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olivLaw · European equity research

Hansa Biopharma AB HNSA.ST

Sweden · Nasdaq Stockholm · ISIN SE0002148817 · Vertical: Listed companies from Sweden

39.80SEK+0.15% · 1 dayClose 05 Nov 2026

Hansa Biopharma develops enzymes that cleave immunoglobulin G, aimed at transplant patients with pre-formed antibodies, autoimmune diseases and gene therapy. The current relevance lies in the BLA filed with the FDA for imlifidase, based on the ConfIdeS study with 64 patients, and in the post-authorization study in Europe with 50 patients.

At the close of 05 Nov 2026, Hansa Biopharma AB (HNSA.ST) stock was 39.80 SEK (+0.15% on the day), with market capitalisation 3.2 bn SEK, beta 0.64, 52-week range 24.88–46.68 SEK.

Data as of · AI analysis dated · Source: ESEF annual reports and closing prices, computed by olivLaw.

Market cap
3.2 bn SEK
shares as of 31 Dec 2025
P/E (TTM)
unavailable
Diluted EPS TTM -6.58 · TTM to 31 Dec 2025
E/P (TTM)
-16.53%
TTM to 31 Dec 2025
Dividend yield
unavailable
Beta (2y)
0.64
Volatility (1y) 63%
52-week range
24.8846.68

Price history

Loading chart…

Technical reading

RSI (14)
61.0
strong (55–70)
Bollinger (20, 2)
34.31 – 40.37
in the upper half of the band · %B 0.91 · band width 16.2%
SMA 50 / 200
37.90 / 34.53
uptrend (price > SMA50 > SMA200)
MACD (12, 26, 9)
0.79 / 0.41
MACD above signal

Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).

Performance

CompanyEURO STOXX 50vs EURO STOXX 50Vertical median
1 month+17.6%−0.6%+18.3 pp—
3 months+5.2%−4.2%+9.3 pp—
6 months+39.3%+4.3%+34.9 pp—
Year to date+15.8%+7.5%+8.3 pp—
1 year+35.3%+9.9%+25.4 pp−8.5%
3 years+67.6%+49.8%+17.8 pp+12.3%
5 years−58.3%+42.8%−101.1 pp—
Max drawdown (1y)
−39.3%
12 Feb 2026 → 23 Apr 2026
Max drawdown (5y)
−79.9%
15 Nov 2021 → 13 Oct 2023
Compound annual growth (5y)
−16.1%
EURO STOXX 50 +7.4%

Price returns, dividends excluded.

Quarterly results

ESEF annual reports carry no quarters: the results are annual (below).

E/P over time

E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.

Fiscal years

Fiscal year202320242025
Revenue134.1 m171.3 m222.3 m
Revenue YoYunavailable+27.8%+29.7%
Net income-831.7 m-807.2 m-534.1 m
Net income YoYunavailableunavailableunavailable
Diluted EPS-15.83-12.85-6.58
Diluted EPS YoYunavailableunavailableunavailable
net %-620.3%-471.2%-240.3%
Free cash flow-755.9 m-675.0 m-549.2 m

Balance sheet & financial health

Fiscal year 2025 · 31 Dec 2025

Cash
701.1 m SEK
Financial debt
927.4 m SEK
Net debt
226.3 m SEK
Equity
-89.0 m SEK
Total assets
1.2 bn SEK
Debt / equity
unavailable
Current ratio
1.94x
ROE
unavailable
ROA
-54.3%
FCF margin
-247.1%

Financial statements (source on every figure)

Revenue and net income (SEK)

