All amounts are in U.S. dollars (unless otherwise
noted)
QUEBEC CITY,
March 21, 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 fourth quarter and the year ended December 31, 2012.
Key Developments in 2012
AEZS-108 (Doxorubicin Peptide Conjugate)
- Special Protocol Assessment ("SPA") granted by the U.S. Food
and Drug Administration ("FDA") for the initiation of a Phase 3
study in advanced recurrent endometrial cancer. This is an
open-label, randomized, multicenter trial which will be conducted
in North America and Europe, comparing 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.
- Initiation of the Phase 2 portion of the Phase 1/2 trial in
castration- and taxane-resistant prostate cancer ("CRPC") supported
by a three-year $1.6 million grant
from the National Institutes of Health ("NIH") to an investigator
to support this study. Results for the Phase 1 portion demonstrated
that AEZS-108 was well tolerated and early evidence of antitumor
activity was observed in men with CRPC.
AEZS-130 (Oral Ghrelin Agonist)
- Phase 3 trial results for AEZS-130 as a diagnostic test for
adult growth hormone deficiency ("AGHD") presented at the
6th International Congress of the Growth Hormone
Research and Insulin-like Growth Factor Society in Munich, Germany. The data expanded on the
previously disclosed data in June
2012 at the 94th ENDO Annual Meeting and Expo.
Both sets of data confirm AEZS-130's potential of possibly becoming
the first approved oral diagnostic test for AGHD.
- Subsequent to year-end, New Drug Application ("NDA") as a
diagnostic test for AGHD remains in preparation.
Perifosine (Oral AKT Inhibitor)
- Phase 3 trial results for perifosine + capecitabine ("Xeloda")
showed no benefit in overall survival and in progression-free
survival in the refractory colorectal cancer ("CRC") setting.
- Subsequent to year-end, the Company determined to discontinue
the Phase 3 trial with perifosine in multiple myeloma further
to the Data Safety Monitoring Board's ("DSMB") recommendation to do
so, following its preplanned safety and efficacy first interim
analysis. The DSMB reported that it was unlikely the study would
achieve a significant difference in its primary endpoint,
progression-free survival. No safety concerns were raised.
Corporate Developments
At-the-Market Issuance Program
- During 2012, the Company issued a total of 1.2 million common
shares (retroactively adjusted to reflect the Share Consolidation
described below) under the January
2012 At‑The-Market ("ATM") Program for aggregate gross
proceeds of $8.8 million.
Share Consolidation and NASDAQ Minimum Bid Price
Compliance
- The Company consolidated its issued and outstanding common
shares on a 6-to-1 basis (the "Share Consolidation"), effective as
of October 2, 2012, in order to
regain compliance with The NASDAQ Stock Market
("NASDAQ") minimum bid price requirement. Aeterna
Zentaris' common shares began trading on a consolidated basis on
October 5, 2012 and the Company
regained NASDAQ compliance on October 19,
2012.
Public Offering
- On October 17, 2012, the Company
completed a public offering (the "Offering") of 6.6 million units
at a purchase price of $2.50 per
unit, generating net proceeds of $15.1
million.
Cash and cash equivalents totalled $39.5 million as at December 31, 2012, compared to $46.9 million as at December 31, 2011.
Juergen Engel, Ph D, Aeterna
Zentaris President and Chief Executive Officer, commented, "2012
was a challenging year. We had to face disappointing Phase 3
results for perifosine in colorectal cancer, and more recently, in
multiple myeloma. Despite these obstacles, we believe we
demonstrated our ability to take on these challenges as we analyzed
the situation, made the necessary strategic adjustments and
implemented cost cutting measures needed to move forward. We now
look to 2013 with great anticipation, as we focus on reaching the
next milestones for our major drug development programs: our Phase
3 trial in endometrial cancer under an SPA, as well as Phase 2
trials in triple-negative breast cancer, bladder and prostate
cancer with AEZS-108 and the NDA filing for AEZS-130 as an oral
diagnostic test for AGHD."
Dennis Turpin, CPA, CA, SVP and
Chief Financial Officer at Aeterna Zentaris stated, "Based on our
current expectations, with $39.5
million in cash and cash equivalent as at December 31, 2012, we believe we have sufficient
capital resources to fund our planned operations into at least the
first half of 2014."
CONSOLIDATED RESULTS AS AT AND FOR THE FOURTH QUARTER ENDED
DECEMBER 31, 2012
Revenues were $9.5 million
for the three-month period ended December
31, 2012, compared to $12.6
million for the same period in 2011. The decrease is mainly
due to the recording of a $2.6
million milestone payment from Yakult with respect to the
initiation of a Phase 1 trial with perifosine in CRC in
Japan during the last quarter of
2011.
