Mr. Roberto Bellini reports
BELLUS HEALTH REPORTS RESULTS FOR THIRD QUARTER ENDED SEPTEMBER 30, 2011, AND PROVIDES UPDATE ON VIVIMINDA PARTNERSHIPS
Bellus Health Inc. has released its financial results
for the third quarter ended Sept. 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 3 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
- During the quarter, Bellus Health and its strategic partner Celtic Therapeutics continued recruitment for the global confirmatory phase 3 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.
- 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:
- Italy:
- FB Health LLC, 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 total consumer sales of over $1-million in Italy. On Oct. 1, 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.
- Canada:
- 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 Vivimind's website, and will gradually be made available through specific points of sale.
- Middle East:
- 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.
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.
(in thousands of dollars, Three months ended Three months ended
except per share data) Sept. 30, 2011 Sept. 30, 2010
Revenues 745 764
Research and development expenses, net (185) (2,971)
General and administrative expenses (718) (2,351)
Finance income, net 403 180
Net income (loss) 245 (4,378)
Basic earnings (loss) per share -- (0.02)
Diluted loss per share -- (0.02)
The company's full consolidated financial statements and accompanying
management's discussion and analysis for the three- and nine-month
periods ended Sept. 30, 2011, will be available shortly on SEDAR and on the company's website.
For the three-month period ended Sept. 30, 2011, net income amounted
to $245,000 (nil per share), compared with a net loss of $4,378,000
(two cents 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.
Revenues amounted to $745,000 for the three-month period ended Sept.
30, 2011, compared with $764,000 for the corresponding period the
previous year. Revenues mainly consist of revenue from the asset sale
and licence agreement, as well as the service agreement entered into
with Celtic in 2010.
Research and development expenses, net of research tax credits and
grants, amounted to $185,000 for the three-month period ended Sept.
30, 2011, compared with $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 2
clinical trial, which ended in the first half of 2010, and the NRM8499
phase 1 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.
General and administrative expenses amounted to $718,000 for the
three-month period ended Sept. 30, 2011, compared with $2,351,000 for
the same period the previous year. The decrease is mainly due to a
reduction in the work force and other cost-reduction initiatives
implemented by the company to reduce its fixed-cost base and extend its
financial resources.
Finance income amounted to $3,065,000 for the three-month period ended
Sept. 30, 2011, compared with $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.
As at Sept. 30, 2011, the company had available cash and cash
equivalents of $4.96-million. 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.
We seek Safe Harbor.
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