Margins

Income statement · SEK

Revenue
2023
134.1 m
2024
171.3 m
2025
222.3 m

esef· 26 Oct 2026verified

Cost of revenue
2023
63.1 m
2024
83.6 m
2025
83.6 m

esef· 26 Oct 2026verified

Gross profit
2023
71.0 m ≈
2024
87.8 m ≈
2025
138.7 m ≈

esef· 26 Oct 2026derived

Research & development
2023
411.3 m
2024
375.7 m
2025
304.7 m

esef· 26 Oct 2026verified

Operating income
2023
-788.5 m
2024
-637.9 m
2025
-520.7 m

esef· 26 Oct 2026verified

Interest expense
2023
105.5 m
2024
187.2 m
2025
122.5 m

esef· 26 Oct 2026verified

Pre-tax income
2023
-830.8 m
2024
-804.2 m
2025
-531.8 m

esef· 26 Oct 2026verified

Income tax
2023
908.0 k
2024
3.0 m
2025
2.3 m

esef· 26 Oct 2026verified

Net income
2023
-831.7 m
2024
-807.2 m
2025
-534.1 m

esef· 26 Oct 2026verified

Diluted EPS
2023
-15.83
2024
-12.85
2025
-6.58

esef· 26 Oct 2026verified

Weighted average diluted shares
2023
52.5 m
2024
62.8 m
2025
81.2 m

esef· 26 Oct 2026verified

Balance sheet · SEK

Cash
2023
732.1 m
2024
405.3 m
2025
701.1 m

esef· 26 Oct 2026verified

Inventories
2023
1.5 m
2024
2.6 m
2025
6.1 m

esef· 26 Oct 2026verified

Current assets
2023
855.2 m
2024
467.2 m
2025
796.6 m

esef· 26 Oct 2026verified

Property, plant & equipment, net
2023
6.3 m
2024
4.7 m
2025
2.9 m

esef· 26 Oct 2026verified

Total assets
2023
1.0 bn
2024
800.6 m
2025
1.2 bn

esef· 26 Oct 2026verified

Accounts payable
2023
87.0 m
2024
37.6 m
2025
54.1 m

esef· 26 Oct 2026verified

Short-term debt
2023
—
2024
0
2025
136.9 m

esef· 26 Oct 2026verified

Long-term debt
2023
844.9 m
2024
1.1 bn
2025
790.5 m

esef· 26 Oct 2026verified

Current liabilities
2023
321.0 m
2024
255.7 m
2025
410.7 m

esef· 26 Oct 2026verified

Equity
2023
-167.9 m †
2024
-589.8 m †
2025
-89.0 m †

esef· 26 Oct 2026verified

Shares outstanding at year end
2023
52.5 m
2024
62.8 m
2025
81.2 m

esef· 26 Oct 2026derived

Cash flow · SEK

Operating cash flow
2023
-755.7 m
2024
-674.9 m
2025
-549.2 m

esef· 26 Oct 2026verified

Capex
2023
284.0 k
2024
116.0 k
2025
0

esef· 26 Oct 2026verified

Free cash flow
2023
-755.9 m ≈
2024
-675.0 m ≈
2025
-549.2 m ≈

esef· 26 Oct 2026derived

Investing cash flow
2023
-284.0 k
2024
-116.0 k
2025
0

esef· 26 Oct 2026verified

Financing cash flow
2023
-7.5 m
2024
346.8 m
2025
848.0 m

esef· 26 Oct 2026verified

Computed indicators

Growth

Revenue growth (YoY)
29.7%
computed by olivLawFY 2025
Revenue CAGR 3Y
unavailable
input data missing
Revenue CAGR 5Y
unavailable
input data missing
EBIT growth (YoY)
unavailable
the base of the ratio is not positive
Net income growth (YoY)
unavailable
the base of the ratio is not positive
Net income CAGR 3Y
unavailable
input data missing
Net income CAGR 5Y
unavailable
input data missing
EPS growth (YoY)
unavailable
the base of the ratio is not positive
EPS CAGR 3Y
unavailable
input data missing
EPS CAGR 5Y
unavailable
input data missing
FCF growth (YoY)
unavailable
the base of the ratio is not positive

Profitability

Gross margin
62.4%
computed by olivLawFY 2025
EBITDA margin
unavailable
input data missing
EBIT margin
-234.3%
computed by olivLawFY 2025
Net margin
-240.3%
computed by olivLawFY 2025
FCF margin
-247.1%
computed by olivLawFY 2025

Returns

ROE
unavailable
equity is negative: the ratio is not economically meaningful (not by itself insolvency; usually the result of buybacks)
ROA
-54.3%
computed by olivLawFY 2025 · balance sheet at 31 Dec 2025
ROIC
unavailable
equity is negative: buybacks shrink the invested capital and ROIC would come out large without meaning anything
ROCE
-68.9%
computed by olivLawFY 2025 · balance sheet at 31 Dec 2025
Payout ratio (EPS)
unavailable
input data missing
Payout ratio (FCF)
unavailable
input data missing

Balance sheet

Net debt
226.3 m SEK
computed by olivLawbalance sheet at 31 Dec 2025
Net debt / EBITDA
unavailable
input data missing
Debt / equity
unavailable
equity is negative: the ratio is not economically meaningful (not by itself insolvency; usually the result of buybacks)
Interest coverage
-4.3x
computed by olivLawFY 2025

Liquidity

Current ratio
1.9x
computed by olivLawbalance sheet at 31 Dec 2025
Quick ratio
1.9x
computed by olivLawbalance sheet at 31 Dec 2025
Cash ratio
1.7x
computed by olivLawbalance sheet at 31 Dec 2025

Cash

Operating cash flow
-549.2 m SEK
computed by olivLawFY 2025
Capital expenditure
0 SEK
computed by olivLawFY 2025
Free cash flow
-549.2 m SEK
computed by olivLawFY 2025
FCF conversion
unavailable
insufficient data
Cash conversion
unavailable
input data missing

Efficiency

Days sales outstanding
unavailable
input data missing
Days inventory outstanding
19 days
computed by olivLawFY 2025 · balance sheet at 31 Dec 2025
Days payables outstanding
200 days
computed by olivLawFY 2025 · balance sheet at 31 Dec 2025
Cash conversion cycle
unavailable
input data missing

Market and valuation

Market capitalisation
3.2 bn SEK
computed by olivLawbalance sheet at 31 Dec 2025
Enterprise value
3.5 bn SEK
computed by olivLawbalance sheet at 31 Dec 2025
Market cap / net income TTM
unavailable
insufficient data
P/E (TTM)
unavailable
insufficient data
Earnings yield
-16.5%
computed by olivLawFY 2025
P/B
unavailable
equity is negative: the ratio is not economically meaningful (not by itself insolvency; usually the result of buybacks)
P/S
14.5x
computed by olivLawFY 2025 · balance sheet at 31 Dec 2025
EV/EBITDA
unavailable
input data missing
EV/EBIT
unavailable
insufficient data
EV/Sales
15.6x
computed by olivLawFY 2025 · balance sheet at 31 Dec 2025
P/FCF
unavailable
the base of the ratio is not positive
FCF yield
-17.0%
computed by olivLawFY 2025 · balance sheet at 31 Dec 2025
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero
Shareholder yield (distributions)
unavailable
input data missing

1 indicators that do not apply to the sector.

Valuation

olivLaw classification

Insufficient data
What is missing
  • indicators available: 4 of at least 6
  • score weight coverage: 25.0% of at least 60%
  • valuation methods computed: 0 of at least 1

A scoring methodology on indicators and valuation, not investment advice.

Closing price

39.80 SEK

05 Nov 2026Source: olivLaw, closing series

Market cap: 3.2 bn SEK

Key indicators

Market capitalisation
3.2 bn SEK
computed by olivLawbalance sheet at 31 Dec 2025
P/E (TTM)
unavailable
insufficient data
P/B
unavailable
equity is negative: the ratio is not economically meaningful (not by itself insolvency; usually the result of buybacks)
EV/EBITDA
unavailable
input data missing
ROE
unavailable
equity is negative: the ratio is not economically meaningful (not by itself insolvency; usually the result of buybacks)
Net margin
-240.3%
computed by olivLawFY 2025
Revenue growth (YoY)
29.7%
computed by olivLawFY 2025
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero

Coverage and freshness

27/37 reporting lines present
Latest full fiscal year: 2025
Latest reported period: 31 Dec 2025
Latest balance sheet date: 31 Dec 2025
Share count (cover of the latest filing), as of: 31 Dec 2025
Source: esefpublished 26 Oct 2026
verified 78derived 3

Score by group

25% · Insufficient data

Estimated value range

unavailable — no valuation assumptions for the reporting currency

Valuation assumptions are editorial choices, not measured; beta is not measured.

