Biovica International Ab Class B · OMXSTO:BIOVIC_B
Biovica International Ab Class B — Investor Presentation (September 2023)
36 slides from Biovica International Ab Class B's investor presentation, Sep 14, 2023
Slide 1: Biovica
Slide 2: Forward Looking-Statements Disclaimer
Forward Looking-Statements Disclaimer The Investor Presentation may contain certain statements The Company does not undertake to update or revise the that are forward-looking. These statements may refer in forward-looking statements that may be presented in the particular to the Company’s business s
Slide 3: Executive summary
Executive summary Highly-experienced, US-based The first CE-marked, FDA cleared specialist sales team, fully owned blood test for tumor proliferation, CLIA–certified lab in San Diego, HQ monitoring metastatic breast cancer and research-lab in Uppsala, Sweden treatment efficacy. Initial USD 400-700m
Slide 4: The cancer treatment monitoring gap
The cancer treatment monitoring gap Tumor size 0 BL 1 2 3 4 5 Months after treatment initiation Until progression is detected, patients continue Current treatment monitoring protocols treatment with highly toxic therapies, suffering can only detect progressive disease from side-effects, while missin
Slide 5: DiviTum TKa
DiviTum® TKa A paradigm shift in Breast Cancer treatment monitoring Predictive & prognostic for PFS at baseline and during treatment1,2,3 Allows for the monitoring Complementary to CA15-3 of treatment effect in yet with stronger Detection of tumor mBC patients4 prognostic potential2 progression 83 d
Slide 6: Biovica's first regulatory cleared product based on the DiviTum TKa test
Biovica’s first regulatory cleared product based on the DiviTum®TKa test Regulatory approvals secured in the EU & the US Broad label across HR+ mBC treatment monitoring 510(k) clearance granted in July 2022 DiviTum®TKa is intended to be used as an aid for Unique product classification code created m
Slide 7: Validated by a wealth of scientific evidence
Validated by a wealth of scientific evidence 30+ published and peer-reviewed articles Cancer Area Patients Nr. of studies Strong evidence supporting the use of DiviTum® TKa as a clinical biomarker Breast Cancer 3,039 14 of CDK4/6i response Gastrointestinal 713 4 Collaboration with world-leading Mali
Slide 8: Attractive health economics impact
Attractive health economics impact MONITORING MONITORING SAVINGS DiviTum® TKa health-economic impact on average −$7,400 / Reduction of other monitoring costs by patient decrease in CT scans, Bone scans etc. Cost/patient DiviTum® TKa Earlier reduction in usage of costly CDK4/6 inhibitor treatment onc
Slide 9: Diagnostic & treatment monitoring landscape
Diagnostic & treatment monitoring landscape Imaging Biopsy Blood-based markers • Standard method for treatment • Used for assessing prognosis • Convenient for monitoring evaluation • Invasive, cannot be used for • No marker established as SoC in mBC • Requires 3-4 months follow-up frequent monitorin
Slide 10: Commercialization – capitalizing on a scalable launch strategy
Commercialization – capitalizing on a scalable launch strategy 10
Slide 11: Strategically designed launch plan ensures growth
Strategically designed launch plan ensures growth 2023: Launched Regulatory process & 2023: Partnerships in the commercialization to be 2024: Medicare reimbursement Netherlands, Italy, Poland planned with partner 2023-25: Launch in 2026: 15% market potential Priority market following U
Slide 12: Comprehensive go-to-market strategy
Comprehensive go-to-market strategy Select an indication Generate evidence, Launch in the US Expand into Collaborate with 1 with a large unmet medical need 2 complete regulatory & reimbursement 3 first and then in Europe with partners 4 other markets and indications 5 pharma to generate new products
Slide 13: US & EU commercialisation underway
US & EU commercialisation underway Several key milestones already achieved Commercial Milestones in the US & EU January 2023: Experienced US Sales Force hired March 2023: Commercial Partnership Agreement for Poland, Netherlands April 2023: Commercial Partnership Agreement for sales force in Italy Ma
Slide 14: CLIA Lab: Centralizing process, management & control
CLIA Lab Centralizing process, management & control The CLIA lab model enables Biovica field force DiviTum order Test results Sales Reps, Market Educate office on clinical Send results to physicians / management of the entire value chain Access, Managed Care utility, order logistics & institutions a
Slide 15: CLIA Lab: Building & maintaining stakeholder relationships
CLIA Lab Building & maintaining stakeholder relationships CLIA Lab The CLIA lab approach enables direct relationships with all key shareholders, contributing to extensive market insight and building trust Understanding patient Understanding physician Understanding payer needs needs needs Who is usin
Slide 16: Targeted initiatives driving access & demand
Targeted initiatives driving access & demand Ongoing initiatives targeting the entirety of the value chain aim to create awareness and demand for DiviTum while streamlining the logistical process for all stakeholders Strong KOL & regional thought leader Face to face interactions by our field force,
