Aquestive Therapeutics (AQST) AI Stock Analysis

• Market Cap: $513.63M
• Dividend Yield: N/A
• Average Volume (3M): 4.91M
• Price to Earnings (P/E): ―
• Beta (1Y): 0.79
• Revenue Growth: -26.32%
• EPS Growth: -56.54%
• Country: US
• Employees: 142
• Sector: Healthcare
• Sector Strength: 45
• Industry: Drug Manufacturers - Specialty & Generic
• EPS (TTM): N/A
• Shares Outstanding: 122,003,110
• 10 Day Avg. Volume: 1,963,921
• 30 Day Avg. Volume: 4,910,499
• PEG Ratio: -0.02
• Price to Book (P/B): -5.13
• Price to Sales (P/S): 5.36
• P/FCF Ratio: -8.60
• Enterprise Value/Market Cap: 0.80
• Enterprise Value/Revenue: 9.44
• Enterprise Value/Gross Profit: 15.67
• Enterprise Value/Ebitda: -8.43
• 1Y Price Target: $9.60
• Price Target Upside: 128.03% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 7
• EPS Forecast (FY): -0.55
• Revenue Forecast (FY): $53.78M

• Rating: 44 Neutral
• Price Target: $4.00 ▼(-4.99% Downside)
• Action: Reiterated Date: 02/03/26
• Date: Action: Reiterated 02/03/26

Overall score is pressured primarily by weak financial performance (losses, cash burn, and negative equity). Technical indicators also lean bearish (below key moving averages with negative MACD). Valuation is constrained by unprofitability and no dividend, partially offset by a relatively better earnings-call outlook supported by financing and commercialization planning.

Positive Factors

Financing runway secured

The dual financings extend cash runway through 2027, materially reducing near-term funding pressure. This durable capital base enables prelaunch marketing, payer contracting and supply-chain investment for Anaphylm, lowering the likelihood of disruptive emergency financings.

Regulatory engagement and international filings

Active regulator engagement and planned filings in Canada and Europe diversify approval pathways beyond the U.S. Successful non-U.S. approvals would broaden addressable markets, reduce single-market dependency and create multi-year revenue channels independent of short-term U.S. timing.

Drug-delivery platform and commercial experience

Aquestive's proven drug-delivery IP and prior commercialization of film products supply durable competitive advantages: manufacturing know-how, regulatory experience, and commercial infrastructure that improve odds of successful Anaphylm launch and potential licensing or partnership revenue streams.

Negative Factors

FDA Complete Response Letter (CRL)

The CRL cites human factors and labeling deficiencies, requiring revised packaging, a new HF validation study and a PK study. This regulatory setback will delay U.S. launch, raise prelaunch costs and compress early-market exclusivity windows, impacting long-term commercialization timing.

Negative stockholders' equity

Negative equity is a structural weakness that signals high leverage and limited balance sheet flexibility. Over time it increases risk of dilutive financings or covenant pressures, constraining strategic optionality for commercial scale-up and pipeline investment without external capital.

Persistent operating cash burn

Ongoing negative operating cash flow indicates the business continues to consume cash despite financing. Sustained cash burn increases reliance on capital markets, may force cuts to R&D or commercial investment, and raises execution risk for multi-year launch and international expansion plans.

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

Weak fundamentals: sharply negative revenue growth, ongoing losses (negative net and EBIT margins), negative operating cash flow, and a highly stressed balance sheet with negative stockholders’ equity.

Income Statement

Aquestive Therapeutics has faced significant challenges in its income statement metrics. The company has experienced a declining revenue trend with a negative revenue growth rate of -166.5% in the TTM period. Profitability metrics are concerning, with negative net profit margins and EBIT margins indicating ongoing losses. The gross profit margin remains relatively stable but is overshadowed by the negative net income and EBIT figures.

Balance Sheet

The balance sheet reveals a precarious financial position with negative stockholders' equity, leading to a negative debt-to-equity ratio. This indicates high leverage and potential financial instability. Return on equity is positive but misleading due to negative equity, and the equity ratio is not favorable, suggesting a need for financial restructuring.