Valuation methods

    Assumptions (illustrative, editorial)

    Risk-free rate
    6.5%
    Equity risk premium
    6.0%
    Beta (default)
    1.00
    Cost of equity
    12.5%
    Terminal growth
    3.0%

    Factor scorecard

    Insufficient data

    Minimum-evidence gate: indicators available: 4 of at least 6; score weight coverage: 25.0% of at least 60%; valuation methods computed: 0 of at least 1

    FactorValueScoreWeight used
    ROIC · Qualityunavailableunavailable—
    Net margin · Quality-240.3%3 (vs peers)25%
    FCF conversion · Qualityunavailableunavailable—
    Revenue CAGR 3Y · Growthunavailableunavailable—
    EPS CAGR 3Y · Growthunavailableunavailable—
    Net debt / EBITDA · Balance sheetunavailableunavailable—
    Interest coverage · Balance sheet-4.3x0 (on a fixed band)25%
    Current ratio · Balance sheet1.9x95 (on a fixed band)17%
    P/E (TTM) · Valuationunavailableunavailable—
    EV/EBITDA · Valuationunavailableunavailable—
    FCF yield · Valuation-17.0%0 (on a fixed band)33%
    Shareholder yield (distributions) · Returnsunavailableunavailable—
    Payout ratio (FCF) · Returnsunavailableunavailable—

    Factors without a value were dropped; the remaining weights were renormalised.

    Score groups

    • Balance sheet38/100 · 2/3 factors with a value
    • Growth· partialunavailable · 0/2 factors with a value
    • Quality· partial3/100 · 1/3 factors with a value
    • Returns· partialunavailable · 0/2 factors with a value
    • Valuation· partial0/100 · 1/3 factors with a value

    A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.

    Memo

    Hansa Biopharma AB (HNSA.ST). Latest full fiscal year: 2025; data up to 2025-12-31.

    Figures computed from the financial statements: revenue 222.3 m SEK in 2025; YoY growth 29.7%; net margin -240.3%.

    Valuation cannot be computed from the available data.

    Insufficient data for a verdict (indicators available: 4 of at least 6; score weight coverage: 25.0% of at least 60%; valuation methods computed: 0 of at least 1).

    Text generated deterministically from the figures shown; no language model. Not investment advice.

    What supports the thesis

    • Current ratio: 1.9x

    What contradicts it

    • Net margin: -240.3%
    • Interest coverage: -4.3x
    • FCF yield: -17.0%

    Not assessed (insufficient data or a ratio without meaning): ROIC, FCF conversion, Revenue CAGR 3Y, EPS CAGR 3Y, Net debt / EBITDA, P/E (TTM), EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).

    Versus the vertical median

    Listed companies from Sweden · same country · compared with 39 companies

    Multiples and returns vs the median

    P/E
    —
    vertical median 22.9x
    EV/EBITDA
    —
    vertical median 5.3x
    P/S
    14.5x
    vertical median 1.1x
    above median (+1,198.7%)
    P/B
    —
    vertical median 1.4x
    ROE
    —
    vertical median 7.4%
    Net margin
    -240.3%
    vertical median 4.3%
    below median (−5,690.2%)
    EBIT margin
    -234.3%
    vertical median 6.0%
    below median (−3,997.7%)
    Revenue YoY
    29.7%
    vertical median 1.3%
    above median (+2,125.7%)
    Net debt/EBITDA
    —
    vertical median 1.5x
    Dividend yield
    —
    vertical median 2.5%

    Price rebased to 100 (monthly, 5 years)

