Gentian Diagnostics Asa · OSL:GENT
Gentian Diagnostics Asa — Investor Day (May 2023)
70 slides from Gentian Diagnostics Asa's investor day presentation, May 10, 2023
Slide 1: Capital Markets Day
Capital Markets Day May 10th, 2023
Slide 2: Important notice
Important notice This presentation has been prepared by and is the sole which are subject to risks, uncertainties and other factors with applicable laws and regulations. The Company require responsibility of Gentian Diagnostics ASA (the “Company” that may cause actual events to differ materially fro
Slide 3: Introduction – Dr. Hilja Ibert, CEO
Introduction – Dr. Hilja Ibert, CEO R&D review From science to sales Strategic roadmap Q&A
Slide 4: Efficient diagnostics for better treatment decisions
Efficient diagnostics for better treatment decisions The growing diagnostic market puts increasing pressure on laboratories. Still, many of the existing, clinically relevant biomarkers are only available on slow and inefficient platforms. By converting biomarkers to the most efficient automated, hig
Slide 5: High-impact diagnostics with global commercial traction
High-impact diagnostics with global commercial traction Sales office, Sweden • Gentian is a fast-growing developer and manufacturer of diagnostic tests HQ, Norway • The tests are produced in Moss, Norway, and can be used on all major clinical chemistry analysers • They are sold globally, through dir
Slide 6: Dedicated and experienced management team
Dedicated and experienced management team CEO Consulting Founder CFO & COO CCO CSO VP R&D VP QA & RA VP BD Dr. Hilja Dr. Erling Njaal Markus Dr. Alexandra Dr. Torsten Anne-Mette Jack Ibert Sundrehagen Kind Jaquemar Havelka Knüttel Horsrud Akre Andreassen 20+ years of relevant industry experience acr
Slide 7: Gentian develops and manufactures innovative and efficient diagnostic tests
Gentian develops and manufactures innovative and efficient diagnostic tests IN VITRO DIAGNOSTICS (IVD) GENTIAN DIAGNOSTICS • Tests done on samples that have been • Focused on Immunoassay, the taken from the human body such as largest IVD segment, where an blood. IVD can detect diseases, antibody1 is
Slide 8: Products targeting large and growing disease groups
Products targeting large and growing disease groups DISEASE GROUP PRODUCT APPLICATION ATTRACTIVE CLINICAL BENEFITS Kidney disease Cystatin C Early detection of reduced kidney function Preventing severe kidney failure Inflammation Fast diagnosis of inflammatory bowel disease Reducing time-consuming a
Slide 9: Delivered 26% top-line growth last four years
Delivered 26% top-line growth last four years Total revenue* and CAGR Partnerships prove viability of go-to-market model 120 112 +26% 100 NOKm Global distribution agreement for 100 GCAL®, initial roll-out in Europe 80 79 60 Long-standing commercial partnership for Cystatin C 55 40 20 Partnership for
Slide 10: Long-term ambitions rooted in recent progress
Long-term ambitions rooted in recent progress Four established products with potential to grow 20%+ annually Prove clinical relevance of GCAL and bring NT-proBNP to market 7 products with combined net revenue potential of Bring a steady stream of high-impact diagnostic tests to market NOKUnrisked 1b
Slide 11: R&D review – Dr. Torsten Knüttel, VP R&D
Introduction R&D review – Dr. Torsten Knüttel, VP R&D From science to sales Strategic roadmap Q&A
Slide 12: R&D review
R&D review
Slide 13: R&D team Organization & Capabilities
R&D team Organization & Capabilities R&D Team • 13 Staff • Experience from academia and • International (7 nations) industry (amongst others Roche, • High education, Abbott, Thermo Fisher Scientific) all Master level (8 PhD’s) • 11 patents Research Development & Life Cycle Late Phase Network Technic
Slide 14: R&D team organization and approach to product development
R&D team organization and approach to product development RESEARCH DEVELOPMENT LAUNCH & LIFE CYCLE EXPLORATION PROOF OF CONCEPT OPTIMISATION VERIFICATION VALIDATION LAUNCH Clinical and Technical Prototype Prototype formally Final product Product made commercial feasibility developed and evaluated ag
