Company to hold annual and special meeting of shareholders on
May 8, 2015
All amounts are in US dollars
QUEBEC CITY, May 7, 2015 /PRNewswire/ - Aeterna Zentaris
Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company"), a specialty
biopharmaceutical company engaged in developing and commercializing
novel treatments in oncology, endocrinology and women's health,
today reported financial and operating results for the first
quarter ended March 31, 2015.
Research and development ("R&D") costs, were
$4.5 million for the three-month
period ended March 31, 2015, compared
to $5.8 million for the same period
in 2014. This decrease is attributable to lower comparative
employee compensation and benefits costs, facilities rent and
maintenance as well as other costs. A substantial portion of this
decrease is due to the realization of cost savings in connection
with the Company's global resource optimization program as well as
the lower comparative exchange rate of the EUR against the US
dollar. This decrease was partly compensated by higher third-party
costs, mostly related to the Company's ZoptEC Phase 3 clinical
trial in endometrial cancer.
Selling, general and administrative ("SG&A") expenses
were $5.1 million for the three-month
period ended March 31, 2015, as
compared to $2.4 million for the same
period in 2014. This increase is attributable to the Company's
increased selling activities, associated with the co-promotion
efforts related to EstroGel®, with $1.1 million of first quarter 2015 expenses being
related to higher costs associated with Aeterna Zentaris'
contracted sales force and its own sales and marketing staff.
Additionally, approximately $0.8
million of the quarter-over-quarter increase is attributable
to transaction costs incurred in connection with the completion of
the March 2015 Offering. Other
increases are attributable in large part to lower comparative
foreign exchange gains.
Net loss for the three-month period ended March 31, 2015 was $9.7
million, or $0.13 per basic
and diluted share, compared to $4.4
million, or $0.08 per basic
and diluted share, for the same period in 2014. This increase in
net loss is due largely to higher comparative SG&A expenses and
to higher comparative net finance costs, partially offset by lower
comparative R&D costs.
Cash and cash equivalents totaled $53.3 million as at March
31, 2015, as compared to $34.9
million as at December 31,
2014.
David Dodd, Aeterna Zentaris
Chairman and CEO, commented, "During the quarter and in recent
weeks, both of our late-stage drug development programs reached
important milestones. As for zoptarelin doxorubicin, we received
the DSMB's recommendation to continue our ZoptEC Phase 3 clinical
trial in endometrial cancer as planned, following its first interim
analysis. Now, with over 90% of patients enrolled, we are well on
our way to completing patient recruitment earlier than expected,
and look forward to achieve a second interim analysis by year-end.
Regarding Macrilen™, after recommendations from the FDA and a panel
of endocrinology experts, we announced our decision to proceed with
a confirmatory Phase 3 efficacy clinical trial for the evaluation
of Adult Growth Hormone Deficiency that we expect to initiate
by year-end. At the commercial level, we've initiated the field
selling, in specific US territories, of EstroGel®,
Ascend Therapeutics' leading non-patch hormone replacement therapy
product. Our selling efforts associated with EstroGel®
are expected to result in successfully exceeding pre-established
unit sales baseline thresholds on a total Aeterna Zentaris national
basis. Furthermore, we just added another marketed product, EMD
Serono's Saizen®, for the treatment of growth hormone
deficiency, that we expect to shortly start promoting in specific
US markets. As part of our strategy to become a growth-oriented,
commercially operating specialty biopharmaceutical organization, we
expect to continue to evaluate potential in-licensing and/or
acquisition opportunities, as well as additional promotional or
co-promotional arrangements related to targeted commercial
products, while continuing to develop our key product candidates in
our existing pipeline. Finally, we accentuated the implementation
our global resources optimization program which has resulted in
significant personnel reduction and increased overall
flexibility."
Dennis Turpin, Chief Financial
Officer of the Company added, "With our cash and cash equivalents
position of $53.3 million as at
March 31, 2015, and our controlled
burn rate, the Company has a solid financial position upon which it
can advance its strategic initiatives."
1Q 2015 Highlights
Product Candidate Developments
Zoptarelin Doxorubicin
- On April 27, 2015, the Company
announced that an independent Data and Safety Monitoring Board
("DSMB") for the pivotal Phase 3 ZoptEC (Zoptarelin
Doxorubicin in Endometrial Cancer) clinical trial in
women with advanced, recurrent or metastatic endometrial cancer,
had completed a pre-specified first interim futility analysis. The
DSMB has recommended that the Phase 3 clinical trial continue as
planned. Site initiation for this trial has been completed with
over 120 sites currently in operation and over 465 of the expected
500 patients have been entered into the trial.
- Also, subsequent to quarter-end, the Company announced filing
of an application for a European Patent on a novel method of
manufacturing zoptarelin doxorubicin. The claimed manufacturing
process is expected to result in a significant reduction in cost of
goods sold, providing a stronger competitive position for the
Company.
Macrilen™ (macimorelin)
- On April 13, 2015, subsequent to
quarter-end, the Company announced plans to conduct a new,
confirmatory Phase 3 clinical trial to demonstrate the efficacy of
Macrilen™, a novel orally-active ghrelin agonist for use in
evaluating adult growth hormone deficiency ("AGHD"), as well as a
dedicated thorough QT study to evaluate the effect of Macrilen™ on
myocardial repolarization.
Discovery Library
- On March 31, 2015, the Company
announced the transfer of its discovery library of roughly 100,000
unique compounds to the South Carolina Center for Therapeutic
Discovery and Development (the "Center") which is part of The
Medical University of South Carolina.
