- US $80 million (CAD $100 million) line of credit secured from Structured Alpha LP
- Plasminogen BLA accepted by FDA, PDUFA date fixed at April 14, 2018
- Plasminogen granted rare pediatric disease designation by FDA and priority review status by Health Canada
- PBI-4050 granted Fast Track designation for IPF and green light to initiate the pivotal phase 2/3 clinical trials
- Conference call and live webcast at 11:00 am ET on Tuesday November 14
LAVAL, QUEBEC, CANADA – November 13, 2017 – Prometic Life Sciences Inc. (TSX: PLI, OTCQX: PFSCF) (Prometic) announced today its unaudited financial results for the quarter and the nine month period ended September 30, 2017.
“Both our plasma-derived and small molecules lead clinical programs continue to progress as planned throughout advanced stages of the regulatory approval pathway. The PDUFA date has been set for plasminogen and PBI-4050 has been cleared to commence the pivotal phase 2/3 placebo controlled IPF clinical trial,” said Pierre Laurin, President and Chief Executive Officer of Prometic. “Our focus is now centered on the completion of our commercial and marketing infrastructure in order to be ready to rapidly proceed with the launch of RyplazimTM, pending a positive final outcome of the regulatory approval process for our first plasma-derived drug”.
“The third quarter 2017 financial results continue to be in line with our expectations, the previous quarters and guidance provided. The results demonstrate that the R&D and administration, selling and marketing expenses have stabilized at expected levels as we prepare to operate at a commercial scale,” declared Mr. Bruce Pritchard, Prometic’s Chief Operating Officer and interim Chief Financial Officer. “As recently demonstrated, we will continue to put in place all the necessary elements to insure we can bridge the funding gap to value creation events and financial sustainability as efficiently as possible”.
Third Quarter 2017 Therapeutic Highlights
- The Corporation presented new long term clinical data from its pivotal Phase 2/3 trial of Ryplazim™ (Plasminogen IV) for the additional 36-week treatment period. The new data demonstrated no 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.
- The Corporation secured a Rare Pediatric Disease Designation by the FDA for RyplazimTM, a plasminogen replacement therapy for the treatment of patients with congenital plasminogen deficiency
Small Molecule Therapeutics:
Idiopathic Pulmonary Fibrosis (IPF)
- The Corporation received FDA acceptance of its PBI-4050 Investigational New Drug (IND) application to commence the pivotal Phase 2/3 clinical trial in patients suffering from IPF.
- The Corporation announced that longer-term data from its ongoing Phase 2 open labeclinical trial in subjects suffering from Alström Syndrome in the United Kingdom confirmed that the beneficial clinical effects previously observed are sustained during prolonged treatment.
Third Quarter 2017 Corporate and Operational Highlights
- The Corporation executed definitive agreements in relation to the previously announced partnership with affiliates of Shenzhen Royal Asset Management Co., Ltd. (SRAM).
- The Corporation closed the previously announced $53.1 million bought deal equity offering of common shares through a syndicate of underwriters led by Cantor Fitzgerald Canada Corporation as the lead underwriter and sole bookrunner. Pursuant to the offering, Prometic issued 31,250,000 common shares at a price of $1.70 per share for gross proceeds of $53,125,000.
Subsequent highlights to Third Quarter 2017:
- The Corporation received confirmation from the FDA that its BLA for its plasminogen replacement therapy (RyplazimTM) had been accepted and granted priority review status with a Prescription Drug User Fee Act (PDUFA) action date for April 14, 2018;
- The Corporation received priority review status for the New Drug Submission (NDS) the company plans to file with Health Canada for RyplazimTM for the treatment of patients with plasminogen deficiency;
- The Corporation entered into a binding letter of intent to secure a USD $80 million (CAD $100 million) line of credit from Structured Alpha LP, an affiliate of Peter J. Thomson’s investment firm, Thomvest Asset Management Inc.
2017 Third Quarter Financial Results
The Corporation incurred a net loss of $17.8 million for the quarter ended September 30, 2017, compared to a net loss of $28.0 million for the quarter ended September 30, 2016. The Corporation incurred a net loss of $78.4 million during the nine months ended September 30, 2017 compared to $70.6 million during the nine months September 30, 2016. The decrease in net loss for the third quarter of 2017 as compared to the third quarter of 2016 was mainly attributable to the significantly higher revenues generated from milestone payments and licensing activities. The increase in net loss for the nine months ended September 30, 2017 as compared to the nine months ended September 30, 2016 is mainly attributable to the higher research and development (“R&D”) and administrative, selling and marketing expenses related to the setting up of the extensive commercial and manufacturing infrastructure ahead of the planned commercialization Ryplazim™.
Total revenues for the third quarter ended September 30, 2017 were $24.0 million compared to $3.7 million for the third quarter ended September 30, 2016. Revenues from the sale of goods amounted to $3.9 million for the third quarter ended September 30, 2017, compared to $2.4 million for the quarter ended September 30, 2016. Milestone payments and licensing revenues amounted to $19.7 million for the third quarter ended September 30, 2017 compared to nil for the third quarter of 2016. Total revenues for the nine months ended September 30, 2017 were $32.5 million compared to $12.3 million for the nine months ended September 30, 2016.
The Corporation incurred total R&D costs of $23.2 million for the quarter ended September 30, 2017 compared to $23.6 million for the third quarter of 2016. The Corporation incurred total R&D costs of $72.0 million during the nine months ended September 30, 2017 compared to $59.4 million during the nine months ended Jun 30, 2016. The overall R&D expense is primarily driven by the Plasma-derived therapeutics 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 plasma-derived therapeutics are produced by Prometic at its Laval plant and at the Winnipeg CMO while the small molecule therapeutics are manufactured by a third party for Prometic. The manufacturing cost of the therapeutics to be used in clinical trials and other R&D purposes represented approximately $22.9 million of the $72.0 million in R&D expenses reported during the nine months ended September 30, 2017 and $22.8 million of the $59.4 million in R&D expenses during the nine months ended September 30, 2016.
The increase in R&D expenses, excluding the manufacturing cost of therapeutics to be used in R&D activities discussed above (other R&D), as compared to the nine months of 2016 was primarily due to higher salary and benefit expenditures reflecting the increase in employees working on the clinical trials and at our research facilities. In addition, Contract Research Organizations (“CRO”) and investigator expenses incurred in relation to the clinical trials and pre-clinical activities increased reflecting the increase in the number of trials in progress, the duration and higher patient enrolment of the trials.
Administrative, selling and marketing expenses amounted to $7.7 million during the third quarter of 2017, compared to $6.5 million for the quarter ended September 30, 2016. Administrative, selling and marketing expenses amounted to $22.7 million during the nine months ended September 30, 2017 compared to $16.5 million during the nine months ended September 30, 2016. The increase was mainly attributable to the higher salary and benefit expenses resulting from an increase in headcount mostly in marketing and commercial operations and overall salary increases.
Conference Call Information
Prometic will host a conference call at 11:00 am (ET) on Tuesday November 14, 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 November 14, 2017 at 2:00 pm until November 21, 2017. The numbers to access the replay are 1-416-849-0833 (passcode: 3866799) and 1-855-859-2056 (passcode: 3866799). A live audio webcast of the conference call, with slides, will be available by clicking here.
Additional Information in Respect to the Third Quarter 2017
Prometic’s MD&A and condensed interim consolidated financial statements for the quarter ended September 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