ProMetic Life Sciences Inc.
TSX : PLI

ProMetic Life Sciences Inc.

April 05, 2011 19:51 ET

ProMetic Announces Highlights and Year End Financials for 2010 and Material Subsequent Events

- ProMetic enters into global agreement with Celgene Corporation

- $4 M of repayment obligations originally due in 2011 deferred to July 2012

- Long-term lease and funding secured for new facility to manufacture high-value plasma-derived therapeutics for current and future clients

MONTREAL, QUEBEC, CANADA--(Marketwire - April 5, 2011) - ProMetic Life Sciences Inc. (TSX:PLI) ("ProMetic") today reported on its business highlights and financial results for the year ended December 31, 2010. All amounts are in Canadian dollars unless otherwise indicated. Additionally, ProMetic's 2010 Annual Report has been filed on Sedar (www.sedar.com) and is now available on its web site at www.prometic.com.

Subsequent to year end, positive, significant and material events occurred that are setting the tone for 2011:

  • ProMetic announced that it had entered into an Agreement ("Agreement") with Celgene Corporation ("Celgene"), for the worldwide rights to a commercial application of ProMetic's Protein Technologies. Under the terms of this Agreement, Abraxis BioScience, Inc. ("Abraxis"), a wholly owned subsidiary of Celgene will forgive a $10 million US long-term debt entered into with ProMetic on February 9, 2010, effectively terminating said loan agreement four years prior to its original term in return for intellectual property rights for specific commercial application of its Protein Technologies within restricted fields of use.
  • The results of other negotiations pursued in 2010 became apparent, with the announcement that ProMetic had secured external funding for NewCo, a new subsidiary which will, through a facility leased on very favourable terms, allow the business to capitalize on the development work undertaken by the U.S. subsidiary, ProMetic BioTherapeutics, Inc. ("PBT'). This plant will enable ProMetic and its licensees to manufacture plasma-derived therapeutics at scale and to commercialize products for the multi-million dollar plasma-derived therapeutics market. 
  • The Company also announced that it had reorganized the terms of its secured debt, moving $4 million of debt repayments to July 2012, effectively reclassifying it from short-term to long-term debt and removing a significant short-term pressure on cash flow.

"2010 can best be described as a year of building value and opportunity, a fact supported by the post-balance sheet activity," commented Mr. Bruce Pritchard, ProMetic's Chief Financial Officer. He continued noting: "Annual revenues did not reach anticipated levels. However, the financial results for the first half of 2010 were in line with expectations, but delays in programs caused by both the regulatory process and strategic deals for two of our major customers, Octapharma AG ("Octapharma") and Abraxis caused second half revenues to be disappointing." Mr. Pritchard added: "As always, management responded by slowing expenditures as much as possible, and by funding the shortfall using the least-dilutive means available." 

"While Abraxis' acquisition affected revenue in 2010, we are extremely pleased with the recent agreement with Celgene," stated Mr. Pierre Laurin, ProMetic's President and Chief Executive Officer. Mr. Laurin continued: "This transaction reduces a very significant portion of ProMetic's debt in a manner that is non-dilutive to our existing shareholders, and also provides for a potential long term supply of proprietary affinity adsorbent.

"Moreover, Octapharma has advised that it remains positive regarding the ultimate regulatory approval of its OctaplasLG® product by the MHRA and its ultimate approval in additional key European Union countries. We therefore expect orders for resin to recommence in 2011," mentioned Mr. Pierre Laurin. "Octapharma also announced recently that it is seeking regulatory approval for a prion-depleted version of its UniplasLG® product, which will also rely on ProMetic's prion reduction technology."

2010 Significant Events

Protein Technologies

  • In January 2010, ProMetic entered into a collaboration agreement with Abraxis. to develop and commercialize various applications deriving from ProMetic's prion capture technology platform.
  • In February 2010, ProMetic announced that the project with HemCon Medical Technologies, Inc. to develop a sterile, single-use antibody capture device for the removal of isoagglutinin antibodies initiated in March 2009 met its first development milestone and moved into the second phase of development.
  • In the same month, Novozymes and ProMetic entered into a strategic alliance regarding proprietary albumin purification technology based upon a synthetic-ligand affinity adsorbent developed by ProMetic's UK subsidiary, ProMetic BioSciences Ltd ("PBL"). The new synthetic-ligand affinity adsorbent, AlbuPure®, will be co-marketed by both companies.
  • In March 2010, ProMetic announced that it had completed the first milestone of its strategic collaboration with the Wuhan Institute of Biological Products ("WIBP"), a subsidiary of China National Pharmaceutical Group Corp ("Sinopharm"), China's largest pharmaceutical company. WIBP's products will be manufactured under licence using ProMetic's proprietary protein technologies. These products will then move into clinical trials to demonstrate their bioequivalence to commercialized products in order to obtain required regulatory approval from the Chinese State Food and Drug Administration.
  • During the first half of 2010, ProMetic completed delivery of the largest order for a single Mimetic Ligand™ product. The total order was worth approximately $8.9 million and approximately two-third was recognized in 2010.
  • The WIBP project is progressing according to schedule. After the successful completion of the initial technology transfer stage earlier this year, ProMetic's scientists have initiated the second technology transfer stage and are moving ahead with the retrofit of WIBP's GMP pilot facility. ProMetic's proprietary Plasma Protein Purification System ("PPPS™") will be integrated in WIBP's facility as part of this retrofit.
  • Initiation of the scale-up activities for the manufacturing of the first GMP products for the Chinese market is expected in second quarter of 2011. WIBP will then pursue regulatory approval from the SFDA for these products manufactured under licence using ProMetic's proprietary protein technologies, by demonstrating their bioequivalence to commercialized products.

