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Gentian Diagnostics ASA

Investor Presentation Dec 5, 2019

3604_rns_2019-12-05_9ce9f47b-58ac-4d45-87ac-fdb07c0f5510.pdf

Investor Presentation

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Company Presentation DNB Nordic-American Life Science Conference December 5, 2019

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

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.

jurisdiction in which such offer or solicitation is unlawful.

Nothing contained in this presentation is or should be relied upon as a promise or representation as to the future. Except where inaccuracies in it which may become apparent or providing any additional information.

#DiagnosticEfficiency

www.gentia

n.com

Gentian Diagnostics – Corporate overview

  • Headquartered in Moss, Norway
  • Listed on Merkur Market since December 2016
  • Shares outstanding: 15.4m
  • Market cap end 3Q NOK 723m
  • More than 800 shareholders
  • Major shareholders include Vatne Capital, Holta Invest, Sundrehagen family, Storebrand and DNB asset management
  • Cash position end of 3Q: NOK 170.2m

The in vitro diagnostics market

Products and Pipeline

We innovate diagnostic efficiency - based on deep patent portfolio -

Laboratory Workflow

Laboratory efficiency 2.000 versus 170 tests/hr Instrument independent

Clinical Outcome

Cystatin C

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
  • Beckman Coulter distributes cystatin C to one of the top 3 laboratory chains in the US accounting for > 20% market share of all laboratory testing in US (all tests)

Key customers and KOLs

  • hospitals on the 'America's Best Hospitals' list **, specifically in the area of kidney disease
  • studies published in NEJM
  • UC Irvine

Reduces the need of colon endoscopic examination

fCAL® turbo

  • FDA 510(k) cleared
  • 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

GCAL® Plasma calprotectin immunoassay

www.gentian.com

* Novel biomarker in market development

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 Highlights to date

  • 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 levels correlates with the severity of the disease
  • Prognostic biomarker for ICU admission and mortality
  • Calprotectin successfully identifies patients with signs of infection in the emergency department
  • infections
  • Superior to PCT and HBP in indicating patients with sepsis and differentiation between sepsis and sterile inflammation / trauma

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

Trusted partner model

Sales and revenues

Revenues and Grants Consolidated (NOK)

Sales revenues - geographic split
MNOK 3Q19 3Q18 9M19 9M18
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
Sales revenues -
MNOK
product split
3Q19
3Q18 9M19 9M18
Cystatin C 7.2 6.8 15.8 16.2
3.6 2.0 10.5 6.6
fCAL® Turbo
Other 2.4 1.6 7.6 6.1
Total 13.1 10.4 33.9 28.8
fCAL® Turbo 3.6 2.0 10.5 6.6
Other 2.4 1.6 7.6 6.1
Total 13.1 10.4 33.9 28.8

Financial key figures per 3Q 2019

MNOK 2019 2018 Diff %
Sales 33.9 28.8 5.1 17.7
Other
Revenues
5.0 11.7 -
6.7
-
57.3
Total Revenues 38.9 40.6 -
1.7
-
4.2
COGS 7.5 6.5 1.0 15.4
Production Costs 11.3 10.1 1.2 11.9
R&D Costs 14.7 14.2 0.5 3.5
SG&A 22.1 17.3 4.8 27.7
Capitalization -1.9 -3.1 1.2 38.7
OPEX 46.2 38.5 7.7 20.0
EBITDA -14.9 -4.3 -
10.6
-
33.7
-7.2 -
26.5

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
179.3 198.6 147.0
Cash
and cash equivalent at the end of period
170.2 170.2 194.8
www.gentian.com

Summary

  • Technology innovator with global footprint
  • Customers benefit from product solutions for diagnostic efficiency Targeted investments to secure future ambitions
  • Double digit sales growth
  • Current business plan is fully funded

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

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