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Gentian Diagnostics ASA

Investor Presentation Apr 24, 2020

3604_rns_2020-04-24_a3e4b23b-643a-41d4-81b4-4991f426acc2.pdf

Investor Presentation

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Q1 Presentation 2020 April 24, 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

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.

Agenda

1 Introduction and highlights
2 Q1 Financials
3 Sales, Operations, R&D
4 Outlook

#DiagnosticEfficiency

We innovate diagnostic efficiency - based on deep patent portfolio -

Products and pipeline

Highlights for Q1 2020

  • Record sales revenues of MNOK 16.2 in 1Q20, up from MNOK 10.6 in 1Q19.
  • Sales growth of 53% is based on strong performance of all product lines. Sales grew by 42% in 1Q20 on a currency neutral basis.
  • New publications of clinical study results confirm GCAL as a promising biomarker for earlier detection and better prediction of severity of an infection.

SARS-CoV-2 / COVID-19

  • The health and safety of our employees, as well as our customers and partners, is of primary concern.
  • Gentian has robust business-continuity plans in place, so we can maintain our production lines.
  • We abide by Norwegian health authority policies whilst continuing to seamlessly support our customers.
  • Gentian has offered support to interested site, who would to like to test cystatin C and plasma calprotectin in the context of early detection of the severely affected COVID-19 patients.

Agenda

1 Introduction and highlights
2 Q1 Financials
3 Sales, Operations, R&D
4 Outlook

Financial highlights 1Q 2020

Financial highlights 1Q 2020
MNOK 1Q 2020 1Q 2019
Sales 16.2 10.6
Other
Revenues
2.9 1.5
Total Revenues 19.1 12.1
COGS 9.9 6.6
R&D Costs 5.6 4.1
SG&A 8.6 7.9
Capitalization -0.1 -0.9
24.0 17.7
OPEX -5.6
EBITDA -4.9

Revenues and Grants Consolidated (NOK)

Sales and revenues Sales revenues -
geographic split
MNOK 1Q20 1Q19
Revenues and Grants Consolidated (NOK) US 0.7 0.5
Europe 11.2 7.4
Asia 4.3 2.7
10.6
Total 16.2
Sales revenues - product split
MNOK 1Q20 1Q19
Cystatin C 6.6 4.8
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
fCAL® turbo 5.3 3.9
11.2 7.4
6.6 4.8
5.3 3.9
4.4 1.9
16.2 10.6

Cost of goods sold

  • COGS comprises now both raw material cost and cost of production
  • COGS of 61% of sales in Q1 2020 vs 62% in Q1 2019
  • COGS measured as a percentage of sales will decline as revenue increases, but with quarterly variations

OPEX

Total OPEX ex COGS before capitalization: 14.2MNOK

Cash flow and cash position

MNOK 1Q20 2019 1Q19
Operating activities -
9.7
-
23.1
-
6.2
Investing
activities
-
0.4
-
4.7
-
1.2
Financing
activities
-
0.1
0.7 -
0.0
Changes in cash and cash equivalent -
10.2
-27.1 -
7.4
Cash
and cash equivalent at the beginning of period
171.6 198.6 198.6
Cash
and cash equivalent at the end of period
161.4 171.6 191.3

Agenda

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

Kidney marker: Cystatin C

  • 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 market share holders in the area of clinical chemistry

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

  • Strong quarter with 40% sales growth versus 1Q19
  • Beckman Coulter China shipments were significantly increased
  • Beckman Coulter Europe/US shipments are back to double digit growth
  • Direct sales efforts in the US resulted in first promising results
  • Revenue growth expected in 2020 from all regions with quarterly variations

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

  • Continuous strong sales growth of 36% versus 1Q19 is mainly driven by the addition of new customers converting from other platforms
  • First revenues from US customers expected in 2020 but with delays due to the COVID-19 outbreak
  • 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 treating physicians as fCAL® turbo
  • Currently in validation; launch of fPELA is planned in 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

Clinical study results on the GCAL performance

Calprotectin as an early biomarker of bacterial infections in critically ill patients: an exploratory cohort assessment

Jonsson et al., Critical Care and Resuscitation, 2017

Plasma calprotectin appears to be a useful early marker of bacterial infections in critically ill patients, with better predictive characteristics than WBC (white blood cell count) and PCT (procalcitonin).

Calprotectin is superior to procalcitonin as a sepsis marker and predictor of 30 day mortality in intensive care patients Larsson et al., Scand J Clin Lab Invest. 2020;80(2):156-161

Calprotectin performed better then Procalcitonin in diagnosis of sepsis and distinguishing between septic and non septic patients.

Calprotectin had also higher predictive ability regarding 30-day mortality then Procalcitonin.

Calprotectin, a new biomarker for diagnosis of acute respiratory infections

Havelka et al., Sci Rep. 2020; 10(1):4208

Calprotectin is a promising biomarker for diagnosis of bacterial infections and differentiation between viral infections and bacterial or Mycoplasma infections.

Rapid determination of calprotectin may improve the management of infections and allow more selective use of antibiotics.

Clinical study results on the GCAL performance – New since last presentation Fullerton et al., Critical Care, Meeting abstracts,

Kinetics of calprotectin, procalcitonin and C-reactive protein in healthy volunteers administered intravenous endotoxin

ISICEM 2020

Calprotectin is a promising biomarker for rapid diagnosis of bacterial infections. It increases earlier and peaks more rapidly than standard biomarkers procalcitonin and CRP.

Plasma-calprotectin compared with routine biomarkers for prediction of early severe event in sepsis

Parke et al., Critical Care, Meeting abstracts ISICEM 2020

In patients with sepsis, level of pcalprotectin was significantly higher in those who subsequently developed severe events. P-calprotectin was superior to traditional biomarkers for prediction of severe events in clinical sepsis.

Study Highlights to date: Early - Differentiation - Prediction

  • Useful early biomarker of bacterial infections in critically ill patients, with better predictive characteristics than WBC (white blood cell count), CRP and PCT
  • Increase of calprotectin in the blood is detected several hours before increase of PCT and CRP caused by inflammatory stimuli
  • Better performance than PCT and HBP in differentiation between bacterial and viral respiratory infections
  • Calprotectin successfully identifies patients with signs of infection and distinguish between infections and other diagnosis in patients presented at an Emergency Department.
  • Calprotectin levels correlates with the severity of the disease
  • Prognostic biomarker for development of severe complications and mortality
  • Superior to PCT in indicating patients with sepsis and differentiation between sepsis and trauma patients

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

Agenda

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

New management team member as of Q2 2020 - former employments at Beckman Coulter, Agilent, Becton Dickinson, etc. - Master of Science (Mag. rer. nat.) Biology/Biochemistry, Univ. Vienna

VP Global Sales: Markus Jaquemar started on April 1, 2020

-

Outlook

  • Gentian may be 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 growth to be driven by increased demand in China and an increased focus on the US market.
  • For fCAL® turbo, we may experience reduced demand, at least for a short period of time. This assumption is based on the focus of all health care systems on the COVID-19 management.
  • For GCAL, additional and independent clinical publications are in preparations. The company expects to commission prospective clinical studies in Germany and the UK during 1H2020.

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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