Gentian Diagnostics ASA

Investor Presentation • Aug 21, 2020

Q2 Presentation 2020

August 21st, 2020

Hilja Ibert, CEO Njaal Kind, CFO

Important notice

This presentation has been prepared by and is the sole responsibility of Gentian Diagnostics AS (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. Neither the Company (nor any of its parent or subsidiary undertakings) or the Managers (or any such person's representatives, officers, employees or advisors) 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 forward-looking statements to our actual results. 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 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

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• 1. Introduction and highlights
• 1. Q2 Financials
• 1. Growth opportunities
• 1. Outlook

We innovate diagnostic efficiency

Efficiency gains for immunoassays

5

IVD Reagent Market 2018 65B USD/2023 78B USD CAGR : 4% Source: Kalorama, 2018

Highlights for Q2 2020

• Record sales revenues of MNOK 16.6 in 2Q20, up from MNOK 10.2 in 2Q19.
• Sales growth in 2Q20 of 64 % is based on strong performance of all product lines, partially supported by warehouse safety stock building in China. Sales in the quarter grew by 44 % YoY on a currency neutral basis.
• Successful release of fPELA® turbo, which is marketed by our partner BÜHLMANN Laboratories AG.
• New scientific publications propose calprotectin as a promising biomarker for the management of COVID-19 patients, which represents a new opportunity for our GCAL® assay.
• Gentian awarded up to MNOK 8.0 in funding to support the development of a high-throughput COVID-19 antibody test.

- 1. Introduction and highlights 2. Q2 Financials

• 1. Growth opportunities
• 1. Outlook

Financial highlights 2Q 2020

MNOK	2Q 2020	2Q 2019
Sales	16.6	10.2
Other Revenues	3.2	1.9
Total Revenues	19.9	12.1
COGS	6.3	5.4
R&D Costs	5.0	5.2
SG&A	8.9	6.7
Capitalization	-0.6	-0.5
OPEX	19.6	16.9
EBITDA	0.2	-4.8
EBIT	-1.3	-20.6

Financial highlights 1H 2020

MNOK	1H 2020	1H 2019
Sales	32.9	20.8
Other Revenues	6.1	3.4
Total Revenues	39.0	24.2
COGS	16.2	12.0
R&D Costs	10.7	9.3
SG&A	17.5	14.6
Capitalization	-0.6	-1.4
OPEX	43.7	34.6
EBITDA	-4.7	-10.4
EBIT	-7.8	-27.9

Sales and revenues

Revenues and Grants Consolidated (NOK)

Sales revenues Other Revenues

Sales revenues -		geographic split
MNOK	2Q20	2Q19	1H20	1H19
US	1.0	0.6	1.7	1.1
Europe	9.9	7.7	21.1	15.1
Asia	5.7	1.9	10.1	4.6
Total	16.6	10.2	32.9	20.8
Sales revenues -
		product split
MNOK	2Q20	2Q19	1H20	1H19
Cystatin C	8.5	3.9	15.0	8.6
fCAL® turbo	3.9	3.0	9.2	6.9
Other	4.3	3.3	8.7	5.3
Total	16.6	10.2	32.9	20.8

fCAL® turbo	3.9	3.0	9.2	6.9
Other	4.3	3.3	8.7	5.3
Total	16.6	10.2	32.9	20.8

Sales Cystatin C

Kidney function test, diagnosis and monitoring

• Strong quarter with 120% sales growth versus 2Q19
• Beckman Coulter China shipments were significantly increased
• Beckman Coulter Europe/US also at high levels
• Direct sales efforts in the US continue to deliver promising results
• Revenue growth for 2H2020 expected to be lower than in 1H2020

Sales fCAL® turbo

Test for inflammatory bowel disease (IBD), diagnosis and monitoring

• Despite the negative impact of COVID-19 related measures on the fCAL turbo demand, a sales growth of 29% versus 2Q19 has been achieved
• First revenues from US customers will be delayed due to the COVID-19 outbreak
• Increased quarterly variations expected in 2020

Cost of goods sold

• COGS comprises now both raw material cost and cost of production
• COGS of 38% of sales in Q2 2020 vs 53% in Q2 2019
• COGS measured as a percentage of sales will decline as revenue increases, but with quarterly variations

OPEX

Total OPEX ex COGS before capitalization (2Q20): 14.0MNOK

Cash flow and cash position

MNOK	2Q20	1Q20	2019
Operating activities	1.1	- 9.7	- 23.1
Investing activities	- 1.2	- 0.4	- 4.7
Financing activities	- 0.1	- 0.1	0.7
Changes in cash and cash equivalent	- 0.2	- 10.2	-27.1
Cash and cash equivalent at the beginning of period	161.4	171.6	198.6
Cash and cash equivalent at the end of period	161.2	161.4	171.6

• 1. Introduction and highlights 3. Growth opportunities
• 1. Q2 Financials
• 1. Outlook

Products and pipeline: 1 new product per year

fPELA® turbo

Diagnosis and disease monitoring of Pancreatic Exocrine Insufficiency (PEI)

