Slide 1: Interim Report, Q1 2020
Interim Report, Q1 2020 May 7, 2020 © Copyright BioPorto
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements. Words such as “believe”, “expect”, “may”, “plan”, “strategy”, “estimate”, “target” and similar expressions identify such forward-looking statements. Statements other than historical facts included in this presentation
Slide 3: Agenda
01. Highlights from Q1 2020 Agenda 02. Q1 2020 financial results 03. The NGAL Test regulatory studies 04. gRAD pipeline: Includes tests for COVID-19 05. 2020 milestones 3
Slide 4: Highlights
Highlights © Copyright BioPorto 4
Slide 5: Highlights from Q1 2020
Highlights from Q1 2020 • NGAL sales up 67% compared to Q1 2019 • FDA dialogue and preparations for additional data collection on track, but enrollment of new patients for US study delayed due to COVID-19 shutdown • New collaboration with SDU to develop test for active COVID-19 virus based on gRAD t
Slide 6: Q1 2020 Financials
Q1 2020 Financials © Copyright BioPorto 6
Slide 7: Change in antibody strategy dilutes NGAL-driven growth in Q1 2020
Change in antibody strategy dilutes NGAL-driven growth in Q1 2020 Revenue by Quarter (DKKm) Revenue by Quarter (LTM, DKKm) 2019 7.8 29 2020 6.6 6.7 28 27 27 5.5 26 25 4.2 25 24 24 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 2018 2018 2018 2018 2019 2019 2019 2019 2020 © Copyright BioPorto 7
Slide 8: Very satisfactory growth of 67% in NGAL revenue
Very satisfactory growth of 67% in NGAL revenue Revenue by Product Category (DKKm) NGAL 3.0 2019 2020 +67% Increase in total revenue from 2.1 NGAL sales in Q1 from 2019 to 2020 1.7 Antibodies 1.3 1.0 -42% 0.3 0.2 Antibody sales in 2020 affected 0.1 by portfolio refocus NGAL ELISA kits Antibodies Oth
Slide 9: Fully subscribed with proceeds of DKK 40 million
Pre-emptive rights issue to strengthen BioPorto’s cash position completed in March/April 2020 Fully subscribed with proceeds of DKK 40 million • A total of 24,992,053 new shares offered from March 19, 2020 to April 3, 2020 • Holders of existing shares received one pre-emptive right for each share he
Slide 10: The NGAL Test Regulatory Studies
The NGAL Test Regulatory Studies © Copyright BioPorto 10
Slide 11: US Regulatory Update
US Regulatory Update Patient enrollment delayed due to COVID-19 outbreak Submission to FDA expected in 2H 2020 Oct. 2018 Q2-4 2019 2H 2020 Retrospective study for risk Application submitted to FDA, Enhanced FDA submission assessment in pediatrics reviewed with determination of planned initiated addi
Slide 12: Additional Data Collection
Next Steps Additional Data Collection • BioPorto will include all ICU patients who meet our criteria • This will result in a simpler dataset, and a simpler message for FDA Include in Trial Exclude from Patient Arrives Chart Review Trial in ICU © Copyright BioPorto 12
Slide 13: gRAD pipeline: Includes tests for COVID-19
gRAD pipeline: Includes tests for COVID-19 © Copyright BioPorto 13
Slide 14: Proprietary Platform: gRAD
BioPorto’s patented lateral flow development system Proprietary Platform: gRAD • BioPorto’s patented Generic Rapid Assay Device, gRAD, was developed in 2016 to enable rapid development of lateral flow devices • gRAD has been used in the development of 3 novel lateral flow tests • Features of gRAD in
Slide 15: Product Formats
Unique opportunity to use gRAD technology for two tests Product Formats Single analyte detection Multiplex detection • Qualitative, semi-quantitative and • Qualitative, semi-quantitative and quantitative detection of analytes quantitative detection of multiple analytes • Flexible sample types: urine
Slide 16: Benefits of BioPorto's Solution
Benefits of BioPorto’s Solution Fast Versatile Easy Low Cost Scalable Screen for Accommodates No instruments, *Significantly Design allows active virus in different fewer than 5 steps, less expensive rapid iteration < 10 minutes sample types room temp stable than molecular and scale up *Expectation
Slide 17: BioPorto gRAD Pipeline
BioPorto gRAD Pipeline NGAL for AKI Screen for COVID-19 active virus Test for COVID-19 IgG/IgM NGAL for Sepsis NGAL for Inflammation NGAL for Blast Lung Injury (triage) NGAL in veterinary (race horses) © Copyright BioPorto 17
Slide 18: 2020 milestones
2020 milestones © Copyright BioPorto 18
Slide 19: Targeted 2020 Milestones
Clinical, regulatory and commercial Targeted 2020 Milestones • Finalize collection of data for the FDA application of The NGAL Test for pediatrics and submit application in the second half of 2020 • Collect supplementary data to support submission of an application for The NGAL Test in adults • Co-d
Slide 20: Financial Projections for 2020
Financial Projections for 2020 Approx. Approx. Revenue EBIT loss DKK 30m DKK 73m Growth in sales of The NGAL Test offset to some degree by decline in antibodies and ELISA kits sales. No regulatory sales included in guidance, which is subject to change depending on the development of the global COVID
Slide 21: Investment Highlights
BioPorto Investment Highlights Platforms Broad Target Market • Antibody -> Assay -> Actionable • The NGAL Test Addresses $5 bn AKI market Biomarker Repeatable development path • Significant unmet clinical need • Robust academic & research relationships • Testing can improve management, saving • $4m+
Slide 22: Financial calendar 2020
Financial calendar 2020 August 19, 2020 Q2 2020 Results November 18, 2020 Q3 2020 Results Contact: Ole Larsen (CFO) ol@bioporto.com © Copyright BioPorto