OCULAR THERAPEUTIX, INC (OCUL)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 was operationally strong but financially soft: net revenue fell to $10.7M, down 27.6% year over year, driven by DEXTENZA net product revenue declines tied to pricing strategy impacts and CMS MIPS inclusion; diluted EPS was $(0.38) .
• Results missed Wall Street consensus: revenue of $10.7M vs $16.9M consensus and EPS $(0.38) vs $(0.29) consensus; both represent a miss and suggest near‑term estimate resets for DEXTENZA and opex intensity as SOL trials ramped (*Values retrieved from S&P Global).
• Strategic progress: FDA accepted the SOL‑1 SPA amendment to re‑dose at Weeks 52 and 76; SOL‑R target randomization reduced to ~555 from 825 to accelerate timelines while maintaining 90% power .
• Cash runway of $349.7M supports trials through topline SOL‑1 and SOL‑R and into 2028; company expects quarterly net product revenue to increase through 2025 as clinicians adjust to MIPS and HOPDs resume separate payment .
• No Q1 earnings call was held; management will resume calls in Q2, limiting real‑time Q&A color for this quarter .

What Went Well and What Went Wrong

What Went Well

• SOL program acceleration and regulatory alignment: FDA accepted SOL‑1 re‑dosing at Weeks 52 and 76 to potentially enable 6–12‑month dosing flexibility on label and earlier NDA submission. “We believe these refinements could position AXPAXLI for an unprecedented 6 to 12‑month dosing regimen on the label…” — Pravin U. Dugel, MD .
• Streamlined SOL‑R: Target randomization reduced to ~555 with 90% power per FDA guidance, improving capital efficiency and time to readout .
• Strong liquidity: Cash and cash equivalents of $349.7M (3/31/25) provide runway into 2028 (excludes potential NPDR/DME trial costs), enabling disciplined execution of registrational programs .

What Went Wrong

• Revenue decline and miss: Net revenue fell 27.6% YoY to $10.7M; DEXTENZA net product revenue decreased 27.7%, primarily due to pricing strategy impacts on stocking and buying patterns and 2025 MIPS inclusion effects; this drove a miss vs consensus .
• Operating leverage headwinds: R&D expenses doubled to $42.9M on SOL‑1/SOL‑R trials; Selling & Marketing and G&A rose on pre‑commercialization and personnel costs, widening loss from operations to $(63.9)M .
• Limited investor interaction: The company did not host a Q1 call, reducing immediate clarity on trajectory and near‑term update cadence .

Financial Results

P&L Summary (USD)

Segment/Revenue Mix (USD)

KPIs and Balance Sheet (USD)

Results vs Wall Street Consensus (Q1 2025)

Values with asterisk retrieved from S&P Global.

Guidance Changes

No numerical revenue/margin/EPS ranges were provided for Q1 2025.

Earnings Call Themes & Trends

Note: No Q1 2025 call; themes reflect Q4 2024 call and Q1 PR.

Management Commentary

• “We believe these refinements could position AXPAXLI for an unprecedented 6 to 12‑month dosing regimen on the label… and potentially enable an earlier NDA submission.” — Pravin U. Dugel, MD, Executive Chairman, President & CEO .
• “SOL‑1 retention remains exceptional… Topline data are on track for 1Q 2026.” .
• “The FDA provided positive feedback… for AXPAXLI in NPDR. The Company is actively planning next steps in NPDR and DME.” .
• “Cash balance of $349.7M… sufficient… into 2028.” .
• “Selling and marketing expenses… increased… associated with pre‑commercialization activities for AXPAXLI.” .

Q&A Highlights

No Q1 2025 earnings call was held; the company announced it would not host a first‑quarter call and would resume for Q2 2025 . Key Q&A themes from Q4 2024 call that inform current quarter:

• SOL‑1 re‑dosing rationale and scope: all patients re‑dosed at Weeks 52 and 76; enhances safety exposure and potential label flexibility .
• SOL‑R powering and rescue criteria: maintained robust statistics; non‑inferiority margin −4.5 letters; rescues aligned with FDA guidance and contextualized by positive SOL‑1 durability .
• Regulatory pathway: expectation of two positive adequate and well‑controlled trials (SOL‑1 and SOL‑R) to support NDA; submission intended after SOL‑R Week 56 .

Estimates Context

• Q1 2025 results missed consensus: revenue $10.70M vs $16.95M consensus and EPS $(0.38) vs $(0.29) consensus, reflecting DEXTENZA headwinds and higher opex supporting the SOL program . Consensus values retrieved from S&P Global*.
• Implication: Street models likely to reduce near‑term DEXTENZA sales, raise R&D/S&M run‑rates, and potentially revisit timing assumptions for SOL‑1 topline and commercialization spend, while recognizing runway depth and SOL‑R streamlining (*Values retrieved from S&P Global).

Key Takeaways for Investors

• Near‑term: Expect estimate cuts on revenue and EPS given the Q1 miss and elevated opex; watch for Q2 call color on DEXTENZA trajectory as clinicians adjust to MIPS and HOPD separate payments resume .
• Strategic: Regulatory alignment improved; SOL‑1 re‑dosing and SOL‑R streamlining could enable a differentiated 6–12‑month label narrative and efficient NDA path if trials succeed .
• Liquidity: $349.7M cash supports execution through major catalysts into 2028; financing needs appear limited near term (excluding potential NPDR/DME clinical scope expansion) .
• Catalysts: SOL‑R enrollment updates; NPDR/DME program design following FDA feedback; SOL‑1 topline in 1Q 2026; any interim operational updates on pre‑commercial investments .
• Risk monitor: DEXTENZA demand normalization pace under MIPS, trial conduct/retention, rescue rates, and regulatory interpretation of SOL data remain key variables .
• Positioning: The company’s narrative is increasingly about durable retina therapy leadership; if durability and repeatability translate into label flexibility (6–12 months), commercial adoption could be significant, contingent on payer alignment and center economics .