Devyser Diagnostics AB (publ)

Good morning and welcome to the Devizor Q1 2026 earnings call. My name is Jan Wallström, I'm the CEO of Devizor and would like to thank you everyone for joining our call today. On the call today we have in addition to myself also our CFO Sabina Berlin. I will start with a short summary of highlights from the quarter before handing over to Sabina for a more detailed review of our financial results for January to March. And then we'll go through an update on our recent commercial activities. First quarter came in with a positive EBIT, the fourth consecutive quarter in a row. As you know, we started the journey in the beginning of last year, focusing on the company towards profitable growth. It's been a successful journey and we're happy to deliver a strong growth and positive EBIT. In the first quarter of the year, we continue to grow faster than the market. We grew 24% in fixed currencies. We received quite a few orders from Thermo in this quarter, a step towards a more stable order pattern. We're also very pleased with the gross margin of 82%. It's better than full year 2025, and we will continue to work on improving cost of goods sold. EBIT came in on a positive 2.6 million compared to last year's negative 14.8 in the first quarter. So we're growing faster than the market with a clear focus on profitable growth. In the first quarter, we signed the agreement to acquire CyberGene, a Swedish company with products in similar areas as Devizor, giving us a stronger commercial position in several markets. Cybergene is a Stockholm-based agnostic company and has operated in the same market as Devizor for many years providing Devizor with in-depth knowledge of Cybergene's products and customers. The acquisition was completed on April 1st and we have already integrated the company in our daily operations. Cybergene has demonstrated steady growth driven by a strong product offering and consistent market expansion and will contribute positively to Devizor's gross profit and gross margin. As presented earlier in the year, in Q1, we also signed a significant agreement with Illumina, giving us the opportunity to do regent rental on the European market. As we spoke about in the last quarter, we continue the ongoing MoldDx application for a post-transplant kidney test as a service in the US. Since last quarter, we have gathered more clinical data and we are now analyzing the clinical samples. After that, we will send in a renewed application and hopefully we can have an approved product before the end of the year. At the same time, we continue to work on our FDA project in transplantation and we've had very positive development here. We have all the six sites up and running and we gather patients in a good pace and will continue to do so 2026 and 2027 to be able to file in 2028 if everything develops in a positive way. With that, I would like to hand over to Savina to share more details on our financial results for Q1 2026.

Thank you, Jan. I will continue with a summary of the financials for Q1. Revenue for January to March came in at 62 million compared to 55 million SEC in the same quarter of last year. That amounts to a quarter of a quarter growth of 13%, which equals almost 25% in local currency, as we're still seeing FX headwinds with a strong SAK. Our revenue growth curve continues upwards in the rolling 12. Q2 and Q4 quarters have historically been stronger based on distributed purchasing patterns, but we expect that to flatten out over time. We have a stable underlying growth that is very clear when we work with our growth numbers in docker currency. North America keeps growing at a quick pace and made up 20% of sales in the quarter, built up from revenue from Thermo, the CLIA lab, and a very strong performance from direct sales of the hereditary portfolio in the quarter. EMEA had a slower reported growth in the quarter, but all our indirect markets are performing well, and there will always be fluctuations between individual quarters. Asia Pacific remains at a small but steady level. Q1 saw the same growth in both direct sales and distributor sales of 12% and 13% respectively during the quarter. Apart from the distributors in the Middle East, our sales channels have seen limited impact from the current ongoing conflicts, and we have been able to ship according to plan on all orders. Gross margin came in at 81.6%, a healthy margin that shows the low production cost for our products. Q1 of 2025 had an even higher margin as part of the lumpiness in the margin that we saw last year, and that should now be reduced for 2026 and forward. Our EBIT for the quarter was 2.6 million SEC, and we now have a full 12 months rolling of black numbers. Last year's Q1 was heavily impacted by the reorganization that we initiated early in 2025, and that we have been able to harvest the benefits from during the following quarters. We will continue to drive business with profitable growth and leverage both our strong product portfolio and innovation engine to drive growth and keep being careful with our cost base. We closed the quarter with 75 million second cash, not much below Q4 numbers. Cashflow from operating activities was 12 million positive for the quarter, just as strong as last quarter, showing that our cashflow now fully finances daily operations. Cashflow continues to be an important focus for us as we grow and invest. I remain confident that we will reach cashflow positive, also including investments within the foreseeable future. And with that, I hand back over to Jan.

Thank you, Sabina. I'm pleased to share several promising highlights from our strong Q1. After strong Q4, we continued with an equally strong Q1, 24% growth. We had good results over the board, both in Europe and US. Our direct business in US grew multiple times, showing a continued strong position for us with our hereditary products. We have some challenges as Sabina talked about in the Middle East, but managed to get some of that sale out at the end of the quarter. I'm just back from a productive and positive meeting with Thermo and was happy to see that they continue to win new accounts and grow our joint business in a good way. Looking at the Illumina agreement, as you know, January 28, we announced that we are now a system integrated with Illumina and into the entered into a collaborative framework agreement. Illumina is by far the market leader when it comes to the DNA sequencing market. We presented this order in the previous quarter report, but can now add that we see a strong interest in this solution from our customers. The regent rental model is a proven business model in our market, and we believe it will give us many opportunities to win over more business in the quarters to come. Moving on to an update on our partnership with Thermo Fisher for our transplantation products. Q1 was a good quarter where we have, as I mentioned before, seen several new accounts won. Our recovery sales have developed well before, but it's good to see that our cell-free DNA products also see good market uptake now. In Europe, we're making significant progress related to having CFDNA become recognized and endorsed. as a preferred rule out test of biopsies and supported by the new reimbursement schemes. North America had another strong quarter, both in kit sales to end customers, as well as good development in our CLIA lab. The kit sales growth came mainly from our cystic fibrosis and thalassemia products. The collaboration we decided continues in a good way at the same time as we're working on more customers for the CLIA lab. Sales has developed well in the quarter in Europe as well, but the big news this quarter was the Illumina agreement. On the product side, we launched IVDR products for cystic sclerosis late last year and thalassemia in Q1. These launches have been successful with great interest from customers that has given high growth numbers on tests sold in this quarter. Going forward, we now have four quarters in a row with positive EBIT and continuing profitable growth. We also keep our focus on becoming a one-stop solution for clinical genomic labs with new launches and moving more of our products to IVDR status. We will continue focusing on our collaborations with Thurman Illumina, collaborations that give us access to bigger markets and strong partner organizations. Our focus remains on continuous improvement and increased profitability alongside strong top-line growth. With that, I would like to open up for questions.