Hansa Biopharma AB earnings date
Hansa Biopharma AB (HNSAN) Q3 2026 Earnings Report
MX:HNSAN Q3 2026 EPS Results
- Actual EPS
- -MXN 3.26
- Consensus EPS
- -MXN 2.64
- Beat/Miss
- Missed by -MXN 0.62
- One Year Ago EPS
- -MXN 3.26
MX:HNSAN Q3 2026 Revenue Results
- Actual Revenue
- MXN 266.65M
- Expected Revenue
- MXN 134.42M
- Beat/Miss
- Beat by +MXN 132.23M
- YoY Revenue Growth
- +364.18%
Earnings Announcement Details
- Quarter
- Q3 2026
- Date
- 11/11/2026
- Time
- Before Open
- Conference Call
- Wednesday, November 11, 2026
Hansa Biopharma AB's next earnings date is estimated for February 11, 2027, based on past reporting schedules.
Q3 2026 Earnings Call Audio
No earnings call audio is available for this earnings event.
Q3 2026 Earnings Slide Deck
No slide deck is available for this earnings event.
Q3 2026 Earnings Call Summary
The call was strongly positive, supported by the EUR 110 million SERB upfront payment, SEK 1.3 billion of cash, substantial U.S. launch preparation, encouraging ConfIdeS and PAES clinical outcomes, and progress in the GBS program. The company remains loss-making, antibody-mediated rejection was frequent in the clinical data, and FDA approval, NTAP approval, payer coverage, and commercial uptake remain pending or gradual. Overall, the highlights significantly outweighed the disclosed challenges.
Hansa expects to submit the filing to convert Idefirix’s conditional approval to full approval in Q4, is on track for product availability in Q1 2027, subject to FDA approval, and expects to onboard an additional 16 commercial representatives in the first week of January '27, subject to FDA approval; CMS’s town hall is on December 9 and 10, 2026, the proposed IPPS rule is expected in April of 2027, the final rule on August 1, '27, and NTAP would be effective October 1, '27, if approved. Coverage decisions could be a couple of months or 6 months depending on the plan, formulary processes can take up to 6 months, and coverage decisions are expected to evolve over the next sort of 6, 9 months to show full coverage. HNSA-5487 enrollment of the first patient in the Phase IIa GBS study is anticipated in Q1 2027, with follow-up potentially a period of 3 to 6 months, after which the development plan is expected to continue with a single pivotal Phase III registrational study based on favorable outcomes; R&D is not expected to have a dramatic increase.
- European Out-Licensing Deal Strengthened Balance SheetHansa closed the out-licensing transaction for Europe and MENA, transferred Idefirix market authorization holder responsibilities to SERB in Europe and the U.K., and received the EUR 110 million upfront payment in July. The payment enabled deleveraging and significantly bolstered the cash balance.
- Strong Q3 Revenue Driven by SERB License RevenueQ3 2026 total revenue was SEK 143 million, driven primarily by SEK 122 million of license revenue under the SERB agreement. The license revenue represents part of the EUR 110 million upfront payment and is being recognized on a straight-line basis through December 2028.
- Significant Improvement in Operating Cash Flow and Cash BalanceCash flow from operations was SEK 964 million in Q3 2026 compared with negative SEK 107 million in the comparable period last year. Cash and cash equivalents were SEK 1.3 billion, approximately $135 million, at the end of the period.
- U.S. Launch Preparation AdvancedHansa submitted its NTAP application in October 2026, selected a third-party logistics provider and specialty distributor, and has its U.S. leadership team in place. State licensing has started, with the first state approved, and the company is on track for product availability in Q1 2027, subject to FDA approval.
- U.S. Commercial Organization Being BuiltHansa hired its Head of U.S. Sales, who has 27 years of experience, has launched 10 hospital products, and has participated in 13 launches. Hiring for other U.S. home-office commercial and G&A roles has been completed, and the company expects to onboard an additional 16 commercial representatives in the first week of January 2027, subject to FDA approval.
- Broad U.S. Transplant Center Reach EstablishedThe company is focusing initially on the 100 U.S. transplant centers that represent 80% of kidney transplant volume, including the 25 ConfIdeS centers that represent 25% of annual kidney transplant volume. Hansa has engaged close to 90% of these Tier 1 centers and has identified influential clinical champions at approximately 40 centers.
- Physician and Patient Engagement ExpandedHansa presented ConfIdeS data at TTS and ASHI and presented European Phase III data for the first time at ASN. The company also launched a disease-state educational campaign for healthcare providers and patients and engaged patient advocacy leaders at the AAKP Summit, the REIMAGINE Symposium, and ASN.
- Real-World French Experience ExpandedThe company reported that 99 patients have now been transplanted with imlifidase in France. Hansa described this as real-world evidence from commercial use showing how imlifidase performs in routine clinical practice outside a clinical trial.
