Annual / Quarterly Financial Statement • Feb 9, 2024
Annual / Quarterly Financial Statement
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Fourth quarter 2023 results
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 30% annual revenue growth in 2019-2023. The most recent launch in 3Q 2023 of Retinol Binding Protein (RBP) will support growth for this category. In addition, GCAL® has been launched and is in market development while NT-proBNP is in the product development phase – both having potential to become growth accelerators. The company also has 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 revenues were NOK 142.3 million in 2023. The company's roadmap for long-term growth and value creation is founded on six strategic pillars:
Grow annual revenue from the company's 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.
In the fourth quarter of 2023, the company recorded a significant increase in sales revenue, marking a 34% growth compared to the fourth quarter of 2022. This growth trend was consistent throughout the year, with a 33% increase in annual sales revenue compared to 2022. The organic growth rates were notable at 23% for the quarter and 21% for the full year. These figures demonstrate a robust performance and signify the achievement of the company's annual sales growth objectives.
Sales in 4Q23 were primarily driven by strong growth in Europe with Cystatin C and third-party products as significant contributors. GCAL® also demonstrated strong sales growth from a relatively low base.
Sales of Cystatin C, which supports early detection of reduced kidney function, were MNOK 56.3 in 2023 versus MNOK 40.0 in 2022, an increase of 41%. Sales for the quarter were MNOK 14.0 versus MNOK 9.4 in 4Q22, corresponding to a 49% increase. The growth for Cystatin C is driven by continuously higher adoption in clinical routine as well as increased commercial activities of the existing Gentian partners with some competitive gains within the marketplace. Cystatin C sales in Asia grew 43% during the quarter. US sales returned to strong growth associated to further commercial focus by Gentian, with the main contribution from Cystatin C sales.
Sales of fCAL® turbo, which supports fast diagnosis of inflammatory bowel disease, reached MNOK 43.2 in 2023 compared to MNOK 36.3 in 2022, recording a 19% increase in sales. The 4Q23 sales were MNOK 13.6 compared to MNOK 11.7 in 4Q 2022, a 16% increase vs 4Q22. Record quarterly sales for fCAL® turbo are well in line with the overall trend of continued implementation in routine core lab testing, but also due to deliveries from a 3Q order backlog. The Calprotectin fecal testing market growth is also attracting new players in the market. Gentian's strategic collaboration with Bühlmann Labs, which enables a fully automated solution, is a key factor to secure a strong market position going forward.
The launch of the RBP assay in 3Q23 sparked interest among distributors and IVD partners, leading to increased engagement in 4Q23 with the aim of generating initial revenues in the first half of 2024.
The company's Swedish distribution subsidiary, Gentian Diagnostics AB (GAB), continues to demonstrate a strong positive sales trend for third-party products and for the Gentian portfolio. Revenue from third-party distribution amounted to MNOK 17.0 in 2023 versus MNOK 10.2 in 2022 and MNOK 4.8 in 4Q23
representing an increase of 96% compared to 4Q22. The sales growth is a result of an increasing number of customers, including recently acquired large customers in Norway and Sweden and their routine implementation of products offered by GAB.
Gentian is being recognised by its customers and partners for providing web-based digital documentation services as it enables them a faster and more productive test implementation into clinical routine. In addition, educational content for the Gentian product portfolio was provided via Gentian's Website to support clinicians and laboratory professionals in the best possible use of Gentian's products.
Results from clinical studies continue to support the value of GCAL® in early diagnosis of bacterial infections and prediction of clinical deterioration. Data analysis from two studies performed in adult and paediatric patients are finalised and submitted for publication.
There is an increased interest in the GCAL® immunoassay and growing evidence for use of the calprotectin biomarker in autoimmune diseases, including rheumatic diseases in children and adults. Several studies have confirmed the role of GCAL® in estimation of disease activity and inflammatory response. Gentian has, in collaboration with a leading expert in the field, initiated a study to explore the role of GCAL® in assessment of disease activity and prediction of severe inflammatory response in Hidradenitis suppurativa, a chronic, inflammatory skin disease. The aim of the study is to explore if GCAL® can be used as an indicator for early start of biological treatment and monitoring of treatment response.
