PROMETIC REPORTS ITS 2018 FIRST QUARTER HIGHLIGHTS AND FINANCIAL RESULTS

On May 15, 2018 Prometic Life Sciences Inc. (TSX: PLI, OTCQX: PFSCF) (Prometic) reported its unaudited financial results for the first quarter ended March 31, 2018 (Press release, ProMetic Life Sciences, MAY 15, 2018, View Source [SID1234526654]).

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"Our number one goal for 2018 is to close the gap between the fundamental value created over the last few years and the current share price as it does not reflect, in our view, all the clinical and operational milestones achieved. We have streamlined our clinical development programs to ensure that our most promising clinical assets and their respective indications are prioritized," said Pierre Laurin, President and Chief Executive Officer of Prometic. "We are committed to bringing to market our lead drug candidates for patients, as well as for shareholders. We are working diligently to improve our financial position and time-to-market, by partnering some of our lead drug candidates, in an effort to accelerate and facilitate access to markets."

Commenting on the first quarter 2018 financial results, Bruce Pritchard, Prometic’s Chief Operating Officer and Chief Financial Officer said, "As I outlined at our recent Annual Shareholders’ Meeting, our priorities for the balance of 2018 are clearly established. Our commitment to tightly manage the cash resources is already paying off with less cash used in our operations during the first quarter of 2018, compared to the first quarter of 2017, with the goal of using approximately $15 million less in total for 2018. Our commitment to increase our cash runway is also underway, following the sale of $14 million worth of plasma inventory, early in the second quarter of 2018. We have also completed the review of our clinical and product development programs, concentrating on PBI-4050 in idiopathic pulmonary fibrosis and Alström syndrome, as well as on plasminogen. This allows us to focus our resources, save costs, and work toward partnership activities to increase our cash runway further."

Small Molecule Therapeutics Highlights

PBI-4050 – Mechanism of action and the discovery of a new antifibrotic pathway was published in the American Journal of Pathology
PBI-4050 – Clearance by the US Food and Drug Administration (FDA) for pivotal Phase 3 trial in patients with idiopathic pulmonary fibrosis (IPF), prioritizing IPF as one of our top indications along with Alström syndrome
PBI-4050 – Clinical activity sustained over 52 weeks with reversal of heart and liver fibrosis in Alström syndrome subjects
PBI-4547 – To be advanced in the clinic with a focus on liver fibrosis and metabolic diseases
Plasma Derived Therapeutics Highlights

RyplazimTM (plasminogen) – Comprehensive plan developed to address BLA chemistry, manufacturing and controls (CMC) changes requested by FDA
Inter-Alpha Inhibitor Proteins (IaIp) – Orphan drug and rare pediatric designations secured from the FDA
2018 First Quarter Financial Results

Revenues

Total revenues for the first quarter ended March 31, 2018 were $4.3 million compared to $4.9 million for the first quarter ended March 31, 2017. Revenues from the sale of goods amounted to $3.8 million for the first quarter ended March 31, 2018, compared to $4.4 million for the quarter ended March 31, 2017.

Net Loss

The Corporation incurred a net loss of $34.6 million for the quarter ended March 31, 2018 compared to a net loss for the quarter ended March 31, 2017 of $29.1 million. The increase in net loss year over year is mainly due to the increased finance costs of $2.9 million, the plasma inventory write-down of $1.5 million included in the cost of sales and other production expenses, the reduced margin contribution on the sale of bioseparations products, and the increase in administration, selling and marketing expenses. This was partially offset by the decrease in R&D expenses of $2.0 million during the quarter ended March 31, 2018 compared to the corresponding period in 2017.

Research and Development (R&D)

The Corporation incurred total R&D costs of $22.4 million for the quarter ended March 31, 2018 compared to $24.4 million for the first quarter ended March 31, 2017. R&D expenses include the cost to manufacture plasma-derived therapeutics and small molecule therapeutics to be used in clinical trials and for the development of our production processes. The plasma-derived therapeutics are produced at the Laval plant and the Winnipeg Contract Manufacturing Organization (CMO) where as the small molecule therapeutics are manufactured by a third party pharmaceutical contract manufacturing organization for Prometic. The manufacturing and purchase cost of these therapeutics was $6.3 million during the quarter ended March 31, 2018 compared to $9.2 million during the quarter ended March 31, 2017. The decrease is mainly due to a reduction in production activities during the quarter ended March 31, 2018 compared to the same period in 2017.

Other R&D expenses were $16.1 million during the quarter ended March 31, 2018 compared to $15.2 million for the corresponding period in 2017. The increase of $1.0 million is partially due to an increase in employees working on the clinical trials and at our research centers and in pre-clinical studies of $0.8 million. These increases were partially offset by a decrease in Contract Research Organizations ("CRO") and investigator expenses by $0.4 million.

Administration, Sales & Marketing

Administration, selling and marketing expenses amounted to $7.7 million during the first quarter ended March 31, 2018 compared to $6.9 million during the first quarter ended March 31, 2017. The increase as compared to the first quarter of 2017 was due to the increase in salaries and benefits resulting from an overall increase in headcount, reflecting the build-up of the infrastructure in order to support the eventual sale of commercial product.

Finance Costs

Finance costs were $4.2 million for the quarter ended March 31, 2018 compared to $1.4 million during the corresponding period of 2017, representing an increase of $2.9 million. This increase reflects the higher level of debt during the quarter ended March 31, 2018 compared to the same period of 2017, reflecting the increase in the OID loans and the amounts drawn on the non-revolving credit facility agreement. Total long-term debt on the consolidated statement of financial position was $110.0 million at March 31, 2018 compared to $48.4 million at March 31, 2017.

Additional Information in Respect to the First Quarter Ended March 31, 2018

Prometic’s MD&A and condensed interim consolidated financial statements for the quarter ended March 31, 2018 will be filed on SEDAR (View Source) and will be available on the Company’s website at www.prometic.com.