Biovica International Ab Class B · OMXSTO:BIOVIC_B
Biovica International Ab Class B — Investor Day (May 2020)
48 slides from Biovica International Ab Class B's investor day presentation, May 11, 2020
Slide 1: Biovica Capital Market Day 11 May 2020
Biovica Capital Market Day 11 of May 2020 th 14:00-16:00 CET 1
Slide 2: Capital Market Day 11th of May 2020
Capital Market Day 11th of May 2020 1. Where we are and where we are heading – Anders Rylander, CEO 2. An oncologist's perspective – Samuel Rotstein Ph.D., MD, Karolinska Hospital 3. US launch plan – Robert Dann, SVP Marketing, US Business 4. EU launch & CDx opportunity – Henrik Winther, SVP Busines
Slide 3: Where we are and where we are heading
Where we are and where we are heading Anders Rylander, CEO 3
Slide 4: Unmet needs in Metastatic Breast Cancer
Unmet needs in Metastatic Breast Cancer • Many treatment options • Efficacy evaluation • Treatment resistance • Time consuming diagnostics 4
Slide 5: Editorial articles confirm unmet need and DiviTum potential value
Editorial articles last week confirms unmeet need and DiviTum® potential value ”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 population of patients.” - Amelia
Slide 6: Treatment decisions with greater confidence!
Treatment decisions with greater confidence! Biovica develops and commercializes blood-based biomarker assays to improve monitoring of modern cancer therapies. The DiviTum® assay, a test for accurately measuring cell proliferation, has successfully demonstrated its capabilities to early evaluate the
Slide 7: Key Opinion Leader support - key for clinical acceptance
Key Opinion Leader support - key for clinical acceptance Daniel F. Hayes Angelo Di Leo Martine J. Piccart Matthew P. Goetz M.D, Professor M.D, Ph.D M.D, Professor M.D University of Michigan Hospital of Prato Université Libre de Bruxelles Mayo Clinic Ex. ASCO President IBCSG Exec. Committee Founder B
Slide 8: Strong Clinical Study Results for DiviTum
Strong Clinical Study Results for DiviTum®, peer reviewed and published in oncology journals • 22 published and peer- No of reviewed articles with Cancer area Patients Studies DiviTum® Breast Cancer 1,065 11 Gastrointestinal 713 4 • Results: Lung Cancer 281 2 Blood Cancer 440 4 • Prognostic: risk fo
Slide 9: DiviTum Commercialization process Metastatic Breast Cancer
DiviTum® Commercialization process Metastatic Breast Cancer Product Development Clinical Development Regulatory pathway Clinical Usage Guidelines & Reimbursement & Uptake Commercial partnering Market Access/Launch 9
Slide 10: Biovica roll-out plan Metastatic Breast Cancer
Biovica roll-out plan Metastatic Breast Cancer 1. US launch Clinical Usage & Uptake Market potential $200-350 M 2. EU 5 + Nordics Clinical Usage & Uptake Potential Market potential: $150 – 250 M $400 - 700 M 3. Japan Clinical Usage & Uptake Market potential: $50 – 100 M 4. RoE + RoW Clinical Usage &
Slide 11: Large potential to expand outside initial markets & applications
Large potential to expand outside initial markets & applications! Near term market expansion: • Locally advanced breast cancer, which adds an 43 M people living with cancer additional 30-40% potential on existing markets • Geographic expansion MBC Rest of Europe and Rest Breast cancer 16% of World 4
Slide 12: Capital Market Day 11th of May 2020
Capital Market Day 11th of May 2020 1. Where we are and where we are heading – Anders Rylander, CEO 2. An oncologist's perspective – Samuel Rotstein Ph.D., MD, Karolinska Hospital 3. US launch plan – Robert Dann, SVP Marketing, US Business 4. EU launch & CDx opportunity – Henrik Winther, SVP Busines
Slide 13: An oncologist perspective
An oncologist perspective Sam Rotstein, MD, PhD, Associate Professor Oncology, Karolinska Hospital & Biovica Medical Advisor 13
Slide 14: DiviTum Applications
DiviTum® Applications • Prognostic • High proliferation - Highly active tumor - Bad prognosis - High values • Slow proliferation– Low tumor activity – Good prognosis - Low values • Prediction and monitoring • Increasing/high values – little or no treatment efficacy • Decreasing/unchanged/low values
Slide 15: DiviTum TK - Scientific Rationale for Efficacy Evaluation
DiviTum® TK - Scientific Rationale for Efficacy Evaluation of Cell Cycle Regulating Drugs Specific drugs induce cell cycle • AI’s arrest at the G1/S checkpoint. • Fulvestrant Since TK is expressed • Tamoxifen • Oral SERD’s downstream of the G1/S checkpoint, successful cell cycle inhibition can be de
Slide 16: Todays diagnostics – how does DiviTum fit?
