Slide 1: H1 & Q2 21 Presentation
H1 & Q2 21 Presentation August 25th, 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: Today’s presenters
Today’s presenters Hilja Ibert Njaal Kind CEO CFO & COO
Slide 4: Introduction and Q2 highlights
Introduction and Q2 highlights
Slide 5: 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 6: 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.
Slide 7: 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 Infection Cardiac Cystatin C Canine CRP fCAL® fPELA® GCAL® SARS-CoV-2 NT-proBNP 2006 2012
Slide 8: 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 9: 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 5-7 year revenue ambition NOK 1bn additional commercial partners and regulatory approvals • Prove clinical relevance of GCAL® for
Slide 10: Q2 2021 highlights
Q2 2021 highlights Sales EBITDA • Record total revenues of NOK 31.5m in Q2 21 and NOK NOK 25m NOK -1m 55.7m for H1 21 • EBITDA for 2Q21 was MNOK -0.8 including MNOK 3.5 of +48% vs Q2’20 NOK -1m vs Q2’20 costs related to the transfer of listing to Oslo Børs • Sales revenue of NOK 24.6m in Q2 21, a 48
Slide 11: Operational review and growth opportunities
Operational review and growth opportunities
Slide 12: Sales growth driven by broad-based progress with commercial partners
Sales growth driven by broad-based progress with commercial partners NOKm +48% • 48% sales growth (65% organic) driven by strong development for all products capturing shares in Europe and Asia • Established products Cystatin C, fCAL ® turbo, c-CRP and 25 fPELA addressing serviceable market of ~USD
Slide 13: GCAL market development efforts focusing on validation
GCAL® market development efforts focusing on validation • New biomarker, requiring adoption by key opinion leaders, public and private laboratories • Serviceable market of ~USD 300m, estimated to grow by 15% annually • 6 ongoing studies to confirm GCAL’s clinical relevance for supporting the avoidan
Slide 14: Upcoming product launches progressing as planned
Upcoming product launches progressing as planned • On track for launch of SARS-COV-2 Ab in Q4 21 • Preparations for transfer into validation phase ongoing • Serviceable market of USD 20m in the Nordics • The Norwegian Ministry of Health and Care Services, has made a change in regulations that allows
Slide 15: Regulatory update: IVDR being introduced in 2022
Regulatory update: IVDR being introduced in 2022 • The market Gentian operates in is highly regulated and the company must at all times comply with current legislation • A new legislation is being introduced in Europe from May 2022 • The current in vitro diagnostic directive will be replaced by a ne
Slide 16: On track for one new global commercial partnership per year
On track for one new global commercial partnership per year Partnerships prove viability of go-to-market model • Gentian’s main strategy is to secure broad roll-out through Long-standing commercial partnerships with global diagnostics companies partnership for Cystatin C • Adding one new resource to
Slide 17: Stable gross margin expected next 18 months
Stable gross margin expected next 18 months 30 100% NOKm 25 80% 62% 20 54% 45% 47% 47% 60% 15 40% 10 5 10 13 20% • Ambition for 60% gross margin at volume production 8 9 6 • Expect COGS in % of sales to decline over time as sales 0 0% Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021 grow and new products at
Slide 18: Financial review
Financial review
Slide 19: Financial highlights
Financial highlights NOKm Q2 2021 Q2 2020 H1 2021 H1 2020 Sales 24.6 16.6 44.2 32.9 Other revenues 6.9 3.2 11.5 6.1 Total revenues 31.5 19.9 55.7 39.0 COGS 11.4 6.3 21.8 16.2 Employee benefit expenses 8.7 9.4 18.4 18.4 D&A 2.0 1.6 4.0 3.1 Other OPEX 12.3 3.9 18.3 9.1 EBITDA -0.9 0.2 -2.8 -4.7 EBIT -
Slide 20: Sales and other revenues
Sales and other revenues Sales - geographic split • Total revenue of NOK 31.5m in the quarter, up 58% vs Q2 20 NOKm Q2 21 Q2 20 H1 21 H1 20 • 65% organic sales (48% reported) growth driven by broad-based progress with commercial partners across product portfolio US 1.0 1.0 1.4 1.7 • Established prod
Slide 21: Operating expenditures in the quarter
