Executive Summary

Q4 2024 revenue was $11.9M, down 10% year over year, and sequentially below Q3 2024 ($13.5M); GAAP net loss per share was ($0.19) vs ($0.12) a year ago, and non-GAAP adjusted EBITDA loss widened to $11.0M from $6.6M in Q3 2024 .
The company initiated the NDA filing for Anaphylm (epinephrine) sublingual film; management expects FDA NDA acceptance in Q2 2025 and is targeting a Q1 2026 launch if approved, with potential Ad Comm in H2 2025 .
2025 outlook guides total revenue of $47–$56M and non-GAAP adjusted EBITDA loss of $46–$53M, reflecting pre-commercial Anaphylm spending and Suboxone demand erosion; pro forma cash was ~$93M after February ATM activity, supporting execution .
Libervant (diazepam) for ages 2–5 faces legal risk after a Feb 2025 court ruling; the company is appealing and aims to maintain market access for young patients; national retail distribution occurred in Q4 2024 .
Near-term catalysts: FDA NDA acceptance for Anaphylm, potential Ad Comm scheduling, pediatric data inclusion, payer access progress, and clarity on Libervant’s legal status; medium-term: possible U.S. commercialization path (go-it-alone or partner) and ex-U.S. partnerships .

What Went Well and What Went Wrong

What Went Well

Initiated Anaphylm NDA filing; management: “We will complete this application process over the next several weeks and expect... acceptance... sometime in June” and remains “thrilled” with milestone progress toward Q1 2026 launch .
Clinical and medical affairs momentum: pediatric study “in line with expectations”; OASIS study showed rapid symptom resolution (median 12 minutes; edema ~5 minutes), supporting PK/PD comparability and product profile .
Strengthened liquidity: cash and cash equivalents were $71.5M at 12/31/24; pro forma cash ~$93.0M including $21.4M ATM proceeds on Feb 14, 2025 .

What Went Wrong

Revenue fell 10% YoY to $11.9M due to lower license/royalty (absence of prior-year $1.0M Azstarys milestone) and reduced Suboxone manufacturing volumes; non-GAAP adjusted EBITDA loss widened to $11.0M .
SG&A increased sharply to $16.0M (+67% YoY), driven by Libervant commercialization, Anaphylm pre-commercial, $1.8M severance, and $1.5M legal expenses; R&D rose to $4.9M on Anaphylm development .
Libervant faces legal uncertainty after a Feb 2025 court decision challenging its approval for ages 2–5; management is appealing, with potential marketing risk pending court outcomes .

Financial Results

Quarterly Comparison (Sequential)

Metric	Q2 2024	Q3 2024	Q4 2024
Revenue ($USD Millions)	$20.099	$13.542	$11.867
GAAP Net Loss per Share ($)	($0.03)	($0.13)	($0.19)
Non-GAAP Adjusted EBITDA ($USD Millions)	$1.799	($6.554)	($11.029)
Gross Margin on Total Revenue (GAAP)	77%	67%	62%
Gross Margin on Total Revenue (Non-GAAP)	79%	69%	64%

Year-over-Year (Q4)

Metric	Q4 2023	Q4 2024
Revenue ($USD Millions)	$13.206	$11.867
GAAP Net Loss per Share ($)	($0.12)	($0.19)
Non-GAAP Adjusted EBITDA ($USD Millions)	($2.757)	($11.029)
R&D Expense ($USD Millions)	$2.888	$4.917
SG&A Expense ($USD Millions)	$9.550	$16.009

Revenue Components (Q4)

Component	Q4 2023	Q4 2024
Manufacture & Supply Revenue ($USD Millions)	$11.0	$10.7
License & Royalty Revenue ($USD Millions)	$1.9	$0.8

KPIs and Balance Sheet

KPI	Q4 2023	Q4 2024
Doses Manufactured (Millions)	~45	~43
Cash & Cash Equivalents ($USD Millions)	$23.872	$71.546
Pro Forma Cash ($USD Millions)	N/A	~$93.0 (incl. $21.4M ATM proceeds on 2/14/25)
Weighted Avg Shares (Basic+Diluted)	67.199M	91.199M

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Total Revenue ($USD Millions)	FY 2025	N/A	$47 to $56	Initiated
Non-GAAP Adjusted EBITDA Loss ($USD Millions)	FY 2025	N/A	$46 to $53	Initiated
Total Revenue ($USD Millions)	FY 2024	$57 to $60 (updated in Q2, reiterated in Q3)	Actual: $57.561	Achieved (within range)
Non-GAAP Adjusted EBITDA Loss ($USD Millions)	FY 2024	$20 to $23 (updated in Q2, reiterated in Q3)	Actual: $22.954	Achieved (within range)

