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Hansa Biopharma AB (SE:HNSA)
:HNSA

Hansa Biopharma AB (HNSA) AI Stock Analysis

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SE:HNSA

Hansa Biopharma AB

(HNSA)

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Neutral 56 (OpenAI - 5.2)
Rating:56Neutral
Price Target:
kr41.00
▲(24.32% Upside)
Action:ReiteratedDate:02/18/26
The score is held back primarily by weak financial fundamentals (heavy losses, cash burn, and negative equity/high leverage). Offsetting this are constructive technical momentum and a relatively positive earnings-call outlook driven by 2026 regulatory/commercial catalysts and improved funding runway, while valuation remains difficult to assess due to negative earnings.
Positive Factors
Revenue Growth & Gross Margin
Sustained top-line expansion and a ~62% gross margin indicate product-market traction for Idefirix and improving unit economics. Durable revenue scaling reduces dependence on one-off events and underpins a path toward operating leverage if commercial execution continues and fixed costs are absorbed.
BLA Submission & U.S. Launch Readiness
A completed BLA submission and active U.S. launch preparations materially expand the addressable market beyond Europe. Building commercial infrastructure and pursuing NTAP/coverage are structural moves that, if successful, can transform recurring revenue potential and diversify geographic cash flows over the medium term.
Equity Raise and Operational Runway
A substantial equity financing and ~SEK 701M cash position materially reduce near-term refinancing risk and provide runway to reach regulatory and commercial inflection points. This funding enables continued commercialization investment and trial activity without immediate dependence on dilutive or costly short-term debt.
Negative Factors
Negative Equity & High Leverage
Persistently negative equity and substantial debt materially weaken the capital structure, limiting financial flexibility. This structural imbalance raises refinancing and covenant risks, increases cost of capital, and constrains the company's ability to invest or absorb delays in commercial rollouts or regulatory timelines.
Persistent Negative Cash Flow
Consistent negative operating and free cash flow implies ongoing reliance on external financing. Even with recent fundraising, continued cash burn increases dilution risk and creates execution pressure: missed commercial milestones or slower uptake would quickly stress runway and force unfavorable capital raises.
Pipeline Setback: Anti‑GBM Phase III Failure
A failed Phase III removes a potential label expansion and reduces pipeline optionality, leaving the company more dependent on imlifidase commercial success. This structural loss of diversification increases revenue concentration risk and heightens the impact of any commercial or regulatory setbacks for the lead product.

Hansa Biopharma AB (HNSA) vs. iShares MSCI Sweden ETF (EWD)

Hansa Biopharma AB Business Overview & Revenue Model

Company DescriptionHansa Biopharma AB (publ), a biopharmaceutical company, develops immunomodulatory treatments for enabling transplants and rare immunoglobulin G (IgG)-mediated autoimmune conditions, gene therapy, and cancer using its proprietary enzyme technology platform. The company's lead drug candidate is Imlifidase, an antibody cleaving enzyme therapy that is in phase 3 clinical trial for use in sensitized kidney transplantations patients, as well as for anti-GBM antibody disease; and phase 2 clinical trial for antibody-mediated kidney transplant rejection and Guillain Barré syndrome. It is also developing Novel immunoglobulin cleaving enzymes for Repeat dosing (NiceR) for the treatment of autoimmune diseases, transplantation, and oncology; and Enzyme based antibody Enhancement (EnzE), which is cancer immunotherapy. The company has a preclinical research collaboration agreement with argenx BV to evaluate the therapeutic potential of combining the two companies' IgG-modulating technologies. Hansa Biopharma AB (publ) was incorporated in 2007 and is headquartered in Lund, Sweden.
How the Company Makes MoneyHansa Biopharma generates revenue primarily through the commercialization of its therapeutics, particularly imlifidase, which is being marketed for use in kidney transplantation and other indications. The company may also earn revenue through strategic partnerships and collaborations with larger pharmaceutical firms, which can involve upfront payments, milestone payments based on developmental progress, and royalties from product sales. Additionally, Hansa Biopharma is likely to engage in research agreements and licensing deals that can provide supplementary income as it expands its pipeline of enzyme-based therapies.

