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OI

Ocugen, Inc. (OCGN)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 results: total revenue $1.373M, net loss $(14.739)M, and diluted EPS of $(0.05); operating expenses fell year over year to $15.2M (R&D $8.4M; G&A $6.8M), and cash, cash equivalents, and restricted cash were $27.3M, with cash runway guided into Q1 2026 .
  • Strategic updates: initiated dosing in OCU410ST Phase 2/3 GARDian3 (Stargardt), EMA eligibility to submit OCU400 MAA via centralized procedure, and a binding term sheet for exclusive Korean rights to OCU400 with up to $11M in upfront/near-term milestones, 25% royalty, and sales milestones .
  • OrthoCellix reverse merger announced to unlock NeoCart/regenerative cell therapy value while focusing capital on gene therapy platform; leadership and Retina SAB strengthened to support commercialization and partnerships .
  • No Wall Street consensus estimates were available from S&P Global for revenue/EPS to assess beats/misses; investors should anchor on upcoming clinical catalysts (Stargardt masked interim at ~8 months, OCU410 Phase 2 12‑month data 1Q26) and potential BD funding as stock drivers . S&P Global consensus unavailable.

What Went Well and What Went Wrong

What Went Well

  • Initiated dosing in the OCU410ST Phase 2/3 GARDian3 pivotal confirmatory trial after FDA cleared the IND amendment and granted Rare Pediatric Disease Designation; management highlighted urgency and favorable Phase 1 efficacy (48% slower lesion growth, ~2‑line BCVA gain, p=0.031) .
  • OCU400 Phase 3 liMeliGhT recruitment progressing; EMA granted eligibility to submit MAA via centralized procedure; DSMB reported no SAEs related to OCU400 and recommended continuing dosing .
  • Signed binding term sheet for OCU400 exclusive Korean rights with up to $11M in upfront/near-term milestones, 25% royalty, and sales milestones, preserving larger geographies and manufacturing control; management emphasized non‑dilutive BD funding potential .

What Went Wrong

  • Cash decreased to $27.3M from $58.8M at year‑end, necessitating continued BD and capital markets activity; debt stood at ~$28.0M and net loss remained sizeable at $(14.739)M for the quarter .
  • OCU500 (inhaled vaccine) Phase 1 start moved to Q3 2025 from earlier expectations (Q2 2025), modestly delaying that program’s timeline .
  • Minimal revenue ($1.373M) remains from collaborative arrangements; with no S&P Global consensus, investors lack an external beat/miss anchor, increasing reliance on clinical/regulatory execution to support the equity story . S&P Global consensus unavailable.

Financial Results

MetricQ2 2024Q1 2025Q2 2025
Total Revenue ($USD Millions)$1.141 $1.481 $1.373
Net Loss ($USD Millions)$(15.280) $(15.350) $(14.739)
Diluted EPS ($USD)$(0.06) $(0.05) $(0.05)
R&D Expense ($USD Millions)$8.902 $9.529 $8.402
G&A Expense ($USD Millions)$7.688 $6.453 $6.766
Total Operating Expenses ($USD Millions)$16.590 $15.982 $15.168
Net Income Margin %(−1339.2%) (−1036.6%) (−1073.9%)

KPIs

KPIQ2 2024Q1 2025Q2 2025
Cash, Cash Equivalents & Restricted Cash ($USD Millions)$58.8 $38.1 $27.3
Shares Outstanding (Millions)257.4 292.0 292.2
Long Term Debt, net ($USD Millions)$27.345 $27.669 $28.025

Estimates vs Actuals (S&P Global)

MetricQ2 2025 ActualQ2 2025 S&P Global Consensus
Revenue ($USD Millions)$1.373 N/A (unavailable)
EPS ($USD)$(0.05) N/A (unavailable)

