Biovica International Ab Class B · OMXSTO:BIOVIC_B
Biovica International Ab Class B — Q4 2024 Earnings Presentation
35 slides from Biovica International Ab Class B's earnings presentation, Jun 18, 2024
Slide 1: Biovica International AB
©2023 Biovica International AB
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: Q4 / Year End Report Presenters
Q4 / Year End Report Presenters Anders Rylander CEO Anders Morén CFO Hector Tamburini Head of US Operations Henrik Winther SVP Business Development 3 ©2023 Biovica International AB
Slide 4: Agenda
Agenda Biovica Introduction Q4 Highlights Financial Update US Update Pharma Services Summary and Q&A ©2023 Biovica International AB – Proprietary and Confidential. ©2023 All rights reserved. Biovica International AB
Slide 5: Q&A Session
Q&A Session Financial Analysts on today’s call: • Chien-Hsun Lee - Pareto Securities AG • Luísa Morgado – van Lanschot Kempen • Johan Unnérus - RedEye ©2023 5 Biovica International AB
Slide 6: Biovica Introduction
Biovica Introduction ©2023 Biovica International AB
Slide 7: DiviTum TKa
DiviTum® TKa An early indicator of cancer treatment effectiveness + References: http://biovica.com/technology/publications/ DiviTum® TKa cell proliferation provides quicker evaluation of cancer treatment efficacy. ©2023 Biovica International AB
Slide 8: 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 Breast Cancer 3,039 14 DiviTum® TKa as a clinical biomarker Gastrointestinal 713 4 of CDK4/6i response Malignant Melanoma 86 2 Collaboration
Slide 9: Strategically designed launch plan ensures growth
Strategically designed launch plan ensures growth ©2023 Biovica International AB
Slide 10: Q4 Highlights
Q4 Highlights 10 ©2023 Biovica International AB
Slide 11: Q4 Highlights
Q4 Highlights US: Sales take up continues and strengthens • Has taken longer than forecasted • However, we have started to get momentum (Revenues >100% up vs Q3) Pharma Services: Continued strong growth • YoY: 80% • Q4: 135% Europe: Two new strong partners in Europe • Palex/Spain of to a good start
Slide 12: Q4 2023/2024 Highlights
Q4 2023/2024 Highlights Significant events during the Q4 (Feb-April) • Biovica signed master service agreement for TKa testing with leading pharma company (value of first order, SEK1.7 million). • Biovica signed another master service agreement with Biopharma company (value of first order, SEK 1.2 m
Slide 13: Cost Reduction Program
Cost Reduction Program Reduction of 10 employees (5 US and 5 in Sweden). Rationale: Cost saving and address performance issues US: • Reduction of over-head • Customer facing high performers kept and promoted • Result: leaner and and more effective organization Europe: Reduction of staff within R&D a
Slide 14: Financial Update
Financial Update 14 ©2023 Biovica International AB
Slide 15: YTD Net Sales by Quarter (KSEK)
YTD Net Sales by Quarter (KSEK) 8 000 8 000 7 290 7 000 7 000 6 000 6 000 5 000 5 000 4 000 4 000 3 383 3 000 3 000 2 000 2 000 1 000 1 000 - - Q1 Q2 Q3 Q4 2022/2023 Total 2023/2024 Total • Net Sales Q4: 23/24 1,9 MSEK +225% vs PY Q4 Sales. • Net Sales FY23/24: 7,3 MSEK +115% vs PY ©2023 Biovica Int
Slide 16: YTD US IVD Sales by Quarter (KSEK)
YTD US IVD Sales by Quarter (KSEK) YTD Acc US IVD Net Sales KSEK 900 788 800 700 600 500 400 365 300 200 100 - Q1 Q2 Q3 Q4 • US IVD Net Sales Q4: 23/24 423TSEK • US IVD Net Sales FY23/24: 788 TSEK ©2023 Biovica International AB
Slide 17: Cash Position by quarter (MSEK)
Cash Position by quarter (MSEK) 160,00 140,00 120,00 114,0 100,00 79,4 80,00 60,00 40,00 20,00 - Q1 Q2 Q3 Q4 Cash 2022/2023 Cash 2023/2024 ©2023 Biovica International AB
Slide 18: Net Operating Cash flow by Quarter (MSEK)
Net Operating Cash flow by Quarter (MSEK) Q4 22/23 Q1 23/24 Q2 23/24 Q3 23/24 Q4 23/24 SEK Millions 20 10 13 - 10 - 20 - 25 - 30 - 38 - 40 - 50 Operating Cash flow before change in Working Capital Change in Working Capital Net Operating Cashflow • Q4 Restructuring of SEK 8M inflating both Operating
Slide 19: US Update
US Update 19 ©2023 Biovica International AB
Slide 20: Agenda
