Category: Biotech

ProMetic Life Sciences Inc ( PLI )

Published: 27 March 2014
Written by Editor
TSX   Financial Results   Up on News   Interesting News  

ProMetic Reports its 2013 Fourth Quarter and Financial Year End Results and Business Highlights

- PBI-4050 clinical program progressed with initiation in diabetic patients with chronic kidney disease expected in early H2 2014 - Plasminogen clinical pathway confirmed in a pre-IND meeting with the FDA - initiation in patients expected in early H2 2014 - Additional plasma-derived orphan drugs to be enabled in 2014 by the successful launch of the plasma facility - 2013 revenue of $20.6 million and EBITDA of ($8.7 million), Q4 2013 revenues of $5.1 million and EBITDA of ($3.8 million) - Balance sheet strengthened by financings

ProMetic Life Sciences Inc. (PLI.TO)(PFSCF) ("ProMetic" or the "Corporation") today reported revenues of $5.1 million and $20.6 million for the quarter and year ended December 31, 2013 respectively. This compares to revenues of $8.3 million and $23.3 million for the quarter and year ended December 31, 2012 respectively.

"The strengthening of our market capitalization has allowed us to make the decision to develop more of our own assets ourselves to an advanced stage prior to partnering. This means a greater portion of the future returns generated by our high-value products and assets will remain ours. This change to the commercialization strategy has however resulted in the short term, in lower licensing revenues as well as an increase in spending", observed Mr. Bruce Pritchard, ProMetic's Chief Financial Officer. "Having now improved our capital base by receiving more than $40 million in cash inflows in 2013 from two financing transactions and the Hepalink investment, we can now concentrate our attention on further progressing the key corporate initiatives necessary to build substantial value for shareholders.

Commenting on the progress of the corporate initiatives to build substantial value for the shareholders, Mr. Pierre Laurin, ProMetic's President and Chief Executive Officer stated: "PBI-4050 continues to impress with new data further supporting the use of this product in diabetic patients with chronic diseases as well as in other rare conditions. Our objective for this year is to quickly confirm that the positive effects observed in multiple animal models translates to patients".

"It has always been our goal to leverage our unique proprietary technologies and know-how to build a company that would bring safer, cost-effective and more convenient therapeutic products to largely underserved patient populations. The successful operational launch of our plasma purification facility in Laval, Quebec has brought us closer than ever to making this vision a reality", added Mr. Laurin.

2013 Highlights

Business Highlights

2013 can best be summarized as the year during which ProMetic significantly progressed in its transition towards becoming a vertically integrated, specialty Biopharmaceutical Corporation. Accordingly, ProMetic via using its rich therapeutic product pipeline, has positioned itself to pursue various commercial opportunities in areas of unmet medical needs, including rare diseases and orphan drug opportunities.

In 2013, ProMetic:

  • Received a $10 million strategic equity investment by Shenzhen Hepalink Pharmaceutical Co., LTD. in ProMetic at a premium to the market share price;
     
  • Received an orphan drug designation status for its plasma purified human plasminogen drug by the American Food and Drug Administration ("FDA") for the treatment of hypoplasminogenemia, or type I plasminogen deficiency ("T1PD");
     
  • Received a $4.8 million purchase order under its ongoing supply agreement with Octapharma, relating to the purchase of PrioClear™, a proprietary prion capture resin incorporated into Octapharma's manufacturing process for its solvent/detergent treated plasma product, Octaplas®;
     
  • Selected Alpha1-Antitrypsin (AAT) as its second plasma-derived therapeutic to address a well-defined unmet medical need affecting an estimated 100,000 people in the USA alone with less than 10% treated;
     
  • Presented new pre-clinical data at the 2013 European Respiratory Society ("ERS") annual congress held in Barcelona, Spain, suggesting that PBI-4050 offers a new therapeutic approach to Idiopathic Pulmonary Fibrosis;
     
  • Secured a $10 million loan and issued warrants in a financing transaction with Thomvest Seed Capital Inc. ("Thomvest"), with no principal or interest repayments for 5 years;
     
  • Presented new preclinical data at the 2013 annual meeting of the American Association for the Study of Liver Diseases (AASLD) supporting the claims that PBI-4050 anti-fibrotic activity could also be used to address various liver conditions such as nonalcoholic steatohepatitis ("NASH");
     
  • Raised gross proceeds of $24 million through a public offering of 26,651,400 Common Shares of the Corporation at $0.90 per share
     
  • Presented new preclinical data at the 2013 American Society of Nephrology ("ASN") annual meeting demonstrating the ability of PBI-4050 to reduce fibrosis in the kidney and overall improve the renal function in various animal models;
     
  • Received a $5.1 million purchase order for the supply of affinity resin from an existing client, a global leader in the biotherapeutics industry; and
     
  • Achieved a major corporate milestone by successfully completing the first commercial-scale production run at its plasma purification facility, ProMetic BioProduction Inc., located in Laval, Quebec. This production run was completed on schedule and generated better than expected results.

