BioPorto A/S · OMXCOP:BIOPOR
BioPorto A/S — Investor Presentation (October 2020)
41 slides from BioPorto A/S's investor presentation, October 2020
Slide 1: BioPorto Investor Presentation October 2020
Investor Presentation BioPorto October 2020 © Copyright BioPorto CONFIDENTIAL
Slide 2: Disclaimer
Disclaimer NOT FOR RELEASE OR DISTRIBUTION OR PUBLICATION IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA OR JAPAN OR ANY OTHER JURISDICTION WHERE THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL Confidentiality This document and the information contained herein have been prepared by BioPorto A/S (the
Slide 3: Agenda
1 About BioPorto Agenda 2 Acute Kidney Injury 3 A Novel Solution: The NGAL Test 4 The Addressable Market 5 NGAL Regulatory Strategy 6 A Development Platform - gRAD 7 Summary CONFIDENTIAL 3 CONFIDENTIAL
Slide 4: About BioPorto
About BioPorto • Research assays ELISA Kits • Clinical diagnostics BioPorto is an in vitro diagnostics company that provides tests and antibodies to clinicians and researchers around the world. We use our antibody and assay expertise to • The NGAL Test transform novel research tools into clinically
Slide 5: Mission, Vision and Strategy
Mission, Vision and Strategy BioPorto helps healthcare providers improve patient management and outcomes with products that provide early and specific insights into significant clinical conditions. By 2025, we aspire to become one of the world’s leading companies in diagnostics that improve kidney h
Slide 6: Experienced International Management Team
BioPorto’s leadership Experienced International Management Team Peter Mørch Eriksen CEO CEO of BioPorto since July 2013 20+ years in medtech/life sciences, including CEO of Sense A/S and VP/GM of Medtronic Amy Winslow Ole Larsen Jan Kuhlmann President, Christopher Bird CFO COO BioPorto Diagnostics I
Slide 7: Acute Kidney Injury
Significant Unmet Need Acute Kidney Injury © Copyright BioPorto CONFIDENTIAL 7
Slide 8: Many Patients at Risk
Why is Acute Kidney Injury (AKI) important ? Many Patients at Risk Is affected with AKI during hospitalization, and during admission to the ICU, respectively *Kidney transplant rate is in children; Stem cell is rate in children/adults 1) O’Neal JB, Crit Care. 2016;20(1). 2) Alobaidi R, Semin Nephrol
Slide 9: AKI is a Major Public Health Concern
The unsolved problem AKI is a Major Public Health Concern Third Leading Cause of Death AKI-associated In-hospital Mortality Annual US deaths: 2,813,50310 In hospital AKI9 285,768 All Other Heart Disease10 Causes10 647,457 1,281,170 Rate among non-diabetic adults; among diabetics the increase was 139
Slide 10: Clinical Burden Inside & Outside the Hospital
Clinical Burden Inside & Outside the Hospital IN-HOSPITAL 3 YEARS POST-DISCHARGE • 30% higher risk of hospital readmission14 • 38% more likely to have a major cardiac event15 • Up to 25% progress to Increased Increased Use Increased Overall Chronic Kidney Disease (CKD)17 Length of Stay12 of Dialysis
Slide 11: Economic Burden
Costs of AKI Economic Increased Cost per AKI Episode for Selected Types of AKI Burden AKI is hard to identify, when recognized late, it requires more intensive and costly interventions • Using KDIGO criteria, AKI was associated with a $1,795- $7,933 increase in costs per episode, in the US AKI costs
Slide 12: Cardiac Markers Highlight Innovation Needed in AKI
Cardiac biomarkers vs. kidney biomarkers Cardiac Markers Highlight Innovation Needed in AKI AMI: Acute Myocardial Infarction, AKI: Acute Kidney Injury © Copyright BioPorto CONFIDENTIAL 21) Mythili S, Malathi N. Biomed Rep. 2015 Nov;3(6):743-748. 12
Slide 13: The NGAL Test
A Novel Solution The NGAL Test The NGAL Test is CE marked and available for IVD use in the European Union, Canada, S. Korea and Israel. For research use only in all other territories. © Copyright BioPorto CONFIDENTIAL 13
