Key regulatory approval milestones passed
Second quarter, 1 August - 31 October 2024
- Net sales amounted to SEK 1,855k (2,890k).
- Operating result (EBIT) amounted to SEK -6,007k (-3,409k).
- Net result for the period amounted to SEK-5,951k (-3,256k).
- Earnings per share before dilution amounted to SEK -1.48 (-0.81). Earnings per share after dilution amounted to SEK -1.48 (-0.81).
- Cash flow from operating activities amounted to SEK -6,145k (-4,143k).
- Net cash flow amounted to SEK -9,537k (-11,560k).
We have passed two important milestones regarding regulatory approval. The technical documentation has been approved and we have also resolved outstanding deviations from the review of our quality system (ISO 13485) which was done in July and August.
First half year, 1 May - 31 October 2024
- Net sales increased to SEK 3,530k (6,317k).
- Operating result (EBIT) amounted to SEK -13,627k (-8,821k).
- Net result for the period amounted to SEK -13,480k (-8,255k).
- Earnings per share amounted to -3.35 (-2.05) SEK. Earnings per share after dilution amounted to -3.35 (-2.05) SEK.
- Cash flow from operating activities amounted to SEK -3,665k (-10,013k).
- Net cash flow amounted to SEK -9,746k (-23,930k).
CEO's statement
During the quarter, we have continued to focus on the CE marking of Qlucore Diagnostics for leukemia and passed two important milestones. The technical documentation has been approved and we have also resolved outstanding deviations from the review of the quality management system that was carried out in July and August. We are now awaiting the final decision and the sales launch for clinical use is still estimated to be February 2025. The sales launch for clinical use is still estimated to be February 2025. Our solution enables, the classification of subgroups within different forms of cancer with the aim of improving diagnostics and treatment. We remain unaware of any other IVDR-approved software in this area.
Net sales during the second quarter amounted to SEK 1,855 (2,890) k, which is a decrease of 36 percent. Differences between quarters occur, and this quarter the difference is largely due to the fact that during the corresponding quarter last year, an unusually large number of multi-year deals were completed, involving agreements where the license period extends over several years. In the case of sales of multi-year licenses, these are not accrued, but the entire sales sum affects the revenue in the quarter in which they are invoiced, whereby the revenue can vary greatly between quarters. The transactions are booked on the invoicing date and thus affect the first quarter of the previous year positively and the current quarter negatively.
After the end of the period, in November we launched a new version of Qlucore Omics Explorer. The updates mean significantly improved functionality for analyzing and visualizing integer data. A function growth that is in demand by our customers.
Diagnostics
Sales and marketing are actively underway with both the leukemia model and the lung cancer model. We work both with direct sales to the target group and marketing through, for example, presentations at scientific conferences. During the quarter, we also carried out a European campaign linked to Qlucore Insights with a focus on Germany, Benelux and Italy. In September we exhibited at the European Society for Medical Oncology (ESMO) conference in Barcelona to show the lung model to a wider audience.
We have also presented results at two conferences. At "The Molecular Analysis for Precision Oncology Congress 2024", in London, England, the lung cancer model was presented in a scientific poster. The results show that Qlucore Insights can effectively analyze lung samples and help classify them. The results were produced together with our partner, the Institute of Pathology in Heidelberg and the main author is Alejandro Pallares Robles. The model enables the identification of different forms of lung cancer and the determination of whether it is a metastasis.
We also presented results for the pediatric leukemia model (BCP-ALL) at the "AACR special conference in cancer research: advances in pediatric cancer research", which was held in Toronto, Canada.
According to the IVDR regulations for medical devices, the process of achieving CE marking is a requirement to be used for diagnostics in healthcare. Given the positive feedback from our contracted Notified Body (BSI), the focus is now on preparing for launch and completing final verifications pending the formal certificate. Estimated time for regulatory approval (CE marking) for childhood acute lymphoblastic leukemia (BCP-ALL) is February 2025. For future models, we also envision a high degree of reuse of the investments already made in Qlucore Diagnostics.
The work on the lung cancer, bladder cancer and adult acute myeloid leukemia (AML) projects is also ongoing. All forms of cancer represent strategically important therapeutic areas with great medical needs for improved diagnostics.
The two EU-funded projects in cardiovascular diseases continue to develop positively, further illustrating that our solutions are relevant for many different disease areas.
Global landscape
Global uncertainty with the deteriorating geopolitical situation and the weak economy, has not affected operations during the period, as far as we can judge.
___________________
Our technical and regulatory position is good. To be able to scale up quickly and ensure long-term development, we are evaluating both strategic and operational alternatives as well as different financing solutions to secure liquidity.
Carl-Johan Ivarsson, CEO
Certified Advisor
FNCA Sweden AB
Web: www.fnca.se
Contacts
Press contact:
Michael Bull
Brookscomm
Phone: +44 (0) 1483 537 890
Email: michael@brookscomm.com
Qlucore contact:
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 2024-11-28 18:30 CET.
