Biovica International Ab Class B · OMXSTO:BIOVIC_B
Biovica International Ab Class B — Investor Day (May 2022)
80 slides from Biovica International Ab Class B's investor day presentation, May 17, 2022
Slide 1: Treatment Decisions With Greater Confidence – Capital Markets Day
Treatment Decisions With Greater Confidence Capital Markets Day 2022-05-17 1
Slide 2: Forward Looking-Statements Disclaimer
Forward Looking-Statements Disclaimer The Investor Presentation may contain certain statements that are forward-looking. These statements may refer in particular to the Company’s business strategies, its expansion and growth of operations, future events, trends or objectives and expectations, which
Slide 3: Agenda Capital Markets Day
Agenda Capital Markets Day • Company Overview Anders • US Go-to-Market plan Warren • US Sales strategy Kendon • Biovica CLIA Lab Dan • Scientific update Amy • Pharma Collaborations Henrik • Q&A session Charlotte 3
Slide 4: Company Overview
Treatment Decisions With Greater Confidence Company Overview Anders Rylander 4
Slide 5: Agenda
Agenda 1. Company & Product Overview 2. Clinical Evidence & Collaborations 3. Market & Go-To Market Strategy 4. Team 5 5
Slide 6: About the Presenter
About the Presenter Anders Rylander, CEO & Board Member • CEO & main shareholder in Biovica • Co-founder of Axholmen Management Consulting • CTO at ICA AB • Senior Manager at Accenture 6
Slide 7: Biovica Overview
Biovica Overview • Founded 2009, based on research performed at Uppsala University • IPO 2017, traded on Nasdaq First North Premier • HQ in Uppsala, lab in San Diego • Regulatory: ISO 13485 certified and DiviTum® TKa CE labeled • FDA 510(k) submission Q3 2020 7
Slide 8: DiviTum TKa Provides Early Response Indicator of Treatment Effectiveness
DiviTum®TKa Provides Early Response Indicator of the Effectiveness of Treatment For Cancer Patients Imaging DiviTum®TKa diagnostics + Months DiviTum®TKa measures cell proliferation rate for faster evaluation of cancer treatment efficacy. References: http://biovica.com/technology/publications/ 8
Slide 9: Strong Clinical Results and Data for DiviTum TKa
Strong Clinical Results and Data for DiviTum®TKa Peer- Reviewed & Published in Clinical Oncology Journals Cancer area Patients No of Studies • 24 published and peer-reviewed articles with DiviTum®TKa Breast Cancer 1,293 13 Gastrointestinal 713 4 • Summary of results from articles: Lung Cancer 281 2
Slide 10: DiviTum TKa – Key Commercialization Activities
DiviTum®TKa – Key Commercialization Activities PRODUCT DEVELOPMENT CLINICAL DEVELOPMENT REGULATORY PATHWAY CLINICAL USAGE & UPTAKE GUIDELINES & REIMBURSEMENT COMMERCIAL PARTNERING MARKET ACCESS/LAUNCH 10
Slide 11: Geographical Roll-out Plan & Market Potential in Metastatic Breast Cancer
Geographical Roll-out Plan & Market Potential for DiviTum®TKa in Metastatic Breast Cancer 1. US LAUNCH CLINICAL USAGE & UPTAKE Market potential: 200-350 mUSD TOTAL MARKET POTENTIAL 2. EU-5 & NORDICS CLINICAL USAGE & UPTAKE 400-700 Market potential: 150-250 mUSD mUSD 3. JAPAN CLINICAL USAGE & UPTAKE
Slide 12: FDA 510(k) Application
FDA 510(k) Application • FDA 510(k) submission Q3 2020 • Positive interactive process with FDA, feedback in February • Updated application, addressing all raised questions, was submitted on the 28th of April • Next step, MDUFA decision Source: https://www.fda.gov/medical-devices/premarket-notificati
Slide 13: Budget Impact Model Results
Budget Impact Model Results: Addition of DiviTum®TKa to Care Would Lead to Net Savings of 3x the Spend • Other monitoring costs: Reduced by Scenario 1: decrease in CT scans, bone scans Changes to monitoring only • 1st line therapy: Reduced usage of CDK 4/6 inhibitors • 2nd line and beyond: small inc
