All amounts are in US dollars
QUEBEC CITY, Aug. 7,
2014 /PRNewswire/ - Aeterna Zentaris Inc.
(NASDAQ: AEZS) (TSX: AEZ) (the "Company"), a specialty
biopharmaceutical company engaged in developing and commercializing
novel treatments in oncology and endocrinology, today reported
financial and operating results as at and for the second quarter
ended June 30, 2014.
Research and development ("R&D") costs, net of refundable
tax credits and grants, for the three-month period ended
June 30, 2014 were $5.5 million compared to $5.3 million for the same period in 2013.
Selling, general and administrative ("SG&A") expenses
were $2.9 million for the three-month
period ended June 30, 2014, compared
to $4.4 million for the same period
in 2013. The decrease in SG&A expenses is mainly related to the
recognition in the second quarter of 2013 of non-recurring
termination benefits (approximately $1.4
million) and to the recording of related non-cash
share-based compensation costs, amounting to approximately
$0.7 million.
Net loss for the three-month period ended June 30, 2014 was $5.0
million compared to a net income of $9.3 million for the same period in 2013. The
decrease in net income is due largely to lower net income from
discontinued operations related to the Company's former
Cetrotide® business, partially offset by lower
comparative operating expenses and by higher comparative net
finance income.
Cash and cash equivalents totaled $39.6 million as at June
30, 2014, compared to $43.2
million as at December 31,
2013.
David Dodd, Chairman and CEO of
Aeterna Zentaris, commented, "During the quarter, our main focus
was on refining our launch and commercialization plan for Macrilen™
in the U.S., and on patient recruitment for our ongoing ZoptEC
Phase 3 trial in endometrial cancer with zoptarelin doxorubicin.
For Macrilen™, we continued our focus on issues such as cost of
goods, manufacturing, packaging, distribution and reimbursement,
while building our core business team based in Charleston, South Carolina. The NDA for
Macrilen™ continues to be under review, with a PDUFA date of
November 5 of this year, and we have
been in continued discussions with the FDA; if approved, Macrilen™
would become the first FDA approved oral drug for use in evaluating
AGHD. Regarding the ZoptEC Phase 3 trial, we are very pleased with
the pace at which we have been opening sites and recruiting
patients with over 115 sites now in operation and over 230 patients
recruited. At this rate, we are on track to reach the number of
patients required to secure our first interim analysis in the first
half of 2015. Also during the quarter, we announced the
implementation of a global resources optimization program to
streamline R&D activities, increase commercial operations and
flexibility, ultimately reduce our operating cash burn and more
appropriately, align our financial resources with our strategic
goal of transitioning into a commercially operating specialty
biopharmaceutical company. Finally, we have intensified our
business development efforts, which have already resulted in the
signing of a co-promotion agreement with Ascend Therapeutics to
co-promote EstroGel® and to jump start our commercial
activities. Further, we intend to pursue other opportunities,
including in-licensing transactions, product acquisitions or other
co-promotional arrangements, throughout the remainder of the
year."
Dennis Turpin, CFO of Aeterna
Zentaris commented, "With our cash position, combined with the
streamlining of our R&D activities, we are able to continue to
advance our strategic programs and reach our near-term milestones
related to Macrilen™ and zoptarelin doxorubicin."
Q2 2014 HIGHLIGHTS
Pipeline
Macrilen™ (macimorelin)
- Continued discussions with the FDA and provided the agency with
further information regarding the New Drug Application ("NDA")
review for Macrilen™, which seeks approval as the first
orally-administered drug for the evaluation of Adult Growth Hormone
Deficiency ("AGHD"). Prescription Drug User Fee Act ("PDUFA") date
set for November 5, 2014.
- Continued pre-commercialization activities for Macrilen™ with
the hiring of new employees and a specialized third-party firm
dedicated to this process.
Zoptarelin Doxorubicin
- Additional sites opened and patients recruited for the current
ZoptEC (Zoptarelin doxorubicin in Endometrial
Cancer) Phase 3 trial in endometrial cancer. Currently, over
115 sites are in operation and over 230 patients have been entered
into this trial.
- Poster presented on the design of the ZoptEC Phase 3 trial
in endometrial cancer at the annual meeting of the American Society
of Clinical Oncology in Chicago.
AEZS-134
- Poster on AEZS-134, a highly potent and selective ATP
competitive Erk inhibitor, entitled, "Erk Inhibition as a
Therapeutic Option for the Treatment of Raf- and Mek-Inhibitor
Resistant Tumors", was presented at the American Association
for Cancer Research annual meeting, providing rationale for a
potential treatment option for patients suffering from tumors which
are resistant to currently established therapies such as B-Raf and
Mek inhibitors.
Corporate Developments
- Relocation of U.S. operations to Charleston, South Carolina.
- In May, the Company entered into an At-the-Market ("ATM") Sales
Agreement (the "May 2014 ATM
Program"), with MLV & Co. LLC, under which the Company may, at
its discretion, from time to time during the term of the sales
agreement, sell up to a maximum of 14,018,692 million of its common
shares through ATM issuances on the NASDAQ, up to an aggregate
amount of $15 million.
- Subsequent to quarter-end, between July
1, 2014 and August 7, 2014,
the Company issued a total of approximately 1.4 million common
shares under the May 2014 ATM Program
for aggregate gross proceeds of $1.7
million, less cash transaction costs of $44,000 and previously deferred transaction costs
of $8,000.
