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Aquestive Therapeutics, Inc. (AQST)·Q2 2025 Earnings Summary

Executive Summary

  • FDA accepted the Anaphylm NDA; PDUFA action date is January 31, 2026, with potential AdCom; commercial launch targeted for Q1 2026 if approved .
  • Q2 2025 revenue was $10.00M vs Wall Street consensus of $11.32M (MISS); diluted EPS was -$0.14 vs consensus -$0.17 (BEAT). Manufacturing & supply revenue grew 19% YoY to $9.6M, offsetting Suboxone declines . Values from S&P Global estimates marked with an asterisk.*
  • Full-year 2025 guidance maintained: total revenue $44–$50M and non-GAAP adjusted EBITDA loss $47–$51M; cash was $60.5M, with management pursuing non-dilutive launch financing and ex-U.S. partnering .
  • Strategic catalysts: clarity on AdCom post mid-cycle review, payer access build (including cash-pay program), EMA/Health Canada interactions, and potential EU-only or global rights transactions to fund launch .

What Went Well and What Went Wrong

What Went Well

  • NDA acceptance and on-track reviews: “We recently submitted our 120‑day safety update… there was nothing new or of consequence… we believe the FDA is about to conclude its mid-cycle review” .
  • Commercial readiness and market shaping: “We will be taking a patient‑first approach. On day one, we will have a cash pay program available to patients and caregivers” .
  • Base business resilience: Manufacturing & supply revenue increased to $9.6M, primarily on Ondif growth, helping offset Suboxone declines .
  • Management confidence in clinical package: “We probably have one of the largest epinephrine studies… 10 independent studies… well over 930+ dosings… a strong package” .

What Went Wrong

  • Reported YoY revenue declined due to one-time deferred revenue recognized in Q2 2024; total revenue fell from $20.10M to $10.00M (ex-one-time, +3% YoY) .
  • SG&A increased to $12.7M (+$1.3M YoY) on commercial, regulatory, and personnel costs; non-GAAP adjusted EBITDA deteriorated to -$9.3M (vs +$1.8M in Q2 2024) .
  • Continued net loss of -$13.5M and need for additional launch financing; management evaluating EU-only rights, refinancing, and revenue-interest options .

Financial Results

Summary vs prior year and prior quarter

MetricQ2 2024Q1 2025Q2 2025
Revenue ($USD Millions)$20.10 $8.72 $10.00
Diluted EPS ($)-$0.03 -$0.24 -$0.14
Gross Margin on Total Revenue (GAAP, %)77% 58% 54%
Gross Margin on Total Revenue (Non-GAAP, %)79% 61% 57%
Adjusted EBITDA ($USD Millions)$1.80 -$17.64 -$9.34
Cash & Cash Equivalents ($USD Millions)—$68.66 $60.54

Notes: Q2 2024 revenue included a one-time recognition of deferred revenue from terminated licensing and supply agreements .

Revenue composition

MetricQ2 2024Q1 2025Q2 2025
Manufacture & Supply Revenue ($USD Millions)$8.10 $7.20 $9.60

Operating expenses

MetricQ2 2024Q1 2025Q2 2025
Research & Development ($USD Millions)$4.16 $5.36 $4.11
SG&A ($USD Millions)$11.36 $19.07 $12.71

Estimates vs actual (Q2 2025)

MetricConsensusActualResult
Revenue ($USD Millions)$11.32*$10.00 MISS
Diluted EPS ($)-$0.17*-$0.14 BEAT

Values with asterisks retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total Revenue ($USD Millions)FY 2025$47–$56 (Q4 2024) $44–$50 (Q1 2025) ; Maintained in Q2 2025 Lowered then Maintained
Adjusted EBITDA Loss ($USD Millions)FY 2025$46–$53 (Q4 2024) $47–$51 (Q1 2025) ; Maintained in Q2 2025 Slightly Narrowed then Maintained

Earnings Call Themes & Trends

TopicQ4 2024 (Q-2)Q1 2025 (Q-1)Q2 2025 (Current)Trend
Regulatory/AdComInitiated NDA; FDA noted potential AdCom; pediatric data aligned with expectations Anticipated NDA acceptance and action date; preparing for potential AdCom 120-day safety update submitted; awaiting mid-cycle clarity on AdCom; mock AdCom conducted Continued preparedness; awaiting FDA decision
Payer Access & Cash-PayLibervant distribution experience highlighted Leveraging existing payer contracts; targeting ~80% coverage by back-to-school post-approval Patient-first approach with day-one cash-pay; ongoing payer awareness; copay buy-down as standard tool Building multi-channel access strategy
FinancingProforma cash ~$93M as of FY-end; ATM proceeds Strengthening balance sheet via ex-U.S. partnering and potential debt refi Multiple launch financing proposals (EU-only rights, refinancing, revenue interest); confidence to secure before launch Active pursuit of non-dilutive options
International ExpansionIdentified ex-U.S. markets Plan engagements with EU, UK, Canada post acceptance Meetings secured with Health Canada and EMA; initial EMA briefing book submitted Progressing to filings
Supply Chain/TariffsMinimal risk; IP domiciled in U.S. Positioning robust vs tariffs; supply chain unaffected Tariffs currently not impacting operations Stable
Manufacturing BaseDoses shipped sustaining cash flow Manufacturing diversification; offsetting Suboxone declines M&S revenue up YoY; base business grew adjusted for one-time Mix shift toward newer collaborations
R&D ExecutionAQST-108 Phase 2a planning Deprioritized AQST-108 to fund Anaphylm launch; resume later IND for AQST-108 planned Q4 2025; start studies early 2026 Near-term focus on Anaphylm; 108 resumes post-launch

