Aquestive Therapeutics (AQST) AI Stock Analysis

• Market Cap: $502.65M
• Dividend Yield: N/A
• Average Volume (3M): 4.99M
• Price to Earnings (P/E): ―
• Beta (1Y): 0.70
• Revenue Growth: -26.32%
• EPS Growth: -56.54%
• Country: US
• Employees: 142
• Sector: Healthcare
• Sector Strength: 45
• Industry: Drug Manufacturers - Specialty & Generic
• EPS (TTM): -0.15
• Shares Outstanding: 122,003,110
• 10 Day Avg. Volume: 2,195,561
• 30 Day Avg. Volume: 4,987,712
• PEG Ratio: -0.19
• Price to Book (P/B): -23.41
• Price to Sales (P/S): 17.69
• P/FCF Ratio: -14.87
• Enterprise Value/Market Cap: 0.86
• Enterprise Value/Revenue: 10.00
• Enterprise Value/Gross Profit: 16.58
• Enterprise Value/Ebitda: -8.92
• 1Y Price Target: $9.60
• Price Target Upside: 133.01% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 7
• EPS Forecast (FY): -0.55
• Revenue Forecast (FY): $47.52M

• Rating: 49 Neutral
• Price Target: $4.50 ▲(9.22% Upside)
• Action: Reiterated Date: 03/05/26
• Date: Action: Reiterated 03/05/26

The score is held down primarily by weak financial performance (widening losses, negative gross profit in 2025, rising cash burn, and negative equity). Technicals are moderately constructive near-term but capped by longer-term trend weakness and elevated stochastic. Valuation offers limited support due to losses. Earnings-call updates and recent financing actions provide some offset, but regulatory setbacks for Anaphylm materially increase uncertainty.

Positive Factors

Proprietary oral film platform & diversified revenue

Aquestive’s proprietary oral-film delivery enables both direct product sales and licensing/service revenue from partners. This dual model diversifies cash flows, creates recurring royalty and service opportunities, and provides multiple commercialization pathways that support sustainable revenue generation beyond any single product.

Extended runway from recent financings

Material capital raises materially extend liquidity and reduce near-term fundraising pressure, enabling the company to fund NDA resubmission, human-factors and PK work, and prelaunch commercial build. This funding stability preserves operating flexibility and execution capacity over the medium term.

Regulatory issues are operational, not clinical

The FDA’s concerns focus on packaging, administration human factors and a PK study rather than safety/efficacy or CMC. Operational fixes are typically faster and less costly than new trials, keeping a clear path to resubmission and preserving the product’s fundamental commercial potential across U.S. and international markets.

Negative Factors

Negative gross profit and widening net losses

A negative gross profit indicates core product unit economics are currently unfavorable, reversing prior healthy margins. Persistent, large net losses undermine internal capital generation and signal that the business requires structural margin improvement or sustained external funding to reach break-even and fund growth initiatives.

Consistent cash burn and negative free cash flow

Ongoing negative operating and free cash flow shows losses are cash-backed rather than purely non-cash charges, increasing reliance on external financing. Continued cash burn reduces optionality for commercial investment, heightens dilution risk, and makes execution on international launches and scaling more contingent on capital markets access.

Balance-sheet stress: negative stockholders’ equity

A negative equity position reflects accumulated losses and constrains financial flexibility. It complicates leverage assessment, may limit borrowing options or increase covenant costs, and elevates execution risk for launches and partnerships if additional capital is required or credit terms tighten.

Aquestive Therapeutics Business Overview & Revenue Model

Company Description

Aquestive Therapeutics, Inc., a pharmaceutical company, focuses on identifying, developing, and commercializing various products to address unmet medical needs in the United States and internationally. The company markets Sympazan, an oral soluble film formulation of clobazam for the treatment of lennox-gastaut syndrome; Suboxone, a sublingual film formulation of buprenorphine and naloxone for the treatment of opioid dependence; Zuplenz, an oral soluble film formulation of ondansetron for the treatment of nausea and vomiting associated with chemotherapy and post-operative recovery; and Azstarys, a once-daily product for the treatment of attention deficit hyperactivity disorder. The company's proprietary product candidates comprise Libervant, a buccal soluble film formulation of diazepam for the treatment of seizures; and Exservan, an oral soluble film formulation of riluzole for the treatment of amyotrophic lateral sclerosis. Its proprietary pipeline of complex molecule products include AQST-108, a sublingual film formulation delivering systemic epinephrine for the treatment of conditions other than anaphylaxis; AQST-305, a sublingual film formulation of octreotide for the treatment of acromegaly; and AQST-109, an orally delivered epinephrine product candidate for the emergency treatment of allergic reactions, including anaphylaxis. Further, the company develops KYNMOBI, a sublingual film formulation of apomorphine for the treatment of episodic off-periods in Parkinson's disease. Aquestive Therapeutics, Inc. was incorporated in 2004 and is headquartered in Warren, New Jersey.