Slide 14: An Early Warning System for Kidney Injury
AKI assessment tools: NGAL vs. Standard of Care An Early Warning System for Kidney Injury Neutrophil Gelatinase Serum Creatinine (sCr) Associated Lipocalin (NGAL) • A non-specific marker • Small protein of kidney function27 expressed in • Delayed: peaks 48-72 neutrophils & certain hours after injury
Slide 15: NGAL(+) Identifies Poorer Outcomes
Utility of integrating NGAL with sCr reveals four phenotypes NGAL(+) Identifies Poorer Outcomes Multicenter pooled analysis (2011) evaluated 10 prospective observational studies including 2,322 critically ill patients Utility of integrating NGAL with sCr revealed four phenotypes: Both negative: Pati
Slide 16: NGAL Predicting Tubular Injury
Case Study: 4-month old with history of hypoplastic left heart syndrome, with respiratory failure requiring mechanical ventilation NGAL Predicting Tubular Injury Case Highlights Corresponding to Numbered Arrows29 1. After 4 days in the CICU, nephrology was consulted due to rising creatinine levels w
Slide 17: Potential Benefits Across the Healthcare Ecosystem
The NGAL Test* Potential Benefits Across the Healthcare Ecosystem Patients Providers Faster identification of AKI risk Better triage decisions Earlier interventions to limit Avoid unnecessary tests/therapies kidney damage Faster feedback on interventions Fewer missed cases of AKI Core Lab Hospitals
Slide 18: The Addressable Market
The Addressable Market © Copyright BioPorto CONFIDENTIAL 18
Slide 19: Addressing a Significant Unmet Need
Market Opportunity for The NGAL Test Addressing a Significant Unmet Need Markets & Indications Global Opportunity Expanded Indications Long Term Expansion • Exclusion in the ED • Monitoring ~150M tests; $3Bn • Drug Toxicity • Trauma/Triage Adult ICU Risk Assessment Submit following pediatric clearan
Slide 20: Driving Commercialization Through Partnerships
Planned evolution of commercial activities for The NGAL Test* Driving Commercialization Through Partnerships BioPorto Establish Clinical Value KOL relationships Commercialization Roles Clinical Studies Papers, Posters & Podium Enable Rapid Uptake Key Account Focus Hospital relationships Advocacy/Gui
Slide 21: Supply Chain
Supply Chain • The NGAL Test – Antibodies are sourced from a subcontractor, then supplied to a third-party to complete manufacturing – Manufactured product is assembled, labeled, packaged and shipped from Company headquarters in Hellerup, Denmark • Antibodies – Antibodies for direct sale and for use
Slide 22: Regulatory Strategy
Regulatory Strategy © Copyright BioPorto CONFIDENTIAL 22
Slide 23: Regulatory Strategy for NGAL
Regulatory Strategy for NGAL Pediatrics Adults Additional Indications • Nephrotoxicity − Oncology − Cardiology 1 in 4 affected with AKI during hospitalization 1 in 5 adults affected with AKI − Diabetes (ICU)31 during a hospital episode of care32 − Transplant − Autoimmune Predict AKI Risk in Predict
Slide 24: NGAL 2020 Pediatric Study
Study overview NGAL 2020 Pediatric Study • Prospective trial to establish and validate the performance of The NGAL Test • Pediatric population (≥3 months to <22 years old), urine samples • Patients admitted to the ICU • Predict risk of developing moderate to severe AKI (stages 2/3) – Test within the
Slide 25: NGAL & COVID-19
Recent Developments NGAL & COVID-19 © Copyright BioPorto CONFIDENTIAL 25
Slide 26: Multifactorial Causes of Kidney Dysfunction
AKI and COVID-19 Multifactorial Causes of Kidney Dysfunction • Kidney involvement in hospitalized patients is frequent, ranging from mild dysfunction to progressive acute kidney injury (AKI)33 • Multiple dependent pathways in the setting of COVID-19 increase the risk of acute kidney injury33 • Syste
