Devyser Diagnostics

“Devyser reports continued strong sales growth and high gross margins for the quarter. It is particularly pleasing to see that our investment in the Americas is continuing to produce results, with growth of nearly 300 percent. It was also gratifying that, during the quarter, we were able to successfully conclude important commercial contracts with both Illumina and UK-based Cyted, while continuing to win tenders.” 

Fredrik Alpsten, CEO, Devyser 

The quarter from January to March 2024 

• Net sales amounted to SEK 50.7 million (39.5), corresponding to a 28.5 percent increase. Adjusted for exchange rate fluctuations, net sales increased by 27.7 percent. 
• Gross profit totaled SEK 41.9 million (33.7), corresponding to a gross margin of 82.7 percent (85.2). 
• Operating profit (EBIT) amounted to SEK -12.2 million (-19.1). 
• Profit after tax totaled SEK -12.2 million (-19.9). 
• Earnings per share before and after dilution amounted to SEK -0.75 (-1.24). 
• Cash flow from operating activities stood at SEK -16.5 million (-19.3). 

Important events during the quarter 
IVD development agreement with Illumina Inc. 
In early January, a contract was signed with Illumina for IVD (in vitro diagnostics) development. This was to enable US and European regulatory registrations of Devyser’s NGS tests on MiSeqDx, Illumina’s FDA-regulated and CE-IVD-marked sequencing instrument. 

Devyser Genomic Laboratories signed its first commercial contract 
Devyser Genomic Laboratories, Devyser’s US-based CLIA-certified laboratory, signed its first commercial contract in mid-January with UK-based diagnostics company Cyted. The contract’s term is initially two years, and revenues are estimated to total approximately SEK 25.0 million, of which up to around SEK 6.0 million in 2024. 

Devyser strengthened its management team  
The management team was expanded on February 1 when it was joined by CSO Michael Uhlin. The latter has extensive experience in the global life sciences sector and has long been engaged in translational research and development. Devyser’s senior management now consists of CEO Fredrik Alpsten, CFO Sabina Berlin, CCO Theis Kipling, COO Göran Rydin, CSO Michael Uhlin and CHRO Camilla Wiberg. 

Important events after the end of the quarter 
Devyser granted MDSAP certification in Brazil 
In April, Devyser was granted MDSAP (Medical Device Single Audit Program) certification for its quality management system in Brazil for both analytics and software. The MDSAP certification in Brazil is in addition to the company’s existing certificates in the US and Canada. 

Devyser enters into a partnership with Hamilton for the automation of NGS workflows in laboratories 
In April, a joint marketing agreement was signed with Hamilton Bonaduz AG, a leading global manufacturer of laboratory automation technology. The agreement allows customers to automate Devyser’s products using Hamilton’s robots. 

Devyser granted IVDR approval for post-transplant monitoring software 
In April, Devyser was granted IVDR approval for its Advyser Solid Organs software, which is used with the One Lambda Devyser Accept cfDNA product for post-transplant monitoring. This is Devyser's first IVDR-certified software to be approved in Europe under the new, more comprehensive regulation that came into force in May 2022. 

The share and new issues 
In April, two new share issues were carried out in connection with the exercising of warrants and employee stock options. The issues raised SEK 0.8 million for the company. 

Presentation 
The report will be presented at an audiocast at 09:00 CET today. More information and links are available on https://financialhearings.com/event/49150. 

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