Gentian attended a seminar in Slovakia to present and discuss the use of GCAL® in autoimmune diseases, including rheumatoid arthritis in adults and juvenile idiopathic arthritis in children. The value of the assay in estimation of disease severity and early detection of inflammation has been confirmed by several speakers and routine users attending the seminar.
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 analysers, which will increase laboratory productivity and reduce overall costs. The growing cost burden in healthcare systems due to an aging population and lifestyle choices is driving an increase in the demand for NTproBNP testing.
In the fourth quarter, Gentian continued the noteworthy progress on the technical front. The current prototype has successfully reproduced the results from earlier investigations, which is the basis for the finalization of the optimization phase.
Simultaneously, preparations for production scalability experiments were initiated during the quarter. These experiments aim to evaluate the efficiency of the preferred manufacturing process at elevated volumes.
On the clinical side, the team tested the initial clinical performance of the prototype by using blood samples from patients with confirmed heart failure. As described in earlier reports, the NT- proBNP assay is a tool to assist in the diagnosis of heart failure, including fast and accurate exclusion of congestive heart failure. While the preliminary results show promise, Gentian acknowledges the need for more extensive testing to confirm these findings. Furthermore, additional clinical data is deemed essential to meet regulatory requirements ahead of the anticipated product launch.
Notwithstanding the continuous progress, the company is still 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 fall under the new IVDR regulatory regime, which will add an additional 6-9 months before commercial launch.
The company is currently overseeing two projects in the proof-of-concept stage where one project is in close collaboration with a major IVD player. Gentian's ongoing pipeline activities are progressing through various stages, with decisions to advance into proof-of-concept phases being influenced by both business and technology considerations.
Additionally, Gentian is actively exploring external technologies that will enable it to fulfill its strategic objectives.
Gentian is continuously considering possibilities related to insourcing of products developed by partners which could be manufactured and sold by Gentian.
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 a quarterly record of MNOK 37.8 (MNOK 30.9) for 4Q23. Total operating revenue for the full year of 2023 amounted to MNOK 142.3 (MNOK 111.9).
Sales revenue increased by 34% to MNOK 37.5 in 4Q23 (MNOK 27.9), with organic revenue growth of 23%. Sales revenue in 2023 increased 33% with organic revenue growth of 21%.
Revenue from the US market was MNOK 2.0 for 4Q23 (MNOK 1.1), and MNOK 8.7 in 2023 (MNOK 6.5). Europe recorded strong growth in revenues compared to the same quarter last year, increasing 36% to MNOK 26.5 in the quarter (MNOK 19.6) and grew 30% to MNOK 92.8 (MNOK 71.2) in total in 2023. Sales to Asia grew 22% in 4Q23 compared to the fourth quarter last year and demonstrated strong growth of 43% for the full year 2023 versus 2022.
| MNOK | 4Q23 | 4Q22 | 2023 | 2022 |
|---|---|---|---|---|
| US | 2.0 | 1.1 | 8.7 | 6.5 |
| Europe | 26.5 | 19.6 | 92.8 | 71.6 |
| Asia | 8.9 | 7.3 | 33.7 | 23.6 |
| Total | 37.5 | 27.9 | 135.2 | 101.6 |
The portfolio overall continues to grow according to Gentian's strategy and long-term growth plan. The sales of Cystatin C grew by 49% in the fourth quarter of 2023. Strong growth was achieved in all geographies. Sales of fCAL turbo experienced a 16% increase in sales for 4Q23 compared to 4Q22. 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 100% in 4Q23 compared to 4Q22 and full year growth of 67% in 2023 versus 2022.
| MNOK | 4Q23 | 4Q22 | 2023 | 2022 |
|---|---|---|---|---|
| Cystatin C | 14.0 | 9.4 | 56.3 | 40.0 |
| fCAL®turbo | 13.6 | 11.7 | 43.2 | 36.3 |
| Third party products | 4.8 | 2.4 | 17.0 | 10.2 |
| Other | 5.1 | 4.3 | 18.6 | 15.2 |
| Total | 37.5 | 27.9 | 135.2 | 101.6 |
Approximately 78% (85%) of the sales revenue in the quarter come from long-term contracts with established customers.
Other operating revenue ended at MNOK 0.3 (MNOK 3.0) for 4Q23, and MNOK 7.2 (MNOK 10.3) for 2023. This consists of public grants related to the company's R&D projects and bad will related to the acquisition of the shares in Getica AB.
