Gentian Diagnostics ASA

Investor Presentation • Aug 24, 2023

Q2 23 Presentation

August 24th, 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.

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Efficient diagnostics for better treatment decisions

Introduction

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

Portfolio of high-impact tests provides solid growth opportunity

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

~28% average annual sales growth 2019-22

2 'blockbuster' tests in market and product development

Products targeting large and growing disease groups

DISEASE GROUP		PRODUCT	APPLICATION	ATTRACTIVE CLINICAL BENEFITS
Kidney disease		Cystatin C	Early detection of reduced kidney function	Preventing severe kidney failure
Inflammation & infection		fCAL	Fast diagnosis of inflammatory bowel disease	Reducing time-consuming and costly colonoscopy
		GCAL	Early detection of severe infections, including sepsis	Reducing chance of fatality and treatment costs
		SARS-CoV-2 Ab	Measuring COVID-19 immunity	Supporting community management
		Canine CRP	Early detection and diagnosis of inflammation in dogs	High relevance of results due to dog specific CRP
Cardiac		NT-proBNP	Diagnosis, monitoring and assessment of congestive heart failure	Contributing to standardization of NT-proBNP assays
Pancreas		fPELA	Diagnosis of pancreatic elastase insufficiency in combination with fCAL	Reducing time-consuming and costly colonoscopy

Strong momentum for cystatin C

Driven by support from the healthcare community and updates in recommendations

• Increased use of cystatin C recommended in updated guidelines from global reputable foundations and healthcare scientists
• Updated recommendations reports:
  • Increased accuracy in diagnosis and management of kidney disease by use of cystatin C in combination with serum creatinine
  • Limitations of serum creatinine
  • Improved performance achieved through use of both cystatin C and creatinine
• Cystatin C combined with serum (blood) creatinine, recommended as a confirmatory assessment of GFR or kidney function

Positive market development for GCAL®

About GCAL® Serum & Plasma Calprotectin®

GCAL ® is the first assay available on high-throughput analysers for analysis of circulating calprotectin. Clinical studies confirm the potential of GCAL® for the early detection and prediction of severe infectious diseases. Sepsis kills 11 million people each year, and fast results provided by GCAL® could save lives and significantly reduce healthcare costs.

The market development of GCAL® continued to develop positively, driven by a growing body of scientific evidence supporting the relevance of the immunoassay:

• Data from the CASCADE study (Calprotectin in Acute Infections and Sepsis for Prognosis, Characterization and Diagnosis in the Emergency Department), in collaboration with Charité University Hospital and Labor Berlin were presented at the European Congress of Microbiology and Infectious Diseases (ECCMID) in April 2023. The data confirmed the value of GCAL® in early detection of bacterial infections, estimation of disease severity and prediction of clinical deterioration. Results from this study support the use of calprotectin in the Emergency Department, for early diagnosis of infections and optimal treatment decisions.
• Health economic analysis has been performed supporting that early diagnosis of bacterial infections and earlier start of antibiotic treatment in critically ill patients are beneficial, not only from the clinical, but also from a cost-saving perspective. The health economic model has shown that the use of the GCAL® Calprotectin Immunoassay in comparison to other routinely used biomarkers, reduce total costs by approximately 13 – 18 KEUR per patient in an ICU. This study has been accepted for publication and is published in Biomedicines 2023, 11(8), 2156.

Progress made on 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 underestimation issue caused by glycosylation.

• Gentian's NT-proBNP assay is currently in the optimization phase of development and aims to be the first turbidimetric in vitro diagnostic test for the quantitative measurement of NT-proBNP.
• During the second quarter, the prototype stability has been extended and the performance of the assay has been tested with material from healthy volunteers. The results from these investigations enable further progress in the preparations to study the capacity of the prototype assay in a cohort of clinical patient material.
• In parallel, the measurements and quantifications of the impact of glycosylation on the NT-proBNP molecule have continued, which is of importance for the calibration of the assay.
• 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 About NT-proBNP 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	2,200	220	~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

Delivered 28% sales growth last four years

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20

40

60

80

100

120

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

Four established products with potential to grow 20%+ annually

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

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

Secure one new contract with a global commercial partner per year

Grow gross margin from ~50% in 2021 to 60%+ at volume production

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

Increased distribution supporting long-term growth

2Q23 financials and key milestones Highlights

Sales	Gross margin
MNOK 34.2	56%
+13% vs 2Q22	52% in 2Q22
EBITDA	Several updated
MNOK 3.6	guidelines for
MNOK -1.2 in 2Q22	Cystatin C