    Companies in the vertical

    Market capP/EROENet marginRevenue YoY1A / 3A
    ALFA.STAlfa Laval AB223.0 bn27.019.4%11.9%+4.1%+21% / +38%
    BOL.STBoliden Ab143.0 bn15.213.3%10.1%+4.8%+12% / +81%
    CAST.STCastellum Aktiebolag66.6 bn71.01.2%9.8%−2.6%+27% / +6%
    AAK.STAak Ab (publ)47.5 bn13.917.2%7.5%+2.2%−31% / −14%
    CAMX.STCamurus AB42.5 bn58.519.5%32.5%+21.3%+16% / +55%
    BRAV.STBravida Holding AB30.1 bn24.513.7%4.4%−4.9%+84% / +123%
    ASKER.STAsker Healthcare Group AB29.8 bn60.59.8%2.9%+11.7%−18% / unavailable
    ALLEI.STAlleima AB22.7 bn33.84.1%3.6%−5.4%+11% / +19%
    BURE.STBure Equity AB22.6 bn—-21.0%—unavailable+20% / +19%
    AQ.STAQ Group AB19.7 bn29.214.9%7.5%+6.0%+14% / +119%
    ALTRA.STAltra Fastigheter AB18.4 bn33.93.0%15.1%−2.2%+9% / +19%
    ATT.STAttendo AB (publ)16.8 bn20.715.1%4.3%+0.1%+34% / +223%
    AFRY.STAfry Ab14.9 bn18.76.2%3.1%−5.2%−17% / +4%
    ATRLJ-B.STAtrium Ljungberg AB14.0 bn17.12.9%23.9%−2.0%−33% / −44%
    ALIG.STAlimak Group AB (publ)12.7 bn21.38.2%8.8%−3.2%−18% / +50%
    ACAD.STAcadeMedia AB12.7 bn15.512.7%4.3%+9.7%+22% / +138%
    APOTEA.STApotea AB (publ)10.7 bn46.831.3%3.2%+10.1%+15% / unavailable
    BOOZT.STBoozt AB10.6 bn37.910.4%3.6%+0.5%+58% / +44%
    BUFAB.STBufab AB (publ)5.0 bn9.215.1%6.9%−7.4%+36% / +110%
    ACTI.STActive Biotech AB (publ)4.9 bn—-84.5%—unavailable−32% / −77%
    CEVI.STCellaVision AB4.7 bn30.818.0%20.2%+4.9%+20% / +12%
    COOR.STCoor Service Management Holding AB4.7 bn18.213.0%2.2%+16.7%+1% / +25%
    BHG.STBHG Group AB4.5 bn31.12.5%1.4%+6.2%−18% / +113%
    HNSA.STHansa Biopharma AB3.2 bn——-240.3%+29.7%+18% / +55%
    CARA.STCarasent AB (publ)1.8 bn51.74.1%10.1%+24.9%−8% / +87%

    1- and 3-year price returns: for HNSA.ST from daily closes (the same as the performance table), for the other companies from month-end closes.

    olivLaw engine forecast

    The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.

    The engine has no published run for this company yet.

    Valuation scenarios (editable assumptions)

    Illustrative scenarios

    Illustrative: not forecasts and without probabilities. Each case is one coherent set of assumptions, computed on today's figures.

    Bear
    Allowed range: -50 … 50%
    Allowed range: -100 … 100%
    Allowed range: 0 … 100
    Allowed range: -10 … 20%
    Allowed range: 0 … 100%
    Base
    Allowed range: -50 … 50%
    Allowed range: -100 … 100%
    Allowed range: 0 … 100
    Allowed range: -10 … 20%
    Allowed range: 0 … 100%
    Bull
    Allowed range: -50 … 50%
    Allowed range: -100 … 100%
    Allowed range: 0 … 100
    Allowed range: -10 … 20%
    Allowed range: 0 … 100%
    Nothing is saved.

