Aeterna Zentaris Reports Third Quarter 2012 Financial and Operating Results
QUEBEC CITY, Nov. 13, 2012
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
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 Phase1 bridging study in MM initiated
earlier this year and is also looking to expand work with perifosine in
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 MichaelE. DeBakey
Veterans Affairs Medical Center which is funding the study.
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 theNASDAQ Stock
Market's ("NASDAQ") minimum bid price requirement. The Company's common
shares began trading on a consolidated basis on October5, 2012, and the
Company regained NASDAQ compliance on October 19, 2012.
*Subsequent to quarter-end, on October17, 2012, the Company completed a
public offering of 6.6million units (the "Offering") generating net
proceeds of $15.2million 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 $9.5million 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 September30, 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 $9.3million 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 September30, 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
September30, 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.
Management will be hosting a conference call for the investment community
beginning at 8:30a.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
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
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
Interim Consolidated Statements of Comprehensive (Loss) Income Information
(in thousands, Three months ended September Nine months ended
except for share and 30, September 30,
per share data)
2012 2011 2012 2011
$ $ $ $
Sales and royalties 6,826 8,783 22,373 21,989
License fees and 313 731 1,747 1,437
7,139 9,514 24,120 23,426
Cost of sales 5,556 7,926 19,331 19,446
Research and 4,342 5,663 15,081 16,724
net of refundable
tax credits and
Selling, general and 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) (874) 9,322 6,603 4,799
(Loss) income before (6,554) 1,078 (13,465) (18,707)
Income tax expense — — — (841)
Net (loss) income (6,554) 1,078 (13,465) (19,548)
Foreign currency (97) 907 (300) (958)
Comprehensive (loss) (6,651) 1,985 (13,765) (20,506)
Net (loss) income
Basic (0.35) 0.07 (0.74) (1.28)
Diluted (0.35) 0.06 (0.74) (1.28)
number of shares
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 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 14,328 17,784
Long-term payable (current and 31 88
Warrant liability (current and 2,710 9,204
Non-financial non-current 48,719 52,839
Total liabilities 65,788 79,915
Shareholders' deficiency (7,520) (4,546)
Total liabilities and shareholders' 58,268 75,369
*Comprised mainly of non-current portion of deferred revenues, employee
future benefits and provision.
SOURCE AETERNA ZENTARIS INC.
Ginette Beaudet Vallières
Investor Relations Coordinator
(418) 652-8525 ext. 265
Director of Communications
(418) 652-8525 ext. 406
Press spacebar to pause and continue. Press esc to stop.