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Gentian Diagnostics ASA

Investor Presentation Feb 9, 2024

3604_rns_2024-02-09_464ffcb0-979c-4210-839a-240e0ce63aeb.pdf

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Q4 23 Presentation

9 February 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

Introduction

High-impact diagnostics with global commercial traction

Gentian develops and manufactures innovative and efficient diagnostic tests

IN VITRO DIAGNOSTICS (IVD)

  • Tests done on samples that have been taken from the human body such as blood. IVD can detect diseases, infections or other medical conditions.
  • IVD testing is a core component of routine healthcare check-ups for those who are presenting with symptoms or require procedures.
  • IVD can be used to monitor a person's overall health to help cure, treat, or prevent diseases – and it influences up to 70% of critical healthcare clinical decision-making.

GENTIAN DIAGNOSTICS

  • Focused on Immunoassay, the largest IVD segment, where an antibody1 is used to target and detect the presence of certain biomarkers in a patient sample.
  • Industry-leading expertise in developing highly sensitive particle-enhanced turbidimetric immunoassays (PETIA).
  • PETIA enables moving immunoassays from low-volume to high-volume clinical analysers.

Attractive value proposition: fast results at lower cost

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

  • Hours from initiation of analysis to results
  • Low throughput

Gentian converts existing biomarkers to the most efficient automated, highthroughput analysers

  • 10 minutes from initiation of analysis to results
  • High throughput

Faster results leading to better treatment decisions

3-10x higher throughput, improving laboratory productivity and cost-efficiency

Strategy with focus on profitable sales growth

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

~30% average annual sales growth 2019-23

2 'blockbuster' tests in market and product development

Products targeting important disease groups

Good progress made on NT-proBNP

Successfully assessed the prototype's initial clinical performance

About NT-proBNP

Measuring NT-proBNP levels support diagnosis of 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 need for standardization/harmonization of results.

  • Continued the noteworthy progress on the technical front, with the current prototype successfully reproducing results from earlier investigations.
  • Initial clinical performance of the prototype by using blood samples from patients with confirmed heart failure successfully conducted. However, more testing is required.
  • Preparations for production scalability experiments were initiated during the quarter.
  • 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 2,220 240* ~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

Achieved 30% p.a. sales growth last five years

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

Long-standing commercial partnership for Cystatin C

Partnership for fCAL®turbo initiated through Bühlmann Laboratories

Long-term ambitions rooted in recent progress

Five established products with potential to grow 20%+ annually

Prove clinical relevance of GCAL and bring NT-proBNP to market

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

Secure one new contract with a global commercial partner per year

Grow gross margin from ~50% to 60%+ through economies of scale

Long-term EBITDA margins of 40%

revenue potential of NOK 1bn in 5-7 years Unrisked revenue potential of NOK 1bn*

* Dependent on timing of NT-proBNP launch

Financial review

Strong momentum and positive EBITDA in 2023

4Q23 financials and key milestones Highlights

Sales Gross margin
MNOK 37.5 45%
+34% vs 4Q22 50% in 4Q22
EBITDA
MNOK -1.0
MNOK -1.5 in 4Q22
Continued
progress on
NT-proBNP
development
  • Sales of MNOK 37.5 in 4Q23, up 34% vs 4Q22 (23% organic growth) Full year sales of MNOK 135.2 in 2023, up 33% vs 2022 (21% organic growth)
  • EBITDA of NOK -1.0 million in 4Q23 versus NOK -1.5 million in 4Q22. Irregularities related to raw materials resulted in an increased COGS estimated to NOK 1.8 million in 4Q23. EBITDA for the full year 2023 of NOK 3.3 million, compared to NOK -13.0 million in 2022Y
  • Year-end cash position at NOK 87.6 million, up NOK 6.0 million compared to year-end 2022
  • Cystatin C sales increased 49% in 4Q23 compared to 4Q22 and 41% in 2023 vs 2022
  • Third party sales increased 96% in 4Q23 compared to 4Q22 and 67% in 2023 vs 2022
  • Optimisation of the NT-proBNP prototype continues with noteworthy progress in 4Q23 and preparations for production scalability experiments were initiated

Continued high sales growth in line with target

• Sales of MNOK 37.5 in 4Q23, up 34% vs 4Q22 (23% organic growth). Revenue of MNOK 135.2 in 2023 up 33% vs 2022 (21% organic growth)

Sales Other revenues

  • Revenue growth contribution was achieved by all products and via all sales channels in the fourth quarter and full year of 2023
  • Third party sales increased 96% in 4Q23 vs 4Q22

MNOK

• Total revenues of MNOK 37.8 in the quarter, up 22% from 4Q22

Sales revenue - geographic split

MNOK 4Q23 4Q22 2023 2022
US 2.0 1.1 8.7 6.5
Europe 26.5 19.6 92.8 71.2
Asia 8.9 7.3 33.7 23.9
Total 37.5 27.9 135.2 101.6

