- Extension of maturity dates of Line of Credit and OID Loans
to September 2024
- Implementation of cost control measures to significantly
reduce operational burn and extend cash runway
- Substantial reduction in R&D costs of up to $30 million in 2019 versus 2018
- Successful Type C meeting with FDA: agreement on proposed
plan of action for RyplazimTM (plasminogen)
manufacturing process
- Q3 revenues of $12.3
million
- Granted Rare Pediatric Disease Designation by FDA for
PBI-4050 to treat Alström Syndrome
LAVAL, QC, Nov. 14, 2018 /CNW Telbec/
- Prometic Life Sciences Inc. (TSX: PLI)
(OTCQX: PFSCF) (Prometic or the Corporation) reported today its
unaudited financial results for the third quarter ended
September 30, 2018.
"Several initiatives that we have been pursuing during the past
quarter should bear fruit in the coming weeks and months," said
Pierre Laurin, Prometic's President
and Chief Executive Officer. "We have implemented cost-control
measures to reduce our cash use while at the same time have made
significant progress to advance our two lead drug candidates,
Ryplazim™ (plasminogen) and PBI-4050. As previously stated, our
current business plan calls for a significant reduction in R&D
expenditures of up to $30 million in
2019 as compared to this year's budget. Our primary objective
remains to close the gap between the fundamental enterprise value
we have built and our current market valuation by strengthening our
financial position through the closing of commercial partnerships
and equity-related initiatives."
Commenting on the third quarter 2018 financial results,
Bruce Pritchard, Prometic's Chief
Operating Officer and Chief Financial Officer, said, "We are ahead
of target with the financial guidance provided during the AGM in
May 2018 and our last few conference
calls. We have effectively implemented cost control measures as
evidenced by the trending quarterly decrease in R&D,
Administration and Sales & Marketing expenses as well as
decreases in net loss and cash flows used in operating activities.
Cash used in operations year-to-date was $57
M compared to $95 M for the
same period in 2017".
Small Molecule Therapeutics Highlights
- PBI-4050 – Received a Rare Pediatric Disease designation
from the US Food and Drug Administration for the treatment of
Alström syndrome
- PBI-4050 – Published a paper further elucidating the
mechanism of action of its lead drug candidate, PBI-4050, on liver
fibrosis in the Journal of Pharmacology and Experimental
Therapeutics. The paper entitled "PBI-4050 reduces stellate cell
activation and liver fibrosis through modulation of intracellular
ATP levels and LKB1-AMPK-mTOR pathway" details the antifibrotic
signaling pathway modulated by PBI-4050.
- PBI-4050 – Hosted a Key Opinion Leader meeting in
New York on PBI-4050 as a novel
treatment for Alström syndrome and non-alcoholic steatohepatitis
(NASH).
Plasma-Derived Therapeutics Highlights
RyplazimTM (Plasminogen) - Completed a Type C
meeting in which the FDA agreed with the Company's proposed action
plan for the implementation of additional analytical assays and
in-process controls related to the RyplazimTM
(plasminogen) manufacturing process. As a result of the feedback
received during the Type C meeting, Prometic is finalizing the
process performance qualification (PPQ) protocols in anticipation
of commencing the manufacturing of additional RyplazimTM
(plasminogen) conformance lots.
Subsequent Events to Third Quarter 2018
- Closed a deal with Structured Alpha LP (SALP), an affiliate of
Thomvest Asset Management Inc., to extend the maturity dates of the
USD $80 million (CAD $100 million) line of credit and the Original
Issue Discount Notes to September
2024.
2018 Third Quarter Financial Results
Revenues
Total revenues for the third quarter ended
September 30, 2018 were $12.3 million and $36.8
million for the nine months ended September 30, 2018. Revenues from the sale of
goods, representing most of the 2018 revenues to date, were
$35.3 million during the first nine
months ended September 30, 2018
compared to $11 million during the
corresponding 2017 period. The $24.3
million increase for 2018 is mainly due to $19.7 million in sales of normal source plasma
which occurred in the second and third quarters of 2018 following a
change in the production forecast due to the delay of the BLA
approval for RyplazimTM (plasminogen). The remainder of
the increase of $4.6 million for the
nine month period is due to an increase in third party sales in the
bioseparation segment. 2018 bioseparation sales are expected to
exceed $21 million, which would
represent a 30% increase compared to 2017 bioseparation revenues. A
comparable level of revenue growth for 2019 is anticipated and is
mainly due to the expansion of manufacturing activities by existing
clients who utilize Prometic's products in their production
processes, the adoption of products by new clients, the
introduction of new products and the continuing expansion of the
market for bioseparation products.
Cost of sales and other production expenses
Cost of
sales and other production expenses were $9.2 million for the third quarter ended
September 30, 2018 compared to
$3.8 million for the corresponding
period in 2017, representing an increase of $5.5 million. Cost of sales and other production
expenses were $30.4 million during
the nine months ended September 30,
2018 compared to $7.7 million
for the corresponding period in 2017, representing an increase of
$22.7 million. The increase was due
primarily to the cost of the plasma inventory sold.
