Bioporto A/s · OMXCOP:BIOPOR
Bioporto A/s — Q3 2023 Earnings Presentation
17 slides from Bioporto A/s's earnings presentation, Nov 1, 2023
Slide 1: 2023-Q3 Financial Results & Business Update
2023-Q3 Financial Results & Business Update Empowering Early Detection of Kidney Injury November 1, 2023
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: Q3 2023 Highlights: FDA 510(k) Pre-market Notification Submission Accepted
Q3 2023 Highlights: FDA 510(k) Pre-market Notification Submission Accepted • Recorded first nine-months revenue of DKK 24.4 million, +20% as compared to the same year-ago period driven by an increase in NGAL sales • Regulatory approval pathway for NGAL moved from De Novo application to submission of
Slide 4: KDIGO Clinical Guideline Update
KDIGO Clinical Guideline Update • Comments submitted to KDIGO Statement of Work working group with respect to NGAL as an AKI and AKD as a damage biomarker • Update will refresh the current AKI/AKD practice guideline last updated in 2012 • The non-profit’s clinical AKI/AKD guideline update may includ
Slide 5: Acute Kidney Injury (AKI) - An Unmet Clinical Need
Acute Kidney Injury (AKI) - An 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. • Diffic
Slide 6: AKI is Common and Costly
AKI is Common and Costly 1 2 Increased Length of Stay Increased need for Dialysis Overall Mortality Rate 7 – 23 DAYS4 12% OF CRITICALLY ILL 21%6 ADULTS5 Hospital Patients at Risk of AKI:3 • Cardiac Surgery • Mechanical Ventilation • Sepsis $7,000 $5-20 • Organ or Bone Marrow increase billion Transpl
Slide 7: NGAL: Improving the Standard of Care
NGAL: Improving the Standard of Care Serum Creatinine is Inadequate 2-3 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 2. Haase et al. J Am Coll Cardiol 2011 3. Ricci et
Slide 8: Reagent-only Product Run on Standard Clinical Chemistry Instruments
Reagent-only Product Run on Standard Clinical Chemistry Instruments High-Value Diagnostic price point No investment in capital equipment High margins even at today’s scale © Copyright BioPorto | 8
Slide 9: US Market: Preparations U.S. NGAL Approval Moves Forward With Roche
US Market: Preparations U.S. NGAL Approval Moves Forward With Roche • Awaiting 510(k) pre-market clearance approval in order to market NGAL test for pediatric use in the ICU • Collaboration with our distribution partner Roche Diagnostics moves forward in preparation for approval will allow BioPorto
Slide 10: US TAM Growth: Broadening Compatibility & Adult Label Expansion
US TAM Growth: Broadening Compatibility & Adult Label Expansion TAM $1.2B3 Addition of 3rd Adult Label PEDIATRIC ADULT Indication United States FDA Label Expansion with 1st Adult Indication Addition of 2nd Adult Label Indication Indication Expansion Beyond ICU Expansion of Instrument Roche Agnostic
Slide 11: Our Global Sales Effort
Our Global Sales Effort Multi-pronged sales approach: • • Select and train qualified distributor partners on clinical sales Provide expert Medical Affairs support ~$1B • Engage in Direct Marketing untapped market • Leverage KOLs experienced in NGAL testing Clinical Lab Committees & Lab Electronic He
Slide 12: Gain FDA Approval, Expand Total TAM in the U.S. Grow the Business in ROW
Gain FDA Approval, Expand Total TAM in the U.S. Grow the Business in ROW Our Strategic Focus Strengthen to Scale Attract, Develop & Retain the & Execute Best Employees • Support FDA approval of NGAL • Execute appropriate financing • Proactively recruit the most test for Pediatrics rounds qualified t
Slide 13: Revenue: DKKm 24.4, up 20% YTD over prior year
Revenue: DKKm 24.4, up 20% YTD over prior year Annual Revenue by Product Group* Revenue by Quarter* 2022 2023 NGAL Tests Antibodies Others 14.9 15.2 8.5 8.6 8.0 7.7 12.0 Q4 Q3 6.5 Q4 5.3 Q3 7.9 Q3 Q2 Q3 Q2 Q2 Q2 2.1 Q1 1.3 Q1 Q1 Q1 2022 2023 2022 2023 2022 2023 Q1 Q2 Q3 * all amounts in DKKm © Copyr
Slide 14: NGAL test sales up 50% on LTM basis
NGAL test sales up 50% on LTM basis NGAL test sales by Quarter (LTM, DKKm) NGAL +68% Global NGAL 50% XX% 20.4 17.2 16.0 14.9 13.7 14.1 13.4 13.5 13.9 13.5 13.6 Growth in YTD global NGAL test sales 12.1 12.0 12.4 vs. the previous last twelve months © Copyright BioPorto | 14
Slide 15: Cash position and working capital management
Cash position and working capital management Adjusted EBITDA and cash position (DKKm) • YTD 2023 cash use from operations: Q3 2022 Q4 2022 Q1 2023 Q2 2023 Q3 2023 DKKm 53.4, primarily reflecting payment of 98.9 clinical trial and restructuring costs 81.8 85.4 • Restructuring charge: DKKm 2.9 to bett
Slide 16: 2023 Outlook
2023 Outlook Amounts in millions of Danish Kroner and US Dollars1 Actual at 2023 Outlook Sep 30, 2023 Revenue Cash2 Adj. EBITDA loss DKK 30-33 DKK (56)-(59) DKK 70 $4.4-4.8 $(8.1)-(8.6) $9.9 1All Financial Figures Converted from DKK to USD at a rate of 6.8812 as of September 30, 2023. 2Unaudited. No
Slide 17: Contacts
Contacts: EU: Tim Eriksen, Managing Partner Zenith Advisory, investor@bioporto.com +45 4529 0000 US: Ashley Robinson, Managing Director LifeSci Advisors, arr@lifesciadvisors.com +1 617 430 7577 CPH: BIOPOR