All amounts are in U.S. dollars (except for share
data).
QUEBEC CITY, Aug. 10, 2011
/PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company"), a late-stage drug development company
specialized in oncology and endocrine therapy, today reported
financial and operating results for the quarter ended June 30, 2011.
Second Quarter 2011 Highlights
Perifosine
- April 4, 2011: The Company
announced that two posters on perifosine were presented at the
102nd annual meeting of the American Association for
Cancer Research ("AACR") held in Orlando,
Florida. The first poster illustrated perifosine's antitumor
activity in a variety of gastric cell lines, and also enhanced the
antitumor activity of 5-FU in parts of the cell lines - including
5-FU resistant cell lines. The second poster demonstrated that
perifosine markedly enhanced the antitumor activity of the cellular
TRAIL-based treatment and was able to overcome TRAIL resistance
both in vitro and in vivo.
- Subsequent to quarter-end, on July 26,
2011, the Company announced the completion of patient
recruitment for the ongoing Phase 3 trial with perifosine in
refractory advanced colorectal cancer. The trial, involving over
430 patients, is being conducted pursuant to a Special Protocol
Assessment ("SPA") with the Food and Drug Administration ("FDA")
and with Fast Track designation.
- Subsequent to quarter-end, on July 12,
2011, the European Patent Office granted a patent for the
use of alkyl phosphocholines, and, more specifically for
perifosine, in the preparation of a medicament for the treatment of
benign and malignant tumors, prior to and/or during the treatment
with approved antitumor antimetabolites including 5-FU
("fluorouracil") and capecitabine. This patent will expire on
July 28, 2023.
AEZS-108
- Parallel Scientific Advice process granted by and initiated
with the FDA and EMA, with the aim to have the pivotal program in
endometrial cancer defined by year-end.
- Progression of ongoing Phase 1/2 studies in castration
refractory prostate cancer and in refractory bladder cancer.
AEZS-130
- Subsequent to quarter-end, on July 27,
2011, the Company announced the completion of the Phase 3
trial with AEZS-130 as an oral diagnostic test for Adult Growth
Hormone Deficiency ("AGHD"). The preliminary Phase 3 results were
encouraging and the Company expects to file a New Drug Application
("NDA").
AEZS-120
- Subsequent to quarter-end, on July 20,
2011, the Company announced that it had reached a key
milestone in the non-clinical development of its live recombinant
prostate cancer vaccine candidate, AEZS-120, for oral
administration. The program, partially funded through a grant from
the German government, encompassed the full development of a GMP
process, including GMP production and quality testing of a clinical
batch, as well as a non-clinical safety and toxicology package, as
previously agreed with regulatory authorities. Subject to a
positive review by German regulatory authorities, the Company aims
to start Phase 1 clinical development in 2012.
AEZS-131
- April 5, 2011: The Company
announced that a poster on AEZS-131 was presented at the
102nd annual meeting of the AACR. The poster showed
AEZS-131 to be a highly selective Erk 1/2 inhibitor oral anticancer
compound with in vivo antitumor potency. In in vivo
mouse xenograft experiments utilizing the HCT-116 colon cancer
model, AEZS-131 significantly inhibited tumor growth and was well
tolerated at daily doses up to 120 mg/kg.
Corporate Developments
- During the quarter, the Company completed the drawdowns
remaining under the At-the-Market ("ATM") Sales Agreement entered
into in February 2011. During
the quarter, the Company raised a total of $14.7 million in gross proceeds, bringing the
total aggregate gross proceeds raised under this ATM Sales
Agreement, on a year-to-date basis, to $19.7 million.
- June 29, 2011: The Company
entered into an additional ATM Sales Agreement under which, during
the 24-month term of the agreement, the Company could sell up to a
maximum of 9.5 million of its common shares through ATM
issuances on the NASDAQ Stock Market for aggregate gross proceeds
not to exceed $24.0 million.
