Bioporto A/s · OMXCOP:BIOPOR
Bioporto A/s — Investor Presentation (October 2024)
34 slides from Bioporto A/s's investor presentation, Oct 22, 2024
Slide 1: Building a Commercial Platform
Building a Commercial Platform HC Andersen October 22, 2024 © Copyright BioPorto | 1
Slide 2: Forward-looking Statements
Forward-looking Statements References herein to this presentation shall mean and include this document, to publicly update or revise forward-looking statements to reflect subsequent any oral presentation accompanying this document provided by BioPorto A/S events or circumstances after the date of th
Slide 3: Agenda
Agenda How NGAL moves from research to clinical use 1. Product & Market 2. Commercial Strategy – Making a market 3. Commercial Tactics 4. US Traction 5. ROW Traction 6. Partnerships SVP Global Marketing and US Commercialization 7. Going Forward CONFIDENTIAL | © Copyright BioPorto | 3
Slide 4: Product & Market
Product & Market
Slide 5: Kidney Investments are a new growth area
Kidney Investments are a new growth area Biomarkers in the space which have a similar offering: PenKid from Shingotec KIM1 Cystatin C • Functional, commercially • Research ELISA only, part • Functional, commercially available POC in EMEA, of the Renalytix product = available on Big 5 clinical techni
Slide 6: AKI Diagnostics Market Growing at +5% yearly driven by changing paradigm
AKI Diagnostics Market Growing at +5% yearly driven by changing paradigm • The AKI market is driven by advances in early detection and diagnostic technologies. McKinsey notes a need to move to preventative care. ROW adult US adult • Recent advancements are transforming TAM TAM paradigm from Serum Cr
Slide 7: Our Product: NGAL Improves the Standard of Care in AKI – Market Maker
Our Product: NGAL Improves the Standard of Care in AKI – MARKET MAKER Standard of Care SCr is Inadequate The NGAL Test/ProNephro AKI Serum Creatinine (SCr) Actionable Results within 2 Hours 48-72 Hours to respond • 2-3 days delayed1 • 43% of patients missed using SCr alone2 • 66% of AKI misclassifie
Slide 8: NGAL assays designed to run on major clinical chemistry instruments
NGAL assays designed to run on major 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: Validation of agnostic assay, laboratorian view
Validation of agnostic assay, laboratorian view “The real winners over time will be independent companies like Bio-Porto Diagnostics, which developed an NGAL assay and worked closely with IVD companies so the assay could be adapted to Roche, Olympus, Beckman, Siemens, and so forth. People are uncomf
Slide 10: Commercial Strategy
Commercial Strategy
Slide 11: BioPorto Commercial is on plan
BioPorto Commercial is on plan BioPorto is the NGAL Market Maker From To Diagnostic innovator with Profitable, attractive Dx Current Key Commercial Objectives potential game-changing company with successful • Grow usage in Pediatrics/Young Adults (US) NGAL biomarker for AKI in-market biomarker(s) •
Slide 12: Commercial Strategy for US
Commercial Strategy for US 2024 – June 2025 July 2025 –December 2026 2027-2029 Pediatric Instrument Pediatric Indication Approved Clearance Adult Indication (FDA|IVDR) Expansion Executed • Direct sales to pediatric ICU • Direct sales to pediatric clinics and hospitals Go-to-Market • Distribution via
Slide 13: Commercial Strategy for ROW
Commercial Strategy for ROW 2024 – June 2025 July 2025 –December 2026 2027-2029 Pediatric Instrument Pediatric Indication Approved Clearance Adult indication (FDA|IVDR) Expansion Executed Distributor (Primary focus) Distributor + Go-to-Market • + local demand generation local demand generation (Prim
Slide 14: Commercial Tactics
Commercial Tactics
Slide 15: FDA approval trigged initiation of Marketing and Medical tactics
FDA approval trigged initiation of Marketing and Medical tactics to drive clinical engagement in 2024 in US and RoW Industry Internal Processes Promotion Education • Publications (GUIDANCE, • Website updates • Congresses • Corporate – MSA websites TakingFocus2) • Forecasting in SFDC • Webinars with
Slide 16: Education Process to NGAL market awareness and adoption
Education Process to NGAL market awareness and adoption Value Analysis/ Congresses Regional Blitz Single Institution Coalition building Use Plan • Podiums • Local KOL(s) • Quality metric update • Nephrology SME • Value Analysis – • Special sessions • Luncheon or dinner • Grand Rounds training pubs,
Slide 17: Sales Process at Hospitals
