Biovica International Ab Class B · OMXSTO:BIOVIC_B
Biovica International Ab Class B — Investor Presentation (August 2020)
45 slides from Biovica International Ab Class B's investor presentation, August 2020
Slide 1: Company Presentation August 2020
COMPANY PRESENTATION AUGUST 2020 1
Slide 2: Forward Looking Statement
FORWARD LOOKING STATEMENT The Information contains forward-looking statements. All statements other than statements of historical fact included in the Information are forward- looking statements. Forward-looking statements give the Company’s current expectations and projections relating to its finan
Slide 3: Company Snapshot
COMPANY SNAPSHOT DiviTum® – blood-based biomarker assay for measuring cancer cell proliferation - Prognosis and treatment response monitoring in breast and other cancers - Purpose is to enable better patient outcomes and improved health economics Extensive clinical validation in collaboration world
Slide 4: Upcoming News Flow
UPCOMING NEWS FLOW Q1 – CLINICAL CANCER RESEARCH PUBLISHES RESULTS SUPPORTING DiviTum® AS A TECHNOLOGY FOR EARLY EVALUATION OF METASTATIC BREAST CANCER TREATMENT Q1 – POSITIVE RESULTS FROM SWEDISH STUDY WITH DiviTum® IN METASTATIC BREAST CANCER PUBLISHED IN PRESTIGIOUS JOURNAL 2020 Q2 – COLLABORATIO
Slide 5: Agenda
AGENDA Innovative & proprietary diagnostic technology with clear value proposition Strong clinical evidence for DiviTum® Market potential & pathway towards commercialization Summary Appendix 5
Slide 6: Unmet Needs in Metastatic Breast Cancer
UNMET NEEDS IN METASTATIC BREAST CANCER • Many treatment options • Efficacy evaluation • Treatment resistance • Time consuming diagnostics 6
Slide 7: Unmet Need & Potential Value of DiviTum Confirmed by Editorial Articles
UNMET NEED & POTENTIAL VALUE OF DiviTum® IN CLINICAL PRACTICE CONFIRMED BY EDITORIAL ARTICLES IN MAY 2020 The broad applicability of TK1 as a marker of prognosis and early resistance to a uniform regimen may represent an appealing clinical and research tool that can be generalized to a large populat
Slide 8: DiviTum – Treatment Decisions with Greater Confidence
DiviTum® – TREATMENT DECISIONS WITH GREATER CONFIDENCE DiviTum® may enable determination of the efficacy of cancer therapy A regular measure of cell proliferation may detect changes early DiviTum® may determine treatment response in 2-4 weeks; imaging, 2-4 months1,2 DiviTum® measures cell growth rat
Slide 9: Agenda
AGENDA Innovative & proprietary diagnostic technology with clear value proposition Strong clinical evidence for DiviTum® Market potential & pathway towards commercialization Summary Appendix 9
Slide 10: Strong Clinical Study Results for DiviTum Peer-Reviewed & Published
STRONG CLINICAL STUDY RESULTS FOR DiviTum® PEER-REVIEWED & PUBLISHED IN ONCOLOGY JOURNALS No of Cancer area Patients Publications • 22 published and peer-reviewed articles with DiviTum® Breast Cancer 1,065 11 • Summary of results from articles: Gastrointestinal 713 4 – Prognostic: risk for cancer Lu
Slide 11: DiviTum – Extensive Breast Cancer Study Programme
DiviTum® – EXTENSIVE BREAST CANCER STUDY PROGRAMME Screening Early breast cancer Locally advanced Metastasized breast cancer High risk Stage I-II Stage III Stage IV BRCA, 2013 Prognostic, 2010 TEX, Prognostic, 2013 CDK neoadjuvant, 2017 ET, Prog & Mon 2018 Operable BC, SABCS 2019 EFECT, ET, P & M 20
Slide 12: SWOG's S 0226 Study – Basis for Regulatory Clinical Validation
SWOG’S S 0226 STUDY – THE BASIS FOR DiviTum®’s REGULATORY CLINICAL VALIDATION & USAGE S 0226: Randomized Phase III study in postmenopausal women with metastatic breast cancer treated with 1st line endocrine therapies • 707 patients in the US & Canada • DiviTum study: ~400 patients with blood samples
