Investor Presentation • Jun 18, 2021
Investor Presentation
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Investor presentation June 2021
ADDRESSING HIGH-VALUE MARKETS
This presentation has been prepared by and is the sole responsibility of Gentian Diagnostics ASA (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. The Company (nor any of its parent or subsidiary undertakings) does not 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 forwardlooking statements to our actual results.
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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 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 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 inaccuracies in it which may become apparent or providing any additional information.
«The reason Gentian exists is to deliver diagnostics for better treatment decisions. The high value of the benefits – contributing to protecting life and saving costs – is why our company is faced with a great opportunity»
The Gentian team
CEO Hilja Ibert
25+ years' experience from the international diagnostic industry, including VP International Diagnostic Solutions at Hologic and senior positions within Becton Dickinson and bioMerieux. She was previously the CEO for miDiagnostics in Belgium. Dr. Ibert holds a PhD degree in Nutrition Science from the University of Bonn, Germany.
CSO Erling Sundrehagen
Erling Sundrehagen, cofounder of Gentian, holds 25 int. patents. He has headed the development of a dozen diagnostic products, creating businesses with NOK 1bn+ revenue. Dr. Sundrehagen held management positions in Axis-Shield, Axis Biochemicals and Axis Research, and is dr.med. & cand.real from University of Oslo, Norway.
20+ years experience and extensive track-record from financial management and reporting, corporate governance and Investor Relations. Mr. Kind has served as the CFO for TiZir, UK, Business Analyst in Eramet Comilog Manganese, France, and Investment Director in Tinfos. Kind holds a MSc from BI Norwegian Business School.
CFO & COO
Njaal Kind
VP R&D Torsten Knüttel
18+ years' experience from the diagnostic industry and commercial supply chain. His background includes OEM/B2B business development at Thermo Fisher Scientific and development and production at GE Healthcare. He holds a PhD in Chemistry from the Leibniz University Hannover, Germany.
VP Clinical Affairs Alexandra Havelka
Extensive experience in laboratory medicine. She was previously Biochemist and Unit Manager at Karolinska University Laboratory, with research focusing on biomarkers for inflammation and infection. Dr Havelka holds a PhD in Experimental Oncology from Karolinska Institute in Stockholm, Sweden.
VP Global Sales Markus Jaquemar
30+ years experience in life science and diagnostics commercialisation and marketing. He held marketing, sales and business management positions at Beckman Coulter, Agilent Technologies and Becton Dickinson. He holds a Master's degree in Biology from Vienna University, Austria.
VP QA & RA Anne-Mette Horsrud Akre
20+ years of pharma industry experience, including production of pharmaceuticals and medical devices, quality management and assurance and management positions at GE Healthcare and Fresenius Kabi. She holds a Msc in Biotechnology from the Technical University of Trondheim, Norway.
VP BD Jack Andreassen
20+ years of experience from sales, market and business development from the global diagnostics industry. He was previously Associate Director, Global Market Development for OEM at Thermo Fisher. He holds a Msc in Chemistry, Biochemistry/Molecular Biology from the University of Oslo, Norway.
Employees
~50
Revenue 2020 NOK 79m Up 32% OSE: GENT
~NOK 0.8bn
Ambition to grow portfolio with 1 new diagnostics product per year*
USD 1.3bn serviceable market with 8-9% annual growth
Team with proven trackrecord and industry expertise
2 'blockbuster' tests in market and product development
* 5 products launched, further 2 in development. USD/NOK 8.5 as per 17 June 2021.
A growing diagnostics market puts increasing pressure on clinical laboratory efficiency
Many of the existing, but clinically relevant biomarkers are available only on slow and inefficient platforms
Hours from initiation of analysis to results
Particle-enhanced turbidimetric immunoassays (PETIA) based on proprietary nanoparticle technology and knowhow
Converting existing biomarkers to the most efficient automated, high-throughput analysers
10 minutes from initiation of analysis to results
3-10x higher throughput significantly improves laboratory productivity and costefficiency
Early disease detection and faster availability of clinically relevant information leads to better treatment decisions
| DISEASE GROUP PRODUCT |
APPLICATION | ATTRACTIVE CLINICAL BENEFITS | |||
|---|---|---|---|---|---|
| Kidney disease |
Cystatin C | Early detection of reduced kidney function | Preventing severe kidney failure | ||
| Inflammation & infection |
fCAL | Fast diagnosis of inflammatory bowel disease | Reducing time-consuming and costly colonoscopy | ||
| GCAL | Early detection of severe infections, including sepsis | Reducing chance of fatality and treatment costs | |||
| SARS-CoV-2 Ab | Measuring COVID-19 immunity | Supporting community management | |||
| Canine CRP | Early detection and diagnosis of inflammation in dogs | High relevance of results due to dog specific CRP | |||
| Cardiac | NT-proBNP | Diagnosis, monitoring and assessment of congestive heart failure |
Contributing to standardization of NT-proBNP assays |
||
| Pancreas | fPELA | Diagnosis of pancreatic elastase insufficiency in combination with fCAL |
Reducing time-consuming and costly colonoscopy |
Total Addressable Market: Total demand within targeted markets 2020 (Kalorama 2020). Total Serviceable Market: The segment of the TAM targeted by Gentian's products (company estimates). Gentian's share of revenues net of partner take is 30-50% on average with product variations. Note: SARS-CoV-2 Ab, targeting a USD 20m Nordic serviceable market, not shown separately in graph.
