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 2007
ÆTERNA ZENTARIS INC.
1405, boul. du
Parc-Technologique
Québec, Québec
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
o
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
o
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 7, 2007: Æterna Zentaris Reports Third Quarter 2007
Financial and Operating Results
2
Æterna Zentaris Inc
.
1405 du Parc-Technologique Blvd.
Québec (Québec) Canada G1P 4P5
T 418 652-8525 F
418 652-0881
www.aeternazentaris.com
|
Press Release
|
|
For immediate release
|
Æterna Zentaris Reports Third
Quarter
2007
Financial and Operating Results
All amounts are in U.S.
dollars
Quebec City, Canada, November
7, 2007
Æterna
Zentaris Inc. (TSX: AEZ; NASDAQ: AEZS), a global biopharmaceutical company focused on endocrine therapy and
oncology, today reported financial and operating results for the third quarter
ended September 30, 2007.
Over
the past five months, the executive management team completed a thorough review
of our extensive pipeline and business operations with the goal of identifying
our critical success factors and placing the appropriate clarity and
prioritization surrounding our key value drivers, said David J. Mazzo,
Ph.D., Æterna Zentaris President and Chief Executive Officer. By preparing
this strategic roadmap, we have clearly established a solid foundation for the
basis of our strategy and have identified the strategic levers we believe will ensure
long-term, sustained growth. Our experienced team is highly focused on
execution and committed to realizing the true value of our Company.
KEY
DEVELOPMENTS FOR THE THIRD QUARTER ENDED SEPTEMBER 30, 2007
Change
at the Board Level
The Board of Directors nominated Jürgen Ernst
as Chairman of the Board of Directors and David J. Mazzo, Ph.D.,
the Companys President and Chief Executive Officer (CEO), to its Board of
Directors. Jürgen Ernst succeeds Eric Dupont, Ph.D., who founded the
Company in 1991 and retired from the Board.
Appointment
of Chief Medical Officer
The Company completed its executive management
team with the appointment of Paul Blake, M.D., as Senior Vice President and
Chief Medical Officer.
Managements
Strategic Review
Management completed a thorough review of
its extensive pipeline and business operations.
RESULTS FOR THE THREE-MONTH PERIOD ENDED SEPTEMBER 30, 2007
At September 30,
2007, the Company had consolidated cash and short-term investments of $47.6 million
compared to $61 million as of December 31, 2006.
Consolidated revenues for the three-month
period ended September 30, 2007 were $11.6 million, an increase of 9.4%
compared to $10.6 million for the same period in 2006. The increase in
consolidated revenues is mainly attributed to higher license fees revenues,
partly reduced by lower sales of Cetrotide
®
. The increase in license
fees revenues is related to a milestone payment of $1.4 million received
from our partner, Ardana Biosciences, Ltd., for the initiation of a
Phase 3 study for the diagnosis of growth hormone disorders with our
Growth Hormone Secretagogue, AEZS-130. The sales of Cetrotide
®
were
lower for the three-month period ended September 30, 2007 compared to the same
period in 2006, due to a significant first order of the product related to the
launch in Japan in September 2006.
Consolidated R&D costs, net of tax credits
and grants (R&D), were $10.1 million for the three-month period ended September
30, 2007 compared to $6.2 million for the same period in 2006. The
increase in consolidated R&D expense is related to the additional expenses
incurred for the ongoing Phase 3 program with cetrorelix in BPH, as well
as further advancement of targeted, earlier clinical-stage development programs
including AEZS-108.
Consolidated selling, general and administrative
(SG&A) expenses were $6.1 million for the three-month period ended September
30, 2007 compared to $4.5 million for the same period in 2006. The
increase in consolidated SG&A is related to the restructuring of the
management team and the Board as well as the opening of a new office in Warren,
New Jersey.
Consolidated loss from operations increased to
$9.6 million for the three-month period ended September 30, 2007 compared
to $5.8 million for the same period in 2006. The increase in consolidated loss
from operations is attributable to increased R&D and SG&A expenses,
partly offset by increased revenues.
