- Report of Foreign Issuer (6-K)
November 13 2008 - 3:49PM
Edgar (US Regulatory)
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 2008
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
x
Form 40-F
o
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 13, 2008:
Æterna Zentaris Reports Third Quarter
2008
Financial and Operating Results
|
Æterna Zentaris Inc
.
1405 du Parc-Technologique Blvd.
Québec (Québec)
Canada G1P 4P5 T 418 652-8525 F 418 652-0881
www.aezsinc.com
Press Release
For immediate
release
Æterna Zentaris Reports
Third Quarter
2008
Financial and Operating Results
All amounts are in U.S.
dollars
Quebec City, Canada, November 13,
2008
Æterna
Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), a global biopharmaceutical company
focused on endocrinology and oncology, today reported financial and operating
results for the third quarter ended September 30, 2008.
Third Quarter 2008
Highlights
·
Appointment on September 1, 2008, of Juergen
Engel, Ph.D. as President and CEO of Æterna Zentaris, replacing Juergen Ernst
who had been acting as Interim President and CEO since April 2008. Mr. Ernst,
the former Chairman of the Company, was appointed Executive Chairman effective September 1,
2008;
·
Completion of patient recruitment for the second
efficacy trial of the Phase 3 program in benign prostatic hyperplasia (BPH)
with lead compound, cetrorelix;
·
Start of second stage of recruitment for the Phase 2
trial in ovarian cancer with AEZS-108. The trial is part of a Phase 2 program
in gynaecological cancers which will include up to 82 women;
·
Signing of a license and cooperation agreement for the
commercialization of cetrorelix in BPH, with Handok Pharmaceuticals Co., Ltd.
(Handok) for the Korean market. Subsequent to quarter end, signing of another
agreement with Handok for the commercialization of ozarelix in BPH for the
Korean market; and
·
Recovery of worldwide rights from Ardana plc (LSE:
ARA) for the Growth Hormone Secretagogue (GHS) compound, AEZS-130. Future
development options are currently being evaluated for the use of this compound
in growth hormone deficiencies.
Subsequent to Quarter-End
On November 11,
2008, Æterna Zentaris signed a
definitive agreement to sell to Cowen Healthcare Royalty Partners, L.P. (CHRP)
its rights to royalties on future sales of Cetrotide
®
covered by its license agreement with Merck
Serono. The license agreement between
Æ
terna Zentaris and Merck Serono was signed in
2000 and granted Merck Serono
exclusive
rights
to market, distribute and sell
Cetrotide worldwide, with the exception of Japan, in the field of
in vitro
fertilization.
On closing, Æterna Zentaris will receive
$52.5 million from CHRP. In addition, contingent on 2010 net sales of
Cetrotide
®
reaching a specified level, Æterna Zentaris would receive an additional
payment of $2.5 million from CHRP.
Under the terms of
the agreement, if cetrorelix which is currently in Phase 3 clinical trials for
the treatment of benign prostatic hyperplasia, is approved for sale by the
European regulatory authorities in an indication other than
in vitro
fertilization, Æterna Zentaris has agreed to make a
one-time cash payment to CHRP for an amount ranging from $5 million up to a
maximum of $15 million. The amount which would be due to CHRP will be
higher the earlier the product receives European regulatory approval.
We
are very pleased with the
Cowen Healthcare Royalty Partners transaction for Cetrotide
®
which
is in line with our strategy of generating non-dilutive financing. With this
transaction, we strengthened our financial position to focus on the development
of cetrorelix in BPH, while pursuing partnership opportunities for its future
commercialization, said Juergen Engel, Ph.D., President and Chief
Executive Officer of Æterna Zentaris. At the drug development level, both our
Phase 3 program in BPH with cetrorelix, and our Phase 2 program with our lead
oncology compound, AEZS-108 in ovarian and endometrial cancer, met their
recruitment goals as scheduled and remain on track. First results for
cetrorelix in BPH are still expected in the third quarter of 2009, while those
for AEZS-108 should be disclosed in the next few months.
