Sign in

You're signed outSign in or to get full access.

AT

Aldeyra Therapeutics, Inc. (ALDX)·Q3 2022 Earnings Summary

Executive Summary

  • Aldeyra reported a narrower net loss sequentially and year over year, with Q3 2022 net loss of $14.6M ($0.25 EPS) vs. $17.8M ($0.30) in Q2 2022 and $15.8M ($0.27) in Q3 2021; operating expenses fell YoY to $14.8M, driven by lower external clinical costs offset by higher preclinical, manufacturing, personnel, and consulting .
  • Cash, cash equivalents, and marketable securities were $185.3M; management reiterated runway through end of 2023 to fund NDA submissions and potential initial commercialization of reproxalap and ADX‑2191 if approved .
  • Reproxalap dry eye disease NDA remains on schedule for Q4 2022 following a successful pre‑NDA meeting; the package will include five adequate and well‑controlled trials, multiple signs and symptoms, and up to 12 months of safety data .
  • ADX‑2191 catalysts: pre‑NDA meeting for ocular lymphoma in Q4 2022 (potential NDA as soon as end of 2022) and positive Part 1 GUARD PVR results (primary endpoint p=0.024; numerically fewer TEAEs overall p=0.0002), plus a Type C meeting planned for H1 2023 to discuss completion of development .

What Went Well and What Went Wrong

  • What Went Well

    • Reproxalap NDA timing and scope: “we plan to submit what we believe will be the most comprehensive regulatory package ever for a dry eye disease drug candidate,” including rapid onset activity “within minutes” and up to 12 months safety; >2,000 patients studied with no clinically significant safety signals .
    • ADX‑2191 PVR data: met the primary endpoint vs historical control (p=0.024) and showed numerically fewer TEAEs vs routine surgical care (overall p=0.0002), supporting safety and potential efficacy .
    • Cash runway adequate: $185.3M and guidance to fund operations through end of 2023 including potential initial commercialization, preserving optionality on partnering or self‑launch .

  • What Went Wrong

    • Persistent operating losses: Q3 net loss $14.6M; company remains pre‑revenue and cautions may not ever generate significant revenue .
    • G&A expense increased YoY ($3.2M vs $2.5M) due to higher personnel and consulting; R&D decreased YoY but remains elevated amid ongoing programs .
    • Regulatory uncertainty inherent in NDAs and development timelines (FDA acceptance of post‑hoc analyses, data methods) and potential for delays noted in safe harbor .

Financial Results

MetricQ1 2022Q2 2022Q3 2022
Cash, Cash Equivalents & Marketable Securities ($M)$216.9 $196.7 $185.3
Research & Development Expense ($M)$12.2 $14.6 $11.5
General & Administrative Expense ($M)$4.2 $3.1 $3.2
Total Operating Expenses ($M)$16.5 $17.7 $14.8
Loss from Operations ($M)$(16.5) $(17.7) $(14.8)
Net Loss ($M)$(16.8) $(17.8) $(14.6)
Net Loss per Share (Basic/Diluted)$(0.29) $(0.30) $(0.25)
Estimates ComparisonQ1 2022Q2 2022Q3 2022
EPS – Actual ($)$(0.29) $(0.30) $(0.25)
EPS – Consensus (S&P Global)UnavailableUnavailableUnavailable
Revenue – Actual ($M)Not reported (pre‑commercial) Not reported (pre‑commercial) Not reported (pre‑commercial)
Revenue – Consensus (S&P Global)UnavailableUnavailableUnavailable

Note: S&P Global consensus estimates were unavailable at the time of analysis.

KPIs (operational)

KPIQ1 2022Q2 2022Q3 2022
Reproxalap NDA statusPlanned mid‑year submission Pre‑NDA in Q3; submit in H2 Submit in Q4; package includes 5 trials and up to 12‑mo safety
ADX‑2191 ocular lymphomaPre‑NDA planned H2 Pre‑NDA planned H2 Pre‑NDA scheduled Q4; NDA may be as soon as end‑2022
ADX‑2191 PVR (GUARD)Results expected H2 Results expected H2 Positive Part 1 results (p=0.024); Type C mtg H1 2023
ADX‑629 ethanol toxicityResults expected H2 Results expected H2 Top‑line expected by end of 2022
Reproxalap patients studied (safety)—>1,800 total reproxalap exposure (cited historically) >2,000; no observed clinically significant safety concerns
Cash runway guidanceThrough end of 2023 Through end of 2023 Through end of 2023