Slide 13: Broad Key Opinion Leader Support
BROAD KEY OPINION LEADER SUPPORT – KEY TO CLINICAL ACCEPTANCE Matthew P. Goetz Daniel F. Hayes Angelo Di Leo Martine J. Piccart M.D M.D, Professor M.D, Ph.D M.D, Professor Mayo Clinic University of Michigan Hospital of Prato Université Libre de Bruxelles Ex. ASCO President IBCSG Exec. Committee Foun
Slide 14: Agenda
AGENDA Innovative & proprietary diagnostic technology with clear value proposition Strong clinical evidence for DiviTum® Market potential & pathway towards commercialization Summary Appendix 14
Slide 15: DiviTum – Commercialization Process in Metastatic Breast Cancer
DiviTum® – COMMERCIALIZATION PROCESS IN METASTATIC BREAST CANCER PRODUCT DEVELOPMENT CLINICAL DEVELOPMENT REGULATORY PATHWAY CLINICAL USAGE & UPTAKE GUIDELINES & REIMBURSEMENT COMMERCIAL PARTNERING MARKET ACCESS/LAUNCH 15
Slide 16: Geographical Roll-out Plan & Market Potential for DiviTum
GEOGRAPHICAL ROLL-OUT PLAN & MARKET POTENTIAL FOR DiviTum® IN METASTATIC BREAST CANCER 1. US LAUNCH CLINICAL USAGE & UPTAKE Market potential: 200-350 mUSD TOTAL MARKET POTENIAL 2. EU-5 & NORDICS CLINICAL USAGE & UPTAKE 400-700 Market potential: 150-250 mUSD mUSD 3. JAPAN CLINICAL USAGE & UPTAKE Mark
Slide 17: Need for Early, Accurate Insight into Cancer Treatment Effect
THERE IS A NEED FOR EARLY, ACCURATE INSIGHT INTO THE EFFECT OF A CANCER TREATMENT – DiviTum® MAY PROVIDE THAT INSIGHT • Assessment of disease progression is cumbersome and repetitive: opportunity to simplify and reduce • Confidence and speed in therapy decision based on timely response monitoring. •
Slide 18: Metastatic Breast Cancer Epidemiology/Needs in the US
METASTATIC BREAST CANCER EPIDEMIOLOGY/NEEDS IN THE US 57,000 NEW ARRIVALS AT METASTATIC BREAST CANCER (16,000 NEW DX, 41,000 RECURRENCES) 34,000 WITH DISEASE SUITABLE FOR ENDOCRINE-BASED THERAPIES (ET) 31,000 ARE POST-MENOPAUSAL (WITHIN SCOPE OF EXPECTED LABEL) 1st ET Median treatment 2nd ET Median
Slide 19: The Median Patient & How Treatment Is Currently Monitored
THE MEDIAN PATIENT & HOW TREATMENT IS CURRENTLY MONITORED MEDIAN PATIENT PROFILE HOW TREATMENT IS CURRENTLY MONITORED • Female, mid 60s Complete blood CT Physical exam • HR+ Metastatic breast cancer • Recurrence from an early stage cancer Liver function tests Symptoms CT scans • Health status: gener
Slide 20: US Market Commercialization Timeline 2020-2021
US Market Commercialization timeline 2020-2021 Q3 Q4 Q1 Q2 Q3 Q4 Analytical & Regulatory pathway clinical validation SALES START Pivotal clinical study, other study results Key scientific events Digital/virtual activities Reimbursement strategy & execution Value demonstration studies & guidelines Co
Slide 21: Focus on Key Cancer Centers, Reference Labs, IDNs & Payers
FOCUS ON KEY CANCER CENTERS, REFERENCE LABS, IDNS & PAYERS 71 NCI-DESIGNATED CANCER CENTERS MAJOR REFERENCE LABORATORIES IDNs/PAYERS These will be customers and at the same time, partners 21
Slide 22: Biovica Inc. – Commercial Team Development
BIOVICA INC. – COMMERCIAL TEAM DEVELOPMENT HYBRID MODEL OF SHARED RESPONSIBILITIES WITH PARTNERS BIOVICA CENTRAL TEAM • Marketing • Medical Science • Market Access BIOVICA TERRITORY MANAGEMENT • Manage the local ecosystem of stakeholders: key oncologists, labs, payers, patient advocates PARTNERS (UN
Slide 23: Vision Beyond 1st Launch: Demonstrate Clinical Utility
VISION BEYOND 1ST LAUNCH: DEMONSTRATE CLINICAL UTILITY Additional studies will provide evidence of: 1. The frequency of other monitoring tests may be reduced when used together with DiviTum®. 2. Adding DiviTum® to treatment monitoring may enable detection of progressive disease earlier and change in
