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 February 2003
AETERNA LABORATORIES INC.
(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 November 5, 2003: AEterna Reports Third
Quarter Results
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[GRAPHIC OMITTED]
PRESS RELEASE
FOR IMMEDIATE RELEASE
AETERNA LABORATORIES REPORTS THIRD QUARTER RESULTS
x AETERNA - REVENUES INCREASED 55% AND BURN RATE NARROWED TO $1.1 MILLION
x ATRIUM - SALES INCREASED 22% AND NET EARNINGS INCREASED 23%
x SOLID FINANCIAL POSITION - $75 MILLION IN CASH AND SHORT-TERM
INVESTMENTS, AS WELL AS STRONG PERFORMANCE FROM MARKETED PRODUCTS AND
ATRIUM SUBSIDIARY
All amounts are in Canadian dollars
QUEBEC CITY, CANADA, NOVEMBER 5, 2003 - AEterna Laboratories Inc. (TSX: AEL;
Nasdaq: AELA) today reported total revenues for the third quarter ended
September 30, 2003 of $37.8 million, an increase of 55% compared with total
revenues of $24.4 million for the 2002 third quarter. The gross margin on
product sales for the 2003 third quarter improved to 26% compared with 23% for
the same period last year. Investment in R&D during the third quarter of 2003
was $9.8 million, up from $6.5 million during the comparable period last year.
This R&D increase is primarily associated with the development of 11 products
and the discovery platform gained with the acquisition of Zentaris in December
2002.
With this increase in total revenues and despite higher R&D investments, the
Company reported that its operating loss narrowed for the third quarter 2003 to
$5.3 million, down from an operating loss of $5.5 million for the third quarter
of 2002. Net loss was $9.2 million, or $0.20 per share, in the 2003 third
quarter compared with a net loss of $6.2 million, or $0.15 per share, for the
comparable period in 2002. The net loss increase was largely due to depreciation
and amortization (D&A) related to the acquisition of Zentaris, as well as to
non-cash interest expenditure.
Commenting on the Company's third quarter results, Gilles Gagnon, AEterna's
President and Chief Executive Officer, said, "At the financial level, this
quarter was marked mainly by substantial revenues from Cetrotide(R) marketed for
IN VITRO fertilization and by the strong growth in sales and net earnings from
our subsidiary Atrium Biotechnologies, which acquired Chimiray/Interchemical in
August of this year. At the clinical development level, our kidney cancer Phase
III trial with Neovastat(R) did not reach its primary clinical endpoint.
However, we are pursuing our non-small cell lung cancer Phase III trial, whereby
Neovastat(R) is administered as a first-line therapy along with standard
treatment. In addition, many other products in oncology, endocrinology, and
infectious diseases ensure a constant flow of high potential projects. Two
marketed products are gaining market share; Cetrotide(R), and Impavido(R), the
first oral treatment for black fever and for a parasitic skin disease. In
addition, we are currently completing Phase II trials with Cetrorelix in uterus
myoma, endometriosis and benign prostatic hyperplasia. Considering the scope of
our pipeline, the strength of our international network of partners and the
profitability of our subsidiary Atrium, the Company is well positioned to pursue
its long-term growth."
Dennis Turpin, AEterna's Vice President and CFO, added, "The Company's financial
position remains solid with $75.4 million in cash and short-term investments as
of September 30, 2003, growing revenues from our marketed products, and a strong
performance from Atrium. Furthermore, while we had major R&D investments in this
quarter, only $1.1 million was used for operating activities and $0.3 million
for the acquisition of long-lived assets."
NINE-MONTH RESULTS
AEterna total revenues for the nine months ended September 30, 2003, increased
60% to $117.5 million, compared with $73.2 million for the first nine months of
2002. Product sales increased 22% to $89.3 million. License income and research
contract fees related to marketed products and products in development reached
$28.2 million for the first nine months of 2003. The Company reported a
year-to-date 2003 operating loss of $7.6 million, much reduced from an operating
loss of $14 million for the comparable prior-year period, despite the fact that
R&D investments increased to $31.7 million from $17.1 million during that same
period. The net loss for the first nine months of 2003 was $18.6 million, or
$0.43 per share, compared with a net loss of $17.8 million, or $0.46 per share,
for the first nine months of 2002.
