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EYENOVIA, INC. (EYEN)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 was an execution-heavy quarter: Eyenovia advanced Gen-2 Optejet validation (FDA feedback aligned with plans), kept MicroPine’s Phase 3 CHAPERONE analysis on track for Q4, and seeded Mydcombi adoption to 63 offices with a target of 263 by end of Q3 .
  • Reported net loss of $11.1M and EPS of $(0.21), impacted by $2.9M reacquisition charges for MicroPine and a $0.5M inventory write-down; unrestricted cash was $2.3M at quarter-end (excluding ~$5.8M raised post-Q2) .
  • Clobetasol launch moved to late Q3/early Q4 pending Formosa’s export license; salesforce is prequalifying ~500 offices and co-promotion with NovaBay is active to extend reach .
  • Consensus estimates from S&P Global were unavailable for EYEN; management did not issue formal revenue guidance and indicated guidance would follow product launch ramp .

What Went Well and What Went Wrong

What Went Well

  • Gen-2 Optejet validation track solidified; FDA feedback “largely in agreement” with qualification plans, enabling registration batches in Q4 and submission in 2025 with Mydcombi as lead product .
  • Commercial groundwork: Mydcombi trained/converted 63 offices by June 30 with momentum accelerating; target of >260 new offices by end of Q3 .
  • Pipeline/business development: entered three dry eye collaborations (Formosa—acute; Senju—adjunctive chronic SJP-0035; SGN—chronic cyclosporine), covering multiple segments of a ~$3–$5B market .

What Went Wrong

  • Gross margin negative in Q2 driven by inventory write-down; management flagged a nonrecurring charge within cost of revenue .
  • Opex elevated by one-time reacquisition costs for MicroPine ($2.9M in Q2) and higher R&D/G&A from clinical and salesforce build-out .
  • Clobetasol launch timing delayed by Taiwan export licensing logistics; management expects September/early Q4 timing but acknowledged administrative dependencies .

Financial Results

P&L snapshot vs prior quarter and prior year

MetricQ1 2024Q2 2024YoY (Q2 2023)
Revenue ($USD)$4,993 $22,625 $27,618
Cost of Revenue ($USD)$4,993 $490,361 $693,388
Gross Loss ($USD)$0 $(467,736) $(665,770)
R&D Expense ($USD)$4,431,601 $4,597,173 $2,811,061
G&A Expense ($USD)$3,835,223 $3,758,835 $3,149,809
Reacq. License Rights ($USD)$2,000,000 $2,864,600 $0
Total Operating Expenses ($USD)$10,266,824 $11,220,608 $5,960,870
Operating Loss ($USD)$(10,266,824) $(11,688,344) $(5,960,870)
Other Inc./(Exp.) ($USD)$(655,277) $634,645 $(254,990)
Net Loss ($USD)$(10,922,101) $(11,053,699) $(6,215,860)
EPS (Basic & Diluted) ($USD)$(0.23) $(0.21) $(0.16)
Shares Outstanding (Basic & Diluted)46,606,790 53,121,760 38,093,826

Additional balance sheet and liquidity metrics:

  • Unrestricted cash and cash equivalents at 6/30/24: $2.3M; excludes ~$5.8M gross proceeds raised post quarter .
  • Total current liabilities at 6/30/24: $15.85M .

Q4 2023 context

MetricQ4 2023
Net Loss ($USD)$(8.0M)
EPS ($USD)$(0.18)
Weighted Avg. Shares~45.4M

KPIs and Operating Milestones

KPIQ1 2024Q2 2024Target/Comment
Mydcombi offices onboarded~50 offices 63 offices by 6/30 >260 new offices by end Q3
Field salesforce size~10–12 reps (hiring/training completed by Q2) 10 reps trained Each rep targeting ~50 offices (Clobetasol)
Gen-2 Optejet registration batchesPlanned 2024 Production anticipated Q4 2024 FDA submission in 2025 (Mydcombi lead)
MicroPine CHAPERONEProtocol amendment/early DMC review planned Q4 Efficacy analysis planned Q4 Potential NDA late 2025/early 2026 if positive
Dry eye collaborationsSGN agreement announced Senju (adjunctive) and Formosa (acute) added Cover acute/adjunctive/chronic segments