Slide 15: R&D team organization and approach to product development
R&D team organization and approach to product development RESEARCH DEVELOPMENT LAUNCH & LIFE CYCLE EXPLORATION PROOF OF CONCEPT OPTIMISATION VERIFICATION VALIDATION LAUNCH Clinical and Technical Prototype Prototype formally Final product Product made commercial feasibility developed and evaluated ag
Slide 16: NT-proBNP: Strong value proposition and commercial interest
NT-proBNP: Strong value proposition and commercial interest Clear value proposition • Productivity gain and cost effectiveness vs. current products • Sample throughput of 2,000/h vs 700/h • Enabling instrument independent harmonisation and standardization Strong commercial interest • Established bio
Slide 17: Highly sensitive particle enhanced assay for NT-proBNP quantification
“Highly sensitive particle enhanced assay for NT-proBNP quantification” US Patent application describing the NT-proBNP assay • In the US, a first application has already resulted in a granted patent US 11,609,230 (2023-03-21), this patent can be maintained until 2041 US PATENT • A second US applicat
Slide 18: Recent progress made on NT-proBNP in development
Recent progress made on NT-proBNP in development • Gentian’s NT-proBNP assay is currently in the optimization phase of development and aims to be the first turbidimetric in vitro diagnostic test for the quantitative measurement of NT-proBNP • Work on a simpler and more efficient calibration method o
Slide 19: From science to sales – Markus Jaquemar, CCO, and Dr. Aleksandra Havelka, CSO
Introduction R&D review From science to sales – Markus Jaquemar, CCO, and Dr. Aleksandra Havelka, CSO Strategic roadmap Q&A
Slide 20: From Science to Sales
• Cystatin C – launched 2006 • cCRP – launched 2012 From Science to Sales • fCAL® Turbo – launched 2015 • GCAL® – launched 2019 Gentian’s successful journey • fPELA® Turbo – launched 2020 • SARS-COV2 AB – launched for key products 2022
Slide 21: Historical revenues 2019 to 2022
Historical revenues 2019 to 2022 More than doubled sales revenues in 3 years Sales revenue major products Sales revenue other launched products NOKm, % CAGR NOKm, % CAGR 45 12 40 20% 35% 10 35 20% 17% 30 8 25 6 20 15 4 73% 10 75% 2 5 - - 2019 2020 2021 2022 2019 2020 2021 2022 Cystatin C fCAL GCAL f
Slide 22: Diversified sales model to ensure broad market access and maximize penetration
Diversified sales model to ensure broad market access and maximize penetration Global diagnostics companies Specialized/local distributors Healthcare providers • Enables broad roll-out and • Provides accelerated time to broad • Sales to end-users and key opinion acceptance of products awareness lead
Slide 23: Diagnostic testing market pain points
Diagnostic testing market pain points Fast and Severe Cost pressure accurate results laboratory staff to clinicians shortages
Slide 24: Gentian's successful journey for key products
Gentian’s successful journey for key products This session will focus on the development from clinical evidence to sales and cover: Bühlmann fCAL® Gentian Cystatin C Turbo /fPELA® Gentian GCAL® Turbo
Slide 25: Cystatin C
Cystatin C Preventing severe kidney failures
Slide 26: Cystatin C is a higher value biomarker than standard Creatinine testing
Cystatin C is a higher value biomarker than standard Creatinine testing • Cystatin C is a superior glomerular filtration rate (GFR) marker for the diagnosis and therapeutic control of renal function • Early detection of reduced kidney function • Cystatin C is body mass and race independent, creatini
Slide 27: Cystatin C – achieved milestones
Cystatin C – achieved milestones • Introduced in 2006 • CE-IVD certified 2006 • FDA 510(k) in 2007 • First global partner agreement with Beckman Coulter for China and internationally - 2008 • CE-IVDR achieved 2022 • Exceeded 10M tests production – 2022 • Achieved 40MNOK sales in 2022 • 2 distributio
Slide 28: Gentian is synonymous with Cystatin C
Gentian is synonymous with Cystatin C • The Gentian assay was used to evaluate the commutability of the IFCC reference material (ERM- DA471/IFCC) in 2010 • Gentian Cystatin C established as reference standard in external quality control schemes • Strong brand recognition for Gentian Cystatin C, espe
