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 2005
AETERNA ZENTARIS 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
--- ---
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
--- ---
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 dated November 14, 2005 - AEterna Zentaris
Reports 2005 Third Quarter Financial and Operating Results
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[AETERNA ZENTARIS LOGO]
AETERNA ZENTARIS INC.
1405 du Parc-Technologique Blvd.
Quebec (Quebec) Canada G1P 4P5
T 418 652-8525 F 418 652-0881
www.aeternazentaris.com
PRESS RELEASE
For immediate release
AETERNA ZENTARIS REPORTS 2005 THIRD QUARTER FINANCIAL AND OPERATING RESULTS
SIGNIFICANT MILESTONES ACHIEVED IN ADVANCING CLINICAL DEVELOPMENT PIPELINE
ALL AMOUNTS ARE IN CANADIAN DOLLARS
THIRD QUARTER 2005 HIGHLIGHTS:
Financial
>> Consolidated revenues of $63.4 million, compared to $55.4 million for
Q3 2004;
>> Consolidated R&D expenses of $7.4 million, compared to $6.6 million
for Q3 2004;
>> Consolidated earnings from operations of $1.1 million, compared to
$5.5 million for Q3 2004;
>> Consolidated net loss of $4.8 million, or $0.10 per share, compared to
a consolidated net loss of $2 million, or $0.04 per share for Q3 2004;
and
>> Consolidated cash and short-term position was $55.7 million at the end
of Q3 2005.
Product development
>> Perifosine: Initiated Phase II trial in non-small cell lung cancer in
combination with radiotherapy;
>> Ozarelix: Completed patient enrollment for Phase II trial in prostate
cancer.
QUEBEC CITY, CANADA, NOVEMBER 14, 2005 - AEterna Zentaris Inc. (TSX: AEZ;
NASDAQ: AEZS) today reported financial and operating results for the third
quarter ended September 30, 2005. Consolidated revenues for the third quarter
2005 were $63.4 million compared to $55.4 million for the same period in 2004,
an increase of 14.4%. Consolidated R&D expenses net of tax credits amounted to
$7.4 million in the third quarter of 2005 compared to $6.6 million in the third
quarter of 2004. Consolidated earnings from operations for the third quarter
2005 were $1.1 million, compared to $5.5 million for the third quarter 2004. The
Company's consolidated net loss was $4.8 million, or $0.10 per basic and diluted
share for the third quarter of 2005 compared to a consolidated net loss of $2
million, or $0.04 per basic and diluted share for the comparable period in 2004.
The $8 million increase in consolidated revenues during the third quarter 2005
as compared to the same period in 2004 is attributable to additional revenues
from the acquisitions, in January 2005, of Echelon Biosciences in our
biopharmaceutical segment and of MultiChem by the Company's subsidiary, Atrium
Biotechnologies Inc. This increase is partly offset by the adverse effect of the
strengthening Canadian dollar on the Company's sales denominated in foreign
currencies and by $9.4 million non-periodic payments received in 2004 in the
biopharmaceutical segment.
As of September 30, 2005, the Company had consolidated cash and short-term
investments of $55.7 million, including $40.9 million dedicated to the
biopharmaceutical segment. The Company generated consolidated positive cash flow
from operating activities of $0.7 million in the third quarter 2005. The burn
rate for the biopharmaceutical segment in the third quarter 2005 was $4.8
million as expected.
NINE-MONTH CONSOLIDATED FINANCIAL RESULTS
Consolidated revenues for the first nine months of 2005 increased 19.1% to
$214.1 million, compared to $179.7 million for the same period in 2004. The
Company reported year-to-date 2005 consolidated earnings from operations of
$13.4 million, compared to $16.3 million for the same period a year earlier.
Consolidated net earnings for the first nine months of 2005 were $11.8 million,
or $0.26 per basic share and $0.25 per diluted share compared to a consolidated
net loss of $3.2 million, or $0.07 per basic and diluted share for the first
nine months of 2004.
Dennis Turpin, Vice President and Chief Financial Officer of AEterna Zentaris,
said, "With our strong cash and short-term position in the biopharmaceutical
segment of nearly $41 million, as well as our controlled burn rate of nearly
$1.5 million per month, we believe we are well-positioned to continue to
aggressively advance the development of our core innovative and high potential
pharmaceutical products."
During the third quarter 2005, AEterna Zentaris continued to advance its product
pipeline. The Company initiated its own European multi-center Phase II trial of
perifosine, a novel, first-in-class, oral signal transduction inhibitor, in
combination with radiotherapy, in non-small cell lung cancer (NSCLC). This
randomized, double-blind, placebo-controlled trial will assess the efficacy and
safety of a 150 mg daily dose of perifosine when combined with radiotherapy in
160 patients with inoperable Stage III NSCLC. The trial is being conducted in
collaboration with the Netherlands Cancer Institute. The primary endpoint will
be the extent and duration of local control, i.e., the absence of tumor
recurrence or progression in the area that has been irradiated during a 12-month
follow-up period.
