Q Financial Results

Transcription

1 Q Financial Results May 2015

2 Safe Harbour Forward Looking Statement This presentation 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 thatcould cause actual events or results to materially differ from our current expectations in the Annual Information Form for the year ended December 31, 2014, under the heading Risk Factors. 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. Copyright notice The information contained in this presentation (including names, images, logos and descriptions portraying ProMetic's products and/or services) is the property of ProMetic Life Sciences Inc., of its divisions and / or of its subsidiaries ( ProMetic ) and is protected by copyright, patent and trademarklawand/ or other intellectual property rights. Neither this presentation nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including printing and photocopying, or by any information storage or retrieval system without prior permission in writing from ProMetic. Disclaimer ProMetic reserves the right to make improvements, corrections and/or changes to this presentation at any time. 2

3 Agenda Introduction Third Quarter 2015 Financial Update Plasma derived therapeutics Plasminogen clinical program IVIG clinical program Others Small molecules therapeutics PBI 4050 clinical program Others Recap outlook for Q Q & A 3

4 Introduction Key Highlights to date in H Strong H2 revenue driven by bioseperation products sales guidance $18 M $20 M Plasma collection center ownership secured for strategic long term manufacturing of plasma derived biopharmaceuticals Plasminogen development program made significant progress and achieved new milestones Pg German patient Pg expansion indications IVIG IND cleared by the FDA PBI 4050 Orphan Drug Designation for IPF granted for Europe Successful pre IND meeting with the FDA pivotal add on clinical trial in IPF Confirmed safety in first twelve patients in Metabolic Syndrome with Type 2 Diabetes phase II trial in Canada Green light to expand by DSMB CTA cleared by MHRA to commence phase II trial in the UK in patients with Type 2 diabetes and severe multi organ fibrosis 4 4

5 Q Financial Update May 2015

6 Source of Financial Information The following information comes from or is derived from the condensed interim financial statements for the quarter ended September 30, 2015 and 2014, which were prepared in accordance with International Financial Reporting Standards (IFRS) and from the Management Discussion and Analysis for the quarter ended September 30, Further financial information, including the ProMetic s Annual Information Form, is available on SEDAR ( All tabulated sums are in CAD 000 s except for per share amounts or where indicated. 6 6

7 Revenue Breakdown: Q3 & FY 2015 FC FY 15 Forecast Q4 15 Forecast Q3 15 Q3 14 Product Sales Service Revenues Licensing & Milestone Revenues 7 7

8 Financial Results Q * Adjusted EBITDA is a non GAAP measure that is not defined or standardized under IFRS and it is unlikely to be comparable to similar measures presented by other companies. The Corporation believes that Adjusted EBITDA provides an additional insight in regards to the cash used in operating activities on an on going basis. It also reflects how management analyzes the Corporation s performance and compares that performance against other companies. In addition, we believe that Adjusted EBITDA is a useful measure as some investors and analysts use EBITDA and similar measures to compare us against other companies. 8

9 Balance Sheet September 30, 2015 December 31, 2014 Selected information CAD 000s CAD 000s Cash 42,480 27,102 Accounts Receivable 6,944 11,850 Inventory 8,313 2,586 Capital Assets 17,458 13,784 Intangible Assets 147, ,163 Accounts Payable and Accrued Liabilities 7,588 9,102 Deferred Revenues 2,682 1,041 Warrant Liability 24,676 Long term Debt (Thomvest) 21,448 23,244 Advance on Revenues from Supply Agreement 3,680 3,191 Deferred Tax Liabilities 33,241 37,198 Total Equity 156, ,431 Total Assets 225, ,443 9

