investor presentation jefferies healthcare conference, … life... · all amounts are in canadian...

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Investor Presentation – Jefferies Healthcare Conference, London

November 2017

© Prometic Life Sciences Inc 2017

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 that could

cause actual events or results to materially differ from our current expectations in the Annual Information Form for the year ended December 31, 2016, 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 trademark law and /

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.

Safe Harbour

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The Biology Of Healing And Hope


Prometic Overview

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1. At 30 September 2017

Fully integrated biopharmaceutical company: > 450 employees

Market cap ~ CAD 1.1 Billion1 TSX: PLI

Proforma cash position CAD 175 million1;

Multiple products in clinical development: plasma proteins and small molecule fibrosis programs

Bioseparation business generating meaningful revenues offsetting some R&D costs

HQ in Montreal with R&D and operations in Rockville (USA), Cambridge (UK) and Canada.


Why Invest In Prometic?

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BLA filed for late-stage plasminogen

deficiency program

• Plasminogen Deficiency PDUFA Action Date 14 April 2018

• Orphan Designation for paediatric and adult use

• Eligible for valuable rare paediatric disease priority review voucher

• Anticipated launch Q2 2018

Advanced small-molecule program under PBI-4050;

near term catalysts and positive clinical data

• Orphan Drug Designation both for use in IPF and Alström Syndrome

• Clinical efficacy demonstrated in liver, pancreas, kidney and lung

• Ongoing studies in Alström Syndrome, CFRD, metabolic syndrome and type 2 diabetes

• IND cleared by FDA for pivotal ph II study in IPF.

• Fast Track Designation granted for IPF

Orphan/rare disease focus

• Pipeline targeting more than 10 indications that have either been granted or may receive orphan designation

• Targeting multiple areas of unmet medical needs e.g. plasminogen deficiency, IPF, Alstrom Syndrome

Proprietary technology platforms, with strong

IP protection, capable of generating multiple

therapeutic products

Experienced management team and extensive

public company experience

Significant upcoming newsflow to drive value

– starting soon and sustained into the future

Analysts consensus* recommendation * Consensus from 13 covering analysts

Sell BuyHold

Consensus Target Price: $3.75

Experienced

management team

and extensive public

company experience

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Management Team

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Pierre Laurin BSc Pharm, MSc

President & Chief

Executive Officer

• 33 years of experience in the pharmaceutical and biotechnology industry.

• Involved in Prometic since 1989, President and CEO of the Corporation since its inception

• Raised over $950 million through equity and debt financing and multinational funding.

• Successfully closed over 45 licensing agreements and joint venture agreements with multinationals

• Prior experience also includes positions with various pharmaceutical companies, including Nordic Laboratories (now Sanofi) where he played a pivotal role in the commercial success of Cardizem in Canada.

• Mr. Laurin holds a B.Sc. in Pharmacy and a Master degree in Pharmaceutical Sciences from the University of Montreal.

Bruce Pritchard BA, CA, FIoD

Chief Operating

Officer & Chief

Financial Officer

• 21 years experience in life sciences and pharmaceutical industry

• Joined PLI in 2006 originally as CFO of the UK subsidiary and was appointed CFO of the group in 2008 and COO in August 2014.

• Chartered accountant with many years of experience in general management, operations and corporate accountancy

• Proven track record of success in strategic acquisitions and in raising debt and equity finance.

• A Heriot-Watt University graduate, Mr. Pritchard gained a BA in Accountancy and Computer Science in 1993, Membership of the Institute of Chartered Accountants of Scotland in 1996 and Fellowship of the Institute of Directors in 2014.


Management Team

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• Joined Prometic in 2007

• Consulting Professor in Nephrology at Stanford University

• Previously:

• Vice President, Clinical Affairs – Home modalities at DaVita Inc. responsible for quality of care and related business issues for over 15,000 home dialysis patients in over 650 care centers.

• Senior Vice President, Clinical Affairs for Satellite Healthcare

• Senior Vice President and Chief Medical Officer for Vasca Inc.