Todays diagnostics – how does DiviTum® fit? Diagnostics 1. Clinical examination 2. Image and functional investigation • CT, MR, PET, Bone scan, Mammography, Ultrasound, Regular X-Ray 3. Biopsy, surgery • Hormone receptor determination • Proliferation – Ki-67 • Grade • HER-2 status • CA 15-3
Slide 17: Diagnosing breast cancer
Diagnosing breast cancer Diagnosis Benign (Healthy) Screening Early Triple-test (Stage I & II) diagnostics Locally advanced Treatment Self diagnosis (Stage III) Regimens Metastatic (Stadium IV)
Slide 18: Breast cancer development
Breast cancer development Early (Stage I) Early (Stage II) Pre surgery Surgery Adjuvant treatment Disease-free treatment Locally advanced (Stage III) Recurrence Metastatic 1st line 2nd line 3rd line n line Palliative care (Stage IV) treatment treatment treatment treatment
Slide 19: An unmet medical need and early feedback on treatment efficacy
An unmet medical need and highly important to get early feedback on treatment efficacy • Treatment options • Chemotherapy • Radiation • Endocrine therapies • Targeted therapies • Immuno-Oncology treatment All treatments brings side-effects, sometimes severe
Slide 20: DiviTum provides early response on treatment effectiveness
DiviTum® provides early response to whether or not the patient's cancer treatment is effective Imaging DiviTum ® diagnostics Months DiviTum® measures cell proliferation rate for faster evaluation of cancer treatment effects References: See http://biovica.com/divitum/publications/ 20
Slide 21: DiviTum - Breast Cancer Study Program
DiviTum® - Breast Cancer Study Program 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 2019 PREDIX, C
Slide 22: What is the value of using DiviTum?
What is the value of using DiviTum®? • What does DiviTum mean for the patient? • How useful is DiviTum for oncologists? • Why is DiviTum useful in healthcare?
Slide 23: Capital Market Day 11th of May 2020
Capital Market Day 11th of May 2020 1. Where we are and where we are heading – Anders Rylander, CEO 2. An oncologist's perspective – Samuel Rotstein Ph.D., MD, Karolinska Hospital 3. US launch plan – Robert Dann, SVP Marketing, US Business 4. EU launch & CDx opportunity – Henrik Winther, SVP Busines
Slide 24: US launch plan for DiviTum
US launch plan for DiviTum® Robert Dann, SVP Marketing, US Business 24
Slide 25: Topics
Topics • The metastatic breast cancer patient population: care path, and needs • Clinical evidence and clinical utility supporting the launch and beyond • DiviTum® Go-to-market: • Messaging, key audiences, launch timeline, activities, and resources • Foundations of the DiviTum® forecast 25
Slide 26: The median patient that we are aiming to help
The median patient that we are aiming to help… • Female, mid 60s • Metastatic breast cancer • Recurrent disease from an early stage cancer • Hormone receptor positive disease • Health status: generally good • Time to 1st progression of disease: ~25 months • Treatments: ~3 endocrine-based therapies (
Slide 27: And how her treatment is monitored
And how her treatment is monitored… Symptoms Physical exam Complete blood ct • Multiple tests repeated regularly Liver function tests PET/CT scans Bone scans CT scans • Individual tests not Tumor markers always definitive Monitoring key questions: • When to switch from one ET* to the next • When to
Slide 28: Metastatic breast cancer epidemiology/needs
Metastatic breast cancer epidemiology/needs 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 treatment
Slide 29: SWOG S0226 trial is the basis for regulatory clinical validation
SWOG’s S 0226 trial is the basis for the DiviTum® regulatory clinical validation and for usage S 0226: Randomized Phase III trial, postmenopausal women with metastatic breast cancer treated with 1st line endocrine therapies • 707 patients in the US and Canada from 73 sites • DiviTum study: from ~400
Slide 30: 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 t
Slide 31: DiviTum Value Proposition
