Slide 1: Q3 21 Presentation and projects update
Q3 21 Presentation and projects update October 21st, 2021
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: Gentian's value proposition
Gentian’s value proposition 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, high-throughput analysers, G
Slide 4: Introduction and highlights
Introduction and highlights
Slide 5: Portfolio of high-impact tests provides solid growth opportunity
Portfolio of high-impact tests provides solid growth opportunity 7* tests contributing Revenue ambition to saving costs and of NOK 1bn in protecting life 5-7 years** Delivered ~30% Industry leading annual revenue team and knowhow growth 2017-20 * 5 launched, further 2 in development. **Dependent on
Slide 6: 7 diagnostic tests, including two potential blockbusters
7 diagnostic tests, including two potential blockbusters ESTABLISHED PRODUCTS IN MARKET IN PRODUCT DEVELOPMENT DEVELOPMENT Inflammation Inflammation Kidney disease & infection Inflammation Pancreas & infection Inflammation Cardiac Cystatin C Canine CRP fCAL® fPELA® GCAL® SARS-CoV-2 NT-proBNP 2006 20
Slide 7: Ageing and growing population driving diagnostics demand
Ageing and growing population driving diagnostics demand Market outlook Key drivers USDbn Addressable Market 12 Addressable Market Serviceable Market • Increasing average age and population growth drives 10 increase in chronic diseases and infectious diseases globally +5-6% Serviceable Market 8 • Ge
Slide 8: Ambitions for impact, high growth and value creation
Ambitions for impact, high growth and value creation Market opportunity and long-term ambitions Strategic pillars • Grow annual revenue from established products through additional commercial partners and regulatory approvals 5-7 year revenue ambition* NOK 1bn • Prove clinical relevance of GCAL for
Slide 9: Q3 2021 highlights
Q3 2021 highlights Sales EBITDA • Total operating revenue of NOK 19.4 million, up 20% from Q3 2020. EBITDA of NOK -4.2 million compared to NOK -5.5 in NOK 17.2m NOK -4.2m the corresponding quarter in 2020 +30% vs Q3’20 NOK 1.3m vs Q3’20 • Sales revenue of NOK 17.2 million, up 30% compared to Q3 2020
Slide 10: Financial review
Financial review
Slide 11: Financial highlights
Financial highlights NOKm Q3 2021 Q3 2020 YTD 2021 YTD 2020 Sales 17.2 13.2 61.4 46.1 Other revenues 2.2 2.8 13.7 8.9 Total revenues 19.4 16.1 75.1 55.1 COGS 10.8 7.3 32.6 32.6 Employee benefit expenses 8.9 9.7 27.3 28.1 D&A 2.4 1.5 6.3 4.7 Other OPEX 3.9 4.5 22.2 13.5 EBITDA -4.2 -5.4 -7.0 -10.1 EB
Slide 12: Sales and other revenues
Sales and other revenues Sales - geographic split • Total revenue of NOK 19.4m in the quarter, up 20% vs Q3 20 3Q21 3Q20 YTD21 YTD20 NOKm • 37% growth in organic sales (30% reported) US 0.6 0.6 2.0 2.3 • Particularly driven by increased adoption of Cystatin C as a routine marker for chronic kidney d
Slide 13: Operating expenditures in the quarter
Operating expenditures in the quarter 23 18 17 14 13 Q3 2020 Q4 2020 Q1 2021 Q2 2021 Q3 2021 OPEX • Opex declined by NOK 1.7 million, driven by higher share of capitalisation of R&D expenses • Capitalisation of R&D expenses was NOK 3.9 million, up NOKm Q3 21 Q3 20 YTD 21 YTD 20 from NOK 0.3 million
Slide 14: Strong cash position; fully financed business plan
Strong cash position; fully financed business plan NOKm Q3 21 Q3 20 YTD 21 YTD 20 Operating activities -2.1 -8.6 -13.9 -17.2 Investing activities -4.1 -0.3 -10.3 -1.9 Financing activities -1.1 -0.1 -2.3 -0.2 Changes in cash and cash equivalent -7.3 -8.9 -26.5 -19.3 Cash and cash equivalent at the be
Slide 15: Summary and outlook
Summary and outlook
Slide 16: 2021-2022 milestones
Several de-risking milestones next ~18 months ESTABLISHED PRODUCTS GCAL SARS-COV-2 AB NT-PROBNP Targeting additional large Clinical studies confirming Successful validation and Successful optimisation commercial partners relevance for sepsis and launch, scheduled for Q4 2021 COVID-19 – 6 ongoing Pub
Slide 17: Projects update
gentian Projects update
Slide 18: NT-proBNP update
Erling Sundrehagen, CSO Gentian Diagnostics ASA 21st October 2021 NT-proBNP update
Slide 19: Agenda
Agenda ▪ Introduction ▪ The science behind NT-proBNP ▪ Turbidimetric assay development ▪ Independent reference method development ▪ Outlook
Slide 20: Introduction
Introduction
Slide 21: Indicative advantages and commercial validity of Gentian's NT-proBNP assay
Indicative advantages and commercial validity of Gentian’s NT-proBNP assay Clear value proposition Strong commercial interest • Productivity gain and cost effectiveness • Established biomarker, new technology vs. current products • Market sensing confirms the value • Sample throughput of 2,000/h vs