Slide 24: US Metastatic Breast Cancer Forecast Model & Assumptions
US METASTATIC BREAST CANCER FORECAST MODEL & ASSUMPTIONS Defining the market opportunity Assumption Target population, new/year 31K new/year: women, postmenopausal, HR+/Her2- Relevant treatment 3 lines of therapy/patient. DiviTum can start during care Testing frequency Baseline, monthly to month 6,
Slide 25: Key Success Factors for US Launch
KEY SUCCESS FACTORS FOR US LAUNCH • Demonstration of clinical and economic utility AND change to current practices. • Collaboration on pricing and reimbursement with academics, payers and integrated delivery networks. • A small, skilled Biovica commercial organization supports partners with data, me
Slide 26: European Launch in Metastatic Breast Cancer Starting 2021
EUROPEAN LAUNCH IN METASTATIC BREAST CANCER STARTING Q3/Q4 2021 IN EU-5 & NORDICS Area Assumption Target market Incidence 40k new/Y: women, postmenopausal, HR+/Her2-; 3 lines of therapy/patient. DiviTum® can start during care. Testing Baseline, monthly to month 6, X3 monthly frequency thereafter Tes
Slide 27: Large Potential to Expand Outside Initial Markets & Applications
LARGE POTENTIAL TO EXPAND OUTSIDE INITIAL MARKETS & APPLICATIONS Near term market expansion: 43 million people living with cancer • Locally advanced breast cancer, which adds an additional 30-40% potential on existing markets 16% • Geographic expansion MBC Rest of Europe and Rest of World 46% Medium
Slide 28: Agenda
AGENDA Innovative & proprietary diagnostic technology with clear value proposition Strong clinical evidence for DiviTum® Market potential & pathway towards commercialization Summary Appendix 28
Slide 29: Upcoming News Flow
UPCOMING NEWS FLOW Q1 – CLINICAL CANCER RESEARCH PUBLISHES RESULTS SUPPORTING DiviTum® AS A TECHNOLOGY FOR EARLY EVALUATION OF METASTATIC BREAST CANCER TREATMENT Q1 – POSITIVE RESULTS FROM SWEDISH STUDY WITH DiviTum® IN METASTATIC BREAST CANCER PUBLISHED IN PRESTIGIOUS JOURNAL 2020 Q2 – COLLABORATIO
Slide 30: Company Snapshot
COMPANY SNAPSHOT DiviTum® – blood-based biomarker assay for measuring cancer cell proliferation - Prognosis and treatment response monitoring in breast and other cancers - Purpose is to enable better patient outcomes and improved health economics Extensive clinical validation in collaboration world
Slide 31: Agenda
AGENDA Innovative & proprietary diagnostic technology with clear value proposition Strong clinical evidence for DiviTum® Market potential & pathway towards commercialization Summary Appendix 31
Slide 32: Relevant Links & Resources
RELEVANT LINKS & RESOURCES Capital Markets Day 11 May 2020 https://biovica.com/investor-relations/events/ Shareholder List https://biovica.com/investor-relations/shareholders/ DiviTum® Publications https://biovica.com/divitum/publications/ DiviTum® and Breast Cancer https://www.youtube.com/watch?v=u
Slide 33: Board of Directors
BOARD OF DIRECTORS Lars Holmqvist Henrik Osvald Chairman Board Member Holdings: 410,630 B-shares, Holdings: 474,106 B-shares, 50,000 warrants 25,000 warrants Maria Holmlund Jarl Ulf Jungnelius Board Member Board Member Holdings: 9,750 B-shares, Holdings: 25,000 warrants 25,000 warrants Jesper Söderq
Slide 34: Management Team
MANAGEMENT TEAM Anders Rylander Cecilia Driving Otti Bengtsson Gref CEO EVP CFO/HR/IR R&D Director Holdings: 3,575,640 A-shares, Holdings: 10,000 B-shares, Holdings: 20,000 warrants 379,756 B-shares, 20,000 warrants 40,000 warrants Henrik Winther, Ph.D Robert Dann Wing Cheng, Ph.D SVP Business Devel
Slide 35: DiviTum TKa – Scientific Rationale for Efficacy and Evaluation of Cell Cycle Regulating Drugs