10 Timing and range of costs for clinical programs in 2016 H H Plasminogen deficiency Phase II III (12 15 patients) ~$ 1 M Plasminogen DFU Phase Ib/II POC, ~30 patients ~$ 0.5 M ~$ 1 M IVIG Phase I III, ~50 adults ~$ 2 M ~$ 3 M C1 INH AAT Manufacturing being scaled up to enable filing of INDs in 2016 Clinical trial costs starting in H2 16 ~$ 1 M ~$ 1 M Orphan Rx (TBA) Fg Clinical trials currently scheduled for H PBI 4050 Phase II trials (Canada & UK) ~$ 2 M ~$ 2 M PBI 4050 Pivotal CKD trial USA Canada ~$ 1 M To be determined Pivotal IPF trial USA Canada To be determined 10

11 Q Corporate Update May 2015

12 Plasminogen Milestones achieved Safety further confirmed at higher dose No drug related adverse events, and follow on PK data as expected Confirmation of pharmacokinetic profile Established optimal dose regimen to reverse an acute medical condition Expansion of plasminogen use to additional medical indications 12

13 German plasminogen patient case study Plasminogen successfully used to treat a plasminogen deficient infant in a critical condition Recommended plasminogen dose regimen provided effective clinical result Severe clinical manifestations (including acute lung complications) significantly improved in a 20 month old infant Reduction of the lesions observed within a very few days Patient no longer required ventilator support Provides a clear demonstration of efficacy of plasminogen product in a very serious clinical situation 13

14 EXPANDED THERAPEUTIC USES OF PLASMINOGEN WOUND CARE MANAGMENT Strategic deal with OMNIO AB secures exclusive patent rights for plasminogen use for wound healing Deal provides ProMetic with proof of concept efficacy data in animals and humans > than 2 million affected by diabetic wounds in NA, with ~ 100,000 amputations annually in the US Incremental costs to the healthcare system as high as $13B Scientists at Omnio have decades of expertise and experience working with plasminogen in hard to treat wounds Creation of a Center of Excellence in Umea, Sweden Long term research collaboration in place to study the role of plasminogen in multiple conditions 14

15 Plasminogen Compassionate Use (Named Patient Basis) -1- Diabetic Foot Ulcer Being Considered for Bilateral Below-the-Knee Amputation Patient 77yrs old, 3 yrs with chronic ulcers in both feet BEFORE PLASMINOGEN TREATMENT Distal, partial amputation performed on left foot Right foot had an X- ray verified osteomyelitis Had been treated with antibiotics for long period Walking mainly on his heels Left Foot Right Foot AFTER PLASMINOGEN TREATMENT Patient could walk and balance on the front of his feet Osteomyelitis was completely cured No additional use of antibiotics No side effects

16 Plasminogen Compassionate Use (Named Patient Basis) year old female with arteriosclerosis Postoperative wounds in both legs Post-Operative Wounds BEFORE PLASMINOGEN TREATMENT Bilateral neuropathy in both legs Coronary bypass with vein grafts harvested from her left leg 3 month earlier Painful wound treatments with debridements No improvement Left Leg Right Leg AFTER PLASMINOGEN TREATMENT Patient s wounds were completely closed No side effects

17 Plasminogen Compassionate Use (Named Patient Basis) year old female with a 9 year old wound on the lateral malleal region on her left foot Chronic Wounds ON GOING PLASMINOGEN TREATMENT Wound is almost healed Vitality and social life markedly improved No side effects Time point A Time point B Time point C Time point D 10 Kronor: 3.3cm

18 Significant Market Potential with Unmet Medical Need US$8bn Advanced Wound Care Market 50% of the global market in the US 4-5% annual growth Growth driven by aging population Explosion in diabetes Clinical need for advanced therapies is clear Source: International Diabetes Federation, Diabetes Atlas, 6 th Edition,

19 US MARKET POTENTIAL DIABETIC FOOT ULCERS ~500,000: TARGET PATIENT POPULATION 26M Diabetic Patients ~25% Will get ulcers over their lifetime ~900,000 Patients yearly incidence of ~3.5% ~50% Hard-to-treat wounds with limited options Source: International Diabetes Federation, Diabetes Atlas, 6 th Edition, 2013, CDC, Frankel group, Wound healing Society, Journal of Wound repair 1919

