Opus Genetics, Inc. (IRD)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 revenue was $4.37M, up 155% year over year, driven by Viatris reimbursement for Phentolamine 0.75% development and small RYZUMVI royalties; net loss was $(8.19)M and EPS $(0.24), improving versus $(0.29) in Q1 2024 .
• Cash and cash equivalents increased to $41.8M post March financing, with management guiding runway into Q2 2026; prior FY guidance had extended into second half 2026, implying a modestly tighter runway assumption .
• Strategic execution advanced: durable 12-month adult data in OPGx-LCA5, pediatric cohort enrollment underway with initial multi-patient readout expected Q3 2025; OPGx-BEST1 IND and first-in-human planned for 2025 with early data in Q1 2026 .
• Near-term catalysts include two Phase 3 topline readouts for Phentolamine 0.75% (DLD mid-2025; presbyopia 1H 2025), which, if positive, could enhance non-dilutive funding visibility via Viatris and strengthen optionality for gene therapy programs .

What Went Well and What Went Wrong

What Went Well

• Management highlighted “a strong start in 2025” with durable 12‑month efficacy in OPGx‑LCA5 adult patients and early pediatric improvement, reinforcing clinical proof of concept and regulatory momentum (RMAT, Type D meeting) .
• Portfolio breadth and milestones: OPGx‑BEST1 remains on track for IND filing and Phase 1/2 initiation in 2025 with preliminary data in Q1 2026, expanding exposure to a larger IRD population .
• Capital position strengthened by March financing anchored by Perceptive and Nantahala; cash rose to $41.8M with Viatris reimbursing Phentolamine 0.75% development costs, supporting multi-program execution .

What Went Wrong

• Despite higher revenue, operating expenses grew (R&D to $8.0M; G&A to $6.3M) on clinical and payroll costs, sustaining losses; Q1 net loss widened to $(8.19)M from $(7.11)M YoY .
• Sequential funding runway language tightened versus FY commentary (“second half 2026” to “Q2 2026”), reflecting updated warrants/liability dynamics and program pacing .
• No formal financial guidance (revenue/EPS/margins) and no Q1 2025 earnings call transcript available, limiting clarity on burn trajectory, trial cost phasing, and longer-term OpEx cadence [functions.ListDocuments earnings-call-transcripts result: 0].

Financial Results

Values with asterisk retrieved from S&P Global.

Notes:

• Revenue increases primarily reflect Viatris reimbursement for Phentolamine 0.75% development; royalties remain de minimis .
• Cash uplift driven by March 2025 financing and working capital movements; warrant liabilities introduced in Q1 (current liabilities $24.25M including $12.72M warrants) .

Guidance Changes

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was available; themes derived from Q1 press release and prior period releases .

Management Commentary

• “Opus is off to a strong start in 2025… The evidence of durable efficacy in adult patients is very encouraging… We are now enrolling pediatric patients and are encouraged by the meaningful improvement in visual function and early safety profile observed in the first of these patients at one month.” — CEO George Magrath .
• “We believe that the initial success with our lead IRD program, OPGx‑LCA5, has the potential to translate to the rest of our pipeline… We plan to initiate a Phase 1/2 study with our BEST‑1 program later this year…” — CEO .
• “We ended the first quarter with a strong cash position, having completed a successful financing with leading institutional healthcare investors…” — CEO .

Q&A Highlights

• No Q1 2025 earnings call transcript was available from company documents; Q&A themes cannot be directly assessed for this quarter [functions.ListDocuments earnings-call-transcripts result: 0].
• Context: The company hosted scientific and program update forums (e.g., ARVO, KOL webinars) around LCA5, but formal Q1 earnings Q&A was not located in filings .

Estimates Context

• S&P Global consensus estimates for Q1 2025 EPS and revenue were not available; no target price consensus found. As a result, comparison to Wall Street consensus cannot be made for this quarter. Values retrieved from S&P Global.
• Documented actuals: Revenue $4.37M; EPS $(0.24). Without consensus, we do not characterize beat/miss; near-term estimate revisions will likely hinge on Phase 3 Phentolamine toplines and LCA5 pediatric data cadence .

Key Takeaways for Investors

• Execution momentum in OPGx‑LCA5 (12‑month durability; pediatric cohort underway; RMAT, Type D) increases probability of advancing to pivotal discussions; watch for Q3 2025 pediatric multi‑patient data as a stock catalyst .
• OPGx‑BEST1 timing remains intact (IND/Q4 2025; early data Q1 2026), broadening pipeline optionality into a larger IRD setting; regulatory progress will be key to sustaining sentiment .
• Phentolamine 0.75% Phase 3 readouts (DLD mid‑2025; presbyopia 1H 2025) could bolster non‑dilutive funding (Viatris) and validate the reimbursement‑driven revenue stream observed in Q1; positive outcomes would be supportive for valuation .
• Cash of $41.8M and runway to Q2 2026 provide capacity to reach multiple inflection points; monitor warrant liabilities and sequencing of trial costs for burn visibility .
• Operating expenses are trending higher with clinical activity (R&D +68% YoY; G&A +36% YoY); absent formal guidance, expect continued investment into pivotal preparation and BEST1 initiation .
• With no Q1 consensus screen, investor focus should pivot to binary catalysts and regulatory interactions; communication cadence (press releases, scientific meetings) will drive narrative and positioning .

Appendices

Additional Press Releases and Prior Quarter Context

• FY 2024 release (3/31/2025): financing updates, pipeline breadth, Phentolamine Phase 3 enrollment completion, SPA, and LCA5 12‑month adult data presentation timing at ARVO .
• Q3 2024 release (11/12/2024): acquisition of Opus Genetics; six‑month adult LCA5 improvement, pediatric enrollment plan, Viatris funding of Phentolamine 0.75% development .