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 2006
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
---------------------
-------------------------------------------------------------------------------
1. Press release dated November 13, 2006: AEterna Zentaris
Reports 2006 Third Quarter Results
-------------------------------------------------------------------------------
[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 2006 THIRD QUARTER RESULTS
QUARTER MARKED BY SIGNIFICANT ADVANCEMENTS WITH LHRH ANTAGONIST PLATFORM
ALL AMOUNTS ARE IN U.S. DOLLARS
QUEBEC CITY, CANADA, NOVEMBER 13, 2006 -AEterna Zentaris Inc. (TSX: AEZ; NASDAQ:
AEZS) today reported financial and operating results for the third quarter ended
September 30, 2006.
"The third quarter was marked by significant progress with the clinical
development of our luteinizing hormone-releasing hormone (LHRH) antagonist
compound, ozarelix, for which we disclosed positive Phase 2 results in both
prostate cancer and benign prostatic hyperplasia," said Gilles Gagnon, AEterna
Zentaris' President and Chief Executive Officer. "These very encouraging results
enable us to pursue ozarelix's clinical development in both indications, moving
forward with an ongoing Phase 2b trial in prostate cancer as well as the
potential to initiate a late-stage program in benign prostatic hyperplasia in
2007. Furthermore, we granted Nippon Kayaku an exclusive license to develop and
market ozarelix for all potential oncological indications in Japan.
Additionally, we launched the first LHRH antagonist to enter the Japanese
market, Cetrotide(R) (cetrorelix) for in vitro fertilization with our Japanese
partners. We are pleased with these significant achievements as they clearly
represent our commitment to aggressively move our product candidates through the
pipeline and bring our lead compounds even closer to market."
KEY DEVELOPMENTS FOR THE QUARTER ENDED SEPTEMBER 30, 2006
o POSITIVE PHASE 2 RESULTS FOR OZARELIX IN PROSTATE CANCER - The study
achieved its primary end-point of defining a tolerable dosage regimen
of ozarelix that would ensure continuous suppression of testosterone
at castration level (< 0.5 ng/ml) for a three-month test period. The
detailed results from the study will be presented at the upcoming SIU
(SOCIETE INTERNATIONALE D'UROLOGIE) meeting in Cape Town, South
Africa, on November 13, 2006.
o POSITIVE PHASE 2 RESULTS FOR OZARELIX IN BENIGN PROSTATIC HYPERPLASIA
(BPH) - With highly statistically significant positive data, the study
achieved its primary efficacy end-point of improving clinical symptoms
of BPH, at week 12, as measured by significant changes in the
International Prostate Symptom Score (I-PSS), the standard method of
assessing BPH symptoms.
[AETERNA ZENTARIS LOGO]
o PARTNERSHIP FOR OZARELIX IN JAPAN - AEterna Zentaris granted Nippon
Kayaku an exclusive license to develop and market ozarelix for all
potential oncological indications in Japan.
O CETROTIDE(R)(CETRORELIX) LAUNCHED IN JAPAN FOR IN VITRO FERTILIZATION
- Cetrotide(R)(cetrorelix), the first LHRH antagonist to enter the
Japanese market, has been launched in Japan for IN VITRO
fertilization. Cetrotide(R)(cetrorelix) is being manufactured and
marketed in Japan by partners Nippon Kayaku Co., Ltd. and Shionogi &
Co., Ltd.
FINANCIAL RESULTS FOR THE QUARTER ENDED SEPTEMBER 30, 2006
Consolidated revenues for the quarter ended September 30, 2006 totalled $83.9
million compared to $52.9 million for the same period in 2005.
Consolidated R&D expenses, net of tax credits and grants (R&D) remained steady
during the third quarter at $6.2 million compared to $6.1 million for the same
period in 2005.
Consolidated selling, general and administrative (SG&A) expenses increased to
$15.1 million for the quarter ended September 30, 2006 compared to $9.8 million
for the same period in 2005.
Consolidated net loss for the quarter ended September 30, 2006 was $6.5 million
or $0.12 per basic and diluted share, compared to $3.8 million or $0.08 per
basic and diluted share for the same period in 2005. The increase is mainly
attributable to increased non-recurring corporate expenses and future income tax
expense, partly offset by the increased contribution of Atrium.
Cash, cash equivalents and short-term investments reached $45.8 million for the
quarter ended September 30, 2006 compared to $52.7 million as of December 31,
2005. More than $25 million was dedicated to the Company's Biopharmaceutical
segment as of September 30, 2006. Taking into account the sale of 24% of AEterna
Zentaris' ownership interest in Atrium that occurred on October 18, 2006,
AEterna Zentaris' pro-forma cash and short-term position dedicated to its
Biopharmaceutical segment reached $71 million, compared to $34.8 million as of
December 31, 2005.
Dennis Turpin, Vice President and Chief Financial Officer of AEterna Zentaris,
commented, "With a strong balance sheet, a controlled burn rate and a clear
development strategy, we are well positioned to execute our business plan."
DEVELOPMENTS SUBSEQUENT TO QUARTER END
O CLOSING OF SECONDARY OFFERING OF AETERNA ZENTARIS' 3,485,000
SUBORDINATE VOTING SHARES OF ATRIUM BIOTECHNOLOGIES INC., AT A PRICE
OF CDN$15.80 PER SHARE - In early January 2007, AEterna Zentaris
intends, subject to receiving regulatory and other approvals, to
distribute all of its remaining 11,052,996 subordinate voting shares
of Atrium to its shareholders.
