Investor Presentation • May 10, 2023
Investor Presentation
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May 10th, 2023
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.
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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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R&D review
From science to sales
Strategic roadmap
Q&A

The growing diagnostic market puts increasing pressure on laboratories. Still, many of the existing, clinically relevant biomarkers are only available on slow and inefficient platforms.
By converting biomarkers to the most efficient automated, high-throughput analysers, Gentian contributes to saving costs and protecting life.

Employees
~50
Total revenue 2022 MNOK 112

CEO Dr. Hilja Ibert

Sundrehagen

CCO Markus Jaquemar




VP BD Jack Andreassen
Njaal Kind
CSO Dr. Alexandra Havelka
Dr. Torsten Knüttel
VP R&D
VP QA & RA Anne-Mette Horsrud Akre
20+ years of relevant industry experience across management positions
Track record from leading global diagnostics companies in across all phases










| DISEASE GROUP | APPLICATION PRODUCT |
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 |


Global distribution agreement for GCAL®, initial roll-out in Europe

Long-standing commercial partnership for Cystatin C

Partnership for fCAL initiated through Bühlmann Laboratories

* Including grants and other non-customer related revenue.
Four established products with potential to grow 20%+ annually
Prove clinical relevance of GCAL and bring NT-proBNP to market
Bring a steady stream of high-impact diagnostic tests to market
Secure one new contract with a global commercial partner per year
Grow gross margin from ~50% in 2021 to 60%+ at volume production



revenue potential of NOK 1bn in 5-7 years Unrisked revenue potential of NOK 1bn*
combined net




* Dependent on timing of NT-proBNP launch
R&D review – Dr. Torsten Knüttel, VP R&D
From science to sales
Strategic roadmap
Q&A








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 which should increase laboratory productivity and reduce overall costs. Additional benefit may include addressing the underestimation issue caused by glycosylation.




R&D review
From science to sales – Markus Jaquemar, CCO, and Dr. Aleksandra Havelka, CSO
Strategic roadmap
Q&A



More than doubled sales revenues in 3 years
NOKm, % CAGR


Agreements in place, including Siemens Healthineers, Beckman Coulter and Bühlmann/Roche Diagnostics
Provides accelerated time to broad awareness
Distribution agreements in place across Europe, Asia and North America
Sales to end-users and key opinion leaders drive broader demand

Severe laboratory staff shortages
Fast and accurate results to clinicians

This session will focus on the development from clinical evidence to sales and cover:
Gentian Cystatin C Gentian GCAL®
Bühlmann fCAL® Turbo /fPELA® Turbo







Several growth factors anticipated



NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Diseases

The adoption of the new eGFR 2021 CKD EPI creatinine equation that estimates kidney function without a race variable

Increased use of cystatin C combined with serum (blood) creatinine, as a confirmatory assessment of GFR or kidney function
More than 37 million adults in the United States have kidney diseases and 90% aren't aware they have diminished kidney function

Additional recommendations for the use of Cystatin C
KDIGO is updating its recommendations in 2023 including the suggestion for increased use of Cystatin C testing globally.
KDIGO is a global organization developing and implementing evidence-based clinical practice guidelines in kidney disease.


Gentian supporting key initiatives to improve kidney disease treatment



Strong support from the healthcare community



Diagnosis and monitoring of Inflammatory Bowel Disease (IBD) Reduces the need of colon endoscopic examination


Platform agnostic testing and full automation compatibility drives conversion from time consuming ELISA systems

Estimated market value of 80-100 M\$ with 15-20% segment share for Bühlmann

Continued growth due to increasing demand and competitive conversions as well as regional expansion

Acquisition of strong global commercial partners (distribution and OEM) via Bühlmann - Roche

Customer statements after implementation of patient-performed extraction
Extraction was time-consuming requiring one biomedical technician for a whole day to perform Calprotectin extraction.
Decrease from one whole day of work to approximately 2 hours. Can absolutely be recommended!
"Now there is time for other tasks and that is absolutely crucial in times of staff shortages. We have a superb workflow right now"