Consolidated net loss from continuing operations
for the three-month period ended September 30, 2007 was $8.7 million
compared to $4.7 million for the same period in 2006. This increase in
consolidated net loss from continuing operations is attributable to a
combination of higher R&D, SG&A expenses and other expenses recorded
during the three-month period ended September 30, 2007.
Consolidated net earnings from discontinued
operations for the three-month period ended September 30, 2006 were $3.1 million
and were completely attributable to the Companys former subsidiary Atrium Innovations
which operations were excluded from consolidation effective on October 18,
2006.
Consolidated net loss for the three-month
period ended September 30, 2007 was $8.7 million or $0.16 per basic and
diluted share, compared to $1.6 million or $0.03 per basic and diluted
share for the same period in 2006. The consolidated net loss increase for the three-month
period ended September 30, 2007 is attributable to an increased net loss
from continuing operations combined with the completion of the distribution of
Atrium to Æterna Zentaris shareholders on January 2, 2007.
2
RESULTS FOR THE NINE-MONTH PERIOD ENDED SEPTEMBER 30, 2007
Consolidated revenues for the nine-month period
ended September 30, 2007 were $33.8 million compared to $28.8 million
for the same period in 2006. The increase in consolidated revenues is mainly
attributed to increased sales of Cetrotide
®
, due to the launch in
Japan in September 2006, growth of Impavido
®
, as well as additional
license fees revenues.
Consolidated R&D costs, net of tax credits
and grants, for the nine-month period ended September 30, 2007 were
$26.3 million, compared to $20.2 million for the same period in 2006.
The increase in consolidated R&D expense is related to the additional
expenses incurred for the initiation in 2007 of our ongoing Phase 3
program with cetrorelix in BPH, as well as further advancement of targeted,
earlier clinical-stage development programs including AEZS-108.
Consolidated SG&A expenses for the
nine-month period ended September 30, 2007, were $15.8 million compared to
$12.9 million for the same period in 2006. The increase in consolidated SG&A
expenses is due to additional expenses related to the restructuring of the
management team and the Board, as well as the opening of a new office in Warren,
New Jersey.
Consolidated loss from operations for the
nine-month period ended September 30, 2007 was $23 million compared
to $17.3 million for the same period in 2006. The increase in consolidated loss
from operations is attributable to increased R&D and SG&A expenses,
partly offset by increased revenues.
Consolidated net loss from continuing
operations for the nine-month period ended September 30, 2007 was $18.7
million compared to $15 million for the same period in 2006. This is
attributable to higher R&D and SG&A expenses, partly offset by
increased revenues from Cetrotide
®
and Impavido
®
, lower
other expenses and higher income tax recovery.
Consolidated net earnings from discontinued
operations for the nine-month period ended September 30, 2006 were
$9.3 million and were completely attributable to the Companys former
subsidiary, Atrium Innovations, which operations were excluded from
consolidation effective on October 18, 2006.
Consolidated net loss for the nine-month period
ended September 30, 2007, was $18.7 million or $0.35 per basic and
diluted share, compared to $5.7 million or $0.11 per basic and diluted
share for the same period in 2006. This increase in consolidated net loss is
attributable to an increased net loss from continuing operations combined with
the completion of the distribution of Atrium to Æterna Zentaris shareholders on
January 2, 2007.
CONFERENCE CALL
Management will be
hosting a conference call for the investment community beginning at 10:00 a.m.
Eastern Time today, Wednesday, November 7, 2007, to discuss results for the three-month
period ended September 30, 2007.
To participate in the live conference call by
telephone, please dial 416-644-3425, 514-807-8791 or 800-595-8550. 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 Companys
Web site for 30 days.
3
About Æterna Zentaris Inc.
Æterna Zentaris Inc. is 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 Companys 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
Companys 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. We disclaim any obligation to update any such
factors or to publicly announce the result of any revisions to any of the
forward-looking statements contained herein to reflect future results, events
or developments except if we are requested by a governmental authority or
applicable law.