Hansa Biopharma AB Earnings Call Summary

Earnings Call Date:Feb 11, 2026
(Q4-2025)
|
% Change Since: |
Next Earnings Date:Apr 23, 2026
Earnings Call Sentiment Positive
The call presented multiple strong positives: substantial quarter and full-year revenue growth, a successful SEK 671.5M equity raise providing runway into 2027, a BLA submission to the FDA and active U.S. launch preparations, reduced R&D spend and improvement in operating loss, plus upcoming data readouts and European access wins. Offsetting these are material negatives including a failed Phase III in anti‑GBM (no further trials planned), notable commercial headwinds and near-term variability in Europe (notably Germany), ongoing operating losses and cash burn, and reimbursement/pricing uncertainties in the U.S. Overall, management conveyed confidence and a clear plan to execute in 2026, but execution and regulatory outcomes remain key dependencies.
Q4-2025 Updates
Positive Updates
Strong Q4 and Full-Year Revenue Growth
Q4 total revenue SEK 76.0M (up 135% YoY) with Idefirix product sales SEK 61.1M in Q4 (up 139% YoY). Full-year total revenues SEK 222.3M (~USD 25M), reported as a 46% increase versus 2024; full-year product sales reported at SEK 204.7M (company-stated ~46% increase vs prior year).
Successful Equity Financing and Strong Cash Position
Completed a direct share issue of SEK 671.5M (~USD 71.3M) in Q4 2025. Cash and cash equivalents totaled SEK 701M at December 31, 2025; company says this financing funds operations into 2027.
BLA Submission and U.S. Launch Readiness
BLA for Imlifidase submitted to FDA in December 2025; awaiting acceptance and PDUFA date. Pre-commercial U.S. activities underway: NTAP application planned, market-access and field teams expanding, SVP of commercial hired, and supply/distribution planning in progress. Company notes 200 U.S. transplant centers (100 drive 80% of volume) and detailed center-level data to target launch.
Improved Cost Discipline and Reduced R&D Spend
Full-year R&D expense SEK 304.7M in 2025 (reported down ~19% vs 2024). Q4 R&D SEK 74.4M (down 26% YoY). Full-year operating loss SEK 521M, improved by SEK 116M (18%) vs 2024; Q4 operating loss ~SEK 125M, improved ~28% YoY—company attributes improvements to strong revenue growth and expense control.
Robust Clinical & Data Milestones
ConfIdeS trial in the U.S. reported positive readout and data generation; 5-year Idefirix data published (Transplant International). PAES European Phase III readout and additional real-world data expected in 2026. Company plans development of HNSA-5487 toward a late-stage GBS trial in 2026.
European Market Access and Commercial Wins
Reimbursement now secured in 24 countries. Catalonia (Spain) temporary funding approved (logistics/invoicing setup ongoing). Slovakia reimbursement gained in Q4. French ANSM granted special reimbursement for lung transplant use (off-label pathway), indicating KOL-driven access opportunities.
Organizational and Operational Strengthening
Senior leadership strengthened, debt facility renegotiated, European commercial organization reorganized (Max Sakajja appointed to lead Europe/international), and two equity raises completed—company frames 2025 as a year of transformation to position for global competition and execution.
Negative Updates
Anti‑GBM (Goodpasture) Phase III Trial Did Not Meet Primary or Key Secondary Endpoints
Phase III anti‑GBM study (50 randomized; 49 in full analysis set) failed to reach the primary endpoint (eGFR at 6 months) and key secondary (proportion with functioning kidney at 6 months). No difference in end-stage kidney disease or death within 6 months. Company does not plan further trials in anti‑GBM and is analyzing subgroups.
European Commercial Challenges and Near-Term Revenue Variability
Company acknowledged an 'unusual' European launch with limited clinical experience at launch and a large ongoing Phase III that constrained initial commercial uptake. Management expects relatively weak revenues in Q1 2026 as reorganization and change management initiatives roll out, with hopes for stronger H2 2026.
Germany: Access Disruption and Uncertain Timeline
Germany paused participation in the Eurotransplant Priority Program for highly sensitized patients in 2025, creating a material headwind in a major market. Reinstatement depends on administrative decisions (Bundesrat) with no short-term path to accelerate; KOL-driven ECA guideline work may take until H1 2026 to provide clarity.
Cash Burn and Ongoing Operating Loss Despite Improvement
Cash used in operations reported at SEK 149M for Q4 (and SEK 149M for the full year as stated); full-year operating loss remained SEK 521M despite improvement. Continued reliance on regulatory approvals and successful commercialization to realize profitability.
Reimbursement and Pricing Uncertainties in the U.S.
U.S. reimbursement pathway (DRG, outlier payments, NTAP) is established but outcomes are center- and state-dependent. Coverage/amounts via outlier payments are variable and not guaranteed; NTAP approval is not assured. Pricing discussions and research ongoing; MFN concerns noted but not expected to be immediate material risk.
External Partnership Timing Uncertain
Sarepta collaboration next steps remain under review; timeline for clear communication is unclear due to Sarepta's regulatory priorities, creating uncertainty around that external program's progress.
Company Guidance
Management guided that they expect several 2026 inflection points — FDA acceptance/PDUFA date expected shortly for the Dec 2025 BLA and the company aims to be launch‑ready at PDUFA, plans a late‑stage GBS trial for HNSA‑5487 before year‑end, and expects a relatively weak Q1 2026 followed by a strong H2 2026 as European commercial reorganizations take effect. Key metrics: FY2025 total revenue SEK 222.3m (~$25m, +46% vs 2024) with product sales SEK 204.7m (+46% vs SEK 104.1m); Q4 2025 total revenue SEK 76m (+135% YoY) including Idefirix product sales SEK 61.1m (+139%) and contract sales SEK 14.9m; completed equity raise SEK 671.5m (~USD 71m) funding operations into 2027 and ending cash SEK 701m; cash used in operations SEK 149m; R&D FY SEK 304.7m (‑19% YoY) and Q4 R&D SEK 74.4m (‑26%); SG&A Q4 SEK 101.6m (+15%), FY SEK 357m (+4%, excluding SEK 21m restructuring); operating loss FY SEK 521m (‑18% YoY) and Q4 ~SEK 125m (‑28%). U.S. launch planning targets 200 transplant centers (100 drive 80% of volume; 25 ConfIdeS centers = 25% volume), an addressable U.S. pool of ~15,000 patients with cPRA>80% (7,000 >98%; 3,500 most sensitized), ~27,000 annual transplants, NTAP pursued for Medicare, and a European list‑price reference of ~USD 350,000 per treatment.