Notes: 2025 guidance embeds Libervant 2–5 revenue and Suboxone erosion, plus significant Anaphylm pre-commercial spend, NDA costs, pediatric completion, and potential Ad Comm prep .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 & Q3 2024)	Current Period (Q4 2024)	Trend
Anaphylm Regulatory Path	Target NDA submission Q1 2025; OASIS study to complete; pre‑NDA scheduled Q4 2024	NDA filing initiated; expect FDA acceptance by June 2025; potential Ad Comm in H2 2025	Accelerating
Commercialization Strategy	Planning Q1 2026 launch if approved; medical awareness efforts	Preparing to launch solo with payer access build; open to partner to expand reach; ex‑U.S. partner-only approach	Building capability; partnership optionality
Pediatric Data (Anaphylm)	Planned pediatric study for ≥30 kg	Data “in line with expectations”; supports NDA; initial approval expected for ≥30 kg (~age 7) with junior dose later	On plan
Market Awareness & Payers	Expanding awareness; Libervant retail distribution planned	ATU study suggests physician preference for sublingual film; hiring VP Market Access; payer strategy emphasized	Improving awareness
Libervant Status	Launch for ages 2–5; expanding distribution & coverage	Feb 2025 court ruling challenges approval; appealing; aim to maintain access; Q4 achieved national retail distribution	Legal risk increased
AQST-108 Development	Pre-IND planned Q4 2024; Phase 2a planned H1 2025	IND opening and Phase 2a start in Q2 2025; expect initial data before year-end	Advancing per plan
Base Manufacturing (Suboxone)	Demand; doses manufactured fell YoY; price/timing effects	Q4 doses ~43M vs ~45M prior year; revenue guides for some Suboxone erosion	Gradual erosion

Management Commentary

“We have begun the filing process with the FDA for approval of our Anaphylm epinephrine sublingual film... expect... acceptance of the NDA sometime in June... on track to launch... in the first quarter of 2026, if approved” — Daniel Barber, CEO .
“Our pediatric study... has progressed as expected... will include the necessary pediatric data to support a product label... mirroring the 0.3 mg EpiPen auto‑injector” .
“We believe there are multiple pathways to commercializing Anaphylm... preparing for launching... on our own... open to augmenting with a larger organization if conditions are right” .
“We will open our IND for AQST‑108... expect to start our Phase IIa trial... next quarter... have some level of clinical data... before the end of this year” .
On Libervant: “We remain committed to doing everything we can to keep Libervant on the market for these young patients... we have appealed [the] ruling” .

Q&A Highlights

Ad Comm readiness: external expertise hired; weekly prep; no additional FDA insight yet; management preparing regardless .
Commercial path: baseline plan to launch solo; partner only if expands reach and matches therapeutic commitment; ex‑U.S. will be partnership-only .
Seasonality: optimal launch early February aligns with allergy season ramp (peak Aug–Sep); hiring sales reps immediately post‑approval .
Pediatric data: timing and profiles on track for NDA; initial label for ≥30 kg (one dose at launch), junior dose later .
Salesforce sizing: ~100 reps target for allergists/high-decile pediatrics/PCPs; offers only after approval, preparatory work in Q4 2025 .
Guidance drivers: 2025 revenue includes Libervant 2–5; Suboxone erosion; guidance range will be revisited as year progresses .

Estimates Context

Wall Street consensus (S&P Global) for Q4 2024 EPS and revenue was unavailable at the time of this analysis due to data access limits; therefore, beat/miss versus estimates cannot be determined and will be updated when accessible. Values to be retrieved from S&P Global.

Metric vs Estimates	Q4 2024 Actual	Consensus Estimate	Result
Revenue ($USD Millions)	$11.867	N/A (S&P Global unavailable)	N/A
GAAP EPS ($)	($0.19)	N/A (S&P Global unavailable)	N/A
Non-GAAP Adjusted EBITDA ($USD Millions)	($11.029)	N/A (S&P Global unavailable)	N/A

Key Takeaways for Investors

Regulatory momentum is strong: NDA filed for Anaphylm with acceptance expected by Q2 2025; Ad Comm likely in H2 2025; launch targeted Q1 2026 — watch for NDA acceptance and Ad Comm timing as stock-moving events .
Commercial execution plan is credible but investment-heavy: 2025 guidance embeds significant pre-commercial spend and payer access work; expect SG&A to be weighted to H2 2025 and adjusted EBITDA losses to widen per outlook .
Libervant introduces binary legal risk near term; company is appealing the court decision and aims to maintain access — monitor court updates and any FDA interactions for potential revenue impact (guidance includes Libervant 2–5) .
Base business is gradually eroding (Suboxone), pressuring manufacturing revenue; doses manufactured declined and management guides some demand erosion — treat negative revisions here as estimate risk .
Liquidity position supports execution: cash $71.5M at year-end; ~$93M pro forma after February ATM, enabling NDA filing, Ad Comm prep, and launch planning; reduces financing overhang in the near term .
Partnership optionality could unlock scale: management is open to U.S. partnership if it accelerates market access and reach; ex‑U.S. commercialization will rely on partners — announcements here would be material .
Expect narrative to pivot from R&D to pre-commercial and market access throughout 2025; payer coverage, physician education, and seasonality alignment are critical for Anaphylm’s ramp if approved .

Aquestive Therapeutics, Inc. (AQST)·Q4 2024 Earnings Summary