R&D costs, net of refundable tax credits and grants
were $5.5 million for the three-month
period ended December 31, 2012,
compared to $7.8 million for the same
period in 2011. The decrease is attributable to lower employee
compensation and benefit costs, as no annual cash bonuses were
recorded during the fourth quarter of 2012, as well as 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 PI3K/Erk inhibitors and other
products during the fourth quarter of 2012 and the weakening of the
euro against the US dollar.
Selling, general and administrative ("SG&A") expenses
were $3.5 million for the three-month
period ended December 31, 2012,
compared to $5.4 million for the same
period in 2011. The comparative decrease is mainly related to 2011
events. During the three-month period ended December 31, 2011, the Company recognized an
impairment loss on property, plant and equipment ($0.3 million), an increase in onerous lease
provision ($0.2 million) and
marketing expenses incurred in Europe ($0.5
million). In addition, the quarter-to-quarter decrease is
attributable to the employee benefits expense decrease
($0.4 million) and the related
foreign exchange loss decrease ($0.5
million), partly offset by transaction costs related to
share purchase warrants ($0.4
million).
Net loss for the three-month period ended December 31, 2012 was $6.9
million or $0.29 per basic and
diluted share, compared to $7.5
million or $0.44 per basic and
diluted share for the same period in 2011. The decrease in net loss
is largely due to lower net R&D costs, SG&A expenses and
income tax expense, as well as to higher margin contribution from
Cetrotide®, partly offset by the significant decrease in
license fee revenues, and in net finance income.
CONSOLIDATED RESULTS FOR THE YEAR ENDED DECEMBER 31, 2012
Revenues were $33.7 million
for the year ended December 31, 2012,
compared to $36.1 million for the
same period in 2011. The decrease is mainly due to the recording of
a $2.6 million milestone payment from
Yakult with respect to the initiation of a Phase 1 trial with
perifosine in CRC in Japan during
the last quarter of 2011.
R&D costs, net of refundable tax credits and grants,
were $20.6 million for the year ended
December 31, 2012, compared to
$24.5 million for the same period in
2011. The decrease is attributable to lower employee compensation
and benefit costs, as no annual cash bonuses were recorded during
the fourth quarter of 2012, as well as 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 except for
AEZS-108 and perifosine, and the weakening of the euro against the
US dollar.
Selling, general and administrative ("SG&A") expenses
were $13.2 million for the year ended
December 31, 2012, compared to
$16.2 million for the same period in
2011. The comparative decrease is mainly related to 2011 events.
During the year ended December 31,
2011, the Company recognized an impairment loss on its
Cetrotide® asset ($1.1
million), an impairment loss on property, plant and
equipment ($0.3 million), an increase
in onerous lease provision ($0.2
million) and marketing expenses incurred in Europe ($0.9
million). In addition, the year-over-year decrease in
SG&A expenses is attributable to the decreases in employee
benefit expenses ($0.8 million) and
royalty expenses ($0.2 million), as
well as the weakening of the euro against the US dollar, partly
offset by transaction costs related to share purchase warrants
($0.4 million), share-based
compensation costs related to collaborators ($0.3 million) and an increase in legal fees
($0.3 million).
Net loss for the year ended December 31, 2012 was $20.4 million, or $1.03 per basic and diluted share, compared to
$27.1 million, or $1.72 per basic and diluted share for the same
period in 2011. The decrease is largely due to lower net R&D
costs, SG&A expenses and income tax expense, as well as to
higher margin contribution from sales and higher net finance
income, partly offset by the significant decrease in license fee
revenues.
ADOPTION OF ADVANCE NOTICE BY-LAW
The Company also announces that its Board of Directors has
approved an amendment to its by-laws to add an advance notice
requirement (the "By-Law Amendment"), which requires advance notice
to be given to the Company in circumstances where nominations of
persons for election as a director of the Company are made by
shareholders other than pursuant to: (i) a requisition of a meeting
made pursuant to the provisions of the Canada Business
Corporations Act (the "CBCA"); or (ii) a shareholder proposal
made pursuant to the provisions of the CBCA. Among other things,
the By-law Amendment fixes a deadline by which shareholders must
submit a notice of director nominations to the Company prior to any
annual or special meeting of shareholders where directors are to be
elected and sets forth the information that a shareholder must
include in the notice for it to be valid. In the case of an
annual meeting of shareholders, notice to the Company must be given
not less than 30 and not more than 65 days prior to the date
of the annual meeting, however, in the event the meeting is to be
held on a date that is less than 50 days after the date on which
the first public announcement of the date of the annual meeting was
made, notice may be given not later than the close of business
on the tenth day following such public
announcement. The By-Law Amendment is effective
immediately and will be submitted to shareholders for confirmation
and ratification at the Company's upcoming annual meeting of
shareholders to be held on May 8,
2013.
