Gentian Diagnostics ASA

Investor Presentation • Feb 14, 2020

Q4 Presentation 2019 Oslo, February 14, 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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Agenda

1	Introduction and highlights
2	Q4 Financials
3	Sales, Operations, R&D
4	Outlook

#DiagnosticEfficiency

The in vitro diagnostics market

Products and pipeline

Highlights for Q4 2019

• Record sales revenues of MNOK 14.1 in 4Q19, totaling a 27 % growth y/y
• Total sales revenue for the year of MNOK 48.0 representing 20 % growth compared to 2018
• Strong fCAL® turbo sales in Q4 resulting in a y/y growth of 112% driven by continued growth in kit sales and positive effect from bulk orders fPELA development completed; external validation is ongoing

Main achievements in 2019

• fCAL® turbo sales channel agreement with Roche via our partner Bühlmann
• fCAL® turbo FDA 510(k) clearance
• Cystatin C cooperation with Beckman Coulter extended by another 6 years
• Gentian USA, Inc. collaborates with BioHealth Innovation (BHI) in order to expand Gentian's presence in the USA
• Gentian management strengthened with hiring of Torsten Knüttel as VP R&D

Continued double digit product sales growth

• Gentian continues to deliver double digit sales growth year after year Major growth driver in 2019 is fCAL® turbo
• 43 %
  • Sales growth expected in 2020 from all products

Agenda

1	Introduction and highlights
2	Q4 Financials
3	Sales, Operations, R&D
4	Outlook

Financial highlights 4Q 2019

Financial highlights	4Q 2019
MNOK	4Q 2019	4Q 2018
Sales	14.1	11.1
Other Revenues	2.5	0.4
Total Revenues	16.5	11.4
COGS	6.6	5.9
R&D Costs	7.6	4.8
SG&A	9.7	10.3
Capitalization	-1.2	-2.1
OPEX	22.7	18.9
		-7.4
EBITDA	-6.2

Financial highlights per 4Q 2019

Financial highlights	per 4Q 2019
MNOK Sales	2019 48.0	2018 39.9
Other Revenues	7.4	12.1
Total Revenues	55.4	52.0
COGS	25.4	22.4
R&D Costs	22.3	19.0
SG&A	31.7	27.5
Capitalization	-3.1	-5.2
OPEX	76.4	63.8
		-11.7
EBITDA	-21.0

Revenues and Grants Consolidated (NOK)

Sales and revenues		Sales revenues -		geographic split
	MNOK	4Q19	4Q18	YTD19	YTD18
Revenues and Grants Consolidated	US	0.6	0.9	2.0	2.2
(NOK)	Europe	11.3	7.5	34.1	27.1
	Asia	2.2	2.7	11.8	10.6
	Total	14.1	11.1	48.0	39.9
		Sales revenues -		product split
	MNOK	4Q19	4Q18	YTD19	YTD18
	Cystatin C	3.9	5.6	19.7	21.7
	fCAL® turbo	7.0	3.3	17.5	9.9
Q2 Q3 Q4 Q1 Q2 Q3 Q4 2018 2019	Other	3.1	2.2	10.8	8.3

Cystatin C	3.9	5.6	19.7	21.7
fCAL® turbo	7.0	3.3	17.5	9.9
Other	3.1	2.2	10.8	8.3
			48.0	39.9
Total	14.1	11.1

Cost of goods sold

• COGS will comprise both raw material cost and cost of production from 4Q 2019
• The main reason for the change is to make the accounts more comparable to the reporting made by international peers
• The change is of a technical nature and will not have any effect on EBITDA

OPEX

Cash flow and cash position

MNOK	4Q19	YTD19	YTD18
Operating activities	2.5	- 23.1	- 10.9
Investing activities	- 1.4	- 4.7	- 6.2
Financing activities	0.2	0.7	68.8
Changes in cash and cash equivalent	1.4	-27.1	51.7
Cash and cash equivalent at the beginning of period	170.2	198.6	146.9
Cash and cash equivalent at the end of period	171.6	171.6	198.6

Agenda

1	Introduction and highlights
2	Q3 Financials
3	Sales, Operations, R&D
4	Outlook

We innovate diagnostic efficiency - based on deep patent portfolio -

Laboratory workflow

Laboratory efficiency 2.000 versus 170 tests/hr Instrument independent

Clinical outcome

Kidney marker: Cystatin C

• FDA 510(k) cleared
• Estimated global market value of \$0.5B
• Early detection of reduced kidney function
• Continued growth for the company mainly coming from China and US

Partners

Beckman Coulter is one of top 3 market share holders in the area of clinical chemistry in the US