EBITDA positive in 2Q23 and 1H23

• Record sales of MNOK 34.2 in 2Q23, up 13% vs 2Q22. Revenue of MNOK 65.6 in 1H23 up 30% vs 1H22. Organic growth for the quarter was 2% in 2Q23 vs 2Q22 and 17% in 1H23 vs 1H22
• EBITDA of NOK 3.6 million in 2Q23 and NOK 3.1 million for 1H23, compared to EBITDA of NOK -1.2 million in 2Q22 and NOK -5.4 million 1H22
• Third Party product sales increased by 112% in Q2 and 68% for H1, driven by the new fCAL® turbo contracts in Sweden and Norway
• Increased use of Cystatin C recommended in updated guidelines for clinical use, of which the proposed update from KDIGO* is the most recent one, resulting in further expansion of the global market
• Confirmed value, validated by clinical trial, of GCAL for early detection of severe infections and prediction of clinical deterioration in an emergency setting
• Acquisition of Getica AB (Gothenburg, Sweden) to secure unique R&D capabilities and to gain control of critical production competence with estimated operational gains of approximately NOK 2.0 million from 2024

Continued high sales growth in line with target

• 1H23 sales up 30% vs 1H22 (17% organic) and 2Q23 sales up 13% (2% organic) vs 2Q22
• Revenue growth contribution was achieved by all products, in all regions and via all sales channels in the first half of 2023
• Total revenues of MNOK 36.2 in the quarter, up 10% from 2Q22

Sales revenue - geographic split

MNOK	2Q23	2Q22	1H23	1H22
US	2.8	1.5	4.8	2.8
Europe	25.5	19.2	47.6	34.3
Asia	5.9	9.4	13.3	13.5
Total	34.2	30.1	65.6	50.7

Sales revenue - product split

MNOK	2Q23	2Q22	1H23	1H22
Cystatin C	12.3	14.4	25.9	21.9
fCAL®turbo	12.0	8.8	21.5	15.6
Third-party products	5.7	2.7	9.3	5.5
Other	4.2	4.2	9.0	7.6
Total	34.2	30.1	65.6	50.7

Stable cost development

MNOK	2Q23	2Q22	1H23	1H22
Sales and marketing expenses	5.9	6.8	11.2	11.4
Administration expenses	6.0	7.6	13.2	14.3
Research and development expenses	5.7	5.3	12.4	9.7
Total	17.6	19.7	36.8	35.4

• Total other operating expenses before capitalisation of R&D expenses was MNOK 18.1 in 2Q23, compared to MNOK 20.7 in 2Q22
• Capitalised R&D expenses was MNOK 0.7 in 2Q23 compared to MNOK 1.0 in 2Q22

Investing to scale

2Q23 balance sheet and cash flow

Cash	Capex
MNOK 80.7	MNOK 1.1
MNOK 92.1 in 2Q22	MNOK 8.4 in 2Q22
FCF	Equity ratio
MNOK 4.8	81.8%
MNOK -8.1 in 2Q22	83.3% in 2Q22

Capital priorities

• OPEX of MNOK 18.1* and capex of MNOK 1.1 in 2Q23
• 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	2Q23	2Q22	1H23	1H22
Sales	34.2	30.1	65.6	50.7
Other revenues	2.0	2.8	4.1	5.3
Total revenues	36.2	32.9	69.8	56.0
COGS	-14.9	-14.4	-29.9	-26.0
Employee benefit expenses	-10.7	-11.6	-22.5	-20.1
D&A	-2.4	-2.7	-4.8	-4.8
Other OPEX	-4.6	-5.4	-9.5	-10.5
EBITDA	3.6	-1.2	3.1	-5.4
EBIT	1.2	-4.0	-1.7	-10.2

Cash flow highlights

MNOK	2Q23	2Q22	1H23	1H22
Operating activities	7.1	1.0	3.8	-10.4
Investing activities	-1.1	-8.4	-2.2	-10.6
Financing activities	-1.2	-0.8	-2.3	-1.9
Changes in cash and cash equivalent	4.8	-8.1	-0.7	-22.9
Cash and cash equivalent at the beginning of period	76.0	100.2	81.6	114.9
Cash and cash equivalent at the end of period	80.7	92.1	80.7	92.1

Dedicated and experienced management team

CEO Dr. Hilja Ibert

CFO & COO Njaal Consulting Founder Dr. Erling

CCO Markus Jaquemar

VP BD Jack Andreassen

Kind Sundrehagen

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 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 Norwegian University of Science and Technology	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.

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	536 589	3.48 %
Skandinaviska Enskilda Banken AB	497 273	3.22 %
Verdipapirfondet DNB SMB	361 291	2.34 %
Verdipapirfondet Storebrand Vekst	331 220	2.15 %
J.P. Morgan SE	325 000	2.11 %
Portia AS	300 000	1.95 %
Intertrade Shipping AS	257 716	1.67 %
Cressida AS	235 000	1.52 %
Krefting, Johan Henrik	229 900	1.49 %
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 %
Vingulmork Predictor AS	184 083	1.19 %
Other Shareholders	4 485 674	28.44 %
Total shares	15 422 350	100 %