Gentian Diagnostics ASA

Investor Presentation • Oct 26, 2023

Q3 23 Presentation

26 October 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.

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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

8* 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

~28% average annual sales growth 2019-22

2 'blockbuster' tests in market and product development

Products targeting important disease groups

ESTABLISHED PRODUCTS					IN MARKET DEVELOPMENT			IN PRODUCT DEVELOPMENT
Kidney disease	Inflammation & infection	Inflammation	Pancreas deficiency	Lifestyle associated diseases	Inflammation & infection	Inflammation		Cardiac disease
Cystatin C	Canine CRP	fCAL®	fPELA®	RBP	GCAL®	SARS-CoV-2		NT-proBNP
2006	2012	2015	2020	2023	2019	2022		TBD

Gentian Retinol-Binding Protein (RBP)

Early indication of lifestyle associated diseases

About Gentian RBP

The Gentian RBP assay contributes to the diagnosis and monitoring of lifestyle associated diseases. The turbidimetric assay is open channel and provides fast time to results. The test is CE-marked, UKCA-marked and FDA 510(k) exempt.

Efficient diagnosis and monitoring of lifestyle associated diseases like:

• Vitamin A deficiency
• Malnutrition
• Diabetes
• Renal dysfunction

Advantages

• Replace cumbersome and time-consuming methods like ELISA, HPLC
• Fast time to results
• Easy integration into laboratory workflow
• Assay menu extension as a service for clinicians

Good progress made on NT-proBNP

Significant technical advancements with the current assay prototype

About NT-proBNP

Measuring NT-proBNP levels in plasma supports diagnosis of congestive 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.

• The majority of critical technical specifications were successfully met with the current assay prototype.
• The impact of glycosylation on the clinical assessment will be further investigated.
• Evaluation of the current prototype with relevant patient samples is in preparation to assess clinical performance.
• 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

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*

combined net

* Dependent on timing of NT-proBNP launch

Financial review

Strong momentum and launch of new product

3Q23 financials and key milestones Highlights

Sales	Gross margin
MNOK 32.1	49%
+39% vs 3Q22	45% in 3Q22
EBITDA	Launch of
MNOK 1.2	Gentian RBP
MNOK -6.1 in 3Q22	immunoassay

EBITDA positive in 3Q23 and YTD 2023

• Sales of MNOK 32.1 in 3Q23, up 39% vs 3Q22 (29% organic growth). Revenue of MNOK 97.7 YTD 2023 up 33% (21% organic growth) vs the same period in 2022
• EBITDA of NOK 1.2 million in 3Q23 and NOK 4.3 million YTD 2023, compared to EBITDA of NOK -6.1 million in 3Q22 and NOK -11.5 million YTD 2022
• Cystatin C sales increased 90% in 3Q23 compared to 3Q22 and 39% YTD 2023 vs YTD 2022
• Launch of the Gentian Retinol-Binding Protein (RBP), open channel immunoassay.

Continued high sales growth in line with target

• Sales of MNOK 32.1 in 3Q23, up 39% vs 3Q22 (29% organic growth). Revenue of MNOK 97.7 YTD 2023 up 33% (21% organic growth) vs the same period in 2022
• Revenue growth contribution was achieved by all products and via all sales channels in the first nine months of 2023
• Record high Cystatin C sales
• Total revenues of MNOK 34.8 in the quarter, up 39% from 3Q22

Sales revenue - geographic split

MNOK	3Q23	3Q22	YTD23	YTD22	2022
US	1.9	2.6	6.7	5.4	6.5
Europe	18.7	17.7	66.2	52.0	71.6
Asia	11.5	2.8	24.8	16.3	23.6
Total	32.1	23.1	97.7	73.7	101.6

Sales revenue - product split

MNOK	3Q23	3Q22	YTD23	YTD22	2022
Cystatin C	16.5	8.7	42.4	30.5	40.0
fCAL®turbo	8.1	9.0	29.6	24.6	36.3
Third-party products	2.9	2.2	12.2	7.8	10.2
Other	4.5	3.2	13.5	10.8	15.2
Total	32.1	23.1	97.7	73.7	101.6

Stable cost development

MNOK	3Q23	3Q22	YTD23	YTD22
Sales and marketing expenses	5.4	3.8	16.6	15.2
Administration expenses	6.3	7.9	19.5	22.2
Research and development expenses	5.6	6.7	18.0	16.4
Total	17.3	18.4	54.1	53.8