Research and Development (R&D)
Total R&D
expenses were $24.1 million for the
third quarter ended September 30,
2018 compared to $23.3 million
for the third quarter ended September 30,
2017. Total R&D expenses were $70.5 million for the nine months ended
September 30, 2018 compared to
$72.2 million for the corresponding
period in 2017, representing a decrease of $1.7 million. The completion of the pivotal phase
3 clinical programs for IVIG and for Ryplazim™ (plasminogen) and
termination of non core preclinical and clinical programs will
translate into a significant R&D cost reduction in 2019
compared to 2018.
Administration, Sales & Marketing
Administration,
selling and marketing expenses were $6.2
million for the third quarter ended September 30, 2018 compared to $7.7 million for the third quarter ended
September 30, 2017. The $1.4 million decrease was due to a reduction in
consulting fees and employee compensation expenses. Administration,
selling and marketing expenses declined slightly at $20.9 million during the nine months ended
September 30, 2018 compared to
$22.7 million for the corresponding
period in 2017.
Finance Costs
Finance costs were $5.9 million for the third quarter ended
September 30, 2018 compared to
$2.1 million during the corresponding
period of 2017, representing an increase of $3.8 million. Finance costs were $15.5 million for the nine months ended
September 30, 2018 compared to
$5.3 million during the corresponding
period of 2017, representing an increase of $10.2 million. This increase reflects higher debt
levels during the nine months ended September 30, 2018 compared to the same period of
2017.
Net Loss
Prometic incurred a net loss of $28.9 million for the third quarter ended
September 30, 2018 compared to a net
loss of $17.8 million for the third
quarter ended September 30, 2017.
Prometic incurred a net loss of $96.6
million for the nine months ended September 30, 2018 compared to a net loss of
$78.4 million for the corresponding
period of 2017. The main reason for the increase in the net loss is
that the results for the quarter and the nine months ending
September 30, 2017 included
$19.7 million in milestone and
licensing revenues related to the licensing agreement signed with
Jiangsu Renshou Pharmaceutical Co, Ltd.
With the delay of the anticipated launch of its most advanced
product, RyplazimTM (plasminogen), the Corporation had
to finance its R&D activities via various sources. To date, the
Corporation has financed its activities through the sale of
products in the bioseparations segment, collaboration arrangements
and licensing arrangements, the issuance of debt and equity,
operational restructuring as well as investment tax credits.
Prometic is currently actively involved in negotiating both equity
and equity-linked financing initiatives and continues to be in
dialogue with potential licensing partners. Although the
Corporation believes that it will be able to obtain the necessary
funding as in the past, there can be no assurance of the success of
these plans.
Conference Call Information
Prometic will host a conference call at 11:00 am (ET) on
Thursday November 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 Thursday November 15,
2018 at 2:00 pm. The numbers
to access the replay are 1-416-849-0833 and 1-855-859-2056
(passcode: 1190238). A live audio webcast of the conference call,
with slides, will be available through the following:
https://event.on24.com/wcc/r/1875420/A5BAEDCB1DAD05CDD9CCBE59D000BB89
Additional Information in Respect to the Third Quarter Ended
September 30, 2018
Prometic's MD&A and condensed interim consolidated financial
statements for the quarter ended September
30, 2018 will be filed on SEDAR (http://www.sedar.com) and
will be available on the Company's website at www.prometic.com.
About Prometic Life Sciences Inc.
Prometic (www.prometic.com) is a biopharmaceutical corporation
with two drug discovery platforms focusing on unmet medical needs.
The first platform (small molecule therapeutics) stems from the
discovery of two receptors which we believe are at the core of how
the body heals: namely, promoting tissue regeneration and scar
resolution as opposed to fibrosis. One of the lead drug candidates
emerging from this platform, PBI-4050, is expected to enter pivotal
phase 3 clinical trials for the treatment of Idiopathic Pulmonary
Fibrosis (IPF). The second drug discovery and development platform
(plasma-derived therapeutics) leverages Prometic's experience in
bioseparation technologies used to isolate and purify
biopharmaceuticals from human plasma. The Corporation's primary
goal with respect to this second platform is to address unmet
medical needs with therapeutic proteins not currently commercially
available, such as Ryplazim™ (plasminogen). We are also leveraging
this platform's higher recovery yield potential to advance
established plasma-derived therapeutics such as Intravenous
Immunoglobulin (IVIG). The Corporation also provides access to its
proprietary bioseparation technologies to enable pharmaceutical
companies in their production of non-competing biopharmaceuticals.
Recognized as a bioseparations expert, the Corporation derives
revenue from this activity through sales of affinity chromatography
media which contributes to offset the costs of its own R&D
investments.
We are headquartered in Laval, Quebec
(Canada) and have R&D facilities in Canada, the United
Kingdom ("UK") and the United
States ("USA"), manufacturing facilities in Canada and the Isle
of Man and corporate and business development activities in
Canada, the USA, 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, 2017, 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.
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SOURCE ProMetic Life Sciences Inc.