Cost of goods sold (COGS) was 55% (50%) of sales revenue in 4Q23, and 49% (52%) in 2023. Although the trend over the last year has been positive, the increase in 4Q23 compared to the previous quarters is due to irregularities in some raw materials which resulted in products not reaching the quality specifications and subsequently had to be scrapped. The estimated effect of these quality issues is estimated to MNOK 1.8 on COGS in 4Q 2023. Gentian expects further increases in raw material prices and labour cost, 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 19.6 (MNOK 20.2) in 4Q23.
R&D expenses amounted to 43% (40%) of total other operating expenses before capitalization in 4Q23. Capitalisation of R&D expenses was MNOK 1.3 (MNOK 1.7) in the quarter.
Total other operating expenses after capitalisation of R&D expenses was MNOK 18.3 (MNOK 18.5) in 4Q23.
Operating profit before depreciation and amortization (EBITDA) ended at MNOK -1.0 (MNOK -1.5) for 4Q23 and MNOK 3.3 (MNOK -13.0) for the full year 2023. Net profit was MNOK -9.8 (MNOK -4.6), and MNOK -10.4 (MNOK -23.6) for 2023.
During the quarter, the company decided to discontinue the sales of the SARS Cov-2 AB assay. At this point the company does not foresee a positive change in the current market environment and considers sales opportunities of this assay to be limited. As a result of the decision to discontinue the sale of the assay, the company has written down intangible assets by MNOK 6.5.
The impairment does not have a cash effect.
Cash and cash equivalents as of 31 December 2023 were MNOK 87.6 (MNOK 81.6). The cash is placed in both savings accounts and current accounts.
Accounts receivables as of 31 December 2023 were MNOK 11.5 (MNOK 10.1), and inventory MNOK 37.1 (MNOK 38.5).
The equity ratio was 81.4% as of 31 December 2023.
There are no events after the balance sheet date.
| Note | 2023 | 2022 | 2023 | 2022 | |
|---|---|---|---|---|---|
| (NOK 1000) | Q4 | Q4 | 01.01- 31.12 |
01.01- 31.12 |
|
| Revenue | |||||
| Revenue from contracts with customers | 3 | 37 466 | 27 911 | 135 153 | 101 636 |
| Other operating revenue | 4,14 | 334 | 2 959 | 7 193 | 10 287 |
| Total revenue | 37 800 | 30 870 | 142 347 | 111 922 | |
| Operating expenses | |||||
| Cost of goods sold | 6 | -20 501 | -13 849 | -66 750 | -52 635 |
| Employee benefit expenses | 7,13 | -11 902 | -10 324 | -47 352 | -40 910 |
| Depreciation and amortisation | -2 419 | -2 767 | -9 566 | -10 243 | |
| Impairment | 9 | -6 469 | - | -6 469 | - |
| Other operating expenses | -6 383 | -8 201 | -24 972 | -31 369 | |
| Total operating expenses | 5 | -47 674 | -35 141 | -155 109 | -135 158 |
| Operating result | -9 875 | -4 271 | -12 762 | -23 235 | |
| Finance income | 1 081 | -911 | 5 807 | 3 831 | |
| Finance cost | -998 | 557 | -3 402 | -4 213 | |
| Net financial items | 83 | -354 | 2 405 | -382 | |
| Profit before tax | -9 791 | -4 625 | -10 357 | -23 618 | |
| Income tax expense | |||||
| Profit for the period | - -9 791 |
- -4 625 |
- -10 357 |
- -23 618 |
|
| Other comprehensive income | |||||
| Exchange differences | 299 | 114 | 81 | -331 | |
| Total other comprehensive income | 299 | 114 | 81 | -331 | |
| Total comprehensive income for the period |
-9 492 | -4 512 | -10 276 | -23 949 |
4 th quarter Statement of Profit and Loss is not audited
| Note | 2023 | 2022 |
|---|---|---|
| (Figures in NOK thousands) | 31.12 | 31.12 |
| Assets | ||
| Non-Current Assets | ||
| Intangible assets 9 |
21 158 | 26 820 |
| Property, plants and equipment | 7 751 | 9 251 |
| Right-of-use assets | 10 294 | 12 386 |
| Financial assets | 149 | - |
| Total Non-Current Assets | 39 352 | 48 458 |
| Current Assets | ||
| Inventory | 37 116 | 38 544 |
| Accounts receivables and other receivables | 16 477 | 19 188 |