Slide 29: Cystatin C – Substantial growth potential for Gentian
Cystatin C – Substantial growth potential for Gentian Several growth factors anticipated MARKET 2023 MARKET 2028 Market size ex. China 100MUSD 250MUSD • Market growth through further adoption in recommendations and guidelines • Additional global IVD partners signed up and in the pipeline • Close rel
Slide 30: Momentum driven by change in recommendations
Momentum driven by change in recommendations NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Diseases The adoption of the new eGFR 2021 CKD EPI creatinine equation that estimates kidney function without a race variable Increased use of cystatin C combined with serum (blo
Slide 31: New guidelines in preparation
New guidelines in preparation Additional recommendations for the use of Cystatin C KDIGO (Kidney Disease – Improving Global Outcomes) KDIGO is updating its recommendations in 2023 including the suggestion for increased use of Cystatin C testing globally. KDIGO is a global organization developing and
Slide 32: Strong network with global key opinion leaders
Strong network with global key opinion leaders Gentian supporting key initiatives to improve kidney disease treatment
Slide 33: Strong momentum for Cystatin C
Strong momentum for Cystatin C Strong support from the healthcare community • Broad endorsement from the scientific community • Momentum driven by change in recommendations • Intensive interaction with business partners to drive commercial success
Slide 34: fCAL® turbo
fCAL® turbo Diagnosis and monitoring of Inflammatory Bowel Disease (IBD) Reduces the need of colon endoscopic examination
Slide 35: For diagnosis and monitoring of Inflammatory Bowel Disease (IBD)
For diagnosis and monitoring of Inflammatory Bowel Disease (IBD) Convenient Platform agnostic Estimated market Continued growth Acquisition of turbidimetric testing and full value of 80-100 due to increasing strong global testing of faecal automation M$ with 15-20% demand and commercial samples on c
Slide 36: The only assay on the market with full automation
The only assay on the market with full automation – from patient performed extraction to analysis Customer statements after implementation of patient-performed extraction Customer #1 Former challenges with stool extraction? Extraction was time-consuming requiring one biomedical technician for a whol
Slide 37: Guidelines drive recent adoption in the US
Guidelines drive recent adoption in the US The importance of guidelines Changes in US guidelines • Same level of care for all patients • 2019 – American College of Gastroenterology - Guideline for use of fecal calprotectin • Standardisation of diagnosis and treatment for ulcerative colitis • Endorse
Slide 38: fPELA®
fPELA® Combination test with fCAL® turbo from the same sample Diagnosis and disease monitoring of Pancreatic Exocrine Insufficiency
Slide 39: GCAL® Calprotectin
GCAL® Calprotectin Fast and accurate biomarker for detection of infection and inflammation, including avoidance of sepsis.
Slide 40: Calprotectin – clinically relevant biomarker with high potential
Calprotectin – clinically relevant biomarker with high potential Part of innate immunity - inborn resistance against infections that an individual possesses right from birth • Discovered in early 1980s by Magne Fagerhol and his research team at Oslo University Hospital • Fast release upon activation
Slide 41: Growing number of publications
Growing number of publications More than 6,700 studies on calprotectin Results from 14 peer reviewed have been published in total publications commissioned by Gentian • Proven that GCAL is an early biomarker Strong • Kinetic properties (faster than increase in competitive biomarkers) publications pa
Slide 42: Health economic study points to significant savings potential by use of GCAL
Health economic study points to significant savings potential by use of GCAL in critically ill patients Early detection of infection in ICU patients results in • Shorter stay at the ICU (up to 2 days) and general ward (up to 8 days) • Savings of up to 14 000 EUR per patient • Decreased mortality by