The Company also announced that it had completed enrollment for a Phase II trial
with ozarelix (D-63153) in hormone-dependent prostate cancer, ahead of the
projected schedule. This multi-center trial is designed to evaluate the effects
of ozarelix on hormonal levels, in particular testosterone, as well as objective
anti-tumor effects. This open-label trial involving 48 patients is being
conducted in Europe in collaboration with its partner Spectrum Pharmaceuticals
Inc. (NASDAQ: SPPI).
"During the last quarter, we made significant progress in advancing our exciting
products through our pipeline," said Gilles Gagnon, AEterna Zentaris President
and Chief Executive Officer. "The recent initiation of our Phase II trial in
non-small cell lung cancer with our lead oncology compound, perifosine, was our
seventh clinical development project initiated so far this year. Additionally,
we were very pleased with having completed patient enrollment for our
Phase II trial in prostate cancer with ozarelix, ahead of schedule. These
significant achievements mark critical steps as we continue to execute our
strategy aimed at establishing perifosine as a potential breakthrough cancer
drug and reflects our strong commitment in building a world-class oncology
franchise. We believe we will continue to deliver results and look forward to
reporting on our progress next year," concluded Mr. Gagnon.
CONFERENCE CALL INFORMATION
Management will be hosting a conference call for the investment community
beginning at 10:30 a.m. Eastern Time today to discuss 2005 third quarter
financial and operating results and 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 on 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 growing global biopharmaceutical company engaged in
the discovery, development and marketing of therapies for cancer and endocrine
disorders.
AEterna Zentaris also owns 50.03% of Atrium Biotechnologies Inc. (TSX: ATB.sv),
a developer, manufacturer and marketer of science-based products for the
cosmetics, pharmaceutical, chemical and nutritional industries.
News releases and additional information are available at
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.
-30-
MEDIA RELATIONS
Paul Burroughs
(418) 652-8525 ext. 406
PAUL.BURROUGHS@AETERNAZENTARIS.COM
INVESTOR RELATIONS
Ginette Vallieres
(418) 652-8525 ext. 265
GINETTE.VALLIERES@AETERNAZENTARIS.COM
EUROPE
Matthias Seeber
+49 69 42602 3425
Matthias.seeber@zentaris.com
ATTACHMENT: Financial summary
(IN THOUSANDS OF CANADIAN DOLLARS, EXCEPT SHARE
AND PER SHARE DATA)
QUARTERS ENDED NINE MONTHS ENDED
CONSOLIDATED RESULTS SEPTEMBER 30, SEPTEMBER 30,
UNAUDITED 2005 2004 2005 2004
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$ $ $ $
REVENUES 63,356 55,418 214,098 179,707
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OPERATING EXPENSES
Cost of sales 40,856 30,806 134,417 102,856
Selling, general and administrative 11,816 10,166 36,463 30,499
R&D costs, net of tax credits and grants 7,384 6,595 22,883 23,279
Depreciation and amortization 2,206 2,306 6,936 6,767
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62,262 49,873 200,699 163,401
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EARNINGS FROM OPERATIONS 1,094 5,545 13,399 16,306
Interest income 406 218 1,311 1,000
Interest expense (2,688) (2,289) (8,651) (6,021)
Foreign exchange loss (496) (1,008) (430) (364)
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EARNINGS (LOSS) BEFORE THE FOLLOWING ITEMS (1,684) 2,466 5,629 10,921
Current income taxes (260) (2,835) (5,513) (13,743)
Future income taxes (908) 145 (2,344) 5,089
Gain (loss) on dilution of investments (51) (535) 20,202 (535)
Non-controlling interest (1,850) (1,237) (6,178) (4,948)
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NET EARNINGS (LOSS) FOR THE PERIOD (4,753) (1,996) 11,796 (3,216)
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NET EARNINGS (LOSS) PER SHARE
Basic (0.10) (0.04) 0.26 (0.07)
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Diluted (0.10) (0.04) 0.25 (0.07)
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Weighted average number of shares
Basic 46,139,814 45,628,742 46,139,814 45,564,092
Diluted 46,397,156 46,019,777 46,459,000 46,119,755
Issued and outstanding shares 46,139,814 45,630,439
AS AT AS AT
CONSOLIDATED BALANCE SHEET SEPTEMBER 30, DECEMBER 31,
UNAUDITED 2005 2004
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$ $
Cash and short-terms investments 55,680 58,090
Other current assets 88,423 86,644
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144,103 144,734
Long term assets 203,453 204,494
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Total assets 347,556 349,228
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Current liabilities 87,850 72,265
Deferred revenues 16,359 25,557
Long-term debt 22,018 64,255
Other long-term liabilities 28,942 32,092
Non-controlling interest 65,671 34,767
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220,840 228,936
Shareholders' equity 126,716 120,292
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Total liabilities and shareholders' equity 347,556 349,228
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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 15, 2005 By: /S/MARIO PARADIS
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Mario Paradis
Senior Finance Director and Corporate Secretary