Slide 1: Annual Report 2023
Annual Report 2023 BioPorto A/S Hellerup, April 4, 2024 C O N F I D E N T I A L | © Copyright BioPorto
Slide 2: Forward-Looking Statements
Forward-Looking Statements References herein to this presentation shall mean and include this document, any oral presentation accompanying this document provided by BioPorto A/S (the “Company” or “BioPorto”), and any further information that may be made available in connection with the subject matte
Slide 3: Highlights from 2023
Highlights from 2023 Result for financial year 2023 on FDA 510(k) clearance of ProNephro AKI (NGAL) received in par with preliminary results December 2023 – the first AKI biomarker test cleared for (February 22, 2024) pediatric and young adult use in the US! T O TA L R E V E N U E Process for implem
Slide 4: Financial results 2023
Financial results 2023 C O N F I D E N T I A L | © Copyright BioPorto
Slide 5: Revenue increased 7% to DKK 31 million in 2023
Revenue increased 7% to DKK 31 million in 2023 Annual Revenue by Product Group* Revenue by Quarter* 2022 2023 NGAL Tests Antibodies Others 18.6 8,5 8,6 8,7 8,0 7,7 Q4 14.9 6,5 6,6 12.0 Q4 Q3 5,3 10.7 Q4 Q4 Q3 Q3 Q2 Q3 Q2 Q2 Q2 2.1 Q1 1.7 Q1 Q1 Q1 2022 2023 2022 2023 2022 2023 Q1 Q2 Q3 Q4 * all amoun
Slide 6: NGAL test sales grew 25% in 2023
NGAL test sales grew 25% in 2023 NGAL test sales by Quarter (LTM, DKKm) 20,4 YoY growth in NGAL sales 18,6 relates to research use only 17,2 16,0 in the US, and general use 14,9 +25% 13,9 in Europe, Canada, Israel 13,5 13,5 13,6 12,1 12,0 12,4 and South Korea and other markets where the test is CE m
Slide 7: Tight cost control preserves solid cash position
Tight cost control preserves solid cash position • Adj. EBITDA: Adjusted EBITDA and cash position (DKKm) DKK (56) million in 2023 vs. DKK (67) million in 2022 Q4 2022 Q1 2023 Q2 2023 Q3 2023 Q4 2023 • YTD 2023 cash use from 81,8 85,4 operations: 69,9 DKK 62 million, primarily reflecting 66,4 57,7 pa
Slide 8: Strategy follow-up
Strategy follow-up C O N F I D E N T I A L | © Copyright BioPorto
Slide 9: Acute Kidney Injury (AKI) - A major Unmet Clinical Need
Acute Kidney Injury (AKI) - A major Unmet Clinical Need • An abrupt loss of kidney function that develops rapidly over a few hours or days. • Symptoms may include decreased urinary output, swelling due to fluid retention, nausea, fatigue, and shortness of breath. Often painless without symptoms. • D
Slide 10: AKI is common and costly
AKI is common and costly Hospital Patients at Risk of AKI3: • Cardiac Surgery • Mechanical Ventilation • Sepsis 7 – 23 DAYS6 12% OF CRITICALLY 21%6 ILL ADULTS5 • Organ or Bone Marrow Transplant • Nephrotoxic Agents/Drugs 1.Susantitaphong P. CJASN. 2014;9(6) 3. Zeng X. CJASN 2014 5. Hoste EA. Intensi
Slide 11: Unlocking a USD 3 billion Market Potential for ProNephro AKI
Unlocking a USD 3 billion Market Potential for ProNephro AKI TAM Global USD 3 billion US World wide, all big five instrumentations, Adult USD 1.1 billion all AKI indications Pediatric/Young Adults USD 60-80 million RoW Adult USD 1.7 billion Pediatric/Young Adults USD 90-120 million Management estima
Slide 12: From Diagnostic Innovator to attractive, profitable company with USD +100 million topline in 2029
From Diagnostic Innovator to attractive, profitable company with USD +100 million topline in 2029 Today Key initiatives BioPorto is NGAL test Market Maker Win in Pediatrics/Young ✓ Adults | US & Europe –> we need to build authentic demand Strategic Partnership / NGAL awareness is high, ✓ Instrument
Slide 13: Strategy initiatives and milestones towards 2029
Strategy initiatives and milestones towards 2029 Phase I Phase II Phase III Pediatric indication Pediatric Instrument Clearance Adult indication approved Expansion executed (FDA|IVDR) Key Objectives: Key Objectives : Key Objectives : ✓ Initiate usage in Pediatrics/Young ✓ Drive usage Pediatrics/Youn
Slide 14: Execution on Phase I strategic targets well under way
Execution on Phase I strategic targets well under way Targets for period Status by March 2024 Remaining part of 2024 until mid-2025 Key Objectives : Status: Q2 2024: • Initiate usage in Pediatrics/young ✓ Instrument expansion process • Expand sales of NGAL products and adults (US). initiated (US ped
Slide 15: Instrument Expansion Program on Track
Instrument Expansion Program on Track - extending Serviceable Obtainable Market for ProNephro AKI • ProNephro AKI cleared by FDA for marketing on Roche cobas c 501 analyzers in Pediatric and Young Adult indication. • New global agreement with Roche for cobas c503 in addition to the c501 and c502 ana
Slide 16: Protocol for Adult ProNephro AKI indication drafted – next step is FDA dialog
Protocol for Adult ProNephro AKI indication for General ICU Risk Assessment drafted – next step is FDA dialog • Primary Regulatory Target is FDA clearance for General ICU Risk Assessment - similar to pediatric indication. • Project initiation begun – literature review completed, KOLs and biostatisti
Slide 17: FDA clearance is driver for clinicians to consider NGAL's broad clinical value
FDA clearance is driver for clinicians to consider NGAL’s broad clinical Value and increase sales in Rest of the World 2024 – June 2025 July 2025 –December 2026 2027-2029 Clearance Adult indication 1 Phase I 2 Phase II 3 (FDA|IVDR) • Distributor (Primary focus) • Distributor + Go-to- • + local deman
Slide 18: BioPorto to raise up to USD 20 Million by 2025
BioPorto to raise up to USD 20 Million by 2025 and use proceeds to Unlock the USD 2.8 Billion Adult Market for ProNehpro AKI • To maximize BioPorto’s growth and value creation potential, opportunities to bolster its financial position are being investigated. • The company anticipates raising up to U
Slide 19: Financial outlook
Financial outlook C O N F I D E N T I A L | © Copyright BioPorto
Slide 20: 2024 Financial outlook (unchanged)
2024 Financial outlook (unchanged) Amounts in millions of Danish Kroner and US Dollars1 2024 2024 Key revenue drivers for 30% growth DKK 40 DKK (75)-(90) • Increased sales of NGAL, primarily in the US with halo effect in RoW. million million Adj. EBITDA Revenue • Backend-loaded as Roche commercializ
Slide 21: Long term financial ambition (unchanged)
Long term financial ambition (unchanged) 2026 2029 Revenue Revenue USD 15-25 USD +100 • Grow revenues with 3-5x from 2023 level by 2026 by expanding million million ProNephro AKI sales in the US and ROW. • Steep growth in 2027 and onwards, Cash Flow positive Cash Flow following an FDA clearance for
Slide 22: Q&A Financial Calendar
Q&A Financial Calendar April 30, 2024 Annual General Meeting May 8, 2024 Interim report, Q1 2024 August 1, 2024 Interim report, Q2 2024 October 30, 2024 Interim report, Q3 2024 C O N F I D E N T I A L | © Copyright BioPorto