UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C.
20549
FORM 6-K
REPORT OF
FOREIGN PRIVATE ISSUER
Pursuant
to Rule 13a-16 or 15d-16 under
the
Securities Exchange Act of 1934
For the month of March 2010
Commission file number 0-30752
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 if
the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(1):
o
Indicate by check mark if the registrant is submitting the Form 6-K
in paper as permitted by Regulation S-T Rule 101(b)(7):
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.
|
Æterna Zentaris
Reports Fourth Quarter and Full-Year 2009
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.aezsinc.com
|
Press Release
|
|
For immediate release
|
Æterna Zentaris Reports
Fourth Quarter and Full-Year
2009
Financial and Operating Results
All amounts are in U.S.
dollars
Quebec City, Canada, March 24,
2010
-
Æterna
Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the Company), a late-stage
drug development company specialized in oncology and endocrine therapy, today
reported financial and operating results as at and for the fourth quarter and
the full year ended December 31, 2009.
2009 Highlights
Perifosine
·
Updated positive Phase 2 efficacy and safety data as
well as new survival data for perifosine in combination therapy for relapsed/refractory
multiple myeloma, were presented at the American Society of Hematologys (ASH)
annual meeting. Results showed that the overall response rate was 41% and
median overall survival was reported at 25 months for all evaluable patients. The
combination therapy maintained an acceptable safety profile and no unexpected
adverse events were reported.
·
Positive Phase 2 data on perifosine in advanced
metastatic colon cancer and in advanced renal cell carcinoma were presented at
the American Society of Clinical Oncologys (ASCO) annual meeting. The data demonstrated
perifosines anti-cancer activity and efficacy both as a single agent and in
combination therapy. Data at ASCO and ASH meetings were generated by the
Companys North
American partner, Keryx
Biopharmaceuticals (Keryx).
·
A Phase 3 registration trial with perifosine in
relapsed/refractory multiple myeloma was initiated under a Special Protocol
Assessment (SPA). Perifosine was also granted Orphan Drug and Fast Track
designations by the Food and Drug Administration (FDA) in this same
indication. The trial is being conducted by Keryx.
3
AEZS-108
·
Positive Phase 2 preliminary results with AEZS-108 in
platinum-resistant and taxane-pretreated ovarian cancer were disclosed, which
showed that the study met its primary efficacy endpoint of 5 or more responders
in 41 evaluable patients.
·
Positive Phase 2 preliminary results with AEZS-108 in advanced
or recurrent endometrial cancer were disclosed. The study met its pre-defined
primary efficacy endpoint of 5 or more responder patients. The trial in
endometrial and ovarian cancer was conducted in collaboration with the German
oncology study cooperative group,
Arbeitsgemeinschaft
Gynackologisehe Onkologie
(AGO). Data for both indications were
presented at the American Association for Cancer Researchs (AACR) annual
meeting.
AEZS-112
·
Phase 1 results with AEZS-112 in advanced solid tumors
or lymphoma were disclosed, showing prolonged courses of stable disease,
excellent tolerability and potential for long-term use as a combination
treatment for cancer.
AEZS-130
·
A Poster was presented at the Endocrine Societys (ENDO)
annual meeting, on AEZS-130 (Solorel
TM
), reporting the first clinical data relating to its
use as a simple oral diagnostic test for adult Growth Hormone Deficiency (GHD).
Cetrorelix
·
A licensing agreement with sanofi-aventis U.S. (sanofi-aventis)
for the development, registration and marketing of cetrorelix in benign
prostatic hyperplasia (BPH) for the U.S. market was signed. The agreement
provided Æterna Zentaris with a $30 million gross upfront payment.
·
Results of two Phase 3 efficacy studies with
cetrorelix in BPH which did not achieve their primary endpoint were disclosed.
·
The Companys licensing agreement with sanofi-aventis
for cetrorelix in BPH, subsequent to the aforementioned Phase 3 results,
was terminated.
Corporate Developments
·
The Company completed two registered direct offerings of
common shares and warrants to certain U.S. institutional investors, for combined
gross proceeds of $15.5 million.
