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 April 2003
AETERNA LABORATORIES INC.
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(Translation of registrant's name into English)
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-____
DOCUMENTS INDEX
DOCUMENTS DESCRIPTION
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1. Press Release of April 30, 2003: AEterna Laboratories
Reports First Quarter Results
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[LOGO - AETERNA LABORATORIES]
PRESS RELEASE
FOR IMMEDIATE RELEASE
AETERNA LABORATORIES REPORTS FIRST QUARTER RESULTS
Company benefiting from recent Zentaris acquisition
ALL AMOUNTS ARE EXPRESSED IN CANADIAN DOLLARS
QUEBEC CITY, CANADA, APRIL 30, 2003 -- AEterna Laboratories Inc. (NASDAQ: AELA,
TSX: AEL) reported consolidated revenues for the first quarter ended March 31,
2003 of $40.8 million and a net loss of $4.8 million, or $0.12 per share,
compared to revenues of $25.3 million, and a net loss of $5.7 million, or $0.17
per share, for the same period in 2002. First quarter highlights include
marketing and development agreements with LG Life Sciences (Neovastat(R)),
German Remedies Limited (Impavido(R)), Baxter Healthcare S.A. (D-63153), as well
as $25 million in convertible term loans with two strategic long-time partners,
and settlement of the $40 million balance of the Zentaris purchase price. The
acquisition of Zentaris has provided AEterna with an expanded 12 product
portfolio ranging from preclinical to marketing stage.
"The increase in revenues for this quarter reflects our ability to quickly and
successfully integrate our new biopharmaceutical subsidiary Zentaris, which was
only acquired last December," said Gilles Gagnon, President and Chief Executive
Officer at AEterna. "We are reaping benefits from our expanded portfolio which
is generating significant revenues from both new strategic partnerships, as well
as sales of Cetrotide(R) for IN VITRO fertilization. At the clinical level, our
ongoing Neovastat Phase III trial in kidney cancer will be unblinded in the
months ahead and positive results could translate into a major breakthrough for
AEterna as the first company to market an angiogenesis inhibitor for the
treatment of cancer."
FINANCIAL RESULTS
Revenues for the three-month period ended March 31, 2003 were $40.8 million
compared to $25.3 million for the same period last year. This increase of $15.5
million or 61% comes mainly from the biopharmaceutical segment with revenues
totalling $12.5 million. The balance of $3 million comes from the Cosmetics &
Nutrition (C&N) and the Distribution segments, representing a 12% growth
compared to the first quarter of 2002.
The acquisition of Frankfurt-based Zentaris, in December 2002, provided all of
the revenues in the biopharmaceutical segment for the quarter. Revenues in this
segment were generated by Cetrotide(R) sales and royalties, as well as milestone
payments, research and development contract fees and amortization of upfront
payments.
For this same quarter, investments in R&D reached $10.9 million compared to $5.3
million during the same period last year. This increase is attributable to the
acquisition of Zentaris whose R&D investments totalled $5.6 million for this
first quarter. R&D investments are dedicated to our lead antiangiogenic compound
in oncology, Neovastat, to Cetrorelix, our lead compound in endocrinology, and
to our recently acquired Zentaris drug discovery unit, including a 100,000
proprietary compound library.
The Company has recorded a net loss of $4.8 million, or $0.12 per share, for the
quarter, compared to a net loss of $5.7 million or $0.17 per share for the same
period in 2002. The new revenues from Zentaris for the biopharmaceutical segment
explain the reduction of the net loss in comparison with 2002.
In March 2003, the Company settled the $40 million balance of the purchase price
of Zentaris with Degussa AG and closed $25 million in convertible term loans
with SGF Sante and Solidarity Fund QFL. The Company's cash and short-term
investment position was $52.4 million at quarter end.
"With both our biopharmaceutical products segment and our profitable subsidiary,
Atrium Biotechnologies, generating cash, we are efficiently controlling our burn
rate," said Dennis Turpin, Vice President and Chief Financial Officer at
AEterna. "AEterna is in a solid financial position with $52.4 million in cash
and short-term investments."
SCIENTIFIC AND CLINICAL DEVELOPMENT
Neovastat's ongoing double-blind randomized placebo controlled Phase III trial
for renal cell carcinoma, involves 302 patients. Patient recruitment was
completed in December 2001 and the trial is still at the patient survival
monitoring stage. Following discussions with the FDA (USA), Health Products and
Food Branch (Canada) and Medicines Control Agency (UK), analysis of the trial's
database will start when the number of deceased patients has reached 230. As of
today, this number has not been reached. Furthermore, it has been agreed with
these health authorities that should that number not be reached by September 30,
2003, analysis of the trial's database would begin at that time and all patients
still taking part in the trial would receive Neovastat. Trial results will be
available during the current year.
Furthermore, the following people were appointed to AEterna's Scientific
Advisory Board:
- Dr. Klaus H.R. Diedrich, MD, Director of the Department of Gynecology and
Obstetrics at the University Clinic in Luebeck, Germany.
- Dr. Rene Frydman, MD, Head, Department of Gynecology and Obstetrics at the
Hopital Antoine Beclere in Clamart, a suburb of Paris.
- Dr. Fernand Labrie, OC, OQ, MD, PhD, Head, Centre hospitalier de
l'Universite Laval (CHUL) Research Centre in Quebec City.
BUSINESS DEVELOPMENT
- Agreement for marketing Neovastat in Korea with LG Life Sciences. The
agreement provides AEterna with upfront and milestone payments, as well as
a return on manufacturing and sales of Neovastat. This partnership also
extends AEterna's coverage for Neovastat to 50% of the oncology world
market and allows the Company to surpass the $50 million mark in milestone
payments.