Hansa Biopharma AB Financial Statement Overview

Summary
Revenue growth and solid gross margin are positives, but the financial profile is dominated by deep ongoing losses, persistent negative operating/free cash flow, and a pressured capital structure with negative equity and substantial debt—raising funding and balance-sheet risk.
Income Statement
28
Negative
Revenue is scaling quickly (up ~24% in 2025 after growth in 2024), and gross margin remained solid in 2025 (~62%). However, profitability is still very weak: operating results and net income are deeply negative each year, with 2025 net margin around -238% (an improvement vs. 2024’s ~-471% and 2023’s ~-620%, but still highly loss-making). Overall, the top-line trajectory is improving, but the business has not yet demonstrated a path to sustainable operating leverage.
Balance Sheet
18
Very Negative
The balance sheet is pressured by high leverage alongside negative equity in recent years (equity turned negative from 2023 onward), which materially increases financial risk and limits flexibility. Total debt remains substantial (roughly 0.8–1.1bn over 2022–2025), and negative equity makes leverage indicators unfavorable and signals a thinner capital buffer. While total assets increased in 2025 versus 2024, the capital structure remains the key weakness.
Cash Flow
22
Negative
Cash generation is consistently negative, with operating cash flow and free cash flow both materially below zero every year (2025 operating/free cash flow about -549m). Cash burn improved versus 2024 (less negative), but free cash flow growth has been volatile and turned sharply negative in 2025. Free cash flow is also negative in absolute terms despite net losses, reinforcing that the company likely depends on external funding to sustain operations.
BreakdownDec 2025Dec 2024Dec 2023Dec 2022Dec 2021
Income Statement
Total Revenue222.26M171.32M134.09M154.53M33.88M
Gross Profit138.71M87.76M70.95M116.05M18.45M
EBITDA-409.35M-642.07M-714.55M-554.26M-538.83M
Net Income-529.25M-807.24M-831.72M-611.13M-548.28M
Balance Sheet
Total Assets1.17B800.64M1.02B1.69B1.01B
Cash, Cash Equivalents and Short-Term Investments701.08M405.28M732.06M1.50B888.96M
Total Debt933.82M1.08B866.77M791.09M35.38M
Total Liabilities1.25B1.39B1.19B1.08B255.24M
Stockholders Equity-84.13M-589.83M-167.88M602.91M757.57M
Cash Flow
Free Cash Flow-549.17M-675.00M-755.94M-506.06M-483.57M
Operating Cash Flow-549.17M-674.88M-755.65M-502.73M-481.17M
Investing Cash Flow0.00-116.00K-284.00K229.31M-2.40M
Financing Cash Flow847.96M346.81M-7.54M1.12B-4.86M

Hansa Biopharma AB Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price32.98
Price Trends
50DMA
34.30
Negative
100DMA
33.24
Negative
200DMA
31.06
Positive
Market Momentum
MACD
-0.95
Positive
RSI
45.64
Neutral
STOCH
27.01
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For SE:HNSA, the sentiment is Neutral. The current price of 32.98 is below the 20-day moving average (MA) of 34.93, below the 50-day MA of 34.30, and above the 200-day MA of 31.06, indicating a neutral trend. The MACD of -0.95 indicates Positive momentum. The RSI at 45.64 is Neutral, neither overbought nor oversold. The STOCH value of 27.01 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for SE:HNSA.