Slide 14: Biovica Commercial Roadmap
Legend Biovica Commercial Roadmap 15% of market potential 50% of market potential MARKET POTENTIAL BREAST CANCER LAUNCHc BUILD REVENUES REALIZE POTENTIAL LAUNCHc BUILD REVENUES REALIZE POTENTIAL 400-700 LAUNCHc BUILD REVENUES REALIZE POTENTIAL METASTATIC mUSD/y LAUNCHc BUILD REVENUES REALIZE POTENTI
Slide 15: Management Team & Key Personnel
Management Team & Key Personnel Anders Rylander Cecilia Driving Helle Fisker CEO EVP CFO VP Commercial Europe Holdings: 3,575,640 A-shares, Holdings: 20,000 B-shares, Holdings: 20.000 warrants 379,756 B-shares, 90,000 warrants 65,000 warrants Tomas Andersson Joakim Arwidson Henrik Winther, Ph.D. VP
Slide 16: Board of Directors
Board of Directors Lars Holmqvist Annika Carlsson Berg Chairman Board Member Holdings: 534,536 B-shares, Holdings: 50,000 warrants 100,000 warrants Maria Holmlund Henrik Osvald Board Member Board Member Holdings: 9,750 B-shares, Holdings: 624,106 B-shares, 75,000 warrants 50,000 warrants Jesper Söde
Slide 17: US Go-To Market Plan
Treatment Decisions With Greater Confidence US Go-To Market Plan Warren Cresswell 17
Slide 18: Agenda
Agenda 1. Go-to-Market Strategy 2. Critical Success Factors 3. Our Immediate Focus 18 18
Slide 19: About the Presenter
About the Presenter Warren Cresswell, President of the Americas • 25-years of Diagnostic Experience in Medical Device (IVD 510(k) & PMA), CLIA Lab (LDT), and Pharma • Built Dx Orgs, Developed & Launched High Value Multi-Analyte Algorithm Based Dx Assays, and Implemented Effective Reimbursement Strat
Slide 20: US Healthcare Market Entry
US Healthcare Market Entry • DiviTum® TKA addresses a significant unmet medical need • Our go-to-market strategy is well though out, executable and aligns with the most successful high value diagnostic companies in the US • Our US team is highly experienced in launching novel, high value diagnostic
Slide 21: US Go-to-Market Strategic Options
US Go-to-Market Strategic Options Direct Sales to Distributor Model Clinical Labs CLIA Lab Model Requires FDA cleared IVD via Requires FDA cleared IVD via FDA clearance or LDT (no label 510k or PMA, restrictive 510k or PMA, restrictive restrictions), immediate market labeling labeling entry Market t
Slide 22: Successful High Value Dx Companies Follow the CLIA Lab Strategy
Successful High Value Dx Companies Follow the CLIA Lab Go-To-Market Strategy Managing critical success factors position the company for long-term sustainable growth. Key critical success factors include: 1. Stakeholder Relationships - patient, physician and payer 2. Reimbursement – insurance coverag
Slide 23: CLIA Lab Enables Ownership of Stakeholder Relationships
CLIA Lab Enables Ownership of Stakeholder Relationships Physicians HCPs Understand how the treater is using DiviTum®TKa How many and how often patients are being tested Patients Clinical decisions being made based on test results Who is using DiviTum®TKa Testing occurrence Test results
Slide 24: CLIA Lab Enables Management of Reimbursement
CLIA Lab Enables Management of Reimbursement Public Insurance Hospitals & General Reference Labs Separate Reimbursement Channels Private Insurance Patients 24
Slide 25: CLIA Lab Enables Expanded Access to Use DiviTum TKa
CLIA Lab Enables Expanded Access to Use DiviTum®TKa • A CLIA lab enables Patient Access to DiviTum®TKa anywhere in the US • Samples will be sent to San Diego via next day air • Test results provided within 24 hours after sample acquisition 25
Slide 26: CLIA Lab Enables the Creation of a Sample Biobank