4
Subsequent to Year-End
·
A statistically significant benefit in survival from
updated results of a Phase 2 study of perifosine in advanced metastatic colon
cancer was reported by Keryx.
·
A publication in the February 2010 issue of the
Journal of Clinical Cancer Research
reported positive Phase
2 results for perifosine as a single agent for the treatment of advanced
Waldenstroms macroglobulinemia.
·
The FDA granted a SPA for the Phase 3 trial of
perifosine in combination therapy for refractory metastatic colorectal cancer.
The trial is to be conducted by Keryx.
·
The Committee for Orphan Medicinal Products of the
European Medicines Agency issued a positive opinion to Æterna Zentaris for
orphan medicinal product designation for perifosine in multiple myeloma.
Juergen Engel, Ph.D., Æterna Zentaris President
and Chief Executive Officer, commented,
2009 was obviously a year of mixed results for us, starting off well
with the licensing agreement with sanofi-aventis for cetrorelix in BPH, and
ending with the disappointing results for our Phase 3 efficacy studies with
this compound. Nevertheless, we achieved great successes with other innovative
compounds from our pipeline, namely the initiation of the registration Phase 3
study with perifosine in multiple myeloma by our partner Keryx following
encouraging Phase 2 results, and the positive preliminary Phase 2 results for
AEZS-108 in ovarian and endometrial cancer. Additionally, we re-acquired all
rights to AEZS-130, currently in Phase 3 as a promising oral diagnostic test
for adult GHD. Over the course of this year, we look forward to further
progress in North America with Keryxs Phase 3 trial with perifosine in
multiple myeloma, as well as their initiation of a Phase 3 trial with this same
compound in colon cancer. We hope to benefit from this development in order to
ultimately achieve registration in other territories. As for AEZS-108, we anticipate
reporting final results for our Phase 2 trial in endometrial and ovarian cancer.
We also expect to perform additional studies with this compound in either one
of these indications, as well as in prostate and bladder cancer, based on
available financial resources and sponsorships. As for AEZS-130, we aim to
successfully complete the Phase 3 trial as a diagnostic test for adult GHD and
file a New Drug Application to the FDA. Overall in 2010, our focus will be on
continuing the development of our innovative late-stage compounds and on
garnering interest from potential partners for the benefit of both patients and
shareholders.
Dennis Turpin, the Companys
Senior Vice President and Chief Financial Officer, added, As at December 31,
2009, we had a cash position of $38.1 million with no debt. In 2010, with our
partner Keryx assuming significant R&D costs related to the Phase 3 program
with perifosine, and our earlier-stage projects associated with grants, R&D
credits or collaboration agreements, we can expect a substantial reduction of
our R&D expenses. With these measures, we feel we are in a relatively comfortable
position to execute our business plan throughout the year.
CONSOLIDATED RESULTS AS AT AND FOR THE FOURTH QUARTER ENDED
DECEMBER 31, 2009
Revenues
were $40.2 million for the quarter ended December 31,
2009, compared to $7.2 million for the same quarter in 2008. The
significant increase in revenues is due primarily to the Companys having
recognized the remaining unamortized portion, or approximately
$30.4 million, of the upfront payment received from sanofi-aventis as part
of its development and marketing agreement for cetrorelix in BPH.
5
Net research and development
(R&D) expenses
were
$10.6 million for the quarter ended December 31, 2009, compared to
$12.2 million for the same quarter in 2008. The decrease in R&D
expenses primarily relates to lower costs having been incurred in connection
with the Companys Phase 3 program for cetrorelix in BPH, given the
progressive completion through the end of 2009 of efficacy and safety studies
associated with that compound.
Selling, general and
administrative (SG&A) expenses
were $6.2 million for the quarter ended December 31, 2009,
compared to $3.0 million for the same quarter in 2008. The increase in
SG&A expenses is predominantly related to the expensing of the remaining
unamortized portion, or approximately $3.0 million, of the royalty paid to
Tulane University in connection with the agreement entered into with, and
subsequently terminated by, sanofi-aventis.
