BELLUS Health reports results for third quarter ended September 30, 2011, and provides update on VIVIMIND™ partnerships

LAVAL, QC, Nov. 9, 2011 /CNW Telbec/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") reported today its financial results for the third quarter ended September 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 III 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 ("Celtic") continued recruitment for the global confirmatory Phase III 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 ("FB Health"), 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 aggregate consumer sales of over 1 million dollars in Italy. On October 1st, 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 www.vivimind.ca 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. Unless otherwise specified, all currency figures reported in this news release are in Canadian dollars.

  Three-months ended
September 30, 2011
Three-months ended
September 30, 2010
  (in thousands of dollars, except per share data)
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 September 30, 2011, will be available shortly on SEDAR at www.sedar.com and on the Company's web site at www.bellushealth.com.

  • For the three-month period ended September 30, 2011, net income amounted to $245,000 (nil per share), compared to a net loss of $4,378,000 ($0.02 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 September 30, 2011, compared to $764,000 for the corresponding period the previous year.  Revenues mainly consist of revenue from the asset sale and license 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 September 30, 2011, compared to $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 II clinical trial, which ended in the first half of 2010, and the NRM8499 Phase I 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 September 30, 2011, compared to $2,351,000 for the same period the previous year. The decrease is mainly due to a reduction in the workforce 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 September 30, 2011, compared to $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 September 30, 2011, the Company had available cash and cash equivalents of $4,960,000. 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.

About BELLUS Health
BELLUS Health is a development-focused health company concentrating on the development of products that provide innovative health solutions and address critical unmet medical needs. For further information on BELLUS Health, please visit www.bellushealth.com.

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.

 

SOURCE BELLUS HEALTH INC.

For further information:

Caroline Martel
NATIONAL Public Relations
514-843-2313
cmartel@national.ca

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BELLUS HEALTH INC.

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