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 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 August 11, 2006: AEterna Zentaris
Reports 2006 Second Quarter Results
AEterna Zentaris
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 SECOND QUARTER RESULTS
QUARTER MARKED BY SEVERAL SIGNIFICANT ADVANCEMENTS IN PIPELINE
ALL AMOUNTS ARE IN U.S. DOLLARS
QUEBEC CITY, CANADA, AUGUST 11, 2006 -- AEterna Zentaris Inc. (TSX: AEZ;
NASDAQ: AEZS) today reported financial and operating results for the second
quarter ended June 30, 2006.
"During the second quarter, we made great strides in advancing our products
through the pipeline at all stages as exemplified by Cetrotide(R)'s marketing
approval in Japan, our successful meeting with the FDA leading to the
upcoming filing of an IND to move forward into Phase 3 clinical development
of cetrorelix in benign prostatic hyperplasia (BPH), as well as the
disclosure of positive clinical results in cancer with perifosine and AN-152.
Most recently, we disclosed positive Phase 2 results for ozarelix in prostate
cancer which will enable us to pursue further clinical trials in this
indication. Additionally, we signed a license and collaboration agreement in
Japan with Nippon Kayaku for ozarelix in oncology," said Gilles Gagnon,
AEterna Zentaris' President and Chief Executive Officer. "We are very pleased
with these achievements which are an integral part of the Company's strategy
designed to build a strong and innovative pipeline focused on oncology and
endocrinology. We now look forward to continued success as we aggressively
advance our lead compounds."
KEY DEVELOPMENTS FOR THE QUARTER ENDED JUNE 30, 2006
o MARKET APPROVAL FOR CETROTIDE(R) (CETRORELIX) IN JAPAN FOR IN VITRO
FERTILIZATION -- Cetrotide(R) (cetrorelix) will be manufactured and
marketed in Japan by AEterna Zentaris' partners Nippon Kayaku Co.,
Ltd. and Shionogi & Co., Ltd. with an expected launch in Japan by
year-end;
o GREEN LIGHT FROM FDA TO FILE IND TO MOVE FORWARD INTO PHASE 3
PROGRAM WITH CETRORELIX IN BPH -- The FDA reviewed the safety and
efficacy data from an extensive Phase 2 program with cetrorelix for
the treatment of benign prostatic hyperplasia (BPH). AEterna
Zentaris plans to submit an Investigational New Drug (IND)
application to the FDA by year-end for the initiation of a Phase 3
program for cetrorelix in BPH;
AEterna Zentaris
o POSITIVE INTERIM PHASE 2 DATA OF PERIFOSINE IN ADVANCED RENAL CELL
CARCINOMA -- Interim results of a multi-center Phase 2 trial by the
Company's partner, Keryx Biopharmaceuticals, showed a 43% partial
response rate;
o POSITIVE DATA FROM ONGOING PHASE 1 TRIAL WITH AN-152 FOR
GYNAECOLOGICAL AND BREAST CANCERS PRESENTED AT ASCO -- Phase 1
results for AEterna Zentaris' cytotoxic conjugate AN-152 in patients
with gynaecological and breast cancers showed that the compound has
a good safety profile and no dose-limiting toxicities reached so
far in the selected dose levels;
o POSITIVE IN VIVO DATA ON ZEN-019 (ORAL LHRH ANTAGONIST
PEPTIDOMIMETIC) PRESENTED AT ENDO 2006 -- ZEN-019 demonstrated IN
VIVO activity by suppressing plasma testosterone levels. IN VIVO
data showed that using ZEN-019 with a single, oral administration
(20 mg/kg) in rats, led to efficient and revocable suppression of
plasma testosterone levels for up to 12 hours. Furthermore, a repeat
of the dosing of ZEN-019 increased the suppression time without
accumulation in the plasma.
FINANCIAL RESULTS FOR THE QUARTER ENDED JUNE 30, 2006
Consolidated revenues for the quarter ended June 30, 2006 totalled $83.4
million compared to $60.1 million for the same period in 2005.
Consolidated Research and Development expenses, net of tax credits and grants
increased to $7.4 million for the quarter ended June 30, 2006 compared to
$6.1 million for the same period in 2005.
Consolidated selling, general and administrative expenses totalled $15.5
million for the quarter ended June 30, 2006 compared to $10 million for the
same period in 2005.
Consolidated net loss for the quarter ended June 30, 2006 was $1.6 million or
$0.03 per basic and diluted share compared to consolidated net earnings of
$13.3 million or $0.28 per diluted share for the same period in 2005. Without
taking into account a non-cash and non-recurring gain on dilution of
investments of $16.4 million recorded last year following the Company's
subsidiary Atrium Biotechnologies' Initial Public Offering (IPO), AEterna
Zentaris would have recorded a consolidated net loss of $3.1 million or $0.07
per basic and diluted share in the second quarter of 2005, compared to the
$1.6 million or $0.03 per basic and diluted share consolidated net loss
registered for the second quarter 2006. This $1.5 million decrease is mainly
attributable to increased net earnings of $1.1 million from Atrium
Biotechnologies and to the reduction of the operating loss from AEterna
Zentaris' Biopharmaceutical segment.
Cash, cash equivalents and short-term investments reached $47 million for the
quarter ended June 30, 2006 compared to $52.7 million as of December 31,
2005. More than $27 million was dedicated to the Company's Biopharmaceutical
segment as of June 30, 2006.
Dennis Turpin, Vice President and Chief Financial Officer of AEterna
Zentaris, commented, "As we continue to successfully implement our strategy,
we are pleased to maintain a sound financial position, including the ability
to leverage our assets as we continue to execute our plan and
2
AEterna Zentaris
aggressively advance our pipeline. We are financially poised to continue our
investment in R&D, as well as support our growing business."