Net earnings
were $12.0 million, or $0.19 per basic and
diluted share, for the quarter ended December 31, 2009, compared to a net
loss of $14.5 million, or $0.27 per basic and diluted share, for the same
quarter in 2008. The significant increase in net earnings is largely
attributable to the significant increase in license fee revenues, combined with
lower comparative R&D expenses, as discussed above, partly offset by
increased SG&A expenses and depreciation and amortization charges.
Cash and cash equivalents
were $38.1 million as at December 31, 2009.
CONSOLIDATED
RESULTS AS AT AND FOR THE FULL YEAR ENDED DECEMBER 31, 2009
Revenues
were $63.2 million for the year ended December 31,
2009, compared to $38.5 million for the year ended December 31, 2008. The
increase in revenues in 2009 is almost exclusively attributable to license fee
revenues related to the upfront payment received from sanofi-aventis, partly
offset by lower royalty revenues having been recognized in 2009 in connection
with our agreement with Merck Serono for Cetrotide
®
.
R&D costs
were $44.2 million for the year ended December 31,
2009, compared to $57.4 million for the year ended December 31, 2008.
The decrease in R&D costs is largely attributable to a lower volume of
expenses having been incurred in 2009 related to the continued advancement
during the first nine months of 2009, followed by the winding down of the
Companys development activities linked to cetrorelix in BPH subsequent to its
announcements that its related Phase 3 studies did not reach their primary
endpoints.
SG&A expenses
decreased to $16.0 million for the year ended December 31,
2009, compared to $17.3 million for the year ended December 31, 2008.
The decrease is related to comparative euro-to-US dollar exchange rate
fluctuations and to the absence in 2009 of certain non-recurring corporate
expenses due to cost-saving measures that were implemented beginning in the
second quarter of 2008, despite the additional selling expenses charged during
2009 as pertaining to the royalty paid to Tulane University.
Net loss
was $24.7 million, or $0.43 per share for the year ended December 31,
2009, compared to $59.8 million, or $1.12 per basic and diluted share, for
the year ended December 31, 2008. The significant decrease in net loss is
due to the significant year-over-year increase in license fee revenues,
associated mainly with agreements for cetrorelix and ozarelix, combined with lower
comparative R&D, SG&A and income tax expenses, partly offset by lower
comparative sales and royalties and increased depreciation and amortization
expenses and foreign exchange losses.
6
Adoption of New Shareholder Rights Plan
The Companys
Board
of Directors (the Board) adopted a new shareholder rights plan to be dated March 29,
2010 (the Rights Plan). The Rights Plan will ensure that the Company and its
shareholders continue to receive the benefits associated with the Companys
current shareholder rights plan, which expires on March 29, 2010. The
Rights Plan has been adopted at this time to prevent any gap in shareholder protection
and will be effective at the close of business on March 29, 2010.
The Rights Plan is designed to encourage the fair
treatment of the Companys shareholders, should an unsolicited take-over bid be
made for the Company, by providing the Board and shareholders sufficient time
to explore and, if appropriate, develop alternatives for maximizing shareholder
value, providing adequate time for competing bids to emerge, by ensuring that shareholders
have an equal opportunity to participate in such a bid
and receive full and fair value for their shares
and by giving the Board and shareholders adequate time to properly
assess the bid and to lessen the pressure to tender that is typically
encountered by a shareholder of a corporation that is subject to a bid.
The Rights Plan was not adopted by the Board in
response to any offer or specific takeover bid for the Company, and the Company
is not aware of any such offer or takeover bid that has been made or is
contemplated. The Rights Plan has received conditional acceptance from the
Toronto Stock Exchange. The Rights Plan must be ratified by shareholders of the
Company within six months of the Rights Plan adoption, and shareholders will
be asked to ratify and approve the Rights Plan at the annual and special
meeting of shareholders of the Company to be held on May 13, 2010 (the Meeting).
