Executive Summary

Q1 2025 missed Wall Street on both revenue and EPS: revenue $8.72M vs $12.23M consensus*, EPS ($0.24) vs ($0.17) consensus*. The shortfall stemmed from lower Suboxone-related manufacturing revenues and reduced license/royalty streams while SG&A rose on PDUFA and legal costs .
Full-year 2025 guidance was cut on revenue and narrowed on adjusted EBITDA loss due to Libervant’s regulatory status change and paused commercialization: revenue now $44–$50M (prior $47–$56M), non-GAAP adjusted EBITDA loss $47–$51M (prior $46–$53M) .
Strategic pivot to prioritize Anaphylm launch: NDA submitted; acceptance expected mid-Q2 2025, launch targeted Q1 2026 if approved. Management is reallocating capital (de-emphasizing AQST-108 near term, no appeal on Libervant) and building a seasoned team (EpiPen alumni) to drive pre-commercial readiness .
Near-term catalysts: 74‑day FDA acceptance letter for Anaphylm (anticipated mid-June), potential Ad Comm, ex‑U.S. partnering discussions to strengthen cash runway, and payer contracting groundwork leveraging existing Libervant distribution relationships .

What Went Well and What Went Wrong

What Went Well

“Major milestone... submission of the NDA for Anaphylm” with pediatric PK consistent with adult data; label alignment with 0.3 mg autoinjector proposed .
Prelaunch execution: HCP engagement (targeting 25 conferences, ~16 posters/manuscripts in 2025) and payer dialogues underway; leveraging prior Libervant contracts to compress time-to-access .
Commercial team depth: “marketing team that built EpiPen to over a $1 billion brand,” positioning and advertising ahead of schedule for early 2026 launch .

What Went Wrong

Revenue down 28% YoY to $8.72M, driven by manufacturing and license/royalty declines; SG&A up to $19.1M on $4.8M PDUFA fee, $2.3M legal costs, and ~$2.1M commercial spend .
Net loss widened to ($22.9M) and adjusted EBITDA loss to ($17.6M); gross margin compressed (GAAP 58%) vs 64% prior year .
Libervant approval revised to tentative following court decision; sales/marketing paused and 2025 outlook revised lower, removing anticipated Libervant contributions .

Financial Results

Quarterly trends

Metric	Q3 2024	Q4 2024	Q1 2025
Revenue ($USD Millions)	$13.542	$11.867	$8.720
GAAP Gross Margin (%)	67%	62%	58%
Non-GAAP Gross Margin (%)	69%	64%	61%
GAAP Net Loss ($USD Millions)	($11.509)	($17.055)	($22.930)
Diluted EPS ($USD)	($0.13)	($0.19)	($0.24)
Non-GAAP Adjusted EBITDA ($USD Millions)	($6.554)	($11.029)	($17.639)
Cash And Equivalents ($USD Millions)	$77.893	$71.546	$68.657

Year-over-year – Q1

Metric	Q1 2024	Q1 2025
Revenue ($USD Millions)	$12.053	$8.720
GAAP Gross Margin (%)	64%	58%
Non-GAAP Gross Margin (%)	66%	61%
GAAP Net Loss ($USD Millions)	($12.828)	($22.930)
Diluted EPS ($USD)	($0.17)	($0.24)
Non-GAAP Adjusted EBITDA ($USD Millions)	($7.170)	($17.639)

Q1 2025 Actual vs Consensus

Metric	Consensus	Actual
Revenue ($USD Millions)	$12.2305*	$8.720
Primary EPS ($USD)	($0.17)*	($0.24)
Primary EPS - # of Estimates	5*	—
Revenue - # of Estimates	8*	—

*Values retrieved from S&P Global.

