specified otherwise. Neurochem will host
a conference call today at 4:30 P.M. EST. The telephone number to access the
conference call is (888) 766-8353. A replay of the call will be available until
March 1, 2004. The telephone number to access the replay of the call is (800)
558-5253 code: 21186123.
Highlights of the transitional financial period included the successful
completion of an initial public offering in the United States and a share
offering in Canada totaling 5.75 million common shares for gross proceeds of
$85.0 million (U.S. $62.5 million). Neurochem was subsequently added to the
NASDAQ Biotechnology Index (NBI) and to the S&P/TSX Composite Index. The Company
released continued positive results for Alzhemed(TM) in an open-label extension
Phase II study after both nine and twelve months of treatment in patients with
Alzheimer's Disease. Neurochem further strengthened its Board of Directors and
was pleased to welcome Dr. Frederick H. Lowy, Rector and Vice-Chancellor of
Concordia University and Mr. Graeme K. Rutledge, consultant. For the six-month
period ended December 31, 2003, the Company reported a net loss of $16,773,000
($0.63 per share), compared to $10,539,000 ($0.52 per share) for the same period
the previous year. For the quarter ended December 31, 2003, Neurochem reported a
net loss of $9,986,000 ($0.34 per share), compared to $6,577,000 ($0.31 per
share) for the same period the previous year.
"Neurochem is making important strides to becoming a leader in the field of
neurology," said Dr. Francesco Bellini, Neurochem's Chairman and CEO. "The very
encouraging results of our clinical trials are supported by a growing management
and scientific team, promising and complementary development programs targeting
the treatment of Alzheimer's Disease, and by strong financial resources as our
product candidates advance toward the marketplace."
-2-
To date, in fiscal 2004, Neurochem announced:
o the formation of a strategic alliance with the National Research Council
of Canada's Institute for Biological Sciences and an in-licensing
agreement with Praecis Pharmaceuticals Incorporated for the development
of a vaccine to prevent and treat Alzheimer's Disease.
o a third unanimous recommendation by Neurochem's independent Data Safety
Monitoring Board (DSMB) to continue its Phase II/III clinical trial for
the orphan drug candidate, Fibrillex(TM). This product candidate is
indicated for the treatment of Amyloid (AA) Amyloidosis, a fatal
disorder associated with chronic inflammatory and infectious diseases.
o a Fast Track Product designation for Fibrillex(TM) by the U.S. FDA. The
Phase II/III clinical trial is scheduled for completion in January 2005.
o continued expansion of its management team with the addition of Ms.
Christine Lennon as Vice President, Business Development and Ms. Judith
Paquin as Vice President, Human Resources.
FINANCIAL RESULTS HIGHLIGHTS
The following information should be read in conjunction with the selected
financial information contained herein.
For the quarter ended December 31, 2003, net loss amounted to $9,986,000 ($0.34
per share) compared to $6,577,000 ($0.31 per share) for the same period last
year. For the six month-period ended December 31, 2003, net loss amounted to
$16,773,000 ($0.63 per share), compared to $10,539,000 ($0.52 per share) for the
same period last year.
Research and development (R&D) expenses, before research tax credits and grants,
amounted to $4,682,000 for the current quarter, compared to $5,487,000 for the
same period last year. For the six month-period ended December 31, 2003, R&D
expenses amounted to $8,522,000, compared to $9,450,000 for the corresponding
period last year. These decreases are due to a reduction in clinical trial
expenses related to Alzhemed(TM), following the completion of the Phase II
clinical trial in June 2003. For the six month-period ended December 31, 2003,
research and development expenses were incurred to support the on-going
Fibrillex(TM) Phase II/III clinical trials and open-label extension study, the
Alzhemed(TM) open-label Phase II extension study and advancement towards it's
phase III clinical trials, the Cerebril(TM) Phase II clinical trial as well as
on-going research programs. As at December 31, 2003, the Company had 171
patients in its various clinical trials.
Research tax credits amounted to $599,000 this quarter compared to $210,000 for
last year's quarter. For the six-month period ended December 31, 2003, research
tax credits amounted to $914,000, compared to $423,000 for the corresponding
period last year. Research tax credits represent refundable tax credits earned
under the Quebec Scientific Research and
-3-
Experimental Development program. These increases are due to higher eligible
expenses during the current period as well as prior years' credit claims
resolved during the current period.
Research and other grants amounted to $107,000 this quarter, compared to
$577,000 for last year's quarter. For the six-month period ended December 31,
2003, research and other grants amounted to $208,000, compared to $1,150,000 for
the corresponding period last year. In the prior year, research grants refer
principally to investment contributions under the Technology Partnerships Canada
("TPC") Program received by the Company for the development of Alzhemed(TM)
($919,000) as well as payments received from the FDA for the development of
Fibrillex(TM) ($231,000) whereas the current six-month period consists of only
grants received from the FDA for Fibrillex(TM).
General and administrative (G&A) expenses for the quarter totaled $4,436,000
compared to $1,752,000 for the same quarter last year. For the six-month period
ended December 31, 2003, these expenses amounted to $7,454,000, compared to
$2,469,000 for the prior year. These increases are due to expansion of the
corporate infrastructure necessary to support the growth and the increase in the
overall activity level of the company in the areas of accounting, legal,
administration and senior management; legal expenses incurred in relation with
an on-going litigation and other corporate-related matters; and increased
awareness and educational activities related to AA Amyloidosis, Fibrillex(TM)'s
target indication and set up of a marketing team.
