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Gentian Diagnostics ASA

Investor Presentation Sep 7, 2022

3604_rns_2022-09-07_fe4f2746-0320-4dd4-aa0e-6218588cb52c.pdf

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Pareto Healthcare Conference September 2022

Innovative and efficient diagnostics

ADDRESSING HIGH-VALUE MARKETS

Important notice

This presentation has been prepared by and is the sole responsibility of Gentian Diagnostics ASA (the "Company" or "Gentian"). The presentation is furnished to you solely for your information and may not be reproduced or redistributed, in whole or in part, to any other person. The information herein and any other material discussed is subject to change.

The presentation contains certain forward-looking statements relating to the business, future financial performance and results of the Company and/or the industry in which it operates. Forward-looking statements concern future circumstances and results and other statements that are not historical facts, sometimes identified by the words "believes", "expects", "predicts", "intends", "projects", "plans", "estimates", "aims", "foresees", "anticipates", "targets", and similar expressions. Any forward-looking statements contained herein, including assumptions, opinions and views of the Company or cited from third party sources are solely opinions and forecasts

which are subject to risks, uncertainties and other factors that may cause actual events to differ materially from any anticipated development. Potential investors are expressly advised that financial projections, such as the revenue and cash flow projections contained herein, cannot be used as reliable indicators of future revenues or cash flows. The Company (nor any of its parent or subsidiary undertakings) does not provide any assurance that the assumptions underlying such forward-looking statements are free from errors nor does any of them accept any responsibility for the future accuracy of the opinions expressed in this presentation or the actual occurrence of the forecasted developments. No obligation is assumed to update any forward-looking statements or to conform these forwardlooking statements to our actual results.

The distribution of this presentation may also in other jurisdictions be restricted by law. Accordingly, this presentation may not be distributed in any jurisdiction except under circumstances that will result in compliance with applicable laws and regulations. The Company require persons in possession of this presentation to inform themselves about, and to observe, any such restrictions.

Nothing in this presentation shall constitute an offer to sell or a solicitation of an offer to buy any shares in the Company in any jurisdiction in which such offer or solicitation is unlawful.

Nothing contained in this presentation is or should be relied upon as a promise or representation as to the future. Except where otherwise expressly indicated, this presentation speaks as of the date set out on its cover. In addition, no responsibility or liability or duty of care is or will be accepted by the Company for updating this presentation (or any additional information), correcting any inaccuracies in it which may become apparent or providing any additional information.

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, high-throughput analysers, Gentian contributes to saving costs and protecting life.

Gentian Diagnostics develops and supplies innovative and efficient reagents for the clinical diagnostics market

  • Gentian serves the global market for human and veterinary clinical diagnostic tests
  • Expertise and focus within immunochemistry, specifically in the disease areas infection, inflammation, kidney failure and congestive heart failure
  • Gentian's innovative and efficient reagents can be used on all major clinical chemistry analysers, meaning no extra investments is required by the customer
  • Sales mainly through global commercial partners, which are serving the laboratories being the end users
  • 4 established products, 2 products in market development, 1 in product development and 3 projects in exploration and 'proof of concept'

Founded 2001

Employees

>50

Revenue 2021 NOK 100m Up 27% Oslo listing OSE: GENT Market cap ~NOK 0.7bn

Portfolio of high-impact tests provides solid growth opportunity

7* tests contributing to saving costs and protecting life

Ambition to bring a steady stream of high-impact diagnostic tests to market

Annual revenue ambition of NOK 1bn in 4-6 years**

USD 1.3bn serviceable market with 8-9% annual growth

Industry leading team and knowhow

Team with proven trackrecord and industry expertise

~27% average annual revenue growth 2018-21

2 'blockbuster' tests in market and product development

How Gentian contributes to efficient diagnostics for better treatment decisions

The industry challenge

A growing diagnostics market puts increasing pressure on clinical laboratory efficiency

Many of the existing, but clinically relevant biomarkers are available only on slow and inefficient platforms

Hours from initiation of analysis to results

Gentian's solution

Particle-enhanced turbidimetric immunoassays (PETIA) based on proprietary nanoparticle technology and knowhow

Converting existing biomarkers to the most efficient automated, high-throughput analysers

10 minutes from initiation of analysis to results

3-10x higher throughput significantly improves laboratory productivity and costefficiency

Early disease detection and faster availability of clinically relevant information leads to better treatment decisions

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
& infection
fCAL Fast diagnosis of inflammatory bowel disease Reducing time-consuming and costly colonoscopy
GCAL Early detection of severe infections, including sepsis Reducing chance of fatality and treatment costs
SARS-CoV-2 Ab Measuring COVID-19 immunity Supporting community management
Canine CRP Early detection and diagnosis of inflammation in dogs High relevance of results due to dog specific CRP
Cardiac NT-proBNP Diagnosis, monitoring and assessment
of congestive heart failure
Contributing to standardization
of NT-proBNP assays
Pancreas fPELA Diagnosis of pancreatic elastase insufficiency
in combination with fCAL
Reducing time-consuming
and costly colonoscopy

USD 1.3bn global serviceable market estimated to grow by 8-9% annually next 4-6 years

Total Addressable
Market, USDbn
Total Serviceable
Market, USDm
Target market share,
unrisked
Gentian's
revenue take
Serviceable Market
annual growth rate,
next 4-6 years
Established products 1.5 180 ~25% 30-50% 5-10%
GCAL 2.0 300 ~15% 30-50% 15%
NT-proBNP 1.6 800 ~15% 30-50% 5-8%
SARS-CoV-2 Ab 2.0 20 ~25% 50% n.m.
Total 7.1 1,300 15-20% 30-50% 8-9%

Key risks include market adoption rates for GCAL, and successful launch of NT-proBNP

Sources: Kalorama 2020, company estimates. Note: Potential upside from 3 biomarkers in exploration and 'proof of concept' not included.