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Reproxalap NDA (dry eye)2022Submit mid‑year (Q1) → H2 (Q2) Submit Q4 2022; pre‑NDA alignment achieved Shifted later within H2; reinforced scope
ADX‑2191 NDA (ocular lymphoma)2022Pre‑NDA planned H2 2022 Pre‑NDA scheduled Q4 2022; NDA may be as soon as end‑2022 Timing specified; potential acceleration
ADX‑2191 PVR regulatory pathH1 2023GUARD Part 1 results expected H2 2022 Type C FDA meeting planned H1 2023 to discuss completion New meeting timing post‑data
ADX‑2191 RP Phase 2 resultsH1 2023H1 2023 H1 2023 Maintained
ADX‑629 ethanol toxicity Phase 22022H2 2022 By end of 2022 Narrowed window
Cash runwayThrough 2023Through end of 2023 Through end of 2023 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2022)Previous Mentions (Q2 2022)Current Period (Q3 2022)Trend
Reproxalap NDA scope/strategyMost comprehensive package; Schirmer/redness endpoints and backup trials; safety trial gating mid‑year submission Rapid onset emphasized; successful crossover/TRANQUILITY‑2; pre‑NDA in Q3 Successful pre‑NDA; Q4 submission; rapid onset within minutes; >2,000 pts safety Execution advancing; timing clarified
Commercialization approachOptionality: partner vs internal vs hybrid; payer contracting considerations Reinforced optionality; prepared 3–4 months ahead of launch if internal Positioning on rapid symptomatic onset vs evolving market entrants Increasing clarity on positioning
ADX‑2191 PVRGUARD Part 1 readout H2; regulatory path likely mix of literature + GUARD Dosing/discontinuation acceptable; aim to be <40% re‑detachment Positive GUARD Part 1; Type C meeting H1 2023 Data delivered; pathway formalizing
ADX‑2191 ocular lymphomaNDA without new trials; focus on stability/safety; vitreous‑compatible formulation —Pre‑NDA scheduled Q4; potential NDA end‑2022 Regulatory step scheduled
ADX‑629 systemic platformPhase 2 starts in ethanol toxicity & chronic cough; plans for SLS/MCD; crossover designs; endpoints (signs/symptoms) 4‑pronged program; pediatric safety focus; steroid‑sparing in MCD Alcoholic hepatitis PoC expectations; trial endpoints; broader pipeline, new candidates Broadening indications; near‑term data

Management Commentary

  • “We plan to submit what we believe will be the most comprehensive regulatory package ever for a dry eye disease drug candidate… activity ranging from within minutes of drug administration to up to 12 weeks of treatment… and up to 12 months of reproxalap safety data.” — Todd Brady, CEO .
  • “ADX‑2191 was statistically superior to historical control for the prevention of retinal detachment due to proliferative vitreoretinopathy over six months (P=0.024)… ADX‑2191‑treated patients had numerically fewer side effects… (overall P=0.0002).” — Q3 press release .
  • “Cash… were $185.3 million… sufficient to fund… through the end of 2023, including NDA submissions and initial commercialization of both reproxalap and ADX‑2191 if approved.” — Bruce Greenberg, Interim CFO .
  • “Amongst all of those products… Aldeyra is the only novel drug… the only company that has consistently demonstrated activity on an acute basis… within minutes.” — Todd Brady on differentiation in dry eye .

Q&A Highlights

  • Reproxalap NDA readiness: CEO said “very little” remains before submission; rolling NDA not applicable; safety trial “practically complete” aligned to submission timing .
  • Commercial strategy: Emphasis on rapid onset positioning; market entrants noted but reproxalap differentiated as novel NCE with acute symptom relief; optionality on partner vs internal launch .
  • ADX‑2191 regulatory path: Pre‑NDA for ocular lymphoma focused on process/content; GUARD results support safety/efficacy; Type C for PVR in H1 2023 .
  • ADX‑629 alcoholic hepatitis endpoints and PoC: Assess symptoms and objective signs (acetaldehyde, cytokines, proprioception tests) to determine advancement; mechanism rationale via RASP modulation .

Estimates Context

  • S&P Global consensus EPS and revenue estimates were unavailable for Q3 2022 at the time of analysis. The company does not report product revenue as it is pre‑commercial, so comparisons focus on sequential and year‑over‑year loss and expense trends .
  • Given the sequential improvement in net loss and lower operating expenses YoY, estimate models may modestly lower projected near‑term cash burn while emphasizing regulatory timing risks around the reproxalap NDA and ADX‑2191 filings .

Key Takeaways for Investors

  • Q4 2022 reproxalap NDA submission is the primary near‑term catalyst; the breadth of signs, symptoms, rapid onset, and safety exposure (>2,000 patients) could be narrative‑supportive ahead of potential review .
  • ADX‑2191 offers multiple shots on goal: ocular lymphoma (pre‑NDA Q4, potential NDA end‑2022) and PVR (positive Part 1 GUARD; Type C H1 2023), with RP Phase 2 top‑line in H1 2023 .
  • Cash runway through end of 2023 supports flexibility to partner or self‑launch; interim CFO reiterated funding for initial commercialization if approvals occur, reducing financing overhang near term .
  • Operating discipline: R&D decreased YoY by $1.4M, while G&A rose $0.7M; watch mix as NDA/launch prep ramps and systemic programs advance .
  • Trading setup: Multiple regulatory milestones (NDAs, meetings) and clinical readouts (ADX‑629 by end‑2022) create an event‑driven profile; outcomes will drive estimate revisions and sentiment .
  • Dry eye competitive positioning leans on acute symptomatic relief and NCE differentiation versus cyclosporine‑based entrants and nasal spray approaches; messaging centers on rapid onset .
  • Risk checklist: FDA acceptance of analyses, safety data sufficiency, and label endpoints; management acknowledges regulatory uncertainties and timeline risks in safe harbor .