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Gentian Diagnostics ASA

Investor Presentation May 5, 2023

3604_rns_2023-05-05_2ffe1ccb-e4b2-4e64-a483-2e3c0445ddad.pdf

Investor Presentation

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Q1 23 Presentation

May 5th, 2023

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.

Introduction

Portfolio of high-impact tests provides solid growth opportunity

7* tests contributing to saving costs and protecting life

USD 1.8bn serviceable market with 5-10% annual growth

Industry-leading team and knowhow

Team with proven trackrecord and industry expertise from market leading IVD companies

Entered partnerships with 5 major global IVD companies

Long-term ambition of NOK 1bn revenue and 40% EBITDA margin**

~28% average annual sales growth 2019-22

2 'blockbuster' tests in market and product development

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
Avoidance of underestimation of NT-proBNP
due
to glycosylation
Pancreas fPELA Diagnosis of pancreatic elastase insufficiency
in combination with fCAL
Reducing time-consuming
and costly colonoscopy

Positive market developments for GCAL

About GCAL

The early inflammation biomarker GCAL is the first Calprotectin test available on high-throughput analysers. Clinical studies confirm the potential of GCAL for the early detection and prediction of severe infectious diseases. Sepsis kills 11 million people each year, and fast results provided by GCAL could save lives and significantly reduce healthcare costs.

  • The market development of GCAL® continued to develop positively, driven by a growing body of scientific evidence supporting the relevance of the immunoassay
    • In a study from Karolinska University Hospital calprotectin measured with the GCAL® assay was the only of the studied biomarkers able to differentiate between severely ill patients with infection and patients without infection. In the study, calprotectin was found to be superior to other biomarkers in identifying patients with need for intensive care
    • A health economic model has confirmed that the use of GCAL® for early detection of infection saves costs, reduces duration of patient care and reduces in-hospital mortality for those patients
  • In March 2023, one of the largest hospitals in Sweden, implemented routine clinical use of the assay
  • GCAL® has seen initial success in first European countries together with commercial partners Siemens Healthineers, one of the global leaders in clinical diagnostics, with regional expansion underway
  • The GCAL® validation on additional clinical chemistry platforms continues, now also including the Beckman Coulter DXC700 AU platform, introduced in 2022

Progress made on NT-proBNP

About NT-proBNP

Measuring NT-proBNP levels in plasma supports diagnosis of congestive heart failure. The Gentian assay will be the first test of its kind available on high-throughput analysers which should increase laboratory productivity and reduce overall costs. Additional benefit may include addressing the underestimation issue caused by glycosylation.

  • 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 continued during the quarter.
  • Achieved notable advancements in enhancing the stability of our working prototype.
  • Begun preparations to examine the performance of our prototype assay in patient samples with confirmed clinical status of acute or chronic heart failure.
  • The development period after completion of optimisation is estimated to 6 to 9 months, with an additional 6-9 months to ensure compliance under the new IVDR regulatory regime before commercial launch.

USD 1.8bn global serviceable market estimated to grow by 5-10% annually next 4-6 years

Total Addressable
Market, USDm
Total Serviceable
Market, USDm
Target market share,
unrisked
Gentian's
revenue take
Serviceable Market
annual growth rate,
next 4-6 years
Established products 2,200 220 ~25% 30-50% 5-10%
GCAL infection
(sepsis)
1,000 440 ~15% 30-50% 7%
GCAL inflammation 1,250 250 Under evaluation 30-50 Under evaluation
NT-proBNP 1,700 900 ~15% 30-50% 5-10%
Total 6,100 1,810 >15% 30-50% 5-10%

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

Solid progress on sales growth and partnerships with leading global diagnostic companies

0

20

40

60

80

100

120

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

Long-standing commercial partnership for Cystatin C

Partnership for fCAL initiated through Bühlmann Laboratories

Financial review

Increased distribution supporting long-term growth

1Q23 financials and key milestone Highlights

Sales Gross margin
MNOK 31.4 52%
+53% vs 1Q22 44% in 1Q22
EBITDA
MNOK -0.5
MNOK -4.2 in 1Q22
New studies
confirm clinical
relevance of
GCAL