| Cash and cash equivalents | 87 642 | 81 599 |
| Total Currents Assets | 141 235 | 139 332 |
| Total Assets | 180 587 | 187 790 |
| Equity and liabilities | ||
| Paid-in equity | ||
| Share capital 11 |
1 542 | 1 542 |
| Share premium | 302 244 | 302 244 |
| Other paid-in equity | 16 984 | 13 946 |
| Total paid-in equity | 320 771 | 317 732 |
| Retained earning | ||
| Retained earning | -173 839 | -163 562 |
| Total retained equity | -173 839 | -163 562 |
| Total equity | 146 932 | 154 170 |
| Liabilities | ||
| Lease liabilities 10 |
9 006 | 11 624 |
| Total non-current liabilities | 9 006 | 11 624 |
| Current liabilities | ||
| Accounts payable and other current liabilities | 24 648 | 21 996 |
| Total current liabilities | 24 648 | 21 996 |
| Total liabilities | 33 655 | 33 620 |
| Total equity and liabilities | 180 587 | 187 790 |
4 th quarter Statement of Financial Position is not audited
(figures in NOK thousands)
| Other | ||||||
|---|---|---|---|---|---|---|
| Share | Share | paid-in | Retained | Translation | Total | |
| capital | premium | capital | earnings | differences | equity | |
| Equity at 01.01.2022 | 1 542 | 302 244 | 10 593 | -139 433 | -180 | 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 comprehensive income | -331 | -331 | ||||
| Equity at 31.12.2022 | 1 542 | 302 244 | 13 946 | -163 051 | -511 | 154 170 |
| Equity at 01.01.2023 | 1 542 | 302 244 | 13 946 | -163 051 | -511 | 154 170 |
| Net result for the year | -10 357 | -10 357 | ||||
| Other comprehensive income | ||||||
| Proceeds from share issue | ||||||
| Cost of share issue | ||||||
| Share based payments | 3 038 | 3 038 | ||||
| Other comprehensive income | 81 | 81 | ||||
| Equity at 31.12.2023 | 1 542 | 302 244 | 16 984 | -173 408 | -430 | 146 932 |
4 th quarter Statement of changes in equity has been corrected according to the groups actual split in equity. The Statement of changes in equity is not audited.
| 2023 | 2022 | 2023 | 2022 | |
|---|---|---|---|---|
| (NOK 1000) | Q4 | Q4 | 01.01- 31.12 |
01.01- 31.12 |
| Operating activities | ||||
| Net profit (loss) | -9 791 | -4 625 | -10 357 | -23 618 |
| Depreciation and amortisation | 2 419 | 2 767 | 9 566 | 10 243 |
| Impairment | 6 469 | - | 6 469 | - |
| Gain on bargain purchase | - | - | -892 | - |
| Change Inventory | 4 030 | -3 208 | 2 692 | -8 765 |
| Change Accounts Receivables | 4 947 | -5 567 | -1 158 | -3 550 |
| Change Accounts Payables | -862 | -887 | -878 | -532 |
| Accrued cost of options | 755 | 894 | 3 038 | 3 353 |
| Change in other assets and liabilities | 5 716 | 168 | 6 971 | 8 917 |
| Net cash flow from operating activities | 13 684 | -10 458 | 15 451 | -13 952 |
| Investing activities | ||||
| Payments of property, plant and equipment | -222 | -670 | -955 | -8 637 |
| Investment in intangible assets | -1 318 | -453 | -3 532 | -6 029 |
| Purchase of shares in other companies net of cash acquired |
- | - | -390 | - |
| Net cash flow from investing activities | -1 541 | -1 123 | -4 877 | -14 666 |
| Financing activities | ||||
| Lease payments | -1 157 | -812 | -4 598 | -4 325 |
| Proceeds from issue of share capital | - | - | - | - |
| Net cash flow from financing activities | -1 157 | -812 | -4 598 | -4 325 |
| Net change in cash and cash equivalent | 10 987 | -12 394 | 5 976 | -32 943 |
| Cash and cash equivalents at beginning of period | 76 393 | 93 880 | 81 599 | 114 936 |
| Effect of currency translation of cash and cash equivalents |
262 | 114 | 67 | -395 |
| Net Cash and cash equivalents at period end | 87 642 | 81 599 | 87 642 | 81 599 |
4 th quarter Cash Flow Statement is not audited Notes
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 subsidiaries Gentian AS and Getica AB, located in Norway and Sweden.
