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Ocuphire Pharma, Inc. (OCUP)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 results showed continued operating losses amid lower collaboration revenue: License and collaborations revenue was $1.11M, net loss was $(7.77)M, and diluted EPS was $(0.30) .
  • Cash and cash equivalents were $41.4M at quarter-end, with management reiterating runway anticipated into mid-2025; opex rose year over year driven by APX3330 prep, while G&A fell versus Q2 2023 .
  • Clinical execution advanced: VEGA-3 (presbyopia) began recruiting; LYNX-2 (dim light disturbances) continued strong enrollment; APX3330 Phase 2/3 SPA discussions with FDA ongoing, positioning 2025 topline catalysts .
  • Wall Street consensus via S&P Global was unavailable; third-party sources indicated misses vs EPS and revenue expectations, but conflicting estimates warrant caution in interpretation .

What Went Well and What Went Wrong

What Went Well

  • Clinical momentum: “The VEGA-3 Phase 3 trial in presbyopia, funded by our commercial partner, has begun recruiting… The LYNX-2 Phase 3 study in dim light disturbances has seen strong enrollment” .
  • Regulatory progress: “We continue to work collaboratively with the FDA on our submitted Special Protocol Assessment (SPA) for Phase 2/3 and the overall clinical development plan for APX3330” .
  • Cost discipline in G&A year-over-year: G&A was $3.4M vs $4.3M in Q2 2023 as payroll and other operating expenses declined .

What Went Wrong

  • Revenue declined sharply YoY: License and collaborations revenue fell to $1.11M from $3.67M in Q2 2023 as reimbursed R&D services tapered; includes $19K royalty from RYZUMVI™ .
  • Higher R&D spend YoY tied to APX3330 manufacturing/toxicology and payroll: R&D was $6.09M vs $4.72M in Q2 2023 .
  • Operating losses widened YoY: Loss from operations was $(8.33)M vs $(5.39)M, with net loss $(7.77)M vs $(4.96)M, and diluted EPS $(0.30) vs $(0.24) .

Financial Results

Income Statement Comparison

MetricQ2 2023Q1 2024Q2 2024
License & collaborations revenue ($USD Millions)$3.674 $1.711 $1.112
Total operating expenses ($USD Millions)$9.063 $9.419 $9.440
Loss from operations ($USD Millions)$(5.389) $(7.708) $(8.328)
Other income, net ($USD Millions)$0.428 $0.602 $0.563
Net loss ($USD Millions)$(4.961) $(7.106) $(7.765)
Diluted EPS ($USD)$(0.24) $(0.29) $(0.30)

Margins and Efficiency

MetricQ2 2023Q1 2024Q2 2024
Net Income Margin %(135.1%) (415.3%) (698.5%)
EBIT Margin % (Operating Income = EBIT)(146.6%) (450.6%) (749.2%)
Total Operating Expenses / Revenue (x)2.47x 5.50x 8.49x

Note: Margins are calculated from reported revenue, operating income, and net loss figures in the cited documents.

KPIs and Balance Sheet Snapshot

KPIQ4 2023 (12/31)Q1 2024 (3/31)Q2 2024 (6/30)
Cash & cash equivalents ($USD Millions)$50.501 $47.161 $41.409
Accounts receivable ($USD Millions)$0.926 $1.924 $1.358
Accrued expenses ($USD Millions)$1.815 $3.649 $3.490
G&A expense ($USD Millions)$—$4.670 $3.354
R&D expense ($USD Millions)$—$4.749 $6.086
RYZUMVI™ royalties ($USD)$—$3,000 $19,000

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayThrough mid-2025“Sufficient to fund operations into mid-2025” (as of Q1 2024) “Runway anticipated into mid-2025” (as of Q2 2024) Maintained
VEGA-3 (presbyopia) timelinePhase 3 toplinePhase 3 expected to continue H1’24 under partner funding Recruiting; topline expected in 2025 Updated (timing specified)
LYNX-2 (DLD) timelinePhase 3 toplineLYNX-2 under SPA; Phase 3 to continue H1’24 Enrollment strong; topline expected in 2025 Updated (timing specified)
APX3330 DR registrational pathwaySPASPA submitted Feb 2024; dialogue ongoing Ongoing FDA discussions on SPA and plan Maintained (process continues)

No formal quantitative guidance on revenue, margins, OpEx, tax rate, or OI&E was provided in Q2 2024 filings/press releases .

Earnings Call Themes & Trends

No Q2 2024 earnings call transcript was available in our document repository or via targeted searches, so themes are tracked using company press releases.

