- 2014 revenues of $23.0 million and net profit of $2.6 million, Q4 2014 revenues of $10.5 million with net profit of $8.5 million
- Initiation of 3 different PBI-4050 clinical programs in patients suffering from diabetic kidney disease, idiopathic pulmonary fibrosis and metabolic syndrome and its resulting type 2 diabetes
- Initiation of plasminogen clinical program following IND clearance by FDA
- Licensing of PPPSTM technology for the manufacturing of several plasma-derived biopharmaceuticals to be manufactured and commercialized in Russia and CIS following the strategic alliance with GENERIUM Pharmaceuticals
- Balance sheet strengthened by financings exceeding $48 million in total
- Addition of ProMetic to the S&P/TSX Composite Index
LAVAL, QUEBEC, CANADA – March 31, 2015 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF)
(“ProMetic” or the “Corporation”) today reported revenues of $23.0 million and a net profit of $2.6 million and revenues of $10.5 million and a net profit of $8.5 million for the year and quarter ended December 31, 2014 respectively. This compares to revenues of $20.6 million and a net loss of $17.4 million and revenues of $5.1 million and a net loss of $7.5 million for the year and quarter ended December 31, 2013 respectively.
“The continuation of our transition towards becoming a vertically integrated biopharmaceutical company was greatly facilitated in 2014 by the strengthening of both our market capitalization and overall general financial position. We have continued to increase our investment in the development of more of our own assets by successfully completing 2 different financings totaling more than $48 million”, mentioned Mr. Bruce Pritchard, ProMetic’s Chief Operating and Chief Financial Officer. “ProMetic is now well positioned to continue executing on its value creation strategic corporate initiatives”.
Commenting on the various milestones achieved in 2014, Mr. Pierre Laurin, ProMetic’s President and Chief Executive Officer stated: “All our operational and clinical milestone achievements throughout 2014 have favorably positioned ProMetic to benefit from its rapidly growing and significant product pipeline. With numerous drug candidates progressing through and towards advanced stages of clinical development, ProMetic now possesses all the required elements to become a leader in the field of large unmet medical conditions and rare diseases”.
ProMetic successfully continued its transition into a vertically integrated biopharmaceutical corporation with a rapidly growing pipeline of drug candidates targeting underserved patient populations in both existing and emerging markets.
In 2014, ProMetic:
- Entered into definitive agreements with GENERIUM Pharmaceuticals for several plasma-derived biopharmaceuticals to be manufactured and commercialized in Russia and CIS. The strategic alliance includes the granting of manufacturing rights by ProMetic to GENERIUM for several plasma-derived biopharmaceuticals using ProMetic’s proprietary PPPSTM technology to be manufactured in a up to 600,000 liters per year facility to be built and operated by GENERIUM in Russia;
- Announced the pursuit of a clinical program designed to evaluate the benefits of PBI-4050 in patients affected by the metabolic syndrome and resulting type 2 diabetes;
- Entered into an agreement with a syndicate of underwriters under which the underwriters agreed to buy on a bought deal basis, 15.2 million common shares in the capital of the Corporation, including the overallotment, at a price of $1.90 per share for gross proceeds of $28.8 million;
- Disclosed new preclinical data on PBI-4050 from studies performed by Vanderbilt University in very severe model of accelerated type 2 diabetes where PBI-4050 attenuated the development of diabetic nephropathies in type 2 diabetes;
- Received approval to commence clinical trials for its orally active small molecule lead compound, PBI-4050, in patients suffering from Chronic Kidney Disease following the CTA clearance by Health Canada;
- Received clearance by the FDA for its IND application for its intravenous plasminogen for the treatment of type I plasminogen deficiency;
- Announced the pursuit of Idiopathic Pulmonary Fibrosis as one of its PBI-4050 orphan indications;
- Announced its addition to the S&P/TSX SmallCap Index;
- Secured a follow-on investment from Thomvest Seed Capital Inc. consisting of a $20 million loan;
- Announced the launch of fibrinogen for commercial sales during the fourth quarter of 2014 after its successful scale-up at its Laval based plasma purification facility;
- Completed successfully its PBI-4050 Phase I clinical trial in 40 healthy volunteers where it was found to be safe, very well tolerated without any serious adverse events reported;
- Received a $5.6 million purchase order from Octapharma relating to the purchase of PrioClearTM, a proprietary prion capture resin incorporated in Octapharma’s manufacturing process for its solvent/detergent treated plasma product, OctaplasLG®
- Increased its ownership in NantPro following the amendment of its related corporate and commercial agreement with NantPharma LLC providing ProMetic with the effective control of NantPro and a greater portion of the future value and revenues associated with the development and sales of IVIG in the US market;
- Presented new preclinical data at the annual meeting of the 2014 European Association for the Study of the Liver supporting the claim of PBI-4050 anti-fibrotic activity to address various liver conditions;
- Presented new preclinical data at the 2014 International Society of Nephrology Nexus Symposium demonstrating that PBI-4050 was shown to significantly reduce oxidative stress markers as well as inflammatory and pro-fibrotic cytokines in animal models designed to emulate chronic kidney disease and diabetic kidney disease: and
- Appointed Dr. John Moran as its new Chief Medical Officer.
