QURENasdaqPharmaceutical PreparationsUS GAAP · USD

uniQure N.V.

uniQure N.V. is a gene therapy company focused on developing and commercializing treatments for severe genetic and other diseases. Its business centers on adeno-associated virus (AAV) gene therapy programs, including clinical-stage candidates and a marketed therapy, with operations spanning the United States and Europe.

Ask about the company
Revenue16.1m USD
−40.6 %y/y
Operating profit (EBIT)-185m USD
−0.6 %y/y
EBIT margin-1,151.4%
−471.8 ppy/y
Net income-199m USD
+16.9 %y/y
Free cash flow-178m USD
+4.1 %y/y

Fiscal year 2025 · change from previous year

Development 2020–2025

-400-2000200400600m USD2020: 38 m USD2020: EBIT -125 m USD20202021: 524 m USD2021: EBIT 311 m USD20212022: 106 m USD2022: EBIT -143 m USD20222023: 16 m USD2023: EBIT -283 m USD20232024: 27 m USD2024: EBIT -184 m USD20242025: 16 m USD2025: EBIT -185 m USD202516-185
RevenueOperating profit (EBIT)
Ask Clarifo about uniQure N.V.

Business

Share of revenue
Clinical-stage gene therapy programs70 %

Research, development, and clinical testing of AAV-based therapies for rare and severe diseases.

Commercial royalty and license revenue20 %

Royalty and license income tied to HEMGENIX® sales under collaboration arrangements.

Collaboration and development services10 %

Services performed for partners under development and supply agreements.

Products

Reported · share of revenue
99.0%FY2025100 %
  • License99.0 %
  • Collaborative Revenue1.0 %

Source: 10-K FY2025, revenue the company reports per product line (SEC XBRL). Shares are of the lines shown and add up to 100 %.

Customers

uniQure’s direct customers are primarily pharmaceutical partners and collaborators, while the eventual end users are patients treated through healthcare providers. In its commercial model, third-party payers, physicians, and specialty treatment centers are important because they influence adoption and reimbursement for approved therapies. The company also relies on contract manufacturing and development counterparties to execute clinical and supply activities.

Pharmaceutical collaboration partners

Partners like CSL Behring that buy development, supply, or royalty-linked rights under collaboration agreements.

Healthcare providers and physicians

Specialists who recommend and administer gene therapies once products are approved.

Third-party payers

Insurers and reimbursement bodies that influence access and commercial uptake of approved therapies.

Patients with rare genetic diseases

Patients targeted by the company’s gene therapy pipeline, including Huntington’s disease and other rare disorders.

Clinical and manufacturing service providers

CROs, CMOs, and other vendors that conduct trials, manufacture materials, and support development.

Strategy

uniQure’s strategy is centered on advancing its lead gene therapy programs through clinical development and regulatory review, with AMT-130 a key focus. It also seeks to monetize approved or partnered assets through collaboration, license, and royalty arrangements while using external service providers for development and manufacturing execution. The company’s direction depends on converting scientific data into regulatory and commercial milestones.

Advance AMT-130 for Huntington’s diseaseShort term

The lead program is central to the company’s clinical and commercial value creation.

Expand and progress the gene therapy pipelineMedium term

A broader pipeline reduces dependence on a single asset and supports long-term optionality.

Monetize partnered assets and royalty streamsMedium term

Partnered programs can generate non-dilutive revenue and validate the platform.

Manage external execution riskShort term

Clinical and manufacturing outcomes depend heavily on third-party service providers.

Geography

uniQure operates across the United States and Europe, where it runs clinical development and supports partner-related activities. Its reporting also reflects meaningful euro and U.S. dollar exposure, indicating a cross-border operating structure and foreign exchange sensitivity. The company’s clinical programs, regulatory interactions, and supply arrangements are tied to both U.S. and European markets.

Risks

uniQure is highly dependent on the clinical success of AMT-130, so setbacks in efficacy, safety, manufacturing, or regulatory review could materially impair the business. The company also faces execution risk from third-party vendors, product liability exposure, and healthcare compliance obligations tied to commercialization and payer relationships. As a cross-border biotech, it is exposed to foreign exchange volatility and complex data privacy, regulatory, and reimbursement regimes.

Sorted by severity
LowMediumHighLowMediumHighImpact →Likelihood →Dependence on AMT-130 clinical success1Third-party execution and data quality risk2Product liability and patient safety claims3Healthcare compliance and anti-bribery risk4
Impact is the risk’s severity and likelihood how probable it is over the next few years, both assessed from the company’s reports. Numbers match the list.
  1. Dependence on AMT-130 clinical successImpact: CriticalLikelihood: High

    The lead program is a major driver of future value, so failure would materially impair prospects.

    Exposure: Huntington’s disease program

  2. Third-party execution and data quality riskImpact: HighLikelihood: Medium

    CROs and other vendors conduct key studies and supply activities outside direct employee control.

    Exposure: Clinical trials and development programs

  3. Product liability and patient safety claimsImpact: HighLikelihood: Low

    Clinical and commercial gene therapies can trigger claims related to adverse events or administration procedures.

    Exposure: Clinical trials and approved products

  4. Healthcare compliance and anti-bribery riskImpact: MediumLikelihood: Low

    Commercialization involves physicians, payers, and third parties subject to U.S. and international healthcare laws.

    ExposureSalesDistributionPayer arrangements
  5. Foreign exchange volatilityImpact: Medium

    The company holds and transacts in euros and U.S. dollars, creating translation and remeasurement effects.

    ExposureCross-border cashBorrowingsIntercompany balances
Ask Clarifo about uniQure N.V.

Accounting

Judgemental items
License and collaboration revenue recognition

Revenue timing depends on royalty earnings and completion of partner service obligations.

Impact: Can cause uneven quarterly revenue and comparability issues

Contract manufacturing accounting

Prior HEMGENIX® manufacturing revenue and related costs were recognized before the Lexington transaction.

Impact: Affects historical revenue mix and gross margin presentation

Fair value of pre-funded warrants

Changes in fair value flow through earnings and can create non-cash volatility.

Impact: Can materially affect reported loss in a period

Foreign currency remeasurement

Euro and U.S. dollar balances are remeasured each period.

Impact: Creates gains or losses unrelated to core operating performance

Contingent consideration

The uniQure France business combination includes estimate-sensitive contingent consideration.

Impact: Valuation changes can affect liabilities and earnings

Similar listed companies

Publicly listed companies with a comparable business focus.

Humacyte, Inc.

HUMA · Biological Products, (No Diagnostic Substances)

MeiraGTx Holdings plc

MGTX · Biological Products, (No Diagnostic Substances)

OnKure Therapeutics, Inc.

OKUR · Pharmaceutical Preparations

REGENXBIO Inc.

RGNX · Biological Products, (No Diagnostic Substances)

Unicycive Therapeutics, Inc.

UNCY · Pharmaceutical Preparations

Immunocore Holdings plc

IMCR · Biological Products, (No Diagnostic Substances)

Last updated: 24/09/2026

uniQure N.V. (QURE) Revenue, Earnings & Financials 2025 – Clarifo