Investor Presentation • May 5, 2023
Investor Presentation
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www.gentian.com
Gentian Diagnostics (OSE: GENT), founded in 2001, develops and manufactures high-quality, in vitro diagnostic reagents. Gentian's expertise and focus lies within immunochemistry, specifically infections, inflammations, kidney failures and congestive heart failures. By converting existing and clinically relevant biomarkers to the most efficient automated, high-throughput analysers, the company contributes to saving costs and protecting life. Gentian is based in Moss, Norway, serving the global human and veterinary diagnostics markets through sales and representative offices in Sweden, USA and China. For more information, please visit www.gentian.com.
Gentian Diagnostic's purpose is to deliver efficient diagnostics for better treatment decisions.
The growing diagnostics market puts increasing pressure on clinical laboratory efficiency. However, many of the existing, clinically relevant biomarkers are available only on slow and inefficient platforms. Gentian's solution is to utilize PETIA (particle-enhanced turbidimetric immunoassays), based on proprietary nanoparticle technology and knowhow, to convert existing biomarkers to the most efficient automated, high-throughput analysers.
Gentian's portfolio of high-impact diagnostic tests targets several large and growing disease areas such as infections and inflammation, kidney failure and congestive heart failure. The company has four established products –
Cystatin C, fCAL® turbo, Canine CRP and fPELA turbo – that contributed to 28% annual revenue growth in 2019-2022. In addition, SARS-CoV-2 Ab and GCAL® have been launched and are in market development while NT-proBNP is in the product development phase – with the two latter having potential to become growth accelerators. The company also has three undisclosed projects in exploration and 'proof of concept' phases.
In 2021, Gentian announced a long-term ambition to generate an estimated annual revenue of NOK 1.0 billion in 5-7 years, dependent on the timing of NT-proBNP launch yet to be concluded. In comparison, total revenue was NOK 111 million in 2022. The company's roadmap for long-term growth and value creation is founded on six strategic pillars:

Grow annual revenue from the company's four established products by 20%+ annually – by expanding market access through additional commercial partners and regulatory approvals.

Demonstrate clinical relevance of GCAL® for the early detection of severe infections.

Bring a steady stream of new high-impact diagnostic tests to market.

Secure one new contract with a global commercial partner every year, building on already established partnerships with major diagnostic companies across products.

Grow gross margin from ~50% to 60%+ through economies of scale.

Deliver long-term EBITDA margins of 40% through operational leverage and cost discipline.

Sales revenue grew 40% organically in 1Q23 versus 1Q22, ending the quarter at MNOK 31.4. The reported growth was 53%. The company remains committed to the overall objective of growing sales revenue with more than 20% year on year. 1Q23 sales were favourably impacted by several factors including the normalisation of regular laboratory test numbers performed after the COVID pandemic situation. Revenue growth contribution was achieved by all products, in all regions and through all sales channels; from direct sales to distribution partners and global IVD (in vitro diagnostics) partners.
Sales of Cystatin C, which supports early detection of reduced kidney function, were MNOK 13.6 for the quarter versus MNOK 7.5 in 1Q22, corresponding to an 81% increase. Market conditions in China continue to normalise and demand from other parts of Asia has increased. In the US the company's direct efforts as well as sales through a distribution agreement with a large IVD company, announced in 2022, has resulted in continued positive development. Growth in the US is also influenced by recently published new guidelines for the implementation of Cystatin C testing. Gentian's ability to serve its US customers through establishing a local distribution centre in the US has also added to the positive effect. Operationally focused sales and marketing efforts from Gentian's partner Beckman Coulter also resulted in gaining new customers in the US and Europe.
Sales of fCAL® turbo, which supports fast diagnosis of inflammatory bowel disease, reached MNOK 9.5 in 1Q23, a 40% increase vs 1Q22. With the US regulatory 510(K) clearance previously achieved, and with significant lab staff shortage in the US driving the need for highly productive and automated testing, the fCAL turbo benefits from increased adoption in the largest global IVD market. The successful partnership with Bühlmann Laboratories and the strong execution of their commercial channel strategy is a key contributor to the growing sales.
The company's Swedish distribution subsidiary, Gentian Diagnostics AB (GAB), continued to demonstrate a positive sales trend for thirdparty products but also for the Gentian portfolio. Revenue from third-party distribution amounted to MNOK 3.6 in 1Q23. This represents an increase of 27% compared to 1Q22, including sales growth from direct commercial activities in Norway and Finland, which started in 2022.
A differentiating element and contributing to the company's sales growth in Europe is the early achieved IVDR registration of its major products (GCAL®, Cystatin C, fCAL® turbo) during 2022.
The GCAL® immunoassay, for the quantification of calprotectin in serum and plasma, has been demonstrated to improve patient outcomes and relevance for the early detection of infections, which supports the avoidance of sepsis as well as diagnosis of inflammatory diseases.
