MeiraGTx Holdings plc (MGTX)·Q3 2025 Earnings Summary

Executive Summary

• Q3 2025 came in significantly below consensus: revenue was $0.41M vs Wall Street estimate of ~$6.97M*, and EPS was -$0.62 vs -$0.49*, driven by the wind-down of PPQ service activity with J&J IM; net loss widened to -$50.5M .
• Strategic momentum post-quarter: signed a broad ophthalmology collaboration with Eli Lilly for AAV-AIPL1 with $75M upfront, >$400M milestones and royalties; company also advanced its Hologen AI collaboration funding, receiving $22M in Q4-to-date and $50M of $200M due post FDI clearance .
• Pipeline and regulatory: AAV2‑hAQP1 Phase 2 in RIX on track to complete enrollment by year‑end, with pivotal data that could support a BLA in early 2027 and potential approval later in 2027; AAV‑GAD Phase 3 Parkinson’s initiation “in the coming months”; BBS10 program received RPDD and first child treated under UK Specials license .
• Liquidity improved with partnerships: cash/cash equivalents were $14.8M at quarter end, plus receivables; management projects funding into H2 2027 including Lilly upfront and anticipated Hologen funding, and plans to repay $75M debt due Aug 2026 .
• Near-term stock catalysts: Lilly deal validation for ocular platform, AAV‑GAD Phase 3 start, RIX Phase 2 enrollment completion, and regulatory filing progress for AAV‑AIPL1 .

What Went Well and What Went Wrong

What Went Well

• Signed strategic collaboration with Eli Lilly granting worldwide rights to AAV‑AIPL1 and exclusive access to MeiraGTx intravitreal capsids, AI-driven promoters, and riboswitch rights in eye; $75M upfront and >$400M in milestones plus royalties .
  • Quote (CEO): “The unprecedented data from the 11 LCA4 children born blind who all gained vision after treatment with AAV‑AIPL1 illustrates the power of gene therapy in the eye…” .
• AAV‑GAD advanced with RMAT and Phase 3 initiation imminently; joint venture financing structure with Hologen to fund development and exclusive manufacturing agreements established .
• Operational execution in RIX: Phase 2 AQUAx2 aligned with FDA on clinical endpoints/CMC; enrollment targeting completion by year‑end; PPQ manufacturing activities underway .

What Went Wrong

• Revenue collapsed YoY as PPQ services wound down (service revenue $0.41M vs $10.91M in Q3 2024), driving operating loss and wider net loss; FX swung to a $1.6M loss vs $3.5M gain last year .
• Q3 EPS missed consensus (-$0.62 actual vs -$0.49*), and revenue missed materially (~$0.41M actual vs ~$6.97M*), highlighting limited near-term revenue visibility absent PPQ *.
• Quarter-end cash of $14.8M underscores reliance on external funding; while partnerships bolster runway, execution/timing of Hologen funding tranches remains a watch item (management notes $22M received in Q4-to-date, remainder expected in Q4 2025) .

Financial Results

KPIs and Balance Sheet

Vs Estimates – Q3 2025

Values with asterisks retrieved from S&P Global.

Guidance Changes

Earnings Call Themes & Trends

Note: A Q3 2025 earnings call transcript was not available in our document set. The table below tracks narrative themes across management’s Q1, Q2, and Q3 press releases and 8‑Ks.

Management Commentary

• CEO on Lilly collaboration and AIPL1 efficacy: “We are excited to be entering into this collaboration with Lilly… the unprecedented data from the 11 LCA4 children born blind who all gained vision after treatment with AAV‑AIPL1…” .
• CEO on late‑stage programs: “Our pivotal Phase 2 study of AAV‑hAQP1… remains on track to achieve target enrollment at the end of this year… we anticipate initiating a Phase 3 study evaluating AAV‑GAD for the treatment of Parkinson’s disease in the coming months” .
• CEO on riboswitch platform: “Completed optimization of our lead riboswitch program… native human leptin controlled by a daily oral small molecule… demonstrated complete durability… over more than a year of oral dosing” .

Q&A Highlights

• No Q3 2025 earnings call transcript was available; guidance clarifications and narrative themes are drawn from the 8‑K press release and related company press releases .

Estimates Context

• Consensus (S&P Global) expected revenue of ~$6.97M* and EPS of -$0.49* for Q3 2025; actuals were $0.41M revenue and -$0.62 EPS, reflecting a material miss on both metrics *.
• Target Price Consensus Mean stood at ~$28.57* (7 estimates), unchanged across near-term periods*.
  Values with asterisks retrieved from S&P Global.

Key Takeaways for Investors

• Near-term P&L remains highly sensitive to PPQ service revenue timing; Q3 showed the downside as PPQ activities substantially completed, resulting in a significant revenue/EPS miss vs consensus *.
• Strategic de‑risking via partnerships: Lilly collaboration provides immediate non‑dilutive capital and validates ocular platform; Hologen structure underpins AAV‑GAD funding and exclusive manufacturing scale-up .
• RIX AAV2‑hAQP1 program is approaching an enrollment milestone with a defined regulatory path (early‑2027 BLA potential); monitor for year‑end enrollment completion and PPQ progress .
• AAV‑GAD Phase 3 initiation is a key 6‑month catalyst; AI‑enhanced imaging endpoints may support disease‑modification claims, a potential label differentiator in Parkinson’s .
• Liquidity runway now guided into H2 2027 including $75M Lilly upfront and expected Hologen tranches; debt repayment plan (Aug 2026) affirmed—watch funding receipts cadence .
• Regulatory/rare pediatric designations (RPDD for BBS10) and Lancet‑supported AIPL1 efficacy underpin an expedited filing narrative—partner validation increases probability of success .
• Trading lens: Expect stock sensitivity to execution milestones (RIX enrollment completion, GAD Phase 3 start), additional Lilly/Hologen cash timing, and any bota‑vec commercialization updates tied to milestone triggers .

Notes:
- Q3 2025 earnings call transcript was not found in our document catalog. Coverage is based on the Q3 8‑K Exhibit 99.1 and relevant press releases.
- S&P Global consensus figures are marked with an asterisk and labeled accordingly.

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