Ocugen, Inc. (OCGN)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025: Revenue was $1.48M, net loss was $(15.35)M or $(0.05) per share; operating expenses were $16.0M; cash and restricted cash were $38.1M with runway into Q1 2026 .
• Pipeline momentum: EMA granted eligibility to submit an OCU400 MAA via the centralized procedure (ATMP), OCU410ST received FDA alignment for a Phase 2/3 pivotal confirmatory trial (target BLA 2027), and OCU410 Phase 2 dosing completed ahead of schedule (target Phase 3 in 2026; BLA 2028) .
• Estimates context: Wall Street consensus estimates for Q1 2025 EPS and revenue were not available via S&P Global; therefore no beat/miss assessment versus estimates is possible (S&P Global; no consensus available) [functions.GetEstimates].
• Near-term catalysts: OCU400 Phase 3 enrollment completion remains on track for 1H 2025 with filings targeted mid-2026; OCU410ST Phase 2/3 initiation mid-2025; OCU410 (ArMaDa) Phase 2 interim data expected in fall 2025; OCU500 Phase 1 (NIAID-sponsored) initiation targeted for Q2 2025 .

What Went Well and What Went Wrong

What Went Well

• Regulatory de-risking for OCU400: “EMA granted eligibility to submit our OCU400 MAA via centralized procedure as an ATMP,” which management called “a significant project milestone” supporting 2026 filings .
• Portfolio execution across three gene therapies: “All three gene therapies are advancing through the clinic, and we're on track to meet our goal of three BLAs/MAAs in the next three years” (OCU400 ’26, OCU410ST ’27, OCU410 ’28) .
• Safety/tolerability updates: OCU410 Phase 2 DSMB review with “no serious adverse events related to OCU410,” and OCU200 Phase 1 DSMB greenlight to continue (favorable safety signal) .

What Went Wrong

• Cash draw and higher R&D as programs advance: Cash declined to $38.1M from $58.8M QoQ; R&D increased to $9.5M from $6.8M YoY, lifting total OpEx to $16.0M (vs. $13.2M YoY) .
• Limited financial leverage from revenue: Revenue remained de minimis ($1.48M), with loss from operations $(14.50)M; net loss per share unchanged at $(0.05), reflecting pre-commercial stage and modest collaboration revenue .
• Data visibility: No interim look for the blinded OCU400 Phase 3 trial; EMA alignment for OCU410ST clinical design still pending, tempering near-term data catalysts and European clarity for Stargardt .

Financial Results

Income statement and operating metrics (USD Millions, except per-share)

Balance sheet/cash runway

Estimates vs. Actuals (S&P Global)

• Consensus EPS (Q1 2025): Not available (no consensus) [functions.GetEstimates].
• Consensus Revenue (Q1 2025): Not available (no consensus) [functions.GetEstimates].
  Note: Estimates sourced from S&P Global; no consensus values available.

Segment breakdown/KPIs

• No reportable segments; revenue primarily collaboration-related .
• Key KPIs: clinical milestones (OCU400 Ph3 enrollment, OCU410ST P2/3 start, OCU410 Phase 2 interim timing) rather than commercial KPIs .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• Strategy and ambition: “We’re on track to meet our goal of three BLAs/MAAs in the next three years,” positioning Ocugen’s platform as “a one-time therapy for life” across large patient populations .
• EU milestone: “EMA granted eligibility to submit our OCU400 MAA via centralized procedure as an ATMP…a significant project milestone” .
• Execution cadence: “Dosing was complete…in the Phase 2 portion of the OCU410…ArMaDa clinical trial,” and “Phase II/III…for OCU410ST…can be the basis of a BLA submission” .
• Safety emphasis: No SAEs related to OCU410 in Phase 2 to date; DSMB cleared OCU200 to proceed, with favorable safety profile .

Q&A Highlights

• OCU400 Phase 3 timeline and data visibility: Enrollment on track 1H’25; no interim analysis due to blinding; full data expected post-completion .
• Manufacturing: Process validations completing in 2025; initial commercial supply with partner (then tech transfer to in-house Malvern facility) .
• OCU200 update: Phase 1 completion targeted for late 2025 with safety/early efficacy update before year-end .
• EMA alignment for OCU410ST: U.S. registration design agreed; EU discussions ongoing to mirror FDA approach .
• OCU500 funding: NIAID relationship “on track” with increased engagement; Phase 1 initiation targeted for Q2 2025 .

Estimates Context

• S&P Global consensus for Q1 2025 EPS and revenue was not available; we cannot assess beats/misses versus Wall Street this quarter (Estimates sourced from S&P Global; no consensus values available) [functions.GetEstimates].
• Given the absence of consensus and pre-commercial stage, investor models should focus on cash runway, OpEx trajectory, and clinical/regulatory milestones to drive scenario-based valuation .

Key Takeaways for Investors

• Clinical catalysts stack in 2025–2027: OCU410 (GA) Phase 2 interim in fall 2025, OCU410ST pivotal start mid-2025 with 12-month BLA dataset in 2027, and OCU400 filings targeted mid-2026—each a stock-moving event path .
• Regulatory de-risking: EMA MAA eligibility (ATMP) for OCU400 improves EU visibility and supports 2026 filing timing .
• Cash runway into Q1 2026 reiterated; however, advancing multiple pivotal programs may necessitate opportunistic financing or partnering—monitor dilution/partnership headlines .
• Execution plus safety: Clean safety readouts to date (OCU410, OCU200) and platform consistency are differentiators in a cautious gene therapy tape .
• Limited near-term OCU400 data visibility (no interim) may cap momentum until enrollment completion and readout; trading focus likely shifts to OCU410 interim (fall 2025) and OCU410ST trial start .
• EU path for OCU410ST still being discussed; alignment would be an incremental catalyst for global scope .
• No sell-side consensus this quarter; stock likely trades on clinical/regulatory headlines and capital strategy rather than quarterly P&L noise [functions.GetEstimates].