Biovica International Ab Class B · OMXSTO:BIOVIC_B
Biovica International Ab Class B — Investor Presentation (April 2019)
39 slides from Biovica International Ab Class B's investor presentation, April 2019
Slide 1: Best possible treatment from day one
Klicka här för att ändra mall för rubrikformat Best possible treatment from day one 1|
Slide 2: Today's presenter
TODAY’S PRESENTER [] About Anders Rylander CEO Anders Rylander holds a MSc in Mechanical Engineering from the Swedish Royal Institute of Technology. He has been a management consultant for over 15 years in Biovica develops and commercializes blood-based biomarker assays that improve companies such a
Slide 3: History of Biovica
History [] of Biovica 2008 2009 2010 2011 2012 Biovica is founded Re-start First EU-funding New CEO Winner of NSA The company was founded to During the financial crisis of 2008, Rönnerbol Holding AB changed Anders Rylander takes office as Biovicas research has gained develop and commercialize Biovic
Slide 4: Table of contents
TABLE OF CONTENTS 1. Introduction INVESTMENT HIGHLIGHTS 2. Addressing a large unmet clinical need 3. Innovative and proprietary diagnostic technology 4. Strong clinical evidence for DiviTum® 5. Clear commercialization strategy 6. Robust pipeline of upcoming value triggers APPENDIX A. Appendix 4|
Slide 5: Cancer diagnosis – a prerequisite for efficient cancer treatment
2. ADDRESSING A LARGE UNMET CLINICAL NEED Cancer diagnosis – a prerequisite for efficient cancer treatment OVERVIEW OF CANCER DIAGNOSTICS OVERVIEW OF BIOMARKERS AND WHY THEY ARE NEEDED CANCER DIAGNOSIS CANCER BIOMARKERS Primary aim with cancer diagnosis is to determine type of treatment Biomarkers a
Slide 6: Case study: Pfizer – Ibrance in metastatic breast cancer
2. ADDRESSING A LARGE UNMET CLINICAL NEED Case study: Pfizer – Ibrance in metastatic breast cancer AREA OF PROBLEM BIOVICA’S SOLUTION – DIVITUM® ‣ Ibrance (Palbociclib) belongs to a new class of drugs (CDK- ‣ DiviTum® is a blood test that makes it possible to evaluate inhibitors), which have achieve
Slide 7: Large unmet need for selecting and evaluating cancer treatment
2. ADDRESSING A LARGE UNMET CLINICAL NEED Large unmet need for selecting and evaluating cancer treatment Urgent need for a tool to predict and monitor treatment response KOLs have acknowledged the problem and calls for a solution +43m People in the world living with cancer There are estimated to be
Slide 8: Unmet need for biomarkers for personalized cancer treatments
2. ADDRESSING A LARGE UNMET CLINICAL NEED Unmet need for biomarkers for personalized cancer treatments Efficacy evaluation Treatment resistance Time consuming diagnostics Many treatment options Cost challenges 8|
Slide 9: Cost for cancer treatments exceeds USD 100 billion
2. ADDRESSING A LARGE UNMET CLINICAL NEED Cost for cancer treatments exceeds USD 100 billion Oncology Therapeutics (BUSD)1 Oncology Development Pipeline1 120 700 100 600 500 80 400 60 300 40 200 20 100 0 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2013 2014 2015 2016 2017 Oncology
Slide 10: Biovica focuses primarily on metastatic breast cancer
2. ADDRESSING A LARGE UNMET CLINICAL NEED Biovica focuses primarily on metastatic breast cancer Distribution of metastatic cancer types LARGE ADDRESSABLE MARKET Breast cancer (16-17%) 450,000 There are currently approximately 450,000 patients with metastatic breast cancer in US and Europe1 patients
Slide 11: Competing technologies suffer from various drawbacks
2. ADDRESSING A LARGE UNMET CLINICAL NEED Competing technologies suffer from various drawbacks DIRECT COMPETITORS OTHER COMPETING DIAGNOSTIC METHODS BLOOD BASED BIOMARKERS CIRCULATING TUMOR CELLS IMAGING DIAGNOSTICS BIOPSY The technology The technology The technology The technology ‣ Includes e.g. C
Slide 12: Table of contents
TABLE OF CONTENTS 1. Introduction INVESTMENT HIGHLIGHTS 2. Addressing a large unmet clinical need 3. Innovative and proprietary diagnostic technology 4. Strong clinical evidence for DiviTum® 5. Clear commercialization strategy 6. Robust pipeline of upcoming value triggers APPENDIX A. Appendix 12 |
Slide 13: DiviTum a blood based biomarker assay
3. INNOVATIVE AND PROPRIETARY DIAGNOSTIC TECHNOLOGY DiviTum® a blood based biomarker assay Blood based ELISA – standardized platform Monitor and predict treatment response Patented method and kit CE-marked 13 |
