Bioporto A/s · OMXCOP:BIOPOR
Bioporto A/s — Investor Presentation (February 2024)
28 slides from Bioporto A/s's investor presentation, Feb 22, 2024
Slide 1: Investor Presentation BioPorto A/S
Investor Presentation BioPorto A/S Hellerup, February 22, 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 and Strategic Objectives
Highlights and Strategic Objectives C O N F I D E N T I A L | © Copyright BioPorto
Slide 4: Highlights from 2023
Highlights from 2023 T O TA L R E V E N U E Submission of application and pediatric and young adult FDA DKK 31 million 510(k) clearance of ProNephro AKI (NGAL) in December 2023 – a 7% increase over same period the the first AKI biomarker test cleared for pediatric and young adult prior year use in t
Slide 5: 2024 Diagnostic Innovator: ProNephro AKI to boost revenue to USD 100+ million by 2029
ProNephro AKI for adults and pediatrics will boost revenue to USD +100 million by 2029 • Successful FDA clearance process for ProNephro AKI driven by strong team and close dialog with FDA. • Accelerated strategy to focus on 1) securing commercial traction in the US for clinical testing of pediatric
Slide 6: From Diagnostic Innovator to attractive, profitable Dx company by 2029 with USD +100m topline
From Diagnostic Innovator to attractive, profitable Dx company by 2029 with USD +100m topline • Revenue expected to increase By 2029 to USD 15-25 million by 2026 as BioPorto expands its Phase I Phase II Phase III 2024 to mid-2025 Mid-2025 to 2026 2027 to 2029 serviceable market by +50% via expansion
Slide 7: About Acute Kidney Injury
About Acute Kidney Injury C O N F I D E N T I A L | © Copyright BioPorto
Slide 8: 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 9: 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 10: ProNephro improves the Standard of Care
ProNephro improves the Standard of Care Serum Creatinine is Inadequate Hospital Patients at Risk of AKI3: • 2-23 days delayed1. • 43% of patients missed using SCr alone2. • 66% of AKI is misclassified3. • 70% of clinicians believe they are missing AKI4. 1. Devarajan P. Biomark Med. 2010;4(2):265-280
Slide 11: Enables personalized, differentiated treatment based on AKI phenotypes
..and enables clinicians to deliver personalized, differentiated treatment based on AKI phenotypes Serum Creatinine is Inadequate 1. Devarajan P. Biomark Med. 2010;4(2):265-280 2. Haase et al. J Am Coll Cardiol 2011 3. Ricci et al J Cardiothorac Vasc Anesth. 2022 4. A Multidisciplinary and Internati
Slide 12: Strategic roadmap
Strategic roadmap C O N F I D E N T I A L | © Copyright BioPorto
Slide 13: USD 3 Billion market for ProNephro AKI
USD 3 Billion market for ProNephro AKI TAM Global USD 3 Billion US World wide, all big five instrumentations, Adult USD 1.1 Bn all AKI indications Pediatric/Young Adults USD 60-80 million RoW Adult USD 1.7 Bn Pediatric/Young Adults USD 90-120 million Management estimates S2N Data, BIS data US Ped Ri
Slide 14: New Strategic Plan
New Strategic Plan Phase I Phase II Phase III Pediatric / Young Adult Instrument Clearance Adult indication Indication approved Expansion executed (FDA|IVDR) Key Objectives: Key Objectives : Key Objectives : ü Initiate usage in Pediatrics/young ü Drive usage Pediatrics/Young Adults ü Initiate Adult
Slide 15: From 58%-104% CAGR in 2024-2026 to broader portfolio and high growth by 2029
From 58%-104% CAGR in 2024-2026 to broader portfolio and high growth by 2029 Today Key initiatives From To BioPorto is the ProNephro AKI (NGAL) Diagnostic Innovator with Profitable, attractive potential game-changing Diagnostic company with Win in Pediatrics/Young Market Maker – we need ü NGAL bioma
Slide 16: Roadmap for Pediatrics
Roadmap for Pediatrics C O N F I D E N T I A L | © Copyright BioPorto