CLIA Lab Enables the Creation of a Sample Biobank • Patient samples will be collected with consent • Samples will be further analyzed and the data interrogated • Accelerates our product pipeline opportunities • Biobank is an asset that continues to mature over time 26
Slide 27: CLIA Lab Enables Data Development & Mining
CLIA Lab Enables Data Development & Mining • Data creation will happen quickly once DiviTum®TKa is launched • Data will drive: o Product positioning o Product development o Lifecycle management o Publications o Clinical dossier o Other applications 27
Slide 28: The CLIA Lab Model Enables Management of the Entire Business Process
The CLIA Lab Model Enables Management of the Entire Business Process 28
Slide 29: Our Immediate Focus
Our Immediate Focus Kendon Richards Dan Kiser Amy Williams Sales CLIA Clinical Certification Development Marketing Demand CAP Clinical Data & Managed Operations Accreditation Generation Reimbursement Care Market Access Receive, Test & Result Market Access Medical Affairs Highly experienced candidate
Slide 30: US Sales Plan
Treatment Decisions With Greater Confidence US Sales Plan Kendon Richards 30
Slide 31: Agenda
Agenda 1. Specialty Dx Selling Process 2. Establishment of Specimen Channels 3. Reimbursement Pathways 4. Sales Organization Staffing 5. Physician Targeting 31 31
Slide 32: About the Presenter
About the Presenter Kendon Richards, Executive Director of Sales • 25+ years of Pharmaceutical and Specialty Diagnostic Experience • Built Pharma and Dx Sales Orgs, Successfully launched 15 products (8 in the Specialty Dx space), Led Salesforce Integration and Implementation of Effective Reimburseme
Slide 33: Selling Process for Dx Specialty Products
Selling Process for Dx Specialty Products Leverage demand to Create awareness / interest expand coverage 06 01 Drive product demand Dx Obtain prescriber advocacy 05 Selling 02 Process 04 03 Manage specimen path / Establish ordering channels logistical hurdles • Specimen handling pathways • Contracte
Slide 34: Dx Specialty Products Selling Process
Dx Specialty Products Selling Process • HCPs use a variety of routes to have blood drawn • HCPs in the same office may prefer different specimen channels or have access to different channels • Insurance coverage and in-network privileges at local Hospitals / IDN’s influence a prescriber's access to
Slide 35: Specimen Access Channels
Specimen Access Channels Establish channels for specimens to be routed to the Biovica CLIA Lab • Partner with in-office phlebotomists • Contract with Hospitals / IDNs • Specimen handling agreements • Contracting / Lab pricing agreements • Routing specimens through General Reference laboratories • Sp
Slide 36: Key Pathways for DiviTum TKa Reimbursement
3 Key Pathways for DiviTum®TKa Reimbursement Patient out-of-pocket costs can vary from office to office and patient to patient. • Reasonable patient out of pocket cost for self-pay • Biovica to submit insurance claim Patient • Patient financial assistance ‘safety net’ Self-Pay is slide $ Reimburseme
Slide 37: Sales Structure
Sales Structure • Well balanced Regions constructed to optimize efficiencies and drive sales • Strategically segment/target customers; allocate call capacity against HIGHEST potential customers Right Customer Right Message Right Frequency 37
Slide 38: Building a World Class Dx Sales Team
Building a World Class Dx Sales Team Hiring the Right People Using Extensive Network Highly experienced Track record of Existing relationships specialty Dx sales establishing specimen contracting with key professionals channels hospital systems/IDNs Proven history of Expertise in working successfull