Slide 22: NT-proBNP detecting, monitoring and assessing congestive heart failure
NT-proBNP detecting, monitoring and assessing congestive heart failure • Well established biomarker, fully integrated in the clinical routines • More than 60 million patients with heart failure per year • A health challenge that is increasing rapidly due to an ageing population and increasing obesit
Slide 23: The science behind NT-proBNP
The science behind NT-proBNP
Slide 24: The market is moving towards NT-proBNP, which is more stable than BNP
The market is moving towards NT-proBNP, which is more stable than BNP in the bloodstream • BNP half life in blood stream: appr. 20 minutes • NT-proBNP half life in blood stream: appr. 60-120 minutes Source: Human proBNP, BNP and NT-proBNP, Technotes HyTest
Slide 25: Existing assays underestimate the amount of NT-proBNP
Existing assays underestimate the amount of NT-proBNP …due to NT-proBNP being heavily glycosylated in the middle molecule region Existing assays do not recognise glycosylated The Gentian assay binds in a non-glycosylated NT-proBNP molecules area of the NT-proBNP molecule Existing NT-proBNP assays Ge
Slide 26: Existing publication supports Gentian developing a turbidimetric assay
Existing publication supports Gentian developing a turbidimetric assay Influence of enzymes on diagnostic and prognostic accuracy* 30 000 • Non-HF (n=167) HF (n=142) 2015 publication confirmed underestimation in 25 000 NT-proBNP assays, which validated Gentian’s NT-proBNP (ng/L) efforts to develop a
Slide 27: Publication in 2015 highlights lack of transferability of results
Publication in 2015 highlights the the lack of transferability of the results obtained using different techniques to measure BNP and NT-proBNP levels clinical samples Head-to-head comparison of 10 natriuretic peptide assays Delphine Collin-Chavagnac * , Monique Dehoux , Fran ç ois Schellenberg , Bru
Slide 28: Turbidimetric assay development
Turbidimetric assay development
Slide 29: Gentian has achieved turbidimetric assay calibration
Gentian has achieved turbidimetric assay calibration NT-proBNP calibration curve – Peptide 1 calibrators • In 2021, Gentian achieved turbidimetric assay Response calibration which was published in a patent application NT-proBNP (ng/L) Patent application: WO/2021/028520
Slide 30: Strong correlation between samples and methods, but need for a reference method
Gentian’s assay indicates strong correlation between samples and methods, but the need for a reference method was identified Measurement of correlation on Mindray and Turbidimetric NT-proBNP measurement vs Architect c4000 Roche Elecsys Measured NT-proBNP concentration NT-proBNP – Architect c4000(ng/
Slide 31: Gentian reference method development
Gentian reference method development
Slide 32: Introduction
Introduction • Results from market confirm the lack of harmonisation and standardisation of NT-proBNP assays as a key concern among laboratory managers and clinicians • Based on that, Gentian recently succeeded in developing an independent reference method based on established technology • This refe
Slide 33: Gentian's reference method shows increased NT-proBNP concentration compared to Roche
Gentian’s reference method shows increased NT- proBNP concentration compared to Roche Measured NT-proBNP concentration by Gentian reference method 30000 Measured NT-proBNP – Gentian 25000 R² = 0,9622 • Results of Gentian’s reference method reference method (ng/L) show higher NT-proBNP concentrations
Slide 34: Gentian has succeeded in creating an algorithm that correlates the results
Gentian has succeeded in creating an algorithm that correlates the results Algorithm Input Equation to obtain Correlating Gentian reference Output Turbidimetric assay the expected output turbidimetric assay method calibration from the given input results • To fully qualify the reference method, more
Slide 35: Outlook
Outlook
Slide 36: Addressing NT-proBNP challenges and establishing a new timeline towards launch
Addressing NT-proBNP challenges and establishing a new timeline towards launch «As communicated previously, we have encountered challenges in the optimization phase. Many of these are known challenges that we have successfully dealt with before, and as such, we will apply all the tools available to
Slide 37: NT-proBNP challenges and how they are being addressed