Slide 17: Commercial strategy for Pediatric/Young Adult ProNephro AKI (US)
Commercial strategy for Pediatric/Young Adult ProNephro AKI (US) 2024 – June 2025 July 2025 –December 2026 2027-2029 1 Pediatric / Young Adult Indication approved 2 Instrument Expansion executed 3 Clearance Adult indication (FDA|IVDR) • Direct sales to ICU • Direct sales to pediatric clinics and hos
Slide 18: Strategic Partnerships to drive Instrument Expansion
Strategic Partnerships to drive Instrument Expansion - extending Serviceable Obtainable Market for ProNephro AKI • ProNephro AKI was cleared in December 2023 by FDA for marketing on Roche cobas c 501 analyzers in Pediatric and Young Adult indication • BioPorto has initiated clearance processes for a
Slide 19: Roadmap for Adult
Roadmap for Adult C O N F I D E N T I A L | © Copyright BioPorto
Slide 20: Market Attractiveness: FDA Clearance strategy utilizes Basket Clinical Study
FDA Clearance strategy utilizes Basket Clinical Study Comparison of Potential NGAL Adult Indications Higher Non-Kidney Transplant AKI DX 5.0 Non-Kidney Transplant (33K Tests) KEY Monitoring Cirrhosis ATN DX Indication (334K Tests) (539K Tests) Cirrhosis ICU Kidney Transplant Monitoring 4.0 (127K Tes
Slide 21: Adult ProNephro AKI indication for General ICU Risk Assessment expected to be submitted to FDA in 2026
Adult ProNephro AKI indication for General ICU Risk Assessment expected to be submitted to FDA in 2026 • Primary Regulatory Target is FDA clearance for General ICU Risk Assessment - similar to pediatric indication. • Project initiation has begun – literature review completed, KOLs have been engaged
Slide 22: Adult remains RoW primary Source of Business
Adult remains RoW primary Source of Business. Recent FDA clearance is driver for clinicians to consider NGAL’s broad clinical Value 2024 – June 2025 July 2025 –December 2026 2027-2029 1 Pediatric / Young Adult Indication approved 2 Instrument Expansion executed 3 Clearance Adult indication (FDA|IVDR
Slide 23: Financial guidance
Financial guidance C O N F I D E N T I A L | © Copyright BioPorto
Slide 24: 2024 Financial outlook
2024 Financial outlook 2024 2024 Key revenue drivers DKK ~40 DKK ~(80) • Pediatric/Young Adult approval US million million • Halo effect RoW Adj. EBITDA Revenue • Increased investment in demand driving activities USD 6 USD (11)-(13) Key EBITDA driver million million • EBITDA impact of FTE ramp up to
Slide 25: Long term financial ambition
Long term financial ambition 2026 2029 Revenue Revenue USD 15-25 USD +100 million million • Grow revenues with 3-5x from 2023 level by 2026 by expanding ProNephro AKI sales in the US and ROW. Cash Flow • Steep growth in 2027 and onwards, Positive at Cash Flow Positive, following an FDA clearance for
Slide 26: Unlocking USD 2.8 Billion in the Adult Market with A Vital USD 20 Million Capital Infusion
Unlocking USD 2.8 Billion in the Adult Market with A Vital USD 20 Million Capital Infusion from Current, Strategic, and Institutional Investors • To maximize BioPorto’s growth and value creation potential, the company is investigating opportunities to bolster its financial position • The FDA clearan
Slide 27: Summary
Summary BioPorto evolves from a Diagnostic Innovator to profitable, attractive Company by 2029 • 2026 : USD 15-25M Top-Line • 2029 : USD +100M Top-Line Key Must-Wins • Win in Pediatrics / Young Adults US|Europe • Kick-start Adult RUO* & Clinical usage • Adult FDA submission 2026 C O N F I D E N T I
Slide 28: Financial calendar 2024
Financial calendar 2024 April 4 April 30 May 8 August 1 October 30 2024 2024 2024 2024 2024 Annual Annual Interim Interim Interim Report General Report, Q1 Report, Q2 Report, Q3 2023 Meeting 2024 2024 2024 C O N F I D E N T I A L | © Copyright BioPorto | 28