Slide 39: Targeting HCPs With Highest Potential to Order DiviTum TKa
Targeting HCPs With The HIGHEST Potential To Order DiviTum®TKa In Areas Where Business Will Be Accessible Influential Oncology Oncologists who are Key Opinion Leaders high volume treaters of metastatic breast cancer NCI & NCCN Areas where sample Cancer access channels can be Centers established, cos
Slide 40: US CLIA LAB
Treatment Decisions With Greater Confidence US CLIA LAB Dan Kiser 40
Slide 41: Agenda
Agenda U.S. Commercial Lab for DiviTum®TKa 1. Staff 2. Regulatory 3. Quality 4. Operations 41 41
Slide 42: About the Presenter
About the Presenter Dan Kiser, Quality, Regulatory & Lab Operations • 25-years Regulatory & Operations in CLIA, IVD, Medical Device & Pharma • Certified ISO Lead Auditor and Six- sigma Black Belt 42
Slide 43: Key Lab Personnel
Key Lab Personnel Curtis McGuyer, MD, Laboratory Director • Board-certified in anatomic and clinical pathology, as well as cytopathology • CAP Regional Commissioner for Laboratory Accreditation CMS Region 10 43
Slide 44: Regulatory Overview
Regulatory Overview Commercial Laboratory • CLIA Certificate of Registration – Allows nonwaived (high complexity) testing until the laboratory is surveyed or accredited • CAP Accreditation • CLIA Certificate of Accreditation (COA) • New York State Clinical Laboratory Evaluation Program • Washington
Slide 45: Laboratory Quality
Laboratory Quality Quality System • Laboratory Quality Management Plan & Safety Manual • HIPAA Compliance • Material & Equipment Controls • Process Validation (Sample Collection, Prep, Testing, & Reporting) • Retained Samples (Biobank) Operational Excellence • Test Results to the ordering physician
Slide 46: Lab Facility Operations
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Slide 47: US Operations Milestones
US Operations Milestones CLIA Lab application Executed lab facility / & certification Scale organization & property lease in process launch DiviTum®TKa San Diego, California 17 May 2022 Researched CLIA Lab space Hired key people for FDA 510 clearance options Commercial and Operational readiness 47
Slide 48: Clinical Evidence & Collaborations
Treatment Decisions With Greater Confidence Clinical Evidence & Collaborations Amy Williams 48
Slide 49: Agenda
Agenda DiviTum®TKa Clinical Development Update 1. New DiviTum®TKa clinical data from 2021/22 2. Expansion of clinical utility for DiviTum®TKa based on new data 3. US Scientific Advisory Board feedback 4. Upcoming ASCO presentation: DiviTum®TKa versus ctDNA 49 49
Slide 50: About the Presenter
About the Presenter Amy Williams, PhD, Head of Clinical Development and Medical Affairs • PhD in Pathology from Boston University School of Medicine • 20+ years of experience in oncology drug development – from discovery through launch and beyond • Most recent experience with Novartis Oncology, Brea
Slide 51: Key Clinical Development Personnel
Key Clinical Development Personnel Mattias Bergqvist, Clinical Development Director • 10 years at Biovica as Clinical Development Director • 15 years at AstraZeneca, Therapy Area Director Oncology Nordics, Global Brand Manager Breast Cancer • Responsible for directing ex-US clinical trial program 51
Slide 52: New DiviTum TKa Clinical Data
New DiviTum®TKa Clinical Data • Key clinical trial readouts in 2021-22 provided meaningful data that strengthened the unique value proposition for DiviTum®TKa 52 52
Slide 53: New DiviTum TKa Clinical Data
New DiviTum®TKa Clinical Data • Key clinical trial readouts in 2021-22 provided meaningful data that strengthened the unique value proposition for DiviTum®TKa BioItaLEE Study ESMO September 2021 53 53
