While the company has achieved significant progress with the successful Phase 3 trial and sees a large opportunity in the U.S. market, it faces challenges in Europe with declining revenues and specific market issues in Germany and Spain. Financial metrics also indicate an increased operating loss, although the cash position and gross margin have improved.
Company Guidance
During Hansa Biopharma's Q3 2025 results conference call, the company reported significant developments, including the successful outcome of their Phase 3 ConfIdeS trial with a strong p-value of 0.0001, emphasizing its potential in meeting unmet medical needs for highly sensitized patients. The company also highlighted restructuring efforts and financial milestones, such as a 25% increase in year-to-date product sales to SEK 143.6 million, despite a 37% decrease in total revenue for the quarter to SEK 31 million. SG&A expenses rose by SEK 16.6 million compared to the previous year, while R&D expenses were reduced by 11.8%. The company's operating loss for the quarter was SEK 147.6 million. Hansa Biopharma remains optimistic about the U.S. market, targeting a BLA filing by the end of the year and a potential launch in the second half of 2026, with expectations of a strengthened cash position following two equity raises and a pro forma cash and cash equivalents total of SEK 888 million.
Successful Phase 3 ConfIdeS Trial Outcome
The Phase 3 ConfIdeS trial showed a strong p-value of 0.0001, indicating significant unmet medical need for highly sensitized patients. This supports the forthcoming BLA filing in the U.S.
U.S. Market Opportunity
The U.S. market represents a significant growth opportunity with 15,000 highly sensitized patients on the transplant waitlist and robust clinical data supporting a potential launch in the second half of 2026, subject to FDA approval.
Strong Cash Position
The company reported cash and cash equivalents of SEK 252.1 million, increasing to SEK 888 million including net proceeds from a recent capital raise.
Improved Gross Margin
The company's gross margin for the nine months ended September 30, 2025, was 60%, up from 50% for the same period in 2024.
Hansa Biopharma AB (SE:HNSA) Earnings, Revenues Date & History
The upcoming earnings date is based on a company’s previous reporting, and may be updated when the actual date is announced
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
SE:HNSA Earnings-Related Price Changes
Report Date
Price 1 Day Before
Price 1 Day After
Percentage Change
Oct 30, 2025
kr34.46
kr30.66
-11.03%
Jul 17, 2025
kr25.94
kr27.90
+7.56%
Apr 24, 2025
kr22.30
kr23.68
+6.19%
Feb 06, 2025
kr33.62
kr27.10
-19.39%
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
FAQ
When does Hansa Biopharma AB (SE:HNSA) report earnings?
Hansa Biopharma AB (SE:HNSA) is schdueled to report earning on Feb 05, 2026, Before Open (Confirmed).
What is Hansa Biopharma AB (SE:HNSA) earnings time?
Hansa Biopharma AB (SE:HNSA) earnings time is at Feb 05, 2026, Before Open (Confirmed).
Where can I see when companies are reporting earnings?
You can see which companies are reporting today on our designated earnings calendar.