ProMetic Reports its 2013 Fourth Quarter and Financial Year End
Results and Business Highlights
- PBI-4050 clinical program progressed with initiation in
diabetic patients with chronic kidney disease expected in early H2
2014
- Plasminogen clinical pathway confirmed in a pre-IND meeting
with the FDA - initiation in patients expected in early H2 2014
- Additional plasma-derived orphan drugs to be enabled in 2014
by the successful launch of the plasma facility
- 2013 revenue of $20.6 million and EBITDA of ($8.7 million), Q4
2013 revenues of $5.1 million and EBITDA of ($3.8 million)
- Balance sheet strengthened by financings
LAVAL, QUEBEC--(Marketwired - Mar 26, 2014) - ProMetic Life
Sciences Inc. (TSX: PLI)(OTCQX:PFSCF) ("ProMetic" or the
"Corporation") today reported revenues of $5.1 million and $20.6
million for the quarter and year ended December 31, 2013
respectively. This compares to revenues of $8.3 million and $23.3
million for the quarter and year ended December 31, 2012
respectively.
"The strengthening of our market capitalization has allowed us
to make the decision to develop more of our own assets ourselves to
an advanced stage prior to partnering. This means a greater portion
of the future returns generated by our high-value products and
assets will remain ours. This change to the commercialization
strategy has however resulted in the short term, in lower licensing
revenues as well as an increase in spending", observed Mr. Bruce
Pritchard, ProMetic's Chief Financial Officer. "Having now improved
our capital base by receiving more than $40 million in cash inflows
in 2013 from two financing transactions and the Hepalink
investment, we can now concentrate our attention on further
progressing the key corporate initiatives necessary to build
substantial value for shareholders.
Commenting on the progress of the corporate initiatives to build
substantial value for the shareholders, Mr. Pierre Laurin,
ProMetic's President and Chief Executive Officer stated: "PBI-4050
continues to impress with new data further supporting the use of
this product in diabetic patients with chronic diseases as well as
in other rare conditions. Our objective for this year is to quickly
confirm that the positive effects observed in multiple animal
models translates to patients".
"It has always been our goal to leverage our unique proprietary
technologies and know-how to build a company that would bring
safer, cost-effective and more convenient therapeutic products to
largely underserved patient populations. The successful operational
launch of our plasma purification facility in Laval, Quebec has
brought us closer than ever to making this vision a reality", added
Mr. Laurin.
2013 Highlights
Business Highlights
2013 can best be summarized as the year during which ProMetic
significantly progressed in its transition towards becoming a
vertically integrated, specialty Biopharmaceutical Corporation.
Accordingly, ProMetic via using its rich therapeutic product
pipeline, has positioned itself to pursue various commercial
opportunities in areas of unmet medical needs, including rare
diseases and orphan drug opportunities.
In 2013, ProMetic:
- Received a $10 million strategic equity investment by Shenzhen
Hepalink Pharmaceutical Co., LTD. in ProMetic at a premium to the
market share price;
- Received an orphan drug designation status for its plasma
purified human plasminogen drug by the American Food and Drug
Administration ("FDA") for the treatment of hypoplasminogenemia, or
type I plasminogen deficiency ("T1PD");
- Received a $4.8 million purchase order under its ongoing supply
agreement with Octapharma, relating to the purchase of PrioClear™,
a proprietary prion capture resin incorporated into Octapharma's
manufacturing process for its solvent/detergent treated plasma
product, Octaplas®;
- Selected Alpha1-Antitrypsin (AAT) as its second plasma-derived
therapeutic to address a well-defined unmet medical need affecting
an estimated 100,000 people in the USA alone with less than 10%
treated;
- Presented new pre-clinical data at the 2013 European
Respiratory Society ("ERS") annual congress held in Barcelona,
Spain, suggesting that PBI-4050 offers a new therapeutic approach
to Idiopathic Pulmonary Fibrosis;
- Secured a $10 million loan and issued warrants in a financing
transaction with Thomvest Seed Capital Inc. ("Thomvest"), with no
principal or interest repayments for 5 years;
- Presented new preclinical data at the 2013 annual meeting of
the American Association for the Study of Liver Diseases (AASLD)
supporting the claims that PBI-4050 anti-fibrotic activity could
also be used to address various liver conditions such as
nonalcoholic steatohepatitis ("NASH");
- Raised gross proceeds of $24 million through a public offering
of 26,651,400 Common Shares of the Corporation at $0.90 per
share
- Presented new preclinical data at the 2013 American Society of
Nephrology ("ASN") annual meeting demonstrating the ability of
PBI-4050 to reduce fibrosis in the kidney and overall improve the
renal function in various animal models;
- Received a $5.1 million purchase order for the supply of
affinity resin from an existing client, a global leader in the
biotherapeutics industry; and
- Achieved a major corporate milestone by successfully completing
the first commercial-scale production run at its plasma
purification facility, ProMetic BioProduction Inc., located in
Laval, Quebec. This production run was completed on schedule and
generated better than expected results.