The market development of GCAL® continued to develop positively, driven by a growing body of scientific evidence supporting the relevance of the immunoassay and initial traction with global partners.
The global distribution agreement for GCAL® with Siemens Healthineers, one of the global leaders in clinical diagnostics has shown initial commercial success in selected European countries. Regional expansion is under way, including non-European markets.
GCAL® sales from direct and partner efforts continue to evolve positively with recurring sales from both existing and new routine customers. During the quarter, Gentian established a new commercial agreement with a distribution partner in the Netherlands, Belgium and Luxemburg.
Further, the GCAL® validation on additional clinical chemistry platforms continues. Now also including the Beckman Coulter DXC700 AU platform, introduced in 2022.
There is a growing interest in the GCAL ® assay from healthcare providers and, as a result, an increased adoption in routine use. In March 2023, one of the largest hospitals in Sweden, implemented routine clinical use of the assay.
It demonstrates Gentian's commitment to providing quality products to the market, which contributed to strengthen customer relations.
Quarterly variations to sales are expected to continue as sales are affected by the timing of large orders.
The value of GCAL ® for patients presented at the Emergency Department has been confirmed in several studies. A study from Karolinska University Hospital confirmed use of calprotectin for estimation of disease severity in patients with suspected sepsis. Calprotectin, measured with the GCAL ® assay was the only of the studied biomarkers able to differentiate between severely ill patients with infection and patients without infection. Moreover, calprotectin identified patients with need for high level of care and transfer to the Intensive Care Unit and was found to be superior to other routinely used biomarkers. The authors concluded that early identification of patients with severe disease requiring higher level of care is of critical importance for optimal patient care and use of healthcare resources. Consequently, the authors suggested that calprotectin may be a useful biomarker in the management of patients with sepsis. This study was published in the scientific journal BMC Emergency Medicine with the title "Plasma calprotectin as an indicator of need of transfer to intensive care in patients with suspected sepsis at the emergency department".
The value of the GCAL ® assay in estimation of disease severity has been confirmed also in patients with COVID-19. Researchers from Karolinska University Hospital presented a poster at the International Symposium on Intensive Care & Emergency Medicine (ISICEM) in March 2023, showing that calprotectin, measured with the GCAL ® assay was able to identify patients with severe COVID-19. Furthermore, an increase in calprotectin concentration in samples collected during hospital stay indicated clinical deterioration. Authors concluded that calprotectin is a useful biomarker for assessment and monitoring of clinical severity in COVID-19.
There is a growing body of scientific evidence supporting that early diagnosis of bacterial infections and earlier start of antibiotic treatment in critically ill patients are beneficial, not only from the clinical, but also from a cost-saving perspective. A health economic model, developed for use of GCAL® in ICU (Intensive Care Unit) has confirmed that the use of GCAL® for early detection of infection saves
costs, reduces the duration of patient care in the ICU and in general ward, and reduces inhospital mortality in those patients. Compared to other routinely used biomarkers, calprotectin, analysed by GCAL® Calprotectin Immunoassay, has shown to reduce total costs by approximately 13 000 – 18 000 EUR per patient, overall mortality rate by 0.11, and mean length of stay in an ICU and general ward by 1.3 – 2 days and 6.9 – 8 days, respectively. The model supports previous findings that early detection of severe infections and sepsis has both cost-saving and life-saving impact in the ICU setting.
Gentian's NT-proBNP assay is currently in the optimization phase of development and aims to be the first turbidimetric in vitro diagnostic test for the quantitative measurement of NTproBNP. The goal is to make NT-proBNP testing more accessible on high-volume clinical chemistry analyzers, which should increase laboratory productivity and reduce overall costs. The growing cost burden in healthcare systems due to an aging population and lifestyle choices is driving the demand for NT-proBNP testing.
As outlined in the fourth quarter report, Gentian has been focused on developing a simpler and more efficient calibration method. In the first quarter, our team continued to work on this new method and initiated investigations to measure and quantify the impact of glycosylation on the NT-proBNP molecule. This will enable us to establish a benchmark for the degree of underestimation of true NT-proBNP concentrations by existing assays in clinical samples.
In addition, we have achieved notable advancements in enhancing the stability of our working prototype. Lastly, we have begun preparations to examine the performance of our prototype assay in patient samples with
confirmed clinical status of acute or chronic heart failure.
At this time, we are unable to provide a specific timeline for the completion of the remaining optimization phase. However, if the product successfully completes this phase, subsequent phases are typically characterized by lower risk. We estimate that the development period for NT-proBNP after completion of optimization will be between 6 and 9 months.
It is important to note that the product will now fall under the new IVDR regulatory regime, which will add an additional 6-9 months before commercial launch. As per our established practice, if the current optimization efforts do not prove successful, we will consider returning the project to the exploration phase.