Cash Flow

Cash flow analysis shows a slight improvement in free cash flow growth, but operating cash flow remains negative, indicating ongoing cash burn. The operating cash flow to net income ratio is negative, reflecting inefficiencies in converting income to cash. The free cash flow to net income ratio is slightly above 1, suggesting some alignment between cash flow and accounting profits, but overall cash flow health is weak.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	43.40M	57.56M	50.58M	47.68M	50.83M	45.85M
Gross Profit	26.16M	39.69M	29.75M	28.29M	35.84M	32.88M
EBITDA	-48.63M	-26.62M	1.18M	-39.58M	-45.11M	-39.15M
Net Income	-68.98M	-44.14M	-7.87M	-54.41M	-70.54M	-55.78M
Balance Sheet
Total Assets	163.56M	101.42M	57.42M	57.07M	61.99M	62.88M
Cash, Cash Equivalents and Short-Term Investments	129.06M	71.55M	23.87M	27.27M	28.02M	31.81M
Total Debt	128.86M	38.00M	33.32M	57.49M	56.42M	40.48M
Total Liabilities	167.67M	161.58M	163.91M	175.62M	144.13M	111.38M
Stockholders Equity	-4.11M	-60.16M	-106.49M	-118.55M	-82.13M	-48.50M
Cash Flow
Free Cash Flow	-50.94M	-35.92M	-7.38M	-12.31M	-33.89M	-45.98M
Operating Cash Flow	-50.45M	-35.76M	-6.38M	-9.79M	-32.98M	-45.46M
Investing Cash Flow	-492.00K	-159.00K	-995.00K	-2.52M	-913.00K	-517.00K
Financing Cash Flow	102.11M	83.59M	3.97M	11.56M	30.11M	28.46M

Aquestive Therapeutics Technical Analysis

• Technical Analysis Sentiment: Neutral
• Last Price: 4.21
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Negative
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AQST, the sentiment is Neutral. The current price of 4.21 is above the 20-day moving average (MA) of 3.97, below the 50-day MA of 4.43, and below the 200-day MA of 4.67, indicating a neutral trend. The MACD of -0.03 indicates Negative momentum. The RSI at 54.55 is Neutral, neither overbought nor oversold. The STOCH value of 78.41 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral 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	$469.05M	6.29	39.94%	―	-0.85%	-13.50%
EBS	53 Neutral	$465.42M	10.84	10.46%	―	-29.91%	―
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
ORGO	47 Neutral	$385.92M	27.40	9.04%	―	2.24%	-67.56%
EOLS	47 Neutral	$278.08M	-4.70	―	―	15.10%	0.18%
ESPR	46 Neutral	$781.74M	-6.10	―	―	2.83%	13.61%
AQST	44 Neutral	$513.63M	-5.99	―	―	-26.32%	-56.54%

Aquestive Therapeutics Corporate Events

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.

Aquestive Therapeutics Advances Anaphylm Towards FDA Approval

Aquestive Therapeutics has announced updates regarding its product pipeline, particularly the advancement of Anaphylm (dibutepinephrine) Sublingual Film and other candidates like AQST-108 and Libervant. The company is working towards FDA approval and international market entry, with potential implications for its market positioning and stakeholder interests, contingent on overcoming regulatory and competitive challenges.

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.

Aquestive Therapeutics Reports Q3 2025 Financial Results

Aquestive Therapeutics reported its third quarter 2025 financial results and provided a business update, highlighting preparations for the potential U.S. launch of Anaphylm, a needle-free oral medication for severe allergic reactions, pending FDA approval in early 2026. The company also advanced its regulatory activities for Anaphylm in Canada and the EU, expanded its patent estate, and continued developing its product pipeline, including a topical gel for alopecia areata. Financially, the company saw a 4% year-over-year revenue increase excluding deferred revenue impacts, despite a net loss of $15.4 million due to higher commercial and regulatory expenses.

The most recent analyst rating on (AQST) stock is a Hold with a $7.00 price target. To see the full list of analyst forecasts on Aquestive Therapeutics stock, see the AQST Stock Forecast page.