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 2008

 

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 13, 2008: Æterna Zentaris Reports Third Quarter 2008 Financial and Operating Results

 



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 2008 Financial and Operating Results

 

All amounts are in U.S. dollars

 

Quebec City, Canada, November 13, 2008 Æterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), a global biopharmaceutical company focused on endocrinology and oncology, today reported financial and operating results for the third quarter ended September 30, 2008.

 

Third Quarter 2008 Highlights

 

·                  Appointment on September 1, 2008, of Juergen Engel, Ph.D. as President and CEO of Æterna Zentaris, replacing Juergen Ernst who had been acting as Interim President and CEO since April 2008. Mr. Ernst, the former Chairman of the Company, was appointed Executive Chairman effective September 1, 2008;

 

·                  Completion of patient recruitment for the second efficacy trial of the Phase 3 program in benign prostatic hyperplasia (BPH) with lead compound, cetrorelix;

 

·                  Start of second stage of recruitment for the Phase 2 trial in ovarian cancer with AEZS-108. The trial is part of a Phase 2 program in gynaecological cancers which will include up to 82 women;

 

·                  Signing of a license and cooperation agreement for the commercialization of cetrorelix in BPH, with Handok Pharmaceuticals Co., Ltd. (Handok) for the Korean market. Subsequent to quarter end, signing of another agreement with Handok for the commercialization of ozarelix in BPH for the Korean market; and

 

·                  Recovery of worldwide rights from Ardana plc (LSE: ARA) for the Growth Hormone Secretagogue (GHS) compound, AEZS-130. Future development options are currently being evaluated for the use of this compound in growth hormone deficiencies.

 

Subsequent to Quarter-End

 

On November 11, 2008, Æterna Zentaris signed a definitive agreement to sell to Cowen Healthcare Royalty Partners, L.P. (“CHRP”) its rights to royalties on future sales of Cetrotide® covered by its license agreement with Merck Serono. The license agreement between Æterna Zentaris and Merck Serono was signed in 2000 and granted Merck Serono exclusive rights to market, distribute and sell Cetrotide worldwide, with the exception of Japan, in the field of in vitro fertilization. On closing, Æterna Zentaris will receive $52.5 million from CHRP. In addition, contingent on 2010 net sales of Cetrotide®

 



 

reaching a specified level, Æterna Zentaris would receive an additional payment of $2.5 million from CHRP.

 

Under the terms of the agreement, if cetrorelix which is currently in Phase 3 clinical trials for the treatment of benign prostatic hyperplasia, is approved for sale by the European regulatory authorities in an indication other than in vitro fertilization, Æterna Zentaris has agreed to make a one-time cash payment to CHRP for an amount ranging from $5 million up to a maximum of $15 million. The amount which would be due to CHRP will be higher the earlier the product receives European regulatory approval.

 

“We are very pleased with the Cowen Healthcare Royalty Partners transaction for Cetrotide® which is in line with our strategy of generating non-dilutive financing. With this transaction, we strengthened our financial position to focus on the development of cetrorelix in BPH, while pursuing partnership opportunities for its future commercialization,” said Juergen Engel, Ph.D., President and Chief Executive Officer of Æterna Zentaris. “At the drug development level, both our Phase 3 program in BPH with cetrorelix, and our Phase 2 program with our lead oncology compound, AEZS-108 in ovarian and endometrial cancer, met their recruitment goals as scheduled and remain on track. First results for cetrorelix in BPH are still expected in the third quarter of 2009, while those for AEZS-108 should be disclosed in the next few months.”

 

CONSOLIDATED RESULTS FOR THE THIRD QUARTER ENDED SEPTEMBER 30, 2008

 

Consolidated sales and royalties increased to $8.6 million for the three-month period ended September 30, 2008, compared to $7.4 million for the same period in 2007. The increase in sales and royalties for the three-month period ended September 30, 2008 compared to the same period last year is related primarily to additional sales of Cetrotide®, partly offset by the exclusion of sales from Impavido® in the third quarter of 2008.

 

License fees revenues decreased to $2.4 million for the three-month period ended September 30, 2008 compared to $3.7 million for the same period in 2007. The decrease for the three-month period ended September 30, 2008, compared to the same period in 2007, is mainly attributable to a milestone payment received in 2007 from Ardana plc.

 

Consolidated R&D costs, net of tax credits and grants were $13.9 million for the three-month period ended September 30, 2008 compared to $9.8 million for the same period in 2007. Additional R&D expenses for the three-month period ended September 30, 2008, compared to the same period in 2007 are mainly related to the advancement of the Phase 3 program in BPH with the compound, cetrorelix.

 

Consolidated selling, general and administrative (SG&A) expenses were $3.3 million for the three-month period ended September 30, 2008 compared to $5.8 million for the same period in 2007. The decrease in SG&A expenses for the three-month period ended September 30, 2008 compared to the same period in 2007 is primarily related to organizational changes and cost saving measures that were implemented in the second quarter of 2008.

 

Consolidated net loss for the three-month period ended September 30, 2008 was $13.9 million or $0.26 per basic and diluted share compared to $8.7 million or $0.16 per basic and diluted share for the same period in 2007. The increase in net loss for the three-month period ended September 30, 2008 compared to the same period last year, is mainly related to the advancement of the cetrorelix Phase 3 program for BPH, lower manufacturing margins and foreign exchange loss.

 

2



 

The cash and short-term investments were $11 million as at September 30, 2008.

