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Gentian Diagnostics ASA

Investor Presentation Oct 31, 2024

3604_rns_2024-10-31_525792d4-eba5-4d90-9bcc-36f8bdc5c4c3.pdf

Investor Presentation

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Q3 24 Presentation

31 October 2024

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

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

Proven business model 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

Scalable, lean and flexible commercial model

~30% average annual sales growth 2019-23

2 'blockbuster' tests in market and product development

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%

NOK 1bn in 5-7 years Targeting a serviceable market of USD 1.8bn*

Highlights

Improved margin and continued positive EBITDA

3Q24 financials and key milestones Highlights

Sales Gross margin
MNOK 32.7 52%
+2% vs 3Q23 46% in 3Q23
EBITDA Cash position
MNOK 5.0 MNOK 93.8
MNOK 1.2 in 3Q23 MNOK 76.4 in 3Q23
  • Sales of fCAL® turbo increased by 76% in 3Q24 compared to 3Q23.
  • Bühlmann, Gentian's exclusive commercial partner for fCAL turbo and fPELA turbo, announced a worldwide collaboration with Beckman Coulter for both products
  • A significant milestone was achieved for the NT-proBNP assay with initial clinical evaluation on 220 patient samples in collaboration with leading Norwegian experts in Cardiology indicating good clinical performance.
  • Gentian was awarded a patent in Europe for a novel NTproBNP reference method.

Strong performance in Europe and continued US growth

Highlights

  • Sales of fCAL® turbo increased 76% in 3Q24 driving sales growth in Europe
  • Year to date sales growth in the US driven by customer additions
  • Soft Cystatin C sales to China during the quarter
  • Third party products recording strong growth of 50% in 3Q24

Sales revenue - geographic split

MNOK 3Q24 3Q23 YTD24 YTD23 2023
US 2.4 1.9 8.1 6.7 8.7
Europe 27.3 18.7 83.8 66.2 92.8
Asia 3.0 11.5 17.6 24.8 33.7
Total 32.7 32.1 109.5 97.7 135.2

Sales revenue - product split

MNOK 3Q24 3Q23 YTD24 YTD23 2023
Cystatin C 9.0 16.5 37.2 42.3 56.3
fCAL® turbo 14.3 8.1 43.0 29.6 43.2
Third-party
products
4.3 2.9 13.6 12.2 17.0
Other 5.1 4.6 15.7 13.6 18.7
Total 32.7 32.1 109.5 97.7 135.2

Continuously improving cost development

Gross margin %

Operating expenses

MNOK 3Q24 3Q23 YTD24 YTD23 2023
Sales and
marketing expenses
6.1 5.5 19.0 17.0 23.1
Administration
expenses
3.8 6.3 16.3 19.7 25.1
Research and
development
expenses
5.5 6.7 16.6 21.4 36.1
Total 15.3 18.6 51.9 58.1 84.2
  • Operating expenses ended at NOK 15.3 million in 3Q24 compared to NOK 18.6 million in 3Q23
  • Capitalised R&D expenses was MNOK 2.6 in 3Q24 compared to MNOK 0.7 in 3Q23

Significant EBITDA improvement due to improved gross margin and OPEX discipline

EBITDA development (MNOK)

  • Gross margin improved to 52% vs 46% in 3Q23 and to 54% year to date compared to 49% YTD last year
  • Strong improvement of EBITDA in the first nine months of 2024 to NOK 16.5 million vs 3.3 million in total for 2023

Stable cash position

3Q24 balance sheet and cash flow

.

Cash Capex
MNOK 93.8 MNOK 2.7
MNOK 76.4 in 3Q23 MNOK 1.2 in 3Q23
FCF Equity ratio
MNOK 12.5 85.4%
MNOK -4.3 in 3Q23 82.8% in 3Q23

Capital priorities

  • MNOK 17.4 million cash increase compared to 3Q23
  • Cash flow in 3Q24 influenced by a strong reduction in receivables to a level below normal
  • 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)

  • Updated global guidelines expected to further support adoption and usage of Cystatin C
  • Demand in Europe and the US remains strong with continued growth
  • Sales in Asia slowing due to the introduction of a new tender process in China

fCAL® turbo – continued adoption in central laboratory environments

Sales of fCAL® turbo last 2 years (MNOK)

  • Sales growth of 76% in 3Q24 compared to 3Q23 and 27% in year-to-date 2024 vs YTD 2023
  • Automation and ease-of-use drive continued adoption into core laboratory settings
  • Increased order volumes from large IVD partner

Third-party products – stabilised sales in line with previous quarters

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

  • Q3 sales up 50% compared to Q3 last year
  • Sales in line with previous quarters demonstrating the continued higher recurring sales level than previous years

Strong performance in Europe and the US

Sales by region last 2 years (MNOK)

  • 3Q24 sales growth was 46% in Europe and 28% in the US compared to 3Q23
  • Significant decline in 3Q24 is entirely attributed to lower sales to China

R&D update and summary

NT-proBNP development proceeding as planned

Initial clinical evaluation show good 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.