Hansa Biopharma AB Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
59
Neutral
kr2.07B9.60167.77%2687.51%
56
Neutral
kr3.14B-5.27-5.69%21.58%
55
Neutral
kr1.07B7.0781.19%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
47
Neutral
kr1.42B-5.81-36.52%533.73%20.92%
44
Neutral
kr2.87B-5.68-71.87%-91.85%-6.65%
44
Neutral
kr1.01B-7.05-35.03%25.14%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
SE:HNSA
Hansa Biopharma AB
32.98
9.54
40.70%
SE:BINV
BioInvent International AB
22.30
-3.40
-13.23%
SE:SANION
Saniona AB
16.38
9.10
125.00%
SE:VICO
Vicore Pharma Holding AB
10.20
2.68
35.64%
SE:XSPRAY
Xspray Pharma AB
25.15
-5.00
-16.59%
SE:CANTA
Cantargia AB
4.04
2.44
152.50%

Hansa Biopharma AB Corporate Events

Hansa Biopharma Wins FDA Review Acceptance for Imlifidase Kidney Transplant Therapy
Feb 18, 2026

Hansa Biopharma has had its Biologics License Application for imlifidase accepted for review by the U.S. Food and Drug Administration, a key regulatory milestone for its first-in-class IgG-cleaving enzyme therapy. The filing is backed by pivotal Phase 3 ConfIdeS data showing significantly improved kidney function and dialysis independence in highly sensitized kidney transplant patients, potentially strengthening Hansa’s position in transplant medicine and expanding treatment options for those who struggle to receive compatible organs.

Imlifidase, already conditionally approved as IDEFIRIX in several European markets as well as in Australia and Switzerland, is designed to rapidly inactivate donor-specific antibodies to enable HLA-incompatible kidney transplantation. The FDA’s acceptance of the application, supported by a generally well-tolerated safety profile and long-term follow-up commitments, underscores regulatory momentum that could translate into broader global adoption and greater access for end-stage renal disease patients facing long wait times for transplantation.

The most recent analyst rating on (SE:HNSA) stock is a Hold with a SEK40.00 price target. To see the full list of analyst forecasts on Hansa Biopharma AB stock, see the SE:HNSA Stock Forecast page.

Hansa Biopharma Delivers Strong Q4 Growth and Files FDA Application for Imlifidase
Feb 11, 2026

Hansa Biopharma reported a strong fourth quarter, with revenue rising 135% year-on-year to 76.0 MSEK and full-year revenue reaching 222.3 MSEK, driven by 46% growth in IDEFIRIX product sales and broader uptake across key European markets, including Germany and progress on temporary funding in Catalunya, Spain. The company strengthened its balance sheet via a directed share issue of about 671.5 MSEK, reorganized its European and international commercial and medical affairs leadership, and ended the year with 701.1 MSEK in cash and short-term investments, while still posting a full-year loss of 529.3 MSEK as it invests in pipeline expansion.

Strategically, Hansa submitted a Biologics License Application to the U.S. FDA for imlifidase in desensitization of highly sensitized kidney transplant candidates, with a potential priority review decision that could set a PDUFA date as early as August 2026 and a European confirmatory PAES trial readout expected mid-2026. The clinical portfolio advanced with initial data from the GNT-018-IDES gene therapy pre-treatment trial in Crigler–Najjar syndrome demonstrating rapid AAV antibody removal, a decision to progress HNSA-5487 into Guillain-Barré syndrome following planned FDA discussions, and a setback in the anti-GBM Phase 3 study where the primary endpoint was not met due to unexpectedly strong outcomes from optimized standard of care, underscoring both the promise and risk in Hansa’s rare disease pipeline for investors and patients.

The most recent analyst rating on (SE:HNSA) stock is a Hold with a SEK36.00 price target. To see the full list of analyst forecasts on Hansa Biopharma AB stock, see the SE:HNSA Stock Forecast page.

Hansa Biopharma Sets February Date for 2025 Year-End Results Call
Jan 26, 2026

Hansa Biopharma will publish its year-end report for January–December 2025 on 11 February 2026 and hold a conference call the same day, during which senior management will review financial results and provide an update on the company’s business and development pipeline. The webcasted presentation, supported by slides available on the company’s website, underscores Hansa’s efforts to maintain transparency with investors and other stakeholders as it advances its IgG-cleaving enzyme platform and late-stage assets in rare immunological diseases.

