LAVAL, QC, Aug. 8, 2012 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") today reported its financial results for the second quarter ended June 30, 2012.
Second Quarter 2012 Highlights
- Completed a $17.25 million strategic partnership and financing with Pharmascience Inc. (Pharmascience), including $8.15 million in non-dilutive capital and a $9.1 million investment for a 10.4% ownership stake;
- Concluded the quarter with a cash position of $21.2 million as of June 30, 2012;
- Settled all outstanding convertible securities principally through the issuance of common shares of the Company;
- Consolidated its common shares on the basis of one new post-consolidation common share for every 30 pre-consolidation common shares;
- Presented an update on the KIACTA™ Phase III Confirmatory Study at the XIII International Symposium on Amyloidosis. Preliminary, blinded data demonstrates that demographics and baseline characteristics are similar to BELLUS Health's previous Phase II/III study for KIACTA™ and also confirm an effective trial design based on the strong results of that first Phase II/III study;
- Received a $0.65 million payment from Advanced Orthomolecular Research Inc. (AOR) in relation to AOR's exclusive license of VIVIMIND™ for Canada and acquisition of BELLUS Health's wholly-owned Canadian subsidiary, OVOS Natural Health Inc., in December 2010;
- Entered into a licence and distribution agreement with LevPharm Ltd. (LevPharm), pursuant to which BELLUS Health granted LevPharm exclusive distribution rights for VIVIMIND™ in Israel.
"Our actions in the second quarter, particularly the closing of the partnership with Pharmascience, provide us with the financial stability to complete the Phase III program for KIACTA™," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "In addition, BELLUS Health now has the resources to pursue other opportunities to add to its promising pipeline."
BELLUS Health is developing KIACTA™ as a potential treatment for AA amyloidosis, a fatal 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. KIACTA™ has been granted Orphan Drug designation or its equivalent in the United States and Europe, which would provide seven and ten years of market exclusivity, respectively, as well as a reduction in application and review fees.
Summary of Financial Results
All currency figures reported in this press release are in Canadian dollars, unless otherwise specified. Comparative per share data for 2011 have been retrospectively adjusted to reflect the consolidation of the Company's common shares.
Three-months ended June 30, 2012 |
Three-months ended June 30, 2011 |
|
(in thousands of dollars, except per share data) | ||
Revenues | 706 | 719 |
Research and development expenses, net | (343) | (305) |
General and administrative expenses | (1,880) | (789) |
Finance income | 95 | 4,310 |
Finance costs | (16,800) | (1,832) |
Gain on sale of unrecognized assets | 8,150 | - |
Other income | 650 | - |
Net (loss) income | (9,422) | 2,103 |
Basic (loss) earnings per share | (0.39) | 0.23 |
Diluted loss per share | (0.39) | (0.04) |
The Company's full consolidated financial statements and accompanying management's discussion and analysis for the three- and six-month periods ended June 30, 2012, 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 June 30, 2012, net loss amounted to $9,422,000 ($0.39 per share), compared to net income of $2,103,000 ($0.23 per share) for the corresponding period the previous year. The increase in net loss is primarily due to items recorded in the current quarter in relation to the strategic partnership, financing and capital reorganization namely a non-cash loss on settlement of convertible securities, partially offset by a gain on sale of unrecognized assets.
- General and administrative expenses amounted to $1,880,000 for the three-month period ended June 30, 2012, compared to $789,000 for the corresponding period the previous year. The increase is due to transaction costs incurred in relation to the strategic partnership, financing and capital reorganization.
- Finance income amounted to $95,000 for the three-month period ended June 30, 2012, compared to $4,310,000 for the corresponding period the previous year. The decrease is mainly attributable to finance income recorded in relation to the decrease in the fair value of the embedded conversion option liability on the 2009 Notes in the amount of $4,247,000 for the three-month period ended June 30, 2011.
- Finance costs amounted to $16,800,000 for the three-month period ended June 30, 2012, compared to $1,832,000 for the corresponding period the previous year. The increase is primarily due to a non-cash loss on settlement of convertible securities in the amount of $15,084,000 (including the change in fair value of the embedded conversion option liability on the 2009 Notes) recorded in relation to the strategic partnership, financing and capital reorganization.
- Gain on sale of unrecognized assets amounted to $8,150,000 for the three-month period ended June 30, 2012 (nil for the corresponding period the previous year), in relation to the non-dilutive capital payment received from Pharmascience.
- Other income amounted to $650,000 for the three-month period ended June 30, 2012 (nil for the corresponding period the previous year), and represents a milestone payment received from AOR during the current quarter in relation to the achievement of a pre-established milestone.
Phase III Confirmatory Study for KIACTA™ (eprodisate)
The international, randomized, double-blind, placebo-controlled, event-driven study will involve approximately 230 patients diagnosed with AA amyloidosis recruited from more than 70 sites in 28 countries worldwide. Recruitment is ongoing and is expected to be completed in the second half of 2013. The Phase III Confirmatory Study is an event-driven trial which will conclude when 120 patients have reached worsening events linked to deterioration of kidney function. The completion of the study is expected in the second half of 2015.
About BELLUS Health
BELLUS Health is a development-focused healthcare company focusing on products that provide innovative health solutions and address critical unmet medical needs. The Company's lead program is a novel drug candidate KIACTA™, which is 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 Celtic Therapeutics Inc. AA amyloidosis affects approximately 35,000 to 50,000 individuals in the United States, Europe and Japan.
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 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. 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 | [email protected]
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