MGTXNasdaqBiological Products, (No Diagnostic Substances)US GAAP · USD

MeiraGTx Holdings plc

MeiraGTx Holdings plc is a clinical-stage genetic medicines company developing adeno-associated virus (AAV) gene therapies for inherited retinal disease, central nervous system disorders, and other serious conditions. The company also operates manufacturing capabilities in the UK and Ireland, which it uses to support its own pipeline and third-party or collaboration-related supply and testing activities.

Kysy yhtiöstä
Liikevaihto81,4milj. USD
+144,6 %v/v
Liikevoitto (EBIT)−106milj. USD
+35,5 %v/v
EBIT-marginaali−130,2%
+363,2 %-yks.v/v
Nettotulos−114milj. USD
+22,7 %v/v
Vapaa kassavirta−50,2milj. USD
+54,1 %v/v

Tilikausi 2025 · muutos edellisvuodesta

Kehitys 2020–2025

−200−150−100−50050100milj. USD2020: 16 milj. USD2020: EBIT −63 milj. USD20202021: 38 milj. USD2021: EBIT −73 milj. USD20212022: 16 milj. USD2022: EBIT −116 milj. USD20222023: 14 milj. USD2023: EBIT −137 milj. USD20232024: 33 milj. USD2024: EBIT −164 milj. USD20242025: 81 milj. USD2025: EBIT −106 milj. USD202581−106
LiikevaihtoLiikevoitto (EBIT)

Liiketoiminta

Osuus liikevaihdosta
Ophthalmology gene therapies35 %

AAV-based product candidates targeting inherited retinal diseases and other eye disorders.

Neurology gene therapies25 %

Locally delivered genetic medicines for central nervous system indications, including AAV-GAD and AAV-BDNF.

Manufacturing services25 %

Internal and collaboration-linked manufacturing of viral vectors and gene therapy materials.

Quality control and testing services10 %

Release, stability, and QC testing for commercial and investigational medicinal products.

Collaboration and supply agreements5 %

Upfront, milestone, and supply-related arrangements with pharmaceutical and biotech partners.

Tuotteet

Raportoitu · osuus liikevaihdosta
92,1%FY2025100 %
  • License92,1 %
  • Related Party Service Revenue7,9 %

Lähde: 10-K FY2025, yhtiön tuotelinjoittain raportoima liikevaihto (SEC XBRL). Osuudet on laskettu näytetyistä riveistä ja ne summautuvat 100 %:iin.

Asiakkaat

MeiraGTx primarily serves pharmaceutical and biotech collaborators that need gene therapy development, manufacturing, and supply capabilities. Its end markets also include patients and physicians in rare disease, ophthalmology, and neurology if its product candidates are approved and commercialized. In the near term, a meaningful part of the business is collaboration-driven rather than product-sales-driven, with partners funding development, manufacturing, and future supply arrangements.

Pharmaceutical collaboration partners

Partners that fund, co-develop, or commercialize gene therapy programs and buy supply/manufacturing commitments.

Biotech and clinical development partners

Smaller developers that need AAV manufacturing, QC testing, and clinical supply for trials.

Rare disease patients and physicians

Future end users of ophthalmology programs if approved, especially inherited retinal disease patients.

Neurology treatment centers

Future clinical and commercial users of CNS gene therapies delivered through local administration.

Strategia

MeiraGTx is focused on advancing its clinical pipeline while building the manufacturing and regulatory infrastructure needed to support both trials and eventual commercialization. A key strategic element is collaboration: the company uses partnerships to fund development, secure supply commitments, and expand the reach of its programs without bearing all commercialization costs alone.

Advance lead gene therapy programsLyhyt aikaväli

Clinical progress is the main path to value creation in a company with no approved products.

Scale manufacturing and QC capabilitiesKeskipitkä aikaväli

Commercial success depends on reliable GMP supply, release testing, and regulatory compliance.

Secure collaboration funding and supply agreementsLyhyt aikaväli

Partnerships reduce financing burden and can create future revenue streams before product launch.

Maantiede

The company is headquartered in the United States but its operating footprint is concentrated in the UK and Ireland, where it runs manufacturing and QC facilities. The reports specifically reference London and Shannon, and the Shannon site received expanded Irish regulatory authorization to manufacture clinical-trial material. Geography matters because the business depends on cross-border regulatory approvals, GMP compliance, and supply-chain continuity across the US, UK, EU, and other jurisdictions.

Riskit

The company remains pre-commercial and has a history of operating losses, so its ability to fund development is a central risk. Execution risk is also high because gene therapy manufacturing is technically complex, heavily regulated, and dependent on third-party and cross-border supply chains. If clinical data, regulatory approvals, or manufacturing scale-up disappoint, the company may need to delay programs, raise capital on unfavorable terms, or reduce its pipeline.

Järjestetty vakavuuden mukaan
MatalaKohtalainenKorkeaMatalaKohtalainenKorkeaVaikutus →Todennäköisyys →Need for additional capital1Manufacturing and supply-chain disruption2Regulatory compliance failure3Clinical development failure4International commercialization complexity5
Vaikutus on riskin vakavuus ja todennäköisyys sen toteutumisen todennäköisyys lähivuosina, molemmat arvioitu yhtiön raporttien perusteella. Numerot vastaavat listaa.
  1. Need for additional capitalVaikutus: KorkeaTodennäköisyys: Korkea

    The company expects continued losses and has not generated product-sales revenue, so it must fund trials and manufacturing externally.

    KohdistuuEquityDebtCollaborationsLicensing
  2. Manufacturing and supply-chain disruptionVaikutus: KorkeaTodennäköisyys: Kohtalainen

    Gene therapy production depends on specialized facilities, plasmid supply, and GMP-compliant third parties.

    Kohdistuu: Clinical and commercial supply

  3. Regulatory compliance failureVaikutus: KorkeaTodennäköisyys: Kohtalainen

    FDA, MHRA, EMA, and HPRA requirements govern manufacturing, testing, and commercialization.

    KohdistuuLicensesApprovalsProduct release
  4. Clinical development failureVaikutus: KorkeaTodennäköisyys: Kohtalainen

    Pipeline value depends on proving safety and efficacy in rare disease and CNS indications.

    Kohdistuu: Ophthalmology and neurology programs

  5. International commercialization complexityVaikutus: KeskitasoTodennäköisyys: Matala

    Foreign markets can impose different reimbursement, privacy, and IP rules that raise launch friction.

    KohdistuuOutside the USUKEU

Kirjanpito

Harkinnanvaraiset erät
Collaboration and service revenue recognition

Revenue appears tied to PPQ services and related agreements, so timing depends on performance obligations and contract terms.

Vaikutus: Can create quarter-to-quarter volatility in reported revenue

Related-party contract assets and deferred revenue

The company references related-party balances tied to collaboration and asset purchase arrangements.

Vaikutus: Affects timing of revenue and working capital

Share-based compensation

A significant non-cash expense for a development-stage biotech with limited operating revenue.

Vaikutus: Impacts operating loss and cash flow reconciliation

Foreign currency translation

Operations in the UK and Ireland create translation effects when subsidiaries are consolidated into USD.

Vaikutus: Moves other comprehensive loss and equity

Capitalized manufacturing and facility assets

Build-out of GMP manufacturing and QC facilities requires judgment on useful lives and impairment.

Vaikutus: Can affect depreciation, asset carrying values, and future impairment charges

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Päivitetty: 24.9.2026