Gilles Gagnon, President and Chief Executive Officer at AEterna Zentaris
concluded, "Over the past few months, we have successfully achieved major
milestones. We now look forward to continuing this great momentum for the
remainder of the year and emerge in early 2007 as a late-stage pure play
biopharmaceutical company, in an effort to further unlock value to our
shareholders."
2
[AETERNA ZENTARIS LOGO]
Management will be hosting a conference call for the investment community
beginning at 10:30 a.m. Eastern Time today, Monday, November 13, to discuss 2006
third quarter financial and operating results, followed by a question and answer
session.
To participate in the live conference call by telephone, please dial
416-644-3415, 514-807-8791 or 800-814-4857. 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 focused on
endocrine therapy and oncology with proven expertise in drug discovery,
development and commercialization.
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-
CONTACTS
MEDIA RELATIONS INVESTOR RELATIONS
Paul Burroughs Jenene Thomas
(418) 652-8525 ext. 406 (418) 655-6420 or (908) 996-3154
paul.burroughs@aeternazentaris.com jenene.thomas@aeternazentaris.com
ATTACHMENT: Financial summary
3
[AETERNA ZENTARIS LOGO]
(IN THOUSANDS OF US DOLLARS, EXCEPT SHARE
AND PER SHARE DATA)
QUARTERS ENDED NINE MONTHS ENDED
CONSOLIDATED RESULTS SEPTEMBER 30, SEPTEMBER 30,
UNAUDITED 2006 2005 2006 2005
----------------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------
$ $ $ $
REVENUES 83,893 52,879 251,760 174,888
----------------------------------------------------------------------------------------------------------------------------
OPERATING EXPENSES
Cost of sales 55,664 34,073 165,479 109,800
Selling, general and administrative 15,125 9,836 44,209 29,785
R&D costs, net of tax credits and grants 6,194 6,147 20,475 18,692
Depreciation and amortization 2,517 1,837 7,376 5,666
----------------------------------------------------------------------------------------------------------------------------
79,500 51,893 237,539 163,943
----------------------------------------------------------------------------------------------------------------------------
EARNINGS FROM OPERATIONS 4,393 986 14,221 10,945
Interest income 539 339 1,414 1,071
Interest expense (1,971) (2,241) (7,198) (7,067)
Foreign exchange gain (loss) 109 (404) 26 (351)
----------------------------------------------------------------------------------------------------------------------------
EARNINGS (LOSS) BEFORE THE FOLLOWING ITEMS 3,070 (1,320) 8,463 4,598
Current income taxes (2,010) (251) (6,401) (4,503)
Future income taxes (4,244) (753) (2,425) (1,915)
Gain (loss) on dilution of investments (5) 109 (140) 16,502
Non-controlling interest (3,316) (1,544) (10,144) (5,047)
----------------------------------------------------------------------------------------------------------------------------
NET EARNINGS (LOSS) FOR THE PERIOD (6,505) (3,759) (10,647) 9,635
----------------------------------------------------------------------------------------------------------------------------
NET EARNINGS (LOSS) PER SHARE
Basic (0.12) (0.08) (0.21) 0.21
----------------------------------------------------------------------------------------------------------------------------
Diluted (0.12) (0.08) (0.21) 0.20
----------------------------------------------------------------------------------------------------------------------------
Weighted average number of shares
Basic 52,692,065 46,139,814 51,900,754 46,139,814
Diluted 53,040,488 46,397,156 52,390,209 46,459,000
Issued and outstanding shares 53,160,970 46,139,814
4
[AETERNA ZENTARIS LOGO]
BIOPHARMACEUTICAL SEGMENT - SELECTED FINANCIAL INFORMATION
(IN THOUSANDS OF US DOLLARS)
QUARTERS ENDED NINE MONTHS ENDED
UNAUDITED SEPTEMBER 30, SEPTEMBER 30,
2006 2005 2006 2005
-------------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------------
$ $ $ $
REVENUES
Sales and royalties 8,419 5,462 20,222 17,741
License fees 2,211 3,562 8,539 15,190
-------------------------------------------------------------------------------------------------------------------------
10,630 9,024 28,761 32,931
-------------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------------
COST OF SALES 3,992 1,941 8,037 6,110
SELLING AND ADMINISTRATIVE 4,540 3,840 12,900 11,125
R&D EXPENSE, NET OF TAX CREDITS AND GRANTS 6,181 6,067 20,247 18,498
DEPRECIATION AND AMORTIZATION 1,673 1,536 4,889 4,794
-------------------------------------------------------------------------------------------------------------------------
16,386 13,384 46,073 40,527
-------------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------------
LOSS FROM OPERATIONS (5,756) (4,360) (17,312) (7,596)
-------------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------------
CASH FLOWS USED BY OPERATING ACTIVITIES (1,711) (3,814) (8,753) (3,567)
-------------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------------
CONSOLIDATED BALANCE SHEET AS AT As at
SEPTEMBER 30, December 31,
UNAUDITED 2006 2005
--------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------
$ $
Cash and short-term investments 45,753 52,705
Other current assets 111,634 110,971
----------------------------------------------
157,387 163,676
Long-term assets 274,253 263,835
----------------------------------------------
Total assets 431,640 427,511
----------------------------------------------
----------------------------------------------
Current liabilities 63,450 64,174
Long-term debt 99,144 135,743
Other long-term liabilities 54,367 53,532
Non-controlling interest 77,938 64,531
----------------------------------------------
294,899 317,980
Shareholders' equity 136,741 109,531
----------------------------------------------
Total liabilities and shareholders' equity 431,640 427,511
----------------------------------------------
----------------------------------------------
5
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 14, 2005 By: /s/Mario Paradis
------------------------ -------------------------------------------
Mario Paradis
Vice President, Finance, Administration and
Corporate Secretary