Immunovia Ab · OMXSTO:IMMNOV
Immunovia Ab — Investor Day (June 2020)
61 slides from Immunovia Ab's investor day presentation, Jun 30, 2020
Slide 1: Immunovia Investor Day
Immunovia Investor Day Lund, Sweden June 30, 2020
Slide 2: Forward Looking Statements
Forward Looking Statements IMPORTANT: The following applies to this document, the oral presentation of the information in this document by Immunovia AB (publ) (the “Company”) or any person on behalf of the Company, and any question-and-answer session that follows the oral presentation (collectively,
Slide 3: Immunovia Investor Day Agenda
Immunovia Investor Day Agenda Julie Silber Director of Investor Relations Introduction Carl Borrebaeck Founder & Chairman of the Board Mats Grahn Chief Executive Officer The Market & IMMray™ Platform Mats Grahn Chief Executive Officer Road To Market Laura Chirica Chief Commercial Officer Our Strateg
Slide 4: Welcome & Introduction
Welcome & Introduction Carl Borrebaeck Mats Grahn Founder & Chairman of the CEO Board 4
Slide 5: IMMray Platform and Market Overview
IMMrayTM Platform and Market Overview Mats Grahn CEO 5
Slide 6: Significant Unmet Medical Need
Significant Unmet Medical Need Early Detection Of Pancreatic Cancer ~50% Five Year Survival <5% Early Diagnosis In Pancreatic Cancer Is The Only Hope Today >80% Late Diagnosis 4.6 Months Median Survival Someone Diagnosed With Pancreatic Cancer In Europe 6
Slide 7: Pancreatic Cancer High Risk Groups
Pancreatic Cancer 3 High Risk Groups Hereditary Early Familial symptoms NOD • Familial autosomal ≥ 2 close • Depression • New onset diabetes type II fam members • Indigestion/Nausea after 50 years of age • Familiar non-autosomal ≥ 3 • Jaundice • 8-10 times increased risk of close fam members • Mid b
Slide 8: IMMray Targets A Large Growing Market
IMMray™ Targets A Large Growing Market Initial Addressable Market in EU/US: ~$4.4bn (USD) Pancreatic Cancer Risk Groups $3,600M $600M $240M Hereditary Early symptoms New Onset Diabetes over 50 years of age • 200,000 patients • 1 million new patients / year • >3 million new patients / year • 2 tests
Slide 9: IMMray Platform
IMMray™ Platform Patient Sample Testing In The Lab 9
Slide 10: Pancreatic Cancer Patent Portfolio
Pancreatic Cancer Patent Portfolio Patent Summary PDAC-I filed 25 Mar 2008 PDAC-V filed 10 May 2017 PDAC-II filed 5 Mar 2012 PDAC-VI filed 31 Jan 2018 PDAC-III filed 11 Nov 2014 PDAC-VII will be filed early July 2020 PDAC-IV filed 22 Sep 2016 10
Slide 11: State-of-the-Art Production Facility
State-of-the-Art Production Facility Lund, Sweden 11
Slide 12: Summary
Summary Immunovias vision is to dominate the pancreatic cancer diagnostics market • First to a 4 BUSD Market • Fully Funded Commercial Rollout • Target a Long Term 30% Market Share 12
Slide 13: Road to Market
Road to Market Laura Chirica Chief Commercial Officer 13
Slide 14: Laura Chirica, PhD
Laura Chirica, PhD Immunovia Chief Commercial Officer +20 years experience in developing and leading successful global commercial strategies with large marketing, sales, application support and customer support teams from Europe, US and Asia BSc in Biotechnology, MSc in Biochemistry and PhD in Bioch
Slide 15: IMMray PanCan-d Road to Market
IMMrayTM PanCan–d Road to Market Timeline IMMray™ PanCan-d Q4 2020 PROSPECTIVE STUDIES REIMBURSED SALES RETROSPECTIVE /OPTIMIZATION/VALIDATION SELF PAY-SALES ACCREDITATIONS CONFIRMATORY MARKET EXPANSION STUDIES 2016 - 2019 2020-2022 2023- 15
Slide 16: Road to market IMMray PanCan-d
Road to market IMMray™ PanCan-d Main programs Target Key Customers Reimbursement in priority geographies Immunovia Dx Laboratories - Guidance Experts - Reference labs (EU/US) - Health Economic Studies - Cancer Centre Clinicians - Private/Public Insurance - Private/Public Centre Clinical Studies Prog
Slide 17: Road to market IMMray PanCan-d
Road to market IMMray™ PanCan-d Main programs Target Key Customers Reimbursement in priority geographies Immunovia Dx Laboratories - Guidance Experts - Reference labs (EU/US) - Health Economic Studies - Cancer Centre Clinicians - Private/Public Insurance - Private/Public Centre Clinical Studies Prog
Slide 18: World's Largest Key Opinion Leader Network