How the Company Makes Money

Aquestive Therapeutics generates revenue primarily through the commercialization of its products, including prescription sales of Suboxone film. The company also engages in partnerships and collaborations with other pharmaceutical entities to develop and market new therapies, which can include milestone payments and royalties on product sales. Additionally, AQST may receive funding from government grants or private investments aimed at supporting its research and development efforts. By leveraging its expertise in drug delivery technologies, the company aims to expand its portfolio of products and increase its market reach, contributing to its overall revenue growth.

Aquestive Therapeutics Financial Statement Overview

Summary

Despite strong reported 2025 revenue growth off a weak 2024 base, profitability deteriorated sharply (negative gross profit and deeper net losses), cash burn increased with negative operating cash flow and free cash flow, and the balance sheet remains constrained by persistently negative equity.

Income Statement

Revenue growth is strong on paper in 2025 (up ~265% YoY) but comes off a depressed 2024 level, and profitability deteriorated sharply: gross profit turned negative in 2025 (vs. ~69% gross margin in 2024) and net losses widened to about -$83.8M (net margin ~-188%). While 2023 showed a much smaller loss and briefly positive EBITDA, the broader multi-year picture is persistent operating losses and highly volatile margins, indicating an uneven path to sustainable profitability.

Balance Sheet

The balance sheet remains stressed by consistently negative stockholders’ equity across all periods, which limits financial flexibility and makes leverage harder to evaluate cleanly (debt-to-equity is negative due to negative equity). Total debt is moderate in absolute dollars (~$42.5M in 2025), but the capital structure is weakened by accumulated losses. A positive is asset growth in 2025 (total assets up materially vs. 2024), though the company still carries elevated balance-sheet risk given the equity deficit.

Cash Flow

Cash generation remains a key weakness: operating cash flow and free cash flow are negative every year shown, including 2025 (operating cash flow about -$52.4M; free cash flow about -$53.0M), implying ongoing cash burn. Cash burn worsened versus 2024 (when free cash flow was about -$35.9M). Free cash flow tracks net losses (free cash flow to net income ~1x), suggesting losses are broadly cash-backed rather than purely non-cash—reinforcing funding needs if profitability doesn’t improve.

Breakdown	TTM	Dec 2025	Dec 2024	Dec 2023	Dec 2022	Dec 2021
Income Statement
Total Revenue	43.40M	44.55M	57.56M	50.58M	47.68M	50.83M
Gross Profit	26.16M	-15.58M	39.69M	29.75M	28.29M	35.84M
EBITDA	-48.63M	-71.05M	-26.62M	1.18M	-39.58M	-45.11M
Net Income	-68.98M	-83.78M	-44.14M	-7.87M	-54.41M	-70.54M
Balance Sheet
Total Assets	163.56M	160.43M	101.42M	57.42M	57.07M	61.99M
Cash, Cash Equivalents and Short-Term Investments	129.06M	121.17M	71.55M	23.87M	27.27M	28.02M
Total Debt	128.86M	42.48M	38.00M	33.32M	57.49M	56.42M
Total Liabilities	167.67M	194.09M	161.58M	163.91M	175.62M	144.13M
Stockholders Equity	-4.11M	-33.66M	-60.16M	-106.49M	-118.55M	-82.13M
Cash Flow
Free Cash Flow	-50.94M	-52.99M	-35.92M	-7.38M	-12.31M	-33.89M
Operating Cash Flow	-50.45M	-52.43M	-35.76M	-6.38M	-9.79M	-32.98M
Investing Cash Flow	-492.00K	-562.00K	-159.00K	-995.00K	-2.52M	-913.00K
Financing Cash Flow	102.11M	102.62M	83.59M	3.97M	11.56M	30.11M

Aquestive Therapeutics Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 4.12
• 50DMA: Positive
• 100DMA: Negative
• 200DMA: Negative
• MACD: Negative
• RSI: Neutral
• STOCH: Negative

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AQST, the sentiment is Positive. The current price of 4.12 is above the 20-day moving average (MA) of 3.98, below the 50-day MA of 4.37, and below the 200-day MA of 4.68, indicating a neutral trend. The MACD of 0.01 indicates Negative momentum. The RSI at 57.93 is Neutral, neither overbought nor oversold. The STOCH value of 88.53 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for AQST.

Aquestive Therapeutics Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
SIGA	77 Outperform	$445.42M	-25.73	39.94%	―	-0.85%	-13.50%
EBS	53 Neutral	$461.80M	12.57	10.46%	―	-29.91%	―
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
AQST	49 Neutral	$502.65M	-9.40	―	―	-26.32%	-56.54%
ORGO	47 Neutral	$369.20M	26.21	9.04%	―	2.24%	-67.56%
ESPR	46 Neutral	$695.67M	-4.19	―	―	2.83%	13.61%
EOLS	46 Neutral	$267.71M	―	―	―	15.10%	0.18%

Aquestive Therapeutics Corporate Events

Aquestive Therapeutics Amends RTW Deal, Strengthens Financing Outlook

On March 3, 2026, Aquestive Therapeutics amended its existing revenue-sharing Purchase and Sale Agreement with RTW Investments to extend the marketing approval deadline for its lead product candidate Anaphylm to June 30, 2027, easing timing pressure around regulatory milestones. In connection with the amendment, RTW funds received a warrant to buy up to 375,000 Aquestive common shares at $4.00 per share through March 3, 2029, and affiliated RTW funds committed to purchase at least $5 million of common stock within 90 days, bolstering the company’s balance sheet as it works toward resubmitting Anaphylm’s NDA and preparing for a potential launch.

