“The fourth quarter confirmed the positive earnings trend that we have seen throughout the year. Operating profit amounted to SEK 18.0 million (-3.7) for the quarter and to SEK 10.1 million (-62.3) for the full year. Devyser is therefore reporting a positive operating result on a full-year basis for the first time since its growth journey began. This outcome shows that our transformation measures to achieve profitability are working, measures in which cost discipline and clear priorities have been key factors.”

Jan Wahlström, CEO, Devyser

The quarter from October to December 2025

• Net sales amounted to SEK 72.0 million (64.2), corresponding to a 12.1 percent increase. Adjusted for exchange rate fluctuations, net sales increased by 20.9 percent.
• Gross profit totaled SEK 57.2 million (54.2), corresponding to a gross margin of 79.5 percent (84.4).
• Operating profit (EBIT) amounted to SEK 18.0 million (-3.7).
• Profit after tax totaled SEK 13.6 million (-3.2).
• Earnings per share before and after dilution amounted to SEK 0.82 (-0.19).
• Cash flow from operating activities stood at SEK 11.7 million (-5.9).

The period from January to December 2025

• Net sales amounted to SEK 250.5 million (216.9), corresponding to a 15.5 percent increase. Adjusted for exchange rate fluctuations, net sales increased by 20.2 percent.
• Gross profit totaled SEK 201.9 million (172.7), corresponding to a gross margin of 80.6 percent (79.6).
• Operating profit (EBIT) amounted to SEK 10.1 million (-62.3).
• Profit after tax totaled SEK -8.4 million (-61.5).
• Earnings per share before and after dilution amounted to SEK -0.51 (-3.75).
• Cash flow from operating activities stood at SEK 8.2 million (-50.7).
• The Board is not proposing a dividend for 2025.

Important events during the quarter
IVDR approval of Devyser CFTR
Devyser`s NGS test for CFTR received IVDR approved in November, ensuring that clinical laboratories that use Devyser CFTR tests can operate with increased regulatory certainty, reliable compliance and in line with the latest European standards.

First patient enrolled in Devyser Accept cfDNA study
In November, the first patient was enrolled in the Devyser Accept cfDNA clinical trial, marking an important milestone in the launching of a targeted next-generation sequencing solution for kidney transplant monitoring on the US diagnostic market.

CMS price setting for PrenatalDetect RHD test strengthens presence in the US market
At the end of November, the Centers for Medicare & Medicaid Services (CMS) set the final price at $192. The non-invasive fetal RhD typing test is carried out at Devyser Genomic Laboratories, the company’s CLIA-certified and CAP-accredited lab in the United States. The price set will be included in the 2026 Medicare Clinical Laboratory Fee Schedule (CLFS) and is effective from January 1, 2026.

Health Canada grants IVD approval of Devyser’s NGS-based chimerism test, the first of its kind in Canada
In December, One Lambda Devyser Chimerism and Advyser Chimerism were granted Class III in vitro diagnostic (IVD) medical device approval by Health Canada, the first ever IVD-labeled chimerism test to be approved in Canada.

Devyser wins French tender worth up to SEK 9.5 million
In December, Devyser won a tender for Devyser Compact. The contract with Assistance Publique-Hôpitaux de Marseille (AP-HM) is valid for four years and the order value is estimated at SEK 9.5 million.

Important events after the end of the quarter
Strategic supply agreement with Illumina
In January, a supply agreement was signed with Illumina, and under the agreement, Devyser will be able to offer select Illumina sequencing instruments alongside Devyser’s reagent solutions, enabling customers to access advanced sequencing technology with a lower initial capital investment. The framework is designed to simplify procurement, speed up implementation and support laboratories in expanding their testing capabilities.

Announcement of agreement to acquire Cybergene AB
In February, Devyser announced that it has entered into an agreement to acquire Cybergene AB.

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://events.inderes.com/devyser-diagnostics/q4-report-2025/dial-in 
 
The presentation will also be webcast and can be accessed from the following web address: 
https://devyser-diagnostics.events.inderes.com/q4-report-2025

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