Mr. Roberto Bellini reports
BELLUS HEALTH REPORTS RESULTS FOR YEAR ENDED DECEMBER 31, 2011, AND PROVIDES UPDATE ON KIACTAA PHASE 3 CONFIRMATORY STUDY
Bellus Health Inc. has released its financial results
for the year ended Dec. 31, 2011, and provided an update on its
pipeline of products.
Highlights:
- Japanese Pharmaceutical and Medical Device Agency (PMDA-Japan) has
accepted sponsor's proposal to expand the Kiactaa phase 3 confirmatory
trial to Japan;
- Continued enrolment of patients in the Kiactaa phase 3 registration
trial;
- Turned Viviminda business cash-flow positive in 2011;
- Further expanded Viviminda's marketing and sales network through licence
agreements in new markets;
- Completed phase 1 trial of NRM8499: the compound was found to be safe
and well tolerated at the intended therapeutic dose;
- Completed several strategic initiatives that reduced use of cash and
extended the company's financial resources to mid-2013.
"During 2011, Bellus Health continued to execute on its business plan,
making significant progress on several fronts," said Roberto Bellini,
president and chief executive officer of Bellus Health. "In particular,
the expansion of the Kiactaa phase 3 registration trial to Japan is an
important milestone for the company and now positions Kiactaa for
marketing approval in the three major global pharma markets, the United
States, Europe and Japan, on completion of the phase 3 study," Mr.
Bellini added.
Kiactaa (eprodisate) for the treatment of AA amyloidosis
During 2011, Bellus Health and its strategic partner Celtic Therapeutics
continued the patient recruitment for the global phase 3
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. The
international, randomized, double-blind, placebo-controlled,
event-driven study will involve approximately 230 patients diagnosed
with AA amyloidosis recruited from 83 sites in 28 countries worldwide,
including those in Japan. Thus far, a total of 72 clinical centres in
26 countries are actively recruiting patients. The Japanese portion of
the study is scheduled to enroll 10 to 20 patients in up to seven clinical
centres. These sites are expected to be activated in the second half of
2012 and will recruit patients for at least one year. Recruitment is
continuing and is expected to be completed in the second half of 2013.
The phase 3 confirmatory study is an event-driven trial which will
conclude when 120 patients have reached worsening events linked to
deterioration of kidney function. Further to the expansion of the study
to Japan and the extension of the recruitment period, the completion of
the study is now expected in the second half of 2015.
There will be periodic data safety monitoring review boards that will
independently assess the safety of Kiactaa (eprodisate) throughout the
study. The first such monitoring review board is scheduled to convene
in April, 2012. No efficacy interim analysis will be performed.
Kiactaa (eprodisate) has been granted orphan drug designation in the
United States and received orphan medicinal product designation in
Europe, which normally provide for market exclusivity of seven years
and 10 years, respectively, once the drug is approved. Kiactaa
(eprodisate) has also received orphan drug designation in Switzerland.
Viviminda, a natural health product designed to protect memory function
Following the agreements entered into in 2010 relating to the
distribution of Viviminda in Italy with FB Health LLC, and the exclusive licence and supply agreement for the distribution of
Viviminda in Canada with Advanced Orthomolecular Research Inc. (AOR),
the company entered into an exclusive licence and distribution
agreement with Agahan Ayandeye Pars Inc. in 2011 for
the rights to Viviminda in Egypt, United Arab Emirates, Pakistan, Iran
and certain other Gulf states. The Agahan Group expects to launch
Viviminda in the first half of 2012. The company also entered into an
exclusive licence and distribution agreement with Integris Pharma Ltd.
in 2011, which has secured the exclusive right to market and
sell Viviminda in Greece and Cyprus. Integris expects to launch
Viviminda in Greece and Cyprus in the middle of 2012.
The company is actively pursuing additional partnerships in order to
further expand Viviminda's commercial footprint throughout the world.
NRM8499, a pro-drug of tramiprosate for the treatment of Alzheimer's disease
In January, 2011, Bellus Health announced the results of the phase I
clinical trial for NRM8499, which investigated the safety, tolerability
and pharmacokinetic profile of NRM8499 as compared with tramiprosate in a
group of 67 young and elderly healthy subjects. The phase I clinical
trial data demonstrated that NRM8499 were safe and well tolerated at the
intended therapeutic dose. Moreover, the gastrointestinal tolerability
and pharmacokinetic profile of tramiprosate was meaningfully improved
with NRM8499. The company is currently exploring strategic partnership
opportunities with the aim of further pursuing the development process
of NRM8499.
