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Transcript of Investor Presentation Jefferies Healthcare Conference, … Life... · All amounts are in Canadian...
1
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
2
3
The Biology Of Healing And Hope
© Prometic Life Sciences Inc 2017
Prometic Overview
4
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.
© Prometic Life Sciences Inc 2017
Why Invest In Prometic?
5
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
6
© Prometic Life Sciences Inc 2017
Management Team
7
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.
© Prometic Life Sciences Inc 2017
Management Team
8
• 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
9
© Prometic Life Sciences Inc 2017
Ryplazim™ : Prometic’s First Product Pending Approval By FDA
10
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)
© Prometic Life Sciences Inc 2017
Positive Results Achieved in Phase 2/3 in Patients with Plasminogen Congenital Deficiency
11
• 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
© Prometic Life Sciences Inc 2017
Over 2,000 patients with Congenital Plasminogen Deficiency in the USA
12
~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
© Prometic Life Sciences Inc 2017
QuintilesIMS sourced the Medical Claims database to identify HCPs diagnosing patients with Ligneous Conjunctivitis
13
• 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
© Prometic Life Sciences Inc 2017
Prepared for immediate commercial roll-out of Plasminogen
14
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 Life Sciences Inc 2017
Prometic at the American Academy of Ophthalmology Annual Meeting (Nov 11-14 2017, New Orleans)
15
© Prometic Life Sciences Inc 2017
Potential additional indications for Plasminogen
16
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
© Prometic Life Sciences Inc 2017
Plasminogen Clinical Program
17
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
18
© Prometic Life Sciences Inc 2017
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
• Safe & Well tolerated – no drug related SAEs
• Clinical activity observed at 12 weeks, maintained after 24 weeks of treatment
• On-going placebo controlled trial – interim data in H1 2018
24 Patients enrolled:
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
• Safe & Well tolerated – no drug related SAEs
• More data in Q4 2017 from on-going trial in the UK
• Pre-IND meeting with regulatory Authorities to define regulatory pathway
12 Patients enrolled:
Clinical & statistical significance demonstrated on first 8 patients treated ≥ 36 weeks
© Prometic Life Sciences Inc 2017
IPF Market Opportunity
21
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
© Prometic Life Sciences Inc 2017 22
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
© Prometic Life Sciences Inc 2017 23
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
PBI-4050 1200 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
PBI-4050 800 mg once daily
PBI-4050 1200 mg once daily
Interim analysis at 6 months – maintain only the optimal dose for remainder of the 52 week study
© Prometic Life Sciences Inc 2017
Alstrӧm Patients develop accelerated liver fibrosis as well as fibrosis of other organs
24
Decreasing % of people that go on to develop fibrosis, cirrhosis
© Prometic Life Sciences Inc 2017
8 subjects with Alström Syndrome treated for ≥ 36 weeks with PBI-4050 had a significantdecrease in their Fibroscan Score
25
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
© Prometic Life Sciences Inc 2017 26
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
© Prometic Life Sciences Inc 2017
SMT – PBI-4050 – Phase 2/3 Clinical programs & Type C – Pre-IND meetings
27
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
28
© Prometic Life Sciences Inc 2017
Plasma-derived Therapeutics - Milestones for the next 6 – 9 months
29
• 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
© Prometic Life Sciences Inc 2017
Small Molecules Therapeutics - Milestones for the next 6 – 9 months
30
• 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
31
© Prometic Life Sciences Inc 2017
Prometic Bioseparations
32
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
33
© Prometic Life Sciences Inc 2017
Financial snapshot
34
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
Consensus Target Price: $3.75
(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
© Prometic Life Sciences Inc 2017
Illustrative cost vs Revenue Progression
35
2015 2016 2017 2018 2019 2020
RevenueCosts
(Ops & R&D)
• Bioseparation• PBI-4050 • PBI-4547 • Plasminogen• IVIG• Other Rx
• Bioseparation• PBI-4050 • Plasminogen
• Bioseparation
© Prometic Life Sciences Inc 2017
Investment Summary
36
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
Consensus Target Price: $3.75
37
Thank You