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terna Zentaris Inc. 1405 du
Parc-Technologique Blvd.
Qu bec (Qu bec) Canada G1P 4P5
| Press Release | |
| For immediate release |
Aeterna Zentaris Reports First Quarter 2010 Financial and Operating Results
All amounts are in U.S.
Quebec City, Canada, May 13,
Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) ( the Company ), a late-stage drug
development company specialized in oncology and endocrinology, today reported
financial and operating results as at and for the three months ended March 31,
January 25, 2010: Updated results of a Phase 2 study related to the use of perifosine in
the treatment of advanced metastatic colon cancer showing a statistically
significant benefit in survival, including 5 FU-refractory patients.
January 29, 2010: Publication in the February 2010
issue of the Journal of Clinical Cancer Research of positive Phase 2 results
for perifosine as a single agent for the treatment of advanced Waldenstrom s
February 3, 2010: Special Protocol Assessment ( SPA )
granted by the United States Food and Drug Administration ( FDA ) for the Phase
3 trial of perifosine in combination with capecitabine (Xeloda ) in refractory advanced colorectal cancer. The trial
is to be conducted by Keryx Biopharmaceuticals, Inc.
( Keryx ) (NASDAQ: KERX), Aeterna Zentaris partner and licensee for
perifosine in North America.
March 1, 2010: Disclosure that the Committee for
Orphan Medicinal Products of the European Medicines Agency ( EMA ) had issued a
positive opinion for orphan medicinal product designation for perifosine for
the treatment of multiple myeloma.
Subsequent to Quarter-End
April 5, 2010: Perifosine receives FDA Fast Track
Designation for the Phase 3 X-PECT (Xeloda + Perifosine Evaluation in Colorectal cancer Treatment)
April 8, 2010: Initiation of a Phase 3
registration trial with perifosine in refractory advanced colorectal cancer by
April 15, 2010: Positive Scientific Advice from
the EMA for the Phase 3 program with perifosine in multiple myeloma. Data from
ongoing Phase 3 study, sponsored by Keryx, can be used to register
perifosine in multiple myeloma in Europe.
Presentations of preclinical data on Erk inhibitor, AEZS-131, and Erk/PI3K dual
inhibitor, AEZS-132, as well as preclinical data from a study sponsored by the
National Institutes of Health with perifosine in oncology at the American
Association for Cancer Research Annual Meeting in Washington, D.C.
April 20, 2010: Completion of a
$15.0 million registered direct offering with certain institutional
April, 23, 2010: Company regained compliance with
Nasdaq s minimum bid price listing requirement.
May 6, 2010: Company receives orphan-drug
designation from the FDA for AEZS-108 in ovarian cancer.
May 12, 2010: FDA approves the Company s
Investigational New Drug (IND) application for AEZS-108 in LHRH-receptor
positive urothelial (bladder) cancer.
Juergen Engel, Ph.D.,
Aeterna Zentaris President and Chief Executive Officer commented, This has
been a very exciting quarter as we made great strides in the development of our
lead oncology compound, perifosine, now in Phase 3 registration trials for
multiple myeloma and refractory advanced colorectal cancer. Furthermore, the
different designations recently granted by the FDA in both indications and the
EMA s positive Scientific Advice for multiple myeloma, will accelerate as well
as facilitate the future review and marketing authorization processes in North
Dennis Turpin, Senior Vice
President and Chief Financial Officer of Aeterna Zentaris added, With more
than $40 million in cash, including proceeds from our recent $15 million
registered direct offering and no debt, combined with our expected
significantly reduced burn rate, we are in a solid financial position to
execute our focused drug development and business strategy.
CONSOLIDATED RESULTS FOR THE THREE MONTHS ENDED MARCH 31,
Revenues were $6.4 million for the three-month period ended March 31,
2010, compared to $6.1 million for the same period in 2009. The increase is
mainly due to a comparative increase in sales of Cetrotide to certain
customers in the first quarter of 2010. This increase was partly offset by
lower amortization of upfront license fee payments in 2010 related to our
agreement with sanofi-aventis U.S. LLC ( sanofi-aventis ), which was entered
into in March 2009, in connection with our now discontinued development
program involving cetrorelix for the treatment of Benign Prostatic Hyperplasia
( BPH ), and subsequently terminated.
Research and development ( R&D )
costs, net of tax credits and grants, were $5.7 million for the three-month
period ended March 31, 2010, compared to $11.4 million for the same
comparative decrease in net R&D costs is almost entirely attributable to
the winding down and termination of development activities related to
cetrorelix in BPH, despite the presence in the first quarter of 2010 of
residual expenditures associated with certain remaining contractual
Selling, general and
administrative ( SG&A ) expenses were $2.8 million for the three-month period ended March 31,
2010, compared to $3.6 million for the same period in 2009. This decrease
is primarily related to lower comparative salary and benefit costs, lower legal
expenses and other cost-saving measures.
Net loss was $5.9 million, or $0.09 per basic and diluted
share, for the three-month period ended March 31, 2010, compared to
$12.4 million, or $0.23 per basic and diluted share, for the same period
in 2009. This decrease is mainly related to lower comparative net R&D
costs, lower SG&A expenses and higher foreign exchange gains, partly offset
by lower comparative license fee revenues and lower sales and royalty margins.
Cash and cash equivalents were $26.9 million as at March 31, 2010.
This amount excludes an estimated $13.7 million of net proceeds received in
connection with the registered direct offering completed on April 20,
Management will be hosting a conference call
for the investment community beginning at 2:30 p.m. Eastern Time today,
Thursday, May 13, 2010, to discuss first quarter 2010 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, or may
listen through the Internet at www.aezsinc.com. A replay will be available on the Company s website
for 30 days following the live event.