- $101 million of new 2017 cash inflows closed from debt, equity & corporate transactions
- On-going review of plasminogen BLA with the U.S. FDA
- 48-week clinical data from plasminogen phase 2/3 trial confirms no recurrence of lesions, no safety or tolerability issues observed.
- Concurrence from the FDA on the design of PBI-4050’s planned phase 2/3 pivotal clinical trial for Idiopathic Pulmonary Fibrosis
- 24-week clinical data confirm efficacy and safety of PBI-4050 maintained in metabolic syndrome & diabetic patients
LAVAL, QUEBEC, CANADA – August 14, 2017 – Prometic Life Sciences Inc. (TSX: PLI, OTCQX: PFSCF) (Prometic) announced today its unaudited financial results for the quarter and the six month ended June 30, 2017.
“We are extremely pleased with the longer term clinical performance of our plasminogen drug candidate in patients with plasminogen deficiency. Proving sustained efficacy in 100% of these patients in the trial also bodes well for the health economics profile of Ryplazim™”, stated Mr. Pierre Laurin, President and Chief Executive Officer of Prometic. “The performance of PBI-4050 in our IPF phase 2 clinical trial and the efficacy also observed in other phase 2 trials with even longer treatment exposure, support our chosen clinical indications and regulatory pathways, and the initiation of our forthcoming Phase 2/3 pivotal clinical trials in IPF”.
“Our second quarter 2017 financial results are in line with our expectations and last few quarters. We have and will continue to concentrate our efforts and resources on lower-risk clinical programs and activities with the shortest possible regulatory pathways and fastest timelines to value creation”, mentioned Mr. Bruce Pritchard, Prometic’s Chief Operating Officer and interim Chief Financial Officer. “The current level of R&D and selling and marketing expenses is reflective of the extensive commercial and manufacturing infrastructure required to maximize commercial opportunities arising from our deep product pipeline”.
Following the departure of Mr. Greg Weaver as Prometic’s Chief Financial Officer, Mr. Bruce Pritchard, Prometic’s current Chief Operating Officer, will also resume the Chief Financial Officer’s responsibilities in the interim until the appointment of a new Chief Financial Officer, the search for whom is already underway. Mr. Pritchard previously held the Chief Financial Officer Position for 9 years.
Second Quarter 2017 Therapeutic Highlights
- The Corporation is responding diligently to all FDA requests in relation to the BLA review. The Corporation will provide further updates on the expected timeline of regulatory approval as soon as available; and
- The Corporation provided further data to the FDA to support its claims that the serious and life-threatening clinical manifestations associated with congenital plasminogen deficiency occurs predominantly in pediatric patients, as required to qualify for a rare pediatric disease designation.
Small Molecule Therapeutics:
- 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.
- 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; and
- The Corporation presented new data at the 2017 American Diabetes Association’s (ADA) 77th Scientific Sessions in San Diego from the completed metabolic syndrome Phase 2 trial which also showed that, after 12 weeks of treatment with PBI-4050, a statistically significant reduction of microparticles shedding from the kidney in the patients’ urine was observed. Additional data demonstrated that the positive clinical benefits observed at 12 weeks were sustained after 24 weeks of treatment.
Second Quarter 2017 Corporate and Operational Highlights
- 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 closed the follow-on investment from Structured Alpha LP, an affiliate of Peter J. Thomson’s investment firm, Thomvest Asset Management Inc., consisting of a $25 million loan; and
- The Corporation announced an agreement with Cantor Fitzgerald Canada Corporation acting as a lead underwriter and sole bookrunner, on its own behalf and on behalf of a syndicate of underwriters under which the underwriters agreed to buy on a bought deal basis, 31,250,000 common shares in the capital of the Corporation at a price of $1.70 per share for gross proceeds of $53.1 million. The offering closed on July 6, 2017 with substantial U.S. institutional investor participation.
Subsequent highlights to Second Quarter 2017
- The Corporation presented new long term clinical data from its pivotal Phase 2/3 trial of Ryplazim™ (Plasminogen IV) regarding the additional 36-week treatment period. The new data demonstrated that its plasminogen treatment prevented the recurrence of lesions in the 10 patients treated with RyplazimTM for a total of 48 weeks. No safety or tolerability issues related to this longer-term dosing were observed; and
- The Corporation executed definitive agreements in relation to the previously announced joint venture with affiliates of Shenzhen Royal Asset Management Co., Ltd. (SRAM).
2017 Second Quarter Financial Results
The Corporation incurred a net loss of $31.5 million for the quarter ended June 30, 2017, compared to a net loss of $24.6 million for the quarter ended June 30, 2016 and to a net loss of $29.1 million for the quarter ended March 31, 2017. The Corporation incurred a net loss of $60.6 million during the six months ended June 30, 2017 compared to $42.6 million during the six months ended June 30, 2016. The increase in net loss as compared to the second quarter of 2016 is mainly attributable to higher R&D and Administrative, selling and marketing expenses.
The Corporation incurred total R&D costs of $24.5 million for the quarter ended June 30, 2017 compared to $19.4 million for the second quarter of 2016 and $24.3 million for the quarter ended March 31, 2017. The Corporation incurred total R&D costs of $48.8 million during the six months ended June 30, 2017 compared to $35.8 million during the six months ended June 30, 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.
The increase in R&D expense as compared to the second quarter of 2016 is primarily due to the higher expenses related to the manufacturing cost of therapeutics to be used in clinical trials and for 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 therapeutics phase 3 clinical trials represents approximately 32% of the R&D expenses reported during the quarter ended June 30, 2017.
Administrative, selling and marketing expenses amounted to $8.1 million during the second quarter of 2017, compared to $5.2 million for the quarter ended June 30, 2016 and $6.9 million during the first quarter of 2017. Administrative, selling and marketing expenses amounted to $15.0 million during the six months ended June 30, 2017 compared to $10.0 million during the six months ended June 30, 2016. The increase as compared to the second 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.
Total revenues for the second quarter ended June 30, 2017 were $3.6 million compared to $3.3 million for the second quarter ended June 30, 2016, and total revenues of $4.9 million for the first quarter ended March 31, 2017. Revenues from the sale of goods amounted to $2.7 million for the second quarter ended June 30, 2017, compared to $2.5 million for the quarter ended June 30, 2016 and $4.4 million for the first quarter ended March 31, 2017. Total revenues for the six months ended June 30, 2017 were $8.5 million at the same level as the comparative period of 2016. The Corporation continues to anticipate revenue growth from the sale of goods segment based on solid business fundamentals and attributes quarter-to-quarter revenue variability on the timing and scale of core customer orders.
Conference Call Information
Prometic will host a conference call at 11:00 am (EST) on Tuesday August 15, 2017. 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 Tuesday August 15, 2017 at 2:00 pm until August 22, 2017. The numbers to access the replay are 1-416-849-0833 (passcode: 65097120) and 1-855-859-2056 (passcode: 65097120). A live audio webcast of the conference call will be available through this link.
Additional Information in Respect to the Second Quarter 2017
Prometic’s MD&A and condensed interim consolidated financial statements for the quarter ended June 30, 2017 will be filed on SEDAR (http://www.sedar.com) and will be available 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 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 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.