- Report of Foreign Issuer (6-K)
May 07 2009 - 2:12PM
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 May 2009
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.
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Press Release dated May 6, 2009: Æterna
Zentaris Reports First Quarter 2009
Financial and Operating Results
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2
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Æterna Zentaris Inc.
1405 du Parc-Technologique Blvd.
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Québec (Québec) Canada G1P 4P5
T 418 652-8525 F
418 652-0881
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www.aezsinc.com
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Press Release
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For immediate
release
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Æterna Zentaris Reports
First Quarter
2009
Financial and Operating Results
All amounts are in U.S.
dollars
Quebec City, Canada, May 6,
2009
Æterna
Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the Company), a global
biopharmaceutical company focused on endocrinology and oncology, today reported
financial and operating results as at and for the three months ended March 31,
2009.
First Quarter 2009
Highlight
Signing of
partnership with sanofi-aventis for cetrorelix in benign prostatic hyperplasia
(BPH) for the U.S. market:
·
I
nitial $30 million upfront payment to the Company;
·
Up to $135 million in additional payments upon
achieving certain pre-established regulatory and commercial milestones;
·
E
scalating double-digit royalties
on future net sales of cetrorelix for BPH in the U.S.;
·
Sanofi-aventis
responsible for the commercialization and booking of sales in the U.S.;
·
The Company retained certain rights to co-promote
cetrorelix for BPH in the U.S.
Juergen Engel, Ph.D., Æterna
Zentaris President and Chief Executive Officer commented, The first quarter
of 2009 was marked by the signing of a major agreement with sanofi-aventis for
the development, registration and marketing of our lead compound, cetrorelix,
in BPH for the United States market. The agreement is an important milestone in
our quest to bring cetrorelix to market, provide millions of men with a novel
treatment for BPH and generate significant long-term revenue for the Company.
We expect to disclose results of our Phase 3 program with cetrorelix in
BPH over the next few months as we continue to evaluate other strategic
partnerships for this compound. Furthermore, we will push forward our promising
drug candidates in oncology, such as AEZS-108 and AEZS-112, while in
collaboration with our partners, we expect to move perifosine and ozarelix to
the final development stages.
3
Dennis Turpin, Senior Vice
President and Chief Financial Officer of Æterna Zentaris added,
The recent partnership with sanofi-aventis has further strengthened our
financial position
. We are now well
poised to continue to advance our lead compounds in endocrinology and oncology.
CONSOLIDATED RESULTS FOR THE THREE MONTHS ENDED MARCH 31,
2009
Consolidated revenues
were $6.1 million for the three-month period
ended March 31, 2009, compared to $9.7 million for the same period in
2008. The decrease is related to lower royalty revenues having been recognized
in the first quarter of 2009. The comparative decrease is also attributable to
euro to US dollar exchange rate fluctuations,
given the comparative strengthening of the US dollar in the first quarter of
2009 vis-à-vis the euro.
Consolidated selling, general and administrative
expenses
were $3.6 million for
the three-month period ended March 31, 2009, compared to $4.4 million
for the same period in 2008. This decrease is primarily related to comparative
euro to US dollar exchange rate fluctuations,
given the comparative strengthening of the US dollar
in the first quarter of 2009 vis-à-vis the euro,
as well as to continuing cost-saving measures that were implemented
beginning in the second quarter of 2008.
Consolidated R&D costs, net of tax credits and
grants,
were
$11.4 million for the three-month period ended March 31, 2009,
compared to $13.7 million for the same period in 2008.
The comparative decrease in net R&D costs
is largely attributable to euro to US dollar exchange rate fluctuations.
Consolidated net loss
was $12.4 million, or $0.23 per basic and diluted share, for the
three-month period ended March 31, 2009, compared to $10.9 million,
or $0.20 per basic and diluted share, for the same period in 2008. This
increase is mainly related to lower foreign exchange gains recorded in the
three-month period ended March 31, 2009, compared to the same period in
2008. The increase is also related to a gain recorded in the three-month period
ended March 31, 2008 on the disposal of Impavido
®
, partially offset by the reduction in loss from
operations in the three-month period ended March 31, 2009.
Consolidated cash, cash
equivalents and short-term investments
were $62.5 million as at March 31, 2009.
CONFERENCE
CALL
Management will be hosting a conference call
for the investment community beginning at 3:30 p.m. Eastern Time today,
Wednesday, May 6, 2009, to discuss first quarter 2009 results. Individuals
interested in participating in the live conference call by telephone may dial
416-644-3422, 514-807-8791 or 800-587-1893,
or may listen through the Internet at
www.aezsinc.com
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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 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.
4
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, and 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 to do so by a governmental authority
or applicable law.
Investor Relations
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Media Relations
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Ginette Vallières
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Paul Burroughs
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Investor Relations Coordinator
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Director of Communications
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(418)
652-8525 ext. 265
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(418) 652-8525 ext. 406
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gvallieres@aezsinc.com
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pburroughs@aezsinc.com
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Attachment:
Financial summary
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5
Quarterly
Consolidated Statements of Loss (unaudited)
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Quarters ended March 31,
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(in thousands, except per
share data)
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2009
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2008
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$
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$
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Revenues
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Sales and royalties
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4,971
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7,942
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License fees and other
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1,140
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1,806
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6,111
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9,748
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Operating expenses
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Cost of sales
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3,694
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4,604
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Research and development costs, net of tax
credits and grants
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11,437
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13,689
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Selling, general and administrative
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3,554
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4,404
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Depreciation and amortization
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Property, plant and equipment
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311
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369
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Intangible assets
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557
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840
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19,553
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23,906
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Loss from operations
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(13,442
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)
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(14,158
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)
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Other income (expenses)
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Interest income
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156
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277
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Interest expense
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(2
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(15
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Foreign exchange gain
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900
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2,255
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Gain on disposal of long-lived assets held for
sale
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775
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1,054
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3,292
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Net loss for the period
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(12,388
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(10,866
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Net loss per share
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Basic and diluted
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(0.23
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(0.20
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Weighted average number of
shares
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Basic and diluted
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53,187,470
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53,187,470
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Consolidated Balance Sheet
Information (unaudited)
(in
thousands)
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As
at
March 31,
2009
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As
at December 31,
2008
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$
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$
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Cash
and cash equivalents
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61,994
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49,226
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Short-term
investments
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477
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493
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Accounts
receivable and other current assets
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11,008
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12,005
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Property,
plant and equipment
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6,345
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6,682
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Other
long-term assets
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39,207
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39,936
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Total
assets
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119,031
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108,342
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Accounts
payable and other current liabilities
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25,990
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22,121
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Current
portion of long-term payable
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48
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49
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Long-term
payable
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143
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172
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Non-financial
long-term liabilities
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85,000
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64,525
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Total
liabilities
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111,181
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86,867
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Shareholders
equity
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7,850
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21,475
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Total
liabilities and shareholders equity
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119,031
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108,342
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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.
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ÆTERNA ZENTARIS INC.
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Date:
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May 6, 2009
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By:
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/s/Dennis Turpin
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Dennis Turpin
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Senior Vice President and Chief Financial Officer
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