Management Commentary

  • “We are on track in our FDA review process, our Anaphylm advisory committee preparations… and our pre‑commercial launch activities” — Daniel Barber (CEO) .
  • “On day one, we will have a cash pay program available to patients and caregivers” — Daniel Barber (CEO) .
  • “The package is quite robust… 10 independent studies… well over 930+ dosings… it’s a strong package” — Carl Kraus (CMO) .
  • “We continue to evaluate all financing alternatives… EU-only rights, refinancing… revenue interest financing” — Ernie Toth (CFO) .

Q&A Highlights

  • AdCom likelihood and preparedness: Company expects clarity post mid‑cycle; conducted mock AdCom; confident in breadth of clinical package .
  • Payer access and cash‑pay: Day-one cash‑pay program; standard copay support; aiming broad coverage comparable to peers, with ~80% within six months of launch targeted earlier in Q1 commentary .
  • Pediatric study: PK/PD comparable to adults; safety profile aligned; enabled submission down to ~30 kg (~age 7) .
  • DTC strategy and awareness: Heavy HCP focus early, layering DTC as coverage builds; leveraging advocacy and CME/posters; “rising tide” from category DTC benefits all .
  • Financing and ex‑U.S.: Multiple proposals in process, including EU-only rights; plan to secure financing prior to launch; meetings with EMA and Health Canada .

Estimates Context

  • Q2 2025 vs consensus: Revenue $11.32M* vs actual $10.00M (MISS); EPS -$0.17* vs actual -$0.14 (BEAT) .
  • Prior-year Q2 2024 included one-time deferred revenue; consensus $12.38M* vs actual $20.10M; EPS -$0.12* vs -$0.03 .
  • Forward consensus (near-term trajectory):
    • Q3 2025: Revenue $12.94M*, EPS -$0.13*;
    • Q4 2025: Revenue $13.35M*, EPS -$0.14*;
    • Q1 2026: Revenue $11.52M*, EPS -$0.17*;
    • Q2 2026: Revenue $13.98M*, EPS -$0.17*.
    • Target Price Consensus Mean: $10.30* (10 estimates) across periods.

Values with asterisks retrieved from S&P Global.

Forward estimates table

MetricQ3 2025Q4 2025Q1 2026Q2 2026
Revenue Consensus Mean ($USD)12,943,500*13,345,400*11,521,570*13,981,860*
Primary EPS Consensus Mean ($)-0.1325*-0.1378*-0.1720*-0.1680*
EBITDA Consensus Mean ($USD)-9,775,000*-11,275,000*-18,465,000*-17,045,500*
Primary EPS – # of Estimates8*9*5*5*
Revenue – # of Estimates10*10*7*7*
Target Price Consensus Mean ($)10.30*10.30*10.30*10.30*

Key Takeaways for Investors

  • The quarter was strategically strong (NDA acceptance, launch prep, ex‑U.S. regulatory engagement) but financially soft vs consensus on revenue; EPS outperformed as spend was controlled sequentially .
  • Guidance stability signals discipline; watch for AdCom decision and mid‑cycle outputs as near-term catalysts likely to drive sentiment .
  • Manufacturing mix is improving (Ondif growth) as Suboxone sunsets; non‑GAAP margins weaker YoY given absent one-time revenue and elevated pre‑launch opex .
  • Access strategy is pragmatic (cash‑pay day one, copay support), mitigating payer hurdles seen by category peers; expect coverage build through first six months post‑approval .
  • Financing optionality (EU-only/global rights, refi, revenue interest) reduces dilution risk; timing ahead of launch is critical to fund DTC and field force ramp .
  • Stock reaction likely tied to regulatory milestones (AdCom scheduling/outcome) and clear payer access signals; medium-term thesis hinges on improving carry/use rates and conversion to non-injectable epinephrine .
  • Monitor AQST-108 timeline (IND Q4 2025; human studies early 2026) as secondary value driver post-Anaphylm launch .