BELLUS HEALTH REPORTS RESULTS FOR FOURTH QUARTER AND YEAR ENDED DECEMBER 31, 2010
LAVAL, QC, Feb. 23 /CNW Telbec/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS
Health" or the "Company") reported today its financial results for the
fourth quarter and year ended December 31, 2010. All currency figures
reported in this press release, including comparative figures, are in
CDN dollars, unless otherwise specified.
"Our new business model has delivered substantial results in 2010," said
Roberto Bellini, President and Chief Executive Officer of BELLUS
Health. "We continued to add value to the products in our pipeline,
particularly KIACTA™ which has started its confirmatory Phase III
trial. We have also significantly reduced our burn rate through the
implementation of our strategic initiatives to limit our operating
costs. We intend to carry on this path in 2011 to continue building
value for our shareholders," Mr. Bellini added.
Financial Results
For the fourth quarter ended December 31, 2010, the Company recorded a
net loss of $3,817,000 ($0.02 per share), compared to $5,662,000 ($0.03
per share) for the corresponding quarter the previous year. For the
year ended December 31, 2010, the net loss amounted to $20,113,000
($0.10 per share), compared to a net loss of $8,790,000 ($0.06 per
share) for the same period last year.
The decrease in net loss for the fourth quarter ended December 31, 2010,
compared to the corresponding quarter the previous year, is primarily
due to revenue recorded in 2010 in relation to the KIACTA™ asset sale
and license agreement and sale of OVOS Natural Health Inc. ("OVOS
Natural Health"), as well as a decrease in research and development
expenses. The significant variation between the net loss for the years
ended December 31, 2010 and 2009, is mainly attributable to items
recorded in the second quarter of 2009 in relation to the Company's
refinancing that took place in April 2009. During that quarter, the
Company recorded a gain on extinguishment of debt in the amount of
$20,530,000 resulting from amendments to the terms of the convertible
notes issued in 2006 and 2007, as well as a net credit for vacant space
in the amount of $2,277,000 in relation to the vacant portion of the
Company's premises.
As at December 31, 2010, the Company had available cash and cash
equivalents of $10,257,000, compared to $14,017,000 at December 31,
2009. The decrease is primarily due to funds used in operating
activities, offset by funds received in connection with the KIACTA™
asset sale and license agreement.
The Company's consolidated financial statements and accompanying
Management's Discussion and Analysis for the year ended December 31,
2010 will be available shortly on SEDAR at www.sedar.com and on the Company's web site at www.bellushealth.com.
Highlights
Update on the Company's product candidates
The following is an overview of the progress on the Company's product
candidates during 2010:
-
KIACTA™ (eprodisate) for the treatment of Amyloid A (AA) amyloidosis -
On December 14, 2010, a global confirmatory phase III clinical study
was initiated for KIACTA™. The study is designed to confirm the safety
and efficacy of KIACTA™ in preventing renal function decline in
patients with AA amyloidosis. The international, randomized,
double-blind, placebo-controlled, event-driven study will involve
approximately 230 patients diagnosed with AA amyloidosis enrolled from
approximately 90 sites in 30 countries worldwide. It is currently
estimated that the study will be completed in 2014. A similar study
conducted by the Company from 2001 to 2004 achieved statistical
significance in its primary endpoint (p=0.025) (NEJM June 7, 2007,
356:2349-2360). On April 29, 2010, the Company signed an asset sale and
license agreement with Celtic Therapeutics, pursuant to which Celtic
Therapeutics acquired and licensed worldwide rights related to the
Phase III investigational product candidate KIACTA™ for upfront
payments totaling US$10 million. Celtic Therapeutics will fund 100% of
KIACTA™'s development costs through its confirmatory Phase III clinical
study and all other requirements for KIACTA™'s regulatory approval.
-
NRM8499, a prodrug of tramiprosate for the treatment of Alzheimer's
disease - During the first quarter of 2010, the Company initiated a
Phase I clinical study for NRM8499. The randomized, double-blind,
placebo-controlled study investigated the safety, tolerability and
pharmacokinetic profile of NRM8499 in a group of 67 young and elderly
healthy subjects. The Phase I clinical study for NRM8499 was completed
in the fourth quarter of 2010. On January 31, 2011, BELLUS Health
announced the results of the Phase I clinical study which indicated
that NRM8499 was safe and well tolerated at the intended therapeutic
dose. Moreover, the gastrointestinal tolerability and pharmacokinetic
profile of tramiprosate, with regards to the inter-individual
variability in drug systemic exposure, were meaningfully improved with
NRM8499 when compared to the administration of an equivalent dose of
tramiprosate.
Update on VIVIMINDTM and OVOS Natural Health
On September 30, 2010, a Natural Health Product Number (NPN) was issued
by Health Canada for VIVIMIND™, which grants formal authorization for
sale in Canada. During 2010, the Company entered into two strategic
partnerships in relation to VIVIMIND™.
