Aquestive Therapeutics (AQST) AI Stock Analysis

• Market Cap: $227.46M
• Dividend Yield: N/A
• Average Volume (3M): 1.43M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.06
• Revenue Growth: 5.29%
• EPS Growth: -37.31%
• Country: US
• Employees: 142
• Sector: Healthcare
• Sector Strength: 39
• Industry: Drug Manufacturers - Specialty & Generic
• EPS (TTM): -0.24
• Shares Outstanding: 99,327,930
• 10 Day Avg. Volume: 1,842,975
• 30 Day Avg. Volume: 1,434,216
• PEG Ratio: 0.40
• Price to Book (P/B): -4.58
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -8.31
• Enterprise Value/Market Cap: N/A
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: N/A
• Enterprise Value/Ebitda: N/A
• 1Y Price Target: $7.68
• Price Target Upside: 245.95% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 7

The overall stock score reflects significant financial instability, with substantial net losses and negative equity. While there is potential in upcoming product launches and strategic initiatives, current financial and technical weaknesses dominate the stock's outlook.

Positive Factors

Clinical Results

Anaphylm was safe & well-tolerated in the pediatric study with no serious adverse events (SAEs).

Market Potential

The T1A market should be large enough for multiple no-needle epi players including Anaphylm, and no-needle epi products should ultimately 'grow the pie' & drive meaningful expansion of the T1A market beyond current autoinjectors longer-term.

Regulatory Progress

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

Financial Considerations

Aquestive ended with approximately $93M in cash and cash equivalents, which management expects should provide financial runway into 2026.

Regulatory Timelines

Anaphylm NDA submitted, setting up potential approval in early 2026.

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 through the development and commercialization of its proprietary drug delivery systems, particularly focusing on orally dissolving films. The company earns money by selling its own pharmaceutical products, entering into licensing agreements with other pharmaceutical companies, and providing contract development and manufacturing services. Key revenue streams include product sales, milestone payments, royalties from partners utilizing its technology, and service fees from manufacturing and development contracts. Strategic partnerships with larger pharmaceutical companies also play a significant role in supporting its earnings by expanding the reach and application of its innovative drug delivery solutions.

Aquestive Therapeutics Financial Statement Overview

Summary

Aquestive Therapeutics faces financial challenges, with consistent net losses, negative equity, and strained cash flow, despite some revenue growth.

Income Statement

Aquestive Therapeutics has shown a mixed performance in its income statement. The revenue has seen some growth, moving from $50.58M in 2023 to $57.56M in 2024. However, the company continues to report negative net income and EBIT, indicating ongoing operational challenges. The gross profit margin has improved, but the consistent net losses highlight profitability issues that need addressing.

Balance Sheet

The balance sheet of Aquestive Therapeutics reveals significant challenges. The company has negative stockholders' equity, which indicates financial distress, and a high debt-to-equity ratio is not calculable due to negative equity. The negative equity ratio further emphasizes the potential insolvency risk. Overall, the balance sheet reflects a need for improved financial stability.

Cash Flow

Cash flow analysis shows a significant improvement in operating cash flow from -$6.38M in 2023 to -$35.76M in 2024. However, free cash flow remains negative, which is a concern for long-term sustainability. The free cash flow to net income ratio remains negative, indicating the company is not generating sufficient cash to cover its losses.

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

Aquestive Therapeutics Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 2.22
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Positive
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AQST, the sentiment is Negative. The current price of 2.22 is below the 20-day moving average (MA) of 2.73, below the 50-day MA of 2.78, and below the 200-day MA of 3.77, indicating a bearish trend. The MACD of -0.07 indicates Positive momentum. The RSI at 32.21 is Neutral, neither overbought nor oversold. The STOCH value of 28.57 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for AQST.

Aquestive Therapeutics Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
DERM	58 Neutral	$146.12M	―	-72.60%	―	-29.11%	-219.44%
RMTI	55 Neutral	$36.57M	―	-2.12%	―	12.82%	96.46%
Sector *	52 Neutral	$5.14B	3.39	-43.55%	2.83%	16.49%	-0.19%
EBS	49 Neutral	$316.98M	―	-21.63%	―	-18.56%	76.88%
LFCR	49 Neutral	$257.33M	―	-83.58%	―	6.88%	-17.54%
AQST	41 Neutral	$227.46M	―	77.48%	―	5.29%	-37.31%
ESPR	36 Underperform	$154.73M	―	23.44%	―	12.99%	17.78%

Aquestive Therapeutics Corporate Events

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.

Spark’s Take on AQST Stock

According to Spark, TipRanks’ AI Analyst, AQST is a Neutral.

Aquestive Therapeutics is facing significant financial challenges, including persistent net losses and negative equity, which are major concerns. While there is some technical and product pipeline optimism, negative valuation metrics and mixed earnings guidance limit the stock’s appeal.

To see Spark’s full report on AQST stock, click here.

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.

Aquestive Therapeutics Advances Product Pipeline and Market Access

Aquestive Therapeutics has announced its plans to advance several product candidates through clinical development and potential FDA approval. The company’s pipeline includes Anaphylm, a sublingual film for epinephrine delivery, and AQST-108, a topical gel for alopecia areata. Additionally, the company is working on expanding market access for its epilepsy treatment, Libervant, despite challenges related to orphan drug exclusivity. These developments could significantly impact Aquestive’s market position and offer new treatment options for patients.

Aquestive Therapeutics Initiates Anaphylm NDA Filing Process

Aquestive Therapeutics reported its financial results for the fourth quarter and full year of 2024, highlighting the initiation of the Anaphylm NDA filing process with the FDA, with a potential launch in early 2026. The company also announced progress in its AQST-108 topical gel development for alopecia areata, aiming to start Phase 2a trials in 2025. Despite a decrease in total revenues by 10% compared to the previous year, the company is advancing its strategic priorities, including the launch of Libervant for young ARS patients, although facing legal challenges regarding its FDA approval.