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 August 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-
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DOCUMENTS INDEX
DOCUMENTS DESCRIPTION
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1. Press release dated August 6, 2003: AEterna Laboratories Reports
Second Quarter Results
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[AETERNA LOGO]
PRESS RELEASE
FOR IMMEDIATE RELEASE
AETERNA LABORATORIES REPORTS SECOND QUARTER RESULTS
o Revenues increased 66% over second quarter 2002, net loss narrowed
o Cash position strengthened by $35.6 million through bought deal
o License agreement extended with Serono for Cetrotide(R)
o Positive Phase III results with Impavido(R) for cutaneous leishmaniasis
o Atrium acquires Chimiray/Interchemical, a marketer of fine chemicals and
active ingredients
ALL AMOUNTS ARE IN CANADIAN DOLLARS
QUEBEC CITY, CANADA, AUGUST 6, 2003 - AEterna Laboratories Inc. (TSX: AEL;
Nasdaq: AELA) today reported total revenues for the second quarter ended June
30, 2003 of $38.9 million, an increase of 66% compared with total revenues of
$23.4 million for the 2002 second quarter. During the second quarter of 2003,
product sales increased 18% to $27.6 million, and the Company also recorded
$11.3 million in license income and research contract fees related to marketed
products and products in development. The gross margin on product sales for the
2003 second quarter was improved to 26% compared with 24% for the same period
last year.
AEterna's investment in R&D during the second quarter of 2003 was $11 million,
up from $5.3 million during the comparable period last year. The increase is
primarily associated with the acquisition of Zentaris, which provided the
Company with 11 additional products. Spending on the Company's Neovastat(R)
Phase III clinical trials in kidney cancer and in non-small cell lung cancer
remained relatively constant year-over-year.
Even with this substantial increase in R&D investments, the Company reported an
operating loss for the second quarter 2003 of $1 million, down sharply for an
operating loss of $4.5 million for the second quarter 2002. The net loss also
narrowed for 2003 second quarter to $4.6 million, or $0.11 per share, compared
with a net loss of $5.9 million, or $0.15 per share, for the comparable period
in 2002.
Commenting on the Company's second quarter results, Gilles Gagnon, AEterna's
President and Chief Executive Officer, said, "We are realizing substantial
financial benefit from the late 2002 acquisition of Zentaris, as license income
and research contract fees as well as product sales contributed significantly to
our 66% growth. Furthermore, we were delighted with the recently announced
positive Phase III results for Impavido(R) to treat cutaneous leishmaniasis, a
severe
skin disease. As a result of our successful Phase III results, we are
preparing to file for regulatory approval in South America."
Mr. Gagnon added, "In addition to progress with our marketed products, the
extension of our license agreement to 2010 with Serono for Cetrotide(R)
illustrates the Company's ability to add value from strategic alliances with
world-class partners. As we move ahead to the balance of 2003, we look forward
to reporting our Neovastat(R) Phase III renal cell carcinoma trial results.
Neovastat(R) holds potential to be the first antiangiogenic drug on the market
for the treatment of kidney cancer."
"AEterna's cash and short-term investments of $49.2 million as of June 30, 2003
were further supplemented by net proceeds of $33.8 million from the issuance of
4.5 million shares through a bought deal that closed in late July. Reflecting
this financing and today's acquisition by Atrium of Chimiray/Interchemical, our
cash position stands at approximately $75 million. We are comfortable that we
have the necessary capital to pursue our strategic objectives," commented Dennis
Turpin, AEterna's Vice President and Chief Financial Officer.
SIX-MONTH FINANCIAL RESULTS
Total revenues for the first half of 2003 increased 63% to $79.7 million,
compared with $48.8 million for the first half of 2002, including an 18%
increase in product sales to $57.6 million. License income and research contract
fees of $22.1 million for the first half of 2003 are related to marketed
products and products in development. The Company reported a year-to-date 2003
operating loss of $2.3 million, compared with an operating loss of $8.4 million
for the comparable prior-year period despite the fact that R&D investments
increased from $10.5 million to $21.9 million during that same period. The net
loss for the first six months of 2003 was $9.4 million, or $0.23 per share,
compared with a net loss of $11.6 million, or $0.30 per share, for the first six
months of 2002.
AETERNA'S 62%-OWNED SUBSIDIARY ATRIUM BIOTECHNOLOGIES CONSOLIDATED RESULTS
During the second quarter of 2003, sales of Atrium Biotechnologies reached $24.7
million, compared with $23.4 million for the comparable period of 2002,
representing a 5% increase. Net earnings were substantially the same, reaching
$1.62 million during the quarter, compared with $1.66 million in 2002. Results
were impacted by the weakness in US currency at that time combined with recent
uncertainty in world market conditions.
For the six-month period ended June 30, 2003, Atrium sales reached $53 million
compared to $48.8 million in 2002, representing an 8.6% increase. For the same
period, the EBITDA increased from $6.6 million to $7 million. Due to the
weakness of the US currency, the foreign exchange loss reached $1.1 million for
the six-month period ended June 30, 2003 compared with $0.3 million in 2002.
Consequently, net earnings were stable at $3.2 million, compared to $3.5 million
for the same period in 2002.
ACQUISITION BY ATRIUM
AEterna announced today that its subsidiary Atrium acquired 100% of all issued
and outstanding shares of the privately-owned French company
Chimiray/Interchemical for approximately 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), and the company generated net
earnings.
"Atrium is an important asset in the global growth strategy of AEterna," said
Gilles Gagnon, President and Chief Executive Officer at AEterna. "With this
third acquisition within the last two years, Atrium continues to successfully
expand the marketing network for all of its products and to pursue its growth."
SIGNIFICANT MILESTONES
During the second quarter of 2003 and subsequent weeks, the Company's
accomplishments included the following:
o POSITIVE PHASE III RESULTS FOR IMPAVIDO(R) IN CUTANEOUS LEISHMANIASIS -
Subsequent to the close of the quarter, the Company reported results of
a Phase III trial evaluating its drug Impavido(R) (miltefosine) for the
treatment of cutaneous leishmaniasis, a severe skin disease. The data
showed that patients taking Impavido(R) had a cure rate of 70%, which
is 220% better than for those in the placebo group. This favorable data
enables 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.
o NEW NEOVASTAT(R) DATA - In April, the Company disclosed new scientific
data on its lead antiangiogenic compound Neovastat(R), which reinforces
the drug's antiangiogenic properties. The data was obtained from two
studies conducted by Dr. Francois Berger, Coordinator of the
Neuroscience molecular team of the INSERM 318 unit in Grenoble, France.
Abstracts reflecting the results of these studies were to be presented
at the American Association for Cancer Research (AACR) meeting in
Toronto, which was cancelled due to Severe Acute Respiratory Syndrome
(SARS).
o NEOVASTAT(R) UPDATE AT ASCO - In June, Dr. Bernard Escudier, Head of
the Immunotherapy Unit at Institut Gustave-Roussy in Paris and lead
investigator in Europe for the Company's Neovastat(R) Phase III trial
in renal cell carcinoma, gave a status report on the trial at the
American Society of Clinical Oncology (ASCO) Meeting in Chicago. In his
presentation, Dr. Escudier stated that data from the study would be
analyzed upon the death of 230 patients, or September 30, 2003,
whichever was sooner. At the time of his presentation, 218 patients had
died. Dr. Charles Lu, of the M.D. Anderson Cancer Center in Houston and
lead investigator for the Company's Phase III trial in non-small cell
lung cancer, also gave a status report on this trial.
o EXTENDED AGREEMENT WITH SERONO UNTIL 2010 FOR CETROTIDE(R) - In June,
the Company announced an extension of the existing license agreement
between its subsidiary Zentaris and Serono for worldwide marketing
rights, excluding Japan, for Cetrotide(R), a novel compound used for IN
VITRO fertilization. The amended agreement provides for Zentaris to
receive a signature fee, as well as fixed annual payments until 2010.
o AETERNA ANNUAL MEETING - In May, AEterna held its annual meeting of
stockholders where Gilles Gagnon presented the Company's strategy for
growth and its value creation objectives. At the meeting, Dr. Hartmut
Michel, Director of the prestigious Max-Planck Institute for Biophysics
in Frankfurt, Germany and 1988 Nobel Prize laureate in
chemistry, was appointed to the Company's Scientific Advisory Board,
while Dr. Eric Dupont, AEterna's Chairman, announced the conversion of
all of his 4,725,000 multiple voting shares into the same number of
subordinate voting shares. This conversion left the Company with a
single class of voting shares.
