Fourth quarter, 1 February - 30 April 2023

• Net sales amounted to SEK 2,597k (3,593k).
• Operating result (EBIT) amounted to SEK -4,328k (-3,576k).
• Net result for the period amounted to SEK -4,057k (-3,721k).
• Earnings per share amounted to SEK -1.01 (-0.92). Earnings per share after dilution amounted to SEK -1.01 (-0.92).
• Cash flow from operating activities amounted to SEK 1,496 (-1,555k).
• CE marking of Qlucore Diagnostics is expected to be completed in February 2025.
• Four new models for Qlucore Insights for precision and companion diagnostics are available: Acute myeloid leukemia (AML), lung cancer, childhood leukemia (ALL) and bladder cancer.
• A new version for data analysis, Qlucore Omics Explorer, 3.9 has been launched.

1 May - 30 April 2022/2023

• Net sales amounted to SEK 12,672k (14,118k).
• Operating result (EBIT) amounted to SEK –16,305 (-11,491k).
• Net result for the period amounted to SEK -15,936k (-11,663k).
• Earnings per share amounted to SEK -3.96 (-3.50). Earnings per share after dilution amounted to SEK -3.96 (-3.50).
• Cash flow from operating activities amounted to SEK -8,049k (-6,806k).
• Cash and short-term investments amounted to SEK 69,732k (97,969k) on the closing day.
• Grants from the EU and Vinnova of SEK 6,127k have been granted during the year.
• Strengthened organization. Team expansion with four new appointments in marketing and sales and one in the development department.
• The Board of Directors proposal to the general meeting, is that no dividend is distributed for the financial year.

CEO’s statement
During the financial year, we have worked intensively to reach our goals. The focus has been on the CE marking of Qlucore Diagnostics with an emphasis on matching the regulatory requirements. Together with partners, we have continued the work of developing and refining models for diagnostics of lung cancer, leukemia (ALL, AML), breast cancer and bladder cancer. These are important deliveries in precision diagnostics, meaning that customers can now look to evaluate Qlucore Insights in four different areas, two in blood cancer and two for solid tumors. We have also continued work on developing new software versions for the data analysis area. The sales resource has been strengthened with three more people.

Net sales during the year were 10% lower than the last year and amounted to SEK 12,672k (14,118k). The organic decline was 19%. This development was in line with our expectations. Last year we had many multi-year deals with customers in the data analysis area, which were recognized as revenue in their entirety during the first year. In addition, last year we invoiced for a one-off development project in the field of precision diagnostics. The data analysis area still accounts for most net sales. Investments in precision diagnostics entail higher costs, which negatively affects the result and is in line with our business plan.

CE marking
We are on our way to obtaining CE certification for our cancer diagnostic software. BSI (British Standards Institution) has been contracted as a Notified Body to carry out the conformity assessment of Qlucore Diagnostics for Acute Lymphoblastic Leukemia (the most common form of childhood leukemia). BSI will assess the technical documentation according to the IVDR (EU In Vitro Diagnostic Medical Devices Regulation). We expect to obtain the certification in February 2025. The timing is later than previously communicated due to the extensive work required to develop the first IVDR approved Qlucore Diagnostics and the high workload of the Notified Body.

Data analysis
In the data analysis area, we have launched Qlucore Omics Explorer 3.9 – a new version with new plots, faster calculations, and new statistical methods. This version will better support our customers' work. In this area, we have strengthened the sales resources with 1.5 full-time positions in both Europe and the USA.
 
Environmental factors
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. Historically, our customers have not been cyclically sensitive, but that can of course change. We have been able to carry out physical customer visits to a greater extent, especially in Europe, which is positive, but we feel there is a certain permanent caution in the wake of the pandemic. 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 is to be introduced in December 2021 and we are experiencing a certain caution in the market regarding new technology. Some actors also expect more changes. At the same time, authorities are initiating more supervision in the area, for example the Swedish Medicines Agency (Läkemedelsverket), announced in April that they are starting supervision of medical technology software. These are factors that together create a certain uncertainty and inertia.

Organization
During the year, we continued to strengthen the organization in accordance with our business plan. Primarily, we have recruited personnel in marketing and sales.
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It has been an intense year in which we have taken big steps forward. The timetable for the CE marking of Qlucore Diagnostics is set, new Qlucore Insights models have been developed and a new software version of Qlucore Omics Explorer has been launched. Internally, we have strengthened our organization within sales. During the year, we also gratifyingly received grants from the EU and Vinnova totaling SEK 6.1 million, which is truly a strong mark of quality.
 
Carl-Johan Ivarsson
CEO