Slide 54: CDK4/6 Inhibitors in Breast Cancer
CDK4/6 Inhibitors in Breast Cancer • Almost ALL HR+ mBC patients will be prescribed a CDK4/6 inhibitor at some point during their course of therapy • If given in the first line metastatic setting, most patients will remain on a CDK4/6i based therapy for 2- 3+ years • Other than ER/PR positivity, the
Slide 55: BioItaLEE Data Shows Distinct TKa Patterns
BioItaLEE Data Shows 3 Distinct TKa Patterns • 287 HR+ Her2- mBC patients PATTERN 1 (n=62) PATTERN 2 (n=135) PATTERN 3 (n=37) TKa<LOD atC1D15 and at C2D1 TKa<LOD at C1D15 and >LOD at C2D1 TKa>LOD at C1D15 • 1st line therapy with ribociclib + letrozole • TKa analyzed at BL, C1D15, C2D1, the on-treatm
Slide 56: TKa Patterns Correlate with Patient Outcome
TKa Patterns Correlate with Patient Outcome Pattern 1: TKa <LOD at D15 and C2D1 Pattern 2: TKa <LOD at D15 and >LOD at C2D1 Pattern 3: TKa >LOD at D15 and C2D1 56 Biovica Confidential Malorni et al, ESMO 2021 poster 292P
Slide 57: Consistent TKa Patterns Observed Across CDK4/6 Inhibitor Trials
Consistent TKa Patterns Observed Across CDK4/6 Inhibitor Trials BioItaLEE (n=287) PYTHIA (n=108) NeoPalAna (n=43) % BELOW LOD on C1D15 85% 83% 86% NO REBOUND on D28 31% 45% 32% REBOUND on D28 69% 55% 68% SAMPLE TIMEPOINT BL D15 D28 Palbo/Ribo OFF ON OFF TREATMENT TREATMENT TREATMENT OFF ET ON C1D1 C
Slide 58: Cycle 1 TKa Dynamics Predict Tumor Response and Patient Benefit
Cycle 1 TKa Dynamics Predict Tumor Response and Patient Benefit to CDK4/6 Inhibitor Based Therapy 3 LEVELS of CELL DURATION OF PATIENT 3 TKa PATTERNS CYCLE ARREST THERAPY OUTCOME 120 INCOMPLETE SHORT POOR 100 80 TRANSIENT MEDIUM GOOD 60 40 20 DURABLE LONG BEST 0 BASELINE DAY 15 DAY 28 ENDOCRINE THER
Slide 59: Utility of DiviTum-TKa in Clinical Practice
Utility of DiviTum-TKa in Clinical Practice Prediction of CDK4/6i response based on cycle 1 TKa pattern CDK4/6i CYCLE 1 Confirm medication compliance TKa PATTERNS Earlier tumor mutation profiling 120 More vigilant monitoring 100 80 Consider switching ET partner 60 Consider switching CDK4/6 drug 40 I
Slide 60: TK-IMPACT Study (currently enrolling)
TK-IMPACT Study (currently enrolling) First study in the US where DiviTum®TKa is being used by oncologists in “real-time” Pre-treatment Every 2 weeks for first 2 months Monthly for next 5 cycles Every 3 months and at time of imaging Initiation of CYCLE 1 CYCLE 2 CYCLE 3 CYCLE 4 CYLCE 5 CYCLE 6 CYL
Slide 61: Scientific Advisory Boards (USA)
Scientific Advisory Boards (USA) 61
Slide 62: Advisory Board Feedback
Advisory Board Feedback • Positive reaction to the new TKa data in CDK4/6 inhibitor treated patients and potential clinical utilities • “Ideas are on target” • “Biovica has the right focus” • “Game changing” • “Potential is huge” • New opportunities identified • New collaborations being discussed/ev
Slide 63: Exciting New Utility for DiviTum TKa
Exciting New Utility for DiviTum®TKa • New data has revealed a novel use for DiviTum®TKa • New patent has been filed • TKa values would identify patients who are likely to respond to a specific class of cancer therapy • Very large market • Addresses an unmet need 63 63
Slide 64: DiviTum TKa and ctDNA Data Comparison from BioItaLEE Trial
• DiviTum®TKa and ctDNA data comparison from BioItaLEE trial • Oral presentation will highlight key similarities and differences - June 6th 6:18PM EDT 64
Slide 65: Pharma Collaborations
Treatment Decisions With Greater Confidence Pharma Collaborations Henrik Winther 65
Slide 66: Agenda
