All amounts are in U.S. dollars
QUEBEC CITY, Nov. 11 /CNW Telbec/ - Æterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company"), a global biopharmaceutical company focused on endocrinology and oncology, today reported financial and operating results as at and for the three-month and nine-month periods ended September 30, 2009.
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Third Quarter 2009 Highlights
- July 7, 2009. Publication in Proceedings of the National Academy of
Sciences, of new data supporting the use of AEZS-123 for the treatment
of alcohol dependence that involves ghrelin.
- August 3, 2009. The Company's licensee partner for perifosine in North
America, Keryx Biopharmaceuticals ("Keryx"), disclosed that it had
reached an agreement with the FDA regarding a Special Protocol
Assessment on the design of a Phase 3 trial for multiple myeloma.
- August 17, 2009. Disclosure of results for two Phase 3 studies with
cetrorelix in benign prostatic hyperplasia ("BPH"). The efficacy study
Z-033 did not achieve its primary endpoint. Results from the safety
study Z-041 were positive and exhibited a similar level of efficacy as
the previously disclosed Phase 2 study results.
- September 16, 2009. Disclosure that Keryx received Orphan Drug
designation from the FDA for perifosine for multiple myeloma.
- September 21, 2009. Disclosure of Phase 1 study results with AEZS-112
in advanced solid tumors or lymphoma showed prolonged courses of stable
disease, excellent tolerability and potential for long-term use as a
combination treatment for cancer.
- September 30, 2009. Disclosure of results for the Thorough QT Z-043
("TQT") study, which is part of the cetrorelix pamoate clinical
development in BPH. The study met its primary endpoint.
Subsequent to Quarter-End
- October 19, 2009. Disclosure of the initiation of activities to
complete a Phase 3 trial with macimorelin (AEZS-130) as a first
approved oral diagnostic test for Growth Hormone Deficiency.
- October 23, 2009. Completion of a $5.5 million registered direct
offering.
- November 2, 2009. Disclosure of positive preliminary results for the
Phase 2 study with AEZS-108 in ovarian cancer.
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Juergen Engel, Ph.D., Æterna Zentaris President and Chief Executive Officer, commented, "During this quarter, we disclosed results for the first of two efficacy trials of our Phase 3 program in BPH with cetrorelix. The first efficacy trial did not reach its primary endpoint, while results for the safety and TQT trials were positive. We remain committed to this program and are working towards receiving the results of the second efficacy study next month. Furthermore, we made significant progress with other innovative late-stage compounds such as perifosine and AEZS-108 in oncology, as well as AEZS-130 in endocrinology, which are further proof of the breadth of our pipeline."
Dennis Turpin, the Company's Senior Vice President and Chief Financial Officer, added, "Our financial position enables us to pursue our business and drug development activities, as planned."
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CONSOLIDATED RESULTS AS AT AND FOR THE THREE-MONTH PERIOD ENDED
SEPTEMBER 30, 2009
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Consolidated revenues were $8.6 million for the three-month period ended September 30, 2009, compared to $11.0 million for the same period in 2008. This decrease is mainly related to lower royalty revenues having been recognized in 2009 in connection with the monetization of the royalties derived from the Company's agreement with Merck Serono. Amortization of the monetization proceeds received for the three months ended September 30, 2009 was lower than the royalty revenues generated and payable directly by Merck Serono during the same period in 2008. Additionally, sales volumes of Cetrotide(R) were lower during the three-month period ended September 30, 2009, compared to the same period in 2008.
Consolidated research and development ("R&D") costs, net of tax credits and grants, were $9.7 million for the three-month period ended September 30, 2009, compared to $13.9 million for the same period in 2008. The comparative decrease in net R&D costs is largely attributable to a lower volume of expenses incurred in connection with the continued advancement of the Phase 3 program for cetrorelix in BPH, since the Company progressively completed, during the third quarter, the safety study Z-041 and the TQT trial.
Consolidated net loss for the three-month period ended September 30, 2009 was $11.3 million, or $0.19 per basic and diluted share, compared to $13.9 million, or $0.26 per basic and diluted share, for the same period in 2008. This decrease is mainly related to lower comparative R&D expenses, partially offset by lower comparative revenues, less cost of sales.
Consolidated cash, cash equivalents and short-term investments were $44.5 million as at September 30, 2009, of which $0.9 million is restricted on a long-term basis.
CONFERENCE CALL
Management will be hosting a conference call for the investment community beginning at 10:00 a.m. Eastern Time today, Wednesday, November 11, 2009, to discuss third quarter 2009 results. Individuals interested in participating in the live conference call by telephone may dial 877-974-0453, 416-644-3431 or 514-227-8860, 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.
About Æterna Zentaris Inc.
Æterna Zentaris Inc. is a global biopharmaceutical company focused on endocrine therapy and oncology, with proven expertise in drug discovery, development and commercialization. News releases and additional information are available at www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which 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 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 the 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 except if we are required by a governmental authority or applicable law.
Attachment: Financial summary
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Interim Consolidated Statements of Loss (Unaudited)
(in thousands, except share and per share data)
Three months ended Nine months ended
September 30, September 30,
2009 2008 2009 2008
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$ $ $ $
Revenues
Sales and royalties 5,539 8,630 15,937 24,822
License fees and
other 3,026 2,399 7,118 6,412
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8,565 11,029 23,055 31,234
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Operating expenses
Cost of sales 4,488 4,986 12,727 14,348
Research and
development costs,
net of tax credits
and grants 9,738 13,880 33,251 44,914
Selling, general and
administrative
expenses 3,193 3,277 9,849 14,287
Depreciation and
amortization
Property, plant
and equipment 341 433 983 1,199
Intangible assets 594 839 1,714 2,555
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18,354 23,415 58,524 77,303
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Loss from operations (9,789) (12,386) (35,469) (46,069)
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Other income
(expenses)
Interest income 41 149 315 737
Interest expense (2) - (4) (68)
Foreign exchange
(loss) gain (1,538) (1,324) (1,598) 429
Loss on disposal of
long-lived assets
held for sale - (90) - (125)
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(1,499) (1,265) (1,287) 973
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Loss before income
taxes (11,288) (13,651) (36,756) (45,096)
Income tax expense - (228) - (228)
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Net loss for the
period (11,288) (13,879) (36,756) (45,324)
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Net loss per share
Basic and diluted (0.19) (0.26) (0.67) (0.85)
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Weighted average
number of shares
Basic and diluted 58,506,619 53,187,470 55,135,876 53,187,470
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Interim Consolidated Balance Sheet Information (Unaudited)
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As at As at
September 30, December 31,
(in thousands) 2009 2008
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$ $
Cash and cash equivalents 43,051 49,226
Short-term investments 562 493
Accounts receivable and other current assets 11,127 12,005
Restricted cash 901 -
Property, plant and equipment 6,738 6,682
Other long-term assets 41,237 39,936
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Total assets 103,616 108,342
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Accounts payable and other current liabilities 23,015 22,121
Current portion of long-term payable 56 49
Long-term payable 140 172
Non-financial long-term liabilities 88,390 64,525
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Total liabilities 111,601 86,867
Shareholders' equity (deficiency) (7,985) 21,475
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Total liabilities and shareholders'
equity (deficiency) 103,616 108,342
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For further information: Investor Relations: Ginette Vallières, Investor Relations Coordinator, (418) 652-8525 ext. 265, gvallieres@aezsinc.com; Media Relations: Paul Burroughs, Director of Communications, (418) 652-8525 ext. 406, pburroughs@aezsinc.com
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