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Gentian Diagnostics ASA

Investor Presentation Oct 27, 2022

3604_rns_2022-10-27_5eed36d2-fd12-41aa-bfb1-8f98f6d8c369.pdf

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Q3 22 Presentation

October 27th, 2022

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.

Introduction

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.

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

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. Kind holds a MSc from BI Norwegian Business School.

Njaal Kind

CSO 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.

VP Science/Clinical 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

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.

University of Trondheim,

Norway.

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

Good progress made on NT-proBNP, working prototype developed

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. It is equally precise as the currently available expensive and slower assays and can contribute to better diagnosis, monitoring and treatment. Additional benefits may include results standardization, which is a current issue with the existing assays in the market.

  • Investigations during the third quarter showed that the initial results with the lead candidate from the second quarter were reproducible
  • Consequently, more studies to test the robustness of the lead immunoparticle candidate have been carried out resulting in a working prototype
  • The establishment of the reference method at the first trial site has been accomplished as planned
  • Interest from potential partners continued during 3Q, which indicate significant commercial value if development is successful
  • In line with established practice, should the current optimisation efforts prove unsuccessful, the company will consider returning the project to the exploration phase

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 15-25% 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.

Solid progress on 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

* Including grants and other non-customer related revenue.

Financial review

Sales growth and milestones support long-term ambition

Q3 2022 financials Highlights

Sales Gross margin
NOK 23.1m 45%
+34% vs Q3'21 37% in Q3'21
EBITDA IVDR
NOK -6.1m certification
NOK -4.2m in Q3'21 achieved
  • Sales of MNOK 23.1 in Q3 22, up 34% (35% organic growth) vs Q3 21
  • Strong growth in the US enabled by recent distribution agreement
  • Additional US distribution agreement for Cystatin C announced in August 2022 expected to support revenue growth from 2023
  • IVDR certification achieved, demonstrating Gentian's commitment to deliver safe and effective products
  • Good progress made on NT-proBNP, working prototype developed from the new immunoparticle candidate
  • GCAL well received in the market, Siemens collaboration developing positively

Continued high growth driven by established products

  • Sales increased by 34% to NOK 23.1m (35% organic growth)
  • Strong growth in Europe and US, fCAL® main driver
  • Sales to Asia impacted by COVID related lockdowns in China
  • Total revenues of NOK 25.1m in the quarter, up 29% from Q3 21
  • 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 - geographic split

MNOK Q3 22 Q3 21 YTD 22 YTD 21
Europe 17.3 12.4 52.0 42.0
Asia 3.1 4.3 16.3 17.4
USA 2.6 0.6 5.4 2.0
Total 23.1 17.2 73.7 61.4

Sales - product split

MNOK Q3 22 Q3 21 YTD 22 YTD 21
Cystatin C 8.7 7.3 30.6 25.7
fCAL®turbo 9.0 5.4 24.6 22.2
Other 5.4 4.5 18.6 13.5
Total 23.1 17.2 73.7 61.4

Stable cost development

NOKm

Q3 22 Q3 21 YTD 22 YTD 21
Sales and marketing
expenses
3 760 3 338 15 166 11
080
Administration expenses 7 873 5 073 22 184 19
465
Research and
development expenses
6 735 4 369 16 404 18
898
Total 18 368 12 780 53 754 49
443
  • Total other operating expenses before capitalisation of R&D expenses was 19.5 million in Q3 2022 compared to NOK 16.7 million in Q3 2021
  • Admin, sales and marketing expenses increased in line with higher sales while lower R&D related expenses was related to completed projects
  • Capitalised R&D expenses was NOK 1.2 million in Q3 2022 compared to NOK 3.9 million in Q3 2021

Positive free cash flow in Q3, investing to scale

Q3 2022 balance sheet and cash flow Capital priorities

Cash
NOK 93.9m
NOK 131.3m in Q3'21
Capex
NOK 3.1m
NOK -1.0m vs
Q3'21
FCF Break-even
NOK 1.8m pre-R&D
NOK 7.9m vs Q3'21 based on current revenue
  • Positive free cash flow in Q3 2022 as net working capital was reduced
  • Planned spending increase as total number of products launched and sales grow – limited increase in capex
  • Flexible cost base consisting mainly of personnel
  • Long-term net working capital/sales assumed at ~30%, down from ~40% currently

Summary and outlook

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% currently to 60%+ at volume production

Long-term EBITDA margins of 40%

revenue potential of

Revenue ambition

of NOK 1bn

in 4-6 years*

NOK 1bn

in 5-7 years

* Dependent on timing of NT-proBNP launch

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, while
increasing direct sales
Bring additional established
products to the market,
including 3rd
party products
Securing additional global
commercial partners and
continue EU rollout
Continue clinical study program
confirming relevance for the
early detection of infections
Securing additional
endorsements from key opinion
leaders
Initiating rollout in the EU with
focus on the Nordics
Entering commercial
partnerships for the Nordics,
while initiating direct sales
Progress on remaining
challenges in optimisation
phase
Publication on the reference
method for standardisation
Securing endorsements
from
key opinion leaders and
global partners

