“It is very gratifying to see the impact that we are having in the field of diagnostics. I have just returned from the ASHI event, a major transplantation conference in the US, and it is clear that many things are going our way at the moment. This applies not only to transplantation, but also to our other areas of operation.

Several milestones were reached during the quarter. We moved all our production and development to our now approved new premises. A number of product registrations were granted around the world during the quarter, while the development of new products is continuing unabated.”

Fredrik Alpsten, CEO, Devyser

The quarter from July to September 2024

• Net sales amounted to SEK 48.7 million (46.7), corresponding to a 4.4 percent increase. Adjusted for exchange rate fluctuations, net sales increased by 7.2 percent.
• Gross profit totaled SEK 35.2 million (39.6), corresponding to a gross margin of 72.3 percent (85.0).
• Operating profit (EBIT) amounted to SEK -23.7 million (-7.8).
• Profit after tax totaled SEK -23.2 million (-6.0).
• Earnings per share before and after dilution amounted to SEK -1.41 (-0.37).
• Cash flow from operating activities stood at SEK -12.9 million (-13.9).

The period from January to September 2024

• Net sales amounted to SEK 152.7 million (123.9), corresponding to a 23.3 percent increase. Adjusted for exchange rate fluctuations, net sales increased by 23.7 percent.
• Gross profit totaled SEK 118.5 million (104.8), corresponding to a gross margin of 77.6 percent (84.6).
• Operating profit (EBIT) amounted to SEK -59.0 million (-40.4).
• Profit after tax totaled SEK -58.3 million (-40.5).
• Earnings per share before and after dilution amounted to SEK -3.56 (-2.51).
• Cash flow from operating activities stood at SEK -45.4 million (-56.0).

Important events during the quarter
Tender won in Italy
In July, Devyser won a tender with its NGS test for cystic fibrosis, Devyser CFTR. The contract with Policlinico Milano is for three years with the possibility of a one-year extension. The estimated order value is up to SEK 5.9 million.

The share and new share issues
Three new share issues were carried out during the quarter in connection with the exercising of employee stock options. The issues raised SEK 2.2 million for the company.

Important events after the end of the quarter
Devyser presented new innovations and research
Devyser is continuing to invest in product development. At ASHI 2024, the foremost transplantation conference in the US, held at the end of October, six posters and one abstract were presented showcasing new, innovative Devyser products and the clinical results achieved from using them. These showed, among other things, the advantages offered by our products compared with the competition.

Devyser will terminate its liquidity guarantee agreement
In October, Devyser announced that its liquidity guarantee agreement with Carnegie Investment Bank will end on November 29, 2024. Devyser believes that current trading of the share and its liquidity are at good levels and that there is therefore no real need for a liquidity guarantee.

Expanded collaboration with Thermo Fisher
In addition to the commercial terms of the cooperation agreement with Thermo Fisher, we have now also agreed on the plan to take Devyser's product for detection of cell-free DNA in blood of kidney transplant patients to an FDA approval. By gaining access to Thermo Fisher's regulatory resources, with this addition to the agreement, Devyser will significantly increase the chances of a quick and cost-effective FDA approval. As an FDA-approved product does not yet exist, FDA approval could potentially completely transform kidney transplant monitoring in the US. It would give patients access to faster test results.

Chinese regulatory approval for Devyser Compact
Devyser has achieved a significant regulatory milestone with its first market registration from China’s National Medical Products Administration (NMPA) for Devyser Compact, an IVDR-certified genetic test for detecting fetal chromosomal abnormalities. Rapid prenatal aneuploidy detection kits fall under Class III IVD as part of the NMPA product registration process. This approval enables Devyser to market Devyser Compact as an in vitro diagnostic in China and paves the way for future regulatory approvals in the region for its simple, fast, and accurate genetic testing solutions.

Presentation
The report will be presented at an audiocast at 09:00 CET today. Registration through https://ir.financialhearings.com/devyser-diagnostics-q3-report-2024/register.

This report and previous financial reports are available on the company’s webpage https://investors.devyser.com/en/reports-presentations.