TopicPrevious Mentions (Q4 2023 and Q1 2024)Current Period (Q2 2024)Trend
APX3330 (DR) regulatory pathEnd-of-Phase 2 alignment on registrational endpoint; SPA was planned/submitted and dialogue ongoing Ongoing FDA discussions on SPA and development plan Steady progress
Presbyopia (VEGA-3)Phase 3 development expected to continue H1’24 under partner funding Recruiting now; topline expected 2025 Advancing to execution
DLD post-keratorefractive (LYNX-2)SPA agreed; first subject enrolled in Apr 2024 “Strong enrollment”; topline expected 2025 Advancing to execution
Commercialization (RYZUMVI™)FDA approval Sept 2023; launch expected H1’24; $10M milestone in 2023 Royalty recognized ($19K in Q2; $3K in Q1) Early monetization
Cash runwaySufficient into mid-2025 Maintained mid-2025 runway Stable
R&D execution & spendR&D $3.8M in Q4’23 full-year $17.7M; Q1’24 $4.75M Q2’24 R&D $6.09M, higher YoY on APX3330 prep Elevated investment

Management Commentary

  • “We continue to work collaboratively with the FDA on our submitted Special Protocol Assessment (SPA) for Phase 2/3 and the overall clinical development plan for APX3330.” — George Magrath, CEO .
  • “The VEGA-3 Phase 3 trial in presbyopia, funded by our commercial partner, has begun recruiting… The LYNX-2 Phase 3 study in dim light disturbances (‘DLD’) has seen strong enrollment and could provide a differentiated product for patients.” — George Magrath, CEO .
  • “We have been engaged in productive dialogue with the FDA… for future Phase 2/3 registrational trials of APX3330 in diabetic retinopathy… The recent commercial launch of RYZUMVI™ by our partner Viatris… was a major milestone.” — George Magrath, CEO (Q1 press release) .

Q&A Highlights

No Q2 2024 earnings call transcript was found; therefore, no Q&A highlights are available from primary sources [SearchDocuments: none] .

Estimates Context

  • S&P Global/Capital IQ consensus estimates were unavailable for OCUP due to missing CIQ mapping in our data connector; as a result, we cannot anchor estimate comparisons on SPGI for Q2 2024 (SPGI mapping error) [GetEstimates error].
  • Third-party outlets indicate the quarter missed expectations: Public.com shows actual EPS $(0.30) vs estimate $(0.24) (miss), and reports Q1 miss as well . InvestorPlace reports revenue $1.11M vs estimate $2.61M (miss), EPS $(0.30) vs $(0.24) (miss) . Nasdaq/Zacks notes EPS $(0.30) vs $(0.29) consensus (miss) and revenue $1.11M, missing by 38.22% .
  • Given discrepancies across non-SPGI sources, investors should focus on directional takeaway (misses on EPS and revenue) while awaiting standardized SPGI consensus resolution .

External Estimates Snapshot (Non-SPGI)

MetricQ2 2024 Consensus (Public.com)Q2 2024 Consensus (InvestorPlace)Actual Q2 2024
EPS ($USD)$(0.24) $(0.24) $(0.30)
Revenue ($USD Millions)$2.61 $1.112

Note: S&P Global consensus was unavailable; numbers above are from third-party sources and may vary across providers.

Key Takeaways for Investors

  • Revenue decline and rising R&D produced severe negative margins (net margin ~–699% and EBIT margin ~–749%), underscoring dependence on partner funding and pipeline progression to drive future monetization .
  • Cash runway to mid-2025 provides execution time for pivotal catalysts (VEGA-3 and LYNX-2 topline in 2025; APX3330 SPA progress), but quarterly cash declined to $41.4M, reflecting spend levels .
  • Early RYZUMVI™ royalties are small ($19K in Q2, $3K in Q1), reinforcing that near-term economics hinge on collaboration revenue and disciplined opex while clinical proof points mature .
  • Expect estimate revisions to reflect lower revenue and elevated opex; third-party data point to EPS and revenue misses, suggesting near-term pressure until visibility improves on clinical milestones .
  • Trading setup: shares may be sensitive to regulatory updates on APX3330 SPA and trial enrollment cadence; watch for any interim recruitment or safety updates and partner-driven presbyopia/DLD communications .
  • Medium-term thesis: Non-invasive DR therapy (APX3330) remains a strategic opportunity if Phase 2/3 outcomes succeed; partnered presbyopia and DLD indications could diversify revenue if topline data are positive in 2025 .
  • Risk management: Funding needs beyond mid-2025 and trial execution risk (enrollment, endpoints) remain key; monitor partner performance (Viatris) and any changes to reimbursement of PS development .