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 March 2009
AETERNA ZENTARIS INC.
1405, boul. du Parc-Technologique
Quebec, Quebec
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 / /
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 / / 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. AEterna Zentaris Reports Fourth Quarter and Full-Year 2008 Financial and
Operating Results
[AETERNA ZENTARIS LOGO]
AETERNA ZENTARIS INC. 1405 du Parc-Technologique Blvd.
Quebec (Quebec) Canada G1P 4P5 T 418 652-8525 F 418 652-0881
www.aezsinc.com
PRESS RELEASE
For immediate release
AETERNA ZENTARIS REPORTS FOURTH QUARTER AND FULL-YEAR 2008 FINANCIAL AND
OPERATING RESULTS
ALL AMOUNTS ARE IN U.S. DOLLARS
QUEBEC CITY, CANADA, MARCH 11, 2009 - AEterna Zentaris Inc. (NASDAQ: AEZS, TSX:
AEZ) ("the Company"), a global biopharmaceutical company focused on
endocrinology and oncology, today reported financial and operating results for
the fourth quarter and the full year ended December 31, 2008.
2008 HIGHLIGHTS
- February
- First patients treated with AEZS-108 for a Phase 2 trial in
advanced ovarian and endometrial cancers.
- March
- Patient dosing commenced with cetrorelix in the second
efficacy study of the Phase 3 program in benign prostatic
hyperplasia ("BPH").
- Completion of the sale to Paladin Labs of the marketed
product, Impavido(R) (miltefosine), for approximately $9.2
million.
- April
- Appointment of Juergen Ernst, as Interim President and CEO,
the Company's Chairman of the Board at the time, following the
departure of our former President and CEO;
- Completion of patient recruitment for the first efficacy study
of the Phase 3 program in BPH with cetrorelix.
- May
- First patients treated with cetrorelix for the safety trial of
the Phase 3 program in BPH.
- June
- Completion of the sale of the Company's Quebec City property
for a purchase price of $7.1 million.
[AETERNA ZENTARIS LOGO]
- September
- Appointment of Juergen Engel, Ph.D., as Company President and
CEO, succeeding Juergen Ernst who, at the same time, was
appointed as Executive Chairman of the Company.
- October and November
- Completion of patient recruitment for the second efficacy
trial of the Phase 3 program with cetrorelix in BPH.
- Initiation of the second stage of patient recruitment for
AEZS-108 Phase 2 trial in advanced ovarian and endometrial
cancers.
- December
- Sale of AEterna Zentaris rights to royalties on future sales
of Cetrotide(R), covered by the Company's license agreement
with Merck Serono, to Cowen Healthcare Royalty Partners L.P.
("Cowen") for gross consideration of $52.5 million.
- Completion of patient recruitment for the safety trial of the
Phase 3 program in BPH with cetrorelix.
- Appointment of Matthias Seeber, MBA, as Company Senior Vice
President, Administration and Legal Affairs.
- Subsequent to year end
- The Company entered into a development, commercialization and
license agreement with sanofi-aventis for the development,
registration and marketing of cetrorelix in BPH for the United
States market. The agreement includes an initial upfront
payment of $30 million and up to $135 million in additional
payments upon achieving certain pre-established regulatory and
commercial milestones, as well as escalating double-digit
royalties on future net sales of cetrorelix for BPH in the
United States.
Juergen Engel, Ph. D., AEterna Zentaris' President and Chief Executive Officer
commented, "I am proud of our achievements of the past 12 months. At the
financial level, we generated nearly $100 million in 2008 and in the first few
months of 2009, through multiple non-dilutive transactions and a major
pharmaceutical partnership with sanofi-aventis for our lead compound,
cetrorelix. At the drug development level, we completed the recruitment of over
1,600 patients for our Phase 3 program in BPH with cetrorelix, according to
schedule. We now look forward to disclosing results of this program throughout
the second half of 2009. We also made significant progress with our lead
oncology compound, AEZS-108, in endometrial and ovarian cancer with results
expected by the end of this year.
Moving forward, we will continue to concentrate our efforts on bringing
cetrorelix closer to market in collaboration with our partner, sanofi-aventis.
We believe that this compound could prove to be a novel treatment for the
benefit of millions of men with BPH and also build value for our shareholders."
Dennis Turpin, Senior Vice President and Chief Financial Officer of AEterna
Zentaris added, "The non-dilutive transactions and the recent partnership with
sanofi-aventis have provided the Company with an overall stronger financial
position and with the necessary funds to pursue our growth strategy."