Gentian believes the changes in guidelines will over time lead to increased use of fCAL turbo in the US as it will be used as a screening tool prior to colonoscopy and lead to significant healthcare savings
Cost of one colonoscopy: USD 2,750 (national average)*
Cost of one fCAL turbo test: USD 25-30
*Source: New choice health


Combination test with fCAL® turbo from the same sample
Diagnosis and disease monitoring of Pancreatic Exocrine Insufficiency

Fast and accurate biomarker for detection of infection and inflammation, including avoidance of sepsis.
Part of innate immunity - inborn resistance against infections that an individual possesses right from birth










The clinical research program has raised attention with Key Opinion Leaders
Researchers and clinicians at high-ranked hospitals are endorsing GCAL for usage in clinical routine




Calprotectin in Acute Infections and Sepsis for Prognosis, Characterization and Diagnosis in the Emergency Department CASCADE-Trial
Wolfgang Bauer, MD Department of Emergency Medicine Charité – Universitätsmedizin Berlin Germany

399 Number of enrolled patients 197 Adults with clinical suspected acute infection
202 No clinical suspicion of infection
Great performance of calprotectin in detection of bacterial infections
Better performance of calprotectin in prediction of sepsis and mortality, compared to most of routinely used biomarkers and clinical scores.



Patient presents at the emergency department with weakness
Medical history:
Type 1 diabetes
WBC 8.9/nl CRP 28.6 mg/l PCT 0.22 µg/l Calprotectin 17.32 mg/l Normal Slightly elevated Normal Highly elevated
Vital signs BP: 163/89 mmHg HR: 105/min RR: 15/min SaO2: 99% Temp: 36.6°C

Resident in nursing home
Presents at the ED with fever, altered mental status, cloudy urine
Medical history:
Late-stage Alzheimer's disease
WBC 21.9/nl CRP 124.6 mg/l PCT 1.07 µg/l Calprotectin 19.32 mg/l Slightly elevated Highly elevated Slightly elevated Slightly elevated
Vital signs BP: 122/75 mmHg HR: 117/min RR: 24/min SaO2: 92% Temp: 38.1°C



| Clinical studies | Value of GCAL in early detection of infection and inflammation as well as estimation of disease severity have been proven |
||
|---|---|---|---|
| Endorsement from KOL's | Several KOL's on board and increasing demand for new studies and collaboration |
||
| Adoption by leading institutions |
Karolinska, Charité, APHP and Eurofins are examples of routine users | ||
| Commercial partnerships | Two major IVD companies onboard as commercial partners |

Introduction
R&D review
From science to sales
Strategic roadmap – Njaal Kind, CFO and COO
Q&A



Many of the existing, but clinically relevant biomarkers are available only on slow and inefficient platforms

Gentian converts existing biomarkers to the most efficient automated, highthroughput analysers

Faster results leading to better treatment decisions
3-10x higher throughput, improving laboratory productivity and cost-efficiency

| Total Addressable Market, USDm |
Total Serviceable Market, USDm |
Target market share, unrisked |
Gentian's revenue take |
Serviceable Market annual growth rate, next 4-6 years |
|
|---|---|---|---|---|---|
| Established products | 2,200 | 220 | ~25% | 30-50% | 5-10% |
| GCAL infection (sepsis) |
1,000 | 440 | ~15% | 30-50% | 7% |
| GCAL inflammation | 1,250 | 250 | Under evaluation | 30-50% | Under evaluation |
| NT-proBNP | 1,700 | 900 | ~15% | 30-50% | 5-10% |
| Total | 6,100 | 1,810 | >15% | 30-50% | 5-10% |
In 2030, there will be 400 million more people over 60 years than in 2020 – driving demand for diagnostics
Sources: Kalorama 2022, WHO 2022, company estimates. Note: Key risks to target market shares include market adoption rates for GCAL, and successful launch of NT-proBNP. Upside potential from product candidates in exploration and 'proof of concept' phases not included.