ATRIUM CONSOLIDATED THIRD QUARTER RESULTS
During the third quarter of 2003, sales of AEterna's subsidiary, Atrium, reached
$29.9 million, compared with $24.4 million for the comparable period of 2002,
representing a 22% increase. Operating income reached $3.9 million during the
quarter, compared with $2.9 million for the same quarter in 2002, a 37%
increase. Net earnings increased 23% to $2 million, compared with $1.6 million
for the same period a year earlier. This growth is mainly due to the
acquisition, last August, of Chimiray-Interchemical and to the increased gross
margin generated by product sales.
ATRIUM CONSOLIDATED NINE-MONTH RESULTS
For the nine months ended September 30, 2003, Atrium sales reached $82.9 million
compared with $73.2 million for the same period in 2002, representing a 13%
increase. Operating income increased 15% to $10.6 million, from $9.2 million in
2002. Since the start of the year, Atrium has reported $5.2 million in net
earnings compared with $5.1 million in 2002.
THIRD QUARTER 2003 HIGHLIGHTS
x Phase III trial results with Neovastat(R) in kidney cancer - In
September, AEterna reported Phase III trial results for Neovastat(R) in
renal cell carcinoma, a form of kidney cancer. The study involved 305
patients and did not reach its primary clinical endpoint, which was to
increase the median survival time of treated patients by 50%.
x POSITIVE PHASE III RESULTS WITH IMPAVIDO(R) IN CUTANEOUS LEISHMANIASIS
(PARASITIC SKIN DISEASE) - In July, the Company reported positive
results of a Phase III trial evaluating Impavido(R) (Miltefosine) for
the treatment of cutaneous leishmaniasis, a severe skin disease. The
data showed that patients taking Impavido(R) had a 220% better cure
rate than those in the placebo group. These favorable data enable the
Company to apply for marketing authorization in South American
countries where the cutaneous form of the disease is predominant.
Impavido(R) is currently sold in India and is the only oral cure for
the life-threatening visceral form of leishmaniasis (black fever).
x CLOSING OF A $35.6 MILLION BOUGHT DEAL - In July, AEterna closed a
$35.6 million bought deal, issuing 4.5 million subordinate voting
shares at $7.90 per share. The net proceeds of $33.8 million of this
financing will be used to further develop the product pipeline, pursue
the Company's growth strategy and for general corporate purposes.
x ACQUISITION OF CHIMIRAY/INTERCHEMICAL BY ATRIUM - In August, AEterna's
subsidiary, Atrium, acquired 100% of all issued and outstanding shares
of Chimiray-Interchemical for (Euro)11.5 million ($18.4 million),
payable by the issuance of a long-term debt of (Euro)5 million ($8
million) and the residual of (Euro)6.5 million ($10.4 million) in cash.
Based in Paris, Chimiray-Interchemical is focused mainly in the
distribution of fine chemicals and active ingredients. Net sales for
the last twelve-month period were approximately (Euro)35 million ($52
million). The company generated net earnings and was cash flow
positive.
CONFERENCE CALL INFORMATION
Management will be hosting an investment community conference call beginning at
10:00 a.m. Eastern Time today, Wednesday, November 5, to discuss third quarter
results and to answer questions.
To participate in the live call by telephone, please dial 514-807-8791,
416-640-4127 or 800-814-4890. Individuals interested in listening to the
conference call via the Internet may do so by visiting www.aeterna.com. A replay
will be available on the Company's Web site for 30 days.
ABOUT AETERNA LABORATORIES
AEterna Laboratories is a biopharmaceutical company with an extensive portfolio
of marketed and development-stage products in oncology, endocrinology and
infectious diseases. In oncology, Neovastat(R) is in a Phase III trial for
non-small cell lung cancer. In endocrinology, Cetrotide(R) is sold in the U.S.
and Europe to the in vitro fertilization market, and is in Phase II clinical
trials for endometriosis, uterus myoma and enlarged prostate (BPH). A further
seven clinical programs are underway with various compounds.