S&P Global consensus unavailable.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
OCU400 (RP) BLA/MAA filing2026Mid‑2026 target; EMA eligibility to submit MAA via centralized procedure On track for 2026 BLA/MAA; EMA eligibility reaffirmed; DSMB safety maintained Maintained
OCU410ST (Stargardt) Phase 2/3 initiation & BLA2025–2027Initiate mid‑2025; BLA in 2027 IND amendment cleared; first patient dosed July; BLA in 2027 Raised (execution progress)
OCU410 (GA) Phase 3 start & data/BLA2026–2028Initiate Phase 3 in 2026; 12‑month Phase 2 data in 1Q26; BLA in 2028 Phase 2 enrollment complete; plan Phase 3 in 2026; 12‑month data 1Q26; BLA 2028 Maintained
OCU500 (Inhaled vaccine) Phase 1 start2025NIAID to initiate Phase 1 in Q2 2025 NIAID intends to initiate Phase 1 in Q3 2025 Lowered (timing delay)
Cash runwayThrough Q1 2026Into Q1 2026 Into Q1 2026 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
Regulatory acceleration (FDA/EMA)FDA alignment for OCU410ST Phase 2/3; EMA ATMP and MAA path for OCU400; Phase 2 safety updates IND amendment cleared for OCU410ST; EMA eligibility reaffirmed; DSMB safety confirmations Positive momentum
R&D execution (OCU400/410ST/410)OCU400 Phase 3 enrollment; OCU410 Phase 2 dosing complete; Stargardt design and endpoints outlined OCU410ST first patient dosed; OCU410 preliminary efficacy (27% lesion reduction at 6M) and preservation vs PEG; OCU400 DSMB no SAEs Advancing to late-stage
Partnerships & licensingOngoing BD dialogues; manufacturing plans (CanSino, Malvern facility) Binding term sheet for Korea rights (up to $11M, 25% royalty); active partnering across programs De‑risking via BD
Capital & runwayCash to Q1 2026; opportunistic financing options Reiterated runway; exploring non‑dilutive BD and selective equity; Aug 8 registered direct announced (post‑quarter) Stable runway; financing optionality
Manufacturing & supply chainProcess validation targeted for this year; Malvern GMP site build OCU400 process validation on track; VP Manufacturing appointed Readiness improving
OCU500 (vaccines)NIAID-sponsored Phase 1 anticipated Q2 2025 NIAID intends Q3 2025 start Slight delay

Management Commentary

  • “We are securing strategic partnerships and evolving the business to support three successful Biologics License Application (BLA) filings over the next three years.” — Dr. Shankar Musunuri .
  • “There is a real sense of urgency from the agency… As we initiate the Phase II/III registration trial, we’re potentially accelerating clinical development of OCU410ST by two to three years.” — Dr. Shankar Musunuri .
  • “The DSMB recently convened and found no Serious Adverse Events related to OCU400 and recommended to continue study dosing as planned.” — Management prepared remarks .
  • “This regional licensing agreement [Korea]… preserves Ocugen’s rights to larger geographies… and generates return for shareholders.” — Dr. Shankar Musunuri .

Q&A Highlights

  • BD pipeline: Management is “continuously looking for potential partnership opportunities” including regional licenses across programs; OrthoCellix structured to avoid dilution and pursue grants independently .
  • Stargardt trial enrollment: 15 centers activated, inclusion criteria amenable; no anticipated enrollment challenges given ~44K US patient base; on track for BLA 2027 .
  • GA lesion reduction significance: 27% reduction at 6M seen as clinically meaningful with potential preservation and functional gains over time vs limited reductions with current intravitreal therapies .
  • OCU400 DSMB: Safety-only review; no futility analysis; no SAEs or AESIs reported .
  • Korea regulatory path: Expect orphan pathway leveraging U.S./EMA approval without additional trials; similar approach being engaged for other markets (e.g., Japan PMDA) .

Estimates Context

  • S&P Global consensus revenue and EPS for Q2 2025 were unavailable; as a result, no beat/miss determination can be made versus Street expectations. Actuals: revenue $1.373M and EPS $(0.05) . S&P Global consensus unavailable.

Key Takeaways for Investors

  • Late-stage execution is accelerating: OCU410ST registration trial dosing underway and OCU400 Phase 3 progressing with EMA MAA eligibility—key BLA timelines held (2026/2027/2028) .
  • BD advances provide non‑dilutive optionality: Korean OCU400 term sheet (up to $11M upfront/near-term milestones, 25% royalty, sales milestones) and broader partnering discussions reduce financing risk and support runway into Q1 2026 .
  • GA program (OCU410) shows promising interim efficacy and safety vs current therapies; watch for 12‑month Phase 2 data in 1Q26 and Phase 3 initiation in 2026 as medium‑term value inflection points .
  • Maintain focus on safety: DSMB updates continue to de‑risk OCU400 and OCU410; absence of SAEs strengthens regulatory case ahead of filings .
  • Near‑term catalysts: OCU410ST masked interim (8 months on 24 subjects), Q4 2025 OCU410 interim update, and potential closing of Korean definitive agreement—each can drive sentiment .
  • Capital planning: Cash fell to $27.3M and debt ~$28.0M; expect further BD activity and opportunistic financing to bridge to major data/filing milestones (registered direct post‑quarter provides additional flexibility) .
  • Regulatory engagement remains constructive: FDA and EMA interactions have enabled acceleration and clarity on pathways, a critical underpinning of the investment case .