All amounts are in US dollars
QUEBEC CITY,
May 8, 2014 /CNW Telbec/ - 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 first quarter ended
March 31, 2014.
Revenues for the three-month period ended March 31, 2014 were nil compared to $6.1 million for the same period in 2013 which
had resulted predominantly from the non-recurring, accelerated
recognition of remaining unamortized deferred revenue related to an
upfront payment received from a licensing partner following the
termination of related R&D activities.
Research and development ("R&D") costs, net of refundable
tax credits and grants, for the three-month period ended
March 31, 2014 were $5.8 million, compared to $4.4 million for the same period in 2013. A
substantial portion of the quarter-over-quarter increase in
third-party R&D costs relates to development initiatives
associated with zoptarelin doxorubicin, and in particular with the
Company's Phase 3 ZoptEC trial initiated in 2013 with its partner,
Ergomed Clinical Research Ltd. ("Ergomed").
Net (loss) income for the three-month period ended
March 31, 2014 was $(4.4) million, or $(0.08) per basic and diluted share, compared to
$1.9 million, or $0.07 per basic and diluted share, for the same
period in 2013. This decrease in net income is due largely to lower
revenues, higher operating expenses and higher net loss from
discontinued operations, partially offset by higher comparative net
finance income.
Cash and cash equivalents totalled $45.8 million as at March
31, 2014, compared to $43.2
million as at December 31,
2013. The increase in cash and cash equivalents is due to
the receipt of net proceeds of $12.2
million pursuant to a public offering and of $0.3 million pursuant to drawdowns made under an
"At-the-Market" ("ATM") sales agreement program entered into in
May 2013, partially offset by
variations in components of our working capital and by recurring
disbursements.
David Dodd, Aeterna Zentaris
President and CEO, commented, "For our pivotal ZoptEC Phase 3 trial
in endometrial cancer with zoptarelin doxorubicin, we have focused
our efforts on ensuring successful patient recruitment in support
of securing our first interim analysis in the first half of 2015.
We're pleased that the trial is on track from a patient recruitment
and site opening basis, having over 140 patients randomized and
over 100 sites in operation. As for MACRILEN™, for which our NDA is
currently in active review, we continued to refine our launch and
commercialization plan in the US as the first FDA approved oral
product for use in evaluating growth hormone deficiency in adults.
Over the remainder of the year, our primary focus will be on
finalizing our launch and commercialization preparation for
MACRILEN™, and continuing the successful site openings and patient
recruitment for the ZoptEC trial. In addition, we will continue to
aggressively pursue opportunities to in-license, acquire and/or
promote existing marketed products as part of our strategy to
transition into a commercial entity. Finally, we are very pleased
with the recent announcement of our selection of Charleston, SC as the location for our North
American and global commercial operations. We look forward to
operating out of that vibrant life sciences community as we focus
on providing patients with life-enhancing products and developing
long-term value for our shareholders and employees."
Dennis Turpin, CPA, CA, Senior
Vice President and Chief Financial Officer at Aeterna Zentaris
stated, "As at March 31, 2014,
we had a cash and cash equivalents position of $45.8 million which enables us to continue to
move our key product candidates through the pipeline."
Q1 2014 HIGHLIGHTS
Pipeline
MACRILEN™ (macimorelin)
- Filing of a New Drug Application ("NDA") seeking approval for
the commercialization of MACRILEN™ as the first available oral
product indicated for the evaluation of Adult Growth Hormone
Deficiency. NDA currently under substantive review by the US Food
and Drug Administration with a Prescription Drug User Fee Act date
of November 5, 2014.
Zoptarelin Doxorubicin
- Continued progress in site opening and patient recruitment for
the current Phase 3 ZoptEC (Zoptarelin
doxorubicin in Endometrial Cancer) trial in women
with locally advanced, recurrent or metastatic endometrial cancer.
Over 100 sites now open and over 140 patients recruited.
Appointment to Executive Management Team
- Appointment of Richard Sachse,
MD, PhD, as Senior Vice President, Chief Scientific Officer and
Chief Medical Officer. Dr. Sachse is responsible for all areas of
global research and development activities.
Public Offering
- Completion of a public offering of 11 million units, generating
net proceeds of approximately $12.2
million, with each unit consisting of one common share and
0.8 of a warrant to purchase one common share, at a purchase price
of $1.20 per unit.
CONFERENCE CALL
Management will be hosting a conference call for the investment
community beginning at 8:30 a.m. (Eastern
Time) tomorrow, Friday, May 9, 2014, to discuss the 2014
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 of
Financial Condition and Results of Operations for the first quarter
of 2014, 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 US
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
Condensed Interim Consolidated Statements of Comprehensive
(Loss) Income Information
|
Three months ended March 31, |
(in thousands,
except share and per share data) |
2014 |
|
2013 |
|
$ |
|
$ |
Revenues |
|
|
|
License fees and
other |
— |
|
6,062 |
|
— |
|
6,062 |
Operating
expenses |
|
|
|
Research and
development costs, net of refundable tax credits and grants |
5,830 |
|
4,401 |
Selling, general and
administrative expenses |
2,365 |
|
2,824 |
|
8,195 |
|
7,225 |
|
|
|
|
Loss from
operations |
(8,195) |
|
(1,163) |
|
|
|
|
Finance income |
4,919 |
|
2,166 |
Finance costs |
(1,028) |
|
— |
Net finance
income |
3,891 |
|
2,166 |
|
|
|
|
Net (loss) income
from continuing operations |
(4,304) |
|
1,003 |
Net (loss) income
from discontinued operations |
(52) |
|
883 |
Net (loss)
income |
(4,356) |
|
1,886 |
Other comprehensive
(loss) income: |
|
|
|
Items that may be
reclassified subsequently to profit or loss: |
|
|
|
|
Foreign currency translation
adjustments |
23 |
|
240 |
Items that will not be
reclassified to profit or loss: |
|
|
|
|
Actuarial loss on defined benefit
plans |
(959) |
|
— |
Comprehensive
(loss) income |
(5,292) |
|
2,126 |
Net (loss) income
per share (basic and diluted) from continuing operations |
(0.08) |
|
0.04 |
Net (loss) income
(basic and diluted) from discontinued operations |
0.00 |
|
0.03 |
Net (loss) income
(basic and diluted) per share |
(0.08) |
|
0.07 |
Weighted average
number of shares outstanding: |
|
|
|
Basic |
54,921,459 |
|
25,329,288 |
Diluted |
54,921,459 |
|
25,330,128 |
Condensed Interim Consolidated Statement of Financial
Position Information
|
As at March
31, |
|
As at
December 31, |
(in thousands) |
2014 |
|
2013 |
|
$ |
|
$ |
Cash and cash equivalents |
45,752 |
|
43,202 |
Trade and other receivables and other current
assets |
2,590 |
|
2,453 |
Restricted cash |
865 |
|
865 |
Property, plant and equipment |
1,250 |
|
1,351 |
Other non-current assets |
11,191 |
|
11,325 |
Total assets |
61,648 |
|
59,196 |
|
|
|
|
Payables and other current liabilities |
5,763 |
|
7,242 |
Warrant liability |
21,617 |
|
18,010 |
Non-financial non-current
liabilities1 |
17,841 |
|
16,880 |
Total liabilities |
45,221 |
|
42,132 |
Shareholders' equity |
16,427 |
|
17,064 |
Total liabilities and shareholders'
equity |
61,648 |
|
59,196 |
_________________________
1 Comprised mainly of employee future benefits and
provisions. |
SOURCE Aeterna Zentaris Inc.