World’s Largest Key Opinion Leader Network US and Europe Over 30 KOLs worldwide, including: North America Europe Dr. Diane Simeone, New York, USA Prof. Steve Pereira, London, UK Prof. Margaret Tempero, San Francisco, USA Prof. Bill Greenhal, Liverpool, UK Prof. Eithne Costello, Liverpool, Dr. Randal
Slide 19: Road to market IMMray PanCan-d
Road to market IMMray™ PanCan-d Main programs Target Key Customers Reimbursement in priority geographies Immunovia Dx Laboratories - Guidance Experts - Reference labs (EU/US) - Health Economic Studies - Cancer Centre Clinicians - Private/Public Insurance - Private/Public Centre Clinical Studies Prog
Slide 20: Positioning IMMray PanCan-d and Supporting Clinical Studies
Positioning IMMray™ PanCan-d and Supporting Clinical Studies Disease progression Asymptomatic Early symptoms Symptoms and Pancreatic cancer Hospital Pancreatic Cancer Clinics positive imaging recurrence Primary care evaluation HPB / Gastro clinic HPB / Gastro Familial / Familial / hereditary heredit
Slide 21: Prospective Studies
3 Prospective Studies >10,000 subjects in three major risk groups for pancreatic cancer Umeå University Hospital Massachusetts General Umeå, Sweden Hospital Boston, MA University of Massachusetts Sahlgrenska University Hospital Karolinska Institute Healthcare Regional Uppsala Boston, MA Gothenburg,
Slide 22: Road to market IMMray PanCan-d
Road to market IMMray™ PanCan-d Main programs Target Key Customers Reimbursement in priority geographies Immunovia Dx Laboratories - Guidance Experts - Reference labs (EU/US) - Health Economic Studies - Cancer Centre Clinicians - Private/Public Insurance - Private/Public Centre Clinical Studies Prog
Slide 23: Road to Reimbursement
Road to Reimbursement Timeline IMMray™ PanCan-d Q4 2020 Interim Final read read out out PROSPECTIVE STUDIES SELF PAY-SALES CONFIRMATORY MARKET EXPANSION STUDIES FOR COUNTRY SPECIFIC REIMBURSEMENT PAYER ENGAGEMENT CONTINUES WITH INTERIM REIMBURSED SALES PAYER INTERACTION PROSPECTIVE RESULTS 2020-2022
Slide 24: Road to market IMMray PanCan-d
Road to market IMMray™ PanCan-d Main programs Target Key Customers Reimbursement in priority geographies Immunovia Dx Laboratories - Guidance Experts - Reference labs (EU/US) - Health Economic Studies - Cancer Centre Clinicians - Private/Public Insurance - Private/Public Centre Clinical Studies Prog
Slide 25: Global Collaboration With Pancreatic Cancer Patient Organizations
Global Collaboration With Pancreatic Cancer Patient Organizations Canada: Pancreatic Cancer Canada Sweden: Palema US: Nätverket mot cancer Lustgarten Foundation Norway: The Pancreatic Cancer Action Network Pancreaskreft Nettverk (PanCAN) Denmark: The World Pancreatic Cancer Coalition Pancreasnetværk
Slide 26: Road to market IMMray PanCan-d
Road to market IMMray™ PanCan-d Main programs Target Key Customers Reimbursement in priority geographies Immunovia Dx Laboratories - Guidance Experts - Reference labs (EU/US) - Health Economic Studies - Cancer Centre Clinicians - Private/Public Insurance - Private/Public Centre Clinical Studies Prog
Slide 27: Early Diagnosis Saves Lives
Primary Message Early Diagnosis Saves Lives Today 80% PDAC diagnosed in late When PDAC diagnosed in resectable stages stages IMMray™ PanCan-d test takes a snapshot of an individual’s immune response in the early stages of 5-year survival rate 5-9% pancreatic cancer when resection of 5-year survival
Slide 28: Early Detection Targets
Early Detection Targets IMMray™ PanCan-d Emergency New onset Surgeon Symptomatic CT positive diabetes, patients Gastroenterologist MRI / EUS positive 50+ years CT positive MRI / EUS positive MRI CT Scan CT positive GP / EUS CT positive MRI positive Follow up PCP EUS negative CT positive MRI negative
Slide 29: IMMray PanCan-d Virtual / Digital Launch Plan
IMMray™ PanCan-d Virtual / Digital Launch Plan Reaching PDAC risk groups and clinicians 1 6 Events 2 Livestream Launch and Launch Day Learn Event IMMray™ PanCan-d 5 Virtual/Digital 3 Launch Online Sales Tools Channels 4 Communication Advertising Online Launch Campaign 29
Slide 30: Virtual Walk Events