DiviTum® Value Proposition Treatment decisions with greater confidence • Opportunity to reduce assessments for disease progression • When it is time to move to the next therapy, make that decision with more confidence and sooner to when therapy stops working • Improve cost management, workflow, and
Slide 32: US Market Commercialization timeline to mid-2021
US Market Commercialization timeline to mid-2021 2020 2021 Q1 Q2 Q3 Q4 Q1 Q2 Regulatory pathway Commercial sales Pivotal clinical study Key scientific events KOL inputs Reimbursement strategy & execution Commercial team development Value demonstration & guidelines
Slide 33: 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 34
Slide 34: 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 (unde
Slide 35: US MBC forecast model and assumptions
US MBC forecast model and 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, X3 monthly thereaft
Slide 36: Summary: Key success factors for US launch
Summary: 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
Slide 37: Agenda
Agenda 1. Where we are and where we are heading – Anders Rylander, CEO 2. An oncologist's perspective – Samuel Rotstein Ph.D., MD, Karolinska Hospital 3. US launch plan – Robert Dann, SVP Marketing, US Business 4. EU Launch & CDx opportunity – Henrik Winther, SVP Business Development 5. Q&A session
Slide 38: CDx Opportunity
CDx Opportunity Henrik Winther Ph.D., SVP Business Development 39
Slide 39: European launches in MBC starting Q3/Q4 2021
European launches in MBC starting Q3/Q4 2021 - within Big 5 and Nordics Area Assumption Target market Incidence 40k new/Y: women, postmenopausal, HR+/Her2-; 3 lines of therapy/patient. DiviTum can start during care. Testing frequency Baseline, monthly to month 6, X3 monthly thereafter Test opportuni
Slide 40: A CDx test assures safe and effective use of a drug
A CDx test assures the safe and effective use of a pharmaceutical drug CDx test for patient selection: Selecting Treat with drug D CDx Test Diagnostic Positive Looking for patients eligible for drug D treatment Do not treat with drug D Breast Cancer Patients (with different biomarker profiles) Diagn
Slide 41: DiviTum assay as prognostic, monitoring, and companion diagnostic
Biovica’s DiviTum® assay has a broad playing-field - as prognostic, monitoring, and companion diagnostic devices PATIENT FLOW Adjusted Diagnose Treat Monitor Treatment KEY PLAYERS A SIMPLE BLOOD TEST Diagnostic CDx Pharma CDx Pharma Companies 43
Slide 42: Pharma needs monitoring CDx's as a drug brand differentiator
Pharma needs monitoring CDx’s (MDx’s) - 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 re
Slide 43: Expanding the DiviTum market potential by adding clinical utility
Expanding the DiviTum® market potential - by adding more clinical utility Positive 4 4 -On-boarding additional laboratories running Biovica test solutions -Pharma support/funding of Biovica product commercialization feed-back loop DiviTum® Classic Dx: DiviTum® CDx/MDx: Broad cancer-diagnostic field:
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 Revenue and Product Sales Fee-for-Service (FFS) Revenue1 Product Sales Focus 100 CDx/MDx products supporting/accompanying2 90 therapeutic drugs targeting tumor cell proliferation 80 70 DRUG Mode-of-Action Potential Collab
Slide 45: CDx opportunity – Summary
CDx opportunity – 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 47
Slide 46: Reasons to invest in Biovica
Reasons to invest in Biovica • Addresses an unmet need for personalized treatments within metastatic cancer • Immediate potential of $ 400-700 M for initial roll-out (MBC in US, Euro-5, Nordics & Japan) • Significant potential beyond initial roll-out (30-40% expansion with locally advanced BC) • Str
Slide 47: Capital Market Day 11th of May 2020
Capital Market Day 11th of May 2020 1. Where we are and where we are heading – Anders Rylander, CEO 2. An oncologist's perspective – Samuel Rotstein Ph.D., MD, Karolinska Hospital 3. US launch plan – Robert Dann, SVP Marketing, US Business 4. EU launch & CDx opportunity – Henrik Winther, SVP Busines
Slide 48: Q&A session
Q&A session 50