Underlying operations are EBITDA positive pre-R&D

  • Sales of MNOK 31.4 in Q123, up 53% (40% organic growth) from 1Q22
  • All products and geographic areas showed positive sales development in 1Q23 compared to 1Q22
  • Demand for Cystatin C in China stabilised after the end of the coronarelated lock-down
  • New guidelines in the US and co-marketing efforts with commercial partner Beckman Coulter resulted in new customers for Cystatin C in the US and in Europe
  • Further results from scientific studies confirmed the relevance and benefits of GCAL for the early detection and severity assessment of infections
  • EBITDA was MNOK -0.5 in 1Q23. Total R&D costs were MNOK 7.5 in the quarter

Continued high sales growth in line with target

  • 1Q23 sales up 53% (+40% organic) vs 1Q22, in line with the target of 20%+ annual sales growth from established products
  • Revenue growth contribution was achieved by all products, in all regions and via all sales channels
  • Total revenues of MNOK 33.6 in the quarter, up 46% from 1Q22
  • Other revenues related to amounts received from associated research grants and tax incentives, which was lower in the quarter due to completion of development projects

Sales revenue - geographic split

MNOK 1Q23 1Q22 2022 2021
US 2.0 1.3 6.5 2.5
Europe 22.1 15.1 71.5 55.6
Asia 7.3 4.1 23.6 25.0
Total 31.4 20.6 101.6 83.1

Sales revenue - product split

MNOK 1Q23 1Q22 2022 2021
Cystatin C 13.6 7.5 40.0 36.2
fCAL®turbo 9.5 6.8 36.3 28.0
Third-party products 3.6 2.8 10.2 8.1
Other 4.7 3.5 15.2 10.7
Total 31.4 20.6 101.6 83.1

Stable cost development

MNOK

OPEX Capitalised R&D expenses

MNOK 1Q23 1Q22 2022 2021
Sales and marketing
expenses
5.3 4.6 21.5 15.1
Administration expenses 7.2 6.7 28.0 32.8
Research and
development expenses
6.6 4.4 22.8 24.4
Total 19.1 15.7 72.3 72.3
  • Total other operating expenses before capitalisation of R&D expenses was MNOK 19.1 in 1Q23, up 21.7% compared to 1Q22
  • Sales and marketing expenses increased in line with higher sales
  • Capitalised R&D expenses was MNOK 0.8 in 1Q23 compared to MNOK 2.2 in 1Q22

Investing to scale

1Q23 balance sheet and cash flow

Cash Capex
MNOK 76.0 MNOK 1.1
MNOK 100.2 in 1Q22 MNOK 2.2 in 1Q22
FCF Equity ratio
MNOK -4.4 83.2%
MNOK -13.6 in 1Q22 83.3% in 1Q22

Capital priorities

  • OPEX of MNOK 19.1* and capex of MNOK 1.1 in 1Q23
  • OPEX will increase as total number of products are launched and sales grow – limited increase in capex
  • Cost base consisting mainly of personnel
  • Long-term net working capital/sales assumed at ~30%, down from ~40% currently

Appendix

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 -15.5
EBIT -2.9 -6.2 -23.2 -22.8

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
81.6 114.9 114.9 158.0
Cash
and cash equivalent at the end of period
76.0 100.2 81.6 114.9

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

20+ years experience and extensive track-record from financial management and reporting, corporate governance and Investor Relations. Mr. Kind has served as the CFO for TiZir, UK, Business Analyst in Eramet Comilog Manganese, France, and Investment Director in Tinfos. He holds a MSc from BI Norwegian Business School.

Njaal Kind

Consulting Founder Erling Sundrehagen

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.

CCO 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.

CSO

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 R&D Torsten Knüttel

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 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, Norway.

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.

Gentian board of directors

Tomas
Settevik
Espen T.
Jørgensen
Kari E.
Krogstad
Kjersti
Grimsrud
Fredrik
Thoresen
Monika
Neuman
Frank
Frantzen
Chair of
the Board
Board member Board member Board member Board member Board member Board member
Tomas Settevik has
experience in both life
sciences and retail and
is currently an
independent investor
and non-exec director in
several companies. He
was previously CEO of
Stokke, and CEO of
Pronova
BioPharma
after serving as Vice
President
Pharmaceuticals and
Manufacturing. Mr.
Settevik has also held
several senior positions