If ratified by the shareholders, the Rights Plan will remain in effect until
the close of business on the date of termination of the Companys annual
meeting of shareholders in 2016, subject to reconfirmation by the shareholders
at the Companys 2013 annual meeting and subject to earlier termination or
expiration of the Rights Plan in accordance with its terms. The Rights Plan
must be ratified by a majority of the votes cast at the Meeting by independent
shareholders. If the Rights Plan is not ratified at the Meeting, all rights
issued pursuant to the Rights Plan and the Rights Plan itself will terminate
and be null and void and of no further force and effect.
Upon
the occurrence of certain triggering events, including the acquisition by a
person or group of persons of 20% or more of the Companys outstanding voting
shares in a transaction that does not meet the Permitted Bid requirements of
the Rights Plan (or other than pursuant to an exemption available under the
Rights Plan), the rights issued under the Rights Plan will, upon exercise,
entitle holders (other than the acquiring person or group of persons) to
acquire additional common shares of the Company at a significant discount to
the prevailing market price at that time.
The
Rights Plan is not intended to prevent take-over bids. A Permitted Bid must be
made
to all holders of the Companys
voting shares
on identical terms and
conditions by way of a take-over bid circular prepared in compliance with
applicable securities laws and, in addition to certain other conditions, must
remain open for not less than 60 days. Certain holdings of shares, such as
positions held by investment managers, trust companies for managed accounts and
pension plans, will not trigger the Rights Plan unless the holders are participating
in making a take-over bid for the Company.
The issuance of the rights is not dilutive until the
rights separate from the underlying common shares, and become exercisable, or
until the exercise of the rights. The issuance of the rights will not change
the manner in which shareholders currently trade their shares of the Company.
7
The
Rights Plan is similar to other shareholder rights plans recently adopted by
other Canadian companies.
The foregoing
description of the Rights Plan is qualified in its entirety by the full text of
such plan, which
will be filed on SEDAR
at
www.sedar.com and on EDGAR at www.sec.gov.
CONFERENCE
CALL
Management will be hosting a conference call
for the investment community beginning at 10:00 a.m. Eastern Time today, Wednesday,
March 24, 2010, to discuss the 2009 fourth quarter and full-year results. Individuals
interested in participating in the live conference call by telephone may dial
888-231-8191 (North America), or 647-427-7450 or 514-807-9895 (Canada)
. They may also listen through the Internet at
www.aezsinc.com. A replay will be available on the Companys website for 30
days following the live event.
About
Æterna Zentaris Inc.
Æterna Zentaris Inc.
is a late-stage drug development company specialized in oncology and endocrine
therapy. 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 required by a governmental authority or applicable law.
Investor
Relations
Ginette Vallières
Investor Relations
Coordinator
(418) 652-8525 ext.
265
gvallieres@aezsinc.com
Media Relations
Paul Burroughs
Director of
Communications
(418) 652-8525 ext.
