Mr. David Dodd reports
AETERNA ZENTARIS REPORTS FOURTH QUARTER AND FULL-YEAR 2013 FINANCIAL AND OPERATING RESULTS
AEterna Zentaris Inc. has released its financial and operating
results as at and for the fourth quarter and the year ended Dec. 31, 2013.
All amounts are in U.S. dollars.
Revenues for the year ended Dec. 31, 2013, were $6.2-million, compared with $2.1-million for the same period in 2012. This increase is attributable to
the accelerated recognition of deferred revenues.
Research and development costs, net of refundable tax credits
and grants, for the three-month period ended Dec. 31, 2013, were
fairly stable at $5.3-million, compared with $5.5-million for the same
period in 2012. R&D costs, net of refundable tax credits and grants, for the year ended
Dec. 31, 2013, were $21.3-million, compared with $20.6-million for the
same period in 2012.
Net loss for the three-month period ended Dec. 31, 2013, was $8.2-million, or
22 cents per basic and diluted share, compared with $6.9-million, or 29
cents per basic and diluted share, for the same period in 2012. Net income for the year ended Dec. 31, 2013, was $6.8-million, or 24 cents per
basic and diluted share, compared with 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 Dec. 31, 2013, compared with $39.5-million as at Dec. 31, 2012. In January, 2014, subsequent to
year-end, the company completed a public offering of 11 million
units, generating net proceeds of approximately $12.2-million.
Juergen Ernst, chairman of the board, commented, "Two thousand thirteen 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's president and chief executive officer, commented: "Over the last 12
months we made great strides in the transition toward becoming an
operating biopharmaceutical company, filing the new drug application for Macrilena for
the evaluation of adult growth hormone deficiency 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 prelaunch activities for Macrilena 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
Macrilena (macimorelin)
A new drug application was accepted for filing by the U.S. Food and
Drug Administration with a Prescription Drug User Fee Act date
of Nov. 5, 2014. Currently under review, the NDA seeks approval for
the commercialization of Macrilena as the first available oral product
indicated for the evaluation of adult growth hormone deficiency.
Zoptarelin doxorubicin
The company has reached an agreement 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.
AEterna Zentaris has signed a co-development and profit-sharing agreement with Ergomed
Clinical Research Ltd. as the contract clinical development
organization for the current phase 3 ZoptEC trial. Ergomed has agreed
to assume 30 per cent (up to $10-million) of the clinical and regulatory costs
for this trial. In turn, Ergomed will receive a single-digit percentage
of future net income from the product in the endometrial cancer
indication, up to a prespecified amount.
The company has initiated 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) on 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, or outside
Canada, 888-231-8191. They may also listen through the Internet at
the company's website 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 the company's website in the "investors" section.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(in thousands of U.S. dollars, except per-share amounts)
Three months ended Year ended
Dec. 31, Dec. 31,
2013 2012 2013 2012 2011
Revenues
Sales $ - $ - $ 96 $ 834 $ 250
Licence 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)
We seek Safe Harbor.
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