Subsequent to the end of the quarter, the Company 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 other corporate
purposes.
CONFERENCE CALL INFORMATION
Management will be hosting an investment community conference call beginning at
11:00 a.m. Eastern Time today, Wednesday, August 6, to discuss this announcement
and to answer questions.
To participate in the live call by telephone, please dial 514-807-8791,
416-640-4127 from Canada or 1-800-814-4890 from outside Canada. A telephone
replay will be available from 1:00 p.m. Eastern on August 6 until 11:59 p.m.
Eastern on August 8, by dialing 416-640-1917 and entering passcode 1012581#.
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 has an extensive portfolio of marketed and
development-stage biopharmaceutical products focused in oncology and
endocrinology. Its lead oncology compound is Neovastat(R), a proprietary
angiogenesis inhibitor with multiple mechanisms of action in a Phase III
clinical trial for renal cell carcinoma (data available by year-end 2003) and in
a Phase III trial for non-small cell lung cancer. Cetrotide(R), its lead
compound in endocrinology, is sold in the U.S. and Europe to the IN VITRO
fertilization market, and is in clinical testing for endometriosis, uterus myoma
and enlarged prostate (BPH). A further seven clinical programs are underway with
various compounds. 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 and its entities have 300 employees in Canada and Europe, and its 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 1-888-349-3232.
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.
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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 SALES & MARKETING
Kim Golodetz Dr. Mathias Pietras
(212) 838-3777 Tel.: +49 69 426023423
kgolodetz@lhai.com Fax: +49 69 426023444
Bruce Voss E-mail: mathias.pietras@zentaris.de
(310) 691-7100
bvoss@lhai.com
AETERNA LABORATORIES INC. (TSX: AEL ; NASDAQ: AELA)
FINANCIAL SUMMARY
(in thousands of Canadian dollars, except share and per
share data)
QUARTERS ENDED SIX MONTHS ENDED
JUNE 30 JUNE 30
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CONSOLIDATED RESULTS 2003 2002 2003 2002
Unaudited $ $ $ $
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REVENUES
Sales 27,632 23,440 57,610 48,789
License income and research contract fees 11,243 22,078
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38,875 23,440 79,688 48,789
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OPERATING EXPENSES
Cost of sales 20,393 17,803 43,613 37,486
General, selling and administrative 6,505 4,258 11,974 8,172
R&D costs, net of tax credits and grants 10,994 5,253 21,880 10,534
Depreciation and amortization 2,014 599 4,517 1,032
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39,906 27,913 81,984 57,224
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Operating Loss (1,031) (4,473) (2,296) (8,435)
Interest income 226 813 1,163 1,283
Interest and financial expenses (1,295) (74) (2,088) (210)
Foreign exchange loss (971) (282) (1,358) (268)
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LOSS BEFORE THE FOLLOWING ITEMS (3,071) (4,016) (4,579) (7,630)
Current income taxes (1,474) (505) (2,105) (965)
Future income taxes 816 (468) (1,054) (1,173)
Non-controlling interest (842) (910) (1,667) (1,782)
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NET LOSS FOR THE PERIOD (4,571) (5,899) (9,405) (11,550)
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Basic and diluted net loss per share (0.11) (0.15) (0.23) (0.30)
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Weighted average number of shares 40,695,527 40,452,019 40,696,277 38,552,019
Issued and outstanding shares 40,698,027 40,452,519
JUNE 30 DECEMBER 31
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CONSOLIDATED BALANCE SHEETS 2003 2002
$ $
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Cash and short-term investments 49,155 81,534
Other current assets 57,247 94,898
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106,402 176,432
Long-term assets 142,878 154,536
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Total assets 249,280 330,968
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Current liabilities 44,549 132,232
Deferred revenues 13,051 12,438
Non-controlling interest 24,530 24,676
Other long-term liabilities 60,407 51,286
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142,537 220,632
Shareholders' equity 106,743 110,336
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Total liabilities and shareholders' equity 249,280 330,968
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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: AUGUST 6, 2003 By: /s/ CLAUDE VADBONCOEUR
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Claude Vadboncoeur
Vice President, Legal Affairs and
Corporate Secretary