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Aquestive Therapeutics, Inc. (AQST)
:AQST
US Market
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Aquestive Therapeutics (AQST) AI Stock Analysis

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AQST

Aquestive Therapeutics

(NASDAQ:AQST)

Rating:54Neutral
Price Target:
$4.50
▲(13.07% Upside)
Aquestive Therapeutics' overall stock score is primarily impacted by its challenging financial performance, with declining revenues and high leverage posing significant risks. However, positive technical indicators and recent corporate events provide some optimism. The potential market opportunity for Anaphylm, if approved, could improve future prospects, but current financial instability remains a concern.
Positive Factors
Commercialization Path
These deals provide Aquestive with financial runway extending through 2027 and help establish a clear path to commercialization.
FDA Approval Process
Management indicated that their interactions with the FDA have been smooth, which is a positive sign for the approval process.
Strategic Funding
A $75M strategic funding agreement with RTW Investments has been secured, contingent on FDA approval of Anaphylm.
Negative Factors
Financial Overhang
An $85M underwritten equity offering of 21.25M shares has been priced at $4.00 per share, which removes a financial overhang that has weighed on the stock.
Stock Volatility
Potential volatility in the stock could arise depending on whether the FDA decides to hold an advisory committee meeting for Anaphylm.

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 through various streams including product sales, licensing agreements, and collaborations. The company earns money primarily from the sale of its approved products, with Suboxone Film being a significant contributor to its revenue. Additionally, AQST engages in strategic partnerships with other pharmaceutical companies to co-develop products or to license its proprietary drug delivery technologies, which provide upfront payments and royalties on future sales. The company also may receive milestone payments related to the progress of its product candidates in clinical development, further diversifying its revenue sources.

Aquestive Therapeutics Earnings Call Summary

Earnings Call Date:Aug 11, 2025
(Q2-2025)
|
% Change Since: 3.11%|
Next Earnings Date:Nov 10, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted significant progress in the development and pre-launch activities for Anaphylm, indicating promising market expansion opportunities. However, financial challenges, including revenue decline and increased net loss, along with market access barriers, present notable concerns.
Q2-2025 Updates
Positive Updates
FDA Review and Launch Preparation for Anaphylm
The company is on track with the FDA review process for Anaphylm, including pre-commercial launch activities and securing launch financing. The FDA action date is set for January 31, 2026.
Market Opportunity for Anaphylm
The rescue market for severe allergic reactions is expected to grow significantly. Surveys indicate a potential market shift from injectable to non-injectable products, with a market size of up to $2 billion annually.
International Expansion Plans
Meetings with regulatory bodies in Canada and the EU are secured, with plans to complete these meetings by the end of the year and begin filing preparations.
Base Business Growth
The base business showed year-over-year growth in Q2 2025, driven by strong international product performance.
Cash Position and Financial Stability
Aquestive ended the last quarter with $60 million in cash, providing sufficient initial launch funding for Anaphylm.
Negative Updates
Revenue Decline
Total revenues decreased from $20.1 million in Q2 2024 to $10 million in Q2 2025, due to a one-time recognition of deferred revenue in the prior year. Excluding this, revenue increased by 3%.
Increased Net Loss
The net loss for Q2 2025 was $13.5 million, compared to a net loss of $2.7 million in Q2 2024. Excluding deferred revenue, the net loss in Q2 2024 was $13.2 million.
Increased Operating Expenses
Selling, general, and administrative expenses increased to $12.7 million in Q2 2025 from $11.4 million in Q2 2024, driven by higher commercial spending and regulatory fees.
Challenges in Market Access
There are significant barriers in the market access landscape, including delay tactics and prior authorization documentation, making it difficult for patients to access life-saving medicines.
Company Guidance
During Aquestive Therapeutics' second quarter 2025 earnings call, the company provided guidance on several fronts. They are on track with their FDA review process for Anaphylm, their sublingual epinephrine film, with an action date set for January 31, 2026. Aquestive recently submitted a 120-day safety update to the FDA and expects clarity on whether an advisory committee meeting will occur after the FDA's mid-cycle review. The company is preparing for a potential launch, focusing on securing financing and increasing product awareness among physicians and payers. The rescue market for severe allergic reactions is projected to grow from approximately 5 million to 10 million prescriptions annually, potentially reaching over $2 billion in global market value. Aquestive's financial guidance for 2025 remains unchanged, with expected total revenues between $44 million and $50 million and a non-GAAP adjusted EBITDA loss of $47 million to $51 million. The company ended the quarter with $60 million in cash, sufficient for the initial launch of Anaphylm, but they are exploring additional funding options.

Aquestive Therapeutics Financial Statement Overview

Summary
Aquestive Therapeutics is experiencing significant financial difficulties, with declining revenues, negative profit margins, and high leverage. The company's inability to generate positive cash flow from operations, coupled with its reliance on debt financing, poses substantial risks to its financial health.
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.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue44.13M57.56M50.58M47.68M50.83M45.85M
Gross Profit26.96M39.69M29.75M28.29M35.84M32.88M
EBITDA-44.74M-26.62M1.18M-39.58M-45.11M-39.15M
Net Income-65.04M-44.14M-7.87M-54.41M-70.54M-55.78M
Balance Sheet
Total Assets93.70M101.42M57.42M55.67M61.99M62.88M
Cash, Cash Equivalents and Short-Term Investments60.54M71.55M23.87M27.27M28.02M31.81M
Total Debