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Gentian Diagnostics ASA

Investor Presentation Oct 23, 2025

3604_rns_2025-10-23_1d98639c-6964-43e6-966e-5d0366fa3c05.pdf

Investor Presentation

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3Q25 Presentation

23 October 2025

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.

Gentian Diagnostics in a nutshell

Gentian Diagnostics is listed on Euronext Oslo Børs

and ISO13485 certified) and focus on ESG

Appealing value proposition leveraging existing, open-channel instrumentation

Appealing value proposition

Still, many clinically relevant diagnostic biomarkers are only available on slow and inefficient platforms.

By leveraging existing, so-called openchannel instrumentation, Gentian converts these test for high-throughput platforms.

    1. Faster results -> better treatment decisions
    1. Up to 10x improved efficiency and cost savings

Lean business model

Partnerships with global IVD companies

OEM partnerships to secure broad roll-out and acceptance of product

Distributors in select markets

In selected markets we do not serve directly

Direct end-users

Large central laboratories in selected markets

Focused strategy targeting large, existing market with our world-leading knowledge and broad customer support

Gentian targets several unmet needs:

    1. New and upcoming diagnostic biomarkers
    1. Gaps in companies' current portfolio
    1. Quality, supply or regulatory compliance issues with current 3rd party suppliers
    1. Price pressure in selected markets

We differentiate from competition by serving our strategic partners with broad support:

    1. World-class R&D
    1. Kit or bulk production
    1. Technical and clinical data generation
    1. Regulatory and product support

Key disease areas: inflammation & infection, kidney disease, heart failure

ESTABLISHED PRODUCTS

Kidney disease

Cystatin C 2006

Inflammation

fCAL® 2015

Pancreas deficiency

fPELA® 2020

Inflammation & infection

Canine CRP 2012

Kidney disease & nutrition

RBP 2023

Inflammation & infection

GCAL® 2019

LATE STAGE DEVELOPMENT

Cardiac disease

NT-proBNP 2026

Key drivers for long-term growth and value creation

Five established products with solid growth potential

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 Targeting a serviceable market of USD 2.2bn*

3Q highlights: Strong overall performance with especially high growth in the US – gross margin back on track

3Q25 financials and key milestones

Sales MNOK 41.8

+28% vs 3Q24 (+31% organic)

Sales to the US MNOK 10.8

MNOK 2.4 in 3Q24

EBITDA MNOK 8.4

MNOK 5.0 in 3Q24

Gross margin 56%

52% in 3Q24

Additional highlights

  • YTD 2025 sales of NOK 129.9 million up 19% (19% organic growth) versus 2024.
  • EBITDA of NOK 24.1 million for the first nine months of 2025 versus 16.5 million during the same period of 2024.
  • Sales of Cystatin C increased by 73% in 3Q25 compared to 3Q24 driven by strong performance in the US.
  • YTD sales to the US were NOK 21.7 million vs. NOK 8.1 million for the same period in 2024. Sales are positively impacted by NOK 8.3 million (YTD) due to a warehouse shift for one customer. NOK 2.3 million or 10% of sales comes from new accounts acquired in 2025.
  • NT-proBNP moving closer to final stages of verification. The timeline for full commercial launch is now estimated to take place during 4Q 2026.
  • The development project for a major IVD company entered successfully the next development phase (from proof-of-concept to optimization).
  • Several study sites have been activated and approximately 70 patients enrolled in the JIA COMPASS study evaluating the diagnostic and prognostic use of GCAL in children with juvenile idiopathic arthritis (JIA).

Strong momentum in the USA continue

Highlights

  • US sales from NOK 2.4 million in Q3 2024 to NOK 10.8 million in Q3 2025. However, sales are positively impacted due to a warehouse shift for one of our customer (Q3 impact NOK +5.4 million for the USA and corresponding decline for Europe).
  • Cys C with very high growth (both in Q3 and YTD) and fCAL closing the gap from soft Q2 '25. Also, the "other" category with +34% YTD growth.