Gentian currently has two projects in the proofof-concept phase. Market research was conducted in 2022 for one of these projects, which is addressing an alternative IVD market, confirmed a significant commercial potential for this project. The company continues to make investments into exploration projects to ensure future additions to the project pipeline.
Gentian targets disease groups that represent a total addressable market of around BUSD 6.1 globally and an estimated growth rate of 4-5% annually over the next 4-6 years, according to leading market data provider Kalorama (2022). From a macro perspective, key growth drivers include a growing and ageing population contributing to an increase in chronic and infectious diseases globally.
The specific segments targeted by Gentian's products add up to a total serviceable market of BUSD 1.8 (2022), with an estimated annual growth rate of 5-10% over the next 4-6 years. The key driver for the higher expected growth rate in the serviceable market is Gentian's selective approach to target attractive segments.
Overall, Gentian targets a market share of 15- 20% for its product portfolio which is offered through commercial partners. With a commercial strategy to serve the market through OEM and distribution agreements it is expected that the revenue take will vary across products but remain within the 30-50% range for the product portfolio as a whole.
The company's strategy for growing its market share is founded on innovative biomarkers based on PETIA technology and proprietary know-how offering clinically relevant benefits, supported by an effective go-to-market strategy. The benefits include early diagnostic results that enable improved treatment decisions and a 3-10x increase in volume throughput that saves costs and makes Gentian's offering an attractive solution to the increasing pressure on laboratory productivity.
The 5–7-year revenue ambition of NOK 1 billion, which Gentian announced in 2021, and the long-term EBITDA margin target of 40%, are set to be de-risked through several key milestones for the company's product portfolio over the coming 12 months. The revenue ambition is dependent on the timing of NTproBNP launch, which was estimated to contribute with MNOK 200-400 five to seven years after the product has been launched.
The key milestones are:
• Finalize proof-of-concept for two new pipeline projects.
Comparative numbers for Gentian in 2022 in ().
Total operating revenue amounted to MNOK 33.6 (MNOK 23.1) for 1Q23.
Sales revenue increased by 53% to MNOK 31.4 in 1Q23 (MNOK 20.6), with organic revenue growth of 40%.
Revenues from the Asian market were MNOK 7.3 for 1Q23 (MNOK 4.1), a growth of 78%. The growth is partly due to normalization in demand for Cystatin C in China which was affected by COVID related shutdowns in 1Q22. Sales in other geographic areas also developed positively with growth in Europe and the US of 46% and 54%, respectively, compared to 1Q22.
| MNOK | 1Q23 | 1Q22 |
|---|---|---|
| US | 2.0 | 1.3 |
| Europe | 22.1 | 15.1 |
| Asia | 7.3 | 4.1 |
| Total | 31.4 | 20.6 |
During 1Q23 the group has recorded sales growth for all products compared to 1Q22. The development for Cystatin C has been strong with a growth of 81% in 1Q23 compared to 1Q22 driven by a normalisation in order volumes to China and positive development of US and European sales. Sales of fCAL turbo continued to develop positively with sales increasing 40% in 1Q23 compared to 1Q22.The distribution of third-party products conducted by the Swedish subsidiary Gentian Diagnostics AB (GAB), continues to expand its activities in the Nordic region. Sales increased by 29% in 1Q23 compared to 1Q22.
.
| MNOK | 1Q23 | 1Q22 |
|---|---|---|
| Cystatin C | 13.6 | 7.5 |
| fCAL®turbo | 9.5 | 6.8 |
| Third party products | 3.6 | 2.8 |
| Other | 4.7 | 3.5 |
| Total | 31.4 | 20.6 |
Approximately 78% (74%) of the sales revenue in the quarter comes from long-term contracts with established customers.

Other operating revenue ended at MNOK 2.2 (MNOK 2.5) for 1Q23 and consists of public grants related to the company's R&D projects.
Cost of goods sold (COGS) was 48% (56%) of sales revenue in 1Q23. Gentian experienced a positive effect related to the high activity in the quarter which more than absorbed higher prices on raw materials. Considering recent macroeconomic data, Gentian expects further increases in raw material prices and labour cost during 2023, but maintains its ambition that over time, COGS as a percentage of sales revenue will decline with increasing sales.
Total other operating expenses before capitalisation of R&D expenses ended at MNOK 19.9 (MNOK 17.9) in 1Q23.
R&D expenses amounted to 37% (37%) of total other operating expenses before capitalization in 1Q23. Capitalisation of R&D expenses was MNOK 0.8 (MNOK 2.2) in the quarter.
Total other operating expenses after capitalisation of R&D expenses was MNOK 19.1 (MNOK 15.7) in 1Q23.
