FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of November 2004
AETERNA ZENTARIS INC.
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(Formerly named AEterna Laboratories Inc.)
1405, boul. du Parc-Technologique
Quebec, Quebec
Canada, G1P 4P5
(Address of principal executive offices)
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
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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 12g3-2(b) under the Securities Exchange Act of
1934.
Yes No X
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If "Yes" is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82-
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DOCUMENTS INDEX
DOCUMENTS DESCRIPTION
1. Press release dated November 4, 2004 - AEterna Zentaris Reports Third
Quarter 2004 Financial and Operating Results
[AETERNA ZENTARIS LOGO]
Aeterna Zentaris Inc. 1405 du Parc-Technologique Blvd.
Quebec (Quebec) Canada G1P 4P5 T 418 852-8525 F 418 852-0881
www.aeternazentaris.com
PRESS RELEASE
For immediate release
AETERNA ZENTARIS REPORTS THIRD QUARTER 2004
FINANCIAL AND OPERATING RESULTS
ALL AMOUNTS ARE IN CANADIAN DOLLARS
o Consolidated revenues increased 46.6% to $55.4 million
o Consolidated operating income of $5.5 million and net loss of $2 million
o Cetrorelix statistically significant positive Phase II results in
benign prostatic hyperplasia
o Perifosine encouraging Phase II data as a single-agent in soft tissue
sarcom
o License and collaboration agreement with Spectrum Pharmaceuticals
(NASDAQ: SPPI) on fourth generation LHRH antagonist D-63153
o Subsidiary Atrium generated $41 million in sales, an increase of 37%,
$6.5 million in operating income, an increase of 66.7%, and $2.8
million in net earnings, an increase of 38.4%
QUEBEC CITY, CANADA, NOVEMBER 4, 2004 - AEterna Zentaris Inc. (TSX: AEZ; NASDAQ:
AEZS) today reported financial and operating results for the third quarter ended
September 30, 2004. Consolidated revenues for the third quarter 2004 were $55.4
million, an increase of 46.6% compared with total revenues of $37.8 million for
the same period in 2003. Consolidated R&D expenses net of tax credits and grants
amounted to $6.6 million in the third quarter of 2004 compared with $9.8 million
in the third quarter of 2003.
Consolidated operating income for the third quarter 2004 was $5.5 million,
compared with an operating loss of $5.4 million for the third quarter 2003. The
Company's consolidated net loss was $2 million for the third quarter of 2004, or
$0.04 per share, compared with a net loss of $9.3 million, or $0.20 per share,
for the comparable period in 2003. AEterna Zentaris' financial performance for
the third quarter of 2004 reflects continuing growth from its subsidiary Atrium,
as well as milestone and upfront payments received from its development and
commercialization partners related to the advancement of its extensive
pharmaceutical product pipeline. Furthermore, the Company benefits from a
revenue flow from Cetrotide(R) (cetrorelix), a LHRH antagonist, which is
marketed by Serono (NYSE: SRA) for IN VITRO fertilization.
"Our solid results for this quarter have enabled us to reach both our financial
and strategic goals," said Gilles Gagnon, AEterna Zentaris President and Chief
Executive Officer. "In the biopharmaceutical sector, we continued to move
products through the pipeline as we successfully completed our extensive seven
Phase II-trial program of cetrorelix in urology and
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gynaecology. We are currently planning, with our partner Solvay (Euronext
Bruxelles: SOLB), the last phase of the development for cetrorelix to
potentially support a marketing application for the drug. In collaboration with
our North American partner, Keryx Biopharmaceuticals (NASDAQ: KERX), we also
disclosed encouraging results from a Phase II trial on perifosine as a
monotherapy for patients suffering from soft-tissue sarcoma. We now look forward
to continue the development of perifosine as a single agent and in combination
with chemotherapy and/or radiotherapy as a treatment for different forms of
cancer. Finally, our subsidiary, Atrium, has once again delivered an excellent
year-over-year growth and performance across all parameters. We believe that we
are well positioned to reach both our near and long-term goals," concluded Mr.
Gagnon.
Dennis Turpin, AEterna Zentaris Vice President and CFO, added, "With our cash
and short-term position remaining strong at $63 million, the Company is well
positioned to carry out its business plan."
