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MeiraGTx Holdings plc (MGTX)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 service revenue was $3.69M, with net loss of $38.8M and basic/diluted EPS of -$0.48; revenue rose vs Q2 2024 ($0.28M) and vs Q1 2025 ($1.93M), while EPS improved year over year from -$0.76 but worsened sequentially from -$0.51 .
  • Against S&P Global consensus, revenue missed ($3.69M vs $6.48M*) and EPS modestly missed (-$0.48 vs -$0.468*), with 4 estimates contributing to both EPS and revenue consensus*; prior quarter revenue also missed ($1.93M vs $4.44M*) .
  • Management advanced multiple late-stage programs: FDA alignment to consider the RIX Phase 2 AQUAx2 study pivotal, RMAT designation for AAV-GAD in Parkinson’s, and “on track” LCA4 MAA/BLA filings in Q4 2025 .
  • Liquidity: cash and equivalents were $32.2M at quarter-end; together with $17.0M received to date in Q3 2025 and anticipated Hologen proceeds, the company expects funding into 2027 and plans to repay its $75.0M Perceptive loan due Aug 2026 .
  • Near-term stock catalysts: initiation of AAV-GAD Phase 3 (2025), completion of RIX Phase 2 enrollment (Q4 2025), and LCA4 filings (Q4 2025); manufacturing PPQ progress and potential bota-vec commercial supply revenue with J&J are additional drivers .

Note: Estimate values marked with an asterisk (*) are Values retrieved from S&P Global.

What Went Well and What Went Wrong

What Went Well

  • The FDA granted RMAT designation for AAV-GAD in Parkinson’s and completed a GCP inspection of the double‑blind sham‑controlled bridging study with zero observations (no Form 483), enabling expedited Phase 3 planning and potential disease‑modification label discussion using AI imaging analysis .
  • Regulatory alignment on pivotal RIX Phase 2 AQUAx2 (single PRO primary endpoint, 12‑month timeframe, placebo pooling/statistics agreed) and targeted enrollment completion by Q4 2025; pivotal data readout expected late 2026 .
  • LCA4 program: all 11 children treated gained meaningful vision; company “on track” to file UK MAA and US BLA in Q4 2025 under exceptional circumstances, supported by expedited CMC PPQ .

Management quote: “We aligned with the FDA on our ongoing Phase 2 study of AAV‑hAQP1 in radiation induced xerostomia (RIX) to potentially support a BLA. We received RMAT designation for AAV‑GAD in Parkinson’s disease…” — Alexandria Forbes, Ph.D., CEO .

What Went Wrong

  • Revenue mix remains concentrated in related‑party service revenue (PPQ work for J&J), and total revenue ($3.69M) fell short of consensus ($6.48M*) as PPQ timing shifted, resulting in a headline miss .
  • Continued high R&D and G&A spend: R&D $33.5M and G&A $12.3M in Q2; although YoY R&D decreased, overall operating expenses remain substantial, contributing to a net loss of $38.8M .
  • Cash declined to $32.2M vs $68.6M in Q1 and $101.0M in Q2 2024; while management expects runway into 2027 with Hologen proceeds, reliance on partner receipts and debt repayment plans adds execution risk .

Financial Results

Actuals vs Prior Periods and Estimates

MetricQ2 2024 (oldest)Q1 2025Q2 2025 (newest)
Total Revenue ($USD Millions)$0.282 $1.926 $3.691
Basic & Diluted EPS ($USD)-$0.76 -$0.51 -$0.48
Net Loss ($USD Millions)$48.620 $39.981 $38.795
S&P Global Revenue Consensus ($USD Millions)$9.688*$4.440*$6.484*
S&P Global EPS Consensus ($USD)-$0.40*-$0.4867*-$0.4675*
Revenue Surprise ($USD Millions)-$9.406*-$2.514*-$2.793*
EPS Surprise ($USD)-$0.36*-$0.0233*-$0.0125*
YoY Revenue Change (%)——+1,209.6% (from $0.282M to $3.691M)
QoQ Revenue Change (%)——+91.7% (from $1.926M to $3.691M)

Note: Estimate values marked with an asterisk (*) are Values retrieved from S&P Global.