The most recent analyst rating on (SE:HNSA) stock is a Hold with a SEK37.00 price target. To see the full list of analyst forecasts on Hansa Biopharma AB stock, see the SE:HNSA Stock Forecast page.

Hansa Biopharma Wins 2025 SwedenBIO Award as Late-Stage Pipeline Advances
Jan 22, 2026

Hansa Biopharma has been awarded the 2025 SwedenBIO Award, recognizing the company’s role in converting Swedish scientific excellence into global medical impact through its pioneering enzyme technology that enables life-saving transplantation for highly sensitized patients. The accolade underscores Hansa’s growing international profile and momentum going into 2026, as it advances strong U.S. Phase 3 data, prepares for an FDA review, and anticipates a key Phase 3 readout from its European trial later this year—developments that could further strengthen both the company’s commercial position and Sweden’s standing as a leader in life science innovation.

The most recent analyst rating on (SE:HNSA) stock is a Hold with a SEK36.00 price target. To see the full list of analyst forecasts on Hansa Biopharma AB stock, see the SE:HNSA Stock Forecast page.

Hansa Biopharma Files FDA BLA for Imlifidase in High-Risk Kidney Transplant Patients
Dec 19, 2025

Hansa Biopharma has submitted a Biologics License Application to the U.S. Food and Drug Administration for imlifidase as a desensitization treatment for highly sensitized adult patients undergoing deceased donor kidney transplantation, and has requested priority review following Fast Track and Orphan Drug designations. The application is backed by the pivotal U.S. Phase 3 ConfIdeS trial, which showed significantly improved kidney function and dialysis independence at 12 months versus control, reinforcing imlifidase’s potential to reshape access to transplantation for this hard‑to‑treat population and to expand Hansa’s presence in the U.S. renal transplant market if approval is granted.

The most recent analyst rating on (SE:HNSA) stock is a Buy with a SEK111.00 price target. To see the full list of analyst forecasts on Hansa Biopharma AB stock, see the SE:HNSA Stock Forecast page.

Hansa Biopharma to Present at J.P. Morgan Healthcare Conference to Boost Investor Visibility
Dec 19, 2025

Hansa Biopharma AB announced that CEO Renée Aguiar-Lucander will present at J.P. Morgan’s 44th Annual Healthcare Conference in San Francisco on 14 January 2026, joined by key members of the executive team including the CFO, COO, CMO and CLO. Participation in this high-profile investment conference, alongside one-on-one meeting opportunities arranged through a neighboring corporate access event, underscores Hansa’s efforts to raise its visibility among global healthcare investors and industry leaders as it advances its pipeline of treatments for rare immunological diseases.

The most recent analyst rating on (SE:HNSA) stock is a Buy with a SEK111.00 price target. To see the full list of analyst forecasts on Hansa Biopharma AB stock, see the SE:HNSA Stock Forecast page.

Hansa Biopharma’s Phase 3 Trial for Anti-GBM Disease Shows Mixed Results
Dec 16, 2025

Hansa Biopharma announced that its Phase 3 trial for the treatment of anti-glomerular basement membrane (anti-GBM) disease with imlifidase did not meet its primary endpoint of improving renal function. Despite this, the trial showed that 60% of patients treated with imlifidase and standard care did not require dialysis at six months, a significant improvement over historical outcomes. The trial’s results highlight the potential benefits of aggressive treatment for anti-GBM patients, though the imlifidase treatment did not achieve statistically significant results. The company remains optimistic about imlifidase’s potential in other areas, such as gene therapy and kidney transplantation.

The most recent analyst rating on (SE:HNSA) stock is a Hold with a SEK31.00 price target. To see the full list of analyst forecasts on Hansa Biopharma AB stock, see the SE:HNSA Stock Forecast page.

Hansa Biopharma Strengthens European and International Operations
Dec 15, 2025

Hansa Biopharma AB announced a reorganization of its European and International Commercial and Medical Affairs operations to enhance performance and predictability in 2026. The changes include appointing Max Sakajja as Vice President, General Manager Europe and International, and implementing operational adjustments to improve accountability and collaboration. These strategic moves aim to support the company’s growth in Europe and the UK, improve transparency and forecasting, and position Hansa Biopharma for sustainable revenue growth.

The most recent analyst rating on (SE:HNSA) stock is a Hold with a SEK31.00 price target. To see the full list of analyst forecasts on Hansa Biopharma AB stock, see the SE:HNSA Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Feb 18, 2026