Correction: Too low direct sales reported in year-end report "Devyser Diagnostics AB publishes year-end report for January to December 2024"
Devyser issues a correction to the year-end report for 2024 that was sent out earlier today, where an incorrect distribution of the quarter's net sales between direct sales and distributor sales was presented. The correct figure is that direct sales in the quarter amounted to SEK 36.8 million, a growth of 8.4% from the corresponding quarter last year. The table on page 5 of the report has been updated with the correct figures. No other changes have been made. The correct press release is published below in its entirety with the corrected appendix:
“Net sales increased during the fourth quarter by 41.5 percent to SEK 64.2 million, compared with the corresponding quarter of 2023. The growth and strong performance are a result of robust development in every geographical market and several large orders from Thermo Fisher.
The gross margin for the quarter amounted to 84.4 percent, up from 72.3 percent in Q3 2024. The same performance measure for the full-year 2024 amounted to 79.6 percent (85.5), a decrease linked to costs related to the validation of the new production facility, while the fourth quarter showed that we are once again above the target set of 80 percent.
The big financial news for the quarter is the positive operating result of SEK 0.7 million (-18.5), achieved through efficiency improvements implemented during the third quarter and a large inventory build-up order from Thermo Fisher.
Devyser is well-positioned for continued growth with a strong focus on profitability. Our tried and tested business model, built on providing high-quality IVD-approved tests to genetic testing laboratories and transplant centers, has proved capable of delivering good results and opportunities for further growth. By clarifying the strategy as one in which profitability is both a driving force and guides our decisions, in future we will focus on more clearly defined customer segments and work on refining the product portfolio to target specific product lines that have the highest potential.”
Fredrik Dahl, Interim CEO, Devyser
The quarter from October to December 2024
· Net sales amounted to SEK 64.2 million (45.4), corresponding to a 41.5 percent increase. Adjusted for exchange rate fluctuations, net sales increased by 40.8 percent.
· Gross profit totaled SEK 54.2 million (40.0), corresponding to a gross margin of 84.4 percent (88.1).
· Operating profit (EBIT) amounted to SEK 0.7 million (-18.5).
· Profit after tax totaled SEK -3.2 million (-13.1).
· Earnings per share before and after dilution amounted to SEK -0.19 (-0.80).
· Cash flow from operating activities stood at SEK -1.4 million (-13.8).
The period from January to December 2024
· Net sales amounted to SEK 216.9 million (169.3), corresponding to a 28.1 percent increase. Adjusted for exchange rate fluctuations, net sales increased by 28.3 percent.
· Gross profit totaled SEK 172.7 million (144.7), corresponding to a gross margin of 79.6 percent (85.5).
· Operating profit (EBIT) amounted to SEK -58.3 million (-58.9).
· Profit after tax totaled SEK -61.5 million (-53.6).
· Earnings per share before and after dilution amounted to SEK -3.75 (-3.31).
· Cash flow from operating activities stood at SEK -46.8 million (-69.7).
· The Board is not proposing a dividend for 2024.
Important events during 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 terminated its liquidity guarantee agreement
In October, Devyser announced that its liquidity guarantee agreement with Carnegie Investment Bank would 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 collaboration agreement with Thermo Fisher, the companies have now also agreed on the plan to apply for FDA approval for Devyser’s product for the detection of cell-free DNA in the blood of kidney transplant patients. This addition to the agreement will significantly increase Devyser’s chances of obtaining FDA approval quickly and cost effectively, as it means gaining access to Thermo Fisher's regulatory resources. 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.
Regulatory approval of Devyser Compact in China
Devyser has reached a significant regulatory milestone with its first market registration with China’s National Medical Products Administration (NMPA) for Devyser Compact, an IVDR-certified genetic test for the detection of chromosomal abnormalities in fetuses. Rapid prenatal detection is a Class III product in China. The regulatory approval enables Devyser to market Devyser Compact in China, and also lays the foundations for future regulatory approvals.
Devyser obtained Class D IVDR approval for RHD
In December, Devyser obtained IVDR approval for its product for the non-invasive screening of fetal RHD. This is the first approval of a Class D product; this is the highest risk class under the new, more comprehensive regulation, which entered into force in May 2022.
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 3.9 million for the company.
Important events after the end of the quarter
CEO Fredrik Alpsten left Devyser and Board member Fredrik Dahl was appointed as Devyser’s new acting CEO
Fredrik Alpsten and Devyser’s Board of Directors reached an agreement in January whereby he would leave his position as CEO of Devyser. Devyser’s Board of Directors has begun the recruitment of a new CEO. Fredrik Dahl, who has a PhD in Molecular Medicine, is currently a Board member and is well acquainted with the company, has been appointed as acting CEO. Fredrik Dahl has extensive international experience in various management roles at global research and diagnostics companies.
Presentation
The report will be presented at an audiocast at 13:00 CET today. Dial-in number to the teleconference and a conference ID will be received by registering on the link below:
https://conference.inderes.com/teleconference/?id=5008325
The presentation will also be webcast and can be accessed from the following web address:
https://devyser-diagnostics.events.inderes.com/q4-report-2024
This report and previous financial reports are available on the company’s webpage https://investors.devyser.com/en/reports-presentations.