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[AETERNA ZENTARIS LOGO]
CONSOLIDATED RESULTS FOR THE FOURTH QUARTER ENDED DECEMBER 31, 2008
CONSOLIDATED REVENUES were $7.2 million for the quarter ended December 31, 2008,
compared to $10.2 million for the same quarter in 2007. The decrease in revenues
is primarily due to lower quarter-over-quarter royalties related to our license
agreement with Merck Serono. Subsequent to the sale of the Company's rights to
royalties on future sales of Cetrotide(R), covered by the Company's license
agreement with Merck Serono, to Cowen, which was effective, for royalty
determination purposes, on October 1, 2008, our periodic amortization of the
gross proceeds received from Cowen, while still recognized as royalty revenues,
has been lower than the royalty revenues recognized in the past, as receivable
directly from Merck Serono. Additionally, quarter-over-quarter sales and
royalties decreased due to the absence of sales of Impavido(R) in the fourth
quarter of 2008, while license revenues witnessed a decrease due to the
non-recurrence in 2008 of milestone payments received from one of our partners,
related to the perifosine Phase 2 trials.
CONSOLIDATED SELLING, GENERAL AND ADMINISTRATIVE ("SG&A") EXPENSES were $3.0
million for the quarter ended December 31, 2008, compared to $5.1 million for
the same quarter in 2007. The decrease in SG&A expenses is mainly related to the
continued results of cost-saving measures that were implemented beginning in the
second quarter of 2008.
CONSOLIDATED RESEARCH AND DEVELOPMENT ("R&D") EXPENSES were $12.3 million for
the quarter ended December 31, 2008, compared to $13.6 million for the same
quarter in 2007. The decrease in R&D expenses primarily relates to the
comparative reduction in expenses incurred in connection with our Phase 3
program with cetrorelix in BPH, which by the fourth quarter of 2008 was fully
enrolled and less subject to larger front-end expenditures that were necessary
in the earlier, fourth quarter 2007 stage of the program.
CONSOLIDATED NET LOSS was $14.5 million, or $0.27 per basic and diluted share
for the quarter ended December 31, 2008, compared to $13.6 million, or $0.26 per
basic and diluted share, for the same quarter in 2007. The increase in
consolidated net loss is largely attributable to a combination of lower sales
and royalties, lower license fee revenues, lower manufacturing margins on
Cetrotide(R) due in part to a $0.7 million write-down to net realizable value of
certain components of inventory, as well as to higher amortization expense,
partly offset by lower quarter-over-quarter SG&A expenses, higher net foreign
exchange gains and lower income tax expense.
CONSOLIDATED CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS were $49.7
million as at December 31, 2008.
CONSOLIDATED RESULTS FOR THE FULL YEAR ENDED DECEMBER 31, 2008
CONSOLIDATED REVENUES were $38.5 million for the year ended December 31, 2008,
compared to $42.1 million for the year ended December 31, 2007. The decrease in
consolidated revenues in 2008 compared to 2007 is primarily related to lower
sales of Impavido(R), a decrease in consolidated license fee revenues mainly
attributable to non-recurring milestone payments and the termination of a
partner licensing agreement in 2007, partly offset by an increase in sales of
Cetrotide(R).
CONSOLIDATED SG&A EXPENSES decreased to $17.3 million for the year ended
December 31, 2008, compared to $20.4 million for the year ended December 31,
2007. The decrease in SG&A expenses is primarily related to the organizational
changes and cost-saving measures that were implemented beginning in the second
quarter of 2008.
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[AETERNA ZENTARIS LOGO]
CONSOLIDATED R&D COSTS were $57.4 million for the year ended December 31, 2008,
compared to $39.2 million for the year ended December 31, 2007. The increase in
consolidated R&D costs for the year 2008 compared to 2007 is mainly attributable
to the advancement of our Phase 3 program with our lead compound, cetrorelix, in
BPH.
CONSOLIDATED NET LOSS was $59.8 million, or $1.12 per basic and diluted share,
for the year ended December 31, 2008, compared to $32.3 million, or $0.61 per
basic and diluted share, for the year ended December 31, 2007. The increase in
consolidated net loss is attributable to a combination of lower license fee
revenues, lower manufacturing margins, higher R&D costs, higher depreciation and
amortization and higher income tax expense, partly offset by lower SG&A expenses
and higher net foreign exchange gains.
CONFERENCE CALL
Management will be hosting a conference call for the investment community
beginning at 10:00 a.m. Eastern Time today, Wednesday, March 11, 2009, to
discuss fourth quarter and full-year 2008 results. Individuals interested in
participating in the live conference call by telephone may dial 416-646-3095,
514-807-8791 or 800-814-4859, 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 AETERNA ZENTARIS INC.
