Qlucore

Third quarter, 1 November 2023 - 31 January 2024

• Net sales amounted to SEK 4,835k (4,289k).
• Operating result (EBIT) amounted to SEK -2,999k (-2,884k).
• Net result for the period amounted to SEK -2,758k (-2,899k).
• Earnings per share amounted to SEK -0.68 (-0.72). Earnings per share after dilution amounted to SEK -0.68 (-0.72).
• Cash flow from operating activities amounted to SEK -4,742k (-3,863k).
• Net cash flow amounted to SEK -10,811k (-14,211k).
• Submission of the technical file for Qlucore Diagnostics including clinical results.
• Lower costs of approximately SEK 2 million on a quarterly basis starting in the fourth quarter.
• After the reporting period. On February 27, Qlucore received notification of a prestigious grant from the EU of SEK 27 million to accelerate clinical cancer diagnostics.

First nine months, 1 May 2023 - 31 January 2024

• Net sales increased to SEK 11,152k (10,074k).
• Operating result (EBIT) amounted to SEK -11,821k (-11,977k).
• Net result for the period amounted to SEK -11,013k (-11,880k).
• Earnings per share amounted to -2.73 (-2.95) SEK. Earnings per share after dilution amounted to -2.73 (-2.95) SEK.
• Cash flow from operating activities amounted to SEK -14,755k (-9,545k).
• Net cash flow amounted to SEK -34,742k (-27,002k).
• Liquid funds amounted to SEK 34,938k on the closing day.
  

CEO’s statement
During the third quarter, we passed several important milestones and stepped closer to launching a product for clinical use in the precision diagnostics of leukemia. Our solution enables the classification of subgroups within cancer diagnostics, which can lead to more effective treatment.

We have submitted the technical documentation to the Notified Body, following an intensive period which has entailed extensive development efforts and related costs. We are now entering a phase with lower costs.

On February 27, we received notification of a prestigious EU grant of SEK 27 million to accelerate clinical cancer diagnostics for bladder cancer and acute myeloid leukemia in adults (AML). We were one of 42 companies out of 1083 applicants, selected for the EIC Accelerator.

This quarter, our solution, Qlucore Insights, which has already been used in clinical research for leukemia, has been sold to Sahlgrenska Hospital. Sales in the data analytics area have been stable and include a large multi-year business agreement with Boehringer Ingelheim.

The submission of the technical documentation is a significant step towards the launch and sale of Qlucore Diagnostics for acute lymphoblastic leukemia. The submission means that we have a fully developed product and that we have performed the clinical evaluation at several sites. The importance of having completed the clinical evaluation should not be underestimated. In addition to the product being technically ready, it also demonstrates our capacity to carry out tests at several different clinical laboratories in accordance with the requirements set for products to be certified for clinical use according to the IVDR. Now we await feedback from our contracted Notified body.

CE marking according to the IVDR regulations for medical devices is a requirement for use in diagnostics in healthcare. The estimated time of regulatory approval (CE marking) for childhood acute lymphoblastic leukemia (BCP-ALL) is February 2025.

Net sales in the third quarter amounted to SEK 4,835k (4,289k), which is an increase of 13%. We have differences between quarters depending on how renewal transactions are distributed. Overall, the positive trend continues and during the first nine months, turnover increased to SEK 11,152k (10,074k), which corresponds to an increase of 11%. Adjusted for currency effects, the increase was 8%.

Cancer diagnosis
The submission of the technical file enables us to shift our development focus to lung cancer, bladder cancer and acute myeloid leukemia in adults (AML). All these cancers represent strategically important therapeutic areas with a great medical need for improved diagnostics. The degree of reuse for future models is significant and together with the priorities and optimizations now implemented, we expect significantly lower costs next business year (24/25). In the coming quarters, we expect our costs to drop by close to SEK 2 million compared to this quarter, and we expect the cost situation to remain at this lower level going forward.
 
The development takes place together with partners. Models for childhood acute lymphoblastic leukemia (BCP-ALL) and the three other areas are available for use in the Qlucore Insights product. The pediatric acute lymphoblastic leukemia model has already been sold to several customers.

Global landscape
Global uncertainty with the deteriorating geopolitical situation and the deteriorating economy, has not affected operations during the period, as far as we can judge. Furthermore, we have noted a growing trend for redundancies in the technology sector, in areas such as biotech, especially in the USA. We have not yet noticed any direct effect, but it is a sign of increased uncertainty.
 
In December 2021, the EU changed the timetable for how the IVDR[1] is to be introduced and there are now updated proposals for the further adjustment of the introduction.
 
I am very pleased to report that we have passed a significant milestone with the submission of the complete technical file for Qlucore Diagnostics for BCP-ALL. The EU grant of SEK 27 million is a significant stamp of quality for us as a company and a confirmation of our strategy and technical solutions. We are now continuing the work with marketing and new models.
 
Carl-Johan Ivarsson
CEO

[1] EU regulation 2017/746 on in vitro diagnostic medical devices (IVDR).