Aquestive Therapeutics (AQST) AI Stock Analysis

• Market Cap: $339.70M
• Dividend Yield: N/A
• Average Volume (3M): 1.75M
• Price to Earnings (P/E): ―
• Beta (1Y): 0.94
• Revenue Growth: 5.29%
• EPS Growth: -37.31%
• Country: US
• Employees: 142
• Sector: Healthcare
• Sector Strength: 55
• Industry: Drug Manufacturers - Specialty & Generic
• EPS (TTM): -0.24
• Shares Outstanding: 99,327,930
• 10 Day Avg. Volume: 1,829,848
• 30 Day Avg. Volume: 1,749,622
• PEG Ratio: 0.02
• Price to Book (P/B): -0.37
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -3.57
• Enterprise Value/Market Cap: 0.21
• Enterprise Value/Revenue: 0.32
• Enterprise Value/Gross Profit: 1.96
• Enterprise Value/Ebitda: -0.76
• 1Y Price Target: $7.59
• Price Target Upside: 121.93% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 8

• Rating: 53 Neutral
• Price Target: $3.50 ▲(2.34%Upside)

Aquestive Therapeutics faces substantial financial challenges, with negative profit margins and high debt levels. However, positive technical momentum and promising developments related to Anaphylm's FDA approval and market launch provide some optimism for future growth potential.

Positive Factors

Financial Stability

Aquestive ended the quarter with a solid cash position, which is expected to provide financial runway into 2026.

Market Potential

Anaphylm could generate peak sales of over $226M by 2035, indicating significant commercial potential.

Regulatory Approval

FDA acceptance of the Anaphylm NDA submission is expected, and the advisory committee meeting process could highlight the potential benefits of Anaphylm for patients.

Negative Factors

Market Uncertainty

The recent US District Court Ruling for Libervant brings uncertainty to the program's future outlook on the US market.

Regulatory Challenges

The court ruling vacates the FDA’s approval of Aquestive’s drug product Libervant.

Revenue Guidance

Management lowered full-year revenue guidance due to the FDA's revision of Libervant's regulatory status.

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 proprietary pharmaceutical products, particularly those leveraging its PharmFilm® technology. Key revenue streams include product sales of its FDA-approved therapies, licensing agreements with other pharmaceutical companies, and royalty income from out-licensed products. The company also enters into collaborative partnerships to co-develop and co-market products, sharing both development costs and profits. These partnerships and licensing deals are significant contributors to Aquestive's earnings, allowing the company to expand its market reach and leverage its technological innovations.

Aquestive Therapeutics Financial Statement Overview

Summary

Aquestive Therapeutics is facing significant financial challenges with declining revenues, negative profit margins, and high leverage. The balance sheet and cash flow analyses reveal financial instability and liquidity concerns, necessitating substantial restructuring.

Income Statement

Aquestive Therapeutics shows a declining revenue trend with a negative revenue growth rate in the TTM period compared to the previous year. The company has consistently reported negative net and gross profit margins, indicating ongoing profitability challenges. The EBIT and EBITDA margins are also negative, reflecting operational inefficiencies. This performance points to significant struggles in achieving profitability and managing costs effectively.

Balance Sheet

The balance sheet indicates a high level of debt relative to the company's negative equity, resulting in a concerning debt-to-equity ratio. The negative stockholders' equity suggests financial instability, with liabilities far exceeding assets. The equity ratio is negative, highlighting the company's reliance on debt financing. These factors collectively underline the financial risks and potential solvency issues facing the company.

Cash Flow

Cash flow analysis reveals negative operating and free cash flows, with a deteriorating free cash flow growth rate. The operating cash flow to net income ratio is unfavorable, suggesting cash flow management challenges. Despite significant financing inflows, the company struggles to generate positive cash flow from its core operations, which raises concerns about liquidity and sustainability.