2013 Financial Results

This financial information should be read in conjunction with the Corporation's consolidated financial statements for the year ended December 31, 2013 as well as the Management's Discussion and Analysis dated March 25, 2014.

Total revenues for the fourth quarter of 2013, which were derived from product sales, development services and licensing revenues, were $5.1 million. Total revenues for the 2013 financial year were $20.6 million as compared to $23.3 million for the previous financial year.

Revenues from the sale of goods and services totaled $18.0 million in 2013 compared to $16.9 million in 2012.

Licensing revenues were $2.6 million in 2013 compared to $6.4 million in 2012, representing a decrease of $3.8 million. The decrease reflects the Corporation's decision to further invest and advance some of its clinical assets, rather than seeking earlier licensing revenues.

ProMetic generated a net loss of $7.5 million for the quarter ended December 31, 2013 and a net loss of $17.4 million for the 2013 financial year compared to a net loss of $0.4 million for the previous 2012 financial year.

Of the $17.4 million net loss incurred in 2013, a total of $8.9 million comes from non-cash items. $5.5 million comes from the variation in fair value of the warrant liability associated to the Thomvest financing transaction and $3.4 million represent the expense recorded as a result of stock options and restricted stock units issued to employees and board members.

Non rechargeable Research and Development expenses were $13.7 million in 2013 compared to $7.8 million in 2012, representing a $5.9 million increase. The increase mainly comes from a higher level of research activities associated to the PBI-4050 clinical program and the costs associated with the preparation of the Laval plasma purification facility for a GMP validation.

"Our total assets have more than doubled following the closing of the debt and equity transactions completed in 2013. Our cash, accounts receivable and capital assets positions have all significantly increased during the year 2013 compared to 2012", stated Mr. Bruce Pritchard, ProMetic's Chief Financial Officer.

Fourth Quarter and Year End 2013 Conference Call Information

ProMetic will host a conference call at 11:00am (EST) on Thursday, March 27, 2014. The telephone numbers to access the conference call are (647) 788-4922 (International) and 1-877-223-4471 (Toll-free). A replay of the call will be available from March 27, 2014 at 1:30 p.m. until April 12, 2014. The numbers to access the replay are 1-416-621-4642 (passcode:17917398) and 1-800-585-8367 (passcode:17917398). A live audio webcast of the conference call will be available through the following: http://www.gowebcasting.com/5345

Additional Information in Respect to the Three month and Twelve month Periods ended December 31, 2013

ProMetic's MD&A and 2013 Financial Statements have been filed on Sedar (www.sedar.com) and will be available on the Company's website at www.prometic.com.

About ProMetic Life Sciences Inc.

ProMetic Life Sciences Inc. (www.prometic.com) is a long established biopharmaceutical company with globally recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule drug development. ProMetic offers its state of the art technologies for large-scale purification of biologics, drug development, proteomics and the elimination of pathogens to a growing base of industry leaders and uses its own affinity technology that provides for highly efficient extraction and purification of therapeutic proteins from human plasma in order to develop best-in-class therapeutics and orphan drugs. ProMetic is also active in developing its own novel small-molecule therapeutic products targeting unmet medical needs in the field of fibrosis, cancer and autoimmune diseases/inflammation. A number of both the plasma-derived and small molecule products are under development for orphan drug indications. Headquartered in Laval (Canada), ProMetic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and business development activities in the U.S., Europe and Asia.

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 in ProMetic's Annual Information Form for the year ended December 31, 2013, 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:

Pierre Laurin
President and CEO
ProMetic Life Sciences Inc.
This email address is being protected from spambots. You need JavaScript enabled to view it.
450-781-0115
Frederic Dumais
Director, Communications and
Investor Relations
ProMetic Life Sciences Inc.
This email address is being protected from spambots. You need JavaScript enabled to view it.
450-781-0115