• Total other operating expenses before capitalisation of R&D expenses was MNOK 18.0 in 3Q23, compared to MNOK 18.4 in 3Q22
• Capitalised R&D expenses was MNOK 0.7 in 3Q23 compared to MNOK 1.2 in 3Q22

Maintaining a healthy cash position

3Q23 balance sheet and cash flow

Cash	Capex
MNOK 76.4	MNOK 1.2
MNOK 93.9 in 3Q22	MNOK 1.8 in 3Q22
FCF	Equity ratio
MNOK -4.3	82.8%
MNOK 1.8 in 3Q22	82.8% in 3Q22

Capital priorities

• OPEX of MNOK 19.6* and capex of MNOK 1.2 in 3Q23
• OPEX will increase as total number of products are launched and sales grow – limited increase in capex
• Cost base consisting mainly of personnel
• Long-term net working capital/sales assumed at ~30%, down from ~40% currently

Q&A

Appendix

P&L highlights

MNOK	3Q23	3Q22	YTD23	YTD22	2022
Sales	32.1	23.1	97.7	73.7	101.6
Other revenues	2.7	2.0	6.9	7.3	10.3
Total revenues	34.8	25.1	104.5	81.1	111.9
COGS	-16.3	-12.8	-46.2	-38.8	-52.6
Employee benefit expenses	-13.0	-10.0	-35.4	-30.1	-40.9
D&A	-2.4	-2.7	-7.1	-7.5	-10.2
Other OPEX	-4.3	-8.4	-18.6	-23.6	-31.4
EBITDA	1.2	-6.1	4.3	-11.5	-13.0
EBIT	-1.2	-8.7	-2.9	-19.0	-23.2

Cash flow highlights

MNOK	3Q23	3Q22	YTD23	YTD22	2022
Operating activities	-2.0	4.7	1.8	-5.5	-14.0
Investing activities	-1.2	-1.8	-3.3	-12.3	-14.7
Financing activities	-1.1	-1.1	-3.4	-3.2	-4.3
Changes in cash and cash equivalent	-4.3	-1.8	-5.0	-21.1	-32.9
Cash and cash equivalent at the beginning of period	80.7	92.1	81.6	114.9	114.9
Cash and cash equivalent at the end of period	76.4	93.9	76.4	93.9	81.6

Dedicated and experienced management team

CEO Dr. Hilja Ibert

Sundrehagen

Njaal Consulting Founder Dr. Erling

Kind

CCO Markus Jaquemar

CFO & COO

Dr. Alexandra

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

CSO

Havelka

Track record from leading global diagnostics companies across all phases

Board of directors

Tomas Settevik	Espen T. Jørgensen	Kari E. Krogstad	Kjersti Grimsrud	Fredrik Thoresen	Monika Neuman	Frank Frantzen
Chair of the Board	Board member	Board member	Board member	Board member	Board member	Board member
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 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 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	Fredrik Thoresen is a partner in Andenaes gruppen 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 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.	Frank Frantzen has more than 35 years of experience from the diagnostic industry. He has served as principal scientist and has directed larger R&D units in international IVD companies Axis-Shield, Alere and Abbott. Mr. Frantzen left his Senior Director R&D position at Abbott in 2021 and is currently serving as Chief Technology Officer in CardiNor AS. Mr. Frantzen holds a master's degree in chemistry and a PhD, both from the Norwegian University of Science and Technology in Trondheim.

Norwegian University of Science and Technology

in Trondheim.

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	987 104	6.40 %
Safrino AS	749 700	4.86 %
Carpe Diem Afseth AS	544 089	3.53 %
Skandinaviska Enskilda Banken AB	501 000	3.25 %
Verdipapirfondet DNB SMB	361 291	2.34 %
J.P. Morgan SE	325 000	2.11 %
Verdipapirfondet Storebrand Vekst	315 751	2.05 %
Portia AS	300 000	1.95 %
Krefting, Johan Henrik	278 500	1.81 %
Intertrade Shipping AS	257 716	1.67 %
Cressida AS	235 000	1.52 %
Verdipapirfondet Equinor Aksjer NO	227 880	1.48 %
Lioness AS	220 000	1.43 %
Marstal AS	212 407	1.38 %
Mutus AS	210 465	1.36 %
Salix AS	208 954	1.35 %
Silvercoin Industries AS	184 441	1.20 %
Other Shareholders	4 340 958	28.15 %
Total shares	15 422 350	100 %