Gentian Diagnostics ASA

Investor Presentation • Nov 7, 2019

Q3 Presentation 2019

Oslo, 7th November 2019

Hilja Ibert, CEO Njaal Kind, CFO

Important notice 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

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 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 forwardlooking 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 jurisdiction in which such offer or 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

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.

solicitation is unlawful.

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.

Agenda

Gentian is a developer of highly efficient in vitro diagnostics products

Estimated total market value of \$80B

• Target market is immunochemistry
• Focus on inflammatory/infectious,
• cardiac and renal diseases
• Value of target market is estimated to be \$7B

We innovate diagnostic efficiency

Lab efficiency

2.000 versus 170 tests/hr

Highlights for Q3 2019

• Record sales revenues of MNOK 13.1 in 3Q19, up from MNOK 10.4 in 3Q18, totalling a 26 % growth compared to 3Q18
• Record sales revenue for the first nine months of MNOK 33.9 representing 18% growth compared to the same period of 2018
• In July, Beckman Coulter, one of the top 5 global diagnostics companies, and Gentian prolongated their partnership agreement for Cystatin C by 6 years
• In August, Gentian announced the sales channel agreement for fCAL® turbo between Roche Diagnostics and Gentian's sales partner Bühlmann Laboratories AG

Agenda

Financial highlights	3Q 2019
MNOK	3Q 2019	3Q 2018
Sales	13.1	10.4
Other Revenues	1.6	8.0
Total Revenues	14.7	18.4
COGS	2.7	2.7
Production Costs	4.2	3.9
R&D Costs	5.4	5.4
SG&A	7.4	7.4
Capitalization	-0.5	-1.2
OPEX	19.2	18.2
EBITDA	-4.5	0.2
EBIT	- 5.8	-0.7

Financial highlights		Per 3Q 2019
MNOK	2019	2018
Sales	33.9	28.9
Other Revenues	5.0	11.7
Total Revenues	38.9	40.6
COGS	7.5	6.5
Production Costs	11.3	10.1
R&D Costs	14.7	14.1
SG&A	22.1	17.3
Capitalization	-1.9	-3.1
OPEX	53.7	44.9
EBITDA	-14.9	-4.3

Sales and revenues

Revenues and Grants Consolidated (NOK)

	Sales revenues -		geographic split
MNOK	3Q19	3Q18	9M19	9M19
US	0.3	0.3	1.4	1.3
Europe	7.7	6.0	22.8	19.6
Asia	5.0	4.1	9.6	7.9
Total	13.1	10.4	33.9	28.8

Cost of Goods Sold

OPEX

Cash flow and cash position
MNOK	3Q19	9M19	9M18
Operating activities	-8.1	- 25.7	- 17.0
Investing activities	- 1.5	- 3.3	- 3.9
Other changes in financial items	0.0	0.0	0.0
Financing activities	0.5	0.5	68.8
Changes in cash and cash equivalent	-9.1	-28.5	47.9
Cash and cash equivalent at the beginning of period	179.3	198.6	146.9
Cash and cash equivalent at the end of	170.2	170.2	194.8
period

Agenda

Cystatin C

• Body mass independent kidney function marker
• Early detection of reduced kidney function
• Estimated global market value of \$0.5B
• Continued growth for the company mainly coming from China and US

Sales Cystatin C

Kidney function test, diagnosis and monitoring

Cystatin C

• Record sales of Cystatin C, carry-over effect from 1H partly a factor
• Soft 1H19 due to warehouse consolidations in China and Europe
• Strong increase in shipments to Asia
• Warehouse situation in Europe seems to be normalized

fCAL® turbo

• results to clinicians
• Reduces the need for endoscopic examinations of the colon
• Estimated market value of >\$50M
• Continued growth due to increasing demand and competitive conversions

Sales fCAL® turbo

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

Strong quarter for fCAL turbo Growth driven by addition of new customers converting from other platforms First revenues from Bühlmann /

• Roche agreement expected in Q4
• Revenues from US customers expected in 2020

fPELA (Fecal Pancreatic Elastase)

• Marker for pancreatic exocrine insufficiency (PEI)
• Emerging market
• Same sample as fCAL® turbo
• Same end-users as fCAL® turbo
• Launch of fPELA is planned for 2020 by our sales channel partner Bühlmann

GCAL®

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

Market development timeline Process has to be country specific

Study Highlights to date

• Plasma calprotectin is a useful early marker of bacterial infections in critically ill patients, with better predictive characteristics than WBC (white blood cell count), CRP and PCT • Better performance than PCT and HBP in differentiation between bacterial and viral
• Calprotectin successfully identifies patients with signs of infection in the emergency department
• Calprotectin levels correlates with the severity of the disease
• Prognostic biomarker for ICU admission and mortality
• infections
• Superior to PCT and HBP in indicating patients with sepsis and differentiation between sepsis and sterile inflammation / trauma

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

Launch plan G-1001

Particle-enhanced turbidimetric immunoassay (PETIA)

Antigen-antibody complex antigen-antibody complex

Particle-enhanced	turbidimetric immunoassay	(PETIA)
	Latex particles coated with antibodies	Antigen-antibody complex	Turbidimetric measurement of antigen-antibody complex
Detection limits of	Gentian PETIA assays	(examples)
	Product	Limit of quantification [mg/L]	Measuring range [mg/L]
	Plasma Calprotectin	≤ 0.3	0.5 - 20
	Cystatin C	0.28	0.4 - 8.0
	Canine CRP	7.0	10 - 300
Pushing the boundaries	for PETIA
	PETIA	Extending	PETIA boundaries
		ELISA	CLEIA

Agenda

Outlook 2019

• The Company expects continued sales growth in 2019 versus 2018 primarily driven by fCAL® turbo.
• The Cystatin C sales in 2H2019 is expected to be to be significantly higher than 1H2019. One contributing factor to this is good sales growth in China. The company expects the total Cystatin C sales in 2019 to be in line with 2018.
• For fCAL® turbo, the company expects continued sales growth in Europe. First customer conversions in the US after the FDA clearance are to be expected early 2020. In addition, the new collaboration with Roche is expected to have a positive effect on sales as of end of 2019.
• For GCAL, new independent publications are in preparations, some of them with anticipated releases in 2019. In addition, the company is continuing to intensify its efforts to engage with Key Opinion Leaders in the field of infectious diseases around the world, as well as selected hospital laboratories and potential commercial partners.. • The Fecal Pancreatic Elastase development is on plan with aim to launch in 2020. • The G-1001 development is on track with expected launch in 2021.