3Q highlights:

  • Assay development with verification studies proceeding as planned
  • Secured the availability of the first clinical cohort for testing through an agreement with one of Norway's leading hospitals in cardiology
  • Initial clinical evaluation on 220 patient samples in collaboration with leading Norwegian experts in Cardiology indicating good clinical performance
  • Further securing clinical cohorts, additional sample material and expanding collaboration ongoing
  • Patent granted for NT-proBNP reference method

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.

3Q summary Improved margin and continued positive EBITDA

3Q24 financials and key milestones Highlights

Sales Gross margin
MNOK 32.7 52%
+2% vs 3Q23 46% in 3Q23
EBITDA Cash position
MNOK 5.0 MNOK 93.8
MNOK 1.2 in 3Q23 MNOK 76.4 in 3Q23
  • Sales of fCAL® turbo increased by 76% in 3Q24 compared to 3Q23.
  • Bühlmann, Gentian's exclusive commercial partner for fCAL turbo and fPELA turbo, announced a worldwide collaboration with Beckman Coulter for both products
  • A significant milestone was achieved for the NT-proBNP assay with initial clinical evaluation on 220 patient samples in collaboration with leading Norwegian experts in Cardiology indicating good clinical performance.
  • Gentian was awarded a patent in Europe for a novel NTproBNP reference method.

Appendix

P&L highlights

MNOK 3Q24 3Q23 YTD24 YTD23 2023
Sales 32.7 32.1 109.5 97.7 135.2
Cost of goods sold -15.7 -17.4 -50.5 -49.4 -70.9
Gross profit 17.0 14.7 59.0 48.3 64.2
Other
revenues
1.0 2.7 2.8 6.9 7.2
R&D expenses -5.5 -6.7 -16.6 -21.4 -36.1
Sales and marketing expenses -6.1 -5.5 -18.9 -16.9 -23.1
Administrative expenses -3.8 -6.3 -16.3 -19.7 -25.1
Operating profit 2.7 -1.2 9.8 2.9 -12.8
Net financial
items
0.7 0.4 2.5 2.3 2.4
Net profit (loss) 3.4 -0.8 12.3 -0.6 -10.6

Balance sheet highlights

MNOK 3Q24 3Q23 2023
Inventory 42.6 41.1 37.1
Accounts-
and other receivables
11.1 23.8 17.0
Cash and cash equivalents 93.8 76.4 87.6
Total non-current assets 41.6 46.7 39.3
Total assets 189.1 188.0 181.0
Total paid-in equity 316.1 312.9 313.7
Total retained equity -154.7 -157.2 -167.0
Total equity 161.4 155.7 146.6
Total
non-current liabilities
6.7 10.0 9.1
Total current
liabilities
21.0 22.4 25.3
Total equity
and liabilities
189.1 188.0 181.0

Cash flow highlights

MNOK 3Q24 3Q23 YTD24 YTD23 2023
Operating activities 16.4 -2.0 17.5 1.8 15.5
Investing
activities
-2.7 -1.2 -7.7 -3.3 -4.9
Financing
activities
-1.2 -1.1 -3.8 -3.4 -4.6
Changes in cash and cash
equivalent
12.5 -4.3 6.1 -5.0 6.0
Cash
and cash equivalent at the
beginning of period
81.0 80.7 87.6 81.6 81.6
Cash
and cash equivalent at the
end of period
93.8 76.4 93.8 76.4 87.6

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.

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

0

20

40

60

80

100

120

140

160

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

Products targeting important disease groups

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

Markus Jaquemar

CCO

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 and Managing Director of Holta Life Sciences, a large shareholder in Gentian Diagnostics. He has 19 years of experience from financial markets, including positions as equity analyst at DNB Markets, and portfolio manager at Holta Invest AS. 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 sellside 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 694 300 4.50 %
Safrino AS 649 700 4.21 %
Carpe Diem Afseth AS 568 189 3.68 %
J.P. Morgan SE 523 631 3.40 %
Verdipapirfondet Delphi Norge 377 572 2.45 %
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 183 701 1.19 %
Caaby AS 173 500 1.12 %
Other Shareholders 4 549 924 29.50 %
Total shares 15 422 350 100 %

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