Slide 14: DiviTum – enables best possible treatment from day one
3. INNOVATIVE AND PROPRIETARY DIAGNOSTIC TECHNOLOGY DiviTum® – enables best possible treatment from day one DiviTum® helps to determine the efficacy of the cancer therapy Response rate is superior to regular imaging diagnostic DiviTum® can determine a tumor response in 2-4 weeks compared to 2-4 mont
Slide 15: Unique proprietary technology to determine cell proliferation
3. INNOVATIVE AND PROPRIETARY DIAGNOSTIC TECHNOLOGY 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 incorpo
Slide 16: Quick non-invasive test performed during routine blood tests
3. INNOVATIVE AND PROPRIETARY DIAGNOSTIC TECHNOLOGY Quick non-invasive test performed during routine blood tests IMPLEMENTATION OF BIOVICA’S TEST MEASUREMENT OF TK-AKTIVITY 1 2 3 4 5 6 7 • Serum samples are • Following another • Absorbance is • The Oncologist gets • A blood sample is • The plate is
Slide 17: Table of contents
TABLE OF CONTENTS 1. Introduction INVESTMENT HIGHLIGHTS 2. Addressing a large unmet clinical need 3. Innovative and proprietary diagnostic technology 4. Strong clinical evidence for DiviTum® 5. Clear commercialization strategy 6. Robust pipeline of upcoming value triggers APPENDIX A. Appendix 17 |
Slide 18: DiviTum is validated in 16 published studies
4. STRONG CLINICAL EVIDENCE FOR DIVITUM® DiviTum® is validated in 16 published studies Indication Studies Patients Breast cancer 5 635 Breast and Colorectal cancer (GI) 1 79 16 articles, peer reviewed and published in oncology journals Lung cancer 2 281 Results within major oncology areas (Breast, K
Slide 19: DiviTum – strong evidence within breast cancer
4. STRONG CLINICAL EVIDENCE FOR DIVITUM® DiviTum®– strong evidence within breast cancer Summary of results from published (or presented) breast cancer studies Study Stage #Pat Results1 DiviTum able to predict which high-risk-patients (BRCA-positive) that would develop BRCA High risk 80 cancer. BC ea
Slide 20: Ongoing collaborations with world-leading institutes
4. STRONG CLINICAL EVIDENCE FOR DIVITUM® Ongoing collaborations with world-leading institutes Collaboration Study Stage Patients Endpoints 2018 2019 2020 TK-activity for targeted PYTHIA IV 120 drug response TK for targeted drug PREDIX III 200 response and survival TK activity prognostic for LUND MBC
Slide 21: Table of contents
TABLE OF CONTENTS 1. Introduction INVESTMENT HIGHLIGHTS 2. Addressing a large unmet clinical need 3. Innovative and proprietary diagnostic technology 4. Strong clinical evidence for DiviTum® 5. Clear commercialization strategy 6. Robust pipeline of upcoming value triggers APPENDIX A. Appendix 21 |
Slide 22: Clear strategy for commercialization of DiviTum
5. CLEAR COMMERCIALIZATION STRATEGY Clear strategy for commercialization of DiviTum® STEP 3: ESTABLISH PARTNERSHIP FOR SALES STEP 4: FULL SCALE COMMERCIALIZATION AND STEP 1: CREATE DEMAND STEP 2: SECURE ACCESS TO KEY MARKETS AND MARKETING EXPANISION OF INDICATIONS ‣ By utilizing clinical results fro
Slide 23: Business model
5. CLEAR COMMERCIALIZATION STRATEGY Business model Comments Market structure/value chain • Biovica is currently a diagnostic supplier selling directly to the Research Market CLINICAL CUSTOMERS RESEARCH CUSTOMERS • Biovica’s main target is the clinical market. The strategy to commercialize this segme
Slide 24: Biovica go-to market plan
5. CLEAR COMMERCIALIZATION STRATEGY Biovica go-to market plan 2013 2015 2017 2019 2021 Clin. Dev. 1st MBC 1st targeted MBC MBC Regulatory & Demand Targeted Lung & GI Pilot Prod. Dev. DiviTum V2 DiviTum V3 FDA Pre-sub Supp.#1 Supp.#2 Reg. Dev. CE FDA Sales research market Market Acc. Commercial partn
Slide 25: Table of contents
TABLE OF CONTENTS 1. Introduction INVESTMENT HIGHLIGHTS 2. Addressing a large unmet clinical need 3. Innovative and proprietary diagnostic technology 4. Strong clinical evidence for DiviTum® 5. Clear commercialization strategy 6. Robust pipeline of upcoming value triggers APPENDIX A. Appendix 25 |
Slide 26: Several near term value triggers
6. STRONG PIPELINE OF UPCOMING VALUE TRIGGERS Several near term value triggers 2019 2020 Clinical Trails Clinical Trails Results from prospective trials on CDK inhibitors Results from CDK-inhibitor trials ‒ PYTHIA – IBSCG & BIG Publication from Lund trial on metastatic breast ‒ PREDIX – Karoli
