All amounts are in US dollars
QUEBEC CITY, March 20,
2014 /PRNewswire/ - Aeterna Zentaris Inc.
(NASDAQ: AEZS) (TSX: AEZ) (the "Company"), a specialty
biopharmaceutical company engaged in developing novel treatments in
oncology and endocrinology, today reported financial and operating
results as at and for the fourth quarter and the year ended
December 31, 2013.
Revenues for the year ended December 31,
2013 were $6.2 million
compared to $2.1 million for the same
period in 2012. This increase is attributable to the accelerated
recognition of deferred revenues.
Research and development ("R&D") costs, net of refundable
tax credits and grants, for the three-month period ended
December 31, 2013 were fairly stable
at $5.3 million, compared to
$5.5 million for the same period in
2012. R&D costs, net of refundable tax credits and grants, for
the year ended December 31, 2013 were
$21.3 million, compared to
$20.6 million for the same
period in 2012.
Net loss for the three-month period ended December 31, 2013 was $8.2
million, or $0.22 per basic
and diluted share, compared to $6.9
million, or $0.29 per basic
and diluted share, for the same period in 2012. Net income for the
year ended December 31, 2013 was
$6.8 million, or $0.24 per basic and diluted share, compared to a
net loss of $20.4 million, or
$1.03 per basic and diluted share,
for the same period in 2012. The comparative quarter-over-quarter
increase in net loss is mainly due to increased finance costs
(primarily related to the change in fair value of warrant
liability), partially offset by higher net income from discontinued
operations (related to Cetrotide® manufacturing
activities and the recognition of related deferred revenues) and
lower operating expenses. The comparative year-over-year decrease
in net loss is mainly due to higher net income from discontinued
operations and higher revenues, partially compensated by higher
operating costs and lower finance income.
Cash and cash equivalents totalled $43.2
million as at December 31,
2013, compared to $39.5
million as at December 31,
2012. In January 2014,
subsequent to year-end, the Company completed a public offering of
11.0 million units, generating net proceeds of approximately
$12.2 million.
Juergen Ernst, Chairman of the
Board, commented, "2013 and the first few months of 2014 have been
an important period of transition for the Company, as we appointed
a new President and Chief Executive Officer and made other
significant organizational changes, resulting in a strong team
dedicated to the success of this Company."
David Dodd, Aeterna
Zentaris President and CEO, commented, "Over the last twelve
months, we made great strides in the transition toward becoming an
operating biopharmaceutical company, filing the NDA for MACRILEN™
for the evaluation of AGHD and initiating patient recruitment for
the pivotal ZoptEC Phase 3 trial in endometrial cancer with
zoptarelin doxorubicin. We also significantly improved our
financial position in order to secure the necessary funds needed to
pursue these two major programs. Over the course of this year, our
primary focus will be on finalizing our pre-launch activities for
MACRILEN™, and completing initiation of all clinical sites for our
ZoptEC Phase 3 trial, while we continue to aggressively pursue
opportunities to in-license, acquire and/or promote existing
commercial products in order to more quickly transform Aeterna
Zentaris into a successful commercial organization. All of us
within the Company are highly focused on achieving such a
transition."
Pipeline Highlights
MACRILEN™ (macimorelin)
- New Drug Application ("NDA") accepted for filing by the U.S.
Food and Drug Administration ("FDA") with a Prescription Drug User
Fee Act date of November 5, 2014.
Currently under review, the NDA seeks approval for the
commercialization of MACRILEN™ as the first available oral product
indicated for the evaluation of Adult Growth Hormone Deficiency
("AGHD").
Zoptarelin Doxorubicin
- Agreement reached with the FDA on a Special Protocol Assessment
for the Phase 3 ZoptEC (Zoptarelin doxorubicin in
Endometrial Cancer) trial in women with locally
advanced, recurrent or metastatic endometrial cancer. The proposed
trial protocol design, clinical end-points and planned analysis
will therefore be acceptable to support regulatory submission.
- Signing of a co-development and profit sharing agreement with
Ergomed Clinical Research Ltd. ("Ergomed") as the contract clinical
development organization for the current Phase 3 ZoptEC trial.
Ergomed has agreed to assume 30% (up to $10
million) of the clinical and regulatory costs for this
trial. In turn, Ergomed will receive single digit percentage of
future net income from the product in the endometrial cancer
indication, up to a pre-specified amount.
- Initiation of patient recruitment for the Phase 3 ZoptEC trial.
There are currently over 90 sites actively recruiting patients
across 16 countries.