• Vice President for Clinical Development and Marketing for Baxter Healthcare Corporation.

Dr. John Moran MD, FRACP, FACP, FACPE

Chief Medical

Officer

• Joined Prometic in 2006 as Senior Legal Counsel – Intellectual Property and has since been nominated as Corporate Secretary of the Company.

• Extensive experience in the areas of Intellectual Property (prosecution and management of Patent and Trademark portfolios), Technology Transfer (Licencing Agreements, Material Transfer Agreements and Research and Development Contracts), private and public financing (Venture Capital, Institutional, Debt, Equity) as well as general corporate and commercial law.

• Graduated from the University of Montreal with a Bachelor of Law (LLB) in 1999 and was called to the Bar of Quebec in 2001. He holds Bachelor of Science, with Distinction, from Concordia University and is currently completing his Masters degree in taxation at the HEC Montreal.

• Member of the Intellectual Property Institute of Canada and the Young Bar Association of Montreal.

Patrick SartoreBSc, LLB

Chief Legal Officer

& Corporate

Secretary

Plasminogen

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Ryplazim™ : Prometic’s First Product Pending Approval By FDA

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Clinical Facts

• 100% success in meeting primary and secondary endpoints

in in 100% of patients in phase II/III pivotal trial

• Patients completed 48 weeks on drug and maintained

100% response with no recurrence of lesions

Plasminogen Facts

• Plasminogen is a naturally occurring plasma protein synthesized in

the liver, which is vital in wound healing and tissue remodelling

• Plasminogen deficiency is a rare genetic disease that can have

devastating effects on multiple organ systems

Commercial Facts

• Prevalence of approximately 2,000 patients in US with

congenital deficiency

• From first in human trials to commercial launch in

~ 3.5 years

Regulatory Facts

• PDUFA Action Date 14 April 2018

• FDA Fast track and orphan drug designation

• Eligible for valuable rare paediatric disease priority

review voucher

• Health Canada Priority Review (180 vs 300 days)


Positive Results Achieved in Phase 2/3 in Patients with Plasminogen Congenital Deficiency

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• 100% success rate on primary endpoint --targeted increase in the blood plasma concentration level of plasminogen as a surrogate target

• All patients who had active visible lesions when enrolled in the trial had complete healing of their lesions within weeks of treatment (secondary endpoint)

• Safe, well-tolerated and without any drug-related serious adverse events for the treatment of patients with Plasminogen Congenital Deficiency


Over 2,000 patients with Congenital Plasminogen Deficiency in the USA

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~80% of patients have multiple lesions in multiple organ systems

~80% of Congenital Plasminogen deficiency Patients have LC (Ligneous Conjunctivitis)

LC is unique clinical manifestation of plasminogen deficiency


QuintilesIMS sourced the Medical Claims database to identify HCPs diagnosing patients with Ligneous Conjunctivitis

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• Sourced from CMS-1500 form-based claim transactions, the standard reimbursement form for all non-cash claims

• 837p is electronic version

• Standard Form for all non-cash claims

• Includes patient level diagnosis and procedures for visits to U.S. Office-based individual professionals, ambulatory and general healthcare sites

• Represents 937M claims over 3 quarters

• Collected from ~60-70% of US physicians, census & non-census

Data

Sourc

e


Prepared for immediate commercial roll-out of Plasminogen

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Highest Volume, Activity

10-12 Hospital & Acute Care Specialty Reps

• Specialty reps with focus on urgent care

• Pharmacy & Therapeutics reviews

• Headcount calibrated per market requirements

Covering appox. 150 Tier 1 Treatment Centers

• Pediatric treatment centers • Pediatric & Adult Hematology • Pediatric Ophthalmology • Cornea Specialists

8-10 Medical

Science Liaisons

• Evaluating opportunity in acute care settings

• Education; case experience; CME

48 weeks of Phase II/III data provides strong case for reimbursement with payors


Prometic at the American Academy of Ophthalmology Annual Meeting (Nov 11-14 2017, New Orleans)

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Potential additional indications for Plasminogen