Margins (Net Loss Margin)

MetricQ2 2024 (oldest)Q1 2025Q2 2025 (newest)
Net Loss Margin (%)-17,238.7% (−$48.620M / $0.282M) -2,075.7% (−$39.981M / $1.926M) -1,051.7% (−$38.795M / $3.691M)

Revenue Breakdown

Revenue Component ($USD Millions)Q2 2024 (oldest)Q1 2025Q2 2025 (newest)
Service revenue – related party$0.282 $1.926 $3.691

KPIs

KPI ($USD Millions unless noted)Q2 2024 (oldest)Q1 2025Q2 2025 (newest)
Cash, Cash Equivalents & Restricted Cash$101.0 $68.6 $34.4
R&D Expense$34.934 $32.780 $33.495
G&A Expense$11.257 $9.364 $12.313
Cost of Service Revenue$0.000 $1.378 $2.676
Foreign Currency Gain/(Loss)-$0.284 $3.687 $8.624
Interest Expense$3.254 $3.043 $3.034

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Capital runwayThrough 2027“Sufficient capital… into 2027” contingent on Hologen closing “Sufficient capital into 2027,” plus $17.0M received in Q3 and plan to repay $75.0M debt due Aug 2026 Maintained/Enhanced (added debt repayment detail)
RIX Phase 2 AQUAx2 enrollmentQ4 2025Target completion of enrollment in Q4 2025 Target completion of enrollment in Q4 2025 Maintained
RIX pivotal data readoutLate 2026BLA filing supported by this study at end of 2026 Pivotal data readout late 2026 Maintained (clarified wording)
AAV-GAD Phase 3 initiation2025Plan to initiate Phase 3 in H2 2025 Plan to initiate Phase 3 in 2025 Maintained
LCA4 filings (MAA/BLA)Q4 2025Preparing to submit MAA (UK) and aligned with FDA for similar US path On track to file UK MAA and US BLA in Q4 2025 Maintained
Hologen JV cash receipts2025$200M upfront at closing; JV with up to $230M committed $23M received; remainder expected Q3 2025; 250,000 Hologen Class A shares to be granted Updated (progress on receipt timing)

Earnings Call Themes & Trends

Note: A Q2 2025 earnings call transcript was not available in the corpus after targeted searches; themes below reflect press release and prior quarter disclosures, plus relevant February 2025 webcast content.

TopicPrevious Mentions (Q-2: Q3 2024)Previous Mentions (Q-1: Q1 2025)Current Period (Q2 2025)Trend
Regulatory acceleration (RMAT/ILAP)RPDDs; ILAP & expedited UK MAA for AAV‑AIPL1 RMAT for AAV‑GAD; alignment on RIX pivotal design RMAT AAV‑GAD affirmed; FDA GCP clean inspection; RIX pivotal alignment detailed Strengthening
AI/technology initiativesManufacturing & vector optimization; riboswitch platform focus Riboswitch in obesity/CAR‑T; Hologen AI collaboration structure AI imaging analysis with FDA discussion; Hologen Neuro AI JV funding Expanding
R&D execution (Parkinson’s, RIX)Positive AAV‑GAD bridging study; RIX Phase 2 ongoing AAV‑GAD Phase 3 planned; RIX Phase 2 endpoints aligned AAV‑GAD Phase 3 2025; RIX enrollment targeting Q4 2025 On track
Ophthalmology programs (LCA4, XLRP)LCA4 expedited filing path; bota‑vec Phase 3 data pending LCA4 data in The Lancet; filing plans; bota‑vec supply agreement, PPQ finalization On track to file LCA4 in Q4 2025; bota‑vec PPQ completed, potential commercial supply revenue Advancing
Manufacturing/PPQEnd‑to‑end GMP capabilities; PPQ activity PPQ documentation in progress; HPRA licenses renewed PPQ progress cited; UK/IE facility license updates; QC activity ongoing Robust
Liquidity/partner receiptsCash $122.9M; near-term J&J milestones Cash $66.5M; expects Hologen proceeds Cash $32.2M; $17.0M received in Q3; Hologen remainder expected Q3 Tight but improving with receipts

