Aeterna Zentaris Reports First Quarter 2012 Financial and Operating Results
All amounts are in U.S. dollars (unless otherwise noted)
QUEBEC CITY, May 9, 2012 /PRNewswire/ – Aeterna Zentaris Inc.
(NASDAQ: AEZS) (TSX: AEZ) (the ”Company”), today reported financial and
operating results as at and for the first quarter ended March 31, 2012.
AEZS-108 (LHRH-Targeted Cytotoxic Conjugate)
-- Agreement signed with Ventana Medical Systems, Inc., a member of the Roche Group, to develop a companion diagnostic for the immunohistochemical determination of luteinizing hormone-releasing hormone ("LHRH") receptor expression, for AEZS-108. -- Updated results for the Phase 1 portion of the ongoing Phase 2 study in castration- and taxane-resistant prostate cancer ("CRPC") with AEZS-108 presented during a poster session at the American Society of Clinical Oncology Genitourinary Cancers Symposium. Data showed that AEZS-108 was well tolerated and demonstrated early evidence of antitumor activity in men with CRPC.
AEZS-130 (Oral Ghrelin Agonist)
-- Michael E. DeBakey of Veterans Affairs Medical Center, in Houston, Texas initiated a Phase 2A trial with AEZS-130 in patients with cancer cachexia.
Perifosine (Oral Akt Inhibitor)
-- Japanese partner, Yakult Honsha, initiated a Phase 1/2 trial in Japan with perifosine + capecitabine in refractory advanced colorectal cancer. -- Subsequent to quarter-end, topline results for the Phase 3 "X-PECT" (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment") clinical trial evaluating perifosine + capecitabine (Xeloda®) in 468 patients with refractory advanced colorectal cancer, showed that the trial did not meet the primary endpoint of improving overall survival versus capecitabine + placebo. -- Subsequent to quarter-end, the Company and Keryx Biopharmaceuticals agreed to terminate their North American licensing agreement for perifosine; thus the Company regained full rights to the compound in this territory and will continue the ongoing Phase 3 trial in multiple myeloma.
At-The-Market Issuance Program
-- On January 23, 2012, the Company, pursuant to its existing At-The-Market ("ATM") sales agreement dated June 29, 2011 with MLV, initiated a new ATM issuance program ("January 2012 ATM Program") under which it may, at its discretion, from time to time during the term of the sales agreement, sell up to a maximum of 10.4 million of its common shares through ATM issuances on the NASDAQ Global Market. -- Between January 23, 2012 and March 15, 2012, the Company issued a total of 3.6 million common shares under the January 2012 ATM Program for aggregate gross proceeds of $6.4 million. -- Subsequent to quarter-end through May 8, 2012, the Company issued a total of 2.5 million common shares under the January 2012 ATM Sales Agreement for aggregate gross proceeds of $1.8 million.
Cash and cash equivalents totalled $45.6 million as at March 31, 2012, compared to $46.9 million
as at December 31, 2011.
Juergen Engel, Ph.D, Aeterna Zentaris President and Chief Executive
Officer, commented, “The last weeks were quite challenging with the
disappointing results for the perifosine Phase 3 trial in colorectal
cancer. Nevertheless, after regaining North American rights to
perifosine, conducting a thorough analysis of the situation and
consulting with key opinion leaders, we have decided to continue the
Phase 3 trial in multiple myeloma up until the predefined interim
analysis, as we believe this compound still has the potential to become
a novel oral anticancer treatment.
Also during the quarter, other development programs moved forward as
Yakult initiated a trial in colorectal cancer with perifosine and the
Michael E. DeBakey of VA Medical Center initiated a trial with AEZS-130
in cancer cachexia. Furthermore, we signed an agreement with Ventana to
develop a companion diagnostic for AEZS-108.
Over the years, we have shown resilience by overcoming important
obstacles. I am proud to say that still today, our team of seasoned
professionals remains committed in providing cancer patients with novel
treatments, while striving to make Aeterna Zentaris an important
company in this field.”
Dennis Turpin, CA, Senior Vice President and Chief Financial Officer at
Aeterna Zentaris stated, “As of March 31, 2012, we had a cash position
of over $45 million which allows us to be well poised to continue to
move our key product candidates through the pipeline.”
CONSOLIDATED RESULTS AS AT AND FOR THE FIRST QUARTER ENDED MARCH 31,
Revenues were $9.5 million for the quarter ended March 31, 2012, compared to
$7.4 million for the same quarter in 2011. This increase is largely
attributable to comparative higher deliveries of Cetrotide(®) to certain customers and to higher research and development services
provided, partly offset by the relative weakening of the euro against
the US dollar.
R&D costs, net of refundable tax credits and grants were relatively stable at $5.6 million for the quarter ended March 31,
2012, compared to $5.5 million for the same quarter in 2011.
Net loss amounted to $11.5 million, or $0.11 per basic and diluted share, for
the quarter ended March 31, 2012, compared to $10.1 million, or $0.12
per basic and diluted share, for the same quarter in 2011. This
increase is mainly due to higher net finance costs attributable to the
change in fair value of our warrant liability, partly offset by lower
income tax expense.
Management will be hosting a conference call for the investment
community beginning at 8:30 a.m. (Eastern Time) today, Wednesday, May
9, 2012, to discuss the 2012 first 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 (“MD&A”) for the
first quarter 2012 with the associated Unaudited Interim Consolidated
Financial Statements can be found at www.aezsinc.com.
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.
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.
Attachment: Financial summary
Interim Consolidated Statements of Comprehensive Loss Information Three monthsended March 31, (in thousands, except for share and per share data) 2012 2011 $ $ Revenues Sales and royalties 8,308 7,092 License fees and other 1,202 297 9,510 7,389 Operating expenses Cost of sales 7,513 6,023 Research and development costs, net of refundable tax credits and grants 5,572 5,498 Selling, general and administrative expenses 3,213 3,159 16,298 14,680 Loss from operations (6,788) (7,291) Finance income 77 824 Finance costs (4,740) (2,749) Net finance costs (4,663) (1,925) Loss before income taxes (11,451) (9,216) Income tax expense - (841) Net loss (11,451) (10,057) Other comprehensive loss Foreign currency translation adjustments (255) (1,339) Comprehensive loss (11,706) (11,396) Net loss per share Basic and diluted (0.11) (0,12) Weighted average number of shares outstanding Basic and diluted 106,016,843 83,842,054 Interim Consolidated Statement of Financial Position Information Asat As at March 31, December 31, (in thousands) 2012 2011 $ $ Cash and cash equivalents 45,583 46,881 Trade and other receivables and other current assets 12,995 13,258 Restricted cash 834 806 Property, plant and equipment, net 2,452 2,512 Other non-current assets 12,189 11,912 Total assets 74,053 75,369 Payables and other current liabilities 16,684 17,784 Long-term payable (current and non-current portions) 60 88 Warrant liability (current and non-current portions) 12,860 9,204 Non-financial non-current liabilities* 53,126 52,839 Total liabilities 82,730 79,915 Shareholders' deficiency (8,677) (4,546) Total liabilities and shareholders' deficiency 74,053 75,369
* Comprised mainly of non-current portion of deferred revenues, employee
future benefits and provision.
SOURCE AETERNA ZENTARIS INC.