LAVAL, QC, Feb. 24, 2016 /CNW/ - BELLUS Health Inc. (TSX: BLU) (BELLUS Health or the Company), a drug development company focused on rare diseases, today reported its financial and operating results for the year ended December 31, 2015.
2015 and Early 2016 Highlights
- Completion of the KIACTA™ Phase 3 Confirmatory Study for the treatment of AA amyloidosis in January 2016; top-line results expected in Q2 2016;
- Presented data from clinical and pre-clinical studies evaluating Shigamab™ in the treatment of sHUS at the International Symposium on Shiga toxin (verocytotoxin) Producing Escherichia Coli (VTEC) 2015 Conference in Boston;
- Regained exclusive rights to AL amyloidosis program and related compounds;
- Issued 7.3 million common shares on January 1, 2016 to settle convertible notes, as scheduled; further simplification of the Company's capital structure;
- Concluded the year with cash, cash equivalents and short-term investments totaling $9.7 million.
"The KIACTA™ Phase 3 Confirmatory Study is the most comprehensive study ever conducted in AA amyloidosis patients and we look forward to sharing the top line data with patients, physicians and the investment community in the second quarter of 2016," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "We also continue advancing the other rare disease pipeline programs to continue building value for BELLUS Health's shareholders."
KIACTA™ for AA amyloidosis
On January 21, 2016, BELLUS Health and Auven Therapeutics announced the completion of the KIACTA™ Phase 3 Confirmatory Study for the treatment of AA amyloidosis. The Phase 3 study completed enrollment in January 2015 with a total of 261 patients participating in the study. In January 2016, the event-driven study met its completion target of 120 patient events linked to the deterioration of kidney function. Top-line results are expected in the second quarter of 2016.
The Phase 3 study is designed to confirm the safety and efficacy of KIACTA™ in preventing renal function decline in patients diagnosed with AA amyloidosis. KIACTA™'s safety and efficacy were demonstrated in a previous Phase 2/3 study. The Phase 3 Confirmatory Study is the last key step before applications for regulatory approval for KIACTA™ can be filed.
No major safety concerns have been raised by the Data Safety Monitoring Board, which independently assessed the safety of KIACTA™ throughout the study and most recently met in July 2015.
BELLUS Health is partnered with global private equity firm Auven Therapeutics for the development of KIACTA™. Auven Therapeutics acquired the KIACTA™ rights from the Company in 2010, is conducting the KIACTA™ study and funding 100% of the development costs of KIACTA™, including the Phase 3 Confirmatory Study and other related activities, which total costs are currently estimated to be in excess of US$60 million. Overall proceeds from potential future revenue of KIACTA™ will be shared between Auven Therapeutics and BELLUS Health based on a pre-agreed formula, and assuming that total divestiture transaction proceeds reach a pre-determined threshold, the parties will share aggregate proceeds equally.
Auven Therapeutics has engaged Lazard as a financial advisor for the sale of KIACTA™.
KIACTA™ for Sarcoidosis
BELLUS Health's partner, Auven Therapeutics, is currently developing a clinical Phase 2/3 study protocol to evaluate the safety and efficacy of KIACTA™ for the treatment of patients suffering from chronic pulmonary sarcoidosis. An investigational new drug application (IND) for this clinical Phase 2/3 study is expected to be filed with the U.S. Food and Drug Administration in the first half of 2016.
All costs in relation to the development of KIACTA™ in sarcoidosis will be borne by Auven Therapeutics. Proceeds from potential future revenue of KIACTA™, including the rights to KIACTA™ for sarcoidosis, are subject to the proceeds sharing agreement between Auven Therapeutics and BELLUS Health.
Chronic sarcoidosis is a rare, potentially fatal inflammatory condition that affects the lungs. There is no cure for sarcoidosis, and treatment options are limited and can have serious adverse effects.
Shigamab™ for sHUS
A clinical Phase 2 Proof-of-Concept study protocol is currently being designed for the assessment of the efficacy of Shigamab™ in the treatment of the Hemolytic Uremic Syndrome caused by Shiga toxin-producing E. coli (sHUS), a rare disease primarily affecting the kidneys of children. The Company intends to meet with regulatory authorities in 2016 to present its clinical development plan for Shigamab™.
In September 2015, the Company presented data from clinical and pre-clinical studies evaluating Shigamab™ in the treatment of sHUS at the VTEC Conference in Boston. During the conference, BELLUS Health held its first Shigamab™ Scientific Advisory Board meeting.
In parallel with the preparation of the clinical Phase 2 Proof-of-Concept study, BELLUS Health also plans to perform an additional pre-clinical study in a sHUS baboon model to help establish the optimal effective treatment window for Shigamab™ in sHUS patients.
Shigamab™ is a monoclonal antibody therapy being developed for the treatment of sHUS, a rare disease which principally affects the kidneys and often leads to acute dialysis, and in certain cases chronic kidney disease and death, primarily in children.