Pipeline: Finalize proof-of-concept of one new project

Q&A

Appendix

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 0.6bn

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

Combining avian antibodies and PETIA enables fast results and improved lab productivity

Avian antibodies

Avoiding interference enables conversion to PETIA

Antibodies: Proteins used by the immune system to identify bacteria and viruses

Avian antibodies: Extracted from hen eggs. Avoids interference due to lack of complement system binding antibodies and molecules, enabling analysis at lower concentrations than mammalian antibodies and conversion of existing biomarkers to PETIA

Advantages: Gentian uses avian antibodies when applicable and believes extraction from eggs rather than puncturing animals contributes to better animal welfare while also offering a cost advantage at scale

PETIA

Removing separation steps increases throughput and reduces cost

Immunoassays: Biochemical tests measuring molecule presence or concentration in human cells using an antibody

Particle-enhanced turbidimetric immunoassays: Enables moving immunoassays from low-volume to high-volume clinical analysers

Advantages: Moving immunoassays to PETIA enables removing separation steps, which increases throughput and laboratory efficiency compared to the traditional ELISA and other methods

Structured approach to product development

Note: Chance of launch refers to completion of the phase.

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 and acceptance of product
  • Beckman Coulter and Bühlmann/Roche Diagnostics are current partners falling into this category
  • Ambition to secure one new contract with global commercial partner per year

  • Accelerating time to revenue and awareness

  • Distribution agreements in several European countries and South Korea for GCAL, Cystatin C and Canine CRP

  • Direct sales to select end-users and key opinion leaders, including laboratory and hospitals

  • Sales representatives in US, Sweden and HQ in Norway
  • Sales office in Sweden distributes Gentian and Bühlmann Laboratories complimentary products

P&L highlights

NOKm Q3 22 Q3 21 2021
Sales 23.1 17.2 83.1
Other
revenues
2.0 2.2 16.9
Total revenues 25.1 19.4 100.0
COGS 12.8 10.8 43.2
Employee benefit expenses 10.0 8.9 39.5
D&A 2.7 2.4 7.4
Other OPEX 8.4 3.9 32.8
EBITDA -6.1 -4.2 -15.5
EBIT -8.7 -6.6 -22.8

Cash flow highlights

NOKm Q3 22 Q3 21 2021
Operating activities 4.9 -2.1 -27.1
Investing
activities
-3.1 -4.1 -12.8
Financing
activities
0.0 -1.1 -3.1
Changes in cash and cash equivalent 1.8 -7.3 -43.0
Cash
and cash equivalent at the beginning of period
92.1 138.6 158.0
Cash
and cash equivalent at the end of period
93.9 131.3 114.9

Gentian board

Tomas
Settevik
Espen T.
Jørgensen
Tomas
Kramar
Kari E.
Krogstad
Susanne
Stuffers
Fredrik
Thoresen
Monika
Neuman
Frank
Frantzen
Chair of
the Board
Board member Board member Board member Board member New board
member
New board
member
New 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.
Mr. Kramar
has more
than 40 years of
experience from the
diagnostic industry
including Siemens,
Abbott and Roche
Diagnostics. Mr.
Kramar
has held
several senior
positions like Global
Business Manager,
Business Director
and CEO, as well as
being a founding
partner in the Kramar
Group. In addition,
Mr. Kramar
has held
several board
positions over the
years.
Mr. Kramar
holds an MSc degree
in Chemistry from the
Faculty of
Engineering at Lund
University in
Sweden.
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.
Susanne Stuffers is
currently managing
partner of P53 Invest
AS. Previously she
was an equity
analyst with Arctic
Securities covering
the healthcare
sector, and
management
consultant at EY. Ms.
Suffers has held
medical and
commercial roles at
Novartis and has had
clinical practice as a
resident in oncology
at OUS Ullevål. Ms.
Stuffers holds an
M.D. degree from the
Erasmus University
Rotterdam and a
Ph.D. degree in
cancer biomedicine
from the Norwegian
Radium Hospital.
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
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.

Sweden.

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 970 934 6.29%
Safrino AS 800 000 5.19%
Skandinaviska Enskilda Banken AB 489 000 3.17%
Salix AS 390 689 2.53%
Verdipapirfondet DNB SMB 361 291 2.34%
Verdipapirfondet Storebrand Vekst 344 292 2.23%
Equinor Pensjon 300 047 1.95%
Portia AS 300 000 1.95%
Cressida AS 235 000 1.52%
J.P. Morgan SE 232 922 1.51%
Lioness AS 220 000 1.43%
Marstal AS 212 407 1.38%
Mutus AS 210 465 1.36%
Carpe Diem Afseth AS 208 797 1.35%
Krefting, Johan Henrik 196 400 1.27%
Vingulmork Predictor AS 184 083 1.19%
Silvercoin Industries AS 175 657 1.14%
Other Shareholders 4
642 612
30.10%
Total Shares 15
422 350
100.00%

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