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Gentian Diagnostics ASA

Investor Presentation Feb 17, 2022

3604_rns_2022-02-17_5751db06-db02-41da-a9a5-58b1cfbd7a55.pdf

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Q4 21 Presentation

February 17th, 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.

Today's presenters

Hilja Ibert

CEO

Njaal Kind CFO & COO

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, fast and 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 5-7 years**

Delivered ~27% average annual revenue growth 2018-21

* 5 launched, further 2 in development. **Dependent on timing of NT-proBNP launch

7 diagnostic tests, including two potential blockbusters

ESTABLISHED PRODUCTS IN MARKET
DEVELOPMENT
IN PRODUCT
DEVELOPMENT
Kidney disease Inflammation
& infection
Inflammation Pancreas Inflammation
& infection
Inflammation Cardiac
Cystatin C Canine CRP fCAL® fPELA® GCAL® SARS-CoV-2 NT-proBNP
2006 2012 2015 2020 2019 Q1 2022 TBD

Growing into a serviceable market of USD 1.3bn

Total Addressable Market: Total demand within targeted markets 2020 (Kalorama 2020). Total Serviceable Market: The segment of the TAM targeted by Gentian's products (company estimates). Gentian's share of revenues net of partner take is 30-50% on average with product variations. Note: SARS-CoV-2 Ab, targeting a USD 20m Nordic serviceable market, not shown separately in graph.

Ambitions for impact, high growth and value creation

Market opportunity and long-term ambitions Strategic pillars

5-7 year revenue ambition* NOK 1bn

60%+ Gross margin at volume production

Long-term EBITDA margins 40%

  • Grow annual revenue from established products through additional commercial partners and regulatory approvals
  • Prove clinical relevance of GCAL for sepsis and COVID-19
  • Launch one new product per year; SARS-COV-2 Ab scheduled for Q1 2022
  • Secure one new contract with a global commercial partner per year, building on established partnerships
  • Grow gross margin through economies of scale
  • Deliver healthy long-term EBITDA margins through operational leverage and cost discipline

Q4 2021 highlights

Sales
NOK 21.7m
+26% vs Q4'20
EBITDA
NOK -8.5m
NOK -7.4m vs
Q4'20
Cash SARS
NOK 114.9m CoV-2 Ab
NOK -43m vs Q4'20 development completed
  • Total operating revenue of NOK 26.2 million, up 10% from Q4 2020
  • EBITDA of NOK -8.5 million, of which NOK -4.4 related to implementation of a new ERP system, compared to NOK -1.1 in the corresponding quarter in 2020
  • Sales revenue of NOK 21.7 million, up 26% compared y-o-y with organic growth at 33%
  • Development of the SARS CoV-2 assay completed, with launch planned during Q1 2022
  • Finalised negotiations with Siemens Healthineers for commercial rollout of GCAL®, with contract signed in Q1 2022

NT-proBNP timing remains uncertain

  • Revised timeline to be communicated upon completion of the optimization phase
  • Optimization has been more complex than first assumed
  • Making progress with particle coating and stability, and showing reproducible results in controlled environment
  • Remaining challenges with likely interference between the NT-proBNP molecule and clinical plasma material
  • Work ongoing to reveal and remove the interference sources

Main achievements in 2021

  • Achieved 31% sales growth -and 43% organic sales growth - mainly from the established products Cystatin C and fCAL® turbo
  • Expansion of commercial footprint including third party sales in Norway, Finland and Iceland
  • Completed development of the SARS COV-2 Antibody assay
  • Increased momentum for GCAL with several new routine users - secured interest from several global distribution partners
  • Achieved development of an independent reference method for NT-proBNP
  • Successfully transferred the Gentian share to Oslo Børs

Financial review

Financial highlights

NOKm Q4 2021 Q4 2020 2021 2020
Sales 21.7 17.2 83.1 63.3
Other
revenues
4.5 6.6 18.2 15.6
Total revenues 26.2 23.8 101.3 78.9
COGS 10.7 9.1 43.3 32.6
Employee benefit expenses 11.2 8.8 38.4 37.2
D&A 1.0 2.0 7.3 6.6
Other OPEX 12.8 7.0 35.0 20.3
EBITDA -8.5 -1.1 -15.5 -11.2
EBIT -9.5 -3.1 -22.8 -17.8

Sales and other revenues

  • Total revenue of NOK 26.2m in the quarter, up 10% vs Q4 20
  • 33% growth in organic sales (26% reported)

Driven mainly by increased adoption of Cystatin C as a routine marker for chronic kidney disease, and by strong demand growth in China and South Korea

• Other revenues related to amounts received from associated research grants and tax incentives

NOKm

Sales - geographic split

MNOK 4Q21 4Q20 2021 2020
US 0.5 0.7 2.5 3.0
Europe 13.6 13.0 55.6 45.4
Asia 7.6 3.6 25.0 14.9
Total 21.7 17.2 83.1 63.3

Sales - product split

MNOK 4Q21 4Q20 2021 2020
Cystatin C 10.5 6.6 36.2 25.8
fCAL®turbo 5.8 6.2 28.0 20.9
Other 5.4 4.5 18.9 16.6
Total 21.7 17.2 83.1 63.3

Operating expenditures in the quarter

NOKm

4Q21 4Q20 2021 2020
Sales and marketing expenses 4.2 4.6 15.2 14.2
Administration expenses 12.9 3.7 32.3 19.4
Research and development
expenses
6.9 7.5 25.9 23.9
Total 24.0 15.8 73.4 57.5
  • High Opex in the quarter, with administration expenses including NOK 4.4 million related to implementation of new ERP system
  • Sales and marketing and R&D expenses below Q4 2020 and moderately higher than 2020 for the full year
  • Capitalised R&D expenses of NOK 2.5 million in Q4 and NOK 10.2 million for the full year 2021, compared to NOK 2.5 million in Q4 2020 and NOK 3.4 million for the full year 2020

Strong cash position; fully financed business plan

NOKm Q4 21 Q4 20 2021 2020
Operating activities -15.0 2.6 -28.9 -12.5
Investing
activities
-1.9 2.2 -12.2 0.3
Financing
activities
0.5 0.9 -1.8 -1.5
Changes in cash and cash equivalent -16.4 5.7 -42.9 -13.8
Cash
and cash equivalent at the beginning of period
131.3 152.3 158.0 171.6
Cash
and cash equivalent at the end of period
114.9 158.0 114.9 158.0

Summary and outlook

Positive portfolio outlook

ESTABLISHED PRODUCTS GCAL SARS-COV-2 AB NT-proBNP
Targeting additional large
commercial partners
Increasing endorsements from
key opinion leaders
Successful validation and
launch, scheduled for Q1 2022
Continuing work on
optimisation
Additional regulatory approvals,
including IVDR*
Continued double digit sales
Strengthening clinical
confirmation of relevance for
sepsis and Covid-19
Entering commercial
partnerships for the Nordics
Challenges remain with likely
interference between the NT
proBNP
molecule and clinical
plasma
growth expected Securing global commercial
partnerships and initiating EU
rollout
Revision of timeline not
meaningful until optimisation
has been completed
Expecting significant sales
growth going forward

Further potential milestones in pipeline with 3 biomarkers currently in exploration and 'proof of concept'

* IVDR: A new regulation requiring 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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