2014 Financial Results
This financial information should be read in conjunction with the Corporation’s consolidated financial statements for the year ended December 31, 2014 as well as the Management’s Discussion and Analysis dated March 31, 2015.
Total revenues for the fourth quarter of 2014, which were derived from product sales, development services and licensing revenues, were $10.5 million as compared to $5.1 million for the fourth quarter of 2013. Total revenues for the 2014 financial year were $23.0 million as compared to $20.6 million for the previous financial year.
Revenues from the sale of goods and services totaled $15.6 million in 2014 compared to $18.1 million in 2013. The decrease is a result of the NantPro consolidation and the elimination of these service revenues upon consolidation.
Milestone and licensing revenues were $7.4 million in 2014 compared to $2.6 million in 2013, representing an increase of $4.8 million. The increase reflects the upfront payment related to the closing of the strategic alliance with GENERIUM Pharmaceuticals.
ProMetic generated a net profit of $8.5 million for the quarter ended December 31, 2014 and a net profit of $2.6 million for the 2014 financial year compared to a net loss of $7.5 million for the previous 2013 quarter ended December 31, 2013 and a net loss of $17.4 million for the financial year ended December 31, 2014.
The net profits are mainly due to the recognition of a purchase gain on business combination of $14.8 million in regards to the additional 40.83% of equity acquired in NantPro and the recognition of a gain on revaluation of the equity investment of $34.4 million representing the difference between the fair value and the carrying amount of ProMetic’s equity interest in NantPro just before the transaction.
Non rechargeable research and development expenses were $32.1 million in 2014 compared to $13.7 million in 2013, representing an increase of $18.4 million. 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 quadrupled on a year to year comparison basis following the successful completion of the NantPro transaction and closing of 2 financings completed in 2014. Our cash capital and intangible assets positions have all significantly increased during 2014 compared to 2013”, stated Mr. Bruce Pritchard, ProMetic’s Chief Financial Officer.
Amendment and Restatement of Structured Alpha LP (“Structured Alpha”) Loan Agreements
ProMetic and Structured Alpha have entered into amended and restated loan agreements (collectively the “Amended and Restated Loan Agreements”) on March 31, 2015 in respect of the loan agreements dated September 10, 2013 and July 31, 2014 (collectively the “Loan Agreements”), entered into between ProMetic, certain of its affiliates, and Thomvest Seed Capital Inc., an affiliate of Structured Alpha. The Amended and Restated Loan Agreements provide for several amendments in favour of ProMetic, which amongst others include the extension of the maturity date of the Loan Agreements to July 31, 2022, a right of repayment of the Loan Agreements commencing on September 13, 2018 and more flexibility in its affirmative and negative covenants. In consideration for the above modifications, ProMetic granted Structured Alpha 7 million warrants to purchase ProMetic’s common shares at an exercise price equal to the greater of (i) $3,00 per Common Share and (ii) the volume weighted average trading price of the Common Shares on the TSX for the five (5) trading day-period following the date of release of the annual financial statements of the Corporation for the period ended December 31, 2014, the warrants have an expiry date of July 31, 2022. ProMetic also granted Structured Alpha a pre-emptive right to participate in any future public offering or private placement of ProMetic’s common shares or securities convertible or exchangeable into common shares of ProMetic.
“We are pleased with Structured Alpha’s decision to strengthen its relationship with us by further participating in our share capital. The terms of the Amended and Restated Loan Agreements provide us with the necessary flexibility to pursue our growth objectives while we continue to build and advance our product pipeline and diversify our stream of recurring revenues”, said Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic Life Sciences Inc.
Fourth Quarter and Year End 2014 Conference Call Information
ProMetic will host a conference call at 11:00am (EST) on Wednesday, April 1, 2015. 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 April 1, 2015 at 2:00 p.m. until April 7, 2015. The numbers to access the replay are 1-416-621-4642 (passcode: 14920787) and 1-800-585-8367 (passcode: 14920787). A live audio webcast of the conference call will be available through the following: http://www.gowebcasting.com/6400
Additional Information in Respect to the Three month and Twelve month Periods ended December 31, 2014
ProMetic’s MD&A and 2014 Financial Statements will be filed on Sedar (www.sedar.com) and will be available on the Company’s website at prometic.com.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (prometic.com) is an established biopharmaceutical company with widely recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule drug development. ProMetic offers its innovative 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, 2014, 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.