Executive Summary

Q3 2024 was operationally pivotal: clobetasol launched in the U.S., Gen‑2 Optejet registration batch manufacturing commenced, and MydCombi adoption expanded to 230 offices by September 30, though reported product revenue remained de minimis and gross loss persisted due to inventory write-downs .
Financially, net loss improved sequentially to $7.9M and diluted EPS to $(0.11) from $(0.21) in Q2, driven by lower operating expenses and absence of the Q2 license reacquisition charge; YoY net loss modestly widened versus Q3 2023 .
Management guided key timelines: Gen‑2 Optejet sNDA submission with MydCombi in 2025 and possible approval in 2026; MicroPine CHAPERONE interim analysis this quarter with potential NDA in 1H 2026 if positive .
Estimate comparison unavailable: S&P Global consensus data could not be retrieved for EYEN, so beats/misses vs Street are not assessed (Wall Street consensus from S&P Global unavailable).
Near-term stock catalysts: MicroPine interim go/no-go disclosure followed by top-line data within the same quarter, and accelerating commercial adoption of clobetasol and MydCombi supported by a 10-person sales force and simplified distribution model .

What Went Well and What Went Wrong

What Went Well

Clobetasol U.S. launch achieved; first new ophthalmic steroid in 15+ years with strong surgeon interest and convenient BID dosing; early field traction via mom-and-pop pharmacy channel at fixed price regardless of insurance .
Gen‑2 Optejet progress: registration batches commenced, aiming to materially lower COGS and enable margins “up to 90%” on planned product line; foundational pathway using MydCombi for device registration .
MydCombi adoption building: product in use at 200+ offices, with positive feedback (4/5 professionals prefer vs drops), and targeted conversion of another 200 offices in the current quarter; 230 offices reached as of 9/30 .

Selected quotes:

“We achieved another significant commercial milestone during the third quarter with the U.S. launch of clobetasol…” .
“We recently completed the first phase of manufacturing registration batches… a key step in the FDA review process…” .
“We found that after using MydCombi 50 times… 4 out of 5 eye care professionals felt that MydCombi was a substantial improvement over eye drops” .

What Went Wrong

Product revenue remained minimal ($1.6K) with negative gross margin driven by inventory write-downs related to Gen‑1 device and short-dated inventory; gross loss of $(130.9K) in Q3 .
Continued cash constraints necessitating capital raises; Q3 unrestricted cash was ~$7.2M despite ~$10.7M net proceeds raised, and management continues to evaluate long-term financing options .
SG&A increased YoY (reflecting commercialization ramp), and overall operating expenses remained elevated (though improved vs Q2) without offsetting revenue scale in Q3 .

Financial Results

Metric	Q3 2023	Q1 2024	Q2 2024	Q3 2024
Revenue ($USD)	$1,198	$4,993	$22,625	$1,625
Cost of Revenue ($USD)	$(13,416)	$(4,993)	$(490,361)	$(132,522)
Gross Profit (Loss) ($USD)	$(12,218)	$0	$(467,736)	$(130,897)
R&D ($USD)	$3,578,113	$4,431,601	$4,597,173	$3,471,939
SG&A ($USD)	$2,929,855	$3,835,223	$3,758,835	$3,729,091
Reacquisition of License Rights ($USD)	$0	$2,000,000	$2,864,600	$0
Total Operating Expenses ($USD)	$6,507,968	$10,266,824	$11,220,608	$7,201,030
Loss from Operations ($USD)	$(6,520,186)	$(10,266,824)	$(11,688,344)	$(7,331,927)
Other Income (Expense) ($USD)	$(818,547)	$(655,277)	$634,645	$(555,926)
Net Loss ($USD)	$(7,338,733)	$(10,922,101)	$(11,053,699)	$(7,887,853)
Diluted EPS ($USD)	$(0.18)	$(0.23)	$(0.21)	$(0.11)
Weighted Avg Shares	40,139,697	46,606,790	53,121,760	69,558,325
Cash & Equivalents (Quarter-end) ($USD)	N/A	$7,976,106	$2,300,852	$7,188,129

KPIs and Operational Metrics

KPI	Q3 2023	Q1 2024	Q2 2024	Q3 2024
MydCombi offices (cumulative)	N/A	~50 offices trained/converted	+63 new offices Apr–Jun; on-track to 263 by Q3 end	230 offices reached by 9/30
Clobetasol U.S. launch	N/A	Approved 3/4; preparing Q3 launch	Preparing launch; market research positive	Launched; placed in pharmacies supporting 100+ offices
Gen‑2 Optejet	N/A	FDA meeting prep; bridging study plan	Validation plans; production in Q4; 2025 submission	Registration batches commenced
Capital raised (net proceeds)	N/A	+$2.2M in April	+$5.8M gross post-6/30	$10.7M net proceeds raised in Q3

YoY and Sequential Context

YoY: Revenue modest ($1.6K vs $1.2K), SG&A up 27.3% on commercialization, R&D slightly lower; EPS improved to $(0.11) from $(0.18) .
QoQ: EPS improved from $(0.21) to $(0.11) as Q2 included $2.9M license reacquisition expense and higher R&D; Gross loss persisted due to inventory write-down dynamics .