The company also reported fourth-quarter and full-year 2025 results on March 4, 2026, noting that it met 2025 guidance for revenue and non-GAAP adjusted EBITDA loss excluding one-time items and expects to end 2026 with $70 million in cash and equivalents. Operationally, Aquestive is addressing a January 30, 2026 Complete Response Letter from the FDA for Anaphylm with new human factors and PK studies ahead of a planned NDA resubmission in the third quarter of 2026, continued regulatory work in Canada and the EU, ongoing development of AQST-108 following completion of Phase 1 dosing, and stable manufacturing and royalty revenue streams that help support its allergy and neurology-focused growth strategy.

The most recent analyst rating on (AQST) stock is a Buy with a $9.00 price target. To see the full list of analyst forecasts on Aquestive Therapeutics stock, see the AQST Stock Forecast page.

Aquestive Highlights Strategy, Pipeline and Risk Disclosures

On February 2026, Aquestive Therapeutics furnished an investor presentation for institutional investors, analysts and other stakeholders, outlining its corporate strategy and clinical pipeline. The materials, made available via the company’s website and an accompanying SEC filing, detail the advancement plans and regulatory timelines for Anaphylm, Libervant and AQST-108, as well as the company’s capital position, debt obligations and reliance on sunsetting revenue from Suboxone.

The presentation also highlights significant regulatory and commercial risks, including FDA review uncertainties, potential delays, manufacturing and market-acceptance challenges and the impact of royalty and debt agreements on liquidity. Together, these disclosures underscore both the growth opportunity tied to prospective product launches and the substantial execution, financing and competitive hurdles that could affect Aquestive’s future performance and stakeholder outcomes.

The most recent analyst rating on (AQST) stock is a Buy with a $9.00 price target. To see the full list of analyst forecasts on Aquestive Therapeutics stock, see the AQST Stock Forecast page.

FDA Issues Complete Response Letter on Anaphylm Application

On February 2, 2026, Aquestive Therapeutics reported that the U.S. Food and Drug Administration issued a Complete Response Letter on January 30, 2026, for its New Drug Application for Anaphylm, a sublingual epinephrine prodrug film intended to treat Type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or more. The FDA’s concerns were limited to human factors and administration issues—such as difficulty opening the pouch and incorrect film placement—as well as the need for a single pharmacokinetics study related to packaging and labeling modifications, with no additional clinical trials, chemistry, manufacturing and controls, or core comparability data questioned. Aquestive has already modified Anaphylm’s packaging, instructions for use, and labeling, plans to conduct a new human factors validation study and the requested pharmacokinetics study in parallel, and targets a resubmission of the application as early as the third quarter of 2026, while emphasizing its strong cash position to fund U.S. approval and pre-launch activities. In parallel, the company is pushing ahead with its global strategy for Anaphylm, having begun regulatory engagement in Canada, Europe, and the U.K. in 2025; it expects to file for marketing authorization in Europe and submit a New Drug Submission in Canada in the second half of 2026, building on European Medicines Agency feedback that no further clinical trials are needed, a move that could strengthen its competitive position in non-invasive epinephrine treatments and broaden access to its allergy therapy in key international markets.

The most recent analyst rating on (AQST) stock is a Sell with a $3.00 price target. To see the full list of analyst forecasts on Aquestive Therapeutics stock, see the AQST Stock Forecast page.

Aquestive Faces FDA Deficiencies on Anaphylm NDA Review

On January 9, 2026, Aquestive Therapeutics announced that the U.S. Food and Drug Administration has identified unspecified deficiencies in its New Drug Application for Anaphylm, a sublingual epinephrine film for severe allergic reactions, which currently prevents the agency from discussing labeling and post-marketing commitments and could delay a potential approval beyond the January 31, 2026 PDUFA date, although the FDA’s review remains ongoing and no final decision has been made. The company is engaging with the FDA to clarify and resolve the issues while pushing ahead with a global regulatory strategy for Anaphylm, including regulatory interactions in Canada, Europe and the U.K. in 2025 and planned approval submissions in 2026, and reported unaudited cash and cash equivalents of about $120 million as of December 31, 2025, which it believes is sufficient to fund U.S. approval and launch efforts and support its international expansion plans.

The most recent analyst rating on (AQST) stock is a Buy with a $11.00 price target. To see the full list of analyst forecasts on Aquestive Therapeutics stock, see the AQST Stock Forecast page.