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Efficient turbidimetric testing of faecal samples to measure Pancreatic Elastase Combination test with fCAL® turbo in one sample – PEI may be due to various underlying Providing better IVD tools to the markets to establish larger use of fPELA ® turbo in

• diseases, including IBD
• Targeting established fCAL® turbo customers
• diagnostic and monitoring in bowel patients' pathologies and other chronic diseases like diabetes
• Annual test volume could reach 25% of fCAL® turbo

GCAL® Calprotectin immunoassay

Early detection of severe bacterial infections, sepsis and inflammation

GCAL® : Novel biomarker in market development Potential use in early detection of sepsis and other severe infections

• Promising biomarker for detection and monitoring of inflammation in Rheumatoid Arthritis
• First scientific reports show increased levels of calprotectin in COVID-19 patients and indicating the prognostic value of calprotectin in estimation of disease severity, organ damage and mortality
• Prognostic biomarker for disease severity and mortality in sepsis and COVID 19 patients
• Reported infectious diseases market value is \$4.0B (BCC, 2018); the target category is estimated to represent about \$1.0B

GCAL® market development timeline - Process has to be country specific

GCAL® in the context of COVID-19

• Recent studies have confirmed the critical role of neutrophils in patients infected with the SARS-CoV-2 virus
• Two studies performed at universities/hospitals in Michigan, Shanghai and Washington* have focused on calprotectin as an early biomarker for neutrophil activation and its role in COVID-19 disease, they have shown: Significantly elevated levels of calprotectin in the patients hospitalised with the COVID-19 disease
  -
  • Calprotectin levels correlated with the severity of the respiratory failure and the need for mechanical ventilation
  • Elevated levels of calprotectin were also associated with a higher mortality risk due to thrombotic complications which indicates the use of calprotectin as a prognostic biomarker for severity of the disease and risk of mortality DOI: 10.1101/2020.05.06.20093070 2. Zuo et al., Neutrophil extracellular traps (NETs) as markers of disease severity in COVID-19, MedRxiv.
• Gentian has now initiated several study collaborations with hospitals in Sweden, Spain and Germany with the aim to confirm and further investigate the role of GCAL® calprotectin in COVID-19 disease.

* References: 1. Shi et al., Neutrophil calprotectin identifies severe pulmonary disease in COVID-19, MedRxiv. May 2020. PMCID: PMC7274221 Apr2020. PMCID: PMC7276989 DOI: 10.1101/2020.04.09. 20059626

CoV-2 Ab

The first turbidimetric antibody/serology test for SARS-CoV-2

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The alternative to closed system immunochemical SARS-CoV-2 serology testing

• Open system turbidimetric SARS-CoV-2 antibody testing for clinical chemistry analysers
• High throughput and efficient workflow with a cost-effective assay
• Addressing segments of immune status screening of the population, donor identification of convalescent plasma/serum for COVID-19 patients, measure and monitor vaccine response, complementing PCR-based diagnosis
• Designed for maximum sensitivity and specificity
• Product development is supported by the Norwegian Research Council with up to MNOK 8

G-1001

Fast and accurate cardiovascular testing

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G-1001 – cardiac maker designed for high volume clinical chemistry platforms Pushing the boundaries of PETIA - highly sensitive at low concentrations, measure

• Improved workflow and diagnostic efficiency in diagnosis of cardiac diseases
• Immunoassay to be run on open clinical chemistry analysers independent of the platform provider
• No biotin interference, a common problem for current assays in the market
• concentrations in the range down to ng/L levels
• Cardiac Marker segment value is reported to be at 2B USD in 2022, the target category is estimated to be 1B USD

Performance data of Gentian PETIA assay – correlation between clinical analyzers

The graph below shows the correlation between the same patient samples measured on the Mindray BS400 and Abbott Architect c4000 clinical analyzers (same reagents and calibrators used on both instruments).

This is the first time that a turbidimetric method shows consistent values for this kind of biomarker below 1000 ng/L.

Intellectual Property

• Based on the recently achieved milestones, Gentian has further enriched the filed patent application.
• The publication date of this patent application is February 2021.
• The company is constantly assessing the benefits of an IP protection via the patent or a trade secret and a final decision will be taken before the publication date.

• 1. Introduction and highlights 4. Outlook
• 1. Q2 Financials
• 1. Growth opportunities

Outlook

• Gentian may be further affected by the COVID-19 outbreak by reduced demand for diagnostic services for outpatients and we expect some delays with our clinical studies and R&D programs
• The company estimates continued sales growth in 2020 versus 2019, with expected quarterly variations and so far, unpredictable effects of the COVID-19 outbreak
• For Cystatin C, the company expects less orders from China due to high warehouse levels and continuous growth in the US and Europe
• For fCAL® turbo, the company expects to see a slight recovery of the demand in Q3
• For GCAL®, additional and independent clinical publications are in preparation. In addition, the company expects to commission new clinical studies to evaluate the clinical value of GCAL® for the management of COVID-19 patients

Get in touch with us Bjørnåsveien 5, 1596 Moss, Norway

HQ GENTIAN AS

GENTIAN DIAGNOSTICS AB Kungsgatan 8111 43 Stockholm, Sweden 215 N Eola Dr, Orlando, Florida US

GENTIAN USA INC.

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