DEVELOPMENTS SUBSEQUENT TO QUARTER END
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. An important secondary efficacy end-point of the study aimed
at assessing tumour response as determined by a 50% or greater
reduction of serum PSA levels, compared to baseline, was also
achieved.
o LICENCE AND COLLABORATION AGREEMENT WITH NIPPON KAYAKU FOR OZARELIX
IN ONCOLOGY -- AEterna Zentaris granted Nippon Kayaku an exclusive
license to develop and market ozarelix for all potential oncological
indications in Japan.
CONFERENCE CALL INFORMATION
Management will be hosting a conference call for the investment community
beginning at 11:00 a.m. Eastern Time today, Friday, August 11, to discuss
2006 second quarter financial and operating results, followed by a question
and answer session.
To participate in the live conference call by telephone, please dial
800-257-3401. 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 oncology and endocrine therapy with proven expertise in drug discovery,
development and commercialization.
AEterna Zentaris also owns 48.26% of the equity of Atrium Biotechnologies
Inc. (TSX: ATB) and 64.69% of its voting rights. Atrium is 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.
3
AEterna Zentaris
-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
4
AEterna Zentaris
(IN THOUSANDS OF US DOLLARS, EXCEPT SHARE
AND PER SHARE DATA)
QUARTERS ENDED SIX MONTHS ENDED
CONSOLIDATED RESULTS JUNE 30, JUNE 30,
UNAUDITED 2006 2005 2006 2005
------------------------------------------------------------------------------
$ $ $ $
REVENUES 83,390 60,144 167,867 122,009
------------------------------------------------------------------------------
OPERATING EXPENSES
Cost of sales 52,619 38,564 109,815 75,727
Selling, general and
administrative 15,517 10,014 29,084 19,949
R&D costs, net of tax
credits and grants 7,380 6,099 14,281 12,545
Depreciation and amortization 2,478 2,011 4,859 3,829
------------------------------------------------------------------------------
77,994 56,689 158,039 112,050
------------------------------------------------------------------------------
EARNINGS FROM OPERATIONS 5,396 3,456 9,828 9,959
Interest income 455 426 875 732
Interest expense (2,004) (2,668) (5,227) (4,826)
Foreign exchange gain (loss) (295) (155) (83) 53
------------------------------------------------------------------------------
EARNINGS BEFORE THE
FOLLOWING ITEMS 3,552 1,059 5,393 5,918
Current income taxes (2,395) (2,131) (4,391) (4,252)
Future income taxes 630 (65) 1,819 (1,162)
Gain (loss) on dilution of
investments (81) 16,393 (135) 16,393
Non-controlling interest (3,268) (1,980) (6,828) (3,503)
------------------------------------------------------------------------------
NET EARNINGS (LOSS) FOR
THE PERIOD (1,562) 13,276 (4,142) 13,394
==============================================================================
NET EARNINGS (LOSS) PER SHARE
Basic (0.03) 0.29 (0.08) 0.29
------------------------------------------------------------------------------
Diluted (0.03) 0.28 (0.08) 0.28
------------------------------------------------------------------------------
Weighted average number
of shares
Basic 52,682,969 46,139,814 52,098,592 46,139,814
Diluted 53,261,928 46,448,125 52,651,808 46,506,728
Issued and outstanding
shares 53,160,970
5
AEterna Zentaris
BIOPHARMACEUTICAL SEGMENT -- SELECTED FINANCIAL INFORMATION
(IN THOUSANDS OF US DOLLARS)
QUARTERS ENDED SIX MONTHS ENDED
JUNE 30, JUNE 30,
UNAUDITED 2006 2005 2006 2005
------------------------------------------------------------------------------
$ $ $ $
REVENUES
Sales and royalties 5,228 5,381 11,803 12,279
License fees 4,155 4,779 6,328 11,628
------------------------------------------------------------------------------
9,383 10,160 18,131 23,907
==============================================================================
COST OF SALES 1,404 1,835 4,045 4,169
SELLING AND ADMINISTRATIVE 4,515 3,907 8,360 7,285
R&D EXPENSE, NET OF TAX
CREDITS AND GRANTS 7,262 6,081 14,066 12,431
DEPRECIATION AND AMORTIZATION 1,653 1,708 3,216 3,258
------------------------------------------------------------------------------
14,834 13,531 29,687 27,143
==============================================================================
LOSS FROM OPERATIONS (5,451) (3,371) (11,556) (3,236)
==============================================================================
CASH FLOWS GENERATED (USED)
BY OPERATING ACTIVITIES (3,518) 1,076 (7,042) 247
==============================================================================
CONSOLIDATED BALANCE SHEET AS AT As at
JUNE 30, December 31,
UNAUDITED 2006 2005
--------------------------------------------------------------------
$ $
Cash and short-term investments 47,041 52,705
Other current assets 111,178 110,971
--------------------------------
158,219 163,676
Long-term assets 277,404 263,835
--------------------------------
Total assets 435,623 427,511
================================
Current liabilities 62,378 64,174
Long-term debt 100,706 135,743
Other long-term liabilities 54,423 53,532
Non-controlling interest 74,760 64,531
--------------------------------
292,267 317,980
Shareholders' equity 143,356 109,531
--------------------------------
Total liabilities and
shareholders' equity 435,623 427,511
================================
6
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: August 14, 2006 By: /s/ Mario Paradis
---------------------- ------------------------------------------
Mario Paradis
Vice President, Finance, Administration
and Corporate Secretary