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 and the central bank of Norway (Norges Bank).
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 of 31 December 2023, Gentian AS, located in Moss, Norway and Getica AB, located in Gothenburg, Sweden, are 100% owned and controlled subsidiaries.
| Revenue by classification | 4Q23 | 4Q22 | 2023 | 2022 |
|---|---|---|---|---|
| Sales revenue | 37 466 | 27 911 | 135 153 | 101 636 |
| Public grants | 186 | 2 959 | 6 154 | 10 287 |
| Other revenue | 148 | - | 1 040 | - |
| Total | 37 800 | 30 870 | 142 347 | 111 922 |
| Sales revenue Geographical split |
4Q23 | 4Q22 | 2023 | 2022 |
| Europe | 26 530 | 19 555 | 92 757 | 71 571 |
| Asia | 8 893 | 7 271 | 33 673 | 23 609 |
| USA | 2 043 | 1 085 | 8 722 | 6 456 |
| Total | 37 466 | 27 911 | 135 153 | 101 636 |
| Sales revenue by product category |
4Q23 | 4Q22 | 2023 | 2022 |
| Renal diagnostic products | 14 014 | 9 417 | 56 321 | 39 966 |
| Inflammation diagnostic products |
15 881 | 13 563 | 51 770 | 42 886 |
| Other diagnostic products | 7 572 | 4 932 | 27 062 | 18 784 |
| Total | 37 466 | 27 911 | 135 153 | 101 636 |
Gentian has recognised public grants from the Norwegian Research Council, Innovation Norway, Eurostars and SkatteFUNN.
| 4Q23 | 4Q22 | 2023 | 2022 | |
|---|---|---|---|---|
| Norwegian Research Council and Eurostars |
-34 | 1 652 | 3 952 | 6 298 |
| Innovation Norway | - | - | - | - |
| SkatteFUNN | 220 | 1 307 | 2 202 | 3 989 |
| Total | 186 | 2 959 | 6 154 | 10 287 |
| 4Q23 | 4Q22 | 2023 | 2022 | |
|---|---|---|---|---|
| Cost of goods sold | 20 501 | 13 849 | 66 750 | 52 635 |
| Sales and marketing expenses | 5 924 | 6 324 | 22 516 | 21 490 |
| Administration expenses | 5 337 | 5 788 | 24 796 | 27 973 |
| Research and development expenses | 7 024 | 6 412 | 25 012 | 22 817 |
| Depreciation | 2 419 | 2 767 | 9 566 | 10 243 |
| Impairment | 6 469 | - | 6 469 | - |
| Total | 47 674 | 35 141 | 155 109 | 135 158 |
| 4Q23 | 4Q22 | 2023 | 2022 | |
|---|---|---|---|---|
| Change in inventory of goods under manufacture and finished goods |
-640 | 969 | -2 410 | 1 368 |
| Purchase of goods | 12 455 | 6 081 | 39 971 | 24 412 |
| Production salary | 6 697 | 5 577 | 23 443 | 20 978 |
| Other production expense | 1 988 | 1 222 | 5 746 | 5 877 |
| Total | 20 501 | 13 849 | 66 750 | 52 635 |
| 4Q23 | 4Q22 | 2023 | 2022 | |
|---|---|---|---|---|
| Wages and salaries | 14 064 | 12 319 | 54 203 | 48 456 |
| Payroll tax | 2 583 | 1 777 | 8 660 | 5 876 |
| Pension costs (mandatory occupational pension) |
650 | 839 | 3 075 | 3 171 |
| Share based payments | 755 | 894 | 3 038 | 3 353 |
| Other expenses | 547 | 71 | 1 819 | 1 032 |
| Transfer to COGS | -6 697 | -5 577 | -23 443 | -20 978 |
| Total | 11 902 | 10 324 | 47 352 | 40 910 |
The Gentian Group has per 31 December 2023 three ongoing R&D projects. Costs related to the projects consist of salary, external procurement of services, and other operating expenses. One of the projects went over in the development phase in 2021, and consequently the capitalisation of the costs on this project was started. In addition, the R&D department is responsible for application validation.