Slide 27: A Development Platform
BioPorto’s gRAD A Development Platform © Copyright BioPorto CONFIDENTIAL 27
Slide 28: 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 tests • Features of gRAD include: – Optimized with two printed lines: a test line for biotinylated
Slide 29: Benefits of BioPorto's gRAD Solution
Benefits of BioPorto’s gRAD Solution Fast Versatile Easy Low Cost Rapid Iteration Short Flexible design No instruments, Simple format Design allows rapid incubation time allows different fewer than 5 steps, with few iteration <15 minutes sample types room temp stable components (days not weeks) © Co
Slide 30: Platform for Product Development & Growth
gRAD Platform for Product Development & Growth NGALds Leveraging the gRAD platform, BioPorto is developing tests for NGAL as well as three emerging applications: COVIDds 1. NGALds: for near-patient assessment of kidney injury 2. Two COVID-19 assays: a viral diagnostic test and a gRAD serology-based
Slide 31: NGALds for Near-Patient Testing
NGALds for Near-Patient Testing • NGALds is the first assay developed on the gRAD platform • CE Mark expected in Q4 2020 • A rapid lateral flow test to offer semi-quantitative urine NGAL results without complexity or instrumentation – idea for outpatient or low-resource settings • A sandwich lateral
Slide 32: Viral COVIDds
Unique opportunity to use gRAD technology Viral COVIDds Product Format Update & Next Steps • Indication: Screen patients suspected of • Antibody development & testing - ongoing COVID-19 infection for active virus • Antibody selection & optimization - ongoing • Semi-quantitative, rapid immunoassay de
Slide 33: 2020 Milestones
2020 Milestones © Copyright BioPorto CONFIDENTIAL 33
Slide 34: 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 35: Rights Issue
Rights Issue © Copyright BioPorto CONFIDENTIAL 35
Slide 36: Offering Structure and Transaction Overview
Offering Structure and Transaction Overview • Fully-guaranteed rights issue with offering of up to 66,645,476 new shares, gross proceeds of up to DKK 106.6 million and net proceeds of up to DKK 93.6 million Transaction • Subscription price of DKK 1.60 per share with a subscription ratio of 1:3, impl
Slide 37: Use of Proceeds Allocated to The NGAL Test Related Activities and Development of gRAD
Use of Proceeds Allocated to The NGAL Test Related Activities and Development of gRAD Developing new indications using the gRAD platform, expectedly within the areas of COVID-19, Sepsis and Inflammation 15 Developing the Company’s U.S. organization Funding of current operations, including to prepare
Slide 38: Key Elements of Pre-Emptive Rights Issue
Key Elements of Pre-Emptive Rights Issue • Offering of 66,645,476 new shares at a subscription price of DKK 1.60 per share (fully guaranteed) • Holders of existing shares will receive one (1) pre-emptive right for each share held • Three (3) pre-emptive rights allow for subscription of one (1) new s
Slide 39: Important Dates for the Rights Issue
Important Dates for the Rights Issue 25 Sept. 2020 Announcement of Prospectus 25 Sept. 2020 Last day of trading in Existing Shares including Pre-emptive Rights 28 Sept. 2020 First day of trading in Existing Shares ex Pre-emptive Rights 28 Sept. 2020 First day of Rights Trading Period 29 Sept. 2020 A
Slide 40: Risk Factors
Risk Factors Risks related to the Company’s business Risks related to the Company’s intellectual property • The Company’s Products and Future (NGAL) Products may fail to achieve the degree of market acceptance by physicians, laboratory management, healthcare payors and others in the medical communit
Slide 41: Financial Calendar 2020
Financial Calendar 2020 November 18, 2020 Q3 2020 Results Contact: Ole Larsen (CFO) ol@bioporto.com © Copyright BioPorto CONFIDENTIAL