Agenda Sales Performance Reimbursement Status Regulatory Outlook Clinical Trial Activities Real World Patient Data Using DiviTum TKa ©2023 Biovica International AB
Slide 21: Sales Performance
Sales Performance Sales Performance YTD Acc US IVD Net Sales KSEK 900 788 800 Revenues grew >100% Q4 over Q3 700 600 16 ordering institutions in Q4; 4 more than Q3 500 400 365 ~50% patient growth Q4 vs Q3 300 200 More patients with multiple DiviTum tests 100 - Q1 Q2 Q3 Q4 ©2023 Biovica International
Slide 22: Reimbursement Status
Reimbursement Status 1 Medicare 2 Private Insurance 3 Client Bill No claim denials received based on lack of medical necessity or clinical utility Blended channel reimbursement amounts align with prior reimbursement guidance @ $400/test ©2023 Biovica International AB
Slide 23: Regulatory Outlook
Regulatory Outlook DiviTum is available in 49 states and Washington DC Audit and Mar 2023 Permit Feb 2023 Oct 2023 ©2023 Biovica International AB
Slide 24: Interventional & Observational Clinical Trial Activities
Interventional & Observational Clinical Trial Activities Current Indication Clinical utility data development in MBC DiviTum®TKa: A Biomarker Assay for Prediction of Treatment Efficacy and + Disease Progression in HR+ MBC Real Time Data Collection Trial - recruiting patients DiviTum®TKa: A Biomarker
Slide 25: Benefits of Real-World Patient Clinical Experience
Benefits of Real-World Patient Clinical Experience Word spreading among specialists within institutions Advisory Boards: KOL Impact on share their DiviTum US Sales experience with peers Focus on large institutions, with integrated delivery network (IDN) ©2023 Biovica International AB
Slide 26: Pharma Services Update
Pharma Services Update 26 ©2023 Biovica International AB
Slide 27: The Pharma Services & Collaboration Business
The Pharma Services & Collaboration Business - strong Q4 and a YoY revenue growth at 79% 1. Service & Kit Sales 2. CDx Collaborations 3. CDx Product Sales TESA*, MSA** CDx Development CDx product on the market (Multiple projects/MSA) Collaboration fee-for-services Value: ~500M-1.000 M SEK/year Value
Slide 28: Q4 Pharma Business Key Progresses
Q4 Pharma Business Key Progresses - our TKa assay get’s build into several large drug development studies Biovica signed two new MSA’s We also signed three new MSA WO’s including our largest WO ever (MSEK 2.2+) We concluded our lab- and process preparations (both in US and Sweden) to initiate two ma
Slide 29: Summary & QA
Summary & QA ©2023 29 Biovica International AB
Slide 30: Summary & Targets
Summary & Targets Progress made during Q4 Measures cell proliferation from a simple blood sample US: Strong progress in customer and sales uptake DiviTum® TKa addresses an important clinical unmet need Pharma Services: Continued growth with two new MSA’s and three new WO’s Supported by cancer KOLs a
Slide 31: Q&A Session
Q&A Session Financial Analysts on today’s call: • Chien-Hsun Lee - Pareto Securities AG • Luísa Morgado – van Lanschot Kempen • Johan Unnérus - RedEye ©2023 31 Biovica International AB
Slide 32: Biovica International AB
32 ©2023 Biovica International AB
Slide 33: Q4 / End of Year FY23/24 Web Cast Q&A
Q4 /End of Year FY23/24 Web Cast Q&A – 2024-06-18 Background We are grateful for all the questions we received from participants in the Q4 / End of year webcast. We couldn’t answer them all in the meeting due to time constraints. Therefore, in the below we answer the questions we received during the
Slide 34: Web Cast Q&A answers
• In Europe, we’ve done similar presentations where an oncologist with a solid experience in using DiviTum through multiple clinical trials, has shared his/her experience with colleagues. Question #4 Is there a need for additional investments? What is the strategy? Answer #4 – • If investments are r
Slide 35: FLIPPER Study and ASCO data
During the call we also received a question on the significance of the ASCO meeting and the data published there. The study data were produced by one of two significant groups who are active in establishing the local oncology guidelines (for the standard of care managing process). The results they p
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