All amounts are in U.S. dollars (unless otherwise
noted)
QUEBEC CITY,
Nov. 5, 2013 /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 three months ended
September 30, 2013.
Key Highlights
Zoptarelin Doxorubicin (AEZS-108)
- Initiation of patient dosing in the Phase 3 "ZoptEC"
(Zoptarelin doxorubicin in Endometrial Cancer)
trial in women with endometrial cancer resistant to
platinum/taxane-based chemotherapy.
Macimorelin Acetate (AEZS-130)
- Subsequent to quarter-end, submission of a New Drug Application
("NDA") to the United States Food and Drug Administration ("FDA")
for macimorelin acetate for the evaluation of Adult Growth Hormone
Deficiency ("AGHD").
Cetrotide®
- Subsequent to quarter-end, successful completion of the
transfer of Cetrotide® manufacturing rights in all
territories to Merck Serono, in exchange for an upfront payment of
€2.5 million (approximately $3.3
million).
"At-the-Market" Issuance Program
- Between May 21, 2013 and
November 5, 2013, the Company sold a
total of approximately 1.5 million common shares under its
At-the-Market ("ATM") sales program at an average price of
$1.80 per share, for aggregate gross
proceeds of approximately $2.7
million. This includes approximately 0.8 million common
shares at an average price of $1.50 per share, for aggregate gross proceeds of
approximately $1.2 million,
between July 1 and November 5, 2013.
This ATM allows the Company to sell up to a maximum of 2.5 million
common shares through ATM issuances on the NASDAQ Capital
Market® for aggregate gross proceeds not to exceed
$4.6 million.
Registered Direct Offering
- Completion of a registered direct offering of 5.2 million units
at a purchase price of $1.50 per
unit, generating net proceeds of approximately $7 million.
Appointment to Management Team
- Subsequent to quarter-end, appointment of Jude Dinges as Senior Vice President, Chief
Commercial Officer.
Cash and cash equivalents totalled $24.8 million as at September 30, 2013, compared to $39.5 million as at December 31, 2012.
David Dodd, Aeterna Zentaris
President and Chief Executive Officer, commented, "We have spent
the last few months conducting an in-depth review of all our
R&D and corporate activities leading to our new strategic
vision for the Company: transform Aeterna Zentaris into a
biopharmaceutical operating company through the commercialization
of our pipeline, as well as by pursuing in‑licensing and
acquisition opportunities. To that effect, we have submitted a NDA
for macimorelin acetate as potentially the first approved oral
product for the evaluation of AGHD, we have appointed a Chief
Commercial Officer responsible for all macimorelin acetate
branding, marketing and sales activities, as well as for overseeing
future commercial opportunities. We have also prioritized projects
such as the ZoptEC Phase 3 trial in endometrial cancer and the
Phase 2 investigator-driven trials in prostate and breast cancer
with zoptarelin doxorubicin, while deciding to stop the Phase 2
trial in bladder cancer with this product, and transferring the
manufacturing rights related to Cetrotide® to Merck
Serono for $3.3 million. Also, we
continue to review opportunities to better align our resources with
our business priorities to ensure that our investments reflect our
focus on achieving success as a biopharmaceutical operating
company. In that regard, we have taken concrete actions, and in the
months ahead, we will continue focusing all our efforts towards
achieving our new strategic vision for the Company."
Dennis Turpin, CPA, CA, Senior
Vice President and Chief Financial Officer at Aeterna Zentaris
stated, "As of September 30,
2013, we had a cash and cash equivalents position of
$24.8 million which enables us to
continue to move our key product candidates through the
pipeline."
CONSOLIDATED RESULTS AS AT AND FOR THE THIRD QUARTER ENDED
SEPTEMBER 30, 2013
Revenues were $21.1 million
for the three-month period ended September 30, 2013, compared to $7.1 million for the same period in 2012. The
increase is largely attributable to the acceleration of the
recognition of previously deferred revenues received in connection
with the 2008 sale of the Cetrotide® royalty stream to
HealthCare Royalty Partners L.P.
R&D costs, net of refundable tax credits and grants
were $6.2 million for the
three-month period ended September 30,
2013, compared to $4.3 million for the same period in 2012.
The increase is attributable to higher third-party costs associated
with the development of the Company's products.
Selling, general and administrative ("SG&A") expenses
were $3.0 million for the
three-month period ended September 30,
2013, compared to $2.9 million for the same period in
2012.