Sales revenues (MNOK)

Sales revenue - geographic split

MNOK 3Q25 3Q24 YTD25 YTD24 2024
US 10.8 2.4 21.7 8.1 12.2
Europe 26.8 27.3 84.0 83.8 116.2
Asia 4.2 3.0 24.1 17.6 23.7
Total 41.8 32.7 129.9 109.5 152.1

Sales revenue - product split

MNOK 3Q25 3Q24 YTD25 YTD24 2024
Cystatin C 15.5 9.0 50.6 37.2 50.6
fCAL®
turbo
15.9 14.3 43.5 43.0 61.3
Third-party products 3.4 4.3 14.9 13.6 18.3
Other 7.0 5.1 21.0 15.7 21.8
Total 41.8 32.7 129.9 109.5 152.1

Stable cost development

Operating expenses

MNOK 3Q25 3Q24 YTD25 YTD24 2024
Sales and marketing
expenses
7.3 6.4 20.6 18.8 28.1
1 Administration expenses 5.0 3.8 18.1 16.2 21.7
Research and
development expenses
6.1 5.5 16.8 15.7 21.9
18 Total 18.4 15.3 55.5 50.7 71.7
  • Operating expenses ended at 18.4 MNOK in 3Q25 compared to NOK 15.3 million in 3Q24.
  • Capitalised R&D expenses was MNOK 1.3 in 3Q25 compared to MNOK 2.6 in 3Q24.

Gross margin back on track

Gross and EBITDA margin % .

  • Gross margin back to normal level as the production issues we experienced in 2Q25 were quickly resolved.
  • Operations ran smoothly in 3Q25.
  • Ambition of gross margin in the 55%-60% area on current revenue levels is maintained.

Continued EBITDA improvement

EBITDA development (MNOK)

▪ EBITDA YTD 2025 of NOK 24.1 million vs 16.5 million in the same period last year.

Solid cash position

3Q25 balance sheet and cash flow

Cash MNOK 86.6

MNOK 80.2 in 3Q24

Capex MNOK 1.4

MNOK 2.7 in 3Q24

FCF MNOK 6.3

MNOK 12.5 in 3Q24

Equity ratio 86.8%

85.4% in 3Q24

Capital priorities

  • NOK 6.3 million increase in cash from 31 December 2024.
  • Quarter end cash position of NOK 86.6 million
  • Dividend of NOK 6.2 million paid in 2Q25.
  • No interest-bearing debt
  • Long-term net working capital/sales assumed at ~30%.

Cystatin C 73% growth from continued US momentum

Sales of Cystatin C (MNOK)

  • YTD growth +36%. Sales of first three quarters equal to FY 2024.
  • In the US we start to see the impact of new customers (>30) contributing to growth. NOK 2.3 million or 10% of YTD sales comes from new accounts acquired in 2025.
  • 3Q25 sales to China were significantly higher in 2025 vs. 2024, when we experienced an exceptionally low quarter.

fCAL® turbo Second highest quarter closes YoY gap to 2024

  • fCAL turbo sales grew by 11% to NOK 15.9 million in 3Q25, resulting in its second highest quarterly sales.
  • Year to date, fCAL turbo sales have recovered from the dip during the spring and are now at NOK 43.5 million, up 1% compared to 2024.
  • High sales to all major regions.

Other Products 37% growth in Q3 especially driven by fPELA

Sales of other products (MNOK)

  • The other products category grew by 37% compared to 3Q24 generating sales of NOK 7.0 million vs. NOK 5.1 million in 3Q24.
  • YTD sales ended at NOK 21.0 million which equals to 34% growth vs. 2024.
  • In 2025 fPELA and cCRP are delivering clearly above company's average growth, while GCAL has lower-than-expected sales performance.

Third-party products

Record sales in Q2 impacted the Q3 performance

  • After very strong sales in Q2, our third-party products experienced declining sales in 3Q25 vs. previous year (-22%).
  • Lower quarterly sales reflect a temporary dip driven by phasing of customer orders rather than an underlying decline in demand.
  • The YTD revenue is at NOK 14.9 million, representing an increase of 9%.
  • Gentian Diagnostics AB continues to execute its growth strategy through planned expansion into Finland and Denmark, and by strengthening its portfolio with additional thirdparty products.

USA – Europe sales impacted by a warehouse shift in April. However, adjusted US growth YTD +165%. New accounts contributing to growth.

  • YTD sales to the US were NOK 21.7 million vs. NOK 8.1 million for the same period in 2024 (NOK 8.3 million from the warehouse shift).
  • Adjusted growth rate +165%.
  • Sales to Asia grew 42%, from NOK 3.0 million to NOK 4.2 million in 3Q25
  • YTD sales up by 37% (NOK 24.1 million vs. 17.6 million).
  • Recently implemented initiative called "unbundling", together with previously implemented VBP, warrants cautious outlook to 4Q25 and onwards.