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Revenue guidanceFY 2024Management to consider later; comfortable with analyst estimates for 2024 (Q4 call) No formal guidance; will provide once products launch and ramp (Q2 call) Maintained (no quantitative guidance)
Mydcombi office onboardingQ3 2024Continued rollout; ~50 offices by Q1 On track to onboard >260 offices by end of Q3 Raised operational target clarity
Clobetasol U.S. launch timingSummer 2024 Summer/August 2024 target (NovaBay co-promo prep) Logistics delayed; aiming September/early Q4 pending export license Lowered (timing delayed)
Gen-2 Optejet validation2024–2025FDA meeting summer 2024; registration batches by year-end FDA feedback aligned; registration batches in Q4 2024; submission in 2025 (Mydcombi lead) Maintained (timeline reaffirmed)
MicroPine CHAPERONEQ4 2024DMC interim/efficacy analysis planned Q4 Efficacy analysis in Q4; potential NDA late 2025/early 2026 Maintained (path clarified)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’23 and Q1’24)Current Period (Q2’24)Trend
Gen-2 Optejet/device economicsGen-2 planned; FDA meeting summer; COGS ~20% of Gen-1 enabling 60–90% gross margins FDA feedback largely in agreement; registration batches Q4; sNDA in 2025 Positive execution; timeline reaffirmed
Mydcombi commercializationVision Source channel; ~50 offices; licensing coverage; Phase IV lower dose data 63 offices by 6/30; target >260 by Q3; emphasis on training champions and patient experience Accelerating adoption cadence
Clobetasol launchApproved Mar 4; co-promo with NovaBay; aiming summer 2024 Export license logistics delaying launch; prequalifying offices; target September/early Q4 Short-term timing headwind
Dry eye strategySGN collaboration (chronic cyclosporine) Added Senju (adjunctive SJP-0035) and Formosa (acute clobetasol-Optejet) Portfolio broadened across segments
MicroPine pathwayPlan for DMC interim in Q4; NDA late ’25/early ’26 possible Efficacy analysis Q4; single Phase 3 could suffice; device-enabled compliance (OptiCare) Derisking milestone approaching
Capital/cash runwayFY23 cash ~$14.8M; exploring financing options; burn ~$4.5–$5M/qtr Unrestricted cash $2.3M at Q2; raised ~$5.8M post-Q2; evaluating structures; runway toward CHAPERONE data Tight but managed; incremental financing

Management Commentary

  • “Our plans to finalize the Gen-2 device are now set following a meeting with the FDA… submission… in 2025. Meanwhile, our Mydcombi launch continues to track to plan… with many more coming onboard during the third quarter as momentum accelerates.” — CEO Michael Rowe .
  • “We are planning for an efficacy analysis in the fourth quarter… If the results are positive… potentially enable an NDA submission as soon as late 2025 or early 2026.” — CEO Michael Rowe on MicroPine .
  • “We believe that Clobetasol has the potential to become the leading option in the postsurgical space… twice daily dosing… fewer than 1% [IOP increases].” — CEO Michael Rowe .
  • “FDA feedback… largely in agreement with our plans… provides high confidence that… requirements… will be fully satisfied.” — COO Bren Kern on Gen-2 .
  • “Total operating expenses… included approximately $3.8M of noncash expenses… we expect going forward that our R&D and G&A will be a total of $6.0M to $6.1M.” — CFO John Gandolfo .

Q&A Highlights

  • MicroPine regulatory path: DMC efficacy analysis Q4; FDA meeting likely early 2025; NDA late 2025/early 2026 if safety completes by Sep/Oct 2025 and registration batches/stability align .
  • Clobetasol timing: Still targeting launch upon export license; sales prequalification underway; pricing at branded co-pay via e-pharmacy/wholesale to reduce payer friction .
  • Gross margin anomaly: Q2 negative gross margin due to onetime inventory write-down within cost of revenue; otherwise revenue and cost would have aligned .
  • Dry eye endpoints and segmentation: Acute (two 15-day trials), chronic cyclosporine (~16 weeks), adjunctive chronic (likely 1-year safety + efficacy); strategy covers flare-ups + adjunctive + chronic .
  • Cash runway: Runway toward year-end; evaluating debt/convertible structures; access to capital as needed .

Estimates Context

  • S&P Global consensus estimates for EYEN were unavailable at this time; management did not provide formal revenue guidance and indicated guidance will be provided after product launch traction is evident .
  • On Q4 2023, management noted they were comfortable with analyst estimates for 2024 but did not issue their own guidance .
  • Implication: Near-term estimate revisions may reflect clobetasol launch timing shift (export license), Mydcombi adoption cadence, and Gen-2 validation milestones; monitor post-Q3 office onboarding and Q4 revenue inflection.

Key Takeaways for Investors

  • Near-term setup: Watch clobetasol’s U.S. launch timing (export license) and Mydcombi office rollout (>260 by Q3) for first revenue inflection; sales prequalification plus NovaBay co-promo should accelerate adoption once product ships .
  • Gen-2 Optejet is the 2025 catalyst: FDA feedback aligned; registration batches Q4 2024; device economics key to margin uplift across portfolio .
  • MicroPine derisking milestone in Q4 2024: Positive efficacy analysis could compress timelines to NDA (late 2025/early 2026) and position MicroPine as a differentiated pediatric myopia solution with compliance features (OptiCare) .
  • Dry eye optionality expanding: Three collaborations target acute, adjunctive, and chronic segments; SGN’s platform plus Optejet may offer faster onset and better tolerability vs standard cyclosporine .
  • Expense normalization expected: One-time reacquisition and inventory charges inflated Q2 opex/COGS; management expects R&D+G&A ~$6.0–$6.1M going forward .
  • Liquidity: $2.3M cash at Q2 with ~$5.8M raised post-quarter; exploring financing structures; runway targeting CHAPERONE data in Q4 .
  • Trading implications: Stock likely sensitive to (1) clobetasol launch date confirmation and initial sell-through, (2) Mydcombi office count momentum, (3) Gen-2 validation/timeline updates, and (4) MicroPine interim findings in Q4.