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Gentian Diagnostics ASA

Investor Presentation Feb 12, 2025

3604_rns_2025-02-12_fd216b4e-d27f-4b2b-8772-2f83e18aaa1e.pdf

Investor Presentation

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Q4 24 Presentation

12 February 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.

Efficient diagnostics for better treatment decisions

Gentian Diagnostics at a glance

A MedTech company targeting \$1.8Bn serviceable diagnostic market with 5-10% annual growth

Focused strategy, lean business model & appealing value proposition

Industry-leading capabilities - strong focus on inhouse R&D and Operations

At commercial phase and making profit

High quality standards (IVDR and ISO13485 certified) and focus on ESG

Appealing value proposition

Value proposition

Many clinically relevant diagnostic biomarkers are available only on slow and inefficient platforms

By leveraging existing, open-channel instrumentation, Gentian converts these tests to high-throughput analysers

Faster results → better treatment decisions

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 on PETIA*

Highly specialised with PETIA assays on high volume diagnostic segments.

Addressing customer needs with worldclass R&D, production, clinical data generation and regulatory support.

Leveraging growing volumes, cost pressure and market consolidation trends.

Sustained growth with diverse product pipeline, technological improvements for PETIA, or via adjacent new technologies.

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

Key drivers for long-term growth and value creation

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 Targeting a serviceable market of USD 1.8bn*

*Kalorama 2022, Company estimates including RBP

Highlights

4Q highlights: Record sales and profitability improvements

4Q24 financials and key milestones Additional highlights

Sales Gross margin
MNOK 42.6 56%
+14% vs 4Q23 43% in 4Q23
EBITDA US sales
MNOK 8.1 +101%
MNOK -1.0 in 4Q23 vs 4Q23
  • Sales of fCAL® turbo increased 34% in 4Q24 compared to 4Q23
  • The NT-proBNP assay development progressed as planned and further studies indicated comparable performance to existing market leading assays

Full year 2024: Net profit positive in all quarters - initial dividend proposed

Full year 2024 financials and key milestones Additional highlights

Sales Gross margin
MNOK 152.1 54%
+13% vs 2023 47% in 2023
EBITDA Dividend of
MNOK 24.7 NOK 0.40
MNOK 3.3 in 2023 per share
  • Net profit of NOK 45.3 million including capitalisation of tax loss carried forward of NOK 25.2 million
  • The board proposes a dividend of NOK 0.40 per share due to a solid cash position and sound underlying earnings with current growth opportunities fully financed
  • Major milestone achieved with the optimisation of the NTproBNP assay - on track for 2026 launch
  • New KDIGO guidelines issued in Q1 2024 recommending increased use of Cystatin C
  • Successful CEO succession and further strengthening of top management and the board of directors
  • Bühlmann, Gentian's exclusive commercial partner for fCAL turbo and fPELA turbo, announced a worldwide collaboration with Beckman Coulter for both products

Strong sales performance in Europe and continued US growth

Highlights

  • Sales of fCAL® turbo increased 34% in 4Q24 compared to 4Q23, and 42% in 2024 vs 2023
  • Strong US sales growth of 101% in 4Q24 and 39% for the full year 2024 vs 2023
  • Continued soft Cystatin C sales to China during the quarter, but early signs of recovery emerging

Sales revenues (MNOK)

Sales revenue - geographic split

MNOK 4Q24 4Q23 2024 2023
US 4.1 2.0 12.2 8.7
Europe 32.4 26.5 116.2 92.8
Asia 6.2 8.9 23.7 33.7
Total 42.6 37.5 152.1 135.2

Sales revenue - product split

MNOK 4Q24 4Q23 2024 2023
Cystatin C 13.4 14.0 50.6 56.3
fCAL® turbo 18.3 13.6 61.3 43.2
Third-party
products
4.7 4.8 18.3 17.0
Other 6.2 5.1 21.8 18.7
Total 42.6 37.5 152.1 135.2