Slide 17: US Reimbursement channel matrix
US Reimbursement channel matrix Reimbursement Contracted Business Public Insurance Private Insurance Channels (Hospitals) (Medicare) Channel Hospitals pay Biovica directly for Claims are submitted by Biovica and Claims are submitted by Biovica and description patient samples tested are paid by Medic
Slide 18: Extensive KOL network a significant driver for demand
Extensive KOL network a significant driver for demand Focused engagement with targeted medical oncologists, KOLs and cancer centers drives awareness and adoption Feedback from Medical Oncologists: “DiviTum addresses a biomarker white space that is desperately needed to manage MBC patients” -NCI/NCCN
Slide 19: Continuous expansion of clinical utility
Continuous expansion of clinical utility Enrolling prospective studies Planned prospective studies TK-IMPACT Drug level study Early Rx switch TK-PRECISION Observational trial Interventional trial HR+, HER2- mBC HR+, HER2- mBC HR+ mBC ER/PR+, HER- mBC First study in US where DiviTum® Correlate TKa le
Slide 20: Additional opportunities & outlook
Additional opportunities & outlook 20
Slide 21: Thymidine Kinase (TK) – a cancer-agnostic proliferation biomarker
Thymidine Kinase (TK) – a cancer-agnostic proliferation biomarker Healthy Cells Cancer Cells TKa TKa Blood Stream Blood Stream Normal cells express Thymidine Kinase Cancer cells express Thymidine Kinase and which is subsequently degraded release it into the blood stream Low TKa in circulation High T
Slide 22: Potential of selected indications
Potential of selected indications Breast Cancer Other Cancer Indications CDx Metastatic Anti- Castrate-Resistant Non-Small Cell Metastatic Locally Advanced Malignant proliferative Prostate Cancer Lung Cancer Melanoma drugs Annual incidence 287,850 (US)1 51,400 (US)2 610,000 (US) 270,000 (US) 193,055
Slide 23: Pharma Collaborations / CDx
Pharma Collaborations / CDx continues its strong progress with new agreements signed Q1 FY23/24 1. TESA 2. MSA 3. CDx Collaboration 4. CDx Product Technical Evaluation Master Service Agreement CDx Development CDx product on the market Service Agreement (Multiple projects/MSA) Collaboration (2-4 year
Slide 24: Recent news
Recent news 2023-09-28: DiviTum® TKa to pursue Gap-fill process for CMS pricing decision 2023-09-25: Biovica signs second agreement with leading US healthcare provider 2023-09-19: Biovica signs US agreement with leading healthcare provider in Arizona 2023-07-31: Biovica signs US commercial agreement
Slide 25: Board of Directors
Board of Directors Lars Holmqvist Marie Louise Fjällskog Jarl Ulf Jungnelius Chairman Board Member Board Member Holdings: Holdings: Holdings: 659,436 B-shares, 45,000 warrants 75,000 warrants 100,000 warrants Maria Holmlund Annika Carlsson Berg Anders Rylander Board Member Board Member Board Member
Slide 26: Management Team
Management Team Anders Rylander Anders Morén Helle Fisker CEO CFO VP Commercial Europe Holdings: Holdings: Holdings: 3,575,640 A-shares, 23,000 B-shares 18,700 B-shares, 1,562,074 B-shares, 20.000 warrants 90,000 warrants Warren Cresswell Hanna Ritzén Henrik Winther, Ph.D. President Americas COO SVP
Slide 27: Shareholders, financials & financial calendar
Shareholders, financials & financial calendar Shareholder list as of August 2023 Accumulated Net Sales SEK 000 Name Nr. of shares Capital Votes 4 000 Anders Rylander 5,137,714 11.23% 21.08% 3 500 3 000 Avanza Pension 3,491,203 7.63% 5.99% 2 500 Gunnar Rylander 2,085,225 4.56% 6.77% 2 000 Nordnet Pen
Slide 28: Summary & Milestones
Summary & Milestones Measures cell proliferation from a simple blood sample Upcoming Milestones: US milestones DiviTum® TKa addresses an important clinical unmet need 2023: CLIA Lab Certification ✓, PLA Code ✓ & DiviTum® TKa is supported by cancer KOL’s and scientific agreements with payers ✓ & US h
Slide 29: Biovica Overview
Biovica® Overview Founded in 2009, based on research from Uppsala University IPO 2017, traded on Nasdaq First North Premier (Ticker: BIOVIC B) HQ in Uppsala, CLIA lab and offices in San Diego Regulatory: ISO 13485 certified DiviTum® TKa CE marked & FDA 510(k) cleared
Slide 30: Appendix
Appendix 30
Slide 31: BioItaLEE Data Shows Distinct TKa Patterns
BioItaLEE Data Shows 3 Distinct TKa Patterns PATTERN 1 (n=62) PATTERN 2 (n=135) PATTERN 3 (n=37) • 287 HR+ Her2- mBC patients 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 32: 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 32
Slide 33: Consistent TKa patterns across trials
Consistent TKa patterns across 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 Ribociclib OFF ON OFF TREATMENT TREATMENT TREATMENT ET OFF ON C1D1 C1D15 Surgery Malorni, ESMO
Slide 34: 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 TKa PATTERNS Confirm medication compliance Earlier tumor mutation profiling 120 More vigilant monitoring 100 80 Consider switching ET partner 60 Consider switching CDK4/6 drug 40 I
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Slide 36: Treatment Decisions With Greater Confidence
Treatment Decisions With Greater Confidence ™ Blood-based test measures cell proliferation reflecting cancer progression
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