Mr. Roberto Bellini reports
BELLUS HEALTH SECURITYHOLDERS VOTE IN FAVOUR OF $17.25 MILLION STRATEGIC TRANSACTION WITH PHARMASCIENCE
Bellus Health Inc. today conducted its annual and special
meeting of securityholders in relation to the $17.25-million strategic
transaction and financing with Pharmascience Inc. announced on April 5, 2012. The company also reported its financial
results for the first quarter ended March 31, 2012, and provided a
corporate update.
Corporate highlights:
- Securityholders have voted in favour of the $17.25-million strategic
partnership and financing with Pharmascience announced on April 5,
2012. The transaction is expected to close by May 25, 2012.
- Ninety patients have been enrolled in the company's phase III confirmatory
trial for Kiactaa in AA amyloidosis.
- Preliminary, blinded data from the 78 patients profiled in the phase III
trial demonstrate that demographics and baseline characteristics are
very similar to the previous trial.
-
Exclusive licence and distribution agreement was signed with LevPharm
Ltd. for Viviminda in Israel.
"The strategic partnership with Pharmascience that securityholders
approved today will fund the company beyond pivotal data for Kiactaa in
AA amyloidosis. It will also allow us to evaluate opportunities to add
promising compounds to our pipeline," said Roberto Bellini, president
and chief executive officer of Bellus Health. "AA amyloidosis is a
deadly orphan condition with no current treatment and peak annual
revenue potential of $400-million to $600-million. Baseline patient data from
our ongoing phase III trial are very similar to the first phase III trial we completed, confirming that we constructed an effective trial
design based on the strong results of our first phase III trial."
Strategic partnership and financing with Pharmascience
Securityholders approved the strategic partnership and financing with
Pharmascience at the annual and special meeting of securityholders held
today at Bellus Health's premises in Laval, Que. Securityholders
also approved a 30-for-one common share consolidation to take effect
immediately upon closing of the transaction.
Assuming all conditions of the completion of the arrangement are
satisfied or waived, including approval by the Quebec Superior Court of
Justice, the transaction is expected to be completed by May 25, 2012.
Kiactaa (eprodisate) -- addressing a deadly medical condition with no
current treatment
Subsequent to the end of the first quarter of 2012, Bellus Health
announced, in relation to its partnership with Celtic Therapeutics Inc., that 90 of approximately 230 patients had been
enrolled in the global phase III confirmatory clinical trial for
Kiactaa (eprodisate). The trial is designed to confirm the safety and
efficacy of Kiactaa in preventing renal function decline in patients
diagnosed with AA amyloidosis.
On May 10, 2012, Dr. Denis Garceau, senior vice-president, drug
development, of Bellus Health, provided an update on the pivotal study as
part of the XIII International Symposium on Amyloidosis at the
University Medical Center of Groningen in the Netherlands. Dr. Garceau
reported that preliminary, blinded data from the continuing trial
demonstrate that the baseline characteristics and demographics of the
patients profiled to date are very similar to the first phase III study
completed. These data are important because they confirm that the trial
design constructed based on the strong results of the first phase III
study is effective. A summary of the improvements made to the continuing phase III trial design may be found below:
- The duration of the trial was changed from a fixed two-year duration to an
event-driven trial that will end when 120 events are attained. The data
from the first study were used in calculating the number of events (120
events) required to provide an approximately 90-per-cent statistical power (versus 80 per cent in
first study), assuming a comparable effect of Kiactaa treatment.
-
Considering that the phase 3 confirmatory study will be the second
pivotal study to support the Kiactaa new drug application, the regulatory
agencies agreed that the p-value threshold for a successful study could
be increased to 0.05 from 0.01 in the first study.
- The entry criteria regarding renal function were altered slightly to
enroll patients with high proteinuria, which is the patient subgroup
that benefited most from Kiactaa in the first study;
-
The components of the primary end points were changed to improve the
accuracy, sensitivity and validity of the primary efficacy end point.
Viviminda
In April, 2012, Bellus Health entered into a licence and distribution
agreement with LevPharm Ltd., pursuant to which Bellus
Health granted LevPharm exclusive distribution rights for Viviminda in
Israel. LevPharm expects to launch Viviminda in 2013. Viviminda is a
natural health product designed to protect memory function.
SUMMARY OF FINANCIAL RESULTS
(In thousands of dollars, except per-share data)
Three months ended March 31,
2012 2011
Revenues $ 568 $ 746
Research and development expenses, net (329) (811)
General and administrative expenses (1,278) (1,096)
Finance income 734 6,356
Finance costs (2,888) (1,896)
Net (loss) income (3,193) 3,299
Basic (loss) earnings per share (0.01) 0.01
Diluted (loss) per share (0.01) -
(1) The company's full consolidated financial statements, and accompanying
management's discussion and analysis for the three-month period ended
March 31, 2012, will be available shortly on SEDAR and on the company's
website.
For the three-month period ended March 31, 2012, net loss amounted to
$3,193,000 (one cent per share), compared with a net income of $3,299,000
(one cent per share) for the corresponding period the previous year. The
increase in net loss in the current quarter is mainly attributable to a
decrease in finance income period over period, as explained below.
Revenues amounted to $568,000 for the three-month period ended March 31,
2012, compared with $746,000 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 Therapeutics in 2010 for Kiactaa.
Research and development expenses, net of research tax credits and
grants, amounted to $329,000 for the three-month period ended March 31,
2012, compared with $811,000 for the corresponding period the previous
year. The decrease is mainly attributable to a reduction in expenses
incurred in relation to NRM8499 phase I clinical trial for the
treatment of Alzheimer's disease, which ended in the first quarter of
2011, and a reduction in the work force and other cost-reduction
initiatives implemented by the company during the past year.
General and administrative expenses amounted to $1,278,000 for the
three-month period ended March 31, 2012, compared with $1,096,000 for the
corresponding period the previous year. Expenses in 2011 are net of a
gain on sale leaseback of $1,176,000 in relation to the lease of the
company's Laval, Que., premises that was terminated in April, 2011.
Excluding this item, the decrease is mainly due to a reduction in the
work force and other cost-reduction initiatives implemented by the
company during the past year.
Finance income amounted to $734,000 for the three-month period ended
March 31, 2012, compared with $6,356,000 for the corresponding period the
previous year. The decrease is primarily related to finance income
recorded in 2011 in relation to the decrease in the fair value of the
embedded conversion option liability on the 2009 notes in the amount of
$6,067,000. The conversion option of the 2009 notes is considered as an
embedded derivative that should be marked to market through income.
Finance costs amounted to $2,888,000 for the three-month period ended
March 31, 2012, compared with $1,896,000 for the corresponding period the
previous year. The increase is primarily related to finance costs
recorded in 2012 in relation to the increase in the fair value of the
embedded conversion option liability on the 2009 notes in the amount of
$667,000. The increase is also due to the increasing accretion expense
recorded on the 2009 notes as they advance to maturity.
Financial position and going concern
As at March 31, 2012, the company had available cash and cash
equivalents of $4,107,000, compared with $5,105,000 as at Dec. 31,
2011. As at March 31, 2012, the company's cash and cash equivalents on
hand and expected sources of funds are considered, in management's
view, to be sufficient to meet its committed cash obligations and
expected level of expenditures over the next 12 months.
Should the transaction with Pharmascience be completed, whereby
Pharmascience will pay a total of $17.25-million to Bellus Health, it
will remove the going concern material uncertainty for the foreseeable
future.
We seek Safe Harbor.
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