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ABEONA THERAPEUTICS INC. (ABEO)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 marked Abeona’s transition to commercial stage following FDA approval of ZEVASKYN (prademagene zamikeracel) on April 29; U.S. launch commenced with first Qualified Treatment Center (Lurie Children’s) activated and treatments expected to begin in 3Q 2025 .
  • EPS beat: Q1 2025 diluted loss per share was $0.24 vs Wall Street consensus of $0.36 loss; revenue remained $0 given pre-launch status; management highlighted non-operating tailwind from warrant-liability fair value change (+$7.245M) . Values retrieved from S&P Global*.
  • Liquidity and funding: Cash, equivalents, restricted cash and short-term investments were $84.5M at March 31, 2025 (vs $98.1M at Dec 31, 2024); a definitive agreement to sell the Rare Pediatric Disease PRV for $155M is expected to yield ~$152M net proceeds, extending runway “over two years” to projected profitability in early 2026 .
  • Commercial readiness catalysts: ~30 patient/caregiver inbound inquiries in the first two weeks post-approval; executed outcomes-based agreements with payer organizations covering ~100M commercially insured lives; manufacturing capacity to ramp from ~4 patients/month at launch to ~6 by late 2025 and to 8–10 by early 2026 .

What Went Well and What Went Wrong

What Went Well

  • “ZEVASKYN’s approval…is a landmark achievement…signifies Abeona’s transition to a commercial-stage cell and gene therapy company,” driving strong initial demand and engagement with patients, physicians, and payers .
  • Rapid launch progress: first QTC activated ahead of schedule (Lurie Children’s), scheduling systems operational; first patient expected to be treated in 3Q 2025 with biopsies targeted for July and treatment in August .
  • Market access momentum: outcomes-based agreements in place with two large payer contracting organizations, including one covering ~100M commercially insured lives, positioning for broad access .

What Went Wrong

  • No product revenue in Q1 2025 (pre-launch); net loss of $12.0M reflects increased operating expenses from launch and manufacturing scale-up (R&D $9.9M; G&A $9.8M) .
  • Near-term supply gating: manufacturing capacity starts at ~4 patients/month, implying a gradual QTC ramp and potential patient backlog until capacity increases .
  • Reimbursement lead times: sites will pre-negotiate reimbursement case-by-case prior to manufacturing slot allocation, extending the gap between activation and first treatments and pushing initial revenue recognition into Q3 2025 .

Financial Results

MetricQ3 2024Q4 2024Q1 2025Q1 2025 Consensus
Revenue ($USD Millions)$0.00 $0.08*$0.00 $0.00*
Diluted EPS ($USD)$(0.63) $(0.32)*$(0.24) $(0.36)*
Net Loss ($USD Millions)$(30.27) N/A$(12.03) N/A
R&D Expense ($USD Millions)$8.94 N/A$9.94 N/A
G&A Expense ($USD Millions)$6.40 N/A$9.79 N/A

Values retrieved from S&P Global*.

Notes:

  • Q1 2025 Statement of Operations: Revenue “—”, Net Loss $(12.029)M, Diluted loss/share $(0.24), change in fair value of warrant and derivative liabilities +$7.245M .
  • Cash, equivalents, restricted cash and short-term investments: $110.0M (Q3 2024), $98.1M (Dec 31, 2024), $84.5M (Mar 31, 2025) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
First patient treatment timing3Q 20253Q 2025 (post-approval ramp) 3Q 2025; biopsy July, treatment August at Lurie Children’s Maintained
2025 patients treatedFY 2025Not provided prior10–14 patients New
Manufacturing run-rate2025 → early 2026Initial supply-gated launch; target up to 10 patients/month by 1H 2026 ~4/month at launch; ramp to ~6 by end-2025; 8–10/month by early 2026 Clarified/maintained trajectory
Qualified Treatment Centers (QTCs)FY 2025Target 5 QTCs Activate all five QTCs by end-2025 Maintained
Profitability timingEarly 2026Runway into 2026; profitability not specified Expect positive EPS and profitability in early 2026 New/raised visibility
PRV sale proceeds (gross/net)2025PRV expected if approved; potential monetization referenced $155M gross; ~$152M net proceeds post-HSR New

