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 2008
Commission File No. 000-30752
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. Press Release dated May 7, 2008: AEterna Zentaris Reports First Quarter
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 FIRST QUARTER 2008 FINANCIAL AND OPERATING RESULTS
ALL AMOUNTS ARE IN U.S. DOLLARS
QUEBEC CITY, CANADA, MAY 7, 2008 - AEterna Zentaris Inc. (NASDAQ: AEZS, TSX:
AEZ), a global biopharmaceutical company focused on endocrinology and oncology,
today reported financial and operating results for the first quarter ended March
31, 2008.
FIRST QUARTER 2008 HIGHLIGHTS
- Cetrorelix: first patients treated in second efficacy trial of the
Phase 3 program in benign prostatic hyperplasia (BPH);
- AEZS-108: first patients treated in Phase 2 trial in ovarian and
endometrial cancers;
- Miltefosine (Impavido(R)): rights sold to Paladin Labs Inc. (TSX:PLB)
for approximately $8.9 million.
SUBSEQUENT TO FIRST QUARTER END
- Cetrorelix: recruitment of 600 patients completed for first efficacy
trial of the Phase 3 program in BPH;
- Juergen Ernst, AEterna Zentaris Chairman, appointed Interim President
and CEO, replacing David J. Mazzo. Departure of Ellen McDonald, Senior
Vice President, Business Operations and Chief Business Officer;
- Board member Jose P. Dorais appointed to the Corporate Governance,
Nominating and Human Resources Committee, replacing Mr. Juergen Ernst,
the Company's Chairman of the Board and Interim President and CEO, who
had previously stepped down from the committee in connection with his
appointment as Interim President and CEO.
Juergen Ernst, Chairman, Interim President and CEO at AEterna Zentaris
commented, "During the quarter, we continued to move forward with our Phase 3
program in BPH with our lead compound cetrorelix, as we completed patient
recruitment for our first efficacy trial in North America and started patient
dosing in our second similar efficacy trial in Europe. We also achieved an
important milestone with our lead oncology compound AEZS-108, as we started
patient dosing for our Phase 2 trial in endometrial and ovarian cancer.
Subsequent to quarter end, we had to make important changes to our management
team in order not to stray from our corporate strategy which is based on the
following priorities: concentrate on the advancement of our lead value-drivers
cetrorelix in BPH and AEZS-108 in oncology, pursue strategic partnership
opportunities for cetrorelix and other compounds from our rich pipeline,
continue monetizing our non-core assets to provide additional sources of
non-dilutive funding and apply strict control of our burn-rate. We believe that
by staying the course with our strategy, we will be able to meet our mid and
long-term goals for the benefit of both patients and shareholders."
CONSOLIDATED RESULTS FOR THE FIRST QUARTER ENDED MARCH 31, 2008
CONSOLIDATED REVENUES were $9.7 million for the three-month period ended March
31, 2008 compared to $9.2 million for the same period in 2007. The increase in
revenues is primarily related to additional sales of Cetrotide(R) to Merck
Sereno, mainly offset by decreased sales activities of Impavido(R) and
Cetrotide(R) in Japan, as well as a reduction in license fees revenues related
to services rendered through our collaborations with Spectrum Pharmaceuticals,
Inc. and Keryx Biopharmaceuticals, Inc.
CONSOLIDATED SELLING, GENERAL AND ADMINISTRATIVE (SG&A) EXPENSES were $4.4
million for the three-month period ended March 31, 2008 compared to $4.9 million
for the same period in 2007. The decrease in SG&A expenses for the three-month
period ended March 31, 2008, compared to the same period in 2007, is primarily
due to non-recurring corporate expenses related to organizational changes that
were implemented in the first quarter of 2007. A decrease in selling expenses
was further impacted by lower royalties and commission expenses related to lower
sales volumes of Cetrotide(R) in Japan and Impavido(R).
