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MeiraGTx Holdings plc: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 13 August 2026: press release. Guidance figures: 6 new, 3 kept. The quarter’s numbers.

Key takeaways

  • Net income swung to profit: Net income attributable to ordinary shareholders was $160.7 million, or $1.71 diluted per share, against a net loss of $38.8 million a year earlier. Source
  • License revenue drove total revenue: Total revenue was $321.4 million, against $3.7 million a year earlier. License revenue from related parties made up $204.6 million of it. Source
  • R&D rose on bota-vec reacquisition: R&D expense rose $24.3 million, mainly from the reacquisition of bota-vec from J&J under the asset purchase agreement. Source
  • Bota-vec J&J milestone and royalty terms: J&J is eligible for a one-time regulatory and commercial milestone and a mid-teens royalty on global net sales from mid-2029, after the $25 million upfront payment. Source
  • Three-year AAV2-hAQP1 durability: Three-year Phase 1 AQUAx data (n=24) showed durable effects from 12 through 36 months, and AAV2-hAQP1 was safe and well-tolerated at each dose tested. Source
  • Cash rose to $143.2 million: Cash and cash equivalents were $143.2 million at June 30, 2026, up from $65.9 million at December 31, 2025. With restricted cash the total was $145.4 million. Source
  • Oberland initial funding structure: Oberland's initial $135 million was $125 million cash plus a $10 million equity investment. Royalties on three products are capped at a multiple of funded amounts. Source

“During the second quarter of 2026, we made tremendous progress towards transforming MeiraGTx into a commercial company,”

Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx

Guidance

AreaPeriodFigureAgainst last quarter
Bota-vec global regulatory filings Source20262026New
AAV2-hAQP1 BLA filing Sourcemid-2027mid-2027New
AAV2-hAQP1 pivotal data readout (AQUAx2) Sourcesecond quarter of 2027second quarter of 2027Kept
AAV2-hAQP1 approval and U.S. launch Sourceend of 2027 approval; 2028 launchend of 2027; 2028Kept
Bota-vec first commercial launch Source20272027New
Liquidity runway Sourceinto the second half of 2028into the second half of 2028Kept
Oberland tranche tied to AQUAx2 data Source2027$50 millionNew
Oberland tranche tied to bota-vec approval Source2027$50 millionNew
Oberland tranche tied to AAV2-hAQP1 approval Source2028$50 millionNew

What changed from last quarter

  • New: The bota-vec acquisition from J&J closed in May 2026, following the April 2026 agreement. Source
  • New: An investment agreement with Oberland Capital was entered in June 2026, for up to $400 million including up to $375 million non-dilutive capital. Source
  • New: John Knighton was appointed Executive Vice President of Global Manufacturing and Supply Chain in July 2026. Source
  • New: License revenue this quarter reflects licenses granted to Reogen for the AAV-GAD and AAV-BDNF programs and the AAV-GAD delivery device. Source
  • Ended: The original J&J asset purchase and supply agreements were terminated during the second quarter of 2026. Source
  • Ended: The Notes Purchase Agreement with Perceptive Credit Holdings III, LP was terminated, and deferred financing costs were written off. Source
  • New guidance: Dated regulatory timing is given for the first time: bota-vec global filings in 2026 and an AAV2-hAQP1 BLA in mid-2027. Source

Quarter results and revenue mix

  • Net income swung to profit: Net income attributable to ordinary shareholders was $160.7 million, or $1.71 diluted per share, against a net loss of $38.8 million a year earlier. Source
  • License revenue drove total revenue: Total revenue was $321.4 million, against $3.7 million a year earlier. License revenue from related parties made up $204.6 million of it. Source
  • Related-party service revenue rose: Service revenue from related parties was $104.9 million, against $3.7 million a year earlier, mainly from the release of deferred revenue. Source
  • Lilly contract manufacturing added revenue: Service revenue of $11.9 million came from contract manufacturing for Lilly, against nil a year earlier. Source

Cost of revenue and operating expenses

  • Related-party cost of service rose: Cost of service revenue, related party, was $5.8 million, up $3.1 million, mainly from Reogen development and transition services. Source
  • Lilly cost of service revenue: Cost of service revenue was $1.4 million, tied to contract manufacturing services provided to Lilly. Source
  • G&A slightly lower: General and administrative expenses were $12.0 million, down $0.3 million on lower legal fees and share-based compensation, partly offset by business development costs. Source
  • Reogen transition services revenue: Related-party service revenue also included development and transition services provided to Reogen, formerly Hologen Neuro AI, under the Hologen collaboration. Source
  • J&J PPQ work wound down: PPQ services for J&J declined because that work was substantially completed in the first half of 2025. Source

“We are eager to progress this powerful novel technology through clinical development to address conditions that cannot be readily addressed using any of the current therapeutic modalities available.”

Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx

R&D and non-operating items

  • R&D rose on bota-vec reacquisition: R&D expense rose $24.3 million, mainly from the reacquisition of bota-vec from J&J under the asset purchase agreement. Source
  • AAV2-hAQP1 batch and trial costs: AAV2-hAQP1 clinical costs rose on clinical trial batch manufacturing and higher trial spend. AAV-GAD program spend was lower than the prior year. Source
  • Currency swung to a loss: Foreign currency loss was $1.5 million, against an $8.6 million gain a year earlier, reflecting intercompany balances. Source
  • Equity-method loss from Reogen: Loss on equity method investee was $71.9 million, reflecting the Company's share of Reogen's acquired in-process R&D and its ongoing R&D. Source
  • Royalty note costs and derivative loss: Interest expense was $3.5 million, including royalty note transaction costs. A $5.2 million loss on derivative liability came from the Oberland right. Source
  • Income tax expense from collaboration income: Income tax expense was $2.4 million, against nil a year earlier, reflecting taxable income from strategic collaboration and other non-recurring transactions. Source

Pipeline and regulatory progress

  • Bota-vec J&J milestone and royalty terms: J&J is eligible for a one-time regulatory and commercial milestone and a mid-teens royalty on global net sales from mid-2029, after the $25 million upfront payment. Source
  • Bota-vec Phase 3 safety profile: LUMEOS Phase 3 safety was described as expected and manageable, with an improved inflammatory profile versus the Phase 1/2 study. Source
  • Three-year AAV2-hAQP1 durability: Three-year Phase 1 AQUAx data (n=24) showed durable effects from 12 through 36 months, and AAV2-hAQP1 was safe and well-tolerated at each dose tested. Source
  • Bota-vec manufacturing qualified: Process performance qualification is complete for bota-vec. The London facility holds a commercial license, and the Shannon QC facility holds one too. Source
  • Bota-vec designations held: Bota-vec holds Fast Track and Orphan Drug designations from the FDA, and PRIME and Orphan designations in the EU. Source

Capital, cash and financing

  • Cash rose to $143.2 million: Cash and cash equivalents were $143.2 million at June 30, 2026, up from $65.9 million at December 31, 2025. With restricted cash the total was $145.4 million. Source
  • Oberland initial funding structure: Oberland's initial $135 million was $125 million cash plus a $10 million equity investment. Royalties on three products are capped at a multiple of funded amounts. Source
  • Royalty note buyback option: The Company can buy back the entire funded royalty note at any time by paying specified amounts. The agreement has change-of-control provisions. Source
  • July Oberland purchase and share sale: After quarter end, Oberland made a second $25.0 million royalty note purchase and a $10.0 million share sale in July 2026. Source
  • Shares outstanding increased: Ordinary shares outstanding rose to 94.2 million at June 30, 2026, from 81.1 million at December 31, 2025, after the $100 million equity financing. Source

Strategy and platform

  • Preparing for two product launches: Management is building market access and commercial teams to prepare for potential launches of two products over the next two years. Source
  • Riboswitch platform is gene agnostic: The riboswitch platform is described as gene agnostic and usable with lentivirus, AAV, CRISPR or LNP delivery, controlled by a daily oral pill. Source
  • Lilly ophthalmology access rights: Under the Lilly deal, Lilly has exclusive access to ophthalmology gene therapy technologies, including in-house capsids and AI-generated promoters. Source
  • Riboswitch target areas: The riboswitch platform is focused on metabolic peptides such as GLP-1, GIP, Glucagon, Amylin, PYY and Leptin, plus CAR-T and pain targets. Source

People and leadership

  • Penny Fleck brings development experience: Chief Development Officer Penny Fleck has over 20 years at J&J and Takeda, and worked on bota-vec while at J&J. Source
  • John Knighton brings manufacturing background: Knighton previously led cell and gene therapy API development at Janssen, work that supported CARVYKTI approval and commercialization. Source
  • Two senior leaders from J&J: Management says both new senior leaders previously worked at J&J and will help transition the Company toward commercial readiness. Source

Coming up, as management said on 13 August 2026

  • AAV-GAD Phase 3 start: Management expects to start the AAV-GAD Phase 3 study in the coming months, after engaging trial sites globally. Source
  • Ribo-Leptin toward first-in-human: Ribo-Leptin is moving toward first-in-human studies, with clinical requirements being finalized after FDA discussions. Source
  • Neuropathic pain program to follow: Management anticipates a second riboswitch program in neuropathic pain after the first riboswitch clinical study. Source

Figures management reported

FigureReported
Research and development expense Source$57.8 million, three months ended June 30, 2026
Breakthrough Therapy Designation SourceAAV2-hAQP1, granted March 2026
RMAT designation SourceAAV-GAD, granted in 2025
Partner upfront and milestone payments Source$75 million upfront; over $400 million total milestones (Lilly)

Risks management discussed

  • Financial: The runway estimate excludes $135.0 million of potential near-term Lilly milestone cash, which depends on development and approval milestones. Source
  • Financial: The runway estimate also relies on a $95.0 million upfront payment due from Hologen and related reimbursements. Source

Earlier plans management reported on

  • Met: Enrollment in the AQUAx2 study completed in the second quarter, and the 12-month readout remains on track. Source
  • Not stated: The prior release said the Ribo-Leptin IND would open later this year. The current release says the package is being finalized.
  • Not stated: The prior release said the program would be advanced rapidly toward filings. The current release says the company is working expeditiously on submissions.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.