- Substantial Unmet Need in Highly Sensitized Kidney Transplant PatientsManagement highlighted approximately 100,000 people on the U.S. kidney transplant waitlist, including about 15,000 with CPRA above 80%, 7,000 above 98%, and 3,500 above 99%. Patients with CPRA above 99% wait more than 7 years, while about 9,000 recovered kidneys are discarded annually, including more than 5,000 because no recipient could be located and the list was exhausted.
- ConfIdeS Enabled Faster TransplantationIn the ConfIdeS study, 28 patients in the imlifidase arm were transplanted within 24 hours of treatment, compared with 3 patients in the control arm at randomization. Mean time from randomization to transplantation was 1.9 days in the imlifidase arm versus 96.2 days in the control arm.
- ConfIdeS Showed Better 12-Month Kidney FunctionAt 12 months, mean eGFR was 51.5 mL per minute in the imlifidase arm versus 19.3 mL per minute in the control arm, a statistically significant and clinically relevant difference of 32.2 mL per minute. At least 42% of transplanted patients in the imlifidase arm had eGFR of at least 60 mL per minute, and more than 90% had eGFR of at least 30 mL per minute.
- ConfIdeS Reduced Dialysis DependencyAt 12 months, 5 of 32 patients randomized to the imlifidase arm were dialysis dependent compared with 18 patients in the control arm. The difference was statistically significant in favor of the imlifidase arm.
- PAES Study Reported Positive OutcomesIn the European PAES imlifidase cohort, graft failure-free survival was 90%, patient survival was 98%, and death-censored graft survival was 92%. Median eGFR at 12 months was 51 mL per minute, kidney function recovered rapidly during the first 30 days and remained stable through 12 months, and no graft was lost due to antibody-mediated rejection.
- No New Safety Signals in ConfIdeS or PAESIn both the ConfIdeS and PAES studies, the company reported that no imlifidase infusion was interrupted or discontinued due to an adverse event and that no new safety signals were detected. In PAES, imlifidase was described as well tolerated, with patient survival of 98%.
- GBS Program Reached IND SubmissionHansa submitted an IND to the FDA on October 20, 2026, for a Phase IIa study of HNSA-5487 in Guillain-Barre syndrome. The single ascending dose study is planned for 16 patients, with first-patient enrollment anticipated in Q1 2027. The next-generation IgG-cleaving enzyme is designed to produce more than 95% IgG reduction within a few hours and has a significantly reduced antidrug antibody response.
- GBS Development Pathway DefinedThe Phase IIa GBS study is primarily focused on safety and will include efficacy outcomes, with follow-up potentially lasting 3 to 6 months. Management said acceptable safety and evidence of pharmacodynamic IgG cleavage would support moving into a pivotal study, and a Phase III registrational study is expected to follow favorable Phase IIa outcomes.
- U.S. Policy Environment Viewed as SupportiveManagement said the U.S. Kidney Care National Plan is positive for Hansa because it highlights the economic and patient benefits of kidney transplantation, including an estimated $4.7 million economic benefit per kidney transplant, 671 hours saved annually compared with dialysis-related travel and treatment, and $100 billion to $200 billion in potential economic benefits through 2040.
- Gene Therapy Business Development Efforts ExpandedHansa recently added business development resources to explore the broader gene therapy opportunity over the next 12 months, with the goal of potentially entering additional collaborations.
MX:HNSAN Earnings History
| Report Date | Fiscal Quarter | Forecast / EPS | Last Year's EPS | EPS YoY Change | Press Release |
|---|---|---|---|---|---|
| Feb 11, 2027 | 2026 (Q4) | -1.63- | -3.02 | ― | ― |
| Nov 11, 2026 | 2026 (Q3) | -2.64-3.26 | -3.26 | 0.00% (+0.00) | |
| Jul 22, 2026 | 2026 (Q2) | -0.63-4.77 | -4.72 | -1.19% (-0.06) | |
| Apr 23, 2026 | 2026 (Q1) | -2.70-3.60 | -1.03 | -250.91% (-2.57) | |
| Feb 11, 2026 | 2025 (Q4) | -2.94-3.02 | -7.61 | 60.29% (+4.59) | |
| Oct 30, 2025 | 2025 (Q3) | -3.24-3.26 | -2.85 | -14.38% (-0.41) | |
| Jul 17, 2025 | 2025 (Q2) | -3.10-4.72 | -6.15 | 23.33% (+1.44) | |
| Apr 24, 2025 | 2025 (Q1) | -4.98-1.03 | -7.74 | 86.75% (+6.71) | |
| Feb 06, 2025 | 2024 (Q4) | -3.69-7.61 | -4.48 | -70.00% (-3.13) | |
| Oct 17, 2024 | 2024 (Q3) | -4.51-2.85 | -8.91 | 67.99% (+6.06) |
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.
