Mr. Roberto Bellini reports
BELLUS HEALTH REPORTS RESULTS FOR FOURTH QUARTER AND YEAR ENDED DECEMBER 31, 2010
Bellus Health Inc. is providing its financial results for the
fourth quarter and year ended Dec. 31, 2010. All currency figures
reported in this news release, including comparative figures, are in
Canadian 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 Dec. 31, 2010, the company recorded a
net loss of $3,817,000 (two cents per share), compared with $5,662,000 (three cents
per share) for the corresponding quarter the previous year. For the
year ended Dec. 31, 2010, the net loss amounted to $20,113,000
(10 cents per share), compared with a net loss of $8.79-million (six cents per
share) for the same period last year.
The decrease in net loss for the fourth quarter ended Dec. 31, 2010,
compared with the corresponding quarter the previous year, is primarily
due to revenue recorded in 2010 in relation to the Kiacta asset sale
and licence agreement and sale of Ovos Natural Health Inc., as well as a decrease in research and development
expenses. The significant variation between the net loss for the years
ended Dec. 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
$20.53-million 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 Dec. 31, 2010, the company had available cash and cash
equivalents of $10,257,000, compared with $14,017,000 at Dec. 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 licence agreement.
The company's consolidated financial statements and accompanying
management's discussion and analysis for the year ended Dec. 31,
2010, will be available shortly on SEDAR and on the company's website.
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 Dec. 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 end point (p equals 0.025) (New England Journal of Medicine, June 7, 2007,
356: 2,349 to 2,360). On April 29, 2010, the company signed an asset sale and
licence 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 totalling $10-million (U.S.). Celtic Therapeutics will finance 100 per cent 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 Jan. 31, 2011, Bellus Health
announced in Stockwatch 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 regard to the interindividual
variability in drug systemic exposure, were meaningfully improved with
NRM8499 when compared with the administration of an equivalent dose of
tramiprosate.
Update on Vivimind and Ovos Natural Health
On Sept. 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 partnerships in relation to Vivimind.
On Oct. 19, 2010, with the approval of a special committee of the
board of directors of the company, Bellus Health signed a licence and
supply agreement relating to the distribution of Vivimind in Italy
with FB Health LLC. Pursuant to the licence 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 three million euros in commercial milestone payments should
certain mutually agreed upon sales targets be achieved. The licence and
supply agreement also provides for Bellus Health to supply material for
the product to FB Health at a preagreed transfer price. FB Health is
an Italian nutraceutical company controlled by Dr. Francesco Bellini,
chairman of the board of directors of Bellus Health.
On Dec. 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 licence 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
licence 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 preagreed transfer price. The
licence 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 Aug. 9, 2010, the company announced in Stockwatch that it would be focusing on
supporting its current and future 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 Jan. 14, 2011, the company announced in Stockwatch that it 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 ARE Quebec No. 2 Inc., 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 total savings over the
remainder of the original lease term. On Jan. 21, 2011, in
consideration for the exercise of the termination option, Bellus Health
issued 20,656,320 common shares from treasury to ARE at a price of
29 cents per share (rounded to the second decimal point), for a total
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 ARE 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 work force under the
initiatives to reduce its burn rate, Bellus Health also announced today
that David Skinner, vice-president, general counsel and corporate
secretary, will leave the company, effective Feb. 25, 2011.
"Since joining Bellus Health in April, 2003, David Skinner has
demonstrated extraordinary rigour 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 Mr. Bellini.
As part of its mandate as external legal adviser to the company, Davies
Ward Phillips & Vineberg LLP will provide the services of one of its
partners, Sebastien Roy, as corporate secretary, effective Feb.
25, 2011.
Going concern
As at Dec. 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 12 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.
We seek Safe Harbor.
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