406
pburroughs@aezsinc.com
Attachment:
Financial summary
8
Interim Unaudited
and Annual Audited Consolidated Statements of Operations
(in
thousands, except share and per share data)
|
|
Three
months ended
December 31,
|
|
Year
ended
December
31,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
2007
|
|
|
|
(unaudited)
|
|
(audited)
|
|
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
License fees
|
|
35,162
|
|
2,092
|
|
42,221
|
|
8,504
|
|
12,843
|
|
Sales and royalties
|
|
5,020
|
|
4,640
|
|
20,957
|
|
29,462
|
|
28,825
|
|
Other
|
|
|
|
512
|
|
59
|
|
512
|
|
400
|
|
|
|
40,182
|
|
7,244
|
|
63,237
|
|
38,478
|
|
42,068
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales, excluding depreciation and
amortization
|
|
3,774
|
|
4,930
|
|
16,501
|
|
19,278
|
|
12,930
|
|
Research and development costs
|
|
10,744
|
|
12,328
|
|
44,217
|
|
57,448
|
|
39,248
|
|
Research and development tax credits and grants
|
|
(181
|
)
|
(137
|
)
|
(403
|
)
|
(343
|
)
|
(2,060
|
)
|
Selling, general and administrative expenses
|
|
6,191
|
|
3,038
|
|
16,040
|
|
17,325
|
|
20,403
|
|
Depreciation and amortization
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment
|
|
2,302
|
|
316
|
|
3,285
|
|
1,515
|
|
1,562
|
|
Intangible assets
|
|
5,841
|
|
3,084
|
|
7,555
|
|
5,639
|
|
4,004
|
|
Impairment of
long-lived asset held for sale
|
|
|
|
|
|
|
|
|
|
735
|
|
|
|
28,671
|
|
23,559
|
|
87,195
|
|
100,862
|
|
76,822
|
|
Earnings
(loss) from operations
|
|
11,511
|
|
(16,315
|
)
|
(23,958
|
)
|
(62,384
|
)
|
(34,754
|
)
|
Other
income (expenses)
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
34
|
|
131
|
|
349
|
|
868
|
|
1,904
|
|
Interest expense
|
|
(1
|
)
|
(50
|
)
|
(5
|
)
|
(118
|
)
|
(85
|
)
|
Foreign exchange gain (loss)
|
|
488
|
|
2,642
|
|
(1,110
|
)
|
3,071
|
|
(1,035
|
)
|
Other
|
|
|
|
46
|
|
|
|
(79
|
)
|
(28
|
)
|
|
|
521
|
|
2,769
|
|
(766
|
)
|
3,742
|
|
756
|
|
Income
(loss) before income taxes
|
|
12,032
|
|
(13,546
|
)
|
(24,724
|
)
|
(58,642
|
)
|
(33,998
|
)
|
Income tax
(expense) recovery
|
|
|
|
(947
|
)
|
|
|
(1,175
|
)
|
1,961
|
|
Net
earnings (loss) from continuing operations
|
|
12,032
|
|
(14,493
|
)
|
(24,724
|
)
|
(59,817
|
)
|
(32,037
|
)
|
Net loss
from discontinued operations
|
|
|
|
|
|
|
|
|
|
(259
|
)
|
Net
earnings (loss)
|
|
12,032
|
|
(14,493
|
)
|
(24,724
|
)
|
(59,817
|
)
|
(32,296
|
)
|
Net
earnings (loss) per share
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
0.19
|
|
(0.27
|
)
|
(0.43
|
)
|
(1.12
|
)
|
(0.61
|
)
|
Weighted average number
of shares
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
61,993,939
|
|
53,187,470
|
|
56,864,484
|
|
53,187,470
|
|
53,182,803
|
|
9
Consolidated
Balance Sheet Information (Unaudited)
(in thousands)
|
|
As at
December 31,
2009
|
|
As at
December 31,
2008
|
|
|
|
$
|
|
$
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
38,100
|
|
49,226
|
|
Short-term
investments
|
|
|
|
493
|
|
Accounts receivable
and other current assets
|
|
10,913
|
|
12,005
|
|
Restricted cash
|
|
878
|
|
|
|
Property, plant and
equipment, net
|
|
4,358
|
|
6,682
|
|
Other long-term
assets
|
|
32,013
|
|
39,936
|
|
Total assets
|
|
86,262
|
|
108,342
|
|
|
|
|
|
|
|
Accounts payable and other current liabilities
|
|
19,211
|
|
22,121
|
|
Current portion of
long-term payable
|
|
57
|
|
49
|
|
Long-term payable
|
|
143
|
|
172
|
|
Non-financial
long-term liabilities*
|
|
57,625
|
|
64,525
|
|
Total liabilities
|
|
77,036
|
|
86,867
|
|
Shareholders equity
|
|
9,226
|
|
21,475
|
|
Total liabilities and shareholders equity
|
|
86,262
|
|
108,342
|
|
*
Comprised mainly of deferred revenues and employee future benefits.
10
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: March 25,
2010
|
|
By:
|
/s/Dennis Turpin
|
|
|
Dennis Turpin
|
|
|
Senior Vice President
and Chief Financial Officer
|
|
|
|
|
11
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