Operating profit before depreciation and amortization (EBITDA) ended at MNOK -0.5
(MNOK -4.2) for 1Q23. Net profit was MNOK -0.7 (MNOK -6.6).
Cash and cash equivalents as of 31 March 2023 were MNOK 76.0 (MNOK 100.2). The cash is placed in both savings accounts and current accounts.
Accounts receivables as of 31 March 2023 were MNOK 15.5 (MNOK 10.3), and inventory MNOK 39.1 (MNOK 31.4). The inventory increase is partly a result of increased activity and partly due to the company's measures to mitigate potential shortages from a congested supply chain.
The equity ratio was 83.2% as of 31 March 2023
There are no events after the balance sheet date.
| Note | 2023 | 2022 | 2022 | |
|---|---|---|---|---|
| (NOK 1000) | Q1 | Q1 | 01.01- 31.12 |
|
| Revenue | ||||
| Revenue from contracts with customers | 3 | 31 437 | 20 558 | 101 636 |
| Other operating revenue | 4 | 2 163 | 2 532 | 10 287 |
| Total revenue | 33 600 | 23 090 | 111 922 | |
| Operating expenses | ||||
| Cost of goods sold | 6 | -15 017 | -11 613 | -52 635 |
| Employee benefit expenses | 7,13 | -11 815 | -8 542 | -40 910 |
| Depreciation and amortisation | -2 359 | -2 062 | -10 243 | |
| Other operating expenses | -7 285 | -7 120 | -31 369 | |
| Total operating expenses | 5 | -36 475 | -29 336 | -135 158 |
| Operating result | -2 875 | -6 246 | -23 235 | |
| Finance income | 2 516 | 1 071 | 3 831 | |
| Finance cost | -298 | -1 450 | -4 213 | |
| Net financial items | 2 218 | -379 | -382 | |
| Profit before tax | -657 | -6 625 | -23 618 | |
| Income tax expense | - | - | - | |
| Profit for the period | -657 | -6 625 | -23 618 | |
| Other comprehensive income | ||||
| Exchange differences | -3 | 20 | -331 | |
| Total other comprehensive income | -3 | 20 | -331 | |
| Total comprehensive income for the period |
-660 | -6 605 | -23 949 |
1 st quarter Statement of Profit and Loss is not audited
| Note | 2023 | 2022 | 2022 |
|---|---|---|---|
| (Figures in NOK thousands) | 31.3 | 31.3 | 31.12 |
| Assets | |||
| Non-Current Assets | |||
| Intangible assets 9 |
27 192 | 26 401 | 26 820 |
| Property, plants and equipment | 9 225 | 3 826 | 9 724 |
| Right-of-use assets | 11 788 | 14 465 | 11 913 |
| Total Non-Current Assets | 48 205 | 44 691 | 48 458 |
| Current Assets | |||
| Inventory | 39 131 | 31 447 | 38 544 |
| Accounts receivables and other receivables | 22 053 | 25 838 | 19 188 |
| Cash and cash equivalents | 76 017 | 100 237 | 81 599 |
| Total Currents Assets | 137 201 | 157 522 | 139 332 |
| Total Assets | 185 406 | 202 213 | 187 790 |
| Equity and liabilities | |||
| Paid-in equity | |||
| Share capital 11 |
1 542 | 1 542 | 1 542 |
| Share premium | 293 810 | 293 810 | 293 810 |
| Other paid-in equity | 16 047 | 12 184 | 15 294 |
| Total paid-in equity | 311 399 | 307 537 | 310 646 |
| Retained earning | |||
| Retained earning | -157 217 | -139 133 | -156 477 |
| Total retained equity | -157 217 | -139 133 | -156 477 |
| Total equity | 154 183 | 168 404 | 154 170 |
| Liabilities | |||
| Lease liabilities 10 |
11 320 | 14 546 | 11 624 |
| Total non-current liabilities | 11 320 | 14 546 | 11 624 |
| Current liabilities | |||
| Accounts payable and other current liabilities | 19 903 | 19 264 | 21 996 |
| Total current liabilities | 19 903 | 19 264 | 21 996 |
| Total liabilities | 31 223 | 33 810 | 33 620 |
| Total equity and liabilities | 185 406 | 202 213 | 187 790 |
1 st quarter Statement of Financial Position is not audited
(figures in NOK thousands)
| Other | |||||
|---|---|---|---|---|---|
| Share | Share | paid-in | Retained | Total | |
| capital | premium | capital | earnings | equity | |
| Equity at 01.01.2022 | 1 542 | 293 810 | 11 941 | -132 528 | 174 766 |
| Net result for the year | -6 625 | -6 625 | |||
| Other comprehensive income | |||||
| Proceeds from share issue | |||||
| Cost of share issue | |||||
| Share based payments | 243 | 243 | |||
| Other changes in equity | 20 | 20 | |||
| Equity at 31.03.2022 | 1 542 | 293 810 | 12 184 | -139 133 | 168 404 |