Dedicated and experienced management team

CEO Hilja Ibert

25+ years' experience from the international diagnostic industry, including VP International Diagnostic Solutions at Hologic and senior positions within Becton Dickinson and bioMerieux. She was previously the CEO for miDiagnostics in Belgium. Dr. Ibert holds a PhD degree in Nutrition Science from the University of Bonn, Germany.

CFO & COO

Njaal Kind

CSO Erling Sundrehagen

20+ years experience and financial management and reporting, corporate governance and Investor Relations. Mr. Kind has served as the CFO for in Eramet Comilog Manganese, France, and Investment Director in Tinfos. Kind holds a MSc from BI Norwegian Business School. Erling Sundrehagen, cofounder of Gentian, holds 25 int. patents. He has headed the development of a dozen diagnostic products, creating businesses with NOK 1bn+ revenue. Dr. Sundrehagen held management positions in Axis-Shield, Axis Biochemicals and Axis Research, and is dr.med. & cand.real from University of Oslo, Norway.

VP R&D Torsten Knüttel

extensive track-record from TiZir, UK, Business Analyst 18+ years' experience from the diagnostic industry and commercial supply chain. His background includes OEM/B2B business development at Thermo Fisher Scientific and development and production at GE Healthcare. He holds a PhD in Chemistry from the Leibniz University Hannover, Germany.

VP Clinical Affairs Alexandra Havelka

Extensive experience in laboratory medicine. She was previously Biochemist and Unit Manager at Karolinska University Laboratory, with research focusing on biomarkers for inflammation and infection. Dr Havelka holds a PhD in Experimental Oncology from Karolinska Institute in Stockholm, Sweden.

VP Global Sales Markus Jaquemar

30+ years experience in life science and diagnostics commercialisation and marketing. He held marketing, sales and business management positions at Beckman Coulter, Agilent Technologies and Becton Dickinson. He holds a Master's degree in Biology from Vienna University, Austria.

VP QA & RA Anne-Mette Horsrud Akre

20+ years of pharma industry experience, including production of pharmaceuticals and medical devices, quality management and assurance and management positions at GE Healthcare and Fresenius Kabi. She holds a Msc in Biotechnology from the Technical University of Trondheim,

VP BD Jack Andreassen

20+ years of experience from sales, market and business development from the global diagnostics industry. He was previously Associate Director, Global Market Development for OEM at Thermo Fisher. He holds a Msc in Chemistry, Biochemistry/Molecular Biology from the University of Oslo, Norway.

Norway.

Solid progress recent years with sales growth and partnerships with leading global diagnostic companies

Total revenue* and CAGR Partnerships prove viability of go-to-market model

Global distribution agreement for GCAL®, initial roll-out in Europe

Long-standing commercial partnership for Cystatin C

Partnership for fCAL initiated through Bühlmann Laboratories

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

Bring a steady stream of high-impact diagnostic tests to market

Secure one new contract with a global commercial partner per year

Grow gross margin from ~50% in 2020 to 60%+ at volume production

Long-term EBITDA margins of 40%

revenue potential of NOK 1bn in 5-7 years Revenue ambition of NOK 1bn in 4-6 years*

* Dependent on timing of NT-proBNP launch

Sales growth and milestones support long-term ambition

Q2 2022 financials Highlights

Sales EBITDA
NOK 30.1m NOK -1.2m
+22% vs Q2'21 NOK -0.3m in Q2'21
Cash New Cystatin C
NOK 92.1m agreement
NOK 138.6m in Q2'21 Announced post quarter
  • Record sales of MNOK 30.1 in 2Q22, up 22% and 19% organically
  • Announced additional distribution agreement for Cystatin C post quarter, initial rollout in the US
  • Established a Scientific Advisory Board for GCAL® to further accelerate market development
  • Good progress made on NT-proBNP product development
  • Successfully completed extension of the lab and production facilities in Moss designed to support long-term revenue ambition
  • Current demand and commercial progress support ambition of 20% annual sales growth from established products, with further upside from products in market development

Several de-risking milestones expected next 12 months

ESTABLISHED PRODUCTS GCAL SARS-COV-2 AB NT-PROBNP
S
E
N
O
T
S
E
L
MI
Targeting additional large
commercial partners
Additional regulatory approvals,
including IVDR*
Securing additional global
commercial partnerships and
continue EU rollout
Continue clinical study program
confirming relevance for the
early detection of infections,
which supports the avoidance
of sepsis and the severity
assessment of COVID-19
patients
Commercial launch, executed
in March 2022
Initiating rollout in the EU with
focus on the Nordics
Entering commercial
partnerships for the Nordics
Progress on remaining
challenges in optimisation
phase
Publication on the reference
method for standardisation
Securing endorsements
from
key opinion leaders and
global partnerships
Securing additional
endorsements from key opinion
leaders

Further potential milestones in pipeline with 1 project currently in 'proof of concept'

*IVDR: A new regulation coming into force May 2027 for existing products, and for new products being launched after 26 May 2022. IVDR requires extensive documentation of the safety, performance and quality of each diagnostic test from manufacturers through several studies on both analytical and clinical performance.

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