ATRIUM BIOTECHNOLOGIES THIRD QUARTER 2004 RESULTS
During the third quarter of 2004, sales for Atrium, AEterna Zentaris' 60%-owned
subsidiary, were $41 million, an increase of 37% compared with $29.9 million in
sales for the comparable period in 2003. Operating income was $6.5 million
during the quarter, compared with $3.9 million for the same period in 2003,
representing a 66.7% increase. "We achieved our expected growth in this last
quarter compared to the same period last year due to solid organic growth
combined with the strong contribution from Pure Encapsulations, our most recent
acquisition in the United States. Based on these results, we look forward to
another strong quarter in 2004," said Luc Dupont, CEO of Atrium Biotechnologies
Inc.
THIRD QUARTER 2004 HIGHLIGHTS
>> POSITIVE PHASE II RESULTS FOR CETRORELIX OUR LHRH ANTAGONIST IN BPH -
Data from a placebo controlled study involving 250 patients
demonstrated a dose-dependent, durable, and statistically significant
(p less than 0.001) improvement of clinical symptoms characteristic of
Benign Prostatic Hyperplasia (BPH), as well as an excellent safety and
tolerability profile. This study successfully completed the extensive
seven Phase II-trial program in urology and gynaecology sponsored by
our partner Solvay Pharmaceuticals.
>> ENCOURAGING DATA FROM PERIFOSINE OUR FIRST-IN-CLASS ORAL AKT INHIBITOR
in a Phase II single agent soft-tissue sarcoma study.
>> LICENSE AND COLLABORATION AGREEMENT WITH SPECTRUM PHARMACEUTICALS on
fourth generation LHRH antagonist D-63153, with potential indications
in cancer, as well as benign, proliferative disorders.
>> ATRIUM REVENUES OF $41 MILLION, an increase of 37%, operating income of
$6.5 million, an increase of 66.7% and $2.8 million in net earnings,
an increase of 38.4%.
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AETERNA ZENTARIS NINE-MONTH CONSOLIDATED FINANCIAL RESULTS
Consolidated revenues for the first nine months of 2004 increased 52.9% to
$179.7 million, compared with $117.5 million for the first nine months of 2003.
The Company reported a year-to-date 2004 consolidated operating income of $16.3
million, compared with an operating loss of $7.8 million for the comparable
prior-year period. Consolidated net loss for the first nine months of 2004 was
$3.2 million, or $0.07 per share, compared with a net loss of $18.9 million, or
$0.43 per share, for the first nine months of 2003.
ATRIUM NINE-MONTH FINANCIAL RESULTS
For the nine-month period ended September 30, 2004, Atrium sales were $133.8
million compared with $82.9 million in 2003, representing a 61.4% increase. The
operating income increased 88.7% to $20 million, compared with $10.6 million for
the same period in 2003. Net income increased 100% to $10.4 million, compared
with $5.2 million for the same period in 2003.
OUTLOOK 2004 - EARLY 2005
Some of the Company's specific goals for the remainder of 2004 and early 2005
include the following:
>> Initiate additional Phase II trials with perifosine in combination with
chemo/radiotherapy
>> Advance clinical development of cetrorelix with Solvay
>> Advance one preclinical compound into Phase I in oncology
CONFERENCE CALL INFORMATION
Management will be hosting a conference call for the investment community
beginning at 10:00 a.m. Eastern Time today, Thursday, November 4, to discuss
third quarter financial and operating results and to answer questions.
To participate in the live conference call by telephone, please dial
514-807-8791, 416-640-4127 from Canada or 800-814-4941 from outside Canada.
Individuals interested in listening to the conference call via the Internet may
do so by visiting www.aeternazentaris.com. A replay will be available on the
Company's Web site for 30 days.
ABOUT AETERNA ZENTARIS INC.
AEterna Zentaris Inc. is a biopharmaceutical company focused on oncology and
endocrine therapy. Its extensive portfolio, from drug discovery to marketed
products, includes perifosine, an orally-active AKT inhibitor in several Phase
II trials for multiple cancers, and cetrorelix, an LHRH antagonist already
marketed for IN VITRO fertilization under the brand name Cetrotide(R), and also
in advanced clinical development for the treatment of uterine myoma,
endometriosis and benign prostatic hyperplasia (BPH).