2013 Financial Results
This financial information should be read in conjunction with
the Corporation's consolidated financial statements for the year
ended December 31, 2013 as well as the Management's Discussion and
Analysis dated March 25, 2014.
Total revenues for the fourth quarter of 2013, which were
derived from product sales, development services and licensing
revenues, were $5.1 million. Total revenues for the 2013 financial
year were $20.6 million as compared to $23.3 million for the
previous financial year.
Revenues from the sale of goods and services totaled $18.0
million in 2013 compared to $16.9 million in 2012.
Licensing revenues were $2.6 million in 2013 compared to $6.4
million in 2012, representing a decrease of $3.8 million. The
decrease reflects the Corporation's decision to further invest and
advance some of its clinical assets, rather than seeking earlier
licensing revenues.
ProMetic generated a net loss of $7.5 million for the quarter
ended December 31, 2013 and a net loss of $17.4 million for the
2013 financial year compared to a net loss of $0.4 million for the
previous 2012 financial year.
Of the $17.4 million net loss incurred in 2013, a total of $8.9
million comes from non-cash items. $5.5 million comes from the
variation in fair value of the warrant liability associated to the
Thomvest financing transaction and $3.4 million represent the
expense recorded as a result of stock options and restricted stock
units issued to employees and board members.
Non rechargeable Research and Development expenses were $13.7
million in 2013 compared to $7.8 million in 2012, representing a
$5.9 million increase. The increase mainly comes from a higher
level of research activities associated to the PBI-4050 clinical
program and the costs associated with the preparation of the Laval
plasma purification facility for a GMP validation.
"Our total assets have more than doubled following the closing
of the debt and equity transactions completed in 2013. Our cash,
accounts receivable and capital assets positions have all
significantly increased during the year 2013 compared to 2012",
stated Mr. Bruce Pritchard, ProMetic's Chief Financial Officer.
Fourth Quarter and Year End 2013 Conference Call Information
ProMetic will host a conference call at 11:00am (EST) on
Thursday, March 27, 2014. The telephone numbers to access the
conference call are (647) 788-4922 (International) and
1-877-223-4471 (Toll-free). A replay of the call will be available
from March 27, 2014 at 1:30 p.m. until April 12, 2014. The numbers
to access the replay are 1-416-621-4642 (passcode: 17917398) and
1-800-585-8367 (passcode: 17917398). A live audio webcast of the
conference call will be available through the following:
http://www.gowebcasting.com/5345
Additional Information in Respect to the Three month and Twelve
month Periods ended December 31, 2013
ProMetic's MD&A and 2013 Financial Statements have been
filed on Sedar (www.sedar.com) and will be available on the
Company'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 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. 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 both the
plasma-derived and small molecule products are under development
for orphan drug indications. Headquartered in Laval (Canada),
ProMetic has R&D facilities in the UK, the U.S. and Canada,
manufacturing facilities in the UK and business development
activities in the U.S., 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,
2013, 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.
Pierre LaurinPresident and CEOProMetic Life Sciences
Inc.p.laurin@prometic.com450-781-0115Frederic DumaisDirector,
Communications andInvestor RelationsProMetic Life Sciences
Inc.f.dumais@prometic.com450-781-0115