AL Amyloidosis Research Project
The Company also has a research-stage project for AL amyloidosis, a rare disease in which amyloid protein builds up and causes dysfunction in various parts of the body, including the kidneys, heart, liver and peripheral nerves.
In February 2015, the agreement entered into by BELLUS Health with AmorChem Holdings Inc. in 2013 for the development of drug candidates for the treatment of AL amyloidosis was terminated. As a result of the termination, BELLUS Health regained exclusive rights to its AL amyloidosis program and related compounds.
Settlement of Convertible Notes
As scheduled, on January 1, 2016, BELLUS Health issued 7,286,828 common shares from treasury in settlement of convertible notes. The convertible notes' notional amount was approximately $10.9 million and terms of the conversion were determined as part of BELLUS Health's capital reorganization in 2012. The settlement further simplified the Company's capital structure.
Summary of Financial Results
All currency figures reported in this press release are in Canadian dollars, unless otherwise specified.
| Year Ended December |
Year Ended December |
|
| (in thousands of dollars, except per share data) |
||
| Revenues |
4,024 |
2,376 |
| Research and development expenses, net |
(1,008) |
(1,695) |
| General and administrative expenses |
(3,122) |
(3,150) |
| Net finance income |
484 |
452 |
| Deferred tax recovery |
27 |
49 |
| Net income (loss) for the year |
405 |
(1,968) |
| Net income (loss) attributable to |
202 |
(1,931) |
| Basic and diluted earnings (loss) per share |
– |
(0.04) |
The Company's full consolidated financial statements and accompanying management's discussion and analysis for the year ended December 31, 2015 will be available shortly on SEDAR at www.sedar.com and on the Company's website at www.bellushealth.com.
- Revenues amounted to $4,024,000 for the year ended December 31, 2015, compared to $2,376,000 for the previous year. The increase is attributable to higher revenue recognized for accounting purposes in 2015 in relation to the VIVIMIND™ license agreement with FB Health and the service agreement with Auven Therapeutics for KIACTA™.
- Research and development expenses, net of research tax credits, amounted to $1,008,000 for the year ended December 31, 2015, compared to $1,695,000 for the previous year. The decrease is primarily attributable to lower expenses incurred in relation to the development of Shigamab™. The decrease is also attributable to higher research tax credits recognized in 2015 in relation to the realization of tax credits from prior years that met the criteria for recognition during 2015, and the filing in 2015 of additional claims for prior years.
As at December 31, 2015, the Company had available cash, cash equivalents and short-term investments totalling $9,702,000, compared to $12,307,000 as at December 31, 2014.
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. A recent commercial assessment study conducted by Navigant Consulting on behalf of Auven Therapeutics and BELLUS Health identified between 10,000 and 15,000 KIACTA™ eligible patients with AA amyloidosis in the United States and Europe.
KIACTA™ has been granted Orphan Drug designation or its equivalent for the treatment of AA amyloidosis in the United States, Europe and Japan, which provide for market exclusivity for a period of seven to ten years once the drug is approved, as well as a reduction in application and review fees.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a drug development company focused on rare diseases. Its pipeline of rare disease projects includes KIACTA™ in Phase 3 for AA amyloidosis, KIACTA™ for sarcoidosis, clinical stage Shigamab™ for sHUS and a research-stage project for AL amyloidosis. The lead program KIACTA™ is currently in a Phase 3 Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often leads to dialysis and death. BELLUS Health is partnered with global private equity firm Auven Therapeutics for the development of KIACTA™.
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" within the meaning of Canadian securities legislation and regulations. Such statements, based as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown, many of which are beyond BELLUS Health Inc.'s control. Such risks factors include but are not limited to: the ability to obtain financing, the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which the BELLUS Health Inc. does business, stock market volatility, fluctuations in costs, changes to the competitive environment due to consolidation, achievement of forecasted burn rate, potential payments/outcomes in relation to indemnity agreements and contingent value rights, achievement of forecasted pre-clinical and clinical trial milestones, dependence on Auven Therapeutics for the completion of the KIACTA™ Phase 3 Confirmatory Study and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. In addition, the length of the KIACTA™ Phase 3 Confirmatory Study and the sharing of proceeds between Auven Therapeutics and BELLUS Health Inc. from potential future revenue of KIACTA™ are dependent upon a number of factors, including the quantum of proceeds. Consequently, actual future results and events may differ materially from the anticipated results and events expressed in the forward-looking statements. The Company believes that expectations represented by forward-looking statements are reasonable, yet there can be no assurance that such expectations will prove to be correct. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These forward-looking statements speak only as of the date made, and BELLUS Health Inc. is under no obligation and disavows any intention to update publicly or revise such statements as a result of any new information, future event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see BELLUS Health Inc.'s public filings with the Canadian securities regulatory authorities, including the Annual Information Form, for further risk factors that might affect BELLUS Health Inc. and its business.
SOURCE BELLUS Health Inc.
François Desjardins, Vice-President, Finance, 450-680-4525, [email protected]
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