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AEterna Zentaris also owns 60% of Atrium Biotechnologies Inc., which develops,
manufactures and markets active ingredients, specialty fine chemicals, cosmetic
and nutritional products for the cosmetics, chemical, pharmaceutical and
nutritional industries.
News releases and additional information about AEterna Zentaris are available on
its new Web site www.aeternazentaris.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements made pursuant to the safe
harbor provisions of the U.S. Securities Litigation Reform Act of 1995.
Forward-looking statements involve known and unknown risks and uncertainties,
which could cause the Company's actual results to differ materially from those
in the forward-looking statements. Such risks and uncertainties include, among
others, the availability of funds and resources to pursue R&D projects, the
successful and timely completion of clinical studies, the ability of the Company
to take advantage of business opportunities in the pharmaceutical industry,
uncertainties related to the regulatory process and general changes in economic
conditions. Investors should consult the Company's quarterly and annual filings
with the Canadian and U.S. securities commissions for additional information on
risks and uncertainties relating to the forward-looking statements. Investors
are cautioned not to rely on these forward-looking statements. The Company does
not undertake to update these forward-looking statements.
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CONTACTS:
MEDIA RELATIONS INVESTOR RELATIONS
Paul Burroughs Jacques Raymond
(418) 652-8525 ext. 406 (418) 652-8525 ext. 360
paul.burroughs@aeternazentaris.com jacques.raymond@aeternazentaris.com
U.S. INVESTOR RELATIONS EUROPE
Lippert/Heilshorn & Associates Matthias Seeber
Kim Golodetz +49 69 42602 3425
(212) 838-3777 matthias.seeber@zentaris.de
kgolodetz@lhai.com
ATTACHMENT: Financial summary
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FINANCIAL SUMMARY
(in thousands of Canadian dollars,
except share and per share data)
QUARTERS ENDED NINE MONTHS ENDED
SEPTEMBER 30, SEPTEMBER 30,
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CONSOLIDATED RESULTS 2004 2003 2004 2003
Unaudited $ $ $ $
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REVENUES 55,418 37,829 179,707 117,517
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OPERATING EXPENSES
Cost of sales 30,806 23,543 102,856 67,156
Selling, general and administrative 10,166 7,507 30,499 19,540
R&D costs, net of tax credits and grants 6,595 9,844 23,279 31,817
Depreciation and amortization 2,306 2,336 6,767 6,853
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49,873 43,230 163,401 125,366
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Operating income (loss) 5,545 (5,401) 16,306 (7,849)
Interest income 218 497 1,000 1,660
Interest and financial expenses (2,289) (1,399) (6,021) (3,487)
Foreign exchange gain (loss) (1,008) 94 (364) (1,264)
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INCOME (LOSS) BEFORE THE FOLLOWING ITEMS 2,466 (6,209) 10,921 (10,940)
Current income taxes (2,835) (1,447) (13,743) (3,552)
Future income taxes 145 (647) 5,089 (1,701)
Loss on dilution (535) (64) (535) (64)
Non-controlling interest (1,237) (969) (4,948) (2,636)
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NET LOSS FOR THE PERIOD (1,996) (9,336) (3,216) (18,893)
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Basic and diluted net loss per share (0.04) (0.20) (0.07) (0.43)
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Weighted average number of shares
Basic 45,628,742 45,253,682 45,564,092 42,993,432
Diluted 46,019,777 45,635,793 46,119,755 43,151,893
Issued and outstanding shares 45,630,409 40,698,027
SEPTEMBER 30, DECEMBER 31,
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2004 2003
CONSOLIDATED BALANCE SHEETS $ $
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Cash and short-term investments 62,998 64,367
Other current assets 86,937 70,278
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149,935 134,645
Long-term assets 208,498 161,134
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Total assets 358,433 295,779
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Current liabilities 78,999 61,442
Deferred revenues 26,010 10,563
Convertible term loans and long-term debt 68,627 35,052
Other long-term liabilities 30,824 32,649
Non-controlling interest 31,688 29,952
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236,148 169,658
Shareholders' equity 122,285 126,121
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Total liabilities and shareholders' equity 358,433 295,779
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SIGNATURE
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.
AETERNA ZENTARIS INC.
Date: November 4, 2004 By: /s/ Mario Paradis
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Mario Paradis
Senior Finance Director and Corporate Secretary