Qlucore Diagnostics approved and CE-marked
Third quarter, 1 November 2024 - 31 January 2025
- Net sales amounted to SEK 3,217k (4,835k).
- Operating result (EBIT) amounted to SEK -5,091k (-2,999k).
- Net result for the period amounted to SEK -5,118k (-2,758k).
- Earnings per share before dilution amounted to SEK -1.27 (-0.68). Earnings per share after dilution amounted to SEK -1.27 (-0.68).
- Cash flow from operating activities amounted to SEK -5,542k (-4,742k).
- Net cash flow amounted to SEK -7,232k (-10,811k).
- In November, we launched Qlucore Omics Explorer version 3.10. The new version includes a comprehensive suite of new statistical methods from the DESeq2 family of methods, enabling flexible and easy analysis of multi-omics data.
- Work to strengthen liquidity is ongoing. Without a significant capital injection, the continued operation of the company cannot be ensured. Liquidity is expected to last until the summer.
- After the reporting period. In February, we had our quality system approved according to ISO 13485, and we received IVDR approval for Qlucore Diagnostics BCP-ALL 1.0 and it is now CE marked. Marketing and sales activities started immediately.
First nine months, 1 May 2024 - 31 January 2025
- Net sales amounted to SEK 6,747k (11,152k).
- Operating result (EBIT) amounted to SEK -18,718k (-11,821k).
- Net result for the period amounted to SEK -18,597k (-11,013k).
- Earnings per share amounted to -4.62 (-2.73) SEK. Earnings per share after dilution amounted to -4.62 (-2.73) SEK.
- Cash flow from operating activities amounted to SEK -9,207k (-14,755k).
- Net cash flow amounted to SEK -16,978k (-34,742k).
- Liquid funds amounted to SEK 11,702k on the closing day.
CEO's statement
After the end of the period, we received approval and certification of Qlucore Diagnostics BCP-ALL 1.0 and of our quality system according to ISO 13485. This means that we were able to immediately start sales and marketing. Market development is ongoing on a broad front. Introducing new diagnostic tests takes time and we have balanced expectations for how quickly customers will implement our solution. It is a significant milestone that we have now passed. Our product is unique and there are no comparable IVDR-approved products on the market. As planned, we are at the forefront of using genetic information for patient classification in regulatory approved products. We now have a stable platform to broaden the product portfolio to lung cancer, bladder cancer and adult acute myeloid leukemia (AML). A work that is significantly less extensive for each area than for Qlucore Diagnostics 1.0. Lung cancer and bladder cancer are two areas with many annual cases. Our ongoing development for these indications is important to help more patients, which will drive sales and thereby secure opportunities for further product development.
Net sales during the third quarter amounted to SEK 3,217k (4,835k), which is a decrease of 33 percent. It is the sales of Qlucore Omics Explorer that are decreasing the most, while Qlucore Insights is being sold to a lesser extent than planned. Differences between quarters occur, but we also assess that the positive effects of the launch of the latest version of Qlucore Omics Explorer have not met our expectations. For several years, we have prioritized the development of Qlucore Diagnostics to meet the schedule. One effect has been less development resources for Qlucore Omics Explorer, and this is now starting to affect sales. However, the launch of Qlucore Diagnostics means that we once again have greater opportunities to balance development resources in an optimal way between the products.
Our liquidity has deteriorated further following weaker sales in the third quarter. The need for capital injections that we previously announced has become more urgent in this context. The board and management are actively working to secure a significant capital injection to enable continued operations of the company. Liquidity is expected to last until the summer.
Cost savings, mainly in the form of staff and consultant reductions, have been implemented during the period and are estimated to amount to SEK 4,500k on an annual basis. Full effect is expected in the next quarter. In quarter one of the next financial year, additional savings of SEK 600k on an annual basis will be implemented
Diagnostics
Sales and marketing are actively underway with both the leukemia model and the lung cancer model. We have decided to supplement our own sales organization with distributors and agents and the work of identifying and contracting is ongoing.
According to the IVDR regulations for medical devices, the process of achieving CE marking is a requirement to be used for diagnostics in healthcare in Europe.
The degree of reuse, of both documentation and code invested in Qlucore Diagnostics, is high for future diagnostic models. This means that we can work in parallel with the projects in lung cancer, bladder cancer and acute myeloid leukemia in adults (AML). These cancers represent strategically important therapy areas with a large medical need for improved diagnostics. Together, they constitute approximately 16% of all cancer cases. In figures, this amounts to approximately 1 million cases per year in Europe and the USA, increasing to just under 2.5 million when China, India and parts of South America are included.
The two EU-funded projects in cardiovascular diseases continue to develop positively, further illustrating that our solutions are relevant for many different disease areas. The EU has recently approved a comprehensive interim project report.
Global landscape
It is difficult to assess how the geopolitical situation has affected Qlucore's operations during the period. We are experiencing restrictive purchasing behaviours. When possible, customers are also postponing a renewal for a couple of months. There is a clear risk that cuts in American research funding will negatively affect us.
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It has been a significant effort that has required the entire company to deliver Qlucore Diagnostics 1.0 on schedule. Being at the forefront of solutions to improve cancer diagnostics makes us proud and we look forward to future product launches in areas such as lung cancer.
Carl-Johan Ivarsson, CEO
Certified Advisor
FNCA Sweden AB
Web: www.fnca.se
Contacts
Press contact:
Maria Falck Miniotis, Marketing & Communications Manager
Phone: +46 (0) 736 10 26 65
Email: maria.falck@qlucore.com
Carl-Johan Ivarsson, CEO
Phone: +46 (0) 46 286 31 14
Email: carl-johan.ivarsson@qlucore.com
About Qlucore
Qlucore is a leading provider of new generation intuitive bioinformatics software for research and precision and companion diagnostics. Qlucore's mission is to make it easier to analyze the huge amounts of complex data generated by innovations in the fields of genomics and proteomics by providing powerful visualization-based bioinformatics data analysis tools for research and precision diagnostics. Qlucore Omics Explorer software is a easy to use bioinformatics software for research in the life science, plant- and biotech industries, as well as in academia. Qlucore Diagnostics and Qlucore Insights are software platforms with built in AI-based machine learning for multi-omics companion and precision diagnostics. Qlucore was founded in 2007 in Lund, Sweden and has customers in about 25 countries around the world, with sales offices in Europe and North America, and distribution in several countries in Asia. Qlucore is listed on the Nasdaq First North Growth market. www.qlucore.com
This information is information that Qlucore is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-03-26 18:30 CET.