CONSOLIDATED RESULTS FOR THE THIRD QUARTER ENDED SEPTEMBER
30, 2008
Consolidated sales and royalties
increased
to $8.6 million for the three-month period ended September 30, 2008,
compared to $7.4 million for the same period in 2007. The increase in sales and
royalties for the three-month period ended September 30, 2008 compared to
the same period last year is related primarily to additional sales of Cetrotide
®
, partly
offset by the exclusion of sales from Impavido
®
in the third quarter of 2008.
License fees revenues
decreased
to $2.4 million for the three-month period ended September 30, 2008
compared to $3.7 million for the same period in 2007. The decrease for the
three-month period ended September 30, 2008, compared to the same period
in 2007, is mainly attributable to a milestone payment received in 2007 from
Ardana plc.
Consolidated R&D costs, net of tax credits and
grants
were $13.9 million for the three-month period ended September 30,
2008 compared to $9.8 million for the same period in 2007. Additional R&D
expenses for the three-month period ended September 30, 2008, compared to
the same period in 2007 are mainly related to the advancement of the Phase 3
program in BPH with the compound, cetrorelix.
Consolidated selling, general and administrative
(SG&A) expenses
were $3.3 million for the three-month
period ended September 30, 2008 compared to $5.8 million for the same
period in 2007. The decrease in SG&A expenses for the three-month period
ended September 30, 2008 compared to the same period in 2007 is primarily
related to organizational changes and cost saving measures that were
implemented in the second quarter of 2008.
Consolidated net loss
for the
three-month period ended September 30, 2008 was $13.9 million or
$0.26 per basic and diluted share compared to $8.7 million or $0.16 per basic
and diluted share for the same period in 2007. The increase in net loss for the
three-month period ended September 30, 2008 compared to the same period
last year, is mainly related to the advancement of the cetrorelix Phase 3
program for BPH, lower manufacturing margins and foreign exchange loss.
2
The cash and short-term investments were $11
million as at September 30, 2008.
CONFERENCE
CALL
Management will be
hosting a conference call for the investment community beginning at 10:00 a.m.
Eastern Time, today, November 13, 2008, to discuss third quarter 2008
financial results. To participate in the live conference call by telephone,
please dial
416-646-3095, 514-807-8791 or 800-814-4859
. Individuals interested in listening to the
conference call on the Internet may do so by visiting
www.aezsinc.com
.
A replay will be available on the Companys Web site
for 30 days.
About
Æterna Zentaris Inc.
Æterna Zentaris Inc. is a 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.aezsinc.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.
Contacts
Investor
Relations
|
Media
Relations
|
Ginette
Vallières
|
Paul
Burroughs
|
Investor
Relations Coordinator
|
Director
of Communications
|
(418) 652-8525 ext. 265
|
Office: (418) 652-8525 ext.406
|
gvallieres@aezsinc.com
|
Cell:
(418) 575-8982
|
|
pburroughs@aezsinc.com
|
-30-
Attachment:
Financial summary
3
(In thousands of US dollars, except share and per
share data)
|
|
Three months ended Sept. 30,
|
|
Nine months ended Sept. 30,
|
|
(Unaudited)
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
|
|
$
|
|
$
|
|
$
|
|
$
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
Sales and
royalties
|
|
8,630
|
|
7,372
|
|
24,822
|
|
22,392
|
|
License fees
|
|
2,399
|
|
3,671
|
|
6,412
|
|
9,436
|
|
|
|
11,029
|
|
11,043
|