Focus on high acuity, high volume hospitals with PICU and ICU with outreach to ICU teams, nephrology, pharma, transplant, oncology and then lab. Sales Process at Hospitals Find an AKI champion Clinical Edu prep Clinical Edu - Grand Rounds - special controls - Dept Meetings -current publications -sit
Slide 18: US Traction
US Traction
Slide 19: Nationwide - USA
Focus on high acuity, high volume hospitals with PICU and ICU with outreach to ICU teams, nephrology, pharma, transplant, oncology and then lab. Nationwide - USA Cardiac Surgeon Fellow at CCHMC Research using NGAL Find an AKI Negotiated NGAL in contract Nephrology training to team ‘22 champion Examp
Slide 20: US Commercial: Acute Hospital Targets
US Commercial: Acute Hospital Targets Phase 1 - Priority 133 Phase 2 - PICU 325 Phase 3 - Adult 5000 • 14+ PICU beds & • Any # PICU beds • All hospitals, systems fellowship • Risk Strat ≥3mo - • Risk Strat ≥3mo - 133 • Risk Strat ≥3mo - 325 22yr 5,000 65+ 22yr • Market Awareness: • Call points: CC,
Slide 21: BioPorto's NGAL presence today
BioPorto’s NGAL presence today US News Best Children’s Hospitals 2024-2025 Honor Roll ✓ Boston Children’s Hospital ✓ Children’s Hospital Colorado ✓ Children’s Hospital of Philadelphia 7 Current ✓ Cincinnati Children’s NGAL Users ✓ Nationwide Children’s Hospital ✓ Rady Children’s Hospital ✓ Seattle C
Slide 22: Increasing NGAL RUO customer base in US
Increasing NGAL RUO customer base in US • 20+ hospitals, various uses and patient populations • RUO use as LDT of The NGAL Test - clinical and clinical research use • Number of tests monthly ranges from a few to 100s • Transition from RUO to ProNephro AKI once assay is available on instrumentation,
Slide 23: Study sites champion the message to the market
Study sites champion the message to the market Customers now: • Cincinnati Children’s • Boston Children’s • Colorado Children’s • Children’s of Atlanta • Rady Children’s • Riley Children’s Recent or Validating now : • Children’s H of Philadelphia • Texas Children’s • Seattle Children’s Awaiting FDA
Slide 24: Defining success in the US market
Defining success in the US market Needed to complete the “sale” Challenges we are addressing • A champion – time and political clout • Regulatory clearance and LDT regulation • A coalition across specialties and hospital units • Reimbursement – in patient DRG “all in one” payments for initial claim
Slide 25: ROW Traction
ROW Traction
Slide 26: CHUM - Montreal
Focus on high acuity, high volume hospitals with PICU and ICU with outreach to ICU teams, nephrology, pharma, transplant, oncology and then lab. CHUM - Montreal Nephrologist Fellow in Dublin with KOL ‘21 Presentations to CHUM team ‘21, ‘22 Find an AKI Research using NGAL Presentation in Europe ‘21 &
Slide 27: RoW key countries and indications
RoW key countries and indications Targeting large medical centers with high procedure volume Phase 1 Phase 2 Phase 3 • PED + Adult • PED + Adult • PED + Adult • Call points: • Call points: • Call points: 320 Cardiac, ICU, ED 500 Cardiac, ICU, ED +8,500 Cardiac, ICU, ED patients, Surgery patients, Su
Slide 28: RoW NGAL Clinical usage
RoW NGAL Clinical usage • +24 clinical accounts • 5 accounts in implementation • 5 in preparation to implement • 120+ clinician dialogues • 1 account in implementation • 1 account in pre- implementation
Slide 29: Partnerships
Partnerships
Slide 30: Distribution Partnerships
Distribution Partnerships Current Partners Instrument Vendors as Distribution Partners Instrument Distribution Partners (E.g. Roche, Abbott, Siemens, Beckman) • Roche • Supplies full solution to clin chem laboratories • Distributes The NGAL Test globally for c501, • Preferred vendors with establishe
Slide 31: Market Partners
Market Partners To impact protocol use of Biomarkers for AKI Acute Disease Quality Initiative (ADQI) GUIDELINES Consensus meetings on specific topics • Impact protocol usage Feed into guidelines Allow industry partners access to view the process from the • Allow for quicker sidelines uptake of new m
Slide 32: Going Forward
Going Forward
Slide 33: Going into 2025
Going into 2025 • Promotional presence in major markets with “feet on the street” and at congresses using case examples to show practical usage of NGAL • Key milestones • USA 133 forecasted for product availability and clinical readiness • EU 320 clinical use customer targets • Patient Populations:
Slide 34: Contacts:
Contacts: Niels H. Nielsen CFO (nhn@bioporto.com) Tim Eriksen, IR (tee@bioporto.com) Phone: +45 4529 0000 www.bioporto.com