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 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 November 11, 2009: Æterna Zentaris Reports Third Quarter 2009 Financial and Operating Results |
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Æterna Zentaris Inc. 1405 du Parc-Technologique Blvd.
Québec (Québec) Canada G1P 4P5 T 418 652-8525 F 418 652-0881
www.aezsinc.com
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Press Release |
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For immediate release |
Æterna Zentaris Reports Third Quarter 2009 Financial and Operating Results
All amounts are in U.S. dollars
Quebec City, Canada, November 11, 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-month and nine-month periods ended September 30, 2009.
Third Quarter 2009 Highlights
· July 7, 2009. Publication in Proceedings of the National Academy of Sciences, of new data supporting the use of AEZS-123 for the treatment of alcohol dependence that involves ghrelin.
· August 3, 2009. The Companys licensee partner for perifosine in North America, Keryx Biopharmaceuticals (Keryx), disclosed that it had reached an agreement with the FDA regarding a Special Protocol Assessment on the design of a Phase 3 trial for multiple myeloma.
· August 17, 2009. Disclosure of results for two Phase 3 studies with cetrorelix in benign prostatic hyperplasia (BPH). The efficacy study Z-033 did not achieve its primary endpoint. Results from the safety study Z-041 were positive and exhibited a similar level of efficacy as the previously disclosed Phase 2 study results.
· September 16, 2009. Disclosure that Keryx received Orphan Drug designation from the FDA for perifosine for multiple myeloma.
· September 21, 2009. Disclosure of Phase 1 study results with AEZS-112 in advanced solid tumors or lymphoma showed prolonged courses of stable disease, excellent tolerability and potential for long-term use as a combination treatment for cancer.
· September 30, 2009. Disclosure of results for the Thorough QT Z-043 (TQT) study, which is part of the cetrorelix pamoate clinical development in BPH. The study met its primary endpoint.
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Subsequent to Quarter-End
· October 19, 2009. Disclosure of the initiation of activities to complete a Phase 3 trial with macimorelin (AEZS-130) as a first approved oral diagnostic test for Growth Hormone Deficiency.
· October 23, 2009. Completion of a $5.5 million registered direct offering.
· November 2, 2009. Disclosure of positive preliminary results for the Phase 2 study with AEZS-108 in ovarian cancer.
Juergen Engel, Ph.D., Æterna Zentaris President and Chief Executive Officer, commented, During this quarter, we disclosed results for the first of two efficacy trials of our Phase 3 program in BPH with cetrorelix. The first efficacy trial did not reach its primary endpoint, while results for the safety and TQT trials were positive. We remain committed to this program and are working towards receiving the results of the second efficacy study next month. Furthermore, we made significant progress with other innovative late-stage compounds such as perifosine and AEZS-108 in oncology, as well as AEZS-130 in endocrinology, which are further proof of the breadth of our pipeline.
Dennis Turpin, the Companys Senior Vice President and Chief Financial Officer, added, Our financial position enables us to pursue our business and drug development activities, as planned.
CONSOLIDATED RESULTS AS AT AND FOR THE THREE-MONTH PERIOD ENDED SEPTEMBER 30, 2009
Consolidated revenues were $8.6 million for the three-month period ended September 30, 2009, compared to $11.0 million for the same period in 2008. This decrease is mainly related to lower royalty revenues having been recognized in 2009 in connection with the monetization of the royalties derived from the Companys agreement with Merck Serono. Amortization of the monetization proceeds received for the three months ended September 30, 2009 was lower than the royalty revenues generated and payable directly by Merck Serono during the same period in 2008. Additionally, sales volumes of Cetrotide® were lower during the three-month period ended September 30, 2009, compared to the same period in 2008.
Consolidated research and development (R&D) costs, net of tax credits and grants, were $9.7 million for the three-month period ended September 30, 2009, compared to $13.9 million for the same period in 2008. The comparative decrease in net R&D costs is largely attributable to a lower volume of expenses incurred in connection with the continued advancement of the Phase 3 program for cetrorelix in BPH, since the Company progressively completed, during the third quarter, the safety study Z-041 and the TQT trial.