|
31,234
|
|
31,828
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
4,986
|
|
3,290
|
|
14,348
|
|
9,675
|
|
Research and
development costs, net of tax credits and grants*
|
|
13,880
|
|
9,835
|
|
44,914
|
|
25,557
|
|
Selling, general
and administrative*
|
|
3,277
|
|
5,847
|
|
14,287
|
|
15,257
|
|
Depreciation and
amortization:
|
|
|
|
|
|
|
|
|
|
Property, plant
and equipment
|
|
433
|
|
426
|
|
1,199
|
|
1,183
|
|
Intangible
assets
|
|
839
|
|
1,024
|
|
2,555
|
|
3,014
|
|
|
|
23,415
|
|
20,422
|
|
77,303
|
|
54,686
|
|
Loss
from operations
|
|
(12,386
|
)
|
(9,379
|
)
|
(46,069
|
)
|
(22,858
|
)
|
Other
income (expenses)
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
149
|
|
494
|
|
737
|
|
1,369
|
|
Interest expense
|
|
|
|
(15
|
)
|
(68
|
)
|
(68
|
)
|
Foreign exchange
(loss) gain
|
|
(1,324
|
)
|
(170
|
)
|
429
|
|
(766
|
)
|
Loss on disposal
of long-lived assets held for sale
|
|
(90
|
)
|
|
|
(125
|
)
|
|
|
|
|
(1,265
|
)
|
309
|
|
973
|
|
535
|
|
Loss
before income taxes
|
|
(13,651
|
)
|
(9,070
|
)
|
(45,096
|
)
|
(22,323
|
)
|
Income
tax (expense) recovery
|
|
(228
|
)
|
1,012
|
|
(228
|
)
|
4,287
|
|
Net
loss from continuing operations
|
|
(13,879
|
)
|
(8,058
|
)
|
(45,324
|
)
|
(18,036
|
)
|
Net
loss from discontinued operations
|
|
|
|
(646
|
)
|
|
|
(624
|
)
|
Net
loss for the period
|
|
(13,879
|
)
|
(8,704
|
)
|
(45,324
|
)
|
(18,660
|
)
|
Net
loss per share from continuing operations
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
(0.26
|
)
|
(0.15
|
)
|
(0.85
|
)
|
(0.34
|
)
|
Net
loss per share
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
(0.26
|
)
|
(0.16
|
)
|
(0.85
|
)
|
(0.35
|
)
|
Weighted
average number of shares
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
53,187,470
|
|
53,184,803
|
|
53,187,470
|
|
53,181,248
|
|
* Stock-based
compensation costs included in:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
50
|
|
64
|
|
166
|
|
180
|
|
Selling, general
and administrative
|
|
52
|
|
447
|
|
78
|
|
1,312
|
|
|
|
102
|
|
511
|
|
244
|
|
1,492
|
|
Consolidated
Statement of Comprehensive Income
|
|
Three months ended Sept. 30,
|
|
Nine months ended Sept. 30,
|
|
(Unaudited)
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
|
|
$
|
|
$
|
|
$
|
|
$
|
|
Net
loss for the period
|
|
(13,879
|
)
|
(8,704
|
)
|
(45,324
|
)
|
(18,660
|
)
|
Other
comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
Foreign currency
translation
|
|
(3,169
|
)
|
6,315
|
|
(2,650
|
)
|
13,204
|
|
Variation in the
fair value of short-term investments
|
|
(15
|
)
|
81
|
|
(3
|
)
|
(87
|
)
|
Comprehensive
loss
|
|
(17,063
|
)
|
(2,308
|
)
|
(47,977
|
)
|
(5,543
|
)
|
4
(In thousands of US dollars)
CONSOLIDATED
BALANCE SHEETS
|
|
September 30,
|
|
December 31,
|
|
Unaudited
|
|
2008
|
|
2007
|
|
|
|
$
|
|
$
|
|
Cash and short-term
investments
|
|
10,957
|
|
41,387
|
|
Other current assets
|
|
15,374
|
|
18,193
|
|
|
|
26,331
|
|
59,580
|
|
Long-term assets
|
|
46,227
|
|
63,783
|
|
Total assets
|
|
72,558
|
|
123,363
|
|
|
|
|
|
|
|
Current liabilities
|
|
17,611
|
|
22,255
|
|
Deferred revenues
|
|
4,508
|
|
3,333
|
|
Long-term payable
|
|
197
|
|
|
|
Employee future benefits
|
|
9,384
|
|
9,184
|
|
|
|
31,700
|
|
34,772
|
|
Shareholders equity
|
|
40,858
|
|
88,591
|
|
Total liabilities and
shareholders equity
|
|
72,558
|
|
123,363
|
|
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.
|
ÆTERNA ZENTARIS
INC.
|
|
|
|
|
|
|
Date: Nov. 13, 2008
|
|
By:
|
/s/ Dennis
Turpin
|
|
|
Dennis Turpin
|
|
|
Senior Vice
President and Chief Financial Officer
|
|
|
|
|
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