All amounts are in U.S. dollars (unless otherwise
noted)
QUEBEC CITY,
May 7, 2013 /CNW Telbec/ - Aeterna
Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company"), a
late‑stage drug development company specializing in oncology and
endocrinology, today reported financial and operating results as at
and for the first quarter ended March 31,
2013.
Key Drug Developments
AEZS-108 (Doxorubicin Peptide Conjugate)
- First patient treated for Phase 2 trial in triple-negative
breast cancer. Alberto J. Montero,
MD, Assistant Professor, Department of Medicine, Division of
Hematology/Oncology, Sylvester Comprehensive Cancer Center at the
University of Miami Miller School of
Medicine, is the lead investigator of this trial which also
includes sites at the Universities of Regensburg and Goettingen in
Germany.
- Subsequent to quarter-end, a co-development and profit-sharing
agreement was signed with Ergomed Clinical Research Ltd.
("Ergomed") as the contract clinical development organization for
the upcoming Phase 3 trial for AEZS‑108 in endometrial cancer.
Under the terms of the agreement, Ergomed will assume 30% (up to
$10 million) of the clinical and
regulatory costs for this trial, which are estimated at
approximately $30 million over
the course of the study. Ergomed will be entitled to receive an
agreed upon single-digit percentage of any net income received by
the Company for AEZS-108 in this indication, up to a specified
maximum amount. This is an open-label, randomized, multicenter
trial to be conducted in North
America, Europe,
Israel and other countries under a
Special Protocol Assessment ("SPA"). The trial will compare
AEZS-108 with doxorubicin as second line therapy for
locally-advanced, recurrent or metastatic endometrial cancer. The
trial will involve approximately 500 patients and the primary
efficacy endpoint is improvement in median Overall Survival
("OS").
AEZS-130 (Oral Ghrelin Agonist)
- Ongoing preparation of a New Drug Application ("NDA")
submission to the U.S. Food and Drug Administration ("FDA") for
AEZS‑130 as an oral diagnostic test for Adult Growth Hormone
Deficiency ("AGHD"). Phase 3 data have demonstrated that the
compound has the potential to become the first orally-approved
diagnostic test for AGHD, with accuracy comparable to available
testing procedures.
Perifosine (Oral AKT Inhibitor)
- Phase 3 trial in multiple myeloma was discontinued after an
interim analysis by an independent Data Safety Monitoring Board
("DSMB") reported that it was highly unlikely the study would
achieve a significant difference in its primary endpoint,
progression-free survival. The Company will not make any further
investment in the development of perifosine. Should its partners
decide to continue its development, the Company will provide them
with perifosine in return for a service fee.
Key Corporate Developments
Appointment of New President and CEO
- Subsequent to quarter-end, David A.
Dodd was appointed President and Chief Executive Officer of
the Company. Mr. Dodd was also appointed to its Board of
Directors. Mr. Dodd's executive management experience in the
pharmaceutical and biotechnology industries spans more than 35
years. Before joining the Company, he was President, CEO and
Chairman of BioReliance Corporation, a leading provider of
biological safety and related testing services. During his six-year
tenure as President, CEO and Director of Serologicals Corporation,
the market value of that company increased from $85 million to an all-cash sale to Millipore
Corporation for $1.5 billion.
That successful transformation followed his five-year term as
President and CEO of Solvay Pharmaceuticals, Inc. and as Chairman
of its subsidiary Unimed Pharmaceuticals, Inc. Mr. Dodd also
held various senior management positions at Wyeth-Ayerst
Laboratories, the Mead Johnson Laboratories Division at
Bristol-Myers Squibb, and Abbott Laboratories. Mr. Dodd holds a
Master's degree from Georgia State
University, and completed the Harvard
Business School of Advanced Management Program.
Cetrotide® Manufacturing Rights
- In April 2013, the Company
announced binding agreements with various partners and licensees
with respect to the manufacturing rights and obligations for
Cetrotide®, currently marketed for in vitro
fertilization. The principal effect of such agreements is to
transfer the manufacturing rights and to grant a manufacturing
license for Cetrotide® to a subsidiary of Merck KGaA of
Darmstadt, Germany ("Merck
Serono"), in all jurisdictions. The transactions are expected to be
completed on or about October 1,
2013, at which time Zentaris IVF GmbH, a direct wholly-owned
subsidiary of Aeterna Zentaris GmbH ("AEZS Germany") would receive
a one-time payment of €2.5 million, or approximately $3.2 million, as well as certain other
payments related to current assets and equipment to be transfered.
In addition, AEZS Germany and Zentaris IVF GmbH also entered into a
transitional services agreement with Merck Serono under which the
Company will, during a 36-month period, provide various transition
services to assist Merck Serono in assuming responsibility for the
manufacturing of Cetrotide® in consideration for the
payment of a monthly fee to Zentaris IVF GmbH throughout such
period. The Company had previously monetized the royalty stream
related to Cetrotide® in November
2008 in a transaction with HealthCare Royalty Partners L.P.
(formerly Cowen Healthcare Royalty Partners L.P.).
Cash and cash equivalents totalled $33.2 million as at March 31, 2013, compared to $39.5 million as at December 31, 2012.
David A. Dodd, Aeterna Zentaris
President and Chief Executive Officer, commented, "I am very proud
and delighted to join Aeterna Zentaris. I believe that with our
highly motivated staff, as well as our innovative pipeline
augmented by business development, we can achieve long-term growth
and profitability which will benefit both patients and
shareholders. My short-term goals include successfully starting
patient recruitment for the Phase 3 trial in endometrial cancer
with AEZS-108, submitting the NDA for AEZS-130 as an oral
diagnostic test for AGHD and, ensuring that we deliver on the
commitments we make. We hold very highly our responsibility to
delivering on these activities and demonstrating our commitment to
all our stakeholders."