PRODUCT
SALES



Enabling 40% long-term EBITDA margin

• Delivered >25% sales CAGR since 2019-2022
• Targeting 20%+ sales growth 2022-2028
Revenue potential by product group 2028
GCAL NOK 100-300m
Note: Established products include 3rd party products sold through Gentian AB. Pipeline products include NT-proBNP currently in product development and two undisclosed projects in 'proof of concept' phase. In 2023, Gentian upgraded its lab facilities to provide increased efficiency and production capacity in line with the 5-6 year sales potential.

| Attractive value proposition | Faster diagnostic results, enabling better treatment decisions, and 3-10x higher throughput significantly improving laboratory productivity and cost-efficiency |
||
|---|---|---|---|
| Strong demand growth | USD 1.8 billion diagnostics market opportunity growing at 5-10% per year supported by strong underlying demand drivers – a growing and ageing population |
||
| Diversified revenue stream | Proven commercial traction for 5 launched products, de-risking revenue and providing diversified upside potential |
||
| On track for profitability | Operational leverage, 78% of revenue from long-term contracts with customers and comfortable cash position |
||
| Positioned for strong value creation |
Outlook for 20%+ growth from established products, GCAL® potential beginning to materialize and significant further upside in the development pipeline – high scalability enabling 40% EBITDA margin |

R&D review
From science to sales
Strategic roadmap




| ESTABLISHED PRODUCTS | GCAL | PIPELINE PRODUCTS | |
|---|---|---|---|
| S E N O T S E L MI |
Targeting additional large and medium size commercial partners globally Achieve additional regulatory approvals |
Clinical studies confirming patient outcomes and relevance for the early detection of infections, which supports the avoidance of sepsis as well as diagnosis of inflammatory diseases |
Successful optimisation of NT-proBNP Securing endorsements of the assay from key opinion leaders |
| Securing endorsements from key opinion leaders and inclusion in clinical guidelines |
Obtain progress on global commercial partnerships Finalise proof of concept of two new |
||
| Securing further global commercial partnerships with phased regional rollout |
projects Identify and confirm opportunities in exploration phase |
Aiming to bring a steady stream of high-impact diagnostic tests to the market and all the way to commercial success


| MNOK | 1Q23 | 1Q22 | 2022 | 2021 |
|---|---|---|---|---|
| Sales | 31.4 | 20.6 | 101.6 | 83.1 |
| Other revenues |
2.2 | 2.5 | 10.3 | 16.9 |
| Total revenues | 33.6 | 23.1 | 111.9 | 100.0 |
| COGS | -15.0 | -11.6 | -52.6 | -43.2 |
| Employee benefit expenses | -11.8 | -8.5 | -40.9 | -39.5 |
| D&A | -2.4 | -2.1 | -10.2 | -7.4 |
| Other OPEX | -7.3 | -7.1 | -31.4 | -32.8 |
| EBITDA | -0.5 | -4.2 | -13.0 | -15.5 |
| EBIT | -2.9 | -6.2 | -23.2 | -22.8 |

| MNOK | 1Q23 | 1Q22 | 2022 | 2021 |
|---|---|---|---|---|
| Operating activities | -3.3 | -11.4 | -14.0 | -27.1 |
| Investing activities |
-1.1 | -2.2 | -14.7 | -12.8 |
| Financing activities |
-1.1 | -1.1 | -4.3 | -3.1 |
| Changes in cash and cash equivalent | -5.5 | -14.8 | -33.0 | -43.0 |
| Cash and cash equivalent at the beginning of period |
81.6 | 114.9 | 114.9 | 158.0 |
| Cash and cash equivalent at the end of period |
76.0 | 100.2 | 81.6 | 114.9 |

| Assets | 2023 | 2022 |
|---|---|---|
| All numbers in MNOK | 31 March | 31 March |
| Intangible assets | 27.2 | 26.4 |
| Total non-current assets | 48.2 | 44.7 |
| Inventory | 39.1 | 31.4 |
| Accounts receivables | 22.0 | 25.8 |
| Cash and cash equivalents | 76.0 | 100.2 |
| Total current assets | 137.2 | 157.5 |
| Total assets | 185.4 | 202.2 |
| Equity and liabilities | 2023 | 2022 |
|---|---|---|
| All numbers in MNOK | 31 March | 31 March |
| Total paid-in equity | 311.4 | 307.5 |
| Retained earnings | -157.2 | -139.1 |
| Total equity | 154.2 | 168.4 |
| Accounts payable | 19.9 | 19.3 |
| Total liabilities | 31.2 | 33.8 |
| Total equity and liabilities | 185.4 | 202.2 |


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.

