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.

 

Press Release dated November 11, 2009: Æterna Zentaris Reports Third Quarter 2009 Financial and Operating Results

 

2



GRAPHIC

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 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 Company’s 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 Company’s 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 Company’s 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 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.

 

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. 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)

 

 

 

Three months ended
September 30,

 

Nine months ended
September 30,

 

(in thousands, except share and per share data)

 

2009

 

2008

 

2009

 

2008

 

 

 

$

 

$

 

$

 

$

 

Revenues

 

 

 

 

 

 

 

 

 

Sales and royalties

 

5,539

 

8,630

 

15,937

 

24,822

 

License fees and other

 

3,026

 

2,399

 

7,118

 

6,412

 

 

 

8,565

 

11,029

 

23,055

 

31,234

 

Operating expenses

 

 

 

 

 

 

 

 

 

Cost of sales

 

4,488

 

4,986

 

12,727

 

14,348

 

Research and development costs, net of tax credits and grants

 

9,738

 

13,880

 

33,251

 

44,914

 

Selling, general and administrative expenses

 

3,193

 

3,277

 

9,849

 

14,287

 

Depreciation and amortization

 

 

 

 

 

 

 

 

 

Property, plant and equipment

 

341

 

433

 

983

 

1,199

 

Intangible assets

 

594

 

839

 

1,714

 

2,555

 

 

 

18,354

 

23,415

 

58,524

 

77,303

 

Loss from operations

 

(9,789

)

(12,386

)

(35,469

)

(46,069

)

Other income (expenses)

 

 

 

 

 

 

 

 

 

Interest income

 

41

 

149

 

315

 

737

 

Interest expense

 

(2

)

 

(4

)

(68

)

Foreign exchange (loss) gain

 

(1,538

)

(1,324

)

(1,598

)

429

 

Loss on disposal of long-lived assets held for sale

 

 

(90

)

 

(125

)

 

 

(1,499

)

(1,265

)

(1,287

)

973

 

Loss before income taxes

 

(11,288

)

(13,651

)

(36,756

)

(45,096

)

Income tax expense

 

 

(228

)

 

(228

)

Net loss for the period

 

(11,288

)

(13,879

)

(36,756

)

(45,324

)

Net loss per share

 

 

 

 

 

 

 

 

 

Basic and diluted

 

(0.19

)

(0.26

)

(0.67

)

(0.85

)

Weighted average number of shares

 

 

 

 

 

 

 

 

 

Basic and diluted

 

58,506,619

 

53,187,470

 

55,135,876

 

53,187,470

 

 

6



 

Interim Consolidated Balance Sheet Information (Unaudited)

 

(in thousands)

 

As at
September 30,
2009

 

As at
December 31,

2008

 

 

 

$

 

$

 

 

 

 

 

 

 

Cash and cash equivalents

 

43,051

 

49,226

 

Short-term investments

 

562

 

493

 

Accounts receivable and other current assets

 

11,127

 

12,005

 

Restricted cash

 

901

 

 

Property, plant and equipment

 

6,738

 

6,682

 

Other long-term assets

 

41,237

 

39,936

 

Total assets

 

103,616

 

108,342

 

 

 

 

 

 

 

Accounts payable and other current liabilities

 

23,015

 

22,121

 

Current portion of long-term payable

 

56

 

49

 

Long-term payable

 

140

 

172

 

Non-financial long-term liabilities

 

88,390

 

64,525

 

Total liabilities

 

111,601

 

86,867

 

Shareholders’ equity (deficiency)

 

(7,985

)

21,475

 

Total liabilities and shareholders’ equity (deficiency)

 

103,616

 

108,342

 

 

7



 

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: November 12, 2009

 

By:

/s/Dennis Turpin

 

 

 

Dennis Turpin

 

 

 

Senior Vice President and Chief Financial Officer

 

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