Operating expenditures in the quarter 23 18 17 14 15 Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021 • OPEX increased by NOK 9.3 million vs Q2 20 OPEX • Listing cost estimated to NOK 3.5 million booked in Q2 • Increase in R&D spend primarily driven by development of SARS COV-2 and NT-proBNP assays NOKm Q2 2
Slide 22: Strong cash position; fully financed business plan
Strong cash position; fully financed business plan NOKm Q2 21 Q2 20 H1 21 H1 20 Operating activities -2.9 1.1 -11.8 -8.6 Investing activities -4.0 -1.2 -6.2 -1.7 Financing activities -0.6 -0.1 -1.2 -0.1 Changes in cash and cash equivalent -7.5 -0.2 -19.2 -10.4 Cash and cash equivalent at the beginni
Slide 23: Summary and outlook
Summary and outlook
Slide 24: Several de-risking milestones next ~18 months
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 verification during commercial partners relevance for early detection of launch, scheduled for Q4 2021 2021 inf
Slide 25: Q&A
Q&A
Slide 26: Appendix
Appendix
Slide 27: Gentian Diagnostics develops and supplies innovative and efficient reagents for clinical diagnostics
Gentian Diagnostics develops and supplies innovative and efficient reagents for the clinical diagnostics market Sales office, Sweden • Gentian serves the global market for human and veterinary clinical diagnostic tests HQ, Norway • Expertise and focus within immunochemistry, specifically in the dise
Slide 28: How Gentian contributes to efficient diagnostics for better treatment decisions
How Gentian contributes to efficient diagnostics for better treatment decisions The industry challenge Gentian’s solution High-value benefits A growing diagnostics market puts increasing Particle-enhanced turbidimetric 3-10x higher throughput significantly pressure on clinical laboratory efficiency
Slide 29: 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 30: USD 1.3bn global serviceable market estimated to grow by 8-9% annually
USD 1.3bn global serviceable market estimated to grow by 8-9% annually next 5-7 years Serviceable Market Total Addressable Total Serviceable Target market share, Gentian’s annual growth rate, Market, USDbn Market, USDm unrisked revenue take next 5-7 years Established products 1.5 180 ~25% 30-50% 5-1
Slide 31: Combining avian antibodies and PETIA enables fast results and improved lab productivity
Combining avian antibodies and PETIA enables fast results and improved lab productivity Avian antibodies PETIA Avoiding interference enables Removing separation conversion to PETIA steps increases throughput and reduces cost Antibodies: Proteins used by the immune system to identify Immunoassays: Bi
Slide 32: Structured approach to product development
Structured approach to product development EXPLORATION PROOF OF CONCEPT OPTIMISATION VERIFICATION VALIDATION LAUNCH Clinical and Technical feasibility Prototype developed Prototype formally Final product tested Product made available commercial demonstrated, project and risk assessment evaluated aga
Slide 33: 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 • Gentian’s main strategy to secure broad roll-out • Accelerating time to revenue and awareness • Direct sales to select end-users and key o
Slide 34: Gentian management
Gentian management CEO CSO CFO & COO VP R&D VP Clinical Affairs VP Global Sales VP QA & RA VP BD Hilja Erling Njaal Torsten Alexandra Markus Anne-Mette Jack Ibert Sundrehagen Kind Knüttel Havelka Jaquemar Horsrud Akre Andreassen 25+ years’ experience from Erling Sundrehagen, co- 20+ years experience
Slide 35: Gentian board
Gentian board Tomas Espen Tidemann Ingrid Teigland Kari E. Susanne Runar Tomas Settevik Jørgensen Akay Krogstad Stuffers Vatne Kramar Chair of Board member Board member Board member Board member Board member Board member the Board Tomas Settevik has Espen Tidemann Ingrid Teigland Akay is a Kari Krog
Slide 36: Top 20 shareholders
Top 20 shareholders Shareholder No of Shares % Vatne Equity AS 2 010 224 13,04 % Norda ASA 1 250 068 8,11 % Holta Life Sciences AS 1 188 702 7,71 % Safrino AS 1 050 000 6,81 % Verdipapirfondet Delphi Nordic 817 045 5,30 % Salix AS 786 903 5,11 % Skandinaviska Enskilda Banken AB 783 903 5,09 % Verdip