BELLUS Health Reports Results for First Quarter Ended March 31, 2013, and Provides Update on KIACTA(TM) Phase III Confirmatory Study

- Also announces voting results from Annual Meeting of Shareholders -

LAVAL, QC, May 15, 2013 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") today reported its financial results for the first quarter ended March 31, 2013.

First Quarter 2013 Highlights

  • Recruitment continued for Phase III Confirmatory Study for KIACTA™ for the treatment of AA amyloidosis, with approximately 66% of patients recruited to date;

  • Recommendation of the Data Safety Monitoring Board to continue KIACTA™ Phase III Confirmatory Study as per protocol, based on its last review;

  • Concluded the quarter with a cash position of $17.6 million, enabling the Company to finance its operations through the end of KIACTA™ Phase III Confirmatory Study, expected in 2017;

  • Exercised put option to settle one of its credit facilities, leading to estimated savings of more than $200,000 in future interest payments.

"During this reporting period, we maintained our steady pace of enrolment for the Phase III Confirmatory Study for KIACTA™," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "We also continued to evaluate responsible capital allocation opportunities to maximize our financial runway while strengthening our pipeline."

Phase III Confirmatory Study for KIACTA™ (eprodisate)

During the first quarter of 2013, recruitment continued for the Phase III Confirmatory Study for KIACTA™, for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death. The study will involve approximately 230 patients enrolled from more than 70 sites and 30 countries worldwide.

As of May 15, 2013, there are 152 patients enrolled in the Phase III Confirmatory Study, and based on the current recruitment rate, BELLUS Health continues to expect that patient recruitment will be completed in the first half of 2014. The Phase III Confirmatory Study is an event-driven study that will end when 120 events linked to deterioration of kidney function have occurred, which is currently expected to be reached in 2017. BELLUS Health's partner, Auven Therapeutics (previously Celtic Therapeutics), is funding 100% of the development costs of KIACTA™, including the Phase III Confirmatory Study and other related activities, which are estimated to be in excess of US$50 million. Auven Therapeutics and BELLUS Health are expected to share the overall proceeds from potential future revenue of KIACTA™ approximately equally.

Patients completing the Phase III Confirmatory Study will be offered to continue in an extended program. The first patients are expected to be enrolled in the extended program in the second half of 2013.

As part of the Phase III Confirmatory Study, there are periodic meetings of the Data Safety Monitoring Board (DSMB), which independently assesses the safety of KIACTA™ throughout the study. Based on its last review on April 16, 2013, the DSMB recommended that the study continue as per protocol.

VIVIMIND™

VIVIMIND™, BELLUS Health's natural health product designed to protect memory function, was commercially launched in Greece in the first quarter of 2013 by the Company's marketing and distribution partner, Integris Pharma Ltd.

The Company currently has distribution agreements with partners in several countries, including Italy, Canada, Taiwan, Greece, certain countries in the Middle East, Israel and South Korea.

Management is currently exploring opportunities in order to expand its pipeline, including through acquisitions and/or in-licensing. In addition, the Company continues to pursue additional sources of funds including through asset sale and/or further arrangements relating to the distribution of VIVIMIND™.

Summary of Financial Results

All currency figures reported in this press release are in Canadian dollars, unless otherwise specified. Comparative per share data for 2012 have been retrospectively adjusted to reflect the consolidation of the Company's common shares in May 2012.

  Three-months ended
March 31, 2013
Three-months ended
March 31, 2012
  (in thousands of dollars, except per share data)
Revenues 599 568
Research and development
expenses
(395) (329)
General and administrative
expenses
(966) (1,278)
Finance income 256 734
Finance costs (48) (2,888)
Net loss (554) (3,193)
Net loss attributable to
owners of the Company
(537) (3,193)
Basic and diluted loss per share   (0.01) (0.33)

The Company's full consolidated financial statements and accompanying management's discussion and analysis for the three-month period ended March 31, 2013, will be available shortly on SEDAR at www.sedar.com and on the Company's website at www.bellushealth.com.

  • For the three-month period ended March 31, 2013, net loss attributable to owners of the Company amounted to $537,000 ($0.01 per share), compared to $3,193,000 ($0.33 per share) for the corresponding period the previous year. The decrease is primarily due to a reduction in accretion expense and change in fair value of embedded derivative on convertible notes following the settlement of convertible securities, as part of the strategic partnership, financing and capital reorganization that took place in May 2012.

  • Revenues amounted to $599,000 for the three-month period ended March 31, 2013, compared to $568,000 for the corresponding period the previous year. Revenues mainly consist of revenue recognized for accounting purposes from the asset sale and license agreement as well as the service agreement entered into with Auven Therapeutics in 2010 for KIACTA™. Revenues also include revenue recognized for accounting purposes from the agreement with Asclepios Bioresearch (UK) Limited, as well as revenue from distribution agreements in relation to VIVIMIND™.