| Recognised research and development expenses |
4Q23 | 4Q22 | 2023 | 2022 |
|---|---|---|---|---|
| Purchase of external services | 1 803 | 2 664 | 5 700 | 7 972 |
| Salary and other operating expenses | 6 540 | 5 403 | 22 843 | 20 873 |
| Capitalised research and development expenses |
-1 318 | -1 654 | -3 532 | -6 029 |
| Total | 7 024 | 6 412 | 25 012 | 22 817 |
As of 31 December 2023, the recognised intangible assets in the Group amounts to MNOK 21.1. 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.
As per 31 December 2023, the company has fully impaired the capitalised amounts related to SARS Cov-2 AB (MNOK 6.469).
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 4Q23.
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 December 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 Invest AS | 1 228 502 | 7.97 % |
| Verdipapirfondet Delphi Nordic | 959 272 | 6.22 % |
| Safrino AS | 749 700 | 4.86 % |
| Carpe Diem Afseth AS | 548 389 | 3.56 % |
| Skandinaviska Enskilda Banken AB | 436 251 | 2.83 % |
| Verdipapirfondet DNB SMB | 361 291 | 2.34 % |
| J.P. Morgan SE | 350 000 | 2.27 % |
| Viola AS | 320 916 | 2.08 % |
| Verdipapirfondet Storebrand Vekst | 311 308 | 2.02 % |
| Portia AS | 300 000 | 1.95 % |
| Krefting, Johan Henrik | 292 400 | 1.90 % |
| Intertrade Shipping AS | 257 716 | 1.67 % |
| Cressida AS | 235 000 | 1.52 % |
| Lioness AS | 220 000 | 1.43 % |
| Marstal AS | 212 407 | 1.38 % |
| Mutus AS | 210 465 | 1.36 % |
| Salix AS | 208 954 | 1.35 % |
| Verdipapirfondet Delphi Kombinasjon | 196 577 | 1.27 % |
| Other Shareholders | 4 289 610 | 27.81 % |
| Total Shares | 15 422 350 | 100.00% |
| 4Q23 | 4Q22 | 2022 | |
|---|---|---|---|
| Earnings/ loss (-) for the period | -9 791 372 | -4 625 422 | -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 | -0.64 | -0.30 | -1.53 |
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 December 2023, fourteen 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 and 2023, 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.
| 4Q23 | 4Q22 | 2023 | 2022 | |
|---|---|---|---|---|
| Outstanding options at beginning of period | 785 632 | 740 590 | 960 586 | 740 590 |
| Options granted | 339 962 | 219 996 | 339 962 | 219 996 |
| Options forfeited | - | - | - | - |
| Options terminated | -10 000 | - | -10 000 | - |
| Options expired | - | - | -174 954 | - |
| Outstanding options at end of period | 1 115 594 | 960 586 | 1 115 594 | 960 586 |
The outstanding options are subject to the following conditions:
| Expiry date | Average strike price | Number of share options |
|---|---|---|
| 2024-11 | 47.51 | 259 962 |
| 2025-11 | 62.88 | 150 000 |
| 2026-11 | 72.60 | 155 674 |
| 2027-12 | 46.67 | 209 996 |
| 2028-11 | 40.17 | 339 962 |
| 1 115 594 |
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 (42.21%), expected dividend yield (0%), an expected term of 5 years, and annual risk-free interest rate (3.681%). The volatility is based on other comparable companies' stock price volatility.
On 3 July 2023 Gentian Diagnostics ASA acquired 100 % of the shares in Getica AB for a cash consideration of NOK 2.78 million. Getica AB, located in Gothenburg Sweden, has been providing Gentian with antibody purification services through many years in addition to providing diagnostics research and development services. Through this acquisition, Gentian secures critical production competence in an essential step in the manufacturing process. Gentian will also gain access to unique R&D capabilities.
Getica AB was owned by Erling Sundrehagen, who also is the sole owner of Vingulmork Predictor AS.