Revenue composition (selected items)

Metric	Q1 2024	Q1 2025
Manufacture and Supply Revenue ($USD Millions)	$10.5	$7.2

KPIs

KPI	Q3 2024	Q4 2024	Q1 2025
Doses Shipped (000s)	34,418	43,032	27,392

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Total Revenue (in millions)	FY 2025	$47–$56	$44–$50	Lowered
Non-GAAP Adjusted EBITDA Loss (in millions)	FY 2025	$46–$53	$47–$51	Maintained (narrowed range)

Rationale provided: Libervant’s revised regulatory status and paused sales/marketing led to revenue removal and guidance reduction; EBITDA range reflects pre-commercial spend for Anaphylm including PDUFA fee, pediatric study completion, and Ad Comm preparation if required .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3 2024)	Previous Mentions (Q4 2024)	Current Period (Q1 2025)	Trend
Anaphylm regulatory path	Pre‑NDA planned; adult program complete; pediatric to start	NDA filing initiated; acceptance expected Q2 2025	NDA submitted; acceptance expected mid‑June; action date late Jan/early Feb 2026	Advancing on plan
Advisory Committee	Noted may be necessary	Preparing	“We are ready… hope it happens”	Prepared; outcome pending
Prelaunch commercialization	Libervant sales force, access expanding	Market access optimization; medical affairs dissemination	EpiPen‑experienced team; ~50 reps contemplated; positioning/DTC plan set	Scaling up
Payer access	Network expanding for Libervant	Focus on payer engagement pre‑launch	Target ~80% coverage within first 6 months of launch	Positive groundwork
Supply chain/tariffs	—	—	U.S.-based mfg/IP; “largely unaffected by… tariffs”	Stable
Libervant legal/regulatory	Retail availability; ODE; tentatively approved ≥12y blocked till Jan 2027	Court challenge; appealing; still pursuing access	Approval revised to tentative; will not appeal; sales/marketing paused; plan access in 2027	Negative near term
Cash runway/financing	Cash $77.9M; runway reaffirmed into 2026	Pro forma cash ~$93M (ATM); guidance provided	Cash $68.7M; ex‑U.S. licensing and debt refinancing options; defer hiring until approval	Manageable; optionality pursued
AQST-108 prioritization	Pre‑IND planned	Phase 2a planned Q2 2025	De‑emphasized until post‑Anaphylm launch; Phase 2a in 1H 2026	Deferred

Management Commentary

“In the first quarter of 2025, we achieved a major milestone… the submission of the NDA for Anaphylm… preparing for a potential U.S. launch in the first quarter of 2026, if approved” — Daniel Barber, CEO .
“We have the marketing team that built EpiPen to over a $1 billion brand… shifting more of the company’s attention towards ensuring a successful commercial launch” .
“We will probably start at around 50 sales representatives… target ~4,000–5,000 top allergists/pediatricians” — Sherry Korczynski .
“By the end of this year, we expect to have attended 25 conferences and published 16 posters and manuscripts” — Daniel Barber .
“Supply chain currently remains largely unaffected by both implemented and proposed tariffs” — Company statement .
“We will not hire sales reps until we have approval… runway through this year and initial stages of launch next year” — CFO A. Ernest Toth, Jr. .

Q&A Highlights

Commercial readiness: In‑house CMC/manufacturing “well within our capabilities”; product “ready day one” . Sales force sizing ~50 reps; targeted specialist coverage .
Payer access: Leveraging existing Libervant contracts; anticipate ~80% coverage by 6 months post‑launch, coinciding with back‑to‑school season .
Market dynamics: neffy’s promotion expands the market; management views DTC as a rising tide aiding awareness and adoption .
Advisory Committee: Team fully prepared; acceptance timing goal at day‑74 letter; Ad Comm feasibility acknowledged .
Financing strategy: Ex‑U.S. licensing and debt refinancing as non‑dilutive levers; defer AQST‑108 to free capital for Anaphylm .
Libervant: Minimal revenue in Q2; 2025 guidance removes Libervant; expenses pulled back to preserve cash .

Estimates Context

Q1 2025 delivered revenue $8.72M vs $12.23M consensus*, EPS ($0.24) vs ($0.17) consensus*, with 8 revenue and 5 EPS estimates informing the consensus*. The miss reflects weaker manufacturing volumes (Suboxone decline), lower license/royalty flows, and elevated SG&A tied to Anaphylm NDA costs .
With management lowering FY 2025 revenue guidance and narrowing adjusted EBITDA loss ranges, street models likely need to adjust lower for topline and reflect heavier pre‑launch investment intensity .