-30-
Contacts
Jenene Thomas
Senior
Director, Investor Relations & Corporate Communications
(908)
938-1475
jenene.thomas@aeternazentaris.com
Paul Burroughs
Media Relations
Off.: (418) 652-8525 ext. 406
Cell.: (418) 575-8982
paul.burroughs@aeternazentaris.com
Attachment:
Financial summary
4
(In thousands of US dollars, except share
and per share data)
|
|
Three months ended
September 30,
|
|
Nine months ended
September 30,
|
|
CONSOLIDATED RESULTS
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|
Unaudited
|
|
$
|
|
$
|
|
$
|
|
$
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and
royalties
|
|
7,919
|
|
8,419
|
|
24,333
|
|
20,222
|
|
License fees
|
|
3,674
|
|
2,211
|
|
9,438
|
|
8,539
|
|
|
|
11,593
|
|
10,630
|
|
33,771
|
|
28,761
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
3,433
|
|
3,992
|
|
10,092
|
|
8,038
|
|
Research and
development (R&D) costs, net of tax credits and grants
|
|
10,096
|
|
6,181
|
|
26,295
|
|
20,247
|
|
Selling,
general and administrative (SG&A)
|
|
6,055
|
|
4,540
|
|
15,823
|
|
12,900
|
|
Depreciation
and amortization (D&A)
|
|
1,596
|
|
1,673
|
|
4,551
|
|
4,889
|
|
|
|
21,180
|
|
16,386
|
|
56,761
|
|
46,074
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(9,587
|
)
|
(5,756
|
)
|
(22,990
|
)
|
(17,313
|
)
|
|
|
|
|
|
|
|
|
|
|
Other
revenues (expenses)
|
|
(187
|
)
|
184
|
|
(16
|
)
|
(653
|
)
|
Income
tax recovery
|
|
1,070
|
|
903
|
|
4,346
|
|
2,966
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
from continuing operations
|
|
(8,704
|
)
|
(4,669
|
)
|
(18,660
|
)
|
(15,000
|
)
|
Net
earnings from discontinued operations
|
|
|
|
3,100
|
|
|
|
9,289
|
|
Net loss
for the period
|
|
(8,704
|
)
|
(1,569
|
)
|
(18,660
|
)
|
(5,711
|
)
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share from continuing operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
(0.16
|
)
|
(0.09
|
)
|
(0.35
|
)
|
(0.29
|
)
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
(0.16
|
)
|
(0.03
|
)
|
(0.35
|
)
|
(0.11
|
)
|
Weighted
average number of shares Basic and diluted
|
|
53,184,803
|
|
52,692,065
|
|
53,181,248
|
|
51,900,754
|
|
(In thousands of US dollars)
|
|
September 30,
|
|
December 31,
|
|
CONSOLIDATED BALANCE SHEETS
|
|
2007
|
|
2006
|
|
Unaudited
|
|
$
|
|
$
|
|
Cash and short-term investments
|
|
47,646
|
|
61,019
|
|
Other current assets
|
|
19,366
|
|
40,704
|
|
|
|
67,012
|
|
101,723
|
|
Long-term assets
|
|
66,611
|
|
121,768
|
|
Total assets
|
|
133,623
|
|
223,491
|
|
|
|
|
|
|
|
Current liabilities
|
|
18,640
|
|
16,310
|
|
Deferred revenues
|
|
4,476
|
|
8,468
|
|
Long-term debt
|
|
|
|
704
|
|
Other long-term liabilities
|
|
9,825
|
|
19,130
|
|
|
|
32,941
|
|
44,612
|
|
Shareholders equity
|
|
100,682
|
|
178,879
|
|
Total liabilities and shareholders equity
|
|
133,623
|
|
223,491
|
|
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.
|
ÆTERNA ZENTARIS INC.
|
|
|
|
|
|
|
|
Date: November 7, 2007
|
|
By:
|
/s/Mario Paradis
|
|
|
Mario Paradis
|
|
|
Senior Vice President, Administrative and
|
|
|
Legal Affairs and Corporate Secretary
|
|
|
|
|
|
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