Stable cost development

Operating expenses

MNOK 4Q24 4Q23 2024 2023
Sales and marketing
expenses
9.0 6.1 28.0 23.1
Administration
expenses
5.4 5.4 21.7 25.1
Research and
development expenses
4.3 14.7 20.9 36.1
Total 18.7 26.1 70.6 84.2
  • Operating expenses ended at NOK 18.7 million in 4Q24 compared to NOK 26.1 million in 4Q23
  • Capitalised R&D expenses was MNOK 3.0 in 4Q24 compared to MNOK 1.3 in 4Q23

Strong margin improvement

Gross and EBITDA margin %

  • Gross margin increase factors:
    • Favourable product mix
    • Cost improvement initiatives
    • Productivity gains

EBITDA margin increase factors:

  • Higher revenue base
  • Improved gross margin
  • Stable OPEX

Significant EBITDA improvement

EBITDA development (MNOK)

  • Significant EBITDA improvement in 2024 to NOK 24.7 million vs 3.3 million in total for 2023
  • Scale effects are starting to materialize on current revenue level

Solid cash position

4Q24 balance sheet and cash flow

.

Cash Capex
MNOK 84.7 MNOK 3.3
MNOK 87.6 in 4Q23 MNOK 1.5 in 4Q23
FCF Equity ratio
MNOK -8.5 84.5%
MNOK 11.0 in 4Q23 81.4% in 4Q23

Capital priorities

  • Initial dividend of NOK 0.40 per share proposed by the board
  • Cash flow in 4Q24 influenced by an increase in receivables, up from the unusually low level in 3Q
  • No interest-bearing debt
  • Long-term net working capital/sales assumed at ~30%

Product update

Cystatin C Strongly influenced by soft sales in China

Sales of Cystatin C last 2 years (MNOK)

  • Market growth driven by new KDIGO guidelines, with increasing demand for Cystatin C testing
  • Full year sales decreased by 10%
  • Good product demand in Europe and accelerated growth in the US
  • Sales to Asia continued to be negatively impacted by the Value Based Pricing approach in China, but with signs of recovery

fCAL® turbo Continued adoption in central laboratory environments

  • Sales growth of 34% in 4Q24 compared to 4Q23
  • Full year sales growth of 42% in 2024
  • Record sales driven by growing demand for fecal calprotectin testing and market share gain from traditional ELISA tests

Other products

  • Q4 sales of NOK 6.2 million, up 22% compared to Q4 last year
  • Full year sales of NOK 21.8 million, a growth of 17% in 2024
  • Category comprise cCRP, fPELA, GCAL and RBP
  • Sales of cCRP is approximately 50% of category total sales

Third-party products Stabilised sales in line with previous quarters

Sales of third-party products last 2 years (MNOK)

  • Q4 sales down 1% compared to Q4 last year
  • Full year sales growth of 8% in 2024

Strong sales growth in the US

R&D update and summary

NT-proBNP development proceeding as planned

Further studies indicate comparable performance to existing market leading assays

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.

4Q highlights:

  • The assay development progressed as planned and further studies indicated comparable performance to existing market leading assays
  • Collaborations with clinical partners have been further strengthened, with contracts finalized to secure access to additional clinical cohorts.
  • Freedom-to-operate update confirmed no IP related obstacles, solidifying the project's pathway to a successful launch

The aim is to introduce the assay as a research-use-only product in the second half of 2025. Timeline for full commercial lunch will be subject to capacity constraints with external regulatory clearance institutions, a process beyond the company's control. Typically, this regulatory clearance process takes 6-12 months.

