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Gentian Diagnostics ASA

Investor Presentation Apr 28, 2022

3604_rns_2022-04-28_b6948058-035f-480b-991c-60ca79211c0a.pdf

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Q1 22 Presentation

April 28th, 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.

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 and highlights

Portfolio of high-impact tests provides solid growth opportunity

7* tests contributing to saving costs and protecting life

Revenue ambition of NOK 1bn in 4-6 years**

Delivered ~27% average annual revenue growth 2018-21

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

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

Q1 2022 highlights

Sales EBITDA
NOK 20.6m NOK -4.2m
+5% vs Q1'21 NOK -2.0m in Q1'21
Cash First GCAL®
NOK 100.2m shipments
NOK 146.1m in Q1'21 Under Siemens partnership
  • Sales revenue was MNOK 20.6 (+5% vs 1Q21, organic growth +6%); total operating revenue was MNOK 23.1
  • Third-party products sales was MNOK 2.8 (+81%); positive developments continues into Norway, Finland, and Iceland
  • New customers established for Cystatin C in the US
  • Post quarter, the company announced a distribution agreement with a leading global diagnostics company for Cystatin C covering the US
  • The SARS CoV-2 Antibody assay was commercially launched
  • The first GCAL® shipments to customers were executed following the recently initiated commercial partnership with Siemens Healthineers
  • EBITDA was MNOK -4.2 (NOK -2.0 in 1Q21)

Update on the NT-proBNP product development

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.

  • Gentian has made progress on earlier reported challenges and efforts are now focused on interference
  • Testing revealed interference from two sources, screening for additional sources is ongoing and work on potential solutions have been initiated
  • Gentian has experienced increased interest from potential partners over the last months, supporting the commercial potential should the development be successful
  • After optimisation, the company estimates 6-9 months for the finalisation of the development and additional 6-9 months for the registration under the new IVDR regime
  • In line with established practice, should the current optimisation efforts prove unsuccessful, the company will consider returning the project to the exploration phase

Financial review

Financial highlights

NOKm Q1 22 Q1 21 2021
Sales 20.6 19.6 83.1
Other
revenues
2.5 4.6 16.9
Total revenues 23.1 24.2 100.0
COGS 11.6 10.5 43.2
Employee benefit expenses 8.5 9.6 39.5
D&A 2.1 2.0 7.4
Other OPEX 7.1 6.0 32.8
EBITDA -4.2 -2.0 -15.5
EBIT -6.3 -4.0 -22.8

Sales and other revenues

  • 6% growth in organic sales (5% reported) impacted by timing of large orders, underlying sales trend continues positively
  • Sales driven mainly by demand growth in US and Europe, and third-party sales
  • Total revenue of NOK 23.1m in the quarter, down 5% vs Q1 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 Q1 22 Q1 21 2021
US 1.3 0.4 2.5
Europe 15.1 14.0 55.6
Asia 4.1 5.2 25.0
Total 20.6 19.6 83.1

Sales - product split

MNOK Q1 22 Q1 21 2021
Cystatin C 7.5 7.4 36.2
fCAL®turbo 6.8 8.5 28.0
Other* 6.3 3.7 18.9
Total 20.6 19.6 83.1

Operating expenses in the quarter

NOKm

1Q22 1Q21 2021
Sales and marketing expenses 4.6 4.0 15.1
Administration expenses 6.7 5.5 32.8
Research and development
expenses
4.4 6.1 24.4
Total 15.7 15.7 72.3

• Total other operating expenses was 15.7 million in Q1 2022, level with the NOK 15.7 million in Q1 2021

  • The lower R&D expenses was related to projects completed
  • Capitalised R&D expenses was NOK 2.2 million in Q1 2022 compared to NOK 1.5 million in Q1 2021

Strong cash position

NOKm Q1 22 Q1 21 2021
Operating activities -11.4 -9.4 -27.6
Investing
activities
-2.2 -2.2 -13.6
Financing
activities
-1.1 -0.1 -1.7
Changes in cash and cash equivalent -14.8 -11.8 -43.0
Cash
and cash equivalent at the beginning of period
114.9 158.0 158.0
Cash
and cash equivalent at the end of period
100.2 146.1 114.9

Summary and outlook

Solid commercial progress with global diagnostics companies

Top global diagnostics companies offering products developed by Gentian

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

Long-standing commercial partnership for Cystatin C

Partnership for fCAL initiated through Bühlmann Laboratories

  • Gentian's main strategy is to secure broad roll-out through partnerships with global diagnostics companies
  • Global distribution agreement GCAL® signed with Siemens Healthineers in January 2022
  • Successful start with first shipments to customers executed in Q1
  • Commercial progress continued with distribution agreement for Cystatin C covering the US with an undisclosed global diagnostics company announced post quarter
  • On track for closing one new global partner for one Gentian product per year

Several de-risking milestones expected in 2022

ESTABLISHED PRODUCTS GCAL SARS-COV-2 AB NT-PROBNP
S
E
Targeting additional large
commercial partners
Securing additional global
commercial partnerships and
continue EU rollout
Commercial launch, executed
in March 2022
Progress on remaining
challenges in optimisation
phase
N
O
T
S
E
L
MI
2
Additional regulatory approvals,
including IVDR*
Continue clinical study program
confirming relevance for sepsis
and COVID-19
Initiating rollout in the EU with
focus on the Nordics
Entering commercial
Publication on the reference
method for standardisation
2
0
21-2
0
2
Securing additional
endorsements from key opinion
leaders
partnerships for the Nordics Securing endorsements
from
key opinion leaders and
continue to build commercial
interest for the product

Further potential milestones in pipeline with 1 project currently in 'proof of concept' and 2 projects in exploration phase

*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.

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
  • 6 products launched to date, 1 in product development, 1 project in 'proof of concept' phase and 2 projects in exploration
  • Preparing to scale with a fully funded business plan

Founded 2001

Employees

~50

Revenue 2021 NOK 100m Up 27% OSE: GENT

~NOK 0.8bn

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

Structured approach to product development

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, Bühlmann/Roche Diagnostics and most recently Siemens Healthineers 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

Gentian management

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.

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.

CFO & COO VP R&D Torsten Knüttel

Njaal Kind

reporting, corporate

in Eramet Comilog

from BI Norwegian Business School.

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

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.

Gentian board

Tomas
Settevik
Espen Tidemann
Jørgensen
Ingrid Teigland
Akay
Kari E.
Krogstad
Susanne
Stuffers
Runar
Vatne
Tomas
Kramar
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. 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.
Ingrid Teigland Akay is a
life science investor and
medical doctor. She has
previously served as a
Senior Investment
Manager at Inventages.
Ms. Akay has broad
clinical experience in
internal medicine and
surgery at Scandinavian
and UK hospitals. Today
she is Managing Partner
of Hadean
Ventures, a
life science investment
firm with focus on the
Nordics. Ms. Akay holds
a medical degree from
Medizinische
Hochschule
Hannover and an MBA in
Finance from London
Business School.
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.
Mr. Vatne is the principal
and owner of Vatne
Capital, a family office
investing in financial
assets and real estate.
He is co-founder of
Søylen
Eiendom, a
leading Oslo based real
estate company, and
was previously partner
and stock broker
in
Pareto Securities. Mr.
Vatne also serves as
board member of listed
companies Solon
Eiendom
ASA and Self
Storage Group ASA.
Vatne and associated
companies currently own
15.11% of the
outstanding shares in
Gentian Diagnostics
ASA.
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.

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 914 782 5.93 %
Safrino
AS
800 000 5.19 %
Skandinaviska Enskilda Banken AB 563 500 3.65 %
Salix AS 415 122 2.69 %
Verdipapirfondet
DNB SMB
364 866 2.37 %
Verdipapirfondet Storebrand Vekst 339 503 2.20 %
Equinor Pensjon 309 820 2.01 %
Portia AS 300 000 1.95 %
Cressida AS 235 000 1.52 %
Lioness AS 220 000 1.43 %
Marstal AS 212 407 1.38 %
Mutus AS 210 465 1.36 %
Henrik Krefting 201 000 1.30 %
Carpe Diem Afseth AS 187 849 1.22 %
Verdipapirfondet Delphi Kombinasjon 185 949 1.21 %
Vingulmork Predictor AS 184 083 1.19 %
Silvercoin Industries AS 175 257 1.14 %
Other Shareholders 4 654 453 30.18 %
Total shares 2 110 224 13.68 %

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