NT-proBNP challenges and how they are being addressed Particle instability Measurement differences in Consistency of results at low plasma and serum samples concentrations • Known issue for turbidimetric assays • Common issue for NT-proBNP • More work required to achieve assays on the market consist
Slide 38: Aim to update revised timeline in connection with Q4 results
Aim to update revised timeline in connection with Q4 results • While development risks remain, the Gentian team believes the challenges encountered in optimisation can be solved • On the back of initial results from attempts to solve the current challenges, the company aims to revert to the market i
Slide 39: Development of a novel high-throughput SARS-CoV-2 antibody test
Torsten Knüttel, VP R&D Gentian Diagnostics ASA 21st October 2021 Development of a novel high- throughput SARS-CoV-2 antibody test
Slide 40: Agenda
Agenda ▪ Introduction ▪ Pandemic Management ▪ Gentian SARS-CoV-2 Total Antibody Assay ▪ Assay application ▪ Assay quality and efficiency ▪ Documented Protection ▪ Summary & launch information
Slide 41: Introduction
Introduction
Slide 42: Introduction
Introduction • During the early days of COVID-19, Gentian has decided to contribute to the fight against this pandemic with the development of a quantitative antibody assay in case high volume testing will be required • Due to the local partnership with Tromso university and our own commercial footp
Slide 43: Pandemic Management
gentian Pandemic Management
Slide 44: Pandemic Management
Pandemic Management Provide tool for the long-term surveillance of immunity of the society Guide educated decisions about herd immunity and vaccination strategy ‘Documented protection’ possibility for the population and for all Norwegian businesses including tourism/travel
Slide 45: Gentian SARS-CoV-2 Total Antibody Assay
Gentian SARS-CoV-2 Total Antibody Assay
Slide 46: Gentian SARS-CoV-2 Total Antibody Assay
Gentian SARS-CoV-2 Total Antibody Assay Quantitative detection of total antibodies to SARS-CoV-2 spike What (S1) protein Intended to identifying patients with an adaptive immune response to Why SARS-CoV-2, indicating recent or prior infection, or a successful response to vaccination Total Antibody t
Slide 47: Assay application
gentian Assay application
Slide 48: Assay application
Assay application ▪ On already installed Clinical Chemistry Analysers ▪ Large global install base, widely available ▪ No extra infrastructure needed ▪ Standard blood test ▪ Fast High Throughput (up to 2.000 tests/hour) ▪ Results after only 10 minutes analysis time ▪ Immediate use after short applica
Slide 49: Assay quality and efficiency
Assay quality and efficiency
Slide 50: Assay quality and efficiency
Assay quality and efficiency High sensitivity Reliable assay with quantitative results (98%) and specificity (98%)* * Preliminary results Measuring total Capturing the whole immune response and multiple antibody response virus variants targeting S1 Aligned with WHO Comparable results across laborato
Slide 51: Documented Protection
.. F ~ b @-68- : / a a) : 0 Ae aa ° Documented Protection “oe
Slide 52: Documented Protection
Documented Protection Preliminary data from in-house blood samples show strong antibody response after vaccination, increasing from 1st to 2nd dose
Slide 53: Documented Protection – individual case
Documented Protection – individual case Preliminary data from in-house blood samples, following individual total antibody concentration from 1st dose vaccination to 2nd dose vaccination and thereafter Course of total antibody concentration over time as response to SARS-CoV-2 vaccine Dose 1 Dose 2 60
Slide 54: Summary
Summary
Slide 55: The Gentian antibody testing against SARS-CoV-2 can
The Gentian antibody testing against SARS-CoV-2 can Provide answers to individual and the population's immunity before and after vaccination and can be used as a tool for vaccine distribution Indicate how long protection lasts after vaccination or infection Assist with long-term monitoring, planning
Slide 56: Launch of the Gentian SARS-CoV-2 Total Antibody Assay
Launch of the Gentian SARS-CoV-2 Total Antibody Assay ▪ The assay development is currently in the final validation phase ▪ Plan to launch the CE marked assay according to the IVD Directive within Q4 2021
Slide 57: Professor Ørjan Olsvik quote on the Gentian test
“The test developed by Gentian can identify and quantitate the amount of immunoglobulins in the patients blood. This will verify the effect of the vaccine, and this information could be used to decide if the patient need another booster dose of the vaccine. For patients with infections with differen
Slide 58: Q&A
Q&A