On August 14, 2018 Prometic Life Sciences Inc. (TSX: PLI, OTCQX: PFSCF) (Prometic or the Corporation) reported today its unaudited financial results for the second quarter ended June 30, 2018 (Press release, ProMetic Life Sciences, AUG 14, 2018, View Source [SID1234528885]).

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"During the second quarter, the corporation made significant progress advancing its corporate action plan that was introduced during the annual shareholders meeting in May 2018," said Pierre Laurin, President and Chief Executive Officer of Prometic. "Notably, Prometic submitted its plan to the FDA regarding the design and implementation of the required additional in-process controls and assays related to its RyplazimTM (plasminogen) Biologics License Application (BLA). The FDA’s feedback following a review meeting in September will be used to confirm the remaining work to be completed and the associated timelines. We remain committed and focused to gaining the FDA’s approval of RyplazimTM (plasminogen). We continue our PBI-4050 and RyplazimTM (plasminogen) discussions with interested parties in order to conclude partnerships that will provide us with greater financial and operational flexibility. Finally, we met with the FDA today to discuss the regulatory pathway for our anti-fibrotic drug candidate, PBI-4050, for the treatment of Alström syndrome, for which we recently received a Rare Pediatric Disease Designation."

Commenting on the second quarter 2018 financial results, Bruce Pritchard, Prometic’s Chief Operating Officer and Chief Financial Officer, said, "During the second quarter of 2018, we generated $14.0 million of cash from the sale of plasma inventory. We used $44.9 million to fund operations through the first half of the year and remain comfortable with the full-year operating cash usage guidance that we provided at the annual shareholders meeting in May. Also, as previously mentioned, we are actively pursuing multiple initiatives to strengthen our balance sheet and extend our cash runway through value-creating milestones. In the meantime, we will continue to carefully manage our resources and control our costs."

Corporate Highlights

Appointed Mr. Bruce Wendel as Chief Business Development Officer

Small Molecule Therapeutics Highlights

PBI-4050 – Presented new clinical data at the International Liver Congress 2018 suggesting positive clinical activity observed in Alström patients with signs of improved liver function and reduced fibrosis in fat tissues
PBI-4050 – Presented new clinical data at the American Thoracic Society 2018 conference suggesting positive clinical activity was observed on blood biomarkers known to have anti-fibrotic activity
PBI-4547 – Presented new pre-clinical data at the American Diabetes Association scientific sessions suggesting the potential activity of PBI-4547 offers the potential to successfully address significant unmet medical needs in liver fibrosis, nonalcoholic steatohepatitis, nonalcoholic fatty liver disease, obesity and diabetes

Plasma-Derived Therapeutics Highlights

RyplazimTM (Plasminogen) – Submitted plan to FDA regarding the list of items outlined by the FDA, the design and implementation of required additional in-process controls and assays related to the Company’s RyplazimTM (plasminogen) BLA
IVIG – Achieved clinical primary and secondary endpoints in a pivotal phase 3 trial that also demonstrated safety and efficacy data comparable to existing commercial IVIG products, with no significant drug related safety issues.

2018 Second Quarter Financial Results

Revenues

Total revenues for the second quarter ended June 30, 2018 were $20.2 million compared to $3.6 million for the second quarter ended June 30, 2017. Total revenues for the six months ended June 30, 2018 were $24.4 million compared to $8.5 million for the comparable period in 2017. The increase was largely driven by $14.0 million from the sale of plasma inventory in the second quarter ended June 30, 2018. Due to the change in the production forecast resulting from the delay of the Ryplazim (plasminogen) BLA approval, the Corporation opted to sell this inventory and utilize the cash proceeds in its operations. Third party revenues from the sale of bioseparation products totaled $5.7 million for the second quarter ended June 30, 2018, compared to $2.9 million for the quarter ended June 30, 2017. Third party revenues from the sale of bioseparation products amounted to $9.4 million for the six months ended June 30, 2018, compared to $7.0 million for the six months ended June 30, 2017.

Cost of sales and other production expenses

Cost of sales and other production expenses were $16.4 million for the second quarter ended June 30, 2018 compared to $1.6 million for the corresponding period in 2017, representing an increase of $14.9 million. Cost of sales and other production expenses were $21.2 million during the six months ended June 30, 2018 compared to $3.9 million for the corresponding period in 2017, representing an increase of $17.2 million. The increase was due primarily to the cost of the plasma inventory sold of $15.5 million.

Research and Development (R&D)

Total R&D expenses were $24.0 million for the second quarter ended June 30, 2018 compared to $24.5 million for the second quarter ended June 30, 2017. Total R&D expenses were $46.4 million for the six months ended June 30, 2018 compared to $48.9 million for the corresponding period in 2017, representing a decrease of $2.5 million.

Administration, Sales & Marketing

Administration, selling and marketing expenses were $6.9 million for the second quarter ended June 30, 2018 compared to $8.1 million for the second quarter ended June 30, 2017. The $1.1 million decrease was due to a reduction in consulting fees and employee compensation expenses. Administration, selling and marketing expenses declined slightly to $14.6 million during the six months ended June 30, 2018 compared to $15.0 million for the corresponding period in 2017.

Finance Costs

Finance costs were $5.3 million for the second quarter ended June 30, 2018 compared to $1.9 million during the corresponding period of 2017, representing an increase of $3.5 million. Finance costs were $9.6 million for the six months ended June 30, 2018 compared to $3.2 million during the corresponding period of 2017, representing an increase of $6.3 million. This increase reflects higher debt levels during the six months ended June 30, 2018 compared to the same period of 2017 and the higher cost of borrowing on the non-revolving credit facility.

Net Loss

Prometic incurred a net loss of $33.1 million for the second quarter ended June 30, 2018 compared to a net loss of $31.5 million for the second quarter ended June 30, 2017. Prometic incurred a net loss of $67.7 million for the six months ended June 30, 2018 compared to a net loss of $60.6 million for the corresponding period of 2017. The net loss for the first six months of 2018 includes financing costs of $9.6 million as well as the write-down of $1.5 million of inventory. This increase in net loss was partially offset by a $2.5 million decrease in R&D during the first six months of 2018 as compared to the corresponding period in 2017.

Conference Call Information

Prometic will host a conference call at 11:00 am (ET) on Wednesday August 15, 2018. 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 as of Wednesday August 15, 2018 at 2:00 pm. The numbers to access the replay are 1-416-849-0833 and 1-855-859-2056 (passcode: 9986217). A live audio webcast of the conference call, with slides, will be available through the following: View Source

Additional Information in Respect to the Second Quarter Ended June 30, 2018

Prometic’s MD&A and condensed interim consolidated financial statements for the quarter ended June 30, 2018 will be filed on SEDAR (View Source) and will be available on the Company’s website at www.prometic.com.