AEterna owns 100% of the biopharmaceutical company, Zentaris GmbH, based in
Frankfurt, Germany. Zentaris generated more than $30 million in revenues and was
cash flow positive in 2002.
In addition, AEterna owns 62% of Atrium Biotechnologies, a profitable and
growing developer, distributor and marketer of active ingredients, fine
chemicals, cosmetic and nutritional products with sales exceeding $100 million
in 2002.
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. To find out more about the
current Phase III trial in non-small cell lung cancer, call 888-349-3232.
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.
-30-
Contacts:
AETERNA LABORATORIES
MEDIA RELATIONS INVESTOR RELATIONS
Paul Burroughs Jacques Raymond
(418) 652-8525 ext. 406 (418) 652-8525 ext. 360
paul.burroughs@aeterna.com jacques.raymond@aeterna.com
U.S. INVESTOR RELATIONS
Lippert/Heilshorn & Associates
Kim Golodetz
(212) 838-3777
kgolodetz@lhai.com
Bruce Voss
(310) 691-7100
bvoss@lhai.com
Attachment: Financial summary
AETERNA LABORATORIES INC. (TSX: AEL ; NASDAQ: AELA)
FINANCIAL SUMMARY
(in thousands of Canadian dollars, except share and
per share data)
QUARTERS ENDED NINE MONTHS ENDED
SEPTEMBER 30 SEPTEMBER 30
------------------------------------------------------------------------
CONSOLIDATED RESULTS 2003 2002 2003 2002
Unaudited $ $ $ $
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REVENUES
Sales 31,698 24,407 89,308 73,196
License income and research contract fees 6,131 - 28,209 -
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37,829 24,407 117,517 73,196
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OPERATING EXPENSES
Cost of sales 23,543 18,864 67,156 56,350
General, selling and administrative 7,465 3,901 19,439 12,073
R&D costs, net of tax credits and grants 9,788 6,525 31,668 17,058
Depreciation and amortization 2,336 646 6,853 1,679
------------------------------------------------------------------------
43,132 29,936 125,116 87,160
------------------------------------------------------------------------
Operating Loss (5,303) (5,529) (7,599) (13,964)
Interest income 497 729 1,660 2,012
Interest and financial expenses (1,399) (114) (3,487) (324)
Foreign exchange loss 94 84 (1,264) (184)
------------------------------------------------------------------------
LOSS BEFORE THE FOLLOWING ITEMS (6,111) (4,830) (10,690) (12,460)
Current income taxes (1,447) (808) (3,552) (1,773)
Future income taxes (647) (140) (1,701) (1,313)
Gain on dilution (64) 425 (64) 425
Non-controlling interest (969) (869) (2,636) (2,651)
------------------------------------------------------------------------
NET LOSS FOR THE PERIOD (9,238) (6,222) (18,643) (17,772)
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Basic and diluted net loss per share (0.20) (0.15) (0.43) (0.46)
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Weighted average number of shares 45,253,682 40,452,019 42,993,432 38,552,019
Issued and outstanding shares 45,330,992 40,452,519
SEPTEMBER 30 DECEMBER 31
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CONSOLIDATED BALANCE SHEETS 2003 2002
$ $
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Cash and short-term investments 75,367 81,534
Other current assets 70,312 94,898
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145,679 176,432
Long-term assets 158,729 154,536
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Total assets 304,408 330,968
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Current liabilities 64,316 132,232
Deferred revenues 11,993 12,438
Non-controlling interest 26,525 24,676
Other long-term liabilities 69,890 51,286
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172,724 220,632
Shareholders' equity 131,684 110,336
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Total liabilities and shareholders' equity 304,408 330,968
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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 LABORATORIES INC.
Date: November 5, 2003 By: /s/Claude Vadboncoeur
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Claude Vadboncoeur
Vice President, Legal Affairs and
Corporate Secretary