| Equity at 01.01.2022 | 1 542 | 293 810 | 11 941 | -132 528 | 174 766 |
| Net result for the year | -23 618 | -23 618 | |||
| Other comprehensive income | |||||
| Proceeds from share issue | |||||
| Cost of share issue | |||||
| Share based payments | 3 353 | 3 353 | |||
| Other changes in equity | -331 | -331 | |||
| Equity at 31.12.2022 | 1 542 | 293 810 | 15 294 | -156 477 | 154 170 |
| Equity at 01.01.2023 | 1 542 | 293 810 | 15 294 | -156 477 | 154 170 |
| Net result for the year | -657 | -657 | |||
| Other comprehensive income | |||||
| Proceeds from share issue | |||||
| Cost of share issue | |||||
| Share based payments | 753 | 753 | |||
| Other changes in equity | -83 | -83 | |||
| Equity at 31.03.2023 | 1 542 | 293 810 | 16 047 | -157 217 | 154 183 |
1 st quarter Statement of changes in equity is not audited
| 2023 | 2022 | 2022 | |
|---|---|---|---|
| (NOK 1000) | Q1 | Q1 | 01.01- 31.12 |
| Operating activities | |||
| Net profit (loss) | -657 | -6 625 | -23 618 |
| Depreciation and amortisation | 2 359 | 2 062 | 10 243 |
| Change Inventory | -587 | -1 668 | -8 765 |
| Change Accounts Receivables | -5 408 | -3 796 | -3 550 |
| Change Accounts Payables | -1 623 | -3 509 | -532 |
| Accrued cost of options | 753 | 243 | 3 353 |
| Change in other assets and liabilities | 1 883 | 1 901 | 8 917 |
| Net cash flow from operating activities | -3 281 | -11 392 | -13 952 |
| Investing activities | |||
| Payments of property, plant and equipment | -271 | - | -8 632 |
| Investment in intangible assets | -790 | -2 230 | -6 029 |
| Net cash flow from investing activities | -1 061 | -2 230 | -14 666 |
| Financing activities | - | - | - |
| New debt | - | - | - |
| Lease payments | -1 148 | -1 127 | -4 325 |
| Proceeds from issue of share capital | - | - | - |
| Net cash flow from financing activities | -1 148 | -1 127 | -4 325 |
| Net change in cash and cash equivalent | -5 490 | -14 750 | -32 943 |
| Cash and cash equivalents at beginning of period |
81 599 | 114 936 | 114 936 |
| Effect of currency translation of cash and cash equivalents |
-93 | 50 | -395 |
| Net Cash and cash equivalents at period end |
76 017 | 100 237 | 81 599 |
1 st quarter Cash Flow Statement is not audited
Gentian Diagnostics ASA is registered in Norway and listed on the Euronext Oslo Børs. The company's headquarters are in Bjørnåsveien 5, 1596 Moss, Norway. The company is a research and developmentbased company that develops and manufactures biochemical reagents for use in medical diagnostics and research. The customers are medical laboratories and universities worldwide. The group consists of the parent company Gentian Diagnostics ASA and the subsidiary Gentian AS.
In addition, Gentian AS has a wholly owned subsidiary, registered in Florida, USA, named Gentian USA Inc, and a wholly owned subsidiary in Sweden, Gentian Diagnostics AB.
The interim condensed consolidated financial statements for the group are prepared using the same accounting principles and calculation methods as used for the annual financial statements 2022 for Gentian Diagnostics ASA.
The accounting principles used have been consistently applied in all periods presented, unless otherwise stated.
Amounts are in thousand Norwegian kroner unless stated otherwise. The groups presentation currency is NOK (Norwegian kroner). This is also the parent company's functional currency. The company uses currency rates published by DNB ASA.
The quarterly financial statements of the group have been prepared in accordance with IAS 34 Interim Financial Reporting Standards and interpretations in issue but not yet adopted.
No new accounting standards and interpretations have been published that have been assessed to be of material impact for the group in 2023.
The consolidated financial statements comprise the financial statements of the company and its subsidiaries. As at 31 March 2023, Gentian AS, located in Moss, Norway is a 100% owned and controlled subsidiary.