Depreciation and amortization for the current quarter increased to $323,000
($646,000 for the six months) from $306,000 for the comparable quarter last year
($556,000 for the six-months). These increases reflect the depreciation and
amortization associated with the acquisition of additional property and
equipment, as well as additions to patent costs, during the past year.
Interest income amounted to $393,000 this quarter ($520,000 for the six-month
period) compared to $229,000 for the comparable quarter last year ($482,000 for
the six-month period last year). These increases result from higher average cash
balances in the current period, compared to the same period last year offset by
a larger portion of the investment portfolio denominated in US dollars, earning
lower yields.
Interest expense and foreign exchange losses amounted to $1,644,000 for the
current quarter, compared to $48,000 for the same quarter last year. For the
six-month period ended December 31, 2003, interest expense and foreign exchange
losses amounted to $1,793,000 compared to $119,000 for the corresponding period
last year. These increases are attributable to foreign exchange losses
recognized on the US dollar denominated investments held by the Company, due to
the strengthening of the Canadian dollar versus the US dollar during the period.
-4-
Liquidity and Capital Resources
- -------------------------------
As at December 31, 2003, the Company had cash, cash equivalents and marketable
securities of $77,594,000, compared to $16,334,000 at June 30, 2003. The
increase is due to proceeds received from the issue of additional share capital
during the period, 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 at a price of US$10.87 per share.
Total proceeds from the offering were $84,956,000 (US$62,502,500) and the issue
costs totaled $6,813,000. Net proceeds from the offering are being used to fund
clinical trials of the Company's lead product candidates, other research and
development programs, capital expenditures, working capital and general
corporate purposes.
As at January 31, 2004, the Company had 29,860,565 common shares outstanding,
2,213,088 options granted under the stock option plan and 4,000,000 warrants.
-5-
NEUROCHEM INC.
SELECTED FINANCIAL INFORMATION
($'000CDN)(1)
THREE-MONTH PERIOD ENDED SIX-MONTH PERIOD ENDED YEAR ENDED
DECEMBER 31 DECEMBER 31 JUNE 30
------------------------ -------------------------- ----------
CONSOLIDATED STATEMENTS OF 2003 2002 2003 2002 2003
OPERATIONS UNAUDITED UNAUDITED AUDITED UNAUDITED AUDITED
- ---------- ---------- ----------- ----------- ---------- ---------
Expenses:
Research and development $ 4 682 $ 5 487 $ 8 522 $ 9 450 $ 18 782
Research tax credits & grants (706) (787) (1 122) (1 573) (3 305)
General and administrative 4 436 1 752 7 454 2 469 7 184
Depreciation and amortization 323 306 646 556 1 197
---------- ---------- ---------- ---------- ----------
(8 735) (6 758) (15 500) (10 902) (23 858)
Interest income 393 229 520 482 800
Interest expense and
foreign exchange losses (1 644) (48) (1 793) (119) (44)
Gain on disposal of intellectual
property -- -- -- -- 3 484
---------- ---------- ---------- ---------- ----------
Net loss $ (9 986) $ (6 577) $ (16 773) $ (10 539) $ (19 618)
---------- ---------- ---------- ---------- ----------
Net loss per share:
Basic $ (0.34) $ (0.31) $ (0.63) $ (0.52) $ (0.90)
Diluted $ (0.34) $ (0.31) $ (0.63) $ (0.52) $ (0.90)
---------- ---------- ---------- ---------- ----------
Weighted average number of
common shares outstanding:
Basic 29 593 621 21 361 469 26 813 836 20 353 835 21 770 541
Diluted 34 281 376 24 120 291 31 290 776 22 591 719 24 628 551
---------- ---------- ---------- ---------- ----------
</Table>
-6-
AT AT AT
DEC. 31 DEC. 31 JUNE 30
2003 2002 2003
CONSOLIDATED BALANCE SHEETS AUDITED UNAUDITED AUDITED
- --------------------------- ------- --------- -------
Cash, cash equivalents and
marketable securities $ 77 594 $ 21 470 $ 16 334
Other current assets 4 503 2 004 3 513
-------- -------- --------
Total current assets 82 097 23 474 19 847
Long-term investment 4 421 -- 4 421
Capital assets 7 481 6 594 6 656
Other long term assets 226 226 236
-------- -------- --------
Total assets $ 94 225 $ 30 294 $ 31 160
======== ======== ========
Current liabilities $ 6 244 $ 5 350 $ 5 824
Obligations under capital leases 416 842 633
Shareholders' equity 87 565 24 102 24 703
-------- -------- --------
Total liabilities and
shareholders' equity $ 94 225 $ 30 294 $ 31 160
======== ======== ========
(1)Condensed from the Company's 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(TM), an orphan drug with a fast track designation, is in a
Phase II/III clinical trial for AA amyloidosis. Alzhemed(TM) and Cerebril(TM)
have both completed a Phase II clinical trial for the treatment of Alzheimer's
Disease and for the prevention of hemorrhagic stroke caused by cerebral amyloid
angiopathy, respectively. For additional information on Neurochem, please visit
our website at: www.neurochem.com.
-7-
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:
Lise Hebert, Ph.D.
Vice President, Corporate Communications
lhebert@neurochem.com
Tel: (514) 337-4646
Fax: (514) 684-7972