- Subsequent to quarter-end, signing of a co-promotion services
agreement with Ascend Therapeutics. Under the terms of the
agreement, Aeterna Zentaris will market Ascend's hormone
replacement therapy product, EstroGel®, in specific
agreed-upon U.S. territories in exchange for a sales commission.
Ascend will render similar services regarding Aeterna Zentaris'
Macrilen™, an oral product used in the evaluation of AGHD,
following its regulatory approval.
- Subsequent to quarter-end, approval of a global resources
optimization program (the "Program") as part of the Company's
objective to transition into a commercially operating specialty
biopharmaceutical company, by streamlining R&D activities and
increasing commercial operations and flexibility. Termination of 30
employees, representing approximately one-third of current staffing
is expected to be completed over a period of approximately 12
months. Upon completion of the Program, overall annualized savings
are expected to amount to approximately $2.2
million.
CONFERENCE CALL
Management will be hosting a conference call for the investment
community beginning at 8:30 a.m. (Eastern
Time) tomorrow, Friday, August 8, 2014, to discuss the 2014
second 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 second
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 and commercializing 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 June 30, |
Six months ended
June 30, |
(in thousands, except share and per
share data) |
|
2014 |
|
2013 |
|
2014 |
|
2013 |
|
|
$ |
|
$ |
|
$ |
|
$ |
Revenues |
|
|
|
|
|
|
|
|
Sales and royalties |
|
— |
|
96 |
|
— |
|
96 |
License fees and other |
|
— |
|
— |
|
— |
|
6,062 |
|
|
— |
|
96 |
|
— |
|
6,158 |
Operating expenses |
|
|
|
|
|
|
|
|
Cost of sales |
|
— |
|
51 |
|
— |
|
51 |
Research and development costs, net of
refundable tax credits and grants |
|
5,462 |
|
5,308 |
|
11,292 |
|
9,709 |
Selling, general and administrative
expenses |
|
2,948 |
|
4,430 |
|
5,313 |
|
7,254 |
|
|
8,410 |
|
9,789 |
|
16,605 |
|
17,014 |
Loss from operations |
|
(8,410) |
|
(9,693) |
|
(16,605) |
|
(10,856) |
Finance income |
|
3,161 |
|
379 |
|
7,150 |
|
2,183 |
Finance costs |
|
— |
|
(534) |
|
(98) |
|
(172) |
Net finance income (costs) |
|
3,161 |
|
(155) |
|
7,052 |
|
2,011 |
Net loss from continuing
operations |
|
(5,249) |
|
(9,848) |
|
(9,553) |
|
(8,845) |
Net income from discontinued
operations |
|
225 |
|
19,178 |
|
173 |
|
20,061 |
Net (loss) income |
|
(5,024) |
|
9,330 |
|
(9,380) |
|
11,216 |
Other comprehensive (loss)
income: |
|
|
|
|
|
|
|
|
Items that may be reclassified
subsequently to profit or loss: |
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments |
|
(117) |
|
(141) |
|
(94) |
|
99 |
Items that will not be reclassified to
profit or loss: |
|
|
|
|
|
|
|
|
|
Actuarial loss on defined benefit plans |
|
(1,111) |
|
— |
|
(2,070) |
|
— |
Comprehensive (loss)
income |
|
(6,252) |
|
9,189 |
|
(11,544) |
|
11,315 |
Net loss per share (basic and
diluted) from continuing operations |
|
(0.09) |
|
(0.39) |
|
(0.17) |
|
(0.35) |
Net income per share (basic and
diluted) from discontinued operations |
|
— |
|
0.75 |
|
— |
|
0.79 |
Net (loss) income per share (basic
and diluted) |
|
(0.09) |
|
0.36 |
|
(0.17) |
|
0.44 |
Weighted average number of shares
outstanding : |
|
|
|
|
|
|
|
|
Basic |
|
56,513,969 |
|
25,542,263 |
|
55,722,113 |
|
25,436,364 |
Diluted |
|
56,513,969 |
|
25,542,263 |
|
55,722,113 |
|
25,436,385 |
Condensed Interim Consolidated Statement of Financial
Position Information
|
|
As at June 30, |
|
As at December 31, |
(in thousands) |
|
2014 |
|
2013 |
|
|
$ |
|
$ |
Cash and cash equivalents |
|
39,553 |
|
43,202 |
Trade and other receivables and other current
assets |
|
1,971 |
|
2,453 |
Restricted cash |
|
860 |
|
865 |
Property, plant and equipment |
|
829 |
|
1,351 |
Other non-current assets |
|
10,927 |
|
11,325 |
Total assets |
|
54,140 |
|
59,196 |
|
|
|
|
|
Payables and other current liabilities |
|
5,668 |
|
7,242 |
Warrant liability |
|
19,427 |
|
18,010 |
Non-financial non-current
liabilities1 |
|
18,796 |
|
16,880 |
Total liabilities |
|
43,891 |
|
42,132 |
Shareholders' equity |
|
10,249 |
|
17,064 |
Total liabilities and shareholders'
equity |
|
54,140 |
|
59,196 |
_________________________
1 Comprised mainly of employee future benefits
and provisions.
SOURCE Aeterna Zentaris Inc.