| Revenue by classification | 1Q23 | 1Q22 | 2022 | 2021 |
|---|---|---|---|---|
| Sales revenue | 31 437 | 20 558 | 101 636 | 83 122 |
| Public grants | 2 163 | 2 532 | 10 287 | 16 887 |
| Other revenue | - | - | - | - |
| Total | 33 600 | 23 090 | 111 922 | 100 009 |
| Sales revenue Geographical split |
1Q23 | 1Q22 | 2022 | 2021 |
| Europe | 22 062 | 15 140 | 71 571 | 55 676 |
| Asia | 7 339 | 4 076 | 23 609 | 25 008 |
| USA | 2 036 | 1 343 | 6 456 | 2 438 |
| Total | 31 437 | 20 558 | 101 636 | 83 122 |
| Sales revenue by product category |
1Q23 | 1Q22 | 2022 | 2021 |
| Renal diagnostic products | 13 608 | 7 510 | 39 966 | 36 227 |
| Inflammation diagnostic products |
11 335 | 10 739 | 42 886 | 32 331 |
| Other diagnostic products | 6 494 | 2 309 | 18 784 | 14 563 |
| Total | 31 437 | 20 558 | 101 636 | 83 122 |
Gentian has recognised public grants from the Norwegian Research Council, Innovation Norway, Eurostars and SkatteFUNN.
| 1Q23 | 1Q22 | 2022 | 2021 | |
|---|---|---|---|---|
| Norwegian Research Council and Eurostars |
1 475 | 1 589 | 6 298 | 10 943 |
| Innovation Norway | - | - | - | 1 194 |
| SkatteFUNN | 688 | 942 | 3 989 | 4 750 |
| Total | 2 163 | 2 532 | 10 287 | 16 887 |
| 1Q23 | 1Q22 | 2022 | 2021 | |
|---|---|---|---|---|
| Cost of goods sold | 15 017 | 11 613 | 52 635 | 43 176 |
| Sales and marketing expenses | 5 304 | 4 593 | 21 490 | 15 145 |
| Administration expenses | 7 153 | 6 701 | 27 973 | 32 769 |
| Research and development expenses | 6 644 | 4 368 | 22 817 | 24 416 |
| Depreciation | 2 359 | 2 062 | 10 243 | 7 351 |
| Total | 36 475 | 29 336 | 135 158 | 122 856 |
| 1Q23 | 1Q22 | 2022 | 2021 | |
|---|---|---|---|---|
| Change in inventory of goods under manufacture and finished goods |
-791 | 2 632 | 1 368 | 3 727 |
| Purchase of goods | 8 919 | 2 365 | 24 412 | 16 086 |
| Production salary | 5 687 | 5 147 | 20 978 | 18 662 |
| Other production expense | 1 201 | 1 468 | 5 877 | 4 702 |
| Total | 15 017 | 11 613 | 52 635 | 43 176 |
| 1Q23 | 1Q22 | 2022 | 2021 | |
|---|---|---|---|---|
| Wages and salaries | 13 831 | 11 343 | 48 456 | 43 733 |
| Payroll tax | 1 424 | 1 522 | 5 876 | 6 888 |
| Pension costs (mandatory occupational pension) |
860 | 388 | 3 171 | 1 733 |
| Share based payments | 753 | 243 | 3 353 | 4 633 |
| Other expenses | 635 | 194 | 1 032 | 1 214 |
| Transfer to COGS | -5 687 | -5 147 | -20 978 | -18 662 |
| Total | 11 815 | 8 542 | 40 910 | 39 539 |
The Gentian Group has per 31 March 2023 four ongoing R&D projects. Costs related to the projects consist of salary, external procurement of services, and other operating expenses. One project went over in the development phase in 2016 and one additional in 2021, and consequently the capitalisation of the costs in these projects was started.
| Recognised research and development expenses |
1Q23 | 1Q22 | 2022 | 2021 |
|---|---|---|---|---|
| Purchase of external services | 1 534 | 1 876 | 7 972 | 9 023 |
| Salary and other operating expenses | 5 900 | 4 722 | 20 873 | 27 050 |
| Capitalised research and development expenses |
-790 | -2 230 | -6 029 | -11 658 |
| Total | 6 664 | 4 368 | 22 817 | 24 416 |
As of 31 March 2023, the recognised intangible assets in the Group amounts to MNOK 27.2. The intangible assets are derived from capitalisation of R&D expenses.
Intangible assets are tested for impairment at least annually, or when there are indications of impairment.
The impairment test is based on an approach of discounted cash flows. The valuation is sensitive to several assumptions and uncertainties, and the result from the valuation is thus limited to ensure sufficient certainty for the recognised amount in the financial statement.
Loan and loan expenses is recorded in the balance sheet and expensed in the Statement of Profit and Loss at amortised cost. If a loan and loan expenses is related to an asset, and the real value of the asset is lower, the asset is written down to its real value. There was no value adjustment of assets in 1Q23.
Interest bearing debt for Gentian is relating to instrument leases and calculated leases based on contracts according to IFRS 16.