Subsequent to quarter-end and pursuant to this ATM agreement, the
Company issued a total of approximately 1.9 million common
shares for aggregate gross proceeds of $4.3
million, less cash and non-cash transaction costs totalling
$0.3 million.
Cash, cash equivalents and short-term investment totalled
$49.6 million as at June 30, 2011. With the aforementioned ATM
drawdowns that were completed subsequent to quarter-end, the
Company's pro forma cash, cash equivalents and short-term
investment at June 30, 2011 would
total $53.8 million.
Juergen Engel, Ph.D., Aeterna
Zentaris' President and Chief Executive Officer, commented, "This
quarter was marked by key drug development milestones. The patient
recruitment of over 430 patients was completed for the ongoing
Phase 3 trial in advanced refractory colorectal cancer with
perifosine. Furthermore, we were granted a European use patent for
perifosine, which will expire in July
2023. We also successfully completed our Phase 3 trial with
AEZS-130 as an oral diagnostic test for Adult Growth Hormone
Deficiency, and we are undertaking the necessary steps leading to a
New Drug Application filing in the United
States. In addition, we reached a key non-clinical milestone
in the development of our live oral recombinant prostate cancer
vaccine candidate, AEZS-120, and are now planning to start its
clinical development."
Dennis Turpin, CA, Senior Vice President, Chief Financial
Officer of Aeterna Zentaris stated, "We now benefit from over
$49.6 million in cash, cash
equivalents and short-term investment and have gained additional
flexibility to advance our key projects through our most recent
At-the-Market Sales agreement."
CONSOLIDATED RESULTS AS AT AND FOR THE SECOND QUARTER ENDED
JUNE 30, 2011
Revenues were $6.5 million
for the three-month period ended June 30,
2011, as compared to $5.6 million for the same period in 2010.
This increase is largely related to comparative higher-than-normal
deliveries of Cetrotide® to certain customers, as well
as to the comparative strengthening of the euro against the US
dollar.
Research and development costs, net of tax credits and
grants were $5.6 million for
the three-month period ended June 30,
2011, as compared to $5.4 million for the same period in
2010.
Selling, general and administrative expenses were
$3.4 million for the three-month
period ended June 30, 2011 as
compared to $3.7 million for the
same period in 2010.
Net finance (costs) income are comprised predominantly of
net foreign exchange gains and losses, the change in fair value of
the Company's warrant liability and the unrealized gain on the
Company's short-term investment (2011 only). For the three-month
period ended June 30, 2011, net
finance costs totalled $2.6 million, as compared to a net finance
income of $1.8 million for the
same period in 2010. This significant increase in net finance costs
is due to the change in fair value of the Company's warrant
liability. That change results from the periodic "mark-to-market"
revaluation of currently outstanding share purchase warrants.
Additionally, the increase is due to higher foreign exchange
losses, which in turn resulted primarily from the comparative
weakening of the US dollar against the euro during the second
quarter of 2011, partially offset by the unrealized gains on the
Company's short-term investment, which is carried at fair value.
Neither the loss resulting from the periodic mark-to-market
valuation of the warrants nor the gain resulting from the fair
value adjustments to the short-term investment has resulted in any
cash disbursement or cash receipt during the three-month period
ended June 30, 2011.
Net loss for the three-month period ended June 30, 2011 was $10.6 million, or $0.12 per basic and diluted share, as compared to
$6.2 million, or $0.08 per basic and diluted share, for the same
period in 2010. This increase is mainly related to higher net
finance costs related to the periodic mark-to-market valuation of
the warrants (non-cash) and higher foreign exchange losses, partly
compensated by the unrealized gains on the Company's short-term
investment (non-cash).
CONFERENCE CALL
Management will be hosting a conference call for the investment
community beginning at 3:30 p.m. (Eastern
Time) today, Wednesday, August 10,
2011, to discuss the 2011 second quarter results.
