- Cash position of $42.5 million at end of third quarter
- 2015 year-to-date product sales of $9.2 million compared to $7.3 million in 2014
- Plasminogen shown as safe, well tolerated and efficacious in a plasminogen deficient patient
- PBI-4050 positive safety data triggers expansion of phase II clinical trial in metabolic syndrome patients with type 2 diabetes
- Successful PBI-4050 pre-IND meeting with the FDA and granted Orphan Drug Designation in Europe for treatment of Idiopathic Pulmonary Fibrosis
- PBI-4050 cleared to commence trial in patients with type 2 diabetes and multi-organ fibrosis in Europe
- H2 2015 revenue guidance range of $18 million to $20 million
LAVAL, QC, Nov. 12, 2015 /CNW Telbec/ - ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("ProMetic" or the "Corporation") today reported revenues of $5.7 million for the third quarter ended September 30, 2015 compared to $2.3 million for the third quarter ended September 30, 2014, with year-to-date product sales ahead after the first nine months of 2015 at $9.2 million compared to $7.3 million for the first nine months of 2014.
Commenting on the third quarter of 2015 financial results, Mr Pritchard, Chief operating Officer of ProMetic said: "Our third quarter revenues were in line with our expectations. We reaffirm revenue guidance to finish 2015 with a strong fourth quarter and second half of 2015. More importantly, the expected increase in revenues for the fourth quarter of 2015 combined with our cash position will allow us to continue investment into our numerous value creation development programs".
"We are very pleased with the progress made in our various product development programs as confirmed by the positive responses we received from the relevant regulatory authorities", mentioned Mr. Pierre Laurin, President and CEO of ProMetic. "We expect to continue the strong momentum generated into our clinical and production programs, and to be well positioned to continue delivering on the Company's anticipated clinical and corporate milestones".
Third Quarter 2015 Business Highlights
During the third quarter of 2015, ProMetic:
- Received an orphan drug designation status for its human plasma derived plasminogen drug by the European Commission for the treatment of plasminogen deficiency;
- Received confirmation that its plasminogen drug was safe and well tolerated in plasminogen-deficient patients and proceeded with the administration of a higher dose;
- Completed the acquisition of Emergent BioSolutions' ("Emergent") plasma collection center located in Winnipeg, Canada which was announced in May. Emergent's plasma collection center is an FDA and Health Canada licensed plasma collection facility;
- received confirmation that its PBI-4050 was safe and well tolerated in the first 12 metabolic syndrome with associated type 2 diabetes patients and proceeded with the enrollment of an additional 24 patients; and,
- Held a successful Pre-Investigational New Drug ("Pre-IND") meeting with the US Food and Drug Administration ("FDA") for its lead drug candidate, PBI-4050 for patients with IPF which was focused on ProMetic's proposed clinical development program and particularly on an optimal design for the first pivotal clinical trial that will incorporate the current standards of care for IPF in the US.
Subsequent to quarter end:
- Reported successful results of plasminogen in a plasminogen deficient patient in pediatric acute condition;
- Received an orphan drug designation status for its lead drug candidate, PBI-4050, for the treatment of idiopathic pulmonary fibrosis ("IPF"), by the European Commission;
- Reported that the US Food and Drug Administration ("FDA") completed its review and cleared the Investigational New Drug ("IND") application for ProMetic's IVIG for the treatment of primary immunodeficiency diseases ("PIDD");
- Reported that the Medicines and Healthcare Products Regulatory Agency ("MHRA") in the United Kingdom cleared the clinical trial application ("CTA") for its lead drug candidate PBI-4050 in patients suffering from a condition associated with type 2 diabetes and severe multi-organ fibrosis; and,
- Appointed Mr. Gregory Weaver, as its new Chief Financial Officer.
More on Third Quarter 2015 Financial Results
The financial information for the third quarter ended September 30, 2015 should be read in conjunction with the Corporation's condensed interim consolidated financial statements as well as the Management's Discussion and Analysis for the quarter and nine months ended September 30, 2015.
The Corporation finished the third quarter ended September 30, 2015 with a strong cash position of $42.5 million.
Total revenues for the third quarter ended September 30, 2015 were $5.7 million compared to $2.3 million for the third quarter ended September 30, 2014. Revenues from the sale of goods amounted to $5.1 million compared to $1.0 million for the same period in 2014. Service revenues were $0.6 million for the quarter ended September 30, 2015 compared to $0.7 million for the quarter ended September 30, 2014.
ProMetic generated a net loss of $11.5 million before income taxes for the quarter ended September 30, 2015 compared to a net loss of $20.6 million before income taxes for the quarter ended September 30, 2014. The decrease is largely due to the fact that in the third quarter of 2014, the Corporation had recognized a fair value variation of warrant liability of $10.4 million. The Corporation incurred total R&D costs of $11.9 million and administration, selling and marketing expenses costs of $4.1 million in the third quarter of 2015 compared to $7.7 million in total R&D costs and $3.2 million in administration, selling and marketing expenses costs in the third quarter of 2014.
Third Quarter 2015 Conference Call Information
ProMetic will host a conference call at 11:00am (EST) on Friday, November 13, 2015. The telephone numbers to access the conference call are (647) 427-7450 and 1-888-231-8191 (Toll-free). A replay of the call will be available from November 13, 2015 at 2:00 p.m. until November 20, 2015. The numbers to access the replay are 1-416-849-0833 (passcode: 77018963) and 1-855-859-2056 (passcode: 77018963). A live audio webcast of the conference call will be available through the following: http://event.on24.com/r.htm?e=1092379&s=1&k=EAD728432A36B961ED56FDCCC5A09A53
Additional Information in Respect to the Third Quarter ended September 30, 2015
ProMetic's MD&A and condensed interim consolidated financial statements for the quarter ended September 30, 2015 have been filed on SEDAR (http://www.sedar.com/) and will be available shortly on the Corporation'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 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 commercial activities in the U.S., Canada, Europe, Russia, Australia 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, 2014, 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.
SOURCE ProMetic Life Sciences Inc.
For further information: Pierre Laurin, President and CEO, ProMetic Life Sciences Inc, firstname.lastname@example.org, 450.781.0115; Frederic Dumais, Senior Director, Communications & Investor Relations, ProMetic Life Sciences Inc., email@example.com, 450-781-0115