Net income (loss) for the three-month period ended
September 30, 2013 was
$3.8 million or $0.13 per basic and diluted share, compared to
$(6.6) million or $(0.35) per basic and diluted share for the same
period in 2012. The significant increase is due largely to the
significant increases in royalties revenues (non-cash), as
mentioned above, and in net financed income (non-cash), partly
offset by higher net R&D costs.
CONFERENCE CALL
Management will be hosting a conference call for the investment
community beginning at 8:30 a.m. (Eastern
Time) tomorrow, Wednesday, November 6, 2013, to discuss the
2013 third 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 third 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
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing novel treatments in oncology and
endocrinology. The Company's pipeline encompasses compounds from
drug discovery to regulatory approval. 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 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
September 30, |
|
Nine months
ended
September 30, |
(in thousands,
except share and per share data) |
2013 |
|
2012 |
|
2013 |
|
2012 |
|
$ |
|
$ |
|
$ |
|
$ |
Revenues |
|
|
|
|
|
|
|
Sales and royalties |
20,834 |
|
6,826 |
|
60,794 |
|
22,373 |
License fees and other |
225 |
|
313 |
|
6,951 |
|
1,747 |
|
21,059 |
|
7,139 |
|
67,745 |
|
24,120 |
Operating expenses |
|
|
|
|
|
|
|
Cost of sales |
8,860 |
|
5,556 |
|
26,982 |
|
19,331 |
Research and development costs, net of
refundable tax credits and grants |
6,230 |
|
4,342 |
|
15,947 |
|
15,081 |
Selling, general and administrative
expenses |
2,976 |
|
2,921 |
|
12,618 |
|
9,776 |
|
18,066 |
|
12,819 |
|
55,547 |
|
44,188 |
|
|
|
|
|
|
|
|
Income (loss) from
operations |
2,993 |
|
(5,680) |
|
12,198 |
|
(20,068) |
Finance income |
1,384 |
|
34 |
|
3,567 |
|
6,603 |
Finance costs |
(535) |
|
(908) |
|
(707) |
|
— |
Net finance income (costs) |
849 |
|
(874) |
|
2,860 |
|
6,603 |
Net income (loss) |
3,842 |
|
(6,554) |
|
15,058 |
|
(13,465) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
Items that may be reclassified
subsequently to profit or loss |
|
|
|
|
|
|
|
|
Foreign currency translation adjustments |
550 |
|
(97) |
|
649 |
|
(300) |
Comprehensive income
(loss) |
4,392 |
|
(6,651) |
|
15,707 |
|
(13,765) |
Net income (loss) per
share |
|
|
|
|
|
|
|
Basic |
0.13 |
|
(0.35) |
|
0.56 |
|
(0.74) |
Diluted |
0.13 |
|
(0.35) |
|
0.56 |
|
(0.74) |
Weighted average number of shares
outstanding |
|
|
|
|
|
|
|
Basic |
29,627,222 |
|
18,703,023 |
|
26,848,668 |
|
18,295,555 |
Diluted |
29,627,222 |
|
18,703,023 |
|
26,848,668 |
|
18,295,555 |
Interim Consolidated Statement of Financial Position
Information
|
|
As at September 30, |
|
As at December 31, |
(in thousands) |
|
2013 |
|
2012 |
|
|
$ |
|
$ |
Cash and cash equivalents |
|
24,829 |
|
39,521 |
Trade and other receivables and other current
assets |
|
11,435 |
|
13,780 |
Restricted cash |
|
848 |
|
826 |
Property, plant and equipment |
|
1,537 |
|
2,147 |
Other non-current assets |
|
11,322 |
|
11,391 |
Total assets |
|
49,971 |
|
67,665 |
|
|
|
|
|
Payables and accrued liabilities |
|
8,599 |
|
10,470 |
Current portion of deferred revenues |
|
— |
|
5,235 |
Warrant liability |
|
5,399 |
|
6,176 |
Non-financial non-current liabilities* |
|
18,375 |
|
52,479 |
Total liabilities |
|
32,373 |
|
74,360 |
Shareholders' equity (deficiency) |
|
17,598 |
|
(6,695) |
Total liabilities and shareholders' equity
(deficiency) |
|
49,971 |
|
67,665 |
_________________________
* Comprised mainly of non-current portion of deferred
revenues, employee future benefits and provision.
SOURCE Aeterna Zentaris Inc.