Individuals interested in participating in the live conference call
by telephone may dial, in Canada,
514-807-8791 or 416-644-3425, outside Canada, 800-594-3790. 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.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a late-stage oncology drug development
company currently investigating potential treatments for various
cancers including colorectal, multiple myeloma, endometrial,
ovarian, prostate and bladder cancer. The Company's innovative
approach of "personalized medicine" means tailoring treatments to a
patient's specific condition and to unmet medical needs. Aeterna
Zentaris' deep pipeline is drawn from its proprietary discovery
unit providing the Company with constant and long-term access to
state-of-the-art therapeutic options. 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 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
Loss Information |
|
|
Three months ended
June 30, |
Six months ended
June 30, |
(In thousands, except for share and per share
data) |
2011 |
2010 |
2011 |
2010 |
|
$ |
$ |
$ |
$ |
Revenues |
|
|
|
|
Sales and royalties |
6,114 |
5,165 |
13,206 |
10,881 |
License fees and other |
409 |
419 |
706 |
1,125 |
|
6,523 |
5,584 |
13,912 |
12,006 |
|
|
|
|
|
Operating expenses |
|
|
|
|
Cost of sales |
5,497 |
4,415 |
11,520 |
9,032 |
Research and development costs, net of tax credits
and grants |
5,563 |
5,374 |
11,061 |
11,519 |
Selling, general and administrative expenses |
3,434 |
3,745 |
6,593 |
6,802 |
|
14,494 |
13,534 |
29,174 |
27,353 |
|
|
|
|
|
Loss from operations |
(7,971) |
(7,950) |
(15,262) |
(15,347) |
|
|
|
|
|
Finance income |
265 |
2,332 |
1,089 |
3,874 |
Finance costs |
(2,863) |
(558) |
(5,612) |
(448) |
Net finance (costs) income |
(2,598) |
1,774 |
(4,523) |
3,426 |
|
|
|
|
|
Loss before income taxes |
(10,569) |
(6,176) |
(19,785) |
(11,921) |
Income tax expense |
- |
- |
(841) |
- |
|
|
|
|
|
Net loss |
(10,569) |
(6,176) |
(20,626) |
(11,921) |
|
|
|
|
|
Other comprehensive (loss) income: |
|
|
|
|
Foreign currency translation adjustments |
(526) |
573 |
(1,865) |
1,315 |
|
|
|
|
|
Comprehensive loss |
(11,095) |
(5,603) |
(22,491) |
(10,606) |
|
|
|
|
|
Net loss per share |
|
|
|
|
Basic and diluted |
(0.12) |
(0.08) |
(0.23) |
(0.17) |
Weighted average number of shares
outstanding |
|
|
|
|
Basic and diluted |
90,690,019 |
72,918,880 |
88,721,832 |
68,031,569 |
|
Interim Consolidated Statements of Financial
Position Information |
|
(in
thousands) |
As at
June 30,
2011 |
As at
December 31,
2010 |
|
$ |
$ |
|
|
|
Cash and cash equivalents |
46,612 |
31,998 |
Short-term investment |
3,029 |
1,934 |
Trade and other receivables and other current
assets |
10,398 |
9,877 |
Restricted cash |
900 |
827 |
Property, plant and equipment, net |
3,558 |
3,096 |
Other non-current
assets |
14,731 |
13,716 |
Total
assets |
79,228 |
61,448 |
|
|
|
Payables and other current liabilities |
18,233 |
13,350 |
Long-term payable (current and non-current
portions) |
124 |
150 |
Warrant liability (current and non-current
portions) |
15,652 |
14,367 |
Non-financial
non-current liabilities* |
60,511 |
51,156 |
Total liabilities |
94,520 |
79,023 |
Shareholders'
deficiency |
(15,292) |
(17,575) |
Total liabilities
and shareholders' deficiency |
79,228 |
61,448 |
* Comprised mainly of deferred revenues, employee future
benefits and provision.
SOURCE AETERNA ZENTARIS INC.