DiviTum® TKa – SCIENTIFIC RATIONALE FOR EFFICACY AND EVALUATION OF CELL CYCLE REGULATING DRUGS Specific drugs induce cell cycle arrest at the G1/S • AI’s • Fulvestrant checkpoint. Since TKa is expressed downstream of • Tamoxifen • Oral SERD’s the G1/S checkpoint, successful cell cycle inhibition can
Slide 36: Unique Proprietary Technology to Determine Cell Proliferation
UNIQUE PROPRIETARY TECHNOLOGY TO DETERMINE CELL PROLIFERATION DiviTum® measures and analyses the enzymatic activity of TK Detection of TK activity COMMENTS COMMENTS ‒ Analysis is performed using a 96-well microtiter plate ‒ Formed BrdUTP is incorporated via a DNA polymerase into ‒ A sample is incuba
Slide 37: Quick Non-Invasive Test Performed During Routine Blood Tests
QUICK NON-INVASIVE TEST PERFORMED DURING ROUTINE BLOOD TESTS IMPLEMENTATION OF BIOVICA’S TEST MEASUREMENT OF TK-AKTIVITY Blood sample is drawn Serum samples are The plate is washed using Incubation with anti- Following another Absorbance is The Oncologist gets the from the patient mixed and incubate
Slide 38: Breast Cancer Patient Journey – DiviTum's Potential
BREAST CANCER PATIENT JOURNEY – DiviTum®’s POTENTIAL Diagnosis Benign / Healthy Screening Early (Stage I & II) Triple-test diagnostics Locally advanced Self diagnosis Regimens (Stage III) Metastatic (Stadium IV) 38
Slide 39: Breast Cancer Patient Journey – DiviTum's Potential
BREAST CANCER PATIENT JOURNEY – DiviTum®’s POTENTIAL Early (Stage I) Early (Stage II) Pre surgery Post surgery Surgery Control Cure treatment treatment Locally advanced (Stage III) Recurrence Metastatic 2nd line 3rd line 1st line treatment n line treatment Palliative care (Stage IV) treatment treatm
Slide 40: CDx Test Assures Safe & Effective Use of a Pharmaceutical Drug
CDx TEST ASSURES SAFE & EFFECTIVE USE OF A PHARMACEUTICAL DRUG CDx test for patient selection: Treat with drug D Selecting Diagnostic Positive CDx Test Looking for patients eligible for drug D Do not treat with drug D Breast Cancer Patients treatment (with different biomarker profiles) Diagnostic Ne
Slide 41: DiviTum Assay Has a Broad Playing-Field as Prognostic, Monitoring & Companion Diagnostic
DiviTum® ASSAY HAS A BROAD PLAYING-FIELD AS PROGNOSTIC, MONITORING & COMPANION DIAGNOSITIC DEVICES PATIENT FLOW Adjusted Diagnose Treat Monitor Treatment KEY PLAYERS A SIMPLE BLOOD TEST Diagnostic CDx Pharma CDx Pharma Companies 41
Slide 42: Pharma Needs Monitoring CDx (MDx) as a Drug Brand Differentiator
PHARMA NEEDS MONITORING CDx (MDx) AS A DRUG BRAND DIFFERENTIATOR • The MDx increases the safety and efficacy of the Rx and hence differentiates it from any similar drug by: • Cut-off tied to one specific drug – i.e. based on clinical samples from patients receiving one specific drug • Being recommen
Slide 43: Expanding the DiviTum Market Potential by Adding More Clinical Utility
EXPANDING THE DiviTum® MARKET POTENTIAL BY ADDING MORE CLINICAL UTILITY Positive 4 feed-back loop DiviTum® Classic Dx: DiviTum® CDx/MDx: Broad cancer-diagnostic field: Cancer-drug field: - prognostic - monitoring the effect of specific - monitoring for disease progression drugs REVENUE COMPONENT REV
Slide 44: Additional Market Potential for DiviTum as a CDx/MDx Device
ADDITIONAL MARKET POTENTIAL FOR DiviTum® AS A CDx/MDx-DEVICE Fee-for-Service (FFS) Revenue1 Product Sales Focus CDx/MDx products supporting/accompanying2 100 therapeutic drugs targeting tumor cell 90 80 proliferation 70 USD Millions 60 DRUG Mode-of-Action Potential Collaborators 50 40 GM 45-50% CDK
Slide 45: CDx Opportunity in Summary
CDx OPPORTUNITY IN SUMMARY • Improves patient care by allowing for a more safe and effective use of targeted treatments • Synergistic with Biovica “core business” • Self-funded/Pharma sponsored • High value reimbursed products 45
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