- Agreement with German Remedies Limited to sell Impavido(R), the first oral
treatment for black fever, in India and Bangladesh.
- Significant milestone payment from Baxter Healthcare S.A. for D-63153 for
prostate cancer.
- Agreement with Hainan Chang An Pharmaceutical Ltd. to manufacture and sell
Lobaplatin in China for multiple cancer indications.
CORPORATE GOVERNANCE
Gilles Gagnon, President and Chief Operating Officer, was promoted President and
Chief Executive Officer of the Company, while Dr. Eric Dupont, remains the
Company's Executive Chairman of the Board, which is comprised of six external
and three internal members.
ABOUT AETERNA LABORATORIES INC.
AEterna is a biopharmaceutical company focused on the development of novel
therapeutic treatments, mainly in oncology and endocrinology. The product
pipeline includes 12 products ranging from the preclinical to marketing stage.
AEterna's strategic worldwide partners include Access Oncology, Ardana
Bioscience, Baxter Healthcare S.A., German Remedies Ltd., Grupo Ferrer
Internacional, Hainan Chang An Pharmaceutical Ltd., LG Life Sciences Ltd., Mayne
Group, Medac GmbH, Nippon Kayaku, Serono International S.A., Shionogi & Co.,
Ltd., Solvay Pharmaceuticals B.V., and Teikoku Hormone Mfg. Co., Ltd.
AEterna owns 100% of the biopharmaceutical company, Zentaris GmbH, based in
Frankfurt, Germany. AEterna also owns 61.8% of Atrium Biotechnologies Inc.,
which develops and markets nutritional supplements, as well as active
ingredients and fine chemical products intended for the cosmetics, nutrition,
fine chemicals and pharmaceuticals industries. Atrium markets over 500 products
in 20 countries to industry leaders such as Estee Lauder, L'Oreal, Clarins,
Chanel, Aventis, SanofiSynthelabo and Nestle.
AEterna and its entities have 270 employees in Canada and Europe.
AEterna shares are listed on the Toronto Stock Exchange (AEL) and the NASDAQ
National Market (AELA).
News releases and additional information about AEterna are available on its Web
site at www.aeterna.com.
NOTICE: A quarterly conference call and webcast have been scheduled for today,
Wednesday, April 30, 2003 at 11:00 a.m. Eastern time. Participants may access
the live webcast via AEterna's website at www.aeterna.com or by telephone using
the following numbers:
416-640-4127, 514-807-8791 or 1-800-814-4890.
A replay of the conference call will be available at 416-640-1917 passcode
250093# from April 30 at 1:00 p.m., through May 2 at 11:59 p.m. A replay of the
webcast will also be available on AEterna's website from April 30 through May
30, 2003.
SAFE HARBOR STATEMENT
This press release contains forward-looking statements, which are 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 the business opportunities in
the pharmaceutical industry, uncertainties related to the regulatory process and
general changes in economic conditions. Investors should consult the Company's
ongoing 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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CANADA
MEDIA RELATIONS: INVESTOR RELATIONS:
Paul Burroughs Jacques Raymond
Tel.: (418) 652-8525 ext. 406 Tel.: (418) 652-8525 ext. 360
Cell.: (418) 573-8982 Cell.: (514) 703-5654
Fax: (418) 577-7671 Fax: (418) 577-7700
E-mail: paul.burroughs@aeterna.com E-mail: jacques.raymond@aeterna.com
USA EUROPE
THE INVESTOR RELATIONS GROUP INVESTOR RELATIONS
Lisa Lindberg Matthias Seeber
Tel.: (212) 825-3210 Tel.: 011 49 69 4 26 02 34 25
Fax: (212) 825-3229 Fax: 011 49 69 4 26 02 34 44
E-mail: TheProTeam@aol.com E-mail: matthias.seeber@zentaris.de
Attachment: Financial summary
AETERNA LABORATORIES INC. (TSX: AEL, NASDAQ: AELA)
FINANCIAL SUMMARY
(in thousands of Canadian dollars, except per
share data)
THREE MONTHS ENDED ON
MARCH 31
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CONSOLIDATED RESULTS 2003 2002
Unaudited $ $
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REVENUES
Sales 29,978 25,349
License income and research contract fees 10,835 --
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40,813 25,349
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Cost of sales 23,220 19,683
General, selling and administrative 5,469 3,914
R&D, net of tax credits and grants 10,886 5,281
Depreciation and amortization 2,503 433
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42,078 29,311
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Operating Loss (1,265) (3,962)
Interest income 937 531
Interest and financial expenses (793) (183)
Foreign exchange (loss) gain (387) --
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LOSS BEFORE THE FOLLOWING ITEMS (1,508) (3,614)
Current income taxes (632) (460)
Future income taxes (1,869) (705)
Non-controlling interest (825) (872)
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NET LOSS FOR THE PERIOD (4,834) (5,651)
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Basic and diluted net loss per share (0.12) (0.17)
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Weighted average number of shares 40,693,527 32,851,019
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Issued and outstanding shares 40,693,527 32,851,019
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MARCH 31 DECEMBER 31
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CONSOLIDATED BALANCE SHEETS 2003 2002
$ $
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Cash and short-term investments 52,380 81,534
Working capital 64,082 44,200
Total assets 264,323 330,968
Convertible term loans 18,675 --
Long-term debt 9,743 9,969
Non-controlling interest 24,024 24,676
Shareholders' equity 111,613 110,336
Deficit 49,698 44,864
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 LABORATORIES INC.
Date: April 30, 2003 By: /s/ CLAUDE VADBONCOEUR
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Claude Vadboncoeur
Vice President, Legal Affairs and
Corporate Secretary