Virtual Walk Events 1 “Around The World For Awareness Of Pancreatic Cancer” Main Goal ‘Walking Together Around The World’ Will Bring Together Risk Group Individuals, Patients And Their Families To Raise Awareness Of Pancreatic Cancer and IMMray™ PanCan-d Launch In Q4 2020 Secondary Goals • Cover tog
Slide 31: Virtual Events
Virtual Events 1 Main Goal To Present The Results Of The Final Validation Studies For Clinicians To Make Them Aware About The Availability Of The Test Examples: • European Pancreatic Club gone digital: 2 July 2020, Immunovia E-Symposium presentation about latest results and Q4 2020 launch • Pri-Med
Slide 32: Virtual Launch and Learn
Virtual Launch and Learn 2 Main Goal To create sales leads at targeted priority hospitals Concept: • KOL presentations • Recorded content, Q&A live • Start Q3 and continue for 12-18 months 32
Slide 33: Digital Communication
Digital Communication 3 Main Goal To Create Awareness About The Availability Of IMMray™ PanCan-d Communication Tool Target Audience Gastro Clinicians, Surgeons, Primary Care Doctors, Podcasts/Interviews Genetic Counsellors, Patients And Their Families Online TV And Radio Patients And Their Families
Slide 34: Advertising Campaign
Advertising Campaign 4 Awareness of launch Q4 2020 Main Goal To create awareness about the availability of IMMray PanCan-d for all target groups Concept • What does early detection mean for you? • Start Sept until launch in US and Europe • In collaboration with patients, their families and clinician
Slide 35: Digital Sales Tools
Digital Sales Tools 5 Main Goal To educate sales team with digital tools and how to use digital tools Concept: • Virtual sales training • Virtual selling educational program • Virtual sales tools • E- Marketing collaterals • Customer engagement tracking 35
Slide 36: Launch Day
Launch Day 6 Live Stream Digital Launch Event Main Goal To create awareness about the availability of IMMray PanCan-d for all target groups Concept: • Launch E-conference on the launch date, in Q4 2020, • Talks and interviews from: • Survivors/patient org representative • KOLs • Immunovia 36
Slide 37: Road to Market IMMray PanCan-d
Road to Market IMMray™ PanCan-d Main programs Target Key Customers Reimbursement in priority geographies Immunovia Dx Laboratories - Guidance Experts - Reference labs (EU/US) - Health Economic Studies - Cancer Centre Clinicians - Private/Public Insurance - Private/Public Centre Clinical Studies Prog
Slide 38: Launch and Commercialization Countries
Launch and Commercialization Countries IMMray™ PanCan-d 1st Wave US Commercialization 2nd Wave Europe Commercialization Sweden/Nordic UK Spain / Italy DACH Benelux France Canada Countries with prospective site centers, PanFAM, PanSYM, PanDIA, familial pancreatic screening programs, diagnostic/GI cen
Slide 39: Road to Market IMMray PanCan-d
Road to Market IMMray™ PanCan-d Main programs Target Key Customers Reimbursement in priority geographies Immunovia Dx Laboratories - Reference labs (EU/US) - Guidance Experts - Cancer Centre Clinicians - Health Economic Studies - Private/Public Centre - Private/Public Insurance Clinicians Clinical S
Slide 40: Road to Market Sales Strategy
Road to Market Sales Strategy Michael Pettigrew Senior VP Sales North America 40
Slide 41: Michael Pettigrew
Michael Pettigrew Immunovia Senior Vice President Sales Mr. Pettigrew brings over 30 years of experience and has focused his extensive global expertise in the management of marketing & sales, business and strategic account development, licensing, mergers & acquisition, and commercial technology plat
Slide 42: Sales Focus by Clinical Specialty
Sales Focus by Clinical Specialty Emergency New onset Surgeon Symptomatic CT positive diabetes, patients Gastroenterologist MRI / EUS positive 50+ years CT positive MRI / EUS positive MRI CT Scan CT positive GP / EUS CT positive MRI positive Follow up PCP EUS negative CT positive MRI negative Follow
Slide 43: Sales Implementation Strategy
Sales Implementation Strategy By Geography Territory 1 • Gastroenterologists = 1458 • 68 Multidisciplinary GI centers • Genetic Counselor = 154 Territory 2 • Gastroenterologists = 2698 1 • 135 Multidisciplinary GI centers • Genetic Counselor = 160 2 Territory 3 • Gastroenterologist = 2069 • 147 Mult
