Bioporto A/s · OMXCOP:BIOPOR
Bioporto A/s — H1 2019 Earnings Presentation
24 slides from Bioporto A/s's earnings presentation, Aug 15, 2019
Slide 1: Interim Report, first half of 2019
Interim Report, first half of 2019 BioPorto 15 August 2019 © 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. Financials H1 2019 Agenda 02. About BioPorto 03. Acute Kidney Injury 04. The NGAL Test 05. Addressable Market 06. Approval process 3
Slide 4: Highlights of first half of 2019
Highlights of first half of 2019 • Q2 sales of NGAL in U.S. up by 43% and in H1 2019 by 23% • Bulk orders drive sales of antibodies up, while ELISA kits down due to market conditions • Successful share capital increase adds DKK 36m to liquidity • Strengthening of organization in U.S. with important
Slide 5: Pediatric Application to be Resubmitted in Q4 2019
Breakthrough Device Designation by FDA Pediatric Application to be Resubmitted in Q4 2019 Oct. 2018 Q2-4 2019 Retrospective study for risk Breakthrough designation FDA clearance expected assessment in pediatrics granted and application for pediatric critical care initiated submitted to FDA risk asse
Slide 6: International Management Team
BioPorto’s leadership International Management Team Peter Mørch Eriksen CEO Ole Larsen Jan Kuhlmann Amy Winslow Christopher Bird CFO COO President, CMO, BioPorto Inc. BioPorto Diagnostics Inc. © Copyright BioPorto 6
Slide 7: Overall growth in H1 2019 of 13%
Overall growth in H1 2019 of 13% Revenue by Quarter (DKKm) Revenue by Quarter (LTM, DKKm) 2018 28 28 27 2019 8.9 27 26 26 7.8 25 7.2 25 25 25 24 24 24 23 5.5 5.4 23 4.6 22 21 21 20 19 18 17 Q1 Q2 Q3 Q4 Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019 © Copyright BioPor
Slide 8: Solid increase in Q2 revenues from NGAL led by U.S.
Solid increase in Q2 revenues from NGAL lead by performance in U.S. Revenue by Product Category (DKKm) 43% NGAL Q2 2018 Q2 2019 3.8 3.3 Increase in U.S. revenue from NGAL from Q2 2018 to Q2 2019 2.4 8% Antibodies 2.2 1.6 1.4 Increase in Revenue from Antibodies 0.2 0.2 from Q2 2018 to Q2 2019 NGAL EL
Slide 9: YTD growth driven by higher RUO and license fees on NGAL
YTD growth driven by higher RUO and license fees on NGAL and strong antibody development Revenue by Product Category (DKKm) 23% NGAL H1 2018 H1 2019 5.3 5.1 4.3 Increase in total revenue from 4.1 NGAL from H1 2018 to H1 2019 23% Antibodies 3.0 2.5 1.2 Increase in Revenue from Antibodies 0.4 from H1
Slide 10: Platform for Growth
BioPorto Strategic Vision Platform for Growth Antibody Library Assay Development Expertise Actionable Biomarkers Ab Antibody Ab Antibody (Immunity) (Diabetes) Potential Disease Areas & Applications Ab Prediction Antibody Diagnosis Ab (Obesity) Prognosis Theragnosis Prediction Actionable Selected Ass
Slide 11: Why Is AKI Important?
Why Is AKI Important? Acute kidney injury (AKI) is a rapid loss of kidney function which typically happens as a complication of another serious illness or intervention. Because pain and other symptoms don’t usually occur, AKI can be difficult to identify, but to preserve kidney function it is essent
Slide 12: A Major Public Health Concern
Acute Kidney Injury (AKI) A Major Public Health Concern 230% 2 Million $10 Billion Increase in 10 years Deaths worldwide Increase in U.S. of in-hospital AKI in each year hospital costs U.S. AKI is common, complex and lacking diagnostic tools to help quickly identify kidney injury and aid clinicians
Slide 13: Recent Political Focus on Kidney Disease
Trump signs Executive Order to improve treatment of kidney disease Recent Political Focus on Kidney Disease © Copyright BioPorto 13
Slide 14: AMI Validates the Need for AKI Innovation
Cardiac biomarkers vs. kidney biomarkers AMI Validates the Need for AKI Innovation 40% Patients with probable AKI missed by consensus criteria. A similar proportion to that identified by troponin in subjects with myocardial injury missed by conventional biomarkers.1 © Copyright BioPorto 14
Slide 15: Standard of Care is Slow and Non-specific
AKI assessment tools Standard of Care is Slow and Non-specific The NGAL Test* is a tool to aid in the risk assessment of AKI in critically ill patients. As a marker that responds within 2 hours of kidney injury, NGAL can provide a faster assessment of AKI risk – two to three days faster than serum c
Slide 16: NGAL biomarker integrated with sCr
Early identification of AKI risk NGAL biomarker integrated with sCr Cause: AKI due to tubular damage Initiate: Early patient risk stratification, consult KDIGO-based management guidelines Cause: Renal hypoperfusion/volume depletion Initiate: Volume restoration/ hemodynamic stabilization Adapted from
Slide 17: Serial NGAL Testing Improving Care
Case Study: 4 mo. old in the cardiac ICU with hypoplastic left heart syndrome, respiratory failure, mechanical ventilation Serial NGAL Testing Improving Care Case Highlights Corresponding to Numbered Arrows • After 4 days in the CICU, nephrology was consulted due to rising creatinine levels. Initial
Slide 18: Clinical Applications of The NGAL Test
Clinical Applications of The NGAL Test* Adults Pediatrics “The limitation in AKI detection may be limiting doctors’ abilities to get ahead of injury... NGAL is a 1 in 4 real-time tool, potentially 1 in 5 adults affected with AKI allowing us to be proactive during a hospital episode of critically ill
Slide 19: Benefits Across the Healthcare Ecosystem
The NGAL Test 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 Avoid false negative diagnoses
Slide 20: Addresses a Significant Unmet Need
The NGAL Test* Addresses a Significant Unmet Need Trauma, Chemotherapy, etc. (New indications) Exclusion of AKI in the ED (Label expansion) +100M Tests ~$2B Monitoring of AKI (Label expansion) Pediatric ICU 5-10M Tests ~$100-200M (Breakthrough Designation, May 2019) Adult Risk Prediction in ICU +150
Slide 21: Building U.S. Market Awareness of NGAL
Resource allocation Building U.S. Market Awareness of NGAL Patient Organizations • Leverage BioPorto’s strategic investments in (National establishing the clinical need for NGAL as Kidney Foundation) a biomarker for AKI risk assessment • U.S. commercial team expanded Q2 2019 KOLs and Research Use Pe
Slide 22: Targeted 2019 Milestones
Clinical, regulatory and commercial Targeted 2019 Milestones • Submission of The NGAL Test for pediatrics • Build RUO sales and awareness of AKI and NGAL in the U.S. ahead of launch • Supplementary data to FDA to support clearance of The NGAL Test in adults • Build U.S. organization by onboarding le
Slide 23: Revised Financial Projections for 2019
Revised Financial Projections for 2019 Revenue EBIT loss DKK32m DKK65m Operating Loss increased due to reduced Revenue reduced from DKK 40m due to the revenue, investment in U.S. organization delay in NGAL clearance for pediatric and extra costs i.c.w. the delayed clearance © Copyright BioPorto 23
Slide 24: Financial calendar 2019
Financial calendar 2019 August 15 Q2 2019 Results November 7 Q3 2019 Results Contact: Ole Larsen (CFO) [email protected] © Copyright BioPorto