Management Commentary

  • “We aligned with the FDA on our ongoing Phase 2 study of AAV‑hAQP1 in radiation induced xerostomia (RIX) to potentially support a BLA. We received RMAT designation for AAV‑GAD… We continue to have productive dialogue with the MHRA and FDA around expedited approval of AAV‑AIPL1 for LCA4…” — Alexandria Forbes, Ph.D., CEO .
  • “Our late‑stage clinical programs are all advancing as planned… We are most excited about the potential of AAV‑GAD to show disease modifying changes… opportunity to discuss the use for the first time of AI analysis of imaging data to support labeling claims… expect to initiate [Phase 3] later this year.” — Alexandria Forbes, Ph.D., CEO .
  • “We are now engaged with regulators to be in a position to initiate first‑in‑human studies using our transformative riboswitch platform by the end of 2025.” — Alexandria Forbes, Ph.D., CEO .

Q&A Highlights

Note: Q2 2025 earnings call transcript was not found; highlights below reflect relevant February 2025 LCA4 webcast Q&A.

  • Early vision gains and durability: Improvements observed as early as four weeks post‑treatment; durability supported by long follow‑up in cohort one; MHRA did not request additional clinical follow‑up beyond the 11 treated children .
  • Optimal age and bilateral treatment: Younger age likely better; bilateral treatment intervals ranged 2 weeks to 2 months without safety/efficacy differences; shorter gaps preferred to avoid amblyogenic effects .
  • Program context: Treatment under UK Specials License initially; compelling outcomes in first 4 children led to broader treatment and expedited regulatory pathway discussions in UK/US .

Estimates Context

  • Q2 2025 S&P Global consensus: revenue $6.48M* (4 estimates) and EPS -$0.4675* (4 estimates); actual revenue $3.69M and EPS -$0.48, resulting in a revenue miss and a slight EPS miss on this consensus baseline .
  • Q1 2025: revenue $1.93M vs $4.44M* (3 estimates), EPS -$0.51 vs -$0.4867* (3 estimates) — both misses; YoY Q2 2024 revenue was $0.28M vs $9.69M* (2 estimates), reflecting estimate methodology sensitivity to service revenue timing .
  • Implications: Consensus models likely need to lower near‑term revenue assumptions to reflect PPQ revenue timing variability and continued OPEX until program milestones/partner revenue (bota‑vec supply, Hologen flows) ramp.

Note: Estimate values marked with an asterisk (*) are Values retrieved from S&P Global.

Key Takeaways for Investors

  • Execution on expedited regulatory pathways (RMAT, ILAP/exceptional circumstances) de‑risks timelines for AAV‑GAD, RIX, and LCA4; regulatory momentum is a key valuation driver .
  • Revenue is currently service‑based and lumpy; PPQ timing contributed to revenue misses vs consensus — model sensitivity should be reduced until commercial supply or milestones are realized .
  • Liquidity outlook hinges on Hologen JV cash flows and partner receipts; management expects runway into 2027 and plans to repay $75M debt, but near‑term cash efficiency remains critical .
  • Near‑term catalysts: AAV‑GAD Phase 3 initiation (labeling discussion for disease modification via AI imaging), RIX enrollment completion/Q4 2025, LCA4 filings/Q4 2025, and potential bota‑vec commercial supply revenue .
  • Manufacturing strength (PPQ completion, UK/IE licenses) underpins potential revenue from supply agreements and faster regulatory CMC reviews — a strategic advantage vs peers .
  • Watch for consensus revisions post-Q2: lower near‑term revenue/EPS expectations until partner revenue ramps; upside if supply revenue from bota‑vec and Hologen funding accelerate .
  • Trading setup: headline revenue miss was offset by strong clinical/regulatory momentum; stock reaction likely hinges on Phase 3 start clarity, LCA4 filing progress, and visibility into cash inflows .