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Tier 1 Hospitals

• Pediatric – hematology - ophthalmology

• Trauma – Critical Care

Congenital

Plasminogen

Deficiency

~ 2,000 pts

Out patient clinic

• Home infusion / treatment

Plasminogen (Sc)

Severe Burns

~ 15,000 pts / year

Acquired Acute Deficiency –

Critical Care Conditions

> 100,000 pts / year

Plasminogen (IV)

Diabetic Foot ulcers

> 500,000 pts

Ophthalmic

Indications

> 100,000 pts

/ year

Tympanic

Repair

> 80,000 pts

/ year


Plasminogen Clinical Program

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Q4 2017 Q1 2018 Q2 2018 Q4 2018Q3 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q2 2020Q1 2020

Plasminogen SC

Plasminogen IV

Tympanic

Repair

Diabetic Foot

Ulcer (DFU)

CTA Follow-on Phase 2/3 Data Read

Out

DataRead

OutFollow-on Phase 2/3

Severe Burns

CTA

Dr. Cecilia Engmér Berglin at Karolinska University Hospital in Stockholm.

The Karolinska University Hospital is the second largest ear/nose/throat center in the world.

Dr. Jan Apelqvist, who is a world renowned expert in the field of diabetic

foot ulcers and hard-to-treat wounds, at the Department of Endocrinology at

Skane University Hospital in Malmö, Sweden

Critical Care

Acute

plasminogen

Deficiency

Acute Lung Injury

Time lines to be updated – clinical program

to define optimal dose regimen / PK

PBI-4050

Orally ActiveAnti-Fibrotic Drug

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PBI-4050 : Multiple Shots On Goal Targeting Several Fibrotic Indications

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Alström Syndrome(Multi-organ fibrosis) ~1,200 Patients worldwide

Idiopathic Pulmonary Fibrosis (IPF) 130k US Patients

Metabolic Syndrome & Type 2 Diabetes 300m Diabetics worldwide

Chronic Kidney Disease (CKD) 26m US Patients

Indication Phase I Phase II Phase III

PBI-4050 pipeline in a product

© Prometic Life Sciences Inc 2017 20

PBI-4050 : 3 Phase 2 clinical trials confirming efficacy and safety

Idiopathic Pulmonary Fibrosis (IPF)

• PBI-4050 used alone – efficacy trend better than IPF commercial drugs

• PBI-4050 combined with nintedanib – efficacy better than nintedanib alone

• Safe & Well tolerated – no drug related SAEs

• Pivotal Phase II/III program to commence Q1 2018 :

• PBI-4050 as combination therapy with nintedanib &

• PBI-4050 as a stand alone therapy

40 Patients enrolled:

Clinical & statistical significance demonstrated

Metabolic Syndrome & Type 2 diabetes

• PBI-4050 added to diabetic drug regimen - further reduce HbA1c

• PBI-4050 reduced pro-fibrotic biomarkers in kidney and liver


• Clinical activity observed at 12 weeks, maintained after 24 weeks of treatment

• On-going placebo controlled trial – interim data in H1 2018


Clinical & statistical significance demonstrated

Alström Syndrome

• PBI-4050 reduction of fibroscan value and reduction of elevated liver enzyme

• PBI-4050 reduction of pro-fibrotic biomarkers in the kidney


• More data in Q4 2017 from on-going trial in the UK

• Pre-IND meeting with regulatory Authorities to define regulatory pathway


Clinical & statistical significance demonstrated on first 8 patients treated ≥ 36 weeks


IPF Market Opportunity

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Overview and Prevalance

• IPF is a chronic and fatal disease characterized by a progressive decline in lung function

• The term “idiopathic” is used because the cause of pulmonary fibrosis is unknown.

• IPF usually occurs in adult individuals of between 50-70 years of age, particularly those with a history of smoking

• median survival of 2 to 3 years, carries a worse prognosis than many cancers.

• It affects up to 132,000 people in the US and approximately 50,000 new cases are diagnosed each year.

• The market size could be even greater if diagnostic was done more quickly and accurately.