Earnings Call Themes & Trends

TopicQ3 2024 (Prev-2)Q4 2024 (Prev-1)Q1 2025 (Current)Trend
Regulatory/LabelCRL addressed; BLA resubmitted; PDUFA set Apr 29, 2025 USPI draft received; post-marketing discussions ongoing FDA approval achieved; commercial launch underway Resolved/positive
QTC onboardingPlanning 5 COEs; travel patterns support centralized model 5 QTCs to be activated ~2–3 months post-approval First QTC (Lurie) activated; others on track Executing
Market accessCMS ICD-10-PCS/MS-DRG 018; payer education underway Continued payer engagement across commercial/Medicaid Outcomes-based agreements executed; ~100M lives Strengthening
Manufacturing capacityMax 10 patients/month; supply-gated initial launch Ramp to near 10/month by end-2025/early-2026 4/month now; pathways to 6 → 8–10/month On plan
Patient demandPhysician/patient enthusiasm; repeat Phase 3b treatments Expect demand > supply at launch ~30 inbound inquiries in 2 weeks Building
Reimbursement timingStructuring payer processes; case rates likeliest Revenue recognition upon administration Pre-authorization prior to manufacturing; revenue on treatment Operational clarity
Pipeline (ophthalmology RS1)Capsid partnerships; UX111 BLA by partner UX111 Priority Review; PDUFA Aug 18, 2025 RS1 to clinic 2H 2026; cadence aligned with commercial ramp Progressing

Management Commentary

  • CEO: “We are incredibly proud that Abeona is now a commercial stage cell and gene therapy company following the U.S. FDA approval of our first product, ZEVASKYN…The launch is underway, and we are quickly building positive momentum” .
  • CCO: “We remain optimistic about our ability to achieve our 2025 goal of treating 10 to 14 patients as we previously guided and look forward to a robust start to 2026” .
  • CFO: “The net proceeds from the PRV sale…will be about $152 million…This robust financial footing…eliminates the need to raise additional capital…anticipating positive EPS [in] 2026” .
  • CTO: “We are at a capacity of roughly 4 patients per month at launch…ramping to 6…with an anticipation of being at 8 and 10 patients per month by early next year…current facility will support that 10 patients per month” .

Q&A Highlights

  • Site activation/training: Lurie staff trained; processes in place; patients can be identified and scheduled subject to payer authorizations .
  • Throughput capacity: Physicians comfortable with 2 patients/month/site; some centers indicated potential for 4/month depending on bed capacity .
  • Reimbursement cycle: Revenue recognized upon administration; hospitals pre-negotiate with payers prior to manufacturing; cash timing consistent with other cell/gene therapies .
  • PRV sale economics: Net proceeds ~$152M; buyer undisclosed; extends runway to expected profitability in early 2026 .
  • Patient profile: Majority previously exposed to Vyjuvek or Filsuvez; broad interest across pediatric and adult patients with large wound burden .

Estimates Context

MetricQ1 2024 ActualQ4 2024 ActualQ1 2025 ActualQ1 2025 Consensus
Revenue ($USD Millions)$0.13*$0.08*$0.00 $0.00*
Diluted EPS ($USD)$(0.52)*$(0.32)*$(0.24) $(0.36)*

Values retrieved from S&P Global*.

  • Q1 2025 EPS beat consensus by ~$0.12 per share; revenue matched a zero base as expected pre-launch . Values retrieved from S&P Global*.
  • Street models should incorporate Q3 2025 initial treatment timing, outcomes-based payer agreements, and capacity ramp, which will govern revenue recognition trajectory .

Financial Position and KPIs

KPIQ3 2024Q4 2024Q1 2025
Cash, equivalents, restricted cash, ST investments ($USD Millions)$110.0 $98.1 $84.5
PRV sale (gross / net proceeds, $USD Millions)N/AN/A$155 / ~$152
QTCs activated (cumulative)0 0 1 (Lurie Children’s)
Patient inquiries since approval (cumulative)N/AN/A~30
Payer outcomes agreements (lives covered)N/AN/A~100M commercially insured
Manufacturing capacity (patients/month)Planning up to 10 Ramp to near 10 by end-2025/early-2026 ~4 (launch), plan to ~6 by end-2025; 8–10 by early 2026

Key Takeaways for Investors

  • Commercial inflection arriving in 3Q 2025; near-term setup favors catalyst-driven rerating as initial treatments commence at Lurie Children’s with additional QTCs to follow .
  • Execution on payer agreements and outcomes-based contracting (~100M lives) de-risks access; monitor Medicaid carve-outs and J-code progression for further coverage clarity .
  • Capacity is the gating factor: track monthly patient manufacturing slots (4→6→8–10) and QTC throughput to calibrate revenue ramp and backlog dynamics .
  • Funding runway extended: PRV monetization (~$152M net) supports operations through expected profitability in early 2026, reducing dilution risk .
  • Q1 EPS beat driven partly by non-operating item (warrant liability FV change); core P&L will pivot as ZEVASKYN revenue recognition begins on administration in Q3 .
  • Competitive coexistence: high unmet need and durable single-application profile position ZEVASKYN alongside existing RDEB options (Vyjuvek, Filsuvez), with repeat-treatment precedent in trials .
  • Medium-term thesis: scale manufacturing, expand QTC network (target five in 2025), and execute payer strategies to drive a multi-year adoption curve; ophthalmology RS1 program offers optionality into 2H 2026 .

*Values retrieved from S&P Global.