The Center has agreed to conduct screening and pre-clinical
activities with respect to the library with a view toward
submitting to the Company at least one development candidate per
year in its areas of therapeutic interest over a ten-year period
beginning in 2018. The Company will also have a right of first
refusal to license the development candidates.
Commercial Developments
- During the first quarter, the Company's contract sales
representatives initiated calling on prescribing physicians in
their respective US territories as part of Aeterna Zentaris'
co-promotion activities for EstroGel®. Subsequent to
quarter-end, Aeterna Zentaris' sales force began exceeding
pre-established unit sales baseline thresholds on a total nation
basis.
- On May 7, 2015, subsequent to
quarter-end, the Company announced that it had entered into a
promotional services agreement with EMD Serono, Inc., allowing
Aeterna Zentaris to promote Saizen® [somatropin (rDNA
origin) for injection] to designated medical professionals in
specified US territories. Saizen® is a recombinant human
growth hormone registered in the US for the treatment of growth
hormone deficiency in children and adults. Under this agreement,
Aeterna Zentaris will detail Saizen® to designated
medical professionals, representing an important incremental field
promotion activity in support of the EMD Serono's product. Payment
to Aeterna Zentaris will be based on new, eligible patient starts
on Saizen® above an agreed-upon baseline. Aeterna
Zentaris has subcontracted with ASCEND, pursuant to the
co-promotion agreement, to detail Saizen® in territories
not covered by the Company's contracted sales force.
Corporate Developments
Public Offering
- On March 11, 2015, the Company
completed a public offering of 59.7 million units, generating net
proceeds of approximately $34.4
million, with each unit consisting of either one common
share or one warrant to purchase one common share, 0.75 of a
warrant to purchase one common share and 0.50 of a warrant to
purchase one common share, at a purchase price of $0.62 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 8, 2015, to discuss the 2015
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
2015, as well as the Company's consolidated financial statements,
can be found at www.aezsinc.com in the "Investors" section.
Annual and Special Shareholders Meeting
The Company will hold an Annual and Special Shareholders Meeting
also on Friday, May 8, 2015, starting
at 10:30 a.m., Eastern Time, at the
offices of Norton Rose Fulbright
Canada, 1 Place Ville-Marie, Suite 2500, in Montreal, Canada.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women's health. For more information,
visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor 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 and clinical trials, 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, the ability to protect our intellectual property, the
potential of liability arising from shareholder lawsuits 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 place undue reliance 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
Information
|
|
|
Three months ended
March 31,
|
|
|
|
|
(in
thousands)
|
2015
|
|
2014
|
|
$
|
|
$
|
Revenues
|
|
|
|
License
fees
|
73
|
|
—
|
Operating
expenses
|
|
|
|
Research and
development costs
|
4,466
|
|
5,830
|
Selling, general and
administrative expenses
|
5,143
|
|
2,365
|
|
9,609
|
|
8,195
|
Loss from
operations
|
(9,536)
|
|
(8,195)
|
Finance
income
|
1,374
|
|
4,919
|
Finance
costs
|
(1,474)
|
|
(1,028)
|
Net finance
(costs) income
|
(100)
|
|
3,891
|
Net loss from
continuing operations
|
(9,636)
|
|
(4,304)
|
Net loss from
discontinued operations
|
(100)
|
|
(52)
|
Net
loss
|
(9,736)
|
|
(4,356)
|
Other
comprehensive income (loss):
|
|
|
|
Items that may be
reclassified subsequently to profit or loss:
|
|
|
|
|
Foreign currency
translation adjustments
|
1,775
|
|
23
|
Items that will not
be reclassified to profit or loss:
|
|
|
|
|
Actuarial loss on
defined benefit plans
|
(1,301)
|
|
(959)
|
Comprehensive
loss
|
(9,262)
|
|
(5,292)
|
Net loss per share
(basic and diluted) from continuing operations
|
(0.13)
|
|
(0.08)
|
Net loss per share
(basic and diluted) from discontinued operations
|
—
|
|
—
|
Net loss (basic
and diluted) per share
|
(0.13)
|
|
(0.08)
|
Weighted average
number of shares outstanding:
|
|
|
|
Basic
|
71,653,626
|
|
54,921,459
|
Diluted
|
71,653,626
|
|
54,921,459
|
Condensed Interim
Consolidated Statement of Financial Position
Information
|
|
|
|
|
|
As at March
31,
|
|
As at December
31,
|
(in
thousands)
|
2015
|
|
2014
|
|
$
|
|
$
|
Cash and cash
equivalents1
|
53,259
|
|
34,931
|
Trade and other
receivables and other current assets
|
2,292
|
|
1,286
|
Restricted cash
equivalents
|
674
|
|
760
|
Property, plant and
equipment
|
529
|
|
797
|
Other non-current
assets
|
8,520
|
|
9,661
|
Total
assets
|
65,274
|
|
47,435
|
Payables and other
current liabilities2
|
6,078
|
|
7,304
|
Current portion of
deferred revenues
|
239
|
|
270
|
Warrant
liability
|
22,151
|
|
8,225
|
Non-financial
non-current liabilities3
|
16,425
|
|
17,152
|
Total
liabilities
|
44,893
|
|
32,951
|
Shareholders'
equity
|
20,381
|
|
14,484
|
Total liabilities
and shareholders' equity
|
65,274
|
|
47,435
|
_________________________
1
|
Of which
approximately $2.4 million was denominated in EUR as at March 31,
2015 ($3.6 million as at December 31, 2014)
|
2
|
Of which
approximately $0.5 million is related to our provision for
restructuring costs as at March 31, 2015 ($1.5 million as at
December 31, 2014).
|
3
|
Comprised mainly of
employee future benefits and provisions for onerous
contracts.
|
SOURCE Aeterna Zentaris Inc.