  • Europe declined 2% in 3Q25 to NOK 26.8 million vs. NOK 27.3 million in Q3 2024.

  • Warehouse shift impact NOK 5.4 million.

R&D Update

  • The yet undisclosed development project for a major IVD company entered successfully to the next development phase (from proof-of-concept to optimization). The assay is being tested on multiple clinical analyser platforms and reagent formulations are being improved.
  • In 3Q Gentian continued feasibility work on the previously announced novel detection technology with a potential to significantly expand sensitivity limits beyond those of conventional PETIA-based systems. Focus has been on continued technical evaluation and assessing implementation feasibility with clinical chemistry workflows. Also, early market and commercial evaluations have been started.

R&D Spend break-down

MNOK 3Q25 3Q24 YTD25 YTD24
Technical and Clinical
support
2.9 2.2 7.6 7.0
Pipeline development 3.2 3.3 10.3 9.6
Capitalised development
expenses
1.3 2.6 5.5 6.6
Total 7.4 10.7 23.4 23.2

Technical and clinical support relates to spending on products that are developed and on the market.

Pipeline development are expenses on products under development.

Gentian's next generation NT-proBNP – commercial launch targeted for 2026

Assay development advancing towards final validation phase

About NT-proBNP

NT-proBNP is a cornerstone test in heart failure diagnostics. Estimated market value in 2025 is \$1.0 B with 2025-2033 CAGR of +7%. Up to 80% of NT-proBNP molecules may have sugar structures attached to them (glycosylation). Current assays tend to underestimate NT-proBNP levels due to antibodies binding the glycosylated areas. Gentian is developing a glycosylation-independent NT-proBNP assay aiming to improve accuracy and consistency of heart failure diagnostics.

Third quarter highlights:

  • Throughout the third quarter, Gentian made significant efforts in advancing the NT-proBNP project, moving it closer to the final phase of verification. Notably, the calibration model underwent further refinement, resulting in enhanced precision at the lower measuring range - an area particularly important for establishing clinically relevant thresholds.
  • However, the project also encountered unforeseen challenges related to calibrator stability, which have contributed to delays. Nevertheless, progress has been made by identifying improved matrix formulations that are currently under evaluation.
  • In parallel, new analytical testing is being conducted using clinical cohorts through collaborations with external partners, with data evaluation ongoing.
  • Gentian is working to introduce the assay as a research-useonly product by the end of 2025 and aiming for full commercial launch in 4Q 2026.

P&L highlights

MNOK 3Q25 3Q24 YTD25 YTD24 2024
Sales 41.8 32.7 129.9 109.5 152.1
Cost of goods sold -18.4 -15.7 -58.7 -50.5 -69.3
Gross profit 23.4 16.9 71.2 58.9 82.8
Other revenues 1.1 1.0 2.8 2.8 4.6
R&D expenses -6.1 -5.5 -17.8 -16.6 -21.9
Sales and marketing expenses -7.3 -6.1 -20.7 -18.9 -28.1
Administrative expenses -5.0 -3.8 -18.1 -16.3 -21.7
Operating profit 6.1 2.7 17.3 9.8 15.7
Net financial items 0.1 0.7 -1.3 2.5 -2.5
Net profit (loss) 4.0 3.4 9.8 12.3 45.3

Balance sheet highlights

MNOK 3Q25 3Q24 2024
Inventory 52.4 42.6 45.9
Accounts-
and other receivables
33.0 11.1 31.3
Cash and cash equivalents 86.6 93.8 84.7
Total non-current assets 60.7 41.6 67.7
Total assets 232.7 189.1 229.7
Total paid-in equity 319.3 316.1 316.3
Total retained equity -117.3 -154.7 -122.2
Total equity 202.0 161.4 194.1
Total non-current liabilities 1.9 6.7 5.5
Total current liabilities 28.8 20.9 30.1
Total equity and liabilities 232.7 189.1 229.7

