All amounts are in U.S. dollars
QUEBEC CITY, Nov. 13, 2012
/PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company"), an oncology and endocrinology drug
development company currently investigating treatments for various
unmet medical needs, today reported financial and operating results
for the third quarter ended September 30, 2012.
Highlights
Perifosine (Oral Akt Inhibitor)
- The Company increased its focus on patient recruitment for the
ongoing Phase 3 trial in multiple myeloma ("MM") by opening
additional sites in Europe.
Pre-planned interim analysis by an independent Data Safety
Monitoring Board ("DSMB") expected upon reaching approximately 80
events (disease progression or death).
- The Company's partner for the Japanese market, Yakult Honsha
Co. Ltd. ("Yakult"), made progress with the Phase 1 bridging
study in MM initiated earlier this year and is also looking to
expand work with perifosine in other indications.
AEZS-108 (Cytotoxic Peptide Conjugate Linked to
Doxorubicin)
- Subsequent to quarter-end, a Special Protocol Assessment
("SPA") was filed with the Food and Drug Administration ("FDA")
with the goal of initiating a Phase 3 trial in endometrial cancer
during the first quarter of 2013.
AEZS-130 (Oral Ghrelin Agonist)
- Fast Track designation not granted to AEZS-130 as oral
diagnostic test for adult growth hormone deficiency ("AGHD"). The
Company continues to expect to file New Drug Application ("NDA")
during the first quarter of 2013.
- Subsequent to quarter-end, Phase 3 trial results presented at
the International Congress of GRS and IGF Society demonstrated
AEZS-130 to be safe and effective in diagnosing AGHD.
- First patient recruited for Phase 2A trial of AEZS-130 in
cancer-induced cachexia. Study conducted under a Cooperative
Research and Development Agreement ("CRADA") between the Company
and the Michael E. DeBakey Veterans Affairs Medical Center
which is funding the study.
Corporate Developments
Share Consolidation and NASDAQ Minimum Bid Price
Compliance
- Subsequent to quarter-end, the Company's common shares were
consolidated on a 6-to-1 basis in order to regain compliance with
the NASDAQ Stock Market's ("NASDAQ") minimum bid price
requirement. The Company's common shares began trading on a
consolidated basis on October 5,
2012, and the Company regained NASDAQ compliance on
October 19, 2012.
Public Offering
- Subsequent to quarter-end, on October 17, 2012, the Company completed a
public offering of 6.6 million units (the "Offering")
generating net proceeds of $15.2 million intended to be used for the
continued funding of ongoing drug development programs for
perifosine in MM, as well as for AEZS-108 and AEZS-130.
Cash and cash equivalents, excluding the net proceeds
raised in the Offering subsequent to quarter-end, totalled
$33.2 million as at September 30, 2012, compared to $46.9 million as at December 31, 2011.
Juergen Engel, PhD, Aeterna
Zentaris President and Chief Executive Officer, commented, "This
has been quite an eventful quarter for our Company. At the drug
development level, we focused on opening new sites and increasing
patient recruitment for our ongoing Phase 3 trial of perifosine in
multiple myeloma. Meanwhile, our partner, Yakult, continued to make
progress with a Phase 1 trial of perifosine in the same indication
in Japan.
As for AEZS-108, we filed a SPA with the FDA for our upcoming
Phase 3 trial in endometrial cancer. Earlier this week, we were
pleased to report the initiation of the Phase 2 portion of the
investigator driven Phase 1/2 trial of AEZS-108 in prostate
cancer.
Regarding AEZS-130 as an oral diagnostic test for AGHD, all
efforts are concentrated on filing an NDA in the first quarter of
2013. We also announced that a first patient had been recruited for
an investigator driven Phase 2A trial of AEZS-130 in cancer-induced
cachexia.
2013 looks promising, and we remain confident that the market
will come to recognize the full potential of our innovative
pipeline."
Dennis Turpin, CPA, CA, Senior
Vice President and Chief Financial Officer at Aeterna Zentaris
stated, "As of September 30, 2012,
including net proceeds from the Offering, we had a pro forma cash
and cash equivalents position of $48.4
million which means that we should be well poised to
continue to move our key product candidates through the
pipeline."
CONSOLIDATED RESULTS AS AT AND FOR THE THIRD QUARTER ENDED
SEPT. 30, 2012
Revenues were $7.1 million
for the quarter ended September 30,
2012, compared to $9.5 million for the same quarter in 2011.
The decrease is largely attributable to lower deliveries of
Cetrotide® to certain customers and to the relative
weakening of the euro against the US dollar.
R&D costs, net of refundable tax credits and grants
were $4.3 million for the quarter
ended September 30, 2012,
compared to $5.7 million for the same
quarter in 2011. The comparative decrease is attributable to lower
third-party costs associated with the development of perifosine and
AEZS108, combined with the weakening of the euro against the US
dollar.
