LAVAL, QC, Nov. 9, 2011 /CNW Telbec/ - BELLUS Health Inc. (TSX: BLU)
("BELLUS Health" or the "Company") reported today its financial results
for the third quarter ended September 30, 2011.
"We are very pleased with the progress made over the last few months"
said Roberto Bellini, President and Chief Executive Officer of BELLUS
Health. "Patient recruitment for KIACTA™, our lead drug candidate now
in its global confirmatory Phase III clinical trial, is progressing. We
are also very pleased with the work of our distribution partners for
VIVIMIND™. The launch in Italy has been a success and we look forward
to the launch in Canada and Middle East shortly. We also continue to
search for high quality partnerships to further expand VIVIMIND™'s
distribution footprint."
Operating Highlights
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During the quarter, BELLUS Health and its strategic partner Celtic
Therapeutics ("Celtic") continued recruitment for the global
confirmatory Phase III clinical trial for KIACTA™. The trial is
designed to confirm the safety and efficacy of KIACTA™ in preventing
renal function decline in patients diagnosed with AA amyloidosis. It
will involve approximately 230 patients enrolled from approximately 72
sites in 27 countries. Patient recruitment is estimated to be completed
in mid-2012. It is currently expected that the trial will be completed
in 2014.
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As previously announced, the Company recently signed licensing
agreements for the marketing and distribution of VIVIMIND™ in Italy,
Canada, and certain countries in the Middle East.
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| Italy |
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FB Health LLC ("FB Health"), exclusive distributor for VIVIMIND™ in
Italy, is strongly encouraged by market response to the newly available
product. In the first seven months it has been on the market, VIVIMIND™
has surpassed sales expectations, having reached aggregate consumer
sales of over 1 million dollars in Italy. On October 1st, 2011, FB Health launched Viviflux™, a natural health product
containing homotaurine, the active ingredient in VIVIMIND™, aimed at
maintaining and promoting healthy neuronal activity and at reducing the
risk of ischemic events.
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| Canada |
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Exclusive distributor, Advanced Orthomolecular Research Inc. ("AOR"), is
expected to launch VIVIMIND™ on the Canadian market in November 2011.
The product will first be available at www.vivimind.ca and will gradually be made available through specific points of sale.
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| Middle East |
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Agahan Ayandeye Pars Inc. ("Agahan Group"), exclusive distributor for
VIVIMIND™ in certain Middle Eastern countries, has filed for regulatory
approval, which is expected to be granted in early 2012. VIVIMIND™ is
expected to be formally launched in the Middle East in the first
quarter of 2012.
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Summary of Financial Results
These financial results were prepared in accordance with International
Financial Reporting Standards ("IFRS"), as issued by the International
Accounting Standards Board. Comparative figures for 2010 have been
restated to conform to IFRS. Unless otherwise specified, all currency
figures reported in this news release are in Canadian dollars.
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| Three-months ended September 30, 2011 | Three-months ended September 30, 2010 |
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| (in thousands of dollars, except per share data) |
| Revenues |
745
|
764
|
| Research and development expenses, net |
(185)
|
(2,971)
|
| General and administrative expenses |
(718)
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(2,351)
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| Finance income, net |
403
|
180
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| Net income (loss) |
245
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(4,378)
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| Basic earnings (loss) per share |
-
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(0.02)
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| Diluted loss per share |
-
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(0.02)
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The Company's full consolidated financial statements and accompanying
management's discussion and analysis for the three and nine-month
periods ended September 30, 2011, will be available shortly on SEDAR at
www.sedar.com and on the Company's web site at www.bellushealth.com.
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For the three-month period ended September 30, 2011, net income amounted
to $245,000 (nil per share), compared to a net loss of $4,378,000
($0.02 per share) for the corresponding period the previous year. The
increase in net income in the current period is mainly attributable to
a decrease in the fair value of the embedded derivative liability on
the conversion option of the 2009 Notes in the amount of $3,034,000 for
the three-month period.
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Revenues amounted to $745,000 for the three-month period ended September
30, 2011, compared to $764,000 for the corresponding period the
previous year. Revenues mainly consist of revenue from the asset sale
and license agreement as well as the service agreement entered into
with Celtic in 2010.
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Research and development expenses, net of research tax credits and
grants, amounted to $185,000 for the three-month period ended September
30, 2011, compared to $2,971,000 for the corresponding period the
previous year. The decrease is mainly attributable to a reduction in
expenses incurred in relation to the NC-503 (eprodisate) Phase II
clinical trial, which ended in the first half of 2010, and the NRM8499
Phase I clinical trial, which ended in the first quarter of 2011. In
addition, since the second quarter of 2010, the Company has been
implementing cost reduction initiatives to reduce its burn rate.
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General and administrative expenses amounted to $718,000 for the
three-month period ended September 30, 2011, compared to $2,351,000 for
the same period the previous year. The decrease is mainly due to a
reduction in the workforce and other cost reduction initiatives
implemented by the Company to reduce its fixed-cost base and extend its
financial resources.
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Finance income amounted to $3,065,000 for the three-month period ended
September 30, 2011, compared to $2,064,000 for the corresponding period
the previous year. The increase is mainly attributable to a decrease in
the fair value of the embedded derivative liability on the conversion
option of the 2009 Notes.
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As at September 30, 2011, the Company had available cash and cash
equivalents of $4,960,000. Based on the current estimates, the
Company's committed sources of funds and the cash and cash equivalents
on hand are expected, in management's view, to be sufficient to meet
its committed cash obligations and expected level of expenditures into
the first half of 2013.
About BELLUS Health
BELLUS Health is a development-focused health company concentrating on
the development of products that provide innovative health solutions
and address critical unmet medical needs. For further information on
BELLUS Health, please visit www.bellushealth.com.
Forward Looking Statements
Certain statements contained in this news release, other than statements
of fact that are independently verifiable at the date hereof, may
constitute forward-looking statements. Such statements, based as they
are on the current expectations of management, inherently involve
numerous risks and uncertainties, known and unknown, many of which are beyond BELLUS Health Inc.'s control. Such
risks include but are not limited to: the ability to obtain financing
immediately in current markets, the impact of general economic
conditions, general conditions in the pharmaceutical and/or
nutraceutical industry, changes in the regulatory environment in the
jurisdictions in which the BELLUS Health Group does business, stock
market volatility, fluctuations in costs, and changes to the
competitive environment due to consolidation, achievement of forecasted
burn rate, and that actual results may vary once the final and
quality-controlled verification of data and analyses has been
completed. Consequently, actual future results may differ materially
from the anticipated results expressed in the forward-looking
statements. The reader should not place undue reliance, if any, on any
forward-looking statements included in this news release. These
statements speak only as of the date made and BELLUS Health Inc. is
under no obligation and disavows any intention to update or revise such
statements as a result of any event, circumstances or otherwise, unless
required by applicable legislation or regulation. Please see the
Company's public fillings including the Annual Information Form of
BELLUS Health Inc. for further risk factors that might affect the
BELLUS Health Group and its business.
<p> Caroline Martel<br/> NATIONAL Public Relations<br/> 514-843-2313<br/> <a href="mailto:cmartel@national.ca">cmartel@national.ca</a> </p>