“Devyser is able to report strong sales growth and record high gross margins for the fourth quarter. During the quarter, Devyser continued to demonstrate the competitiveness of its products by winning several contracts. Wec saw significant development in the US, where we achieved an important milestone after the end of the quarter with the first commercial contract for Devyser Genomic Laboratories, our CLIA-certified laboratory. After the quarter, we also signed an agreement with Illumina Inc, the global leader in instrument manufacturing. 

The positive trend seen for the first three quarters continued in the fourth quarter. If we look back at the full-year 2023, we would summarize it as a year of strong growth during which we established ourselves in several new markets and strengthened our presence in existing markets. Thanks to increased volumes and higher prices we were able to further bolster our gross margins. 

Overall, 2023 was a very eventful year and our most successful year yet for the company. During the year, 400,000 people worldwide were diagnosed using our products.” 

Fredrik Alpsten, CEO, Devyser 
 
The quarter from October to December 2023 

• Net sales amounted to SEK 45.4 million (34.2), corresponding to a 32.7 percent increase. Adjusted for exchange rate fluctuations, net sales increased by 27.5 percent. 
• Gross profit totaled SEK 40.0 million (27.2), corresponding to a gross margin of 88.1 percent (79.5). 
• Operating profit (EBIT) amounted to SEK -18.5 million (-25.9). 
• Profit after tax totaled SEK -13.1 million (-16.7). 
• Earnings per share before and after dilution amounted to SEK -0.80 (-1.04). 
• Cash flow from operating activities stood at SEK -13.8 million (-13.4). 

The period from January to December 2023 

• Net sales amounted to SEK 169.3 million (126.6), corresponding to a 33.7 percent increase. Adjusted for exchange rate fluctuations, net sales increased by 24.9 percent. 
• Gross profit totaled SEK 144.7 million (103.4), corresponding to a gross margin of 85.5 percent (81.7). 
• Operating profit (EBIT) amounted to SEK -58.9 million (-52.0). 
• Profit after tax totaled SEK -53.6 million (-46.0). 
• Earnings per share before and after dilution amounted to SEK -3.31 (-2.89). 
• Cash flow from operating activities stood at SEK -69.7 million (-40.5). 
• The Board is not proposing a dividend for 2023. 

Important events during the quarter 
Contract for RHD testing won in Wales 
In December, Devyser won a contract for Devyser RHD, the company’s product for the non-invasive testing of maternal plasma during pregnancy to determine fetal RHD status. The contract with Wales Blood Services in Wales is for three years, with an option to extend it for two years. The value of the order is estimated at approximately SEK 1.0 million per year. 
 
CFTR contract won in Italy  
In December, Devyser won a contract for CFTR genotyping tests used for newborn screening and cystic fibrosis detection. The contract with the University Hospital of Bologna is for three years. The value of the order is estimated at approximately SEK 2.0 million per year. 
 
Important events after the end of the quarter 
IVD development agreement with Illumina Inc. 
An IVD (in-vitro diagnostic) development agreement was signed with Illumina to enable regulatory registrations of Devyser’s NGS tests on MiSeqDx, Illumina’s FDA-regulated and CE-IVD-marked sequencing instrument. 
 
Cystic fibrosis contract won in Italy 
Devyser won another contract for CFTR genotyping tests in Italy. The contract with the University Hospital of Verona is for twelve months. The value of the order is estimated at approximately SEK 1.5 million. 
 
Devyser Genomic Laboratories signed its first commercial contract 
Devyser Genomic Laboratories, Devyser’s US-based CLIA-certified laboratory, signed its first commercial contract 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 with the edition of CSO Michael Uhlin, who 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. 
 
Presentation 
The report will be presented at an audiocast at 09:00 CET today. Dial-in number to the teleconference and a conference ID will be received by registering on the link below: 
https://conference.financialhearings.com/teleconference/?id=5003238   
  
The presentation will also be webcast and can be accessed from the following web address:  
https://ir.financialhearings.com/devyser-diagnostics-q4-report-2023   
 
This report and previous financial reports are available on the company’s webpage https://investors.devyser.com/en/reports-presentations.