20 largest shareholders in Gentian Diagnostics ASA as of 31 March 2023 according to VPS and disclosures from investors:
| 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 | 973 999 | 6.32 % |
| Safrino AS | 749 700 | 4.86 % |
| Carpe Diem Afseth AS | 500 650 | 3.25 % |
| Skandinaviska Enskilda Banken AB | 500 000 | 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 % |
| Equinor Pensjon | 245 047 | 1.59 % |
| Cressida AS | 235 000 | 1.52 % |
| Verdipapirfondet Equinor Aksjer NO | 227 880 | 1.48 % |
| Lioness AS | 220 000 | 1.43 % |
| Marstal AS | 212 407 | 1.38 % |
| Mutus AS | 210 465 | 1.36 % |
| Salix AS | 208 954 | 1.35 % |
| Krefting, Johan Henrik | 203 400 | 1.32 % |
| Vingulmork Predictor AS | 184 083 | 1.19 % |
| Other Shareholders | 4 484 960 | 29.08 % |
| Total Shares | 15 422 350 | 100.00% |
| 1Q23 | 1Q22 | 2022 | |
|---|---|---|---|
| Loss for the period | -656 722 | -6 624 894 | -23 617 809 |
| Average number of outstanding shares during | |||
| the period | 15 422 350 | 15 422 350 | 15 422 350 |
| Earnings/ loss (-) per share - basic and diluted | -0.043 | -0.430 | -1.531 |
Share options issued have a potential dilutive effect on earnings per share. No dilutive effect has been recognized as potential ordinary shares only shall be treated as dilutive if their conversion to ordinary shares would decrease earnings per share or increase loss per share from continuing operations. As the group is currently loss-making, an increase in the average number of shares would have anti-dilutive effects.
The company has a share option program covering certain key employees. Per 31 March 2023, fifteen employees were included in the option program.
The share option program for key personnel is settled in shares, however, the company may resolve settlement in cash. The fair value of the issued options is expensed over the vesting period:
For options issued from 2018 and up to 2021,1/3 of the options will vest 24 months after the day of grant, 1/3 will vest 36 months after the day of grant and 1/3 will vest 48 months. For options issued from 2022, 1/2 of the options will vest after 36 months and 1/2 of the options will vest after 48 months. Unvested options will be cancelled if the holder terminates its employment with the group.
The cost of the employee share-based transaction is expensed over the average vesting period. The value of the issued options of the transactions that are settled with equity instruments (settled with the company's own shares) is recognised as salary and personnel cost in profit and loss and in other paidin capital.
The value of the issued options of the programs that are settled in cash (cash-based programs) is recognised as salary and personnel cost in profit and loss and as a liability in the balance sheet. The liability is measured at fair value at each balance sheet date until settlement, and changes in the fair value are recognised in profit and loss.
Social security tax on options is recorded as a liability and is recognised over the estimated vesting period.
| 1Q23 | 1Q22 | 2022 | |
|---|---|---|---|
| Outstanding options at beginning of period | 960 586 | 594 916 | 740 590 |
| Options granted | - | 155 674 | 219 996 |
| Options forfeited | - | -10 000 | - |
| Options exercised | - | - | - |
| Options expired | - | - | - |
| Outstanding options at end of period | 960 586 | 740 590 | 960 586 |
| Expiry date | Average strike price | Number of share options |
|---|---|---|
| 2023-8 | 65.24 | 174 954 |
| 2024-11 | 47.51 | 259 962 |
| 2025-11 | 62.88 | 150 000 |
| 2026-11 | 72.60 | 155 674 |
| 2027-12 | 46.67 | 219 996 |
| 960 586 | ||
The outstanding options are subject to the following conditions:
The fair value of the options has been calculated using Black - Scholes - Merton Option Pricing Model. The most important parameters are share price at the grant date, exercise prices shown above, volatility (42.74%), expected dividend yield (0%), an expected term of 5 years, and annual risk-free interest rate (2.87%). The volatility is based on other comparable companies' stock price volatility.
The group uses Getica AB as a supplier for one of its production steps and has outsourced some R&D project elements to the same supplier. The supplier is owned by Erling Sundrehagen, who also is the sole owner of Vingulmork Predictor AS. The amount invoiced from Getica AB was MNOK 1.3 per 31 March 2023 (MNOK 1.2 per 31 March 2022).
The Group has carried forward losses which are not capitalised as it is uncertain when the Group will be in a tax position. The loss carried forward per 31 March 2023 is estimated to NOK 206.2 million. The Group will continuously assess the probability of when it will be in a tax position and when to consider a capitalisation of the loss carried forward.
Non‐IFRS financial measures / alternative performance measures
In this quarterly report, the Group presents certain alternative performance measures ("APMs"). An APM is defined as a financial measure of historical or future financial performance, financial position, or cash flows, other than a financial measure defined or specific in the applicable financial reporting framework (IFRS). The APMs presented herein are not measurements of financial performance or liquidity under IFRS or other generally accepted accounting principles, are not audited and investors should not consider any such measures to be an alternative to (a) operating revenues or operating profit (as determined in accordance with generally accepted accounting principles), (b) as a measure of the Group's operating performance; or (c) any other measures of performance under generally accepted accounting principles. The APMs presented herein may not be indicative of the Group's historical operating results, nor are such measures meant to be predictive of the Group's future results.