Consolidated net loss for the three-month period ended September 30, 2009 was $11.3 million, or $0.19 per basic and diluted share, compared to $13.9 million, or $0.26 per basic and diluted share, for the same period in 2008. This decrease is mainly related to lower comparative R&D expenses, partially offset by lower comparative revenues, less cost of sales.
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Consolidated cash, cash equivalents and short-term investments were $44.5 million as at September 30, 2009, of which $0.9 million is restricted on a long-term basis.
CONFERENCE CALL
Management will be hosting a conference call for the investment community beginning at 10:00 a.m. Eastern Time today, Wednesday, November 11, 2009, to discuss third quarter 2009 results. Individuals interested in participating in the live conference call by telephone may dial 877-974-0453, 416-644-3431 or 514-227-8860, or may 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 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 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
5
Interim Consolidated Statements of Loss (Unaudited)
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Three
months ended |
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Nine
months ended |
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(in thousands, except share and per share data) |
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2009 |
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2008 |
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2009 |
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2008 |
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$ |
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$ |
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$ |
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$ |
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Revenues |
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Sales and royalties |
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5,539 |
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8,630 |
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15,937 |
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24,822 |
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License fees and other |
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3,026 |
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2,399 |
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7,118 |
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6,412 |
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8,565 |
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11,029 |
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23,055 |
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31,234 |
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Operating expenses |
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|
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|
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Cost of sales |
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4,488 |
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4,986 |
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12,727 |
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14,348 |
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Research and development costs, net of tax credits and grants |
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9,738 |
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13,880 |
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33,251 |
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44,914 |
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Selling, general and administrative expenses |
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3,193 |
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3,277 |
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9,849 |
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14,287 |
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Depreciation and amortization |
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Property, plant and equipment |
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341 |
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433 |
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983 |
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1,199 |
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Intangible assets |
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594 |
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839 |
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1,714 |
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2,555 |
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18,354 |
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23,415 |
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58,524 |
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77,303 |
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Loss from operations |
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(9,789 |
) |
(12,386 |
) |
(35,469 |
) |
(46,069 |
) |
Other income (expenses) |
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Interest income |
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41 |
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149 |
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315 |
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737 |
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Interest expense |
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(2 |
) |
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(4 |
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(68 |
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Foreign exchange (loss) gain |
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(1,538 |
) |
(1,324 |
) |
(1,598 |
) |
429 |
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Loss on disposal of long-lived assets held for sale |
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(90 |
) |
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(125 |
) |
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(1,499 |
) |
(1,265 |
) |
(1,287 |
) |
973 |
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Loss before income taxes |
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(11,288 |
) |
(13,651 |
) |
(36,756 |
) |
(45,096 |
) |
Income tax expense |
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(228 |
) |
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(228 |
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Net loss for the period |
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(11,288 |
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(13,879 |
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(36,756 |
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(45,324 |
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Net loss per share |
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Basic and diluted |
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(0.19 |
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(0.26 |
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(0.67 |
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(0.85 |
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Weighted average number of shares |
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Basic and diluted |
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58,506,619 |
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53,187,470 |
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55,135,876 |
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53,187,470 |
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6
Interim Consolidated Balance Sheet Information (Unaudited)
(in thousands) |
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As at |
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As at |
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$ |
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$ |
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Cash and cash equivalents |
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43,051 |
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49,226 |
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Short-term investments |
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562 |
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493 |
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Accounts receivable and other current assets |
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11,127 |
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12,005 |
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Restricted cash |
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901 |
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Property, plant and equipment |
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6,738 |
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6,682 |
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Other long-term assets |
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41,237 |
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39,936 |
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Total assets |
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103,616 |
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108,342 |
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Accounts payable and other current liabilities |
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23,015 |
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22,121 |
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Current portion of long-term payable |
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56 |
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49 |
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Long-term payable |
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140 |
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172 |
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Non-financial long-term liabilities |
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88,390 |
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64,525 |
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Total liabilities |
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111,601 |
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86,867 |
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Shareholders equity (deficiency) |
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(7,985 |
) |
21,475 |
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Total liabilities and shareholders equity (deficiency) |
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103,616 |
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108,342 |
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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: November 12, 2009 |
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By: |
/s/Dennis Turpin |
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Dennis Turpin |
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Senior Vice President and Chief Financial Officer |
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