    Estimated price (SEK)

    Estimated priceBearBaseBull
    1 years
    insufficient data
    Total return unavailable · Per year unavailable
    insufficient data
    Total return unavailable · Per year unavailable
    insufficient data
    Total return unavailable · Per year unavailable
    3 years
    insufficient data
    Total return unavailable · Per year unavailable
    insufficient data
    Total return unavailable · Per year unavailable
    insufficient data
    Total return unavailable · Per year unavailable
    5 years
    insufficient data
    Total return unavailable · Per year unavailable
    insufficient data
    Total return unavailable · Per year unavailable
    insufficient data
    Total return unavailable · Per year unavailable
    What moves the 3-year price the most

      AI analysis

      AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

      In brief

      Hansa Biopharma develops enzymes that cleave immunoglobulin G, aimed at transplant patients with pre-formed antibodies, autoimmune diseases and gene therapy. The current relevance lies in the BLA filed with the FDA for imlifidase, based on the ConfIdeS study with 64 patients, and in the post-authorization study in Europe with 50 patients.

      SWOT

      Strengths

      • The proprietary IgG cleaving platform has clinical and regulatory validation in several indications, and the company already has a conditionally approved product in Europe 1.
      • Partnerships with gene therapy companies and research institutions extend the uses of the technology without depending on a single indication 1.
      • Clinical evidence from the ConfIdeS study compares favorably with deceased donor transplants at one year, which supports the medical argument 1.

      Weaknesses

      • Dependence on a small number of products and indications means that negative results, such as those from GOOD-IDES-02, carry significant impact 1.
      • Evidence for some indications remains limited to studies with small patient numbers or early-stage trials 1.
      • Commercial launch requires market organization and reimbursement in each country, which can slow adoption 1.

      Opportunities

      • Full approval in Europe and in the US could widen access for sensitized patients who today do not receive an organ 1.
      • Results in gene therapy and autoimmune diseases could open new markets if clinical studies confirm the enzymes' effect 1.
      • Rising incidence of autoimmune diseases can support demand for treatments that quickly reduce autoantibodies 1.

      Threats

      • Competition from immunomodulatory therapies and standard desensitization could quickly limit clinical adoption 1.
      • If the FDA requests additional data, the approval timeline could be delayed, affecting financing 1.
      • Clinical setbacks in other indications could reduce confidence among investors and partners 1.

      Risks

      • FDA decision on imlifidasehigh

        The BLA filed in December 2025 is under the FDA accelerated process, and the outcome is uncertain and could require additional data 1.

      • Post-authorization data in Europemedium

        Moving from conditional to full approval depends on the PAES study results, expected in mid-2026, and could be delayed if the data are weak 1.

      • Failure in anti-GBMmedium

        The GOOD-IDES-02 study missed its primary endpoint, and indication expansion depends on evaluating the data before deciding on next steps 1.

      • Dependence on partnersmedium

        Gene therapy programs depend on external partners such as Sarepta and Genethon, whose priorities may change project timelines 1.

      • Market access and reimbursementlow

        Even if imlifidase is approved, adoption depends on health systems and reimbursement, which can be slow or restrictive 1.

      Investment thesis

      What would need to be true (bull case)

      • If FDA approval is confirmed, the company could offer the first option with clinical evidence for patients with very high sensitization 1.
      • The IgG-cleaving technology can be applied across several areas, from transplant to gene therapy and autoimmune disease, which widens the portfolio's potential 1.
      • Partnerships with gene therapy companies could bring external validation and revenue for niche indications 1.

      What would break the thesis

      • The partial failure in the anti-GBM study shows that clinical benefit is not assured in every indication and that results can be inconsistent 1.
      • If the FDA or European authorities request further data, the commercial timeline could be pushed back and financing could become more costly 1.
      • Competition from standard treatments and new therapies could quickly limit market share, especially if the cost is high 1.

      What to watch

      • FDA decision on the imlifidase BLA2026
      • PAES study results for imlifidase in Europemid-2026
      • Evaluation of GOOD-IDES-02 data and next steps in anti-GBMnext 10-K
      • Clinical progress of HNSA-5487 in Guillain-Barré syndrome2027

      Products, market & competition

      AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

      The business

      Hansa Biopharma is a biopharmaceutical company whose activity rests on its proprietary immunoglobulin G (IgG) cleaving technology. The lead product, imlifidase (IDEFIRIX), targets highly sensitized patients waiting for a kidney transplant, and the company has started commercial rollout in Europe, where it also runs a post-authorization study to support the move from conditional to full approval 1. In December 2025 the company filed a BLA with the FDA under the accelerated process, based on the ConfIdeS study 1.

