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Gentian Diagnostics ASA

Investor Presentation Aug 14, 2019

3604_rns_2019-08-14_fda5c985-537c-4682-8071-19b78efb43cd.pdf

Investor Presentation

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Q2 Presentation 2019

Oslo, 15th August 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 fully dedicated to the in vitro diagnostics market

  • Estimated total market value of 80B\$
  • Target market is immunochemistry
  • Focus on inflammatory/infectious,
  • cardiac and renal diseases

We innovate diagnostic efficiency

Highlights for Q2 2019

  • 16 % growth in sales revenue in 2Q19 compared to 2Q18.
  • Total sales revenues of MNOK 10,2 in 2Q19, up from MNOK 8,7 in 2Q18, which is the 4th time in a row a double digit MNOK performance. • fCAL®turbo with 19% growth from 2Q18
  • and breaking news from our trusted partner Bühlmann, having achieved the 510(k) clearance in the US and a sales channel agreement with Roche Diagnostics. • Beckman Coulter and Gentian have
  • prolongated the trusted partnership agreement by another 6 years.

Agenda

Financial highlights 2Q 2019
MNOK 2Q 2019 2Q 2018
Sales 10.2 8.8
Other
Revenues
1.9 2.1
Total Revenues 12.1 10.9
COGS 2.3 1.6
Production Costs 3.1 2.5
R&D Costs 5.2 4.8
SG&A 6.8 4.7
Capitalization -0.5 -1.2
OPEX 16.9 12.4
EBITDA -4.8 -1.5
-
20.6
-2.5
Financial highlights Per 2Q 2019
MNOK 2019 2018
Sales 20.8 18.4
Other
Revenues
3.4 3.8
Total Revenues 24.2 22.2
COGS 4.8 3.8
Production Costs 7.2 6.2
R&D Costs 9.3 8.7
SG&A 14.6 9.8
Capitalization -1.3 -1.8
OPEX 34.6 26.7
EBITDA -10.4 -4.5

Sales and revenues

Revenues and Grants Consolidated (NOK)

Sales revenues Royalties Governmental grants SkatteFUNN

Sales revenues - geographic split
MNOK 2Q19 2Q18 1H19 1H19
US 0.6 0.6 1.1 1.0
Europe 7.7 7.4 15.1 13.5
Asia 1.9 0.8 4.6 3.9

Cost of Goods Sold

OPEX

Cash flow
and cash position
MNOK 2Q19 1H19 1H18
Operating activities -11.3 -
17.5
-
11.7
Investing
activities
-
0.6
-
1.8
-
2.6
Other changes in financial items 0.0 0.0 0.0
Financing
activities
0.0 -0.1 68.8
Changes in cash and cash equivalent -12.0 -19.4 54.5
Cash
and cash equivalent at the
beginning of period
191.3 198.6 146.9
Cash
and cash equivalent at the end of
179.3 179.3 201.4
period

Agenda

Cystatin C

  • Early detection of reduced kidney function
  • Estimated 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

  • Soft 1H19 due to warehouse consolidations in China and Europe.
  • 2Q19 expected to grow significantly over 1Q19
  • Business in China and focus of company on the US market expected to drive accelerated growth as of Q3/Q4 2019
  • On July 3rd, 2019 Gentian announced a 6 years extension of the global reagent supply agreement with Beckman Coulter, one of the market leading diagnostic companies

fCAL® turbo

  • Testing of faecal samples on clinical chemistry analysers provide significantly faster 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

* Estimated end-user market corresponds to a 15M\$ addressable market for Gentian

Sales fCAL® turbo

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

  • 2Q19 versus 2Q18.
  • Continous growth of fCAL turbo in With the 510(k) clearance for fCAL turbo, Bühlmann achieved the access into the US market.
  • With Gentian being the sole reagent supplier, Bühlmann signed a sales channel agreement with Roche for fCAL turbo. Roche is the market leader in the diagnostic industry.
  • Growth will continue, but variations from quarter to quarter should be expected

GCAL® (continue market development)

  • Early detection and monitoring of sepsis, other severe infections and rheumatoid arthritis
  • Informed treatment decisions and laboratory efficiency
  • Reported infectious diseases market value is 4.0B\$ (BCC, 2018)
  • Estimated inflammation biomarkers market is 0.5B\$

Focus items for 2019

  • Clinical studies and respective publications
  • Engagement with Key Opinion Leaders in key countries
  • First routine users

Educational workshop at Euromedlab 2019, Barcelona

  • Title "Plasma Calprotectin: a promising early biomarker for diagnosis of bacterial infections and sepsis".
  • Discussion of calprotectin and other biomarkers' role in diagnosis of severe infections and sepsis.
  • Review of studies and results supporting the ability of calprotectin to discriminate patients with acute infections from patients with other states of inflammatory responses.

Agenda

Outlook 2019

  • The Company expects continued sales growth in 2019.
  • Cystatin C sales growth expected to be driven by increased demand in China and increased focus on the US market.
  • Continued sales growth for fCAL turbo in Europe. First customer conversions in the US after the FDA clearance to be expected early 2020. The new collaboration with Roche is expected to have a positive effect on sales as of 2020.
  • For GCAL, new independent publications are in preparation. Some of them are expected to be released by the end of 2019. The company enhances the engagement with Key Opinion Leaders, selected hospitals and potential commercial partners. • The Fecal Pancreatic Elastase development is on plan with aim to launch in
  • The G-1001 development is on track with expected launch in 2021.
  • 2020.

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