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.
Revenuesfor 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 lossfor 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 incomefor 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 equivalentstotalled $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.