Biohit reported progress on different continents

Translation: Original published in Finnish on 10/07/2025 at 07:00 am EEST

Biohit that reports semi-annually does not publish business reviews for Q1 and Q3 but the company reports on its progress on the IR blog. In its Q3 blog, the company reported on progress on different countries in more detail. We do not feel the blog contained information that would affect our estimates, so our stance on the stock remains unchanged.  

New distribution agreements in Europe

The company reported it has signed new distribution agreements in Europe in Q3. This follows the distribution agreement announced earlier this year regarding celiac disease. According to the company, interest in Gastropanel has also been growing on the old continent. The news supports the future growth outlook for Europe, which has seen a slight softness in previous reports. 

Progress in South America

In North America, Biohit announced its participation in Business Finland's AMPlify accelerator program for Finnish health sector companies targeting the US market. The aim of the program is to accelerate market entry and receive guidance from local experts. The US has significant commercial potential in health technology, but the market is also highly competitive. In its blog, the company emphasized the importance of a refined sales strategy to succeed in a healthcare system operating with market regulation, reimbursement practices, and business logic. Biohit has stated that it aims to obtain FDA approval (sales and marketing authorization) in the US in 2026.

In South America, the company reported on a pilot program in Chile, based on which the aim is to prioritize patients who will undergo gastroscopy. A similar pilot is next planned to be expanded to Colombia and Peru. The aim is to develop a preventive early diagnosis model for countries with a high gastric cancer risk and to optimally allocate scarce healthcare resources.

We expect a return to growth in H2

Biohit’s H1’25 remained at the previous year’s level in terms of growth, as the situation in the Middle East caused significant headwinds in a key market. However, in other markets, the company's growth was 14%, and we estimate that the company will return to growth in H2'25. Based on the blog, development is currently progressing steadily in various regions, even though the company did not take a stand on the situation in the Middle East. One of the key growth drivers in the coming years is commercialization in the US. The company did not provide any further information on the status of the marketing authorization. We consider FDA approval in 2026 realistic. However, regulatory processes are often delayed compared to targets, so investors should be prepared for the possibility of commercialization being prolonged.