On October 19, 2010, with the approval of a Special Committee of the
Board of Directors of the Company, BELLUS Health signed a license and
supply agreement relating to the distribution of VIVIMIND™ in Italy
with FB Health LLC ("FB Health"). Pursuant to the license and supply
agreement, the Company granted FB Health exclusive distribution rights
for VIVIMIND™ in Italy, for consideration consisting of an upfront
payment and of up to €3 million in commercial milestone payments should
certain mutually agreed upon sales targets be achieved. The license and
supply agreement also provides for BELLUS Health to supply material for
the product to FB Health at a pre-agreed transfer price. FB Health is
an Italian nutraceutical company controlled by Dr. Francesco Bellini,
Chairman of the Board of Directors of BELLUS Health.
On December 31, 2010, the Company entered into a share purchase
agreement with Advanced Orthomolecular Research Inc. ("AOR") with
respect to OVOS Natural Health, the Company's wholly-owned Canadian
nutraceutical subsidiary. In addition, the Company and AOR entered into
an exclusive license and supply agreement relating to the distribution
of VIVIMIND™ in Canada. Pursuant to the share purchase agreement, AOR
acquired all issued and outstanding shares of OVOS Natural Health for a
total consideration of $1 million, consisting of an upfront payment of
$350,000 and of a payment of $650,000 contingent upon the successful
completion of a pre-established milestone event expected to occur
within 18 months of the closing of the transaction. Pursuant to the
license and supply agreement, the Company granted AOR exclusive
distribution rights for VIVIMIND™ in Canada and will be supplying AOR
with the material for the product at a pre-agreed transfer price. The
license and supply agreement also provides for up to $3 million in
commercial milestone payments to BELLUS Health should certain mutually
agreed upon sales targets be achieved.
The Company continues to actively pursue arrangements in relation to the
distribution of VIVIMIND™ in other markets.
Strategic Initiatives to Reduce Burn Rate
During 2010 and following the end of the year, the Company continued its
efforts to reduce its annual expenditures ("burn rate"). Based on the
Company's current estimates, the initiatives implemented by the
Company, as described below including the impact of the corporate
reorganization, are expected to decrease BELLUS Health's monthly burn
rate to approximately $400,000 by the end of the second quarter of
2011.
On August 9, 2010, the Company announced that it would be focusing on
supporting its current and future strategic partnerships and on
undertaking less expensive product development programs for NRM8499 to
reduce its burn rate and extend its cash resources. The Company further
announced that as a result of these initiatives, it would gradually
reduce its head count by more than two thirds. It is expected that the
Company will have approximately 10 employees by the end of the second
quarter of 2011.
On January 14, 2011, the Company announced that it exercised its right
to terminate the lease of its Laval, Quebec 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. ("A.R.E."), the landlord of such
premises. The exercise of such termination option will result in annual
savings of approximately $4.5 million for the Company, representing a
total of approximately $43 million in aggregate savings over the
remainder of the original lease term. On January 21, 2011, in
consideration for the exercise of the termination option, BELLUS Health
issued 20,656,320 common shares from treasury to A.R.E. at a price of
$0.29 per share (rounded to the second decimal point), for an aggregate
value of $6 million. Pursuant to the terms of the amended lease
agreement, 2009, deferred rent in the amount of $4.2 million (including
deferred rent payments for the first quarter of 2011 and all accrued
interest thereon) will be payable to A.R.E. on April 7, 2011, in cash
or, at the Company's option, through an issuance of common shares from
treasury.
Corporate Reorganization
The Company initiated a corporate reorganization process whereby the
Company will unwind its international structure by closing its
subsidiaries in Europe and the United States. The completion of the
corporate reorganization, which is expected to occur in the first
quarter of 2011, will result in the repatriation of BELLUS Health's
intellectual property to Canada.
Departure of Vice President, General Counsel and Corporate Secretary
In connection with the gradual reduction of its workforce under the
initiatives to reduce its burn rate, BELLUS Health also announced today
that Mr. David Skinner, Vice President, General Counsel and Corporate
Secretary, will leave the Company, effective February 25, 2011.
"Since joining BELLUS Health in April 2003, David Skinner has
demonstrated extraordinary rigor and professionalism. His contribution
to managing contractual and enterprise risk, financings and strategic
partnerships and negotiating and implementing M&A transactions has been
invaluable. We wish to thank David for his dedication and wish him the
best success in his future endeavours", said Roberto Bellini.
As part of its mandate as external legal advisor to the Company, Davies
Ward Phillips & Vineberg LLP will provide the services of one of its
partners, Mr. Sébastien Roy, as Corporate Secretary, effective February
25, 2011.
Going Concern
As at December 31, 2010, the Company's committed sources of funds, and
the cash and cash equivalents on hand is expected, in management's
view, to be sufficient to meet its committed cash obligations and
expected level of expenditures over the next twelve months. However, in
the longer term, the ability of the Company to continue as a going
concern is dependent upon raising additional financing through
borrowings, share issuances, receiving funds 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. These factors continue to
raise significant doubt about the Company's ability to continue as a
going concern in the foreseeable future.
About BELLUS Health
BELLUS Health is a development-focused health company concentrating on
research and development of products that provide innovative health
solutions and address critical unmet medical needs. For further
information on BELLUS Health and its drug development programs, please
visit www.bellushealth.com or call the toll-free number 1-877-680-4500.
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.
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