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Aquestive Therapeutics (AQST)
NASDAQ:AQST
US Market

Aquestive Therapeutics (AQST) AI Stock Analysis

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Aquestive Therapeutics

(NASDAQ:AQST)

Rating:53Neutral
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 (AQST) vs. SPDR S&P 500 ETF (SPY)

Aquestive Therapeutics Business Overview & Revenue Model

Company DescriptionAquestive 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 MoneyAquestive 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 Earnings Call Summary

Earnings Call Date:May 12, 2025
(Q1-2025)
|
% Change Since: 20.00%|
Next Earnings Date:Aug 12, 2025
Earnings Call Sentiment Neutral
The earnings call presented a mixed outlook. While there was significant progress in the FDA review and commercial readiness for Anaphylm, the company faced substantial revenue declines and increased losses. The anticipation of Anaphylm's market entry and strategic preparations provide optimism, but financial challenges persist.
Q1-2025 Updates
Positive Updates
Anaphylm FDA Review Progress
Aquestive is over a month into FDA review for Anaphylm Epinephrine Sublingual film. An FDA action date is anticipated for late January or early February of 2026.
Commercial Prelaunch Phase for Anaphylm
Aquestive has officially entered the commercial prelaunch phase for Anaphylm, focusing on assembling a marketing team with significant experience, including members who built EpiPen to a billion-dollar brand.
Increased Awareness Efforts
The company has attended 25 conferences and published 16 posters and manuscripts, with plans to reach 30 publications by the FDA action date.
Strategic Payer Engagement
Aquestive is leveraging existing distribution and payer contracts to prepare for Anaphylm's launch, aiming to save months of startup time.
Negative Updates
Significant Revenue Decrease
Total revenues decreased by 28% to $8.7 million in Q1 2025 compared to $12.1 million in Q1 2024, driven by decreases in manufacturer and supply revenue.
Increased Net Loss
Net loss for Q1 2025 was $22.9 million compared to $12.8 million in Q1 2024, primarily due to increased selling, general, and administrative expenses.
Libervant Revenue Removal
Aquestive revised its financial guidance, excluding revenue for Libervant due to a change in regulatory status, impacting expected total revenue for 2025.
Non-GAAP Adjusted EBITDA Loss
Non-GAAP adjusted EBITDA loss was $17.6 million in Q1 2025 compared to a $7.2 million loss in Q1 2024.
Company Guidance
During the Aquestive Therapeutics First Quarter 2025 Earnings Conference Call, the company provided several key metrics and guidance for the upcoming periods. Dan Barber, CEO, highlighted that they are in the commercial prelaunch phase for Anaphylm, with an FDA action date anticipated in late January or early February of 2026. The company has prepared for the launch by attending 25 conferences and publishing 16 posters and manuscripts, expecting nearly 30 by the FDA action date. In regards to financials, total revenues decreased by 28% to $8.7 million compared to the first quarter of 2024, primarily due to a decrease in manufacturer and supply revenue. The net loss for the quarter was $22.9 million, and the company revised its full-year 2025 revenue guidance to $44 million to $50 million, with a non-GAAP adjusted EBITDA loss of $47 million to $51 million. The company plans to de-emphasize AQST-108 studies to free up capital for Anaphylm's launch, aiming for a fast start in 2026 if the FDA approves the product.

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
45
Neutral
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
30
Negative
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
40
Negative
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
TTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
54.23M57.56M50.58M47.68M50.83M45.85M
Gross Profit
37.09M39.69M29.75M28.29M35.84M32.88M
EBIT
-41.18M-30.77M-15.10M-42.07M-34.68M-42.89M
EBITDA
-35.35M-26.62M1.18M-39.58M-45.11M-39.15M
Net Income Common Stockholders
-54.24M-44.14M-7.87M-60.20M-90.04M-65.36M
Balance SheetCash, Cash Equivalents and Short-Term Investments
68.66M71.55M23.87M27.27M28.02M31.81M
Total Assets
102.23M101.42M57.42M55.67M61.99M62.88M
Total Debt
39.13M38.00M33.32M56.09M56.42M40.48M
Net Debt
-29.52M-33.54M9.45M28.82M28.40M8.67M
Total Liabilities
163.16M161.58M163.91M174.23M144.13M111.38M
Stockholders Equity
-60.93M-60.16M-106.49M-118.55M-82.13M-48.50M
Cash FlowFree 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
22.50M83.59M3.97M11.56M30.11M28.46M

Aquestive Therapeutics Technical Analysis

Technical Analysis Sentiment
Positive
Last Price3.42
Price Trends
50DMA
2.79
Positive
100DMA
2.88
Positive
200DMA
3.67
Negative
Market Momentum
MACD
0.23
Negative
RSI
66.46
Neutral
STOCH
59.73
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 Risk Analysis

Aquestive Therapeutics disclosed 68 risk factors in its most recent earnings report. Aquestive Therapeutics reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Aquestive Therapeutics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (54)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
62
Neutral
$157.95M-48.14%-29.69%-105.88%
55
Neutral
$32.12M-2.12%12.82%96.46%
54
Neutral
$5.34B3.27-45.10%3.30%16.80%0.02%
53
Neutral
$339.70M77.48%5.29%-37.31%
52
Neutral
$231.89M23.44%12.99%17.78%
EBEBS
52
Neutral
$339.24M-21.63%-18.56%76.88%
46
Neutral
$246.96M-83.58%6.88%-17.54%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AQST
Aquestive Therapeutics
3.54
0.86
32.09%
EBS
Emergent Biosolutions
6.24
0.18
2.97%
LFCR
Lifecore Biomedical
6.67
1.78
36.40%
RMTI
Rockwell Med
0.95
-0.90
-48.65%
ESPR
Esperion
1.17
-1.55
-56.99%
DERM
Journey Medical Corp
6.74
1.36
25.28%

Aquestive Therapeutics Corporate Events

Product-Related AnnouncementsRegulatory Filings and Compliance
FDA Accepts Aquestive’s New Drug Application for Anaphylm
Positive
Jun 16, 2025

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.

Executive/Board ChangesShareholder Meetings
Aquestive Therapeutics Holds Annual Stockholders Meeting
Neutral
Jun 11, 2025

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.

Product-Related AnnouncementsBusiness Operations and Strategy
Aquestive Therapeutics Prepares for FDA Approvals and Launches
Positive
Jun 2, 2025

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.

Product-Related AnnouncementsBusiness Operations and StrategyFinancial Disclosures
Aquestive Therapeutics Submits NDA for Anaphylm
Negative
May 12, 2025

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.

Product-Related AnnouncementsRegulatory Filings and Compliance
Aquestive Therapeutics Awaits FDA Decision on Anaphylm NDA
Positive
Apr 1, 2025

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.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.