First quarter, 1 May - 31 July 2023

• Net sales amounted to SEK 3,427k (2,673k).
• Operating result (EBIT) amounted to SEK -5,413k (-4,872k).
• Net result for the period amounted to SEK -5,000k (-4,832k).
• Earnings per share amounted to SEK -1.24 (-1.20). Earnings per share after dilution amounted to SEK -1.24 (-1.20).
• Cash flow from operating activities amounted to SEK -5,870k (-3,847k).
• Net cash flow amounted to SEK -12,370k (-6 936k).
• Focus on the CE marking of Qlucore Diagnostics (childhood leukemia) which is expected to be obtained in February 2025.
• Receives a grant of SEK 200k from Vinnova via the strategic innovation program Medtech4Health for cybersecurity testing of Qlucore Diagnostics.
• Prioritization and optimization, and the fact that development costs culminate this fiscal year (23/24), will facilitate significantly lower costs next fiscal year (24/25).

CEO’s statement
During the quarter, we had good sales in the data analysis area. The product development in cancer diagnostics is going well. Within the cancer diagnostics area, we have the products Qlucore Insights for research applications and Qlucore Diagnostics for clinical diagnostics.

The work to prepare Qlucore Diagnostics for CE marking according to the IVDR regulations is ongoing. Our initial focus remains on acute lymphoblastic leukemia (BCP-ALL), the most common childhood cancer. CE marking according to the IVDR regulations for medical devices is a requirement for use of diagnostics in healthcare.

We have great confidence in our strategy. To conserve existing resources and compensate for the time delay previously communicated, we will focus on the four cancer types where we have progressed the most. These consist of childhood and adult leukemia, bladder cancer and lung cancer. These forms of cancer all represent strategically important therapeutic areas with a great medical need for improved diagnostics. Estimated date of regulatory approval (CE marking) for acute lymphoblastic leukemia (BCP-ALL) is February 2025.

The comprehensive work on the first generation of Qlucore Diagnostics includes three development subprojects. The Qlucore Diagnostics software, the specific model for acute lymphoblastic leukemia and the associated mandatory quality system. Work on all three subprojects culminate in the coming six months. Together with prioritization and optimization, the effect will be significantly lower costs next fiscal year. This is because large parts of completed work can be reused for future CE marking of diagnostic solutions for adult leukemia as well as bladder cancer and lung cancer.

Net sales increased by 24% to SEK 3,427k (2,763k). Adjusted for currency effects, the increase was 19%. The operating result for the first quarter amounted to SEK -5,413k (-4,872k), which is mainly explained by higher costs as the execution of the business plan within cancer diagnostics continues. It includes the development of Qlucore Diagnostics and Qlucore Insights products.

Cancer diagnosis
Together with partners, we continue to develop and refine diagnostic tests (models) for lung cancer, bladder cancer, acute lymphoblastic leukemia (BCP-ALL) and adult acute myeloid leukemia (AML). Models for all four areas are available for use in the Qlucore Insights product and the acute lymphoblastic leukemia model has already been sold to several customers.
 
During the quarter, we have carried out successful data security tests (cybersecurity) with the help of an external independent party. This is a mandatory part of the CE marking work by Qlucore Diagnostics. For the testing, during the quarter we received a grant of SEK 200k from Vinnova via the strategic innovation program Medtech4Health.
  
Global landscape
We still see no direct impact from the ongoing
war in Ukraine, nor do we have customers or suppliers in Russia.
 
Global economic trends, such as rising inflation
and the risk of recession, have 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.
 
The EU changed the timetable for how the IVDR[1] is to be introduced in December 2021 and we are experiencing a certain caution in the market regarding new technology. Some stakeholders also expect more changes.
 
I am very satisfied to state that our development work is going well, and I look with great confidence to the future.
 
Carl-Johan Ivarsson
CEO


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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