Aquestive Therapeutics (AQST) AI Stock Analysis

• Market Cap: $279.11M
• Dividend Yield: N/A
• Average Volume (3M): 1.48M
• Price to Earnings (P/E): ―
• Beta (1Y): 0.86
• 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: 1,037,602
• 30 Day Avg. Volume: 1,477,931
• PEG Ratio: 0.36
• Price to Book (P/B): -4.28
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -5.53
• Enterprise Value/Market Cap: 0.87
• Enterprise Value/Revenue: 1.05
• Enterprise Value/Gross Profit: 6.51
• Enterprise Value/Ebitda: -2.52
• 1Y Price Target: $7.59
• Price Target Upside: 138.68% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 8

• Rating: 45 Neutral
• Price Target: $2.50 ▼(-21.38%Downside)

Aquestive Therapeutics' overall stock score reflects significant financial challenges, including declining revenues and high leverage. Despite strategic initiatives for new product launches, these financial risks and the lack of positive earnings overshadow potential future gains.

Positive Factors

Market Potential

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

Product Development

Aquestive has completed the submission of a New Drug Application (NDA) for Anaphylm, a non-device-based epinephrine product candidate that has demonstrated clinical results comparable to those seen with autoinjectors for the emergency treatment of severe allergic reactions.

Regulatory Progress

Aquestive previously received positive pre-New Drug Application (NDA) written response feedback from the FDA regarding the proposed Chemistry, Manufacturing, Controls (CMC) submission for Anaphylm.

Negative Factors

Financial Guidance

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

Legal and Regulatory Challenges

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

Product Approval

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

Aquestive Therapeutics Business Overview & Revenue Model

Company Description

Aquestive Therapeutics, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative products that address unmet medical needs. The company specializes in orally administered drug delivery systems, leveraging its proprietary PharmFilm technology to create novel dosage forms. Aquestive's core products primarily target central nervous system (CNS) conditions, including epilepsy and anxiety disorders, offering patients alternative administration routes that improve convenience and compliance.

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 is experiencing significant financial challenges, with declining revenues, negative profit margins, and high leverage. The company's inability to generate positive cash flow from operations and its heavy reliance on debt financing pose serious risks to its financial stability.

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: 3.18
• 50DMA: Positive
• 100DMA: Positive
• 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 3.18 is above the 20-day moving average (MA) of 2.58, above the 50-day MA of 2.71, and below the 200-day MA of 3.71, indicating a neutral trend. The MACD of 0.04 indicates Negative momentum. The RSI at 66.71 is Neutral, neither overbought nor oversold. The STOCH value of 91.37 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
DERM	62 Neutral	$181.94M	―	-48.14%	―	-29.69%	-105.88%
EBS	61 Neutral	$341.95M	―	-21.63%	―	-18.56%	76.88%
RMTI	55 Neutral	$34.02M	―	-2.12%	―	12.82%	96.46%
Sector *	53 Neutral	$5.23B	3.23	-44.27%	2.82%	16.82%	0.11%
LFCR	46 Neutral	$254.36M	―	-83.58%	―	6.88%	-17.54%
AQST	45 Neutral	$279.11M	―	77.48%	―	5.29%	-37.31%
ESPR	40 Underperform	$182.07M	―	23.44%	―	12.99%	17.78%

Aquestive Therapeutics Corporate Events

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.

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.