Key customers and KOLs

Gentian is supplier or sub-supplier to many hospitals on the 'America's Best Hospitals' list **, specifically in the area of kidney disease

* Publicly available customer information only

** https://health.usnews.com/best-hospitals

Sales Cystatin C

Kidney function test, diagnosis and monitoring

• Soft quarter is related to shipment delays to China
• Beckman Coulter warehouse situation in Europe seems to be normalised
• Underlaying volume growth at end-user level is estimated to be double digit
• Revenue growth expected in 2020 from all regions

Reduces the need of colon endoscopic examination

fCAL® turbo

• Support diagnosis of inflammatory bowel disease (IBD)
• Testing of fecal samples on clinical chemistry analysers provide significantly faster results to clinicians
• Estimated market value of >\$50M
• Continued growth due to increasing demand and competitive conversions

Partners and key customers

Sales fCAL® turbo

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

• Very strong quarter for fCAL® turbo
• Growth driven by addition of new customers converting from other platforms
• First revenues from Bühlmann / Roche agreement achieved
• First revenues from US customers expected in 2020
• Increased quarterly variations expected in 2020

Pipeline: fPELA (Fecal Pancreatic Elastase)

• Marker for pancreatic exocrine insufficiency (PEI)
• Emerging market
• Same sample as fCAL® turbo
• Same end-users as fCAL® turbo
• Currently in validation; launch of fPELA is planned within Q2 2020

GCAL® Plasma calprotectin immunoassay

* Novel biomarker in market development www.gentian.com

GCAL: Novel biomarker in market development*

• Potential application for early detection of sepsis, other severe infections and rheumatoid arthritis
• Test for differentiating bacterial from viral infections
• Informed treatment decisions for antibiotic stewardship
• Reported infectious diseases market value is \$4.0B (BCC, 2018)

* not available in the USA

Market development timeline Process has to be country specific

Study highlight Q4 2019

After a poster presentation in 2018 (ref. stock exchange release 01.10.2018), our Swedish study sites University of Upsala has published an article in Scandinavian Journal of Clinical and Laboratory Investigation (ICLB).

The article is available online under the title: "Calprotectin is superior to procalcitonin as a sepsis marker and predictor of 30-day mortality in intensive care patients".

This represents another positive step for the continued clinical documentation of GCAL.

Pushing the boundaries of PETIA with G-1001 in the product pipeline

Cardiac disease marker: G-1001*

www.gentian.com * Launch planned in 2021

Pipeline: G-1001

• Cardiac disease marker
• Total cardiac disease marker market value is estimated to be >\$2B
• Launch of G-1001 is planned for 2021
• Go-To-Market via OEM partner(s)
• Short ramp-up time, as it is established in the medical routine

Turbidimetric measurement of Antigen-antibody complex antigen-antibody complex

Dette bildet av Ukjent forfatter er lisensiert under CC BY-SA-NC

Agenda

1	Introduction and highlights
2	Q3 Financials
3	Sales, Operations, R&D
4	Outlook

New management team members as of Q1 2020 - former employments at Fresenius Kabi and GE - Master of Science in Chemistry and Biology Director of Manufacturing: Janne Veggeland started on February 1, 2020 - former employments at ThermoFisher Scientific and GE - Master in Organic Chemistry

VP QA/RA: Anne-Mette Horsrud Akre started on January 1, 2020

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VP Business Development: Jack Andreassen (starting on March 30, 2020) - former employment at ThermoFisher Scientific (Dynal) - Master of Science in Chemistry, Biochemistry and Molecular Biology

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Outlook

• The company estimate continued sales growth in 2020 versus 2019, with expected quarterly variations.
• For Cystatin C the company expects growth to be driven by increased demand in China and an increased focus on the US market. The Gentian subsidiary in Sweden has taken over the distribution of Cystatin C from Triolab.
• For fCAL® turbo, the company expects to experience continued sales growth in Europe. The first customer conversions in the US after the FDA clearance are to be expected in early 2020.
• For GCAL, new and independent clinical publications are in preparations. The company will continue to intensify its strategic plan to engage with Key Opinion Leaders in the field of infectious diseases around the world, as well as globally respected hospital laboratories and potential commercial partners. In this context, the company expects to commission prospective clinical studies in Germany and the UK during 1H2020 with the aim to establish further clinical evidence for GCAL as an early marker for sepsis and other serious infections, and its ability to differentiate between virus and bacterial infections. The launch of Fecal Pancreatic Elastase (fPELA) by our partner Bühlmann is expected to take place within 2Q20.

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.

BEIJING REP. OFFICE Chaoyangmen Outer St Jia No.10 Chaoyang District, Beijing, China