The company uses APMs to measure operating performance and is of the view that the APMs provide investors with relevant and specific operating figures which may enhance their understanding of the Group's performance. Because companies calculate APMs differently, the APMs presented herein may not be comparable to similarly titled measures used by other companies.
Below is an overview of APMs presented, including an overview of reconciliation and calculation of the relevant APMs.
Organic revenue growth is defined as revenue adjusted for currency effects and effects from M&A. Organic revenue growth measurement provides useful information to investors and other stakeholders on underlying growth of the business without the effect of certain factors unrelated to its operating performance.
| Reconciliation | 1Q23 | 1Q22 | 2022 | 2021 |
|---|---|---|---|---|
| (NOK 1000) | ||||
| Revenue from contracts with customers | 31 437 | 20 558 | 101 636 | 83 122 |
| Revenue growth | 10 937 | 917 | 18 538 | 19 795 |
| Impact using exchange rates from last period |
-2 746 | 265 | -1 750 | 4 399 |
| Impact M&A | - | - | - | 1 954 |
| Organic revenue growth | 8 191 | 1 183 | 16 788 | 26 148 |
| Organic revenue growth % | 40 % | 6 % | 21 % | 43 % |
Total other operating expenses is a key financial parameter for the Group and consists of salaries and personnel costs and other operating expenses. Total other operating expenses before capitalisation of R&D expenses consists of Employee benefit expenses and other non-salary related operating expenses before capitalisation of R&D expenses. The performance indicator is provided for the purpose of monitoring the evolution of non-production related costs without the effect of capitalisation of costs.
| Reconciliation | 1Q23 | 1Q22 | 2022 | 2021 |
|---|---|---|---|---|
| (NOK 1000) | ||||
| Employee benefit expenses | 11 815 | 8 542 | 40 910 | 39 539 |
| Other operating expenses | 7 285 | 7 120 | 31 369 | 32 790 |
| Total other operating expenses after capitalisation of R&D expenses |
19 100 | 15 662 | 72 279 | 72 330 |
| Capitalisation | 790 | 2 230 | 6 029 | 11 659 |
| Total other operating expenses before capitalisation of R&D expenses |
19 890 | 17 892 | 78 308 | 83 988 |
| Reconciliation | 1Q23 | 1Q22 | 2022 | 2021 |
|---|---|---|---|---|
| (NOK 1000) | ||||
| Other non-salary related operating expenses after capitalisation of R&D expenses |
7 285 | 7 120 | 31 369 | 32 790 |
| Capitalisation | 333 | 1 020 | 2 336 | 8 579 |
| Other non-salary related operating expenses before capitalisation of R&D expenses |
7 618 | 8 140 | 33 705 | 41 370 |
EBITDA is a measurement of operating earnings before depreciation and amortisation of tangible and intangible assets and impairment charges, and EBIT is the operating result. EBITDA and EBIT are used for providing information of operating performance which is relative to other companies and frequently used by other stakeholders.
| Reconciliation | 1Q23 | 1Q22 | 2022 | 2021 |
|---|---|---|---|---|
| (NOK 1000) | ||||
| Total Revenue | 33 600 | 23 090 | 111 922 | 100 009 |
| Total Operating Expenses | -36 475 | -29 336 | -135 158 | -122 856 |
| EBIT | -2 875 | -6 246 | -23 235 | -22 847 |
| Depreciation and Amortisation | 2 359 | 2 062 | 10 243 | 7 351 |
| EBITDA | -516 | -4 184 | -12 992 | -15 496 |
Cost of goods sold (COGS) refers to the total cost of producing goods for product sales. The key figure COGS % is calculated in relation to revenue from contracts with customers. COGS % is used for providing consistent information of performance related to the production of goods which is relative to other companies and frequently used by other stakeholders.
| 1Q23 | 1Q22 | 2022 | 2021 | |
|---|---|---|---|---|
| (NOK 1000) | ||||
| Revenue from contracts with customers | 31 437 | 20 558 | 101 636 | 83 122 |
| COGS | 15 017 | 11 613 | 52 635 | 43 176 |
| COGS % of Revenue from contracts with customers |
48 % | 56 % | 52 % | 52 % |
Non-cash share-based compensation expense is the share-based compensation recognised in the income statement (employee benefit expenses). Information on the non-cash share-based compensation expense is provided to give information on the no-cash components of the employee benefit expenses.
| 1Q23 | 1Q22 | 2022 | 2021 | |
|---|---|---|---|---|
| (NOK 1000) | ||||
| Non-cash shared-based compensation | 753 | 243 | 3 353 | 4 633 |
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