CONFERENCE CALL
Management will be hosting a conference call for the investment
community beginning at 8:30 a.m. (Eastern
Time) tomorrow, Friday, March 21, 2014, to discuss the 2013
fourth quarter and full year 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 of
Financial Condition and Results of Operations for the fiscal year
2013, as well as the Company's consolidated financial statements,
can be found at www.aezsinc.com in the "Investors" section.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing novel treatments in oncology and
endocrinology. The Company's pipeline encompasses compounds at
various stages of development. For more information, visit
www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbour provisions of the US 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 efficiently commercialize one or more of
its products or product candidates, 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
Consolidated Statements of Comprehensive Income
(Loss)
|
|
Three-month periods
ended December 31, |
|
Years ended December 31, |
(in thousands, except share and per
share data) |
|
2013 |
|
2012 |
|
2013 |
|
2012 |
|
2011 |
|
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
Revenues |
|
|
|
|
|
|
|
|
|
|
Sales |
|
— |
|
— |
|
96 |
|
834 |
|
250 |
License fees and other |
|
— |
|
281 |
|
6,079 |
|
1,219 |
|
4,455 |
|
|
— |
|
281 |
|
6,175 |
|
2,053 |
|
4,705 |
Operating expenses |
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
— |
|
— |
|
51 |
|
591 |
|
212 |
Research and development costs, net of
refundable tax credits and grants |
|
5,345 |
|
5,523 |
|
21,284 |
|
20,592 |
|
24,245 |
Selling, general and administrative
expenses |
|
2,627 |
|
2,877 |
|
12,316 |
|
10,606 |
|
11,955 |
|
|
7,972 |
|
8,400 |
|
33,651 |
|
31,789 |
|
36,412 |
Loss from operations |
|
(7,972) |
|
(8,119) |
|
(27,476) |
|
(29,736) |
|
(31,707) |
Finance income |
|
65 |
|
689 |
|
1,748 |
|
6,974 |
|
6,239 |
Finance costs |
|
(2,689) |
|
(700) |
|
(1,512) |
|
(382) |
|
(8) |
Net finance income |
|
(2,624) |
|
(11) |
|
236 |
|
6,592 |
|
6,231 |
Loss before income taxes |
|
(10,596) |
|
(8,130) |
|
(27,240) |
|
(23,144) |
|
(25,476) |
Income tax expense |
|
— |
|
— |
|
— |
|
— |
|
(1,104) |
Net loss from continuing
operations |
|
(10,596) |
|
(8,130) |
|
(27,240) |
|
(23,144) |
|
(26,580) |
Net income (loss) from discontinued
operations |
|
2,353 |
|
1,183 |
|
34,055 |
|
2,732 |
|
(487) |
Net income (loss) |
|
(8,243) |
|
(6,947) |
|
6,815 |
|
(20,412) |
|
(27,067) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
Items that may be reclassified
subsequently to profit or loss: |
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments |
|
424 |
|
(204) |
|
1,073 |
|
(504) |
|
(789) |
Items that will not be reclassified to
profit or loss: |
|
|
|
|
|
|
|
|
|
|
|
Actuarial gain (loss) on defined benefit
plans |
|
2,346 |
|
(3,705) |
|
2,346 |
|
(3,705) |
|
(1,335) |
Comprehensive income
(loss) |
|
(5,473) |
|
(10,856) |
|
10,234 |
|
(24,621) |
|
(29,191) |
Net loss per share (basic and
diluted) from continuing operations |
|
(0.28) |
|
(0.34) |
|
(0.92) |
|
(1.17) |
|
(1.69) |
Net income (loss) (basic and
diluted) from discontinued operations |
|
0.06 |
|
0.05 |
|
1.16 |
|
0.14 |
|
(0.03) |
Net income (loss) (basic and
diluted) per share |
|
(0.22) |
|
(0.29) |
|
0.24 |
|
(1.03) |
|
(1.72) |
Weighted average number of shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
Basic |
|
37,274,129 |
|
24,181,462 |
|
29,476,455 |
|
19,775,073 |
|
15,751,331 |
Diluted |
|
37,274,129 |
|
24,181,462 |
|
29,476,455 |
|
19,806,687 |
|
15,751,331 |
Consolidated Statement of Financial Position
Information
|
|
As
of December 31, |
(in thousands) |
|
2013 |
|
2012 |
|
|
$ |
|
$ |
Cash and cash equivalents |
|
43,202 |
|
39,521 |
Trade and other receivables and other current
assets |
|
2,453 |
|
13,780 |
Restricted cash |
|
865 |
|
826 |
Property, plant and equipment |
|
1,351 |
|
2,147 |
Other non-current assets |
|
11,325 |
|
11,391 |
Total assets |
|
59,196 |
|
67,665 |
Payables and other current liabilities |
|
7,242 |
|
10,470 |
Current portion of deferred revenues |
|
— |
|
5,235 |
Warrant liability (current and non-current
portions) |
|
18,010 |
|
6,176 |
Non-financial non-current liabilities* |
|
16,880 |
|
52,479 |
Total liabilities |
|
42,132 |
|
74,360 |
Shareholders' equity (deficiency) |
|
17,064 |
|
(6,695) |
Total liabilities and shareholders' equity
(deficiency) |
|
59,196 |
|
67,665 |
_________________________ |
* |
Comprised mainly of non-current portion of deferred revenues,
employee future benefits and provisions. |
SOURCE Aeterna Zentaris Inc.