CONFERENCE CALL
Management will be hosting a conference call for the investment
community beginning at 8:30 a.m. (Eastern
Time) tomorrow, Friday, March 22, 2013, to discuss the 2012
fourth quarter and full year 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 fiscal year 2012 with the associated Audited
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.
Consolidated Statements of Comprehensive Loss
Information
(in thousands, except share and
per share data) |
|
Three-month periods ended
December 31, |
|
Years ended December 31, |
|
|
2012 |
|
2011 |
|
2012 |
|
2011 |
|
2010 |
|
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
Revenues |
|
|
|
|
|
|
|
|
|
|
Sales and royalties |
|
9,165 |
|
9,317 |
|
31,538 |
|
31,306 |
|
24,857 |
License fees and other |
|
380 |
|
3,310 |
|
2,127 |
|
4,747 |
|
2,846 |
|
|
9,545 |
|
12,627 |
|
33,665 |
|
36,053 |
|
27,703 |
Operating expenses |
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
7,489 |
|
8,114 |
|
26,820 |
|
27,560 |
|
18,700 |
Research and development costs, net of refundable
tax credits and grants |
|
5,523 |
|
7,793 |
|
20,604 |
|
24,517 |
|
21,257 |
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses |
|
3,469 |
|
5,408 |
|
13,245 |
|
16,170 |
|
12,552 |
|
|
16,481 |
|
21,315 |
|
60,669 |
|
68,247 |
|
52,509 |
Loss from operations |
|
(6,936) |
|
(8,688) |
|
(27,004) |
|
(32,194) |
|
(24,806) |
Finance income |
|
689 |
|
1,434 |
|
6,974 |
|
6,231 |
|
1,792 |
Finance costs |
|
(700) |
|
(2) |
|
(382) |
|
- |
|
(5,437) |
Net finance (costs) income |
|
(11) |
|
1,432 |
|
6,592 |
|
6,231 |
|
(3,645) |
Loss before income taxes |
|
(6,947) |
|
(7,256) |
|
(20,412) |
|
(25,963) |
|
(28,451) |
Income tax expense |
|
- |
|
(263) |
|
-
|
|
(1,104) |
|
- |
Net loss |
|
(6,947) |
|
(7,519) |
|
(20,412) |
|
(27,067) |
|
(28,451) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
Items that may be reclassified subsequently to
profit or loss |
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments |
|
(204) |
|
169 |
|
(504) |
|
(789) |
|
1,001 |
Items that will not be reclassified to profit or
loss |
|
|
|
|
|
|
|
|
|
|
Actuarial loss on defined benefit plans |
|
(3,705) |
|
(1,335) |
|
(3,705) |
|
(1,335) |
|
191 |
Comprehensive loss |
|
(10,856) |
|
(8,685) |
|
(24,621) |
|
(29,191) |
|
(27,259) |
Net loss per share |
|
|
|
|
|
|
|
|
|
|
Basic |
|
(0.29) |
|
(0.44) |
|
(1.03) |
|
(1.72) |
|
(2.26) |
Diluted |
|
(0.29) |
|
(0.44) |
|
(1.03) |
|
(1.72) |
|
(2.26) |
Weighted average number of shares
outstanding |
|
|
|
|
|
|
|
|
|
|
Basic |
|
24,181,462 |
|
17,185,156 |
|
19,775,073 |
|
15,751,331 |
|
12,609,902 |
Diluted |
|
24,181,462 |
|
17,185,156 |
|
19,775,073 |
|
15,751,331 |
|
12,609,902 |
Consolidated Statement of Financial Position
Information
|
As at December 31, |
(in thousands) |
2012 |
|
2011 |
|
$ |
|
$ |
Cash and cash equivalents |
39,521 |
|
46,881 |
Trade and other receivables and other current
assets |
13,780 |
|
13,258 |
Restricted cash |
826 |
|
806 |
Property, plant and equipment |
2,147 |
|
2,512 |
Other non-current assets |
11,391 |
|
11,912 |
Total assets |
67,665 |
|
75,369 |
Payables and other current liabilities |
15,675 |
|
17,784 |
Long-term payable (current and non-current
portions) |
30 |
|
88 |
Warrant liability (current and non-current
portions) |
6,176 |
|
9,204 |
Non-financial non-current liabilities* |
52,479 |
|
52,839 |
Total liabilities |
74,360 |
|
79,915 |
Shareholders' deficiency |
(6,695) |
|
(4,546) |
Total liabilities and shareholders'
deficiency |
67,665 |
|
75,369 |
_________________________
* Comprised mainly of non-current portion of deferred
revenues, employee future benefits and provision.
SOURCE AETERNA ZENTARIS INC.