VP Northern Europe,
VP Marketing and R&D,
and Managing Director
UK/Nordic –
at Tyco
Healthcare EMEA. Mr.
Settevik holds a degree
from Copenhagen
Business School.
Espen Tidemann
Jørgensen is currently
Portfolio Manager of
Holta
Invest and
Managing Director of
Holta
Life Sciences, a
large shareholder in
Gentian Diagnostics. He
has 18 years of financial
markets experience as
equity analyst at DNB
Markets and investor.
Mr. Jørgensen was
previously member of
the Board of Directors at
Weifa
and Cortendo,
and
is currently board
member at Decisions.
Mr. Jørgensen holds a
Msc
in Economics and
has completed 3 years
of Medicine studies at
the University of Oslo.
Kari Krogstad has more
than 25 years of
experience from the
biomedical industry,
from commercial
leadership roles within
the pharma, biotech and
medtech
sectors. Ms.
Krogstad has held her
current role as President
and CEO at Medistim
ASA since 2009. She
was previously General
Manager at Invitrogen
Dynal. Ms. Krogstad
holds a Cand. Scient.
degree in Molecular
Biology from the
University of Oslo as
well as a Business
degree from IHM
Business School.
Kjersti
Grimsrud is currently
President and COO of Infusion
care at Convatec
plc, where
she has spent the last 5 years.
She has over 30 years'
experience in MedTech and
IVD companies with roles in
science, operations and
commercial in Axis-Shield ASA
and Alere Inc./Abbott, where
she last held the position of VP
Commercial EME (Europe
Middle East) and International
(APAC). Ms Grimsrud served
as a board member of Biotec
Pharmacon
(now ArcticZymes
technologies) from 2011 to
2015. Ms. Grimsrud holds a
master's degree in
biotechnology Norwegian
University of Science and
Technology in Trondheim.
Fredrik Thoresen
is a
partner in
Andenaesgruppen
where he joined in 2021.
Mr. Thoresen
has
previous buy-
and sell
side experience from
Storebrand, SEB, DNB
and Sector Asset
Management. Mr.
Thoresen
has an MBA
in International Business
from Middlebury Institute
of International Studies,
Monterey, California and
a bachelor's degree in
Computer Science and
Economics from
Augustana University,
Sioux Falls, South
Dakota
Monika Neuman has 20
years of experience
from the diagnostics
industry and is currently
Managing Director for
Sarstedt
Group in the
Nordics. During the past
4 years, Ms. Neuman
has been working at
Siemens Healthineers
Laboratory Diagnostics
HQ in Tarrytown, NY, to
set a successful
strategy for launch and
implementation of a new
product portfolio on the
global IVD market. Ms.
Neuman holds a MSc
degree in Biochemistry
and a PhD degree in
Clinical Bacteriology
from Medical Faculty at
Göteborg
University in
Sweden.
Frank Frantzen
has
more than 35 years of
experience from the
diagnostic industry. He
has served as principal
scientist and has
directed larger R&D
units in international IVD
companies Axis-Shield,
Alere and Abbott. Mr.
Frantzen
left his Senior
Director R&D position at
Abbott in 2021 and is
currently serving as
Chief Technology
Officer in CardiNor
AS.
Mr. Frantzen
holds a
master's degree in
chemistry and a PhD,
both from the
Norwegian University of
Science and
Technology in
Trondheim.

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 973 999 6.32 %
Safrino AS 749 700 4.86 %
Carpe Diem Afseth AS 500 650 3.25 %
Skandinaviska Enskilda Banken AB 500 000 3.24 %
Verdipapirfondet DNB SMB 361 291 2.34 %
Verdipapirfondet Storebrand Vekst 331 220 2.15 %
J.P. Morgan SE 325 000 2.11 %
Portia AS 300 000 1.95 %
Equinor Pensjon 245 047 1.59 %
Cressida AS 235 000 1.52 %
Verdipapirfondet Equinor Aksjer NO 227 880 1.48 %
Lioness AS 220 000 1.43 %
Marstal AS 212 407 1.38 %
Mutus AS 210 465 1.36 %
Salix AS 208 954 1.35 %
Krefting, Johan Henrik 203 400 1.32 %
Vingulmork Predictor AS 184 083 1.19 %
Other Shareholders 4 484 960 29.08 %
Total shares 15 422 350 100 %

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