Slide 44: Sales Implementation By Pancreatic Cancer Center
Sales Implementation By Pancreatic Cancer Center National Pancreas Foundation Accredited Center Pancreatic Cancer Center 44
Slide 45: Sales Implementation by Priority Hospitals
Sales Implementation by Priority 1 Hospitals Dartmouth-Hitchcock Medical Center NH University of Vermont Medical Center VT Maine Medical Center ME RI Hospital, The Miriam Hospital, Newport Hospital RI Beth Israel Deaconess Medical Center MA 1 Brigham and Women’s Hospital / Dana Farber Cancer Inst Ma
Slide 46: Target Customers Mass General Hospital
Target Customers Mass General Hospital Targeting Will Be Key Total Accessible Market (Massachusetts General Hospital) Endocrinology, Diabetes and Metabolism 31 Focus on Following: Family Medicine / General Practice 65 • Pancreatic Specialists Gastroenterology 11 • Pancreatic Surgeons General Surgery
Slide 47: Pancreatic Specialists Mass General
Pancreatic Specialists Mass General Pancreatic Specialists (Massachusetts General Hospital) Disorders of The Biliary and Pancreas 1 Endocrine Pancreas 1 ERCP (Endoscopic Retrograde Cholangiopancreatography) 1 Familial Pancreatic Cancer 1 Approximately 30 Pancreatic Liver and Pancreatic Disorders 1 S
Slide 48: Sales Organization
Sales Organization Next Steps FIELD SALES REPRESENTATIVES Customer Relationship Management System INSIDE SALES SUPPORT 48
Slide 49: Sales Expansion Principles
Sales Expansion Principles Based On Population PDAC Incidence Age Distribution Step 3 Step 3 Step 1 9 1 10 2 Based on: 7 Population 5 PDAC incidence 11 3 Age distribution 6 8 4 Step 1 Step 1 Step 3 Step 2 Step 2 Step 2 49
Slide 50: Insight From The Clinical Perspectives
Road to Market Insight From The Clinical Perspectives Dr. Thomas King Medical Director 50
Slide 51: Road to Market IMMray PanCan-d
Road to Market IMMray™ PanCan-d Main programs Target Key Customers Reimbursement in priority geographies Immunovia Dx Laboratories - Guidance Experts - Reference labs (EU/US) - Health Economic Studies - Cancer Centre Clinicians - Private/Public Insurance - Private/Public Centre Clinical Studies Prog
Slide 52: Thomas King, MD, PhD
Thomas King, MD, PhD Immunovia US Laboratory Medical Director Board certified Pathologist with Ph.D. in Molecular Biology and extensive experience as a laboratory director in hospital, academic and corporate settings. MD and PhD, Washington University 1984 Fellow and Inspector, College of American P
Slide 53: Process for CLIA Registration and Accreditation (CAP)
Process for CLIA Registration and Accreditation (CAP) IMMray™ PanCan-d Q4 2020 Sales Start Fit Out Lab Develop & Approve Train Personnel and Verify Apply for MA Accreditation • Equipment Procedures/Methods or Validate Test Method State License by CAP • Personnel • Use of Equipment • Document trainin
Slide 54: Virtual Tour of Immunovia Dx Lab Marlborough USA
Virtual Tour of Immunovia Dx Lab Marlborough USA and IMMray™ PanCan-d Test 54
Slide 55: Summary
Summary Immunovias vision is to dominate the pancreatic cancer diagnostics market • First to a 4 BUSD Market • Well Financed Commercial Rollout • Target a Long Term 30% Marketshare 55
Slide 56: Q&A
Q&A
Slide 57: Process Overview for Lung Cancer Program
Process Overview for Lung Cancer Program Discovery Studies Development Studies to Market Introduction Commercialization Product launch Validation Study Locked signature and algorithms on blinded samples 05 Verification Study KOL Network & Fresh Blood 08 Locked signature and algorithms on known Sampl
Slide 58: Q&A
Q&A
Slide 59: Immunovia Virtual Walk
Immunovia Virtual Walk Let’s Walk, Together, Around The Globe To Raise Awareness For Pancreatic Cancer Interested? Please send us an email at virtualwalk@immunovia.com Registration opens 19 July 2020 59
Slide 60: Summary
Summary Immunovias vision is to dominate the pancreatic cancer diagnostics market • First to a 4 BUSD Market • Well Financed Commercial Rollout • Target a Long Term 30% Market Share 60
Slide 61: Thank you!
Thank you! Julie Silber Director of Investor Relations Immunovia AB Mobile: +46(0)79 3486277 julie.silber@immunovia.com www.immunovia.com