Cash flow highlights

MNOK 3Q25 3Q24 YTD25 YTD24 2024
Operating activities 8.9 16.4 16.5 17.5 13.5
Investing
activities
-1.4 -2.7 -5.9 -7.7 -11.0
Financing
activities
-1.3 -1.2 -10.0 -3.8 -5.0
Changes in cash and cash
equivalent
6.3 12.5 0.6 6.1 -2.4
Cash
and cash equivalent at the
beginning of period
80.2 81.0 84.7 87.6 87.6
Cash
and cash equivalent at the
end of period
86.6 93.8 86.6 93.8 84.7

Achieved 26% p.a. sales growth last six years

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®turbo initiated through Bühlmann Laboratories

Dedicated and experienced management team

CEO Matti Heinonen

CFO & COO Njaal Kind

CGO Markus Jaquemar

CSO Dr. Alexandra Havelka

CTO Dr. Frank Frantzen

VP R&D Dr. Torsten Knüttel

VP QA & RA Anne-Mette Horsrud Akre

20+ years of relevant industry experience across management positions

Track record from leading global diagnostics companies in across all phases

Board of directors

Hilja Ibert

Chair of the Board

Dr. Hilja Ibert has more than 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. In 2018, she was appointed CEO of Gentian Diagnostics ASA, a position she served until May 2024. She is currently a board member in Gradientech and VitaDx.

Dr. Ibert holds a PhD degree in Nutrition Science from the University of Bonn, Germany.

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

Board member

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 from the Norwegian University of Science and Technology in Trondheim.

Runar Vatne

Board member

Mr. Vatne is the principal and owner of Vatne Capital, a family office investing in financial assets and real estate. He has extensive experience from the real estate sector, primarily from Søylen Eiendom, a leading Oslo based real estate company which he co‐founded in 2004. Prior to Søylen Eiendom, Mr. Vatne was a Partner and stock broker in Pareto Securities. Mr. Vatne served as board member of Gentian Diagnostics from November 2019 to May 2022.

Mr. Vatne and companies controlled by him currently own 15.12% of the outstanding shares in Gentian Diagnostics ASA.

Christian Åbyholm

Board member

Christian Åbyholm is a partner in Kvantia AS where he joined in 2007. Prior to joining Kvantia AS, Christian worked as Head of Department within Mergers and Acquisitions in Norsk Hydro and as Senior Vice President in business development in Aker RGI. Christian has also worked in London as an Associate in Equity Research in Morgan Stanley where he was part of the number one European Paper and Packaging team ranked by Institutional Investor. Prior to that, Christian worked as an Analyst in Merrill Lynch's Investment Banking division.

Mr. Åbyholm is a CFA charter holder and has an MBA from IMD and a Siviløkonom degree from Norwegian School of Economics and Business Administration. In addition, Christian has completed first two years of law school at University of Oslo.

Caaby AS, a wholly owned company by Mr. Åbyholm owns 173,500 shares in the company. Kvantia AS and its subsidiaries (Victoria India Fund AS and Obligasjon 2 AS) own 1,992,208 shares in the company. In addition, Christian Åbyholm is Chairman in INSR ASA and Norda ASA, which both own 614,215 shares in the company. The combined shareholding corresponds to 22% of the outstanding shares in Gentian Diagnostics ASA.

Top 20 shareholders

Shareholder No of shares %
Vatne Equity AS 2 110 224 13.68 %
Kvantia AS 1 803 368 11.69 %
Carpe Diem Afseth AS 842 521 5.46 %
Norda ASA 716 099 4.64 %
DNB Carnegie Investment Bank AB 685 046 4.44 %
Safrino AS 649 700 4.21 %
Insr ASA 614 251 3.98 %
J.P. Morgan SE 523 631 3.40 %
DNB Bank ASA, Meglerkonto Innland 450 000 2.92 %
Verdipapirfondet Delphi Norge 384 572 2.49 %
Verdipapirfondet DNB Smb 341 338 2.21 %
Portia AS 300 000 1.95 %
Krefting, Johan Henrik 298 240 1.93 %
Intertrade Shipping AS 257 716 1.67 %
Lioness AS 220 000 1.43 %
Marstal AS 212 407 1.38 %
Sp Capital 22 AS 200 000 1.30 %
Silvercoin Industries AS 187 455 1.22 %
Caaby AS 173 500 1.12 %
T.D. Veen AS 164 967 1.07 %
Other Shareholders 4 287 315 27.80 %
Total shares 15 422 350 100 %

*As of 30 September 2025 according to VPS and disclosures from investors.

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