#Sweden #Stockholm #Sobi #Doptelet #Gamifant

Sobi Adjusts Full Year 2025 Outlook

Swedish Orphan Biovitrum AB (Sobi®) has recently updated its full-year outlook for 2025 following notable performance in the third quarter. This prompt action highlights the company's commitment to transparency and effective stakeholder communication, reflecting significant developments that have influenced financial projections.

Impressive Q3 Revenue Growth

In Q3 2025, Sobi reported a remarkable revenue figure of SEK 7,776 million, marking a substantial 21% increase compared to Q3 2024, adjusted for constant exchange rates. This growth can be attributed to the strong market performance of key products such as Altuvoct, Doptelet, and Gamifant. Such upward momentum has driven Sobi to revise its forecasts for the full year, shifting expectations from a high-single-digit growth percentage to a low double-digit percentage.

The adjusted EBITA (Earnings Before Interest, Taxes, and Amortization) margin for Q3 stood impressively at 47%. Notably, this figure was achieved due to lower-than-expected expenditures in research and development (RD), underscoring disciplined cost management and the successful implementation of organizational changes initiated in Q2 2025. Strategic realigning of selling, general, and administrative (SGA) as well as RD activities have also played a crucial role, particularly in light of the FDA's recent confirmation regarding a review decision on NASP's biologics license application expected mid-2026.

Year-to-Date Performance

As of Q3 2025, Sobi reported a year-to-date revenue totaling SEK 20,417 million, representing a 15% increase year-over-year at constant exchange rates. The ongoing enhancements have resulted in a year-to-date adjusted EBITA margin of 40%. Sobi remains optimistic about maintaining this growth trajectory, owing various factors including improved market performance and judicious cost management.

Anticipated Changes and Impairment Charges

Even with these positive developments, Sobi recorded a sizable non-cash impairment charge of SEK 6,612 million related to Vonjo's product and marketing rights. This impairment charge will be reported as an item affecting comparability, and though it reduces the book value of Vonjo—which still holds a significant potential interest as a long-term growth driver—the charge has not impacted Sobi's cash flow. The firm remains confident in Vonjo's prospects, especially following the anticipated completion of the Pacifica phase 3 study and broader label authorization in the U.S.

Future Market Potential

In other news, Sobi's Tryngolza (olezarsen) has been recently approved for familial chylomicronaemia syndrome in Europe, following promising topline results related to severe hypertriglyceridemia. This condition impacts an estimated 700,000 individuals across leading European markets including France, Germany, Italy, Spain, and the U.K. Given the substantial number affected, Sobi estimates that the market potential could exceed SEK 5 billion within these regions.

The company is planning a regulatory filing in 2026 to address chylomicronemia syndromes in Europe, reinforcing Sobi's commitment to expanding its portfolio within critical therapeutic areas.

Conference Call and Future Communication

Sobi has announced that it will release its Q3 financial report on Monday, October 20, 2025, at 8 AM CEST. Following the publication, a conference call will take place at 1 PM CEST, providing investors, analysts, and media representatives an opportunity to engage with the results and ask questions. Interested parties can participate by dialing in using specific regional numbers provided in the company's press release.

Sobi continues to make strides in the biopharma sector, focusing on delivering innovative treatments to improve the lives of those affected by rare diseases. As always, stakeholders are encouraged to stay abreast of developments through the company's official communication channels.