Current Treatments

Current approved FDA treatments include Esbriet (Pirfenodone, Bayer) and Ofev (Nintedanib, Boehringer Ingelheim) both approved in 2014. Based on company reports, revenues for both products surpassed $1.4bn in 2016 (see graphic) while forecast for 2017-2018 are expected to reach close to $2bn (street estimates).

However both products continue to be ineffective for the whole IPF population and many patients discontinue treatments due to side effects. Current issues include:

• Slow pulmonary function loss

• Modest effect on slowing disease progression

• No demonstration of reversal

• Require management of side effects


PBI-4050 Phase 2 Study Confirms Safety and Early Evidence of Efficacy in IPF Patients

• Early evidence of efficacy in the patients treated with PBI-4050 monotherapy and PBI-4050-nintedanib which compares favourably to the pirfenidone treatment in the ASCEND trial and to the Nintedanibtreatment in the IMPULSIS trials.

• PBI-4050 is very well tolerated whether used alone or in combination with Nintedanib.

• Incidence of AEs with the PBI-4050 alone was very low and mild to moderate, a significant advantage over the current standard of care.

• QoL - Patients report that they feel much better when on the drug

Fibrogen**

-129 ml

Placebo

-308 ml

●

●

**As per Fibrogen’s disclosure for comparative purposes only


PBI-4050 : Idiopathic Pulmonary Fibrosis

Fast Track Designation by the FDA

Green light to initiate Pivotal Phase 2/3 Clinical trials

Patients stable on Nintedanib randomized to receive:

Placebo

PBI-4050 800 mg once daily


Interim analysis at 26 weeks – maintain only the optimal dose for remainder of the 52 week study

Patients that failed to tolerate or progressed with nintedanib or pirfenidone,

randomized to receive:

Placebo



Interim analysis at 6 months – maintain only the optimal dose for remainder of the 52 week study


Alstrӧm Patients develop accelerated liver fibrosis as well as fibrosis of other organs

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Decreasing % of people that go on to develop fibrosis, cirrhosis


8 subjects with Alström Syndrome treated for ≥ 36 weeks with PBI-4050 had a significantdecrease in their Fibroscan Score

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Fatty Liver

Mild Fibrosis

F1

Significant

Fibrosis

F2

Severe Fibrosis

F3

Cirrhosis

F4

Fibroscan

Score

2.5

7

9.5

12.5

0 5 10 15 20 Years

90% of patients

Progress to

liver cirrhosis

Mean fibroscan score of 7.5 kPa at last measurement (p=0.0003)

Many patients

already have

Fatty Liver at

3-4 years old

9.8

7.5

Mean fibroscan score of 9.8 kPa at baseline


Fatty Liver

Mild Fibrosis

F1

Significant

Fibrosis

F2

Severe Fibrosis

F3

Cirrhosis

F4

Fibroscan

Score

2.5

7

9.5

12.5

10.1

17.1

7.1

5.0

7.1

12.4

21.1

9.9

8.1

8.8

5.0

3.83.9

6.6

5.1

6.1

Fibroscan Score

Baseline

Last measurement

Effect of PBI-4050 in Alström Syndrome Patients: Fibroscan Score reduced in all patientstreated for ≥ 36 weeks


SMT – PBI-4050 – Phase 2/3 Clinical programs & Type C – Pre-IND meetings

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Q1 2018 Q2 2018 Q4 2018Q3 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q2 2020Q1 2020

PBI-4050

Phase 2/3 : DKD

Phase 2/3 : IPF –

+ Nintedanib

Phase 2/3 : IPF

Monotherapy

IND

IND

Stage 1 of the Pivotal Phase 2/3 Stage 2 of the Phase 2/3 6-month

Interim

Data

Stage 1 of the Pivotal Phase 2/3 6-month

Interim

Data

Stage 2 of the Phase 2/3

Stage 1 of the Phase 2/3 6-month

Interim

Data

Pre-IND

FDA MeetingAlström Syndrome

Q3 2020

Stage 2 of the Phase 2/3

Possible expansion to a Pivotal Phase 2/3

PBI-4547Phase 1 : HV

SAD & MAD Phase 2 : Indication (TBA)

