- Advanced multiple initiatives aimed at extending cash
runway, including ongoing partnering discussions related to both
PBI-4050 and RyplazimTM (plasminogen)
- Submitted plan to FDA regarding filing of the amended BLA
for RyplazimTM (plasminogen)
- Q2 revenues of $20.2 million,
and net loss of $33.1 million.
R&D and Admin costs down from the same period in 2017.
- Received Rare Pediatric Disease Designation for PBI-4050
from the FDA for the treatment of Alström Syndrome
- Presented new clinical data for PBI-4050 and PBI-4547 in
liver fibrosis and for IVIG in PIDD demonstrating signs of positive
clinical activity at several scientific conferences
LAVAL, QC, Aug. 14, 2018 /PRNewswire/ - 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.
"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 confortable 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:
https://event.on24.com/wcc/r/1806852/F2EF7947E1CD3872CD893D6BC3A09039
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 (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). Furthermore, the Corporation is continuing
to secure its plasma supply through the execution of third party
contracts and expansion of its own collection activities for its
plasma processing needs. 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.
View original
content:http://www.prnewswire.com/news-releases/prometic-reports-second-quarter-2018-financial-results-and-highlights-300697190.html
SOURCE ProMetic Life Sciences Inc.