CFO & COO
Njaal Kind
Consulting Founder Erling Sundrehagen
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. 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.

CCO 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.

CSO 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 R&D Torsten Knüttel

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.

| Tomas Settevik |
Espen T. Jørgensen |
Kari E. Krogstad |
Kjersti Grimsrud |
Fredrik Thoresen |
Monika Neuman |
Frank Frantzen |
|---|---|---|---|---|---|---|
| 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, a large 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. |
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. |
Kjersti Grimsrud is currently President and COO of Infusion care at Convatec plc, where she has spent the last 5 years. She has over 30 years' experience in MedTech and IVD companies with roles in science, operations and commercial in Axis Shield ASA and Alere Inc./Abbott, where she last held the position of VP Commercial EME (Europe Middle East) and International (APAC). Ms Grimsrud served as a board member of Biotec Pharmacon (now ArcticZymes technologies) from 2011 to 2015. Ms. Grimsrud holds a master's degree in biotechnology Norwegian University of Science and Technology |
Fredrik Thoresen is a partner in Andenaes gruppen where he joined in 2021. Mr. Thoresen has previous buy- and sell-side experience from Storebrand, SEB, DNB and Sector Asset Management. Mr. Thoresen has an MBA in International Business from Middlebury Institute of International Studies, Monterey, California and a bachelor's degree in Computer Science and Economics from Augustana University, Sioux Falls, South Dakota |
Monika Neuman has 20 years of experience from the diagnostics industry and is currently Managing Director for Sarstedt Group in the Nordics. During the past 4 years, Ms. Neuman has been working at Siemens Healthineers Laboratory Diagnostics HQ in Tarrytown, NY, to set a successful strategy for launch and implementation of a new product portfolio on the global IVD market. Ms. Neuman holds a MSc degree in Biochemistry and a PhD degree in Clinical Bacteriology from Medical Faculty at Göteborg University in Sweden. |
Frank Frantzen has more than 35 years of experience from the diagnostic industry. He has served as principal scientist and has directed larger R&D units in international IVD companies Axis-Shield, Alere and Abbott. Mr. Frantzen left his Senior Director R&D position at Abbott in 2021 and is currently serving as Chief Technology Officer in CardiNor AS. Mr. Frantzen holds a master's degree in chemistry and a PhD, both from the Norwegian University of Science and Technology in Trondheim. |
in Trondheim.

| Shareholder | No of shares | % |
|---|---|---|
| Vatne Equity AS | 2 110 224 | 13.68 % |
| Kvantia AS | 1 623 368 | 10.53 % |
| Holta Life Sciences AS | 1 214 702 | 7.88 % |
| Verdipapirfondet Delphi Nordic | 987 104 | 6.40 % |
| Safrino AS | 749 700 | 4.86 % |
| Carpe Diem Afseth AS | 532 589 | 3.45 % |
| Skandinaviska Enskilda Banken AB | 499 315 | 3.24 % |
| Verdipapirfondet DNB SMB | 361 291 | 2.34 % |
| Verdipapirfondet Storebrand Vekst | 331 220 | 2.15 % |
| J.P. Morgan SE | 325 000 | 2.11 % |
| Portia AS | 300 000 | 1.95 % |
| Intertrade Shipping AS | 257 716 | 1.67 % |
| Cressida AS | 235 000 | 1.52 % |
| Verdipapirfondet Equinor Aksjer NO | 227 880 | 1.48 % |
| Lioness AS | 220 000 | 1.43 % |
| Krefting, Johan Henrik | 213 800 | 1.39 % |
| Marstal AS | 212 407 | 1.38 % |
| Mutus AS | 210 465 | 1.36 % |
| Salix AS | 208 954 | 1.35 % |
| Vingulmork Predictor AS |
184 083 | 1.19 % |
| Other Shareholders | 4 417 532 | 28.64 % |
| Total shares | 15 422 350 | 100 % |

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