Therapeutics

  • ProMetic presented data on its orally-active PBI-1402 compound at the 15th Congress of the European Hematology Association held in Barcelona, Spain, June 9 - 13, 2010. Clinical and preclinical results were presented about the management of side effects induced by chemotherapy and the treatment of certain cancers such as lung and pancreatic cancers, and certain forms of leukemia.
  • In addition, an oral presentation was made regarding the positive clinical data generated in patients that developed anemia as a result of their chemotherapy. The clinical trial demonstrated a reduction in the need for blood transfusions in chemotherapy-induced anemic patients. Furthermore, the trial data indicated that the level of hemoglobin and red blood cells never exceeded recommended levels even when the drug was used at high dose. This, combined with anti-cancer activity demonstrated in numerous cancer models, supports the potential use of PBI-1402 to address unmet medical needs in oncology.
  • The PBI-1402 development program also led to the discovery of new and proprietary chemical compounds ("NCEs") that regulate fibrosis via a novel mechanism of action. Fibrosis is part of the inflammatory process that leads to a loss of functionality in vital organs such as kidney, heart, liver and lungs in certain chronic diseases that affects hundreds of millions of patients. These first-in-class NCEs are orally active, and have been confirmed to exhibit strong anti-fibrotic activity in various in vivo models.
  • Further advances were also accomplished with the Company's portfolio of autoimmune disease drug candidates.
  • In October 2010, ProMetic signed terms of a strategic agreement for PBI-1402 and PBI-4419 with Allist who will fund the development costs required for the regulatory approval in China for the two products. Allist undertakes to perform development activities according to standards meeting the Food and Drug Administration's ("FDA") requirements, which will then allow ProMetic to have full access to and use of data generated by Allist for markets outside China. This represents an investment by Allist in the programs well in excess of $10 million US. Allist will retain the rights for the Chinese market for PBI-1402 for the chemotherapy-induced anemia and cancer related anemia indications and for PBI-4419 for fibrotic diseases.

Selected Annual Information 

The following selected annual information is derived from the consolidated financial information of the Company for each of the three most recently completed financial years. The financial statements are prepared in accordance with Canadian GAAP. More financial information, including the Company's Annual Information Form, is available on SEDAR (www.sedar.com).

The Company generated revenues of $11.4 million for the year ended 31 December 2010 compared to $13.6 million for the year ended 31 December 2009. Delays in programs caused by both the regulatory process and strategic deals for two of our major customers, Octapharma and Abraxis, impacted significantly on revenues in the second half.

The Company returned a net loss of $11.3 million or $0.03 per share (basic and diluted), for the year ended December 31, 2010, as compared to a net loss of $9.3 million or $0.03 per share (basic and diluted) for year ended December 31, 2009. Analysing the increase in the annual loss of $1.9 million from the previous year, $1.3 million can be explained by the PRDT gain in 2009 not being repeated in 2010 and $0.2 million associated with lower exchange gains in 2010. 

Profit (Loss)* 2010   2009   Change %   2009 (as adjusted)   Change % (as adjusted)  
                     
Therapeutics (1,920 ) (2,727 ) 29.59 % (2,727 ) 29.59 %
                     
Protein Technologies (3,033 ) (872 ) (3377.01 %) (1,387 ) (118.09 %)
                     
Corporate (6,330 ) (5,729 ) (10.44 %) (5,929 ) (6.71 %)
                     
Total Loss (11,283 ) (9,328 ) (20.84 %) (10,043 ) (12.24 %)

* In thousands of dollars

During the last week of March 2011, the Company received funds in lieu of a series of equity investments in the Company by way of private placements totalling $800,000. The aggregate number of common shares to be issued by the Company in relation thereto remains to be confirmed, as the Company awaits relevant common share pricing (VWAP) confirmation from the Toronto Stock Exchange.

Conference call / webcast details 

The Company will be holding a conference call / webcast on Thursday, April 7, 2011, at 10:30 (EDT).

The numbers to access the conference call are (416) 981-9000 (international) and 1 (800) 738-1032 (North America toll free). A live audio webcast of the conference call will be available through ProMetic's website at http://www.prometic.com/en/news-events/events.php.

An audio replay of the call will be available for a period of seven days as of Thursday, April 7, 2011, at 13:00 (EST). The numbers to access the audio replay are (416) 626-4100 (international) and 1 (800) 558-5253 (North America toll free).using access code 21519729. The replay of the web cast may be downloaded directly from ProMetic's web site.

About ProMetic Life Sciences Inc.

ProMetic Life Sciences Inc. ("ProMetic") (www.prometic.com) is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic Ligand™ technology. This technology is used in large-scale purification of biologics and the elimination of pathogens. ProMetic is also active in therapeutic drug development with the mission to bring to market effective, innovative, lower cost, less toxic products for the treatment of hematology and cancer. Its drug discovery platform is focused on replacing complex, expensive proteins with synthetic "drug-like" protein mimetics. Headquartered in Montréal (Canada), ProMetic has R&D facilities in the U.K., the U.S. and Canada, manufacturing facilities in the U.K. and business development activities in the US, Europe, Asia and in the Middle-East.

Forward Looking Statements

This press release contains forward-looking statements about ProMetic's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, ProMetic's ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations on page 23 of ProMetic's Annual Information Form for the year ended December 31, 2010, under the heading "Risk and Uncertainties related to ProMetic's business". As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. All amounts are in Canadian dollars unless indicated otherwise.

Contact Information

  • ProMetic Life Sciences Inc.
    Pierre Laurin, President and CEO
    1-450-781-0115
    p.laurin@prometic.com
    or
    ProMetic Life Sciences Inc.
    Anne Leduc
    Manager, Investor Relations & Communications
    1-450-781-0115
    a.leduc@prometic.com