Slide 43: Broad range of clinical applications – significant market opportunity
Broad range of clinical applications – significant market opportunity Severe infections • Bacterial infections / Sepsis • COVID-19 Inflammatory conditions • Rheumatoid arthritis (RA) • Juvenile Idiopathic arthritis (JIA) and Systemic Juvenile Idiopathic Arthritis (sJIA) • Systemic lupus erythematosu
Slide 44: Endorsement by Key Opinion Leaders
Endorsement by Key Opinion Leaders The clinical research program has Researchers and clinicians at raised attention with Key Opinion high-ranked hospitals are Leaders endorsing GCAL for usage in clinical routine Examples International Sepsis Forum (ISF) Council • Global KOLs within critical care • C
Slide 45: ECCMID 2023 meeting
ECCMID 2023: Large international meeting of clinical microbiologists and infectious diseases specialists with around 14,000 attendees Dr. Evangelos Giamarellos-Bourboulis speaks about value of calprotectin in organ dysfunction
Slide 46: Dr. Wolfgang Bauer presented strong results related to GCAL in acute infections and sepsis
Dr. Wolfgang Bauer presented strong results related to GCAL in acute infections and sepsis Calprotectin in Acute Infections and Sepsis for Prognosis, Characterization and Diagnosis in the Emergency Department CASCADE-Trial Wolfgang Bauer, MD ECCMID 2023 Department of Emergency Medicine Charité – Uni
Slide 47: Prospective evaluation of Calprotectin: CASCADE TRIAL
Prospective evaluation of Calprotectin in a real-life emergency department setting: CASCADE TRIAL 399 Summary Great performance of calprotectin Number of enrolled patients in detection of bacterial infections 197 Better performance of calprotectin in prediction of sepsis and Adults with clinical sus
Slide 48: Prospective evaluation of Calprotectin: CASCADE TRIAL
Prospective evaluation of Calprotectin in a real-life emergency department setting: CASCADE TRIAL ED Case Reports from the trial….
Slide 49: Emergency department case report I
Emergency department case report I Michael, 56 years Patient presents at the emergency department with weakness Vital signs BP: 163/89 mmHg Medical history: HR: 105/min Type 1 diabetes RR: 15/min SaO2: 99% Temp: 36.6°C • Physical exam & chest X-ray & urine test: Normal • Superficial wound on the rig
Slide 50: Emergency department case report II
Emergency department case report II Peter, 85 years Resident in nursing home Vital signs BP: 122/75 mmHg Presents at the ED with fever, altered mental status, cloudy urine HR: 117/min Medical history: RR: 24/min SaO2: 92% Late-stage Alzheimer's disease Temp: 38.1°C • Routinely used biomarkers are sl
Slide 51: GCAL has a wide area of use proven in clinical studies
GCAL has a wide area of use proven in clinical studies Infectious and Pathogen Level of Care Prognosis non-infectious Therapy disease ICU Ward Outpatient
Slide 52: The GCAL value is proven – gaining commercial traction
The GCAL value is proven – gaining commercial traction Value of GCAL in early detection of infection and inflammation as Clinical studies well as estimation of disease severity have been proven Several KOL’s on board and increasing demand for new Endorsement from KOL’s studies and collaboration Adop
Slide 53: Strategic roadmap – Njaal Kind, CFO and COO
Introduction R&D review From science to sales Strategic roadmap – Njaal Kind, CFO and COO Q&A
Slide 54: Strategic roadmap
Strategic roadmap
Slide 55: Attractive value proposition: fast results and lower costs
Attractive value proposition: fast results and lower costs The industry challenge Gentian’s solution High-value benefits Many of the existing, but clinically Gentian converts existing biomarkers relevant biomarkers are available only to the most efficient automated, high- Faster results leading to b
Slide 56: Strong demand growth: USD1.8bn market growing 5-10% annually