Agenda 1. Biovica’s Pharma-collaboration Strategy 2. Current Status of our Pharma- collaborations 3. Financial Impact and Expectations - for the Biovica/Pharma- collaborations 66 66
Slide 67: About the Presenter
About the Presenter Henrik Winther, DVM, PhD • SVP Business Development & Pharma Collaborations • 20+ years in the in vitro diagnostic (IVD) society bringing biomarker assays into the clinical routine market and with managing roles within R&D and BD. • Special passion and general manager roles withi
Slide 68: Two-Staged CDx and MDx Strategy
Biovica’s Two-Staged Companion Diagnostic (CDx) and Monitoring Diagnostic (MDx) Strategy • Stage 1: • Building Trust: The Biovica CDx/MDx business operates as a FFS* R&D partner to Oncology Pharma, offering DiviTum®TKa as a RUO collaborative tool for pre-clinical and phase I/II pharma studies during
Slide 69: Types of Pharma Services/Collaborations
Types of Pharma Services/Collaborations Currently: Research Use Only (RUO) • Planning/guidance of TKa testing in pharma studies/trials • Actual TKa testing of pharma samples • Biovica Labs (Uppsala & San Diego) • Mayo Clinic ICC • UCR Uppsala • Evaluation of TKa test results related to outcome data
Slide 70: TKa Has Demonstrated Convincing Clinical Data as a CDx/MDx-Tool
TKa Has Demonstrated Convincing Clinical Data as a CDx/MDx-Tool 70
Slide 71: SWOG Results: DiviTum TKa Can Predict/Select Patients
SWOG Results: DiviTum®TKa Can Predict/Select Which Patients Will Benefit From Combination Therapy 71
Slide 72: TKa Has Demonstrated Convincing Clinical Data as a CDx/MDx-Tool
TKa Has Demonstrated Convincing Clinical Data as a CDx/MDx-Tool 72
Slide 73: Pharma Have Identified TKa as a Highly Relevant Tool
Pharma Have Identified TKa as a Highly Relevant Tool for the Development of Cell Proliferation Inhibitor Drugs Pharma-partner Indication(s) Drug (Rx) Rx Study Phase Agreement 1. TIER-22 pharma (EU) mBC (HR+, HER2÷). CDK-inhibitor. Phase IIa. TESA3 Patients resistant to CDK4/6i Phase IIb. treatment.
Slide 74: Timeline Considerations for Biovica/Pharma Business Development
Timeline Considerations for the Biovica/Pharma Business Development Plan/Expectations - 6 TESA’s - 3 TESA’s - 4 MSA signed - 1 MSA discussion initiated - 2 Large pharma companies - 3 Mid-sized pharma companies - 6 Mid-sized pharma companies - 3 projects initiated - 10 projects initiated FY 2021/2022
Slide 75: CDx/MDx Revenue Potential By Strategy
CDx/MDx Revenue Potential By Strategy Stage 1: FFS R & D Collaborations Stage 2: True CDx/MDx Development Technical CDx Development & CDx Com- Master Service Research Evaluation Service Registration mercialization Agreement Agreement Agreement Agreement Agreement (MSA) (RA) (DRA) (TESA) (CA) Pharma
Slide 76: Product Sales During Stage 2 Will Significantly Increase CDx Revenue
Product Sales Occurring During Stage 2 Will Significantly Increase the CDx Revenue Key Assumptions M SEK • ~10% RUO projects turn into CDx products • ~20-30% of CDx projects turn into CDx products • ~4Y for CDx product development • ~1,5 Y for Add-on indications Business Model • RUO & CDx Dev projec
Slide 77: Summary & Milestones
Treatment Decisions With Greater Confidence Summary & Milestones Anders Rylander 77
Slide 78: Summary & Milestones
Summary & Milestones • DiviTum®TKa addresses an important clinical unmet need within metastatic cancer. • DiviTum®TKa comes with strong clinical data • DiviTum®TKa is supported by cancer KOL’s and scientific collaborators globally, constituting a strong foundation for the commercialization process.
Slide 79: Q&A
Treatment Decisions With Greater Confidence Q&A Charlotte Stjerngren 79
Slide 80: Thank You!
Thank You! 80