Dennis Turpin, CPA, CA, Senior
Vice President and Chief Financial Officer at Aeterna Zentaris
stated, "Based on our current expectations and with $33.2 million in cash and cash equivalent as
at March 31, 2013, we believe we have
sufficient capital resources to fund our planned operations for at
least the next twelve months."
CONSOLIDATED RESULTS AS AT AND FOR THE FIRST QUARTER ENDED
MARCH 31, 2013
Revenues were $16.6 million for the three-month period
ended March 31, 2013, compared
to $9.5 million for the same
period in 2012. The increase is largely attributable to comparative
higher deliveries of Cetrotide® to certain customers and
to the recognition of unamortized deferred revenues related to
upfront payments received from our licensee partners in connection
with perifosine, following the Company's decision to discontinue
the Phase 3 trials of perifosine.
R&D costs, net of refundable tax credits and grants
were $4.4 million for the
three-month period ended March 31,
2013, compared to $5.6 million for the same period in 2012.
The decrease is attributable to lower employee compensation and
benefit costs due to continued cost-saving measures resulting in a
lower number of employees. The decrease is also related to
comparative lower third-party costs associated with the development
of most of the Company's products.
Selling, general and administrative ("SG&A") expenses
were $3.8 million for the
three-month period ended March 31,
2013, compared to $3.2 million for the same period in
2012.
Net income (loss) for the three-month period ended
March 31, 2013 was $1.9 million or $0.07 per basic and diluted share, compared to
$(11.5) million or $(0.65) per basic and diluted share for the same
period in 2012. The significant increase in net income is due
largely to the significant increases in license fees revenues
(non-cash) and in net finance income (non‑cash), as well as to
lower net R&D costs, partly compensated by higher SG&A.
CONFERENCE CALL
Management will be hosting a conference call for the investment
community beginning at 8:30 a.m. (Eastern
Time) tomorrow, Wednesday, May 8, 2013, to discuss the 2013
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
("MD&A") for the first quarter 2013 with the associated
Unaudited Interim Condensed Consolidated Financial Statements can
be found at www.aezsinc.com in the Investors section.
About Aeterna Zentaris Inc.
Aeterna Zentaris is an oncology and endocrinology drug
development company currently investigating treatments for various
unmet medical needs. The Company's pipeline encompasses compounds
at all stages of development, from drug discovery through to
marketed products. For more information please visit
www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbour provisions of the U.S. 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 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
Interim Consolidated Statements of Comprehensive Income
(Loss) Information
|
|
Three months ended
March 31, |
(in thousands, except share and per share
data) |
|
2013 |
|
2012 |
|
|
$ |
|
$ |
Revenues |
|
|
|
|
Sales and royalties |
|
10,209 |
|
8,308 |
License fees and other |
|
6,390 |
|
1,202 |
|
|
16,599 |
|
9,510 |
Operating expenses |
|
|
|
|
Cost of sales |
|
8,684 |
|
7,513 |
Research and development costs, net of refundable
tax credits and grants |
|
4,401 |
|
5,572 |
Selling, general and administrative expenses |
|
3,794 |
|
3,213 |
|
|
16,879 |
|
16,298 |
|
|
|
|
|
Loss from operations |
|
(280) |
|
(6,788) |
|
|
|
|
|
Finance income |
|
2,166 |
|
76 |
Finance costs |
|
— |
|
(4,739) |
Net finance income (costs) |
|
2,166 |
|
(4,663) |
Income (loss) before income taxes |
|
1,886 |
|
(11,451) |
Income tax expense |
|
— |
|
— |
|
|
|
|
|
Net income (loss) |
|
1,886 |
|
(11,451) |
Other comprehensive income (loss): |
|
|
|
|
Items that may be reclassified subsequently to
profit or loss |
|
|
|
|
Foreign currency translation adjustments |
|
240 |
|
(255) |
Comprehensive income (loss) |
|
2,126 |
|
(11,706) |
Net income (loss) per share |
|
|
|
|
Basic |
|
0.07 |
|
(0.65) |
Diluted |
|
0.07 |
|
(0.65) |
Weighted average number of shares
outstanding |
|
|
|
|
Basic |
|
25,329,288 |
|
17,669,474 |
Diluted |
|
25,330,128 |
|
17,669,474 |
Interim Consolidated Statement of Financial Position
Information
|
|
As at March 31, |
|
As at December 31, |
(in thousands) |
|
2013 |
|
2012 |
|
|
$ |
|
$ |
Cash and cash equivalents |
|
33,183 |
|
39,521 |
Trade and other receivables and other current
assets |
|
12,449 |
|
13,780 |
Restricted cash |
|
806 |
|
826 |
Property, plant and equipment |
|
1,964 |
|
2,147 |
Other non-current assets |
|
10,992 |
|
11,391 |
Total assets |
|
59,394 |
|
67,665 |
|
|
|
|
|
Payables and other current liabilities |
|
13,701 |
|
15,675 |
Long-term payable (current and non-current
portions) |
|
— |
|
30 |
Warrant liability |
|
4,419 |
|
6,176 |
Non-financial non-current liabilities* |
|
45,235 |
|
52,479 |
Total liabilities |
|
63,355 |
|
74,360 |
Shareholders' deficiency |
|
(3,961) |
|
(6,695) |
Total liabilities and shareholders'
deficiency |
|
59,394 |
|
67,665 |
_________________________
* Comprised mainly of non-current portion of deferred
revenues, employee future benefits and provision.
SOURCE AETERNA ZENTARIS INC.