Strong demand growth: USD1.8bn market growing 5-10% annually Serviceable Market Total Addressable Total Serviceable Target market share, Gentian’s annual growth rate, Market, USDm Market, USDm unrisked revenue take next 4-6 years Established products 2,200 220 ~25% 30-50% 5-10% GCAL infection 1,000
Slide 57: Diversified revenue stream: a portfolio of high-impact tests
Diversified revenue stream: a portfolio of high-impact tests ESTABLISHED PRODUCTS IN MARKET DEVELOPMENT ROLL-OUT 2006 2012 2015 2020 2017 2019 Q1 2022 PRODUCT Cystatin C Canine CRP fCAL® fPELA® 3rd party GCAL® SARS-CoV-2 Inflammation Inflammation USE-CASE Kidney disease Inflammation Pancreas Various
Slide 58: On track for profitability: operational leverage, long-term contracts and comfortable cash position
On track for profitability: operational leverage, long-term contracts and comfortable cash position Costs ex R&D Revenue source Cash position % of sales revenue % of sales revenue 1Q23 as of end 1Q23 69% 47% 40% 76 MNOK 56% 52% 48% 78% 2018 2022 Q1'23 COGS Other OPEX Long-term contracts Spot sales
Slide 59: Positioned for strong value creation: high growth and scalability
Positioned for strong value creation: high growth and scalability Enabling 40% long-term EBITDA margin Monthly sales revenue 1Q19-1Q23 Commercial traction Revenue potential by product group LTM, NOKm As per 1Q23 2028 120 • Commercial interest for 100 2x Gentian NT-proBNP in optimisation • Two potent
Slide 60: Highlights
Highlights Faster diagnostic results, enabling better treatment decisions, and 3-10x higher throughput Attractive value proposition significantly improving laboratory productivity and cost-efficiency USD 1.8 billion diagnostics market opportunity growing at 5-10% per year supported by Strong demand
Slide 61: Q&A
Introduction R&D review From science to sales Strategic roadmap Q&A
Slide 62: gentian
gentian
Slide 63: Appendix
Appendix
Slide 64: Several de-risking milestones expected next 12-18 months
Several de-risking milestones expected next 12-18 months ESTABLISHED PRODUCTS GCAL PIPELINE PRODUCTS Targeting additional large and medium Clinical studies confirming patient Successful optimisation of NT-proBNP size commercial partners globally outcomes and relevance for the early detection of infe
Slide 65: P&L highlights
P&L highlights MNOK 1Q23 1Q22 2022 2021 Sales 31.4 20.6 101.6 83.1 Other revenues 2.2 2.5 10.3 16.9 Total revenues 33.6 23.1 111.9 100.0 COGS -15.0 -11.6 -52.6 -43.2 Employee benefit expenses -11.8 -8.5 -40.9 -39.5 D&A -2.4 -2.1 -10.2 -7.4 Other OPEX -7.3 -7.1 -31.4 -32.8 EBITDA -0.5 -4.2 -13.0 -15.
Slide 66: Cash flow highlights
Cash flow highlights MNOK 1Q23 1Q22 2022 2021 Operating activities -3.3 -11.4 -14.0 -27.1 Investing activities -1.1 -2.2 -14.7 -12.8 Financing activities -1.1 -1.1 -4.3 -3.1 Changes in cash and cash equivalent -5.5 -14.8 -33.0 -43.0 Cash and cash equivalent at the beginning of period 81.6 114.9 114.
Slide 67: Balance sheet highlights
Balance sheet highlights Assets 2023 2022 Equity and liabilities 2023 2022 All numbers in MNOK 31 March 31 March All numbers in MNOK 31 March 31 March Intangible assets 27.2 26.4 Total paid-in equity 311.4 307.5 Total non-current assets 48.2 44.7 Retained earnings -157.2 -139.1 Inventory 39.1 31.4 T
Slide 68: Management team
Management team CEO Consulting Founder CFO & COO CCO CSO VP R&D VP QA & RA VP BD Hilja Erling Njaal Markus Alexandra Torsten Anne-Mette Jack Ibert Sundrehagen Kind Jaquemar Havelka Knüttel Horsrud Akre Andreassen 25+ years’ experience from Erling Sundrehagen, co- 20+ years experience and 30+ years e
Slide 69: Board of directors
Board of directors Tomas Espen T. Kari E. Kjersti Fredrik Monika Frank Settevik Jørgensen Krogstad Grimsrud Thoresen Neuman Frantzen Chair of Board member Board member Board member Board member Board member Board member the Board Tomas Settevik has Espen Tidemann Kari Krogstad has Kjersti Grimsrud i
Slide 70: Top 20 shareholders
Top 20 shareholders Shareholder No of shares % Vatne Equity AS 2 110 224 13.68 % Kvantia AS 1 623 368 10.53 % Holta Life Sciences AS 1 214 702 7.88 % Verdipapirfondet Delphi Nordic 987 104 6.40 % Safrino AS 749 700 4.86 % Carpe Diem Afseth AS 532 589 3.45 % Skandinaviska Enskilda Banken AB 499 315 3