20 Cost of Diabetic Foot Ulcers US$13bn ANNUAL EXTRA COST + WORK LOSS +AMPUTATIONS US$45,000 Per amputation 20

21 IVIG Investigational New Drug ( IND ) application cleared for the treatment of primary immunodeficiency diseases ( PIDD ). Pivotal Phase III clinical trial in PIDD open label, single arm, two cohort multicenter study (50 adults (cohort 1) and 25 children (cohort 2)) Primary end points: safety, tolerability, non inferiority (efficacy and pharmacokinetics) Completion expected in 2017 Mainstream plasma derived products such as IVIG to significantly contribute financially and facilitate the development of much needed and more affordable orphan products addressing rare diseases 21

22 Process Product Development platform generating multiple Rx Plasma Bulk API Process Development Finish dosage form Product Development Tech Transfer Scale up GMP Production Clinical Program Commercial Plasminogen Orphan Rx # 1 Plasminogen New Indication IgG IVIG Other IgG Fibrinogen GMP API N / A Fibrinogen Rx Alpha1 antitrypsin C1 INH Therapeutics Orphan Rx # 3, 4, 5 API 22

23 PBI-4050: IPF For Idiopathic Pulmonary Fibrosis (IPF) Orphan Drug Designation granted for IPF in Europe Phase II clinical trial in Canada initiated Successful pre IND meeting with FDA suggesting initiation of a pivotal trial in IPF Add on protocol to standard of care (pirfenidone or nintedanib) Protocol being designed with FDA s input IND submission scheduled for Q

24 PBI-4050: MS & T2D For the Type 2 diabetes with Metabolic Syndrome In the Phase II Canadian trial, Drug Safety Monitoring Board confirmed safety in the initial 12 patients enrolled, enabling expansion of the clinical trial Initiation of clinical trial in Europe for subgroup of patients with type 2 diabetes and severe multi organ fibrosis MHRA cleared the CTA New data was presented at the American Society of Nephrology (ASN) annual meeting More data from Vanderbilt confirming marked reduction of fibrosis in kidney of a pure fibrosis model More data confirming dual effect of PBI 4050 on reduction of kidney fibrosis and improvement of pancreatic function in diabetic mouse model Preliminary review of PBI 4050 effect on biomarkers of metabolic disorders to confirm translation of pharmacological activity from animal to humans Initiation of clinical program in the USA in patients with CKD & type 2 diabetes 24

25 PBI-4050 clinical program Clinical trials Status Next Steps Phase I ascending dose in healthy volunteers Phase Ib CKD & T2 diabetes, multi dose PK Phase II IPF open label Completed, No SAEs Completed, No SAEs, PK confirmed Enrolling patients Phase II metabolic syndrome & T2 diabetes open label DSMB confirmed safety, expanded trial prelim read out in Q4 15 effects on biomarkers Phase II T2 diabetes & fibrosis open label CTA cleared MHRA study initiation in Q4 15 Phase II new orphan indication to be announced Finalizing protocol study initiation in Q1 16 Phase II CKD & T 2 diabetes Finalizing protocol for IND with FDA study initiation in H Phase II III IPF add on protocol Finalizing protocol for IND with FDA study initiation in H

26 In Summary key milestones for H Revenues in H2 expected to range between $18 and $20 million Combination of product sales, service revenues based on already secured orders Excludes business development Business development transactions expected: to contribute financially to provide access to complementary know how intellectual property to provide access to markets Disclosure of new orphan products Manufacturing scale up of PPPS derived products to enable the IND filings in 2016 PBI 4050 preliminary read out in metabolic syndrome & type 2 diabetes PBI 4050 new orphan indication to be announced 26

27 Q&A May 2015