Long-standing commercial partnership for Cystatin C
Partnership for fCAL initiated through Bühlmann Laboratories
Collaboration agreement for Canine CRP
Four established products with potential to grow 20%+ annually
Prove clinical relevance of GCAL and bring NT-proBNP to market
Launch one new product per year
Secure one new contract with a global commercial partner per year
Grow gross margin from ~50% in 2020 to 60%+ at volume production
Long-term EBITDA margins of 40%
revenue potential of NOK 1bn in 5-7 years Revenue ambition of NOK 1bn in 5-7 years
| ESTABLISHED PRODUCTS | GCAL | SARS-COV-2 AB | NT-PROBNP | |
|---|---|---|---|---|
| S E N O T S E L MI 2 2 0 21-2 0 2 |
Targeting additional large commercial partners Additional regulatory approvals, including IVDR* |
Clinical studies confirming relevance for sepsis and COVID-19 – 6 ongoing Securing endorsements from key opinion leaders Securing global commercial partnerships and initiating EU rollout |
Successful validation and launch, scheduled for Q4 2021 Entering commercial partnerships for the Nordics |
Successful verification during 2021 Publication on the reference method for standardisation Successful validation and launch, scheduled for Q1 2022 Securing endorsements from key opinion leaders and global commercial partnerships |
Further potential milestones in pipeline with 3 biomarkers currently in exploration and 'proof of concept'
* IVDR: A new regulation coming into force 26 May 2022, requiring extensive documentation of the safety, performance and quality of each diagnostic test from manufacturers through several studies on both analytical and clinical performance.
Early detection of reduced kidney function
Secured global commercial partnership with Beckman Coulter
Targeting additional large commercial partners
Diagnosis of intestinal bowel disease
Exclusive commercial partnership with Bühlmann Laboratories, including global distribution contract with Roche Diagnostics
Significant demand growth expected
Measuring inflammation levels in dogs
Collaboration with international vet market leaders IDEXX and scil
Targeting further distribution-based sales channels
Determination of pancreatic insufficiency
Developed together with Bühlmann Laboratories as extension to fCAL and successfully sold as bundle
Source: Kalorama 2020, company estimates.
Note: GCAL sales <NOK 1m in 2019 and 2020 included in graph. In addition to sales, Gentian recognized revenue from royalties and public grants 2017-2020, and NOK 4.4m in revenue from the divestiture of its subsidiary PreTect AS in 2020.
The early inflammation biomarker GCAL is the first Calprotectin test available on high-throughput analysers, with first sales realized in 2019. Clinical studies confirm the potential of GCAL for the early detection and prediction of severe infectious diseases. Sepsis kills 11 million people each year, and fast results provided by GCAL could save lives and significantly reduce healthcare costs.
Sources: Kalorama 2020, WHO, company estimates. Total Serviceable Market includes rheumatoid arthritis (RA) and sepsis. 3 studies published and 1 submitted describing the value of GCAL in detection of bacterial infections and sepsis, and evaluation of the disease severity. 2 studies performed with GCAL have confirmed the value of calprotectin in risk assessment of patients with severe COVID-19.
«Sepsis continues to be a growing problem and the emergence of the COVID-19 pandemic has only increased the attention on caring for infected patients. Early detection is crucial for patients. Approximately 1.7 million individuals in the US develop sepsis each year and there is currently no gold standard for diagnosis in the clinical setting.»
Kalorama, «The Worldwide Market for In Vitro Diagnostic Tests, 13th Edition», December 2020
Measuring NT-proBNP levels in plasma supports diagnosis of congestive heart failure. The Gentian assay will be the first test of its kind available on high-throughput analysers. It is equally precise as the currently available expensive and slower assays and can contribute to better diagnosis, monitoring and treatment. Additional benefits may include results standardization, which is a current issue with the existing assays in the market.