  • General and administrative expenses amounted to $966,000 for the three-month period ended March 31, 2013, compared to $1,278,000 for the corresponding period the previous year. The decrease is mainly due to transaction costs recorded in the comparative period in relation to the strategic partnership, financing and capital reorganization that took place in May 2012.

  • Finance income amounted to $256,000 for the three-month period ended March 31, 2013, compared to $734,000 for the corresponding period the previous year. The decrease is mainly attributable to a lower increase in fair value of the New ABCP Notes recorded during the current quarter.

  • Finance costs amounted to $48,000 for the three-month period ended March 31, 2013, compared to $2,888,000 for the corresponding period the previous year. The decrease is primarily due to a reduction in accretion expense and change in fair value of embedded derivative on convertible notes following the settlement of convertible securities, as part of the strategic partnership, financing and capital reorganization that took place in May 2012.

As at March 31, 2013, the Company had available cash, cash equivalents and short-term investments totalling $17.6 million.

On March 28, 2013, effective April 19, 2013, the Company exercised the put option on one of its credit facilities, which reduced both the aggregate credit facilities and nominal value of the related New ABCP Notes by US$3,009,000. Upon the exercise of the put option, the Company transferred to the bank the ownership of the MAV3 IA Tracking Notes, and paid an amount of $1,282,000 (US$1,250,000) to settle the credit facility. This will enable the Company to save more than $200,000 in future interest payments.

BELLUS Health Announces Election of Directors and Independent Auditor at Annual Meeting

Each director nominee listed in the Management Information Circular dated March 19, 2013 was elected as Director of the Company during the Annual Meeting of the Holders of Common Shares held earlier today in Laval, Quebec.

The details of the election are as follows:

Director Nominee  Outcome  Votes For % For Votes
 Withheld 
 % Withheld 
Dr. Francesco Bellini, O.C. Elected  24,913,396   99.96%  9,440 0.04%
Roberto Bellini Elected 24,913,423 99.96% 9,413 0.04%
Franklin M. Berger Elected 24,913,946 99.96% 8,890 0.04%
Charles Cavell Elected 24,907,355 99.94% 15,481 0.06%
Hélène F. Fortin, FCPA auditor, FCA   Elected 24,907,999 99.94% 14,837 0.06%
Pierre Larochelle Elected 24,581,631 98.63% 341,205 1.37%
Donald Olds Elected 24,908,725 99.94% 14,111 0.06%
Joseph Rus Elected 24,908,736 99.94% 14,100 0.06%
Dr. Martin Tolar Elected 24,907,794 99.94% 15,042 0.06%

The results of the final votes regarding all matters subject to a vote during the Annual Meeting that took place earlier today will be made available on SEDAR's site (www.sedar.com).

KPMG LLP, Chartered Accountants, have been appointed as the independent auditor of the Company until the next Annual Meeting of Shareholders. KPMG LLP has been the independent auditor of the Company since September 1995.

About BELLUS Health

BELLUS Health is a development-focused healthcare company concentrating on products that provide innovative health solutions and address critical unmet medical needs. The Company's lead program is KIACTA™, a novel drug candidate currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death. KIACTA™ is partnered with global private equity firm Auven Therapeutics. AA amyloidosis affects approximately 35,000 to 50,000 individuals in the United States, Europe and Japan.

About AA Amyloidosis

AA amyloidosis is a deadly condition that progresses from chronic inflammatory diseases such as rheumatoid arthritis. The disease causes a protein called amyloid A to accumulate in major organs, particularly the kidneys, which leads to organ dysfunction, failure, and eventually death.

There is currently no available treatment for AA amyloidosis and it is estimated that approximately 35,000 to 50,000 patients are living with the disease in the United States, Europe and Japan. Independent research conducted by the Frankel Group in 2009 suggests that peak annual revenues of $400 million to $600 million are achievable.

Because patients diagnosed with AA amyloidosis tend to quickly progress to a costly regimen of dialysis, healthcare payers are anxious to find alternative treatments for this deadly condition. KIACTA™ has been granted Orphan Drug designation or its equivalent in the United States and Europe, which provide seven and ten years of market exclusivity, respectively, once the drug is approved, as well as a reduction in application and review fees.

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, 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 Inc. does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation, achievement of forecasted burn rate, achievement of forecasted clinical trial milestones, and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. The length of KIACTATM Phase III Confirmatory Study is dependent upon many factors including clinical sites activation, patient enrolment rate, patient drop-out rate and occurrence of clinical endpoint events. 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 Company and its business. 

SOURCE: BELLUS Health Inc.

For further information:

Adam Peeler
TMX Equicom
416-815-0700 ext. 225 | apeeler@tmxequicom.com


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