      The strategy extends beyond transplant to gene therapy and autoimmune diseases. IgG-cleaving enzymes are proposed as a way to reduce anti-AAV antibodies that block gene therapy vectors, and in autoimmune diseases the next-generation candidate HNSA-5487 has been directed toward Guillain-Barré syndrome 1.

      Development is organized across several partnered programs, including with Sarepta Therapeutics for DMD gene therapy and with Genethon for Crigler-Najjar syndrome, which spreads risk beyond a single product 1.

      Segments

      Transplantation

      Imlifidase is the main commercial and regulatory product. The ConfIdeS study formed the basis of the BLA, and the post-authorization study in Europe follows graft survival in highly sensitized patients 1.

      Gene therapy

      The programs with Sarepta and Genethon test imlifidase as a pre-treatment before gene therapy administration to remove anti-AAV antibodies. This is a secondary market with clinical validation still at early stages 1.

      Autoimmune diseases

      In this area HNSA-5487 is in the planning phase of clinical development for Guillain-Barré syndrome, where standard treatment relies on IVIg or plasmapheresis 1.

      Market context

      The kidney transplant market for sensitized patients is small but carries high medical need, since many patients wait years for a compatible organ. Dialysis remains the main option before transplant, with five-year survival of about 45 %, which makes removing the immunological barrier clinically valuable 1.

      Adjacent markets such as gene therapy for rare diseases and autoimmune conditions with IgG autoantibodies show growing demand, but access depends on clinical validation and reimbursement, which are not yet established 1.

      Trends

      • Rising autoimmune disease burdentailwind

        The incidence of autoimmune diseases is rising and healthcare costs grow with it, which could support demand for new treatments that rapidly reduce pathogenic IgG 1.

      • Accelerated and conditional approvalsmixed

        The FDA accelerated process and conditional approval in Europe could shorten the path to market, but they oblige the company to deliver solid post-authorization data 1.

      • Anti-AAV barriers in gene therapytailwind

        Anti-AAV antibodies block a share of patients eligible for gene therapy, creating an opportunity for IgG-cleaving enzymes if partnered clinical work confirms the effect 1.

      • Variable clinical resultsheadwind

        The GOOD-IDES-02 study in anti-GBM did not reach its primary endpoint at 6 months, and this result could limit indication expansion if later data are unfavorable 1.

      Competitive position

      The main alternatives for sensitized patients are desensitization with plasmapheresis and IVIg, methods described as demanding and often insufficient. For gene therapy, competition comes from strategies that avoid anti-AAV antibodies, and for autoimmune disease from standard treatments and other enzymes or immunomodulatory therapies 1.

      The company's stated advantage is that imlifidase achieved one-year graft function comparable to matched deceased donor transplants, but long-term evidence and market access will determine its real competitive position 1.

      • Sarepta TherapeuticsSRPT

        Partner in the imlifidase program for pre-treating patients with anti-AAV antibodies before ELEVIDYS, and a relevant actor in DMD gene therapy 1.

      • Genethon

        French research organization, partner in the GNT-018-IDES study for Crigler-Najjar syndrome; not listed on a US exchange 1.

      • Standard IVIg and plasmapheresis treatments

        Non-specific approaches used today in desensitization and in Guillain-Barré syndrome, forming the main clinical alternative 1.

      • AAV vector and gene therapy producers

        Companies developing AAV-based gene therapies that could benefit from reduced antibodies but may also develop their own strategies 1.

      News & filings

      In the press

      Annual reports (ESEF)

      Sources

      1. [1] Annual report, fiscal year ended 2025-12-31 (ESEF) · SEC / Hansa Biopharma AB · 31 Dec 2025

      Figures computed by olivLaw from ESEF annual reports and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.