Net finance income (costs) totalled $(0.9) million for the quarter ended September 30, 2012, compared to $9.3 million for the same quarter in 2011.
The significant fluctuation in net finance (costs) income is mainly
due to the change in fair value of our warrant liability, as well
as to (losses) or gains due to changes in foreign currency exchange
rates, which are mainly related to the period-over-period continued
weakness of the Euro against the U.S. dollar.
Net loss amounted to $6.6
million, or $0.35 per basic
and diluted share for the quarter ended September 30, 2012, compared to a net income
of $1.1 million, or $0.07 per basic and $0.06 per diluted share, for the same quarter in
2011. The significant increase in net loss for the three-month
period ended September 30, 2012,
as compared to the same period in 2011, is due largely to lower net
finance income, partly compensated by lower R&D and SG&A
expenses.
CONFERENCE CALL
Management will be hosting a conference call for the investment
community beginning at 8:30 a.m.
(Eastern Time) tomorrow, Wednesday, November 14, 2012, to
discuss the 2012 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 for the
third quarter 2012 with the associated Unaudited Interim
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.
Interim Consolidated Statements of Comprehensive (Loss)
Income Information
(in thousands, except for share and per share
data) |
Three months ended
September 30, |
Nine months
ended September 30, |
|
2012 |
|
2011 |
|
2012 |
|
2011 |
|
$ |
|
$ |
|
$ |
|
$ |
Revenues |
|
|
|
|
|
|
|
Sales and royalties |
6,826 |
|
8,783 |
|
22,373 |
|
21,989 |
License fees and other |
313 |
|
731 |
|
1,747 |
|
1,437 |
|
7,139 |
|
9,514 |
|
24,120 |
|
23,426 |
Operating expenses |
|
|
|
|
|
|
|
Cost of sales |
5,556 |
|
7,926 |
|
19,331 |
|
19,446
|
Research and development costs,
net of refundable tax credits and grants |
4,342 |
|
5,663 |
|
15,081 |
|
16,724 |
Selling, general and administrative expenses |
2,921 |
|
4,169 |
|
9,776 |
|
10,762 |
|
12,819 |
|
17,758 |
|
44,188 |
|
46,932 |
Loss from operations |
(5,680) |
|
(8,244) |
|
(20,068) |
|
(23,506) |
Finance income |
35 |
|
9,324 |
|
6,610 |
|
4,805 |
Finance costs |
(909) |
|
(2) |
|
(7) |
|
(6) |
Net finance (costs) income |
(874) |
|
9,322 |
|
6,603 |
|
4,799 |
(Loss) income before income taxes |
(6,554) |
|
1,078 |
|
(13,465) |
|
(18,707) |
Income tax expense |
— |
|
— |
|
— |
|
(841) |
Net (loss) income |
(6,554) |
|
1,078 |
|
(13,465) |
|
(19,548) |
Other comprehensive (loss) income:
|
|
|
|
|
|
|
|
Foreign currency translation adjustments |
(97) |
|
907 |
|
(300) |
|
(958) |
Comprehensive (loss) income |
(6,651) |
|
1,985 |
|
(13,765) |
|
(20,506) |
Net (loss) income per share |
|
|
|
|
|
|
|
Basic |
(0.35) |
|
0.07 |
|
(0.74) |
|
(1.28) |
Diluted |
(0.35) |
|
0.06 |
|
(0.74) |
|
(1.28) |
Weighted average number of shares
outstanding |
|
|
|
|
|
|
|
Basic |
18,703,023 |
|
16,214,779 |
|
18,295,555 |
|
15,268,138 |
Diluted |
18,703,023 |
|
16,810,666 |
|
18,295,555 |
|
15,268,138 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interim Consolidated Statement of Financial Position
Information
|
As at September 30, |
|
As at December 31, |
(in thousands) |
2012 |
|
2011 |
|
$ |
|
$ |
Cash and cash equivalents |
33,202 |
|
46,881 |
Trade and other receivables and other current
assets |
10,596 |
|
13,258 |
Restricted cash |
806 |
|
806 |
Property, plant and equipment |
2,146 |
|
2,512 |
Other non-current assets |
11,518 |
|
11,912 |
Total assets |
58,268 |
|
75,369 |
|
|
|
|
Payables and other current liabilities |
14,328 |
|
17,784 |
Long-term payable (current and non-current
portions) |
31 |
|
88 |
Warrant liability (current and non-current
portions) |
2,710 |
|
9,204 |
Non-financial non-current liabilities* |
48,719 |
|
52,839 |
Total liabilities |
65,788 |
|
79,915 |
Shareholders' deficiency |
(7,520) |
|
(4,546) |
Total liabilities and shareholders'
deficiency |
58,268 |
|
75,369 |
_________________________
* Comprised mainly of non-current portion of deferred
revenues, employee future benefits and provision.
SOURCE AETERNA ZENTARIS INC.