Existing tests impacted by glycosylation
Gentian developing a reference method
Serviceable market, Nordics USD 20m ~1% of global market
The aim with SARS-CoV-2 Ab, measuring COVID-19 immunity, is to offer the first such test for high-throughput analysers. By determining immunisation status, including response to vaccines, it can support efficient monitoring and managing of the virus. Key objectives are to contribute in the current COVID-19 pandemic and create a platform for developing new tests for future pandemics. Gentian will focus on commercialisation in the Nordic markets.
Mix of established, high-volume markers and emerging markers
Avoiding interference enables conversion to PETIA
Antibodies: Proteins used by the immune system to identify bacteria and viruses
Avian antibodies: Extracted from hen eggs. Avoids interference due to lack of complement system binding antibodies and molecules, enabling analysis at lower concentrations than mammalian antibodies and conversion of existing biomarkers to PETIA
Advantages: Gentian uses avian antibodies when applicable and believes extraction from eggs rather than puncturing animals contributes to better animal welfare while also offering a cost advantage at scale
Removing separation steps increases throughput and reduces cost
Immunoassays: Biochemical tests measuring molecule presence or concentration in human cells using an antibody
Particle-enhanced turbidimetric immunoassays: Enables moving immunoassays from low-volume to high-volume clinical analysers
Advantages: Moving immunoassays to PETIA enables removing separation steps, which increases throughput and laboratory efficiency compared to the traditional ELISA and other methods
Ambition to secure one new contract with global commercial partner per year
Accelerating time to revenue and awareness
Collaboration agreements with international vet laboratory specialists including IDEXX for Canine CRP
Direct sales to select end-users and key opinion leaders, including laboratory and hospitals
| Total Addressable Market, USDbn |
Total Serviceable Market, USDm |
Target market share, unrisked |
Gentian's revenue take |
Serviceable Market annual growth rate, next 5-7 years |
|
|---|---|---|---|---|---|
| Established products | 1.5 | 180 | ~25% | 30-50% | 5-10% |
| GCAL | 2.0 | 300 | ~15% | 30-50% | 15% |
| NT-proBNP | 1.6 | 800 | ~15% | 30-50% | 5-8% |
| SARS-CoV-2 Ab | 2.0 | 20 | ~25% | 50% | n.m. |
| Total | 7.1 | 1,300 | 15-20% | 30-50% | 8-9% |
Key risks include market adoption rates for GCAL, and successful launches of NT-proBNP
5-7 year revenue ambition NOK 1bn
60%+ Gross margin at volume production
Long-term EBITDA margins 40%
| Sales | EBITDA |
|---|---|
| NOK 20m | NOK -2m |
| +21% vs Q1'20 | NOK +3m vs Q1'20 |
| Cash | Break-even |
| NOK 146m | pre-R&D |
| NOK -12m vs Q1'20 | based on current revenue from four established products |
7* tests contributing to saving costs and protecting life
Revenue ambition of NOK 1bn in 5-7 years
Delivered ~30% annual revenue growth 2017-20
* 5 products launched, further 2 in development.