AEterna 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, 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
Ginette Vallieres
Investor Relations Coordinator
(418) 652-8525 ext. 265
gvallieres@aezsinc.com
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[AETERNA ZENTARIS LOGO]
MEDIA RELATIONS
Paul Burroughs
Director of Communications
(418) 652-8525 ext. 406
pburroughs@aezsinc.com
ATTACHMENT: Financial summary
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[AETERNA ZENTARIS LOGO]
CONSOLIDATED RESULTS OF OPERATIONS
(UNAUDITED)
QUARTERS ENDED YEARS ENDED
DECEMBER 31, DECEMBER 31,
-----------------------------------------------------------------------------------------------------------
(in thousands, except per share data) 2008 2007 2008 2007 2006
===========================================================================================================
$ $ $ $ $
REVENUES
Sales and royalties 4,640 6,435 29,462 28,825 25,123
License fees 2,092 3,705 8,504 12,843 13,652
Other 512 100 512 400 24
-----------------------------------------------------------------------------------------------------------
7,244 10,240 38,478 42,068 38,799
-----------------------------------------------------------------------------------------------------------
OPERATING EXPENSES
Cost of sales 4,930 3,255 19,278 12,930 11,270
Selling, general and administrative
expenses 3,038 5,146 17,325 20,403 16,478
Research and development costs 12,328 13,574 57,448 39,248 27,422
R&D tax credits and grants (137) (1,941) (343) (2,060) (1,564)
Depreciation and amortization
Property, plant and equipment 316 378 1,515 1,562 2,816
Intangible assets 3,084 757 5,639 4,004 6,148
Impairment of long-lived asset held for
sale - 735 - 735 -
-----------------------------------------------------------------------------------------------------------
23,559 21,904 100,862 76,822 62,570
-----------------------------------------------------------------------------------------------------------
LOSS FROM OPERATIONS (16,315) (11,664) (62,384) (34,754) (23,771)
-----------------------------------------------------------------------------------------------------------
OTHER INCOME (EXPENSES)
Interest income 131 535 868 1,904 1,441
Interest expense (50) (23) (118) (85) (1,433)
Foreign exchange gain (loss) 2,642 (269) 3,071 (1,035) 319
Other 46 (27) (79) (28) 409
-----------------------------------------------------------------------------------------------------------
2,769 216 3,742 756 736
-----------------------------------------------------------------------------------------------------------
SHARE IN THE RESULTS OF AN AFFILIATED
COMPANY - - - - 1,575
-----------------------------------------------------------------------------------------------------------
LOSS BEFORE INCOME TAXES FROM
CONTINUING OPERATIONS (13,546) (11,448) (58,642) (33,998) (21,460)
INCOME TAX (EXPENSE) RECOVERY (947) (2,406) (1,175) 1,961 29,037
-----------------------------------------------------------------------------------------------------------
NET (LOSS) EARNINGS FROM CONTINUING
OPERATIONS (14,493) (13,854) (59,817) (32,037) 7,577
NET (LOSS) EARNINGS FROM DISCONTINUED
OPERATIONS - 218 - (259) 25,813
===========================================================================================================
NET (LOSS) EARNINGS FOR THE PERIOD (14,493) (13,636) (59,817) (32,296) 33,390
===========================================================================================================
NET (LOSS) EARNINGS PER SHARE FROM
CONTINUING OPERATIONS
BASIC (0.27) (0.26) (1.12) (0.61) 0.14
DILUTED (0.27) (0.26) (1.12) (0.61) 0.14
NET (LOSS) EARNINGS PER SHARE FROM
DISCONTINUED OPERATIONS
BASIC - - - - 0.50
DILUTED - - - - 0.48
NET (LOSS) EARNINGS PER SHARE
BASIC (0.27) (0.26) (1.12) (0.61) 0.64
DILUTED (0.27) (0.26) (1.12) (0.61) 0.62
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[AETERNA ZENTARIS LOGO]
CONSOLIDATED BALANCE SHEET INFORMATION
(UNAUDITED)
AS AT DECEMBER 31,
-----------------------------------------------------------------------------------
(in thousands) 2008 2007 2006
===================================================================================
$ $ $
Cash and cash equivalents 49,226 10,272 8,939
Short-term investments 493 31,115 51,550
Accounts receivable and other current assets 12,005 18,193 41,234
Property, plant and equipment, net 6,682 7,460 13,001
Other long-term assets 39,936 56,323 108,767
-----------------------------------------------------------------------------------
TOTAL ASSETS 108,342 123,363 223,491
===================================================================================
Accounts payable and other current liabilities 22,121 21,480 15,624
Current portion of long-term debt and payable 49 775 686
Long-term debt and payable 172 - 687
Non-financial long-term liabilities 64,525 12,517 27,615
-----------------------------------------------------------------------------------
TOTAL LIABILITIES 86,867 34,772 44,612
SHAREHOLDERS' EQUITY 21,475 88,591 178,879
-----------------------------------------------------------------------------------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY 108,342 123,363 223,491
===================================================================================
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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.
AETERNA ZENTARIS INC.
Date: March 11, 2009 By: /s/Dennis Turpin
--------------------- -------------------------------------------------
Dennis Turpin
Senior Vice President and Chief Financial Officer