Slide 27: Biovica – the investment case in short
6. STRONG PIPELINE OF UPCOMING VALUE TRIGGERS Biovica – the investment case in short Addressing a large unmet clinical need ‒ 450,000 patients is estimated to live with metastatic breast cancer in EU and US ‒ Up to 80% of breast cancer patients do not respond to the treatment ‒ A SEK 6bn market pote
Slide 28: Table of contents
TABLE OF CONTENTS 1. Introduction INVESTMENT HIGHLIGHTS 2. Addressing a large unmet clinical need 3. Innovative and proprietary diagnostic technology 4. Strong clinical evidence for DiviTum® 5. Clear commercialization strategy 6. Robust pipeline of upcoming value triggers APPENDIX A. Appendix 28 |
Slide 29: Biovica patent portfolio – protection until 2031
A. APPENDIX Biovica patent portfolio – protection until 2031 = Granted = Pending Application date Description Valid until Europe US China Japan Other 2006-02-24 Kit for determination of thymidine kinase activity and 1 3 4 use thereof 2026-02-24 G G G G G P 2011-05-13 Patent to measure deoxynucleosid
Slide 30: Management
A. APPENDIX Management ANDERS RYLANDER PONTUS NOBREUS CEO BUSINESS DEV. DIRECTOR Holdings: 3,575,640 A-, 360,956 B-shares Holdings: 6,000 B-shares, 20,000 warrants Anders has been a management consultant for over 15 years Pontus has had commercial roles for 20 years, especially in in companies such
Slide 31: Board of directors
A. APPENDIX Board of directors LARS HOLMQVIST JARL ULF JUNGNELIUS DIRECTOR CHAIRMAN Holdings: - Holdings: 410,630 B-shares Ulf is a board-certified oncologist trained at the Karolinska MSc in Business Administration. Former Senior Advisor Institute. He has over 20 years of experience in within healt
Slide 32: Overview of Biovica's key opinion leaders
4. STRONG CLINICAL EVIDENCE FOR DIVITUM® Overview of Biovica’s key opinion leaders Matt Ellis Angelo Di Leo M.D, Ph.D M.D, Ph.D Director for Lester and Sue Smith Breast Cancer at Baylor Head of Sandro Pitgliani Medical Oncology Department at Collage of Medicine. Ellis is considered a pioneer within
Slide 33: Overview of Biovica's key opinion leaders
4. STRONG CLINICAL EVIDENCE FOR DIVITUM® Overview of Biovica’s key opinion leaders William Gradishar Martine J. Piccart M.D M.D, PhD Chief of Hematology and Oncology in the Department of Prof. Piccart served as Head of the Department of Medicine Medicine at Northwestern Memorial Hospital, Betsy at t
Slide 34: Shareholder list as per 2018-12-31
A. APPENDIX Shareholder list as per 2018-12-31 Name A-Shares B-Shares Share Capital (%) Votes (%) Anders Rylander 3,575,640 360,956 22.40 33.64 Gunnar Rylander 931,185 52,112 5.60 8.63 Avanza Pension 718,774 4.09 2.18 LYM Consulting AB 493,810 2.81 1.50 Kristina Gronowitz 411,660 2.34 3.75 Lars Holm
Slide 35: Income statement
A. APPENDIX Income statement Q3 Q3 May-Jan May-Oct May-Apr (TSEK) 2018/2019 2017/2018 2018/2019 2017/2018 2017/2018 Net sales 288 51 1 269 1 290 2 723 Other income 320 129 666 323 494 Work performed by the company and capitalized 1 713 1 784 4 565 4 949 6 596 Change in WIP inventory 174 69 101 103 1
Slide 36: Balance sheet
A. APPENDIX Balance sheet Jan 31 Jan 31, Apr 30, Jan 31 Jan 31, Apr 30, (TSEK) 2019 2018 2018 (TSEK) 2019 2018 2018 ASSETS EQUITY Intangible assets 36 577 31 425 33 778 Share capital 1 172 1 172 1 172 Property, plant and equipment 2 542 1 711 2 616 Financial assets -13 -18 0 Other contributed capita
Slide 37: Cash flow statement
A. APPENDIX Cash flow statement Q3 Q3 May-Oct May-Oct May-Apr (TSEK) 2018/2019 2017/2018 2018/2019 2017/2018 2017/2018 Cash flow from operating activities before changes in working capital -5 329 -5 487 -13 267 -11 483 -15 009 Changes in working capita 102 577 242 109 127 Cash flow from operating ac
Slide 38: List of DiviTum publications
A. APPENDIX List of DiviTum® publications Breast Cancer Breast and Colorectal Cancer 1. Bonechi M, Galardi F, Biagioni C, et al. Plasma thymidine kinase-1 activity predicts 9. Bolayirli M, Papila C, Korkmaz G, et al. Serum thymidine kinase 1 activity in solid outcome in patients with hormone recepto
Slide 39: Anders Rylander, CEO Biovica
Anders Rylander, CEO Biovica Tel.: +46 (0)18 444 48 35 E-mail: anders.rylander@biovica.com 39 | www.biovica.com
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