| Tomas Settevik |
Espen Tidemann Jørgensen |
Ingrid Teigland Akay |
Kari E. Krogstad |
Susanne Stuffers |
Runar Vatne |
Tomas Kramar |
|---|---|---|---|---|---|---|
| Chair of the Board |
Board member | Board member | Board member | Board member | Board member | Board member |
| Tomas Settevik has experience in both life sciences and retail and is currently an independent investor and non-exec director in several companies. He was previously CEO of Stokke, and CEO of Pronova BioPharma after serving as Vice President Pharmaceuticals and Manufacturing. Mr. Settevik has also held several senior positions – VP Northern Europe, VP Marketing and R&D, and Managing Director UK/Nordic – at Tyco Healthcare EMEA. Mr. Settevik holds a degree from Copenhagen Business School. |
Espen Tidemann Jørgensen is currently Portfolio Manager of Holta Invest and Managing Director of Holta Life Sciences, the largest shareholder in Gentian Diagnostics. He has 18 years of financial markets experience as equity analyst at DNB Markets and investor. Mr. Jørgensen was previously member of the Board of Directors at Weifa and Cortendo, and is currently board member at Decisions. Mr. Jørgensen holds a Msc in Economics and has completed 3 years of Medicine studies at the University of Oslo. |
Ingrid Teigland Akay is a life science investor and medical doctor. She has previously served as a Senior Investment Manager at Inventages. Ms. Akay has broad clinical experience in internal medicine and surgery at Scandinavian and UK hospitals. Today she is Managing Partner of Hadean Ventures, a life science investment firm with focus on the Nordics. Ms. Akay holds a medical degree from Medizinische Hochschule Hannover and an MBA in Finance from London Business School. |
Kari Krogstad has more than 25 years of experience from the biomedical industry, from commercial leadership roles within the pharma, biotech and medtech sectors. Ms. Krogstad has held her current role as President and CEO at Medistim ASA since 2009. She was previously General Manager at Invitrogen Dynal. Ms. Krogstad holds a Cand. Scient. degree in Molecular Biology from the University of Oslo as well as a Business degree from IHM Business School. |
Susanne Stuffers is currently managing partner of P53 Invest AS. Previously she was an equity analyst with Arctic Securities covering the healthcare sector, and management consultant at EY. Ms. Suffers has held medical and commercial roles at Novartis and has had clinical practice as a resident in oncology at OUS Ullevål. Ms. Stuffers holds an M.D. degree from the Erasmus University Rotterdam and a Ph.D. degree in cancer biomedicine from the Norwegian Radium Hospital. |
Mr. Vatne is the principal and owner of Vatne Capital, a family office investing in financial assets and real estate. He is co-founder of Søylen Eiendom, a leading Oslo based real estate company, and was previously partner and stock broker in Pareto Securities. Mr. Vatne also serves as board member of listed companies Solon Eiendom ASA and Self Storage Group ASA. Vatne and associated companies currently own 14.49% of the outstanding shares in Gentian Diagnostics AS. |
Mr. Kramar has more than 40 years of experience from the diagnostic industry including Siemens, Abbott and Roche Diagnostics. Mr. Kramar has held several senior positions like Global Business Manager, Business Director and CEO, as well as being a founding partner in the Kramar Group. In addition, Mr. Kramar has held several board positions over the years. Mr. Kramar holds an MSc degree in Chemistry from the Faculty of Engineering at Lund University in Sweden. |
| Q1 2021 | Q1 2020 | FY 2020 | |
|---|---|---|---|
| Sales revenue | 19.6 | 16.2 | 63.3 |
| Other operating revenue | 4.6 | 2.9 | 15.6 |
| Total operating revenue | 24.2 | 19.1 | 78.9 |
| Costs of goods sold | -10.5 | -9.9 | -32.6 |
| R&D costs | -7.7 | -5.6 | -27.3 |
| Selling, general & administrative costs | -9.5 | -8.5 | -33.6 |
| Capitalization | 1.5 | 0.1 | 3.4 |
| Total operating expenses/costs | -26.1 | -24.0 | -90.1 |
| EBITDA | -1.9 | -4.9 | -11.2 |
| Depreciation | -2.0 | -1.6 | -6.6 |
| Impairment | - | - | - |
| EBIT | -3.9 | -6.5 | -17.8 |
| Financial income/expense | -1.0 | 0.9 | 0.4 |
| Tax | - | - | - |
| Net profit | -4.9 | -5.5 | -17.5 |
| Shareholder | No of shares | % |
|---|---|---|
| Vatne Equity AS |
2,010,224 | 13.04% |
| Norda ASA |
1,250,068 | 8.11% |
| Holta Life Sciences AS |
1,188,702 | 7.71% |
| Safrino AS |
1,050,000 | 6.81% |
| Salix AS | 798,303 | 5.18% |
| Skandinaviska Enskilda Banken AB |
775,437 | 5.03% |
| Verdipapirfondet Delphi Nordic |
749,227 | 4.86% |
| Verdipapirfondet Storebrand Vekst | 425,572 | 2.76% |
| Verdipapirfondet DNB SMB |
377,682 | 2.45% |
| Equinor Pensjon | 337,320 | 2.19% |
| Portia AS | 300,000 | 1.95% |
| Cressida AS | 235,000 | 1.52% |
| Lioness AS | 220,000 | 1.43% |
| Silvercoin Industries AS | 214,692 | 1.39% |
| Marstal AS | 212,407 | 1.38% |
| Mutus AS | 210,465 | 1.37% |
| Vingulmork Predictor AS | 184,083 | 1.19% |
| Bård Sundrehagen | 181,645 | 1.18% |
| OM Holding AS | 179,000 | 1.16% |
| Viola AS | 170,916 | 1.11% |
| Other Shareholders | 4,341,146 | 28.17% |
| Total Shares | 15,411,889 | 100.00% |
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