Breakdown
TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement		Total Revenue
54.23M	57.56M	50.58M	47.68M	50.83M	45.85M
	Gross Profit
37.09M	39.69M	29.75M	28.29M	35.84M	32.88M
	EBIT
-41.18M	-30.77M	-15.10M	-42.07M	-34.68M	-42.89M
	EBITDA
-35.35M	-26.62M	1.18M	-39.58M	-45.11M	-39.15M
	Net Income Common Stockholders
-54.24M	-44.14M	-7.87M	-60.20M	-90.04M	-65.36M
Balance Sheet		Cash, Cash Equivalents and Short-Term Investments
68.66M	71.55M	23.87M	27.27M	28.02M	31.81M
	Total Assets
102.23M	101.42M	57.42M	55.67M	61.99M	62.88M
	Total Debt
39.13M	38.00M	33.32M	56.09M	56.42M	40.48M
	Net Debt
-29.52M	-33.54M	9.45M	28.82M	28.40M	8.67M
	Total Liabilities
163.16M	161.58M	163.91M	174.23M	144.13M	111.38M
	Stockholders Equity
-60.93M	-60.16M	-106.49M	-118.55M	-82.13M	-48.50M
Cash Flow		Free Cash Flow
-49.04M	-35.92M	-7.38M	-12.31M	-33.89M	-45.98M
	Operating Cash Flow
-48.77M	-35.76M	-6.38M	-9.79M	-32.98M	-45.46M
	Investing Cash Flow
-265.00K	-159.00K	-995.00K	-2.52M	-913.00K	-517.00K
	Financing Cash Flow
22.50M	83.59M	3.97M	11.56M	30.11M	28.46M

Aquestive Therapeutics Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 3.42
• 50DMA: Positive
• 100DMA: Positive
• 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 Positive. The current price of 3.42 is above the 20-day moving average (MA) of 2.99, above the 50-day MA of 2.79, and below the 200-day MA of 3.67, indicating a neutral trend. The MACD of 0.23 indicates Negative momentum. The RSI at 66.46 is Neutral, neither overbought nor oversold. The STOCH value of 59.73 is Neutral, 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
DERM	62 Neutral	$157.95M	―	-48.14%	―	-29.69%	-105.88%
RMTI	55 Neutral	$32.12M	―	-2.12%	―	12.82%	96.46%
Sector *	54 Neutral	$5.34B	3.27	-45.10%	3.30%	16.80%	0.02%
AQST	53 Neutral	$339.70M	―	77.48%	―	5.29%	-37.31%
ESPR	52 Neutral	$231.89M	―	23.44%	―	12.99%	17.78%
EBS	52 Neutral	$339.24M	―	-21.63%	―	-18.56%	76.88%
LFCR	46 Neutral	$246.96M	―	-83.58%	―	6.88%	-17.54%

Aquestive Therapeutics Corporate Events

FDA Accepts Aquestive’s New Drug Application for Anaphylm

On June 16, 2025, Aquestive Therapeutics announced that the FDA accepted its New Drug Application for Anaphylm™, an orally delivered epinephrine for treating severe allergic reactions, with a PDUFA target action date set for January 31, 2026. If approved, Anaphylm would be the first oral epinephrine option in the U.S., potentially transforming anaphylaxis care by addressing barriers such as fear of administration and the inconvenience of carrying bulky devices.

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 Therapeutics Holds Annual Stockholders Meeting

On June 11, 2025, Aquestive Therapeutics, Inc. held its Annual Meeting of Stockholders, where key decisions were made. Daniel Barber and Timothy E. Morris were elected as Class I members of the Board of Directors for a three-year term. Additionally, the stockholders approved executive compensation on a non-binding advisory basis and ratified the appointment of KPMG LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2025.

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 Therapeutics Prepares for FDA Approvals and Launches

Aquestive Therapeutics has announced plans regarding the advancement of its product candidates, including Anaphylm, a sublingual film for epinephrine, and AQST-108, a topical gel for alopecia areata. The company is preparing for potential FDA approvals and market launches, which could significantly impact its market positioning and offer new alternatives in the treatment of these conditions.

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 Therapeutics Submits NDA for Anaphylm

Aquestive Therapeutics reported its first quarter 2025 financial results and provided a business update, highlighting the submission of a New Drug Application (NDA) for Anaphylm, an oral sublingual film for severe allergic reactions. The company plans a potential U.S. launch in early 2026, subject to FDA approval, and is focusing resources on this launch, pausing other projects. Financially, the company saw a 28% decrease in total revenues compared to the first quarter of 2024, primarily due to a decline in manufacture and supply revenue. The net loss increased to $22.9 million, driven by higher selling, general, and administrative expenses.

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 Therapeutics Awaits FDA Decision on Anaphylm NDA

On April 1, 2025, Aquestive Therapeutics announced positive results from its pediatric study for Anaphylm™ (epinephrine) Sublingual Film, marking the completion of its clinical program. The company has submitted a New Drug Application (NDA) to the FDA, expecting potential acceptance in the second quarter of 2025. The study involved patients aged seven to seventeen, showing consistent pharmacokinetic results with previous adult studies, and no serious adverse events were reported. Aquestive plans to launch Anaphylm in the first quarter of 2026, pending FDA approval.