- $69.3 million in new 2017 cash inflows from transactions negotiated in Q1
- $21.1 million from warrants exercise received in Q1
- $25.0 million from the Structured Alpha financing received in Q2
- $23.2 million cash to follow in 2017 from the SRAM China transaction
- PBI-4050s’ clinical efficacy confirmed in completed IPF open label phase 2 clinical trial - PBI-4050 advancing into placebo controlled phase 2/3 clinical trials for IPF and CKD Rolling submission of the plasminogen BLA with the U.S. FDA completed
LAVAL, QUEBEC, CANADA – May 15, 2017 – Prometic Life Sciences Inc. (TSX: PLI, OTCQX: PFSCF) (Prometic or the Corporation) announced today its unaudited financial results for the three months ended March 31, 2017.
“This quarter’s financial results are in line with the Q4 results recently disclosed, including with respect to revenues, as well as a slight drop in R&D expense and EBITDA loss”, stated Greg Weaver, Chief Financial Officer of Prometic. "Our financial position has improved with recent transactions totaling $69.3 million of new cash inflows received or to be received in 2017. Our priorities for the rest of 2017 remain to strengthen our balance sheet, finalize the internal systems to support our first commercial drug launch and generate operational efficiencies as we stay on track to achieve our financial goals”.
Pierre Laurin, Prometic’s President and Chief Executive Officer, said: “Prometic anticipates additional cash inflows to be generated in 2017 and is now well positioned, following the positive clinical data generated so far, to continue advancing its lead clinical programs and to pursue related licensing and strategic partnership opportunities”.
First Quarter 2017 Therapeutic Highlights
The Corporation completed the filing of its plasminogen Biologics License Application (“BLA”) with the US Food and Drug Administration (“FDA”) for the treatment of patients with plasminogen congenital deficiency. Prometic’s plasminogen replacement therapy has been granted Orphan Drug and Fast Track Designations by the FDA.
Small Molecule Therapeutics
Idiopathic Pulmonary Fibrosis
The Corporation announced positive results from its completed open label Phase 2 clinical trial in patients suffering from idiopathic pulmonary fibrosis (“IPF”). In addition to demonstrating that PBI-4050 is safe and very well tolerated, the study also demonstrated early evidence of a clinical benefit with PBI-4050 treatment, whether administered alone or in addition with nintedanib.
The Corporation announced that its drug candidate, PBI-4050, secured an orphan drug designation status for the treatment of Alström Syndrome (“AS”) by the European Commission and by the FDA; and
The Corporation announced that its drug candidate, PBI-4050, has been issued a Promising Innovative Medicine (“PIM”) designation by the UK Medicines and Healthcare Products Regulatory Agency (“MHRA”) for the treatment of Alström Syndrome.
First Quarter 2017 Corporate and operational highlights
The Corporation announced the exercise of 44,791,488 future investment rights at a price of $0.47 per share for total proceeds of $21.1 million to the Corporation by California Capital Equity, LLC;
The Corporation entered into a binding agreement in March 2017 which was subsequently closed in April, to secure a follow-on investment from Structured Alpha LP, an affiliate of Peter J. Thomson’s investment firm, Thomvest Asset Management Inc., whereby the Corporation received $25.0 million in consideration for the issuance of a loan and warrants; and
The Corporation entered into a binding memorandum of terms with Shenzhen Royal Asset Management Co., Ltd. (“SRAM”) to develop, manufacture and commercialize PBI-4050, PBI-4547 and PBI-4425 in the People’s Republic of China.
Subsequent highlights to First Quarter 2017
The Corporation received a $9.5 million purchase order for the supply of affinity resin to an existing client, a global leader in the biopharmaceutical industry;
The Corporation received concurrence from the FDA on the design of the first of its PBI-4050’s planned phase 2/3 clinical trials for IPF based on the efficacy data generated in the recently completed 40 patient Phase 2 open-label study; and
The Corporation presented new results at the International Liver Congress 2017 of the European Association for the Study of the Liver on the positive effects of PBI‑4050 on reduction of non-alcoholic steatohepatitis (“NASH”) in a mouse model of obesity and metabolic syndrome.
2017 First Quarter Financial Results
The Corporation incurred total R&D costs of $24.3 million for the quarter ended March 31, 2017 compared to $28.7 million in Q4 2016 and $16.5 million for the first quarter of 2016. The overall R&D expense is primarily driven by the plasma protein business, where the Corporation is operating as its own proprietary end-to-end source and supply, while the small molecule business is a much smaller contributor to the expense growth.Administrative, selling and marketing expenses amounted to $6.9 million during the first quarter of 2017 compared to $12.8 million during the fourth quarter of 2016 and $4.8 million for the quarter ended March 31, 2016. The increase as compared to the first quarter of 2016 is due to an increase in headcount and the related operating costs and an increase in consulting expenses incurred in preparation for the plasminogen launch scheduled for later in 2017.
Total revenues for the first quarter ended March 31, 2017 were $4.9 million compared to total revenues for the fourth quarter ended December 31, 2016 of $4.1 million and $5.2 million for the first quarter ended March 31, 2016. Revenues from the sale of goods amounted to $4.4 million for the first quarter ended March 31, 2017 compared to $3.3 million for the fourth quarter of 2016 and $4.7 million for the quarter ended March 31, 2016. The Corporation continues to anticipate revenue growth from this business segment based on strong business fundamentals and attributes quarter to quarter revenue variability on the timing and scale of core customer orders.
The increase in R&D expense as compared to the first quarter of 2016 is primarily due to the higher expenses related to the manufacturing cost of therapeutics to be used in clinical trials and contract research organizations and investigators reflecting the increase in patient enrollment; the costs incurred in relation to the filing of the plasminogen BLA; the increase in employee compensation costs and pre-clinical expenditures. The manufacturing costs for therapeutics to be used in the plasma-derived and small molecule therapeutics phase 3 clinical trials represents approximately 37% of the R&D expenses reported during the quarter ended March 31, 2017.
The Corporation incurred a net loss of $29.1 million for the quarter ended March 31, 2017 compared to a net loss for the quarter ended December 31, 2016 of $40.1 million and a net loss of $18.0 million during the quarter ended March 31, 2016. The increase in net loss as compared to the first quarter of 2016 is mainly attributable to higher R&D and Administration, selling and marketing expenses.
Additional Information in Respect to the First Quarter 2017
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 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. 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. Headquartered in Laval (Canada), Prometic has R&D facilities in the U.K., the U.S. and Canada, manufacturing facilities in the U.K. 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, 2016, 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.