 

CONFERENCE CALL

 

Management will be hosting a conference call for the investment community beginning at 10:00 a.m. Eastern Time, today, November 13, 2008, to discuss third quarter 2008 financial results. To participate in the live conference call by telephone, please dial 416-646-3095, 514-807-8791 or 800-814-4859. Individuals interested in listening to the conference call on the Internet may do so by visiting www.aezsinc.com. A replay will be available on the Company’s Web site for 30 days.

 

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 requested by a governmental authority or applicable law.

 

Contacts

 

Investor Relations

Media Relations

Ginette Vallières

Paul Burroughs

Investor Relations Coordinator

Director of Communications

(418) 652-8525 ext. 265

Office: (418) 652-8525 ext.406

gvallieres@aezsinc.com

Cell: (418) 575-8982

 

pburroughs@aezsinc.com

 

-30-

 

Attachment: Financial summary

 

3



 

(In thousands of US dollars, except share and per share data)

 

 

 

Three months ended Sept. 30,

 

Nine months ended Sept. 30,

 

(Unaudited)

 

2008

 

2007

 

2008

 

2007

 

 

 

$

 

$

 

$

 

$

 

Revenues

 

 

 

 

 

 

 

 

 

Sales and royalties

 

8,630

 

7,372

 

24,822

 

22,392

 

License fees

 

2,399

 

3,671

 

6,412

 

9,436

 

 

 

11,029

 

11,043

 

31,234

 

31,828

 

Operating expenses

 

 

 

 

 

 

 

 

 

Cost of sales

 

4,986

 

3,290

 

14,348

 

9,675

 

Research and development costs, net of tax credits and grants*

 

13,880

 

9,835

 

44,914

 

25,557

 

Selling, general and administrative*

 

3,277

 

5,847

 

14,287

 

15,257

 

Depreciation and amortization:

 

 

 

 

 

 

 

 

 

Property, plant and equipment

 

433

 

426

 

1,199

 

1,183

 

Intangible assets

 

839

 

1,024

 

2,555

 

3,014

 

 

 

23,415

 

20,422

 

77,303

 

54,686

 

Loss from operations

 

(12,386

)

(9,379

)

(46,069

)

(22,858

)

Other income (expenses)

 

 

 

 

 

 

 

 

 

Interest income

 

149

 

494

 

737

 

1,369

 

Interest expense

 

 

(15

)

(68

)

(68

)

Foreign exchange (loss) gain

 

(1,324

)

(170

)

429

 

(766

)

Loss on disposal of long-lived assets held for sale

 

(90

)

 

(125

)

 

 

 

(1,265

)

309

 

973

 

535

 

Loss before income taxes

 

(13,651

)

(9,070

)

(45,096

)

(22,323

)

Income tax (expense) recovery

 

(228

)

1,012

 

(228

)

4,287

 

Net loss from continuing operations

 

(13,879

)

(8,058

)

(45,324

)

(18,036

)

Net loss from discontinued operations

 

 

(646

)

 

(624

)

Net loss for the period

 

(13,879

)

(8,704

)

(45,324

)

(18,660

)

Net loss per share from continuing operations

 

 

 

 

 

 

 

 

 

Basic and diluted

 

(0.26

)

(0.15

)

(0.85

)

(0.34

)

Net loss per share

 

 

 

 

 

 

 

 

 

Basic and diluted

 

(0.26

)

(0.16

)

(0.85

)

(0.35

)

Weighted average number of shares

 

 

 

 

 

 

 

 

 

Basic and diluted

 

53,187,470

 

53,184,803

 

53,187,470

 

53,181,248

 

 


* Stock-based compensation costs included in:

 

 

 

 

 

 

 

 

 

Research and development

 

50

 

64

 

166

 

180

 

Selling, general and administrative

 

52

 

447

 

78

 

1,312

 

 

 

102

 

511

 

244

 

1,492

 

 

Consolidated Statement of Comprehensive Income

 

 

 

Three months ended Sept. 30,

 

Nine months ended Sept. 30,

 

(Unaudited)

 

2008

 

2007

 

2008

 

2007

 

 

 

$

 

$

 

$

 

$

 

Net loss for the period

 

(13,879

)

(8,704

)

(45,324

)

(18,660

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

Foreign currency translation

 

(3,169

)

6,315

 

(2,650

)

13,204

 

Variation in the fair value of short-term investments

 

(15

)

81

 

(3

)

(87

)

Comprehensive loss

 

(17,063

)

(2,308

)

(47,977

)

(5,543

)

 

4



 

(In thousands of US dollars)

CONSOLIDATED BALANCE SHEETS

 

 

 

September 30,

 

December 31,

 

Unaudited

 

2008

 

2007

 

 

 

$

 

$

 

Cash and short-term investments

 

10,957

 

41,387

 

Other current assets

 

15,374

 

18,193

 

 

 

26,331

 

59,580

 

Long-term assets

 

46,227

 

63,783

 

Total assets

 

72,558

 

123,363

 

 

 

 

 

 

 

Current liabilities

 

17,611

 

22,255

 

Deferred revenues

 

4,508

 

3,333

 

Long-term payable

 

197

 

 

Employee future benefits

 

9,384

 

9,184

 

 

 

31,700

 

34,772

 

Shareholders’ equity

 

40,858

 

88,591

 

Total liabilities and shareholders’ equity

 

72,558

 

123,363

 

 

5



 

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:  Nov. 13, 2008

 

By:

/s/ Dennis Turpin

 

 

Dennis Turpin

 

 

Senior Vice President and Chief Financial Officer