Strategic cost reduction initiatives
Since the second quarter of 2010, the company has been implementing
cost reduction initiatives to reduce its fixed-cost base and extend
its financial resources. These included the reduction of the company's
head count by more than 75 per cent; the early termination of the lease
agreement for the company's Laval, Que., premises; and the
reorganization of its international structure. As a result, the company
has significantly reduced its required cash outflows.
In early 2011, the company exercised its right to terminate the lease of
its Laval, Que., premises as of April 7, 2011, as provided in the
amended lease agreement dated March 31, 2009, with A.R.E. Quebec No. 2,
Inc., the landlord of such premises. The early termination of the lease
resulted in annual savings of approximately $4.5-million for the
company, representing a total of approximately $43-million in total savings over the remainder of the original lease term. The company has
signed a new lease that began on April 8, 2011, at the same premises,
for less space.
In 2011, Bellus Health completed a corporate reorganization whereby the
company streamlined its international structure by liquidating its
subsidiaries in Europe and the United States. The reorganization
resulted in the repatriation of Bellus Health's intellectual property
to Canada and the reduction of the company's operating expenses by
approximately $1.4-million per year.
Financial results
All currency figures reported in this press release, including
comparative figures, are in Canadian dollars, unless otherwise specified.
For the year ended Dec. 31, 2011, net income amounted to $3,424,000
(one cent per share), compared with a net loss of $24,553,000 (12 cents per
share) for the same period last year. For the fourth quarter ended
Dec. 31, 2011, the company recorded a net loss of $2,223,000 (one cent per share), compared with $12,739,000 (six cents per share) for the
corresponding quarter the previous year.
The increase in net income/decrease in net loss in the current periods,
compared with the corresponding periods the previous year, is partly due
to cost reduction initiatives implemented by the company during the
past years, such as reducing its work force, amending and early
terminating its lease agreement, and streamlining its international
structure. In addition, net income for the year ended Dec. 31,
2011, includes finance income of $13,105,000 recorded in relation to
the decrease in the fair value of the embedded conversion option
liability on the 2009 notes, compared with finance costs of $5,904,000
for the corresponding period in 2010. Net loss for the fourth quarter
ended Dec. 31, 2011, includes finance costs of $243,000 in relation
to the increase in the fair value of the embedded conversion option
liability on the 2009 notes, compared with finance costs of $9,405,000
for the corresponding period in 2010.
As at Dec. 31, 2011, the company had available cash and cash
equivalents of $5,105,000, compared with $10,257,000 as at Dec. 31,
2010. For the year ended Dec. 31, 2011, net decrease in cash and
cash equivalents amounted to $5,152,000, compared with $3.76-million for the
corresponding period the previous year. The net decrease in 2010 is net
of proceeds of $10.2-million received in relation to the Kiactaa asset
sale and licence agreement entered into with Celtic in 2010. Excluding
this cash inflow, net decrease in cash used compared with last year is
attributable to cost reduction initiatives implemented by the company,
as discussed previously.
The company's consolidated financial statements and accompanying
management's discussion and analysis for the year ended Dec. 31,
2011, will be available shortly on SEDAR and on the company's website.
Going concern
As at Dec. 31, 2011, based on current estimates, the company's cash
and cash equivalents on hand, and expected sources of finances are
considered, in management's view, to be sufficient to meet its
committed cash obligations and expected level of expenditures into the
third quarter of 2013. Beyond that, the ability of the company to
continue as a going concern is dependent upon raising additional
financing through borrowings, share issuances, receiving finances through
sale of assets, supply agreements or product licensing agreements, and
from obtaining regulatory approval in various jurisdictions to market
and sell its product candidates and ultimately achieving future
profitable operations. The outcome of these matters is dependent on a
number of factors outside of the company's control. This material
uncertainty may cast significant doubt about the company's ability to
continue as a going concern beyond that period.
Management continues to pursue additional sources of financees including
through further arrangements relating to the distribution of Viviminda
and a potential partnership for NRM8499. While the discussions could
lead to the signing of binding agreements in the future, there can be
no assurance whatsoever that any such transaction will be put in place.
We seek Safe Harbor.
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