IND

Significant Upcoming Newsflow To Drive Value

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Plasma-derived Therapeutics - Milestones for the next 6 – 9 months

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• Plasminogen: commercial launch in the USA PDUFA - 04 2018 – PRIORITY REVIEW GRANTED

• Plasminogen: update on regulatory process with Health Canada – PRIORITY REVIEW GRANTED

• Plasminogen: Rare Pediatric designation GRANTED

• Plasminogen: filing of additional Orphan Drug Designations

• Plasminogen: initiation of clinical program for Tympanic Repair

• Plasminogen: initiation of clinical program for Diabetic Foot Ulcer

• Plasminogen: new data for future use in critical medical conditions

• Plasminogen: partnering for selected indications and geographies

• IVIG: filing of BLA for Canada

• Inter alpha 1: filing for first orphan drug designation


Small Molecules Therapeutics - Milestones for the next 6 – 9 months

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• PBI-4050: more data from on-going clinical trials (e.g. Alström Syndrome)

• PBI-4050: IND clearance by FDA for IPF pivotal Phase 2/3 clinical trials

• PBI-4050: IND clearance by FDA for DKD Phase 2/3 clinical trial

• PBI-4050: series of peer reviewed publications on MoA and efficacy

• PBI-4547: to enter in clinical phase

• PBI-4050: Partnering for selected indications and geographies

Bioseparations

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Prometic Bioseparations

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Expertise / Technologies

• Synthetic small-molecule ligands

• Custom development & manufacturing

Affinity chromatography offers several major advantages compared to other protein purification techniques :

• High yields of purified product

• Reduced processing time

• Reduced cost of goods

Commercial facts

• Established 30 years

• Extensive range of bioseparation products

• 18 Prometic adsorbents used in FDA/ EMEA licensed products/ processes by major Pharma companies

• GMP Manufacturing

• Topline revenue recurring CAD 17 m in 2016 and growing

Financials

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Financial snapshot

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Statement of operations

Sell Buy

* Consensus from 13 covering analysts

Balance sheet

Analysts consensus* recommendation

Hold

Capital structure

• Capital structure: 707.4m outstanding ordinary shares; ~83,8m outstanding

stock options and warrants with proceeds totalling ~$165.1m

• Pro-Forma Cash position: $175 million at 30 Sept 2017

• NOL: ~315m carry-forward losses; Favourable effective tax rates – Group

average ~20%

• Net loss FY2016: $110.7m ; Adjusted EBITDA $(97.6)m

• Cash used in Operating Activities FY2016: $97.7m


(in CAD millions)Year Ended

Dec 2016

Quarter Ended

Sept 30, 2017

Revenues 16.4 24.0

Cost of Goods Sold 6.8 3.8

Research and

development88.1 23.2

Administration, Selling and

Marketing29.3 7.7

Net loss 110.7 17.7

(in CAD millions) At Dec 2016 At Sept 30, 2017

Cash and cash equivalents 38.9 29.1

Inventories 13.7 32.6

Net Current Assets 32.2 58.0

Long Term Debt 48.1 65.1

Total Assets 265.3 294.0

Total Equity 159.3 172.6


Illustrative cost vs Revenue Progression

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2015 2016 2017 2018 2019 2020

RevenueCosts

(Ops & R&D)

• Bioseparation• PBI-4050 • PBI-4547 • Plasminogen• IVIG• Other Rx

• Bioseparation• PBI-4050 • Plasminogen

• Bioseparation


Investment Summary

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Robust pipeline of efficacious and safe orphan products addressing unmet

medical needs

Compelling market opportunities

Proprietary technology platforms, with strong IP protection, capable of

generating multiple therapeutic products

Experienced management team and extensive public company experience

Significant upcoming newsflow to drive value – Starting soon and sustained into

the future

Analysts consensus* recommendation * Consensus from 13 covering analysts

Sell BuyHold


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Thank You

investor presentation jefferies healthcare conference, … life... · all amounts are in canadian...

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