The acquisition was financed in cash. The fair values of the identifiable assets and liabilities of the business as at the acquisition date are as follows.
| Getica AB | |
|---|---|
| (Figures in NOK thousands) | |
| Assets | |
| Non-Current Assets | |
| Property, plants and equipment | 399 |
| Financial assets | 146 |
| Total Non-Current Assets | 545 |
| Current Assets | |
| Inventory | 1 264 |
| Accounts receivables and other receivables | 508 |
| Cash and cash equivalents | 2 388 |
| Total Currents Assets | 4 160 |
| Total Assets | 4 705 |
| Net decrease in cash | -390 |
|---|---|
| Cash received | 2 388 |
| Paid in cash | -2 778 |
| Total consideration for the shares | 2 778 |
| Badwill | -892 |
| Net identifiable assets and liabilities at fair value | 3 670 |
| Total current liabilities | 1 035 |
| Accounts payable and other current liabilities | 1 035 |
| Current liabilities |
For the fourth quarter of 2023, Getica AB have contributed with 0 NOK to the group's sales revenues and NOK -3.0 million to profit before tax. If the business combination had taken place at the beginning of the year, the group's revenues would have been NOK 135.2 million and profit before tax for the group would have been NOK -7.4 million.
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 December 2023 is estimated to NOK 211 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 | 4Q23 | 4Q22 | 2023 | 2022 |
|---|---|---|---|---|
| (NOK 1000) | ||||
| Revenue from contracts with customers | 37 466 | 27 911 | 135 153 | 101 636 |
| Revenue growth | 9 554 | 6 194 | 33 517 | 18 538 |
| Impact using exchange rates from last period |
-3 266 | -1 254 | -11 887 | -1 750 |
| Impact M&A | - | - | - | - |
| Organic revenue growth | 6 289 | 4 940 | 21 630 | 16 788 |
| Organic revenue growth % | 23 % | 23 % | 21 % | 20 % |
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 | 4Q23 | 4Q22 | 2023 | 2022 |
|---|---|---|---|---|
| (NOK 1000) | ||||
| Employee benefit expenses | 11 902 | 10 324 | 47 352 | 40 910 |
| Other operating expenses | 6 383 | 8 201 | 24 972 | 31 369 |
| Total other operating expenses after capitalisation of R&D expenses |
18 285 | 18 525 | 72 323 | 72 279 |
| Capitalisation | 1 318 | 1 654 | 3 532 | 6 029 |
| Total other operating expenses before capitalisation of R&D expenses |
19 603 | 20 179 | 75 855 | 78 308 |
| Reconciliation | 4Q23 | 4Q22 | 2023 | 2022 |
|---|---|---|---|---|
| (NOK 1000) | ||||
| Other non-salary related operating expenses after capitalisation of R&D expenses |
6 383 | 8 201 | 24 972 | 31 369 |
| Capitalisation | 371 | 414 | 1 348 | 2 336 |
| Other non-salary related operating expenses before capitalisation of R&D expenses |
6 754 | 8 614 | 26 320 | 33 705 |
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 | 4Q23 | 4Q22 | 2023 | 2022 |
|---|---|---|---|---|
| (NOK 1000) | ||||
| Total Revenue | 37 800 | 30 870 | 142 347 | 111 922 |
| Total Operating Expenses | -47 674 | -35 141 | -155 109 | -135 158 |
| EBIT | -9 875 | -4 271 | -12 762 | -23 235 |
| Depreciation and Amortisation | 2 419 | 2 767 | 9 566 | 10 243 |
| Impairment | 6 469 | - | 6 469 | - |
| EBITDA | -986 | -1 504 | 3 273 | -12 992 |
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.
| 4Q23 | 4Q22 | 2023 | 2022 | |
|---|---|---|---|---|
| (NOK 1000) | ||||
| Revenue from contracts with customers | 37 466 | 27 911 | 135 153 | 101 636 |
| COGS | 20 501 | 13 849 | 66 750 | 52 635 |
| COGS % of Revenue from contracts with customers |
55 % | 50 % | 49 % | 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.
| 4Q23 | 4Q22 | 2023 | 2022 | |
|---|---|---|---|---|
| (NOK 1000) | ||||
| Non-cash shared-based compensation | 755 | 894 | 3 038 | 3 353 |
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