Appendix

P&L highlights

MNOK 4Q24 4Q23 2024 2023
Sales 42.6 37.5 152.1 135.2
Cost of goods sold -18.8 -21.5 -69.3 -70.9
Gross profit 23.8 15.9 82.8 64.2
Other
revenues
1.8 0.3 4.6 7.2
R&D expenses -5.3 -14.7 -21.9 -36.1
Sales and marketing expenses -9.1 -6.1 -28.1 -23.1
Administrative expenses -5.4 -5.4 -21.7 -25.1
Operating profit 5.9 -9.9 15.7 -12.8
Net financial
items
1.9 0.1 4.3 2.4
Net profit (loss) 33.0 -10.1 45.3 -10.6

Balance sheet highlights

MNOK 2024 2023
Inventory 45.9 37.1
Accounts-
and other receivables
31.3 17.0
Cash and cash equivalents 84.7 87.6
Total non-current assets 67.7 39.3
Total assets 229.7 181.0
Total paid-in equity 316.3 313.7
Total retained equity -122.2 -167.0
Total equity 194.1 146.6
Total
non-current liabilities
5.5 9.1
Total current
liabilities
30.1 25.3
Total equity
and liabilities
229.7 181.0

Cash flow highlights

MNOK 4Q24 4Q23 2024 2023
Operating activities -4.1 13.7 13.5 15.5
Investing
activities
-3.3 -1.5 -11.0 -4.9
Financing
activities
-1.2 -1.2 -5.0 -4.6
Changes in cash and cash
equivalent
-8.5 11.0 -2.4 6.0
Cash
and cash equivalent at the
beginning of period
93.8 76.4 87.6 81.6
Cash
and cash equivalent at the
end of period
84.7 87.6 84.7 87.6

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

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20

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60

80

100

120

140

160

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

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 1,830 >15% 30-50% 5-10%

Key risks to target market shares include market adoption rates for GCAL, and successful launch of NT-proBNP

Dedicated and experienced management team

CEO Matti Heinonen

CFO & COO

Njaal Kind

CSO Dr. Alexandra Havelka

VP R&D

VP BD Jack Andreassen

CCO Markus Jaquemar

CTO Dr. Frank Frantzen

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

Hilja Ibert has 25+ years of experience from the international diagnostic industry, including VP International DiagnosticSolutions at Hologic and senior positions within Becton Dickinson and bioMerieux. She was previously the CEO for miDiagnostics in Belgium and CEO of Gentian Diagnostics ASA from 2018 to 2024. Dr. Ibert holds a PhD degree in Nutrition Science from the University of Bonn, Germany.

Espen T. Jørgensen

Board member

Espen Tidemann Jørgensen is currently Portfolio Manager of Holta Invest, a large shareholder in Gentian Diagnostics. He has 19 years of experience from financial markets. Mr. Jørgensen has previously been a member of the board of directors at Weifa ASA, and Cortendo plc (now Strongbridge BioPharma plc). He is currently a board member at Decisions AS in addition to Gentian Diagnostics ASA. Mr. Jørgensen holds a Master's degree in Economics and has completed 3 years of medical 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

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.

Fredrik Thoresen

Board member

Fredrik Thoresen is a partner in Kvantia AS where he joined in 2021. Mr. Thoresen has previous buy and sell -side experience from Storebrand Asset Management, SEB, DNB Markets, and Sector Asset Management AS. 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.

Top 20 shareholders

Shareholder No of shares %
Vatne Equity AS 2 110 224 13.68 %
Kvantia AS 1 803 368 11.69 %
Holta Invest AS 1 228 502 7.97 %
Verdipapirfondet Delphi Nordic 697 006 4.52 %
Safrino AS 649 700 4.21 %
Carpe Diem Afseth AS 578 189 3.75 %
J.P. Morgan SE 523 631 3.40 %
Verdipapirfondet Delphi Norge 384 572 2.49 %
Verdipapirfondet DNB SMB 356 065 2.31 %
Portia AS 300 000 1.95 %
Krefting, Johan Henrik 298 000 1.93 %
Viola AS 258 421 1.68 %
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 %
Verdipapirfondet Storebrand Vekst 211 665 1.37 %
Mutus AS 210 465 1.36 %
Silvercoin Industries AS 181 277 1.18 %
Caaby AS 173 500 1.12 %
Other Shareholders 4 532 642 29.39 %
Total shares 15 422 350 100 %

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