CONSOLIDATED R&D COSTS, NET OF TAX CREDITS AND GRANTS were $13.7 million for the
three-month period ended March 31, 2008 compared to $7.9 million for the same
period in 2007. Additional R&D expenses of $5.8 million spent in the first
quarter 2008 compared to the same period in 2007 are mainly related to the
advancement of our lead product cetrorelix in Phase 3 for BPH, as well as
further advancement of targeted, earlier-stage development programs including
AEZS-108 and AEZS-112, our tubulin inhibitor, both of which are in oncology.
CONSOLIDATED NET LOSS for the three-month period ended March 31, 2008 was $10.9
million or $0.20 per basic and diluted share, compared to $5.1 million or $0.10
per basic and diluted share for the same period in 2007. The increase in net
loss is primarily attributable to the increased R&D costs related to the
advancement of cetrorelix in Phase 3 for the treatment of BPH.
The consolidated cash and short-term investments were $38.7 million as of March
31, 2008.
2
CONFERENCE CALL
Management will be hosting a conference call for the investment community
beginning at 4:00 p.m. Eastern Time today, Wednesday, May 7, to discuss first
quarter 2008 results.
To participate in the live conference call by telephone, please dial
416-644-3425, 514-807-8791 or 800-796-7558. 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 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. 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.
-30-
CONTACTS
INVESTOR RELATIONS
Dennis Turpin, CA
Senior Vice President and Chief Financial Officer
(908) 330-5188
dturpin@aezsinc.com
MEDIA RELATIONS
Paul Burroughs
Director of Communications
(418) 575-8982
pburroughs@aezsinc.com
ATTACHMENT: Financial summary
3
(IN THOUSANDS OF US DOLLARS, EXCEPT SHARE
AND PER SHARE DATA)
THREE MONTHS ENDED
CONSOLIDATED RESULTS MARCH 31,
UNAUDITED 2008 2007
-----------------------------------------------------------------------------
REVENUES
Sales and royalties $ 7,942 $ 7,204
License fees 1,806 2,029
------------------------
9,748 9,233
------------------------
OPERATING EXPENSES
Cost of sales 4,604 3,310
Selling, general and administrative 4,404 4,892
R&D costs, net of tax credits 13,689 7,907
Depreciation and amortization 1,209 1,427
------------------------
23,906 17,536
------------------------
LOSS FROM OPERATIONS (14,158) (8,303)
------------------------
OTHER REVENUES NET OF EXPENSES 3,292 616
INCOME TAX RECOVERY -- 2,544
------------------------
NET LOSS FROM CONTINUING OPERATIONS (10,866) (5,143)
NET EARNINGS FROM DISCONTINUED OPERATIONS -- 33
------------------------
NET LOSS (10,866) (5,110)
========================
NET LOSS PER SHARE FROM CONTINUING OPERATIONS
Basic and diluted (0.20) (0.10)
NET EARNINGS PER SHARE FROM DISCONTINUED OPERATIONS
Basic and diluted -- --
NET LOSS PER SHARE
Basic and diluted (0.20) (0.10)
WEIGHTED AVERAGE NUMBER OF SHARES
Basic and diluted 53,187,470 53,179,470
(IN THOUSANDS OF US DOLLARS, EXCEPT SHARE
AND PER SHARE DATA)
CONSOLIDATED BALANCE SHEETS MARCH 31, December 31,
UNAUDITED 2008 2007
-------------------------------------------------------------------------------
CASH AND SHORT-TERM INVESTMENTS $ 38,714 $ 41,387
OTHER CURRENT ASSETS 18,527 18,193
----------------------
57,241 59,580
LONG-TERM ASSETS 60,281 63,783
----------------------
TOTAL ASSETS 117,522 123,363
======================
CURRENT LIABILITIES 26,135 22,255
OTHER LONG-TERM LIABILITIES 13,354 12,517
----------------------
39,489 34,772
SHAREHOLDERS' EQUITY 78,033 88,591
----------------------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY 117,522 123,363
======================
4
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: May 8, 2008 By: /s/ Dennis Turpin
------------------------------------
Dennis Turpin
Senior Vice President,
Chief Financial Officer