Devyser Diagnostics AB (publ)

Welcome to the Devizor Diagnostics Q3 Report 2025 presentation. During the questions and answers session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now I will hand the conference over to the speakers, CEO Jan Wallstrom, CFO Sabina Berlin, and CCOT's Kipling. Please go ahead.

Good day and welcome to the Devizor Q3 2025 earnings call. I'm Jan Wallström. I'm the new CEO of Advisor since August 2025, and I 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, and our CCO, Thijs Kipling. I will start with a short summary of our quarterly result and then recap our recent activities that have resulted in an improved efficiency overall for the organization. I will then give an update on the recent product launches and present some additional highlights from the quarter before handing over to Sabina for more detailed review of our financial results in Q3 and then to Thijs for an update on our recent commercial activities. As I said, my name is Jan Wallström. I have now been the CEO of Devizor for my first quarter. It is a privilege to have joined such a talented team of colleagues, a team that over the years has delivered fantastic products in a very important field, and doing so with stellar growth. I have a background from several similar companies, where I have delivered strong growth both on top line and even more so on profitability by assuring a clear focus, continuous improvements in how we work at the same time as staying top in class on our offering. I'm looking forward to this journey at Devizor. Looking into the third quarter highlights, This quarter shows that we're turning the company around onto a path to profitability. We have another record quarter based on revenue with 56 million in sales, representing a growth in local currency of 20%, 60% in Swedish crowns compared to Q3 last year. Gross margin came in at 75%, which is also better than last Q3. Q3 is normally the slowest quarter of the year, and we believe the 20% growth is a strong result. We're most proud in the quarter that we got an EBIT that came in at positive 1.3 million crowns, compared to minus 22 million last year. We currently have a cash position of 85 million. If I then look at the year to date, The reorganization we initiated in February has given us a strong structure that we have been able to capitalize on in second and third quarter. We have shown that we can keep the cost low, and we have delivered a much improved result in Q3 as a result of that. Year to date, we are at EBIT minus eight compared to minus 59 in the same period last year. So the development is really strong. Sales year to date is 179 million, which is a growth of 17%. We are turning around the company to profitability. During the second half, We are focusing on delivering continued strong growth supported by the launch of new products. We launched genomic dot typing HLA loss just before the quarter started. And now we also launched the IVDR product for CFTR. We continue to generate strong product roadmap for the next years that quantifies the opportunities and meets the needs communicated by our customers. We have implemented several internal processes to improve our organization efficiency. This is something that I've done several times before in other companies, and I see that we have a good opportunity to improve our efficiency and profitability going forward. The product launches we had were mainly done in Q2, as I mentioned, the genomic dot typing and HL loss. In Q3, we had fewer news, which is normal in Q3 for us. But yesterday, as you might have seen, we launched CFTR IVDR. That is part of our focus to moving products from research use only and IVD to IVDR, something that Thijs will talk more about later on in the call. This is putting us in a better competitive situation in most markets, but especially in Europe. More feedback on other topics. I would like to highlight a couple of activities from the quarter. Work continues in the CLIA lab and on the ongoing multi-exit evaluation for a post-transplant test in the U.S., MoDiAX provided feedback on our application at the end of October and requested additional supporting data that we're reviewing currently. At the same time, we continue to work on our FDA project in transplantation. And over the quarter, we have been able to register more labs that are participating in the ongoing study that we do. This marks an important step in the process for us, as we now have all the number of labs that we need for the study. With that, I would like to hand over to Sabina to share more details on our financial results for the third quarter. Sabina.

Thank you, Jan. I'll continue with the summary here of the financials for Q3. Revenue for the period July to September came in at 56.4 million SEK compared to 48.7 million SEK in the same quarter of last year. This amounts, as John mentioned, to a quarter of a quarter growth of close to 16%, equaling 19% in local currency. Over the past two years, we have seen an increased lumpiness between separate quarters with softer third quarters due to order patterns and impact from the summer months, with a stable underlying trend. PICE will later go through more about the market dynamics during the quarter. And also going forward, there will always be fluctuation between individual quarters. With two very strong quarters and two softer quarters over the past 12 months, we still see a stable rolling 12 curve that continues in the same tangent as previous years. The Americas continue to show a very strong growth, also in Q3, with 87% growth quarter over quarter, although still from small numbers, with the main growth coming from the CLIA lab and US kit sales. Our EMEA region tends to be slower in the months of July and August due to vacation order patterns, but did pick up in September as usual. Q3 saw direct sales showing the strongest growth out of our two sales channels, confirming a healthy growth trajectory. Distributor sales were very strong in Q2, with this major contribution from the transplantation agreement with Thermal, and Q3 had strong distributor sales last year. Both these factors led to a softer quarter growth-wise on the distributor side this year, as no major orders from Thermal came in in Q3, but we are expecting also this channel to pick up soon again. I will cover more details also about the channel market shortly. Gross margin came in at 75% during the quarter, better than last year, with a year-to-date of 81% well above our financial target. Our EBIT for the quarter of 1.3 million SEC is positive for the second quarter in a row. Although actual positive amounts are still just above zero, it clearly shows the effect of the savings program implemented earlier this year and confirms our ability to move forward a long-term sustainable cash flow positive business. We closed the quarter with 85 million SEK in cash, and the cash flow for the quarter of minus 15.2 million SEK is mainly impacted by capitalized R&D work, as cash flow from operating activities was only minus 0.5 million SEK. We strongly believe that our investments in new products will continue to pay off and support future growth in both the transplantation field and hereditary disease business. I feel confident that our performance will take us to cash flow positive within the foreseeable future. And with that, I hand over to Thijs.