Guidance Changes

Metric/Topic	Period	Previous Guidance	Current Guidance	Change
Gen‑2 Optejet sNDA submission (with MydCombi)	2025	Validation/production in Q4 2024; submit 2025	Submit 2025; possible approval in 2026	Maintained timeline; clarified approval window
MicroPine CHAPERONE interim analysis	Q4 2024	DMC review in Q4; potential acceleration	Independent review “any day”; go/no-go shared within 1 day; full top-line within same quarter	Timing refined; two-step disclosure
MicroPine NDA filing	1H 2026 (if positive interim)	Late 2025/early 2026 potential if expedited	NDA in 1H 2026 if interim positive and FDA alignment	Slightly narrowed to 1H 2026
MydCombi office conversions	Q4 2024	On-track to 263 new offices by Q3 end	Convert an additional 200 offices in current quarter	Raised near-term commercial activity
Financial metrics (Revenue/Margins/OpEx)	N/A	No formal financial guidance	No formal financial guidance; continued cost focus and financing evaluation	Maintained no-quantitative guidance

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 & Q2)	Current Period (Q3)	Trend
Gen‑2 Optejet and OptiCare	Bridging study plan; FDA meeting in summer; goal COGS ↓ to ~$20 cartridge	Registration batches commenced; device efficiencies to drive margins up to 90% on planned product line	Advancing from planning to execution; stronger margin narrative
MicroPine CHAPERONE	Protocol amendment for DMC interim review; potential acceleration	Independent committee meeting imminent; go/no-go and top-line timing detailed; potential NDA 1H 2026	Increased confidence and clarity on timelines
Commercial execution (MydCombi)	50 offices trained; Vision Source/UC formulary wins	200+ offices in use; aim to convert 200 more in Q4; positive feedback (4/5 prefer)	Scaling adoption and retention focus
Clobetasol launch	Preparing Q3 launch; strong market research	U.S. launch completed; distribution via local pharmacies; fixed price model; early reorders	Transitioned to in-market adoption
Dry Eye collaborations (Formosa, Senju, SGN)	Announced agreements targeting $5B market	Detailed development paths; SGN‑101 Phase III‑ready potential in 2025; Senju SJP‑0035 plan	Pipeline visibility improving
Manufacturing/licensing	Redwood City FDA approval; operations build-out	Reno facility audits by FDA and NV Board passed; Arctic Vision milestones potential $37M next 3–6 years	Manufacturing readiness and licensing optionality strengthened

Management Commentary

CEO on clobetasol and portfolio: “Clobetasol… allows us to further leverage our sales force… With two differentiated commercial products… and the advanced Gen‑2 Optejet… foundation… to drive significant growth” .
COO on clobetasol and distribution: “We’re seeing strong interest… placed clobetasol into local pharmacies supporting over 100 offices… low fixed price regardless of insurance status” .
CFO on gross loss dynamics: “Losses are primarily the result of adjustments to write down inventory… We anticipate that positive margins on clobetasol sales will offset those losses as that channel grows” .
CEO on CHAPERONE: “Independent review committee… will tell us whether at least one dose… reached statistical significance… go/no-go shared within a day… top-line within the same quarter” .

Q&A Highlights

CHAPERONE success criteria and power: Interim aims to show at least one dose statistically superior; power “around 85%” at p<0.21 per statistical plan; NDA possible 1H 2026 if positive .
Revenue vs office count: Q3 revenue (~$2K) reflected sampling and launch prep; reorders expected to drive Q4 uptick; university reorder example; clobetasol expected to offset Gen‑1 margin drag .
Distribution model: Clobetasol fixed pricing via local pharmacies reduces prior auth friction; early reorders observed .
Sales execution: Target to hit 200 additional MydCombi offices in Q4; focus on institutions, retention, conversions .
COGS and inventory adjustments: COGS impacted by short-dated inventory and overhead; adjustments vary quarter-to-quarter; largely sunk costs .

Estimates Context

Wall Street consensus (S&P Global) was unavailable for EYEN for Q3 2024 at time of analysis; therefore, we cannot present revenue/EPS beats or misses vs consensus (Values retrieved from S&P Global*).

Key Takeaways for Investors

MicroPine interim analysis is the key binary near-term catalyst; a positive go/no-go followed by top-line within the quarter could materially re-rate the stock and accelerate the NDA path to 1H 2026 .
Gen‑2 Optejet progress de-risks margin structure across the portfolio; successful sNDA in 2025 and 2026 approval would structurally expand gross margins, reducing reliance on equity financing over time .
Clobetasol’s launch leverages a simplified fixed-price distribution channel that may enable rapid uptake independent of payer hurdles; early pharmacy placement and reorders are encouraging .
MydCombi adoption trajectory is intact with sampling-to-reorder cycle; watch Q4 reorder volumes and incremental 200-office conversion for validation of commercial ramp .
Near-term P&L optics remain challenged by Gen‑1 inventory write-downs; mix shift to clobetasol and, later, Gen‑2 deliveries should improve gross margin profile .
Liquidity improved to $7.2M at Q3-end post $10.7M net proceeds, but capital needs remain; progress on Arctic Vision milestones and partner-funded dry eye programs can provide non-dilutive optionality .
Narrative evolution: From planning to execution—Q3 demonstrated tangible commercial and manufacturing steps; sustained delivery on guidance timelines is critical for investor confidence .

Notes: Earnings press release, Form 8‑K (Item 2.02), and Q3 earnings call transcript were read in full to compile this report – – –. Additional relevant Q3 press materials included the clobetasol launch press release –, and prior-quarter earnings documents for trend analysis – –.

EYENOVIA, INC. (EYEN)·Q3 2024 Earnings Summary