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.