All amounts are in U.S. dollars (unless otherwise
noted)
QUEBEC CITY, May 9, 2012
/PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company"), today reported financial and operating
results as at and for the first quarter ended March 31, 2012.
Highlights
AEZS-108 (LHRH-Targeted Cytotoxic Conjugate)
- Agreement signed with Ventana Medical Systems, Inc., a member
of the Roche Group, to develop a companion diagnostic for the
immunohistochemical determination of luteinizing hormone-releasing
hormone ("LHRH") receptor expression, for AEZS-108.
- Updated results for the Phase 1 portion of the ongoing
Phase 2 study in castration- and taxane-resistant prostate
cancer ("CRPC") with AEZS-108 presented during a poster session at
the American Society of Clinical Oncology Genitourinary Cancers
Symposium. Data showed that AEZS-108 was well tolerated and
demonstrated early evidence of antitumor activity in men with
CRPC.
AEZS-130 (Oral Ghrelin Agonist)
- Michael E. DeBakey of Veterans Affairs Medical Center, in
Houston, Texas initiated a
Phase 2A trial with AEZS-130 in patients with cancer
cachexia.
Perifosine (Oral Akt Inhibitor)
- Japanese partner, Yakult Honsha, initiated a Phase 1/2 trial in
Japan with perifosine +
capecitabine in refractory advanced colorectal cancer.
- Subsequent to quarter-end, topline results for the Phase 3
"X-PECT" (Xeloda® + Perifosine Evaluation in Colorectal
cancer Treatment") clinical trial evaluating perifosine +
capecitabine (Xeloda®) in 468 patients with refractory
advanced colorectal cancer, showed that the trial did not meet the
primary endpoint of improving overall survival versus capecitabine
+ placebo.
- Subsequent to quarter-end, the Company and Keryx
Biopharmaceuticals agreed to terminate their North American
licensing agreement for perifosine; thus the Company regained full
rights to the compound in this territory and will continue the
ongoing Phase 3 trial in multiple myeloma.
Corporate Developments
At-The-Market Issuance Program
- On January 23, 2012, the Company,
pursuant to its existing At-The-Market ("ATM") sales agreement
dated June 29, 2011 with MLV,
initiated a new ATM issuance program ("January 2012 ATM Program") under which it may, at
its discretion, from time to time during the term of the sales
agreement, sell up to a maximum of 10.4 million of its common
shares through ATM issuances on the NASDAQ Global Market.
- Between January 23, 2012 and
March 15, 2012, the Company issued a
total of 3.6 million common shares under the January 2012 ATM Program for aggregate gross
proceeds of $6.4 million.
- Subsequent to quarter-end through May 8,
2012, the Company issued a total of 2.5 million common
shares under the January 2012 ATM
Sales Agreement for aggregate gross proceeds of $1.8 million.
Cash and cash equivalents totalled $45.6 million as at March 31, 2012, compared to $46.9 million as at December 31, 2011.
Juergen Engel, Ph.D, Aeterna
Zentaris President and Chief Executive Officer, commented, "The
last weeks were quite challenging with the disappointing results
for the perifosine Phase 3 trial in colorectal cancer.
Nevertheless, after regaining North American rights to perifosine,
conducting a thorough analysis of the situation and consulting with
key opinion leaders, we have decided to continue the Phase 3 trial
in multiple myeloma up until the predefined interim analysis, as we
believe this compound still has the potential to become a novel
oral anticancer treatment.
Also during the quarter, other development programs moved
forward as Yakult initiated a trial in colorectal cancer with
perifosine and the Michael E. DeBakey of VA Medical Center
initiated a trial with AEZS-130 in cancer cachexia. Furthermore, we
signed an agreement with Ventana to develop a companion diagnostic
for AEZS-108.
Over the years, we have shown resilience by overcoming important
obstacles. I am proud to say that still today, our team of seasoned
professionals remains committed in providing cancer patients with
novel treatments, while striving to make Aeterna Zentaris an
important company in this field."
Dennis Turpin, CA, Senior Vice President and Chief Financial
Officer at Aeterna Zentaris stated, "As of March 31, 2012, we had a cash position of over
$45 million which allows us to be
well poised to continue to move our key product candidates through
the pipeline."
CONSOLIDATED RESULTS AS AT AND FOR THE FIRST QUARTER ENDED
MARCH 31, 2012
Revenues were $9.5 million
for the quarter ended March 31, 2012,
compared to $7.4 million for the
same quarter in 2011. This increase is largely attributable to
comparative higher deliveries of Cetrotide® to certain
customers and to higher research and development services provided,
partly offset by the relative weakening of the euro against the US
dollar.
R&D costs, net of refundable tax credits and grants
were relatively stable at $5.6
million for the quarter ended March 31, 2012, compared to $5.5 million for the same quarter in 2011.
Net loss amounted to $11.5
million, or $0.11 per basic
and diluted share, for the quarter ended March 31, 2012, compared to $10.1 million, or $0.12 per basic and diluted share, for the same
quarter in 2011. This increase is mainly due to higher net finance
costs attributable to the change in fair value of our warrant
liability, partly offset by lower income tax expense.
CONFERENCE CALL
Management will be hosting a conference call for the investment
community beginning at 8:30 a.m.
(Eastern Time) today, Wednesday, May
9, 2012, to discuss the 2012 first quarter results.
Individuals interested in participating in the live conference call
by telephone may dial, in Canada,
514-807-9895 or 647-427-7450, outside Canada, 888-231-8191. They may also listen
through the Internet at www.aezsinc.com in the "newsroom" section.
A replay will be available on the Company's website for 30 days
following the live event.
For reference, the Management's Discussion and Analysis
("MD&A") for the first quarter 2012 with the associated
Unaudited Interim Consolidated Financial Statements can be found at
www.aezsinc.com.
About Aeterna Zentaris Inc.
Aeterna Zentaris is an oncology and endocrinology drug
development company currently investigating treatments for various
unmet medical needs. The Company's pipeline encompasses compounds
at all stages of development, from drug discovery through to
marketed products. For more information please visit
www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbour provisions of the U.S. Securities
Litigation Reform Act of 1995. Forward-looking statements involve
known and unknown risks and uncertainties that 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 risk that safety and efficacy data from any of our
Phase 3 trials may not coincide with the data analyses from
previously reported Phase 1 and/or Phase 2 clinical trials, 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 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, unless
required to do so by a governmental authority or by applicable
law.
Attachment: Financial summary
Interim Consolidated Statements of Comprehensive
Loss Information |
|
|
Three months ended
March 31, |
(in thousands, except for share
and per share data) |
2012 |
|
2011 |
|
$ |
|
$ |
Revenues |
|
|
|
Sales and royalties |
8,308 |
|
7,092 |
License fees and other |
1,202 |
|
297 |
|
9,510 |
|
7,389 |
|
|
|
|
Operating expenses |
|
|
|
Cost of sales |
7,513 |
|
6,023 |
Research and development costs, net
of refundable tax credits and grants |
5,572 |
|
5,498 |
Selling, general and administrative
expenses |
3,213 |
|
3,159 |
|
16,298 |
|
14,680 |
|
|
|
|
Loss from operations |
(6,788) |
|
(7,291) |
|
|
|
|
Finance income |
77 |
|
824 |
Finance costs |
(4,740) |
|
(2,749) |
Net finance costs |
(4,663) |
|
(1,925) |
|
|
|
|
Loss before income taxes |
(11,451) |
|
(9,216) |
Income tax expense |
- |
|
(841) |
|
|
|
|
Net loss |
(11,451) |
|
(10,057) |
|
|
|
|
Other comprehensive loss |
|
|
|
Foreign currency translation
adjustments |
(255) |
|
(1,339) |
|
|
|
|
Comprehensive loss |
(11,706) |
|
(11,396) |
|
|
|
|
Net loss per share |
|
|
|
Basic and diluted |
(0.11) |
|
(0,12) |
Weighted average number of shares
outstanding |
|
|
|
Basic and diluted |
106,016,843 |
|
83,842,054
|
|
|
Interim Consolidated Statement of Financial
Position Information |
|
(in thousands) |
As
at
March 31,
2012 |
|
As at
December 31,
2011 |
|
$ |
|
$ |
|
|
|
|
Cash and cash equivalents |
45,583 |
|
46,881 |
Trade and other receivables and other
current assets |
12,995 |
|
13,258 |
Restricted cash |
834 |
|
806 |
Property, plant and equipment,
net |
2,452 |
|
2,512 |
Other non-current assets |
12,189 |
|
11,912 |
Total assets |
74,053 |
|
75,369 |
|
|
|
|
Payables and other current
liabilities |
16,684 |
|
17,784 |
Long-term payable (current and
non-current portions) |
60 |
|
88 |
Warrant liability (current and
non-current portions) |
12,860 |
|
9,204 |
Non-financial non-current
liabilities* |
53,126 |
|
52,839 |
Total liabilities |
82,730 |
|
79,915 |
Shareholders' deficiency |
(8,677) |
|
(4,546) |
Total liabilities and
shareholders' deficiency |
74,053 |
|
75,369
|
____________________
* Comprised mainly of non-current portion of deferred
revenues, employee future benefits and provision.
SOURCE AETERNA ZENTARIS INC.