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.

 

Press Release dated May 6, 2009: Æterna Zentaris Reports First 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

 

 

 

 

 

 

 

Press Release

 

 

For immediate release

 

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:

 

·                  Initial $30 million upfront payment to the Company;

·                  Up to $135 million in additional payments upon achieving certain pre-established regulatory and commercial milestones;

·                  Escalating 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.”

 

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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. A replay will be available on the Company’s 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.

 

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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 Company’s 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 Company’s 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

Media Relations

Ginette Vallières

Paul Burroughs

Investor Relations Coordinator

Director of Communications

(418) 652-8525 ext. 265

(418) 652-8525 ext. 406

gvallieres@aezsinc.com

pburroughs@aezsinc.com

 

 

Attachment: Financial summary

 

 

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Quarterly Consolidated Statements of Loss (unaudited)

 

 

 

Quarters ended March 31,

 

(in thousands, except per share data)

 

2009

 

2008

 

 

 

$

 

$

 

Revenues

 

 

 

 

 

Sales and royalties

 

4,971

 

7,942

 

License fees and other

 

1,140

 

1,806

 

 

 

6,111

 

9,748

 

Operating expenses

 

 

 

 

 

Cost of sales

 

3,694

 

4,604

 

Research and development costs, net of tax credits and grants

 

11,437

 

13,689

 

Selling, general and administrative

 

3,554

 

4,404

 

Depreciation and amortization

 

 

 

 

 

Property, plant and equipment

 

311

 

369

 

Intangible assets

 

557

 

840

 

 

 

19,553

 

23,906

 

Loss from operations

 

(13,442

)

(14,158

)

Other income (expenses)

 

 

 

 

 

Interest income

 

156

 

277

 

Interest expense

 

(2

)

(15

)

Foreign exchange gain

 

900

 

2,255

 

Gain on disposal of long-lived assets held for sale

 

 

775

 

 

 

1,054

 

3,292

 

Net loss for the period

 

(12,388

)

(10,866

)

Net loss per share

 

 

 

 

 

Basic and diluted

 

(0.23

)

(0.20

)

Weighted average number of shares

 

 

 

 

 

Basic and diluted

 

53,187,470

 

53,187,470

 

 

Consolidated Balance Sheet Information (unaudited)

 

(in thousands)

 

As at
March 31,
2009

 

As at December 31,
2008

 

 

 

$

 

$

 

 

 

 

 

 

 

Cash and cash equivalents

 

61,994

 

49,226

 

Short-term investments

 

477

 

493

 

Accounts receivable and other current assets

 

11,008

 

12,005

 

Property, plant and equipment

 

6,345

 

6,682

 

Other long-term assets

 

39,207

 

39,936

 

Total assets

 

119,031

 

108,342

 

 

 

 

 

 

 

Accounts payable and other current liabilities

 

25,990

 

22,121

 

Current portion of long-term payable

 

48

 

49

 

Long-term payable

 

143

 

172

 

Non-financial long-term liabilities

 

85,000

 

64,525

 

Total liabilities

 

111,181

 

86,867

 

Shareholders’ equity

 

7,850

 

21,475

 

Total liabilities and shareholders’ equity

 

119,031

 

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.

 

 

 

ÆTERNA ZENTARIS INC.

 

 

 

 

Date:

May 6, 2009

 

By:

/s/Dennis Turpin

 

 

 

Dennis Turpin

 

 

Senior Vice President and Chief Financial Officer