Sales revenue - product split

MNOK 4Q23 4Q22 2023 2022
Cystatin C 14.0 9.4 56.3 40.0
fCAL®turbo 13.6 11.7 43.2 36.3
Third-party
products
4.8 2.4 17.0 10.2
Other 5.1 4.3 18.6 15.2
Total 37.5 27.9 135.2 101.6

Stable cost development

MNOK

MNOK 4Q23 4Q22 2023 2022
Sales and marketing
expenses
5.9 6.3 22.5 21.5
Administration expenses 5.3 5.8 24.8 28.0
Research and
development expenses
7.0 6.4 25.0 26.0
Total 18.3 18.5 72.3 75.5
  • Total other operating expenses before capitalisation of R&D expenses was MNOK 18.3 in 4Q23, compared to MNOK 18.5 in 4Q22
  • Capitalised R&D expenses was MNOK 1.3 in 4Q23 compared to MNOK 1.7 in 4Q22

Improved cash position

4Q23 balance sheet and cash flow

Cash Capex
MNOK 87.6 MNOK 1.5
MNOK 81.6 in 4Q22 MNOK 1.1 in 4Q22
FCF Equity ratio
MNOK 11.0 81.3%
MNOK -12.4 in 4Q22 82.1% in 4Q22

Capital priorities

  • Cash position increased by NOK 6.0 million in 2023
  • Net working capital of 21% at 31.12.2023 compared to 35% 31.12.2022
  • Long-term net working capital/sales assumed at ~30%
  • Sars-Cov 2 assay written off impairment NOK 6.5 million in 4Q 2023
  • Limited CAPEX of NOK 1.5 million in 4Q23, but OPEX will increase as total number of products are launched and sales grow

Q&A

Appendix

P&L highlights

MNOK 4Q23 4Q22 2023 2022
Sales 37.5 27.9 135.2 101.6
Other
revenues
0.3 3.0 7.2 10.3
Total revenues 37.8 30.9 142.3 111.9
COGS -20.5 -13.8 -66.8 -52.6
Employee benefit expenses -11.1 -10.3 -46.5 -40.9
D&A -2.4 -2.8 -9.6 -10.2
Other OPEX -7.2 -8.2 -25.8 -31.4
EBITDA -1.0 -1.5 3.3 -13.0
EBIT -9.9 -4.3 -12.8 -23.2

Cash flow highlights

MNOK 4Q23 4Q22 2023 2022
Operating activities 13.7 -10.5 15.5 -14.0
Investing
activities
-1.5 -1.1 -4.9 -14.7
Financing
activities
-1.2 -0.8 -4.6 -4.3
Changes in cash and cash equivalent 11.0 -12.4 6.0 -32.9
Cash
and cash equivalent at the beginning of period
76.4 93.9 81.6 114.9
Cash
and cash equivalent at the end of period
87.6 81.6 87.6 81.6

Dedicated and experienced management team

CEO Dr. Hilja Ibert

Njaal Kind

Consulting Founder Dr. Erling Sundrehagen

CCO Markus Jaquemar

CSO Dr. Alexandra Havelka

VP R&D Dr. Torsten Knüttel

VP QA & RA Anne-Mette Horsrud Akre

Jack Andreassen

VP BD

20+ years of relevant industry experience across management positions

Track record from leading global diagnostics companies across all phases

Board of directors

Tomas Settevik

Chair of the Board

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 T. Jørgensen

Board member

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 E. Krogstad

Board member

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.

Kjersti Grimsrud

Board member

Fredrik Thoresen

Board member

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

Board member

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.

Top 20 shareholders

Shareholder No of shares %
Vatne
Equity AS
2 110 224 13.68 %
Kvantia
AS
1 623 368 10.53 %
Holta
Invest AS
1 228 502 7.97 %
Verdipapirfondet
Delphi Nordic
959 272 6.22 %
Safrino
AS
749 700 4.86 %
Carpe Diem Afseth
AS
548 389 3.56 %
Skandinaviska
Enskilda
Banken
AB
436 251 2.83 %
Verdipapirfondet
DNB SMB
361 291 2.34 %
J.P. Morgan SE 350 000 2.27 %
Viola AS 320 916 2.08 %
Verdipapirfondet Storebrand Vekst 311 308 2.02 %
Portia AS 300 000 1.95 %
Krefting, Johan Henrik 292 400 1.90 %
Intertrade Shipping AS 257 716 1.67 %
Cressida AS 235 000 1.52 %
Lioness AS 220 000 1.43 %
Marstal AS 212 407 1.38 %
Mutus AS 210 465 1.36 %
Salix AS 208 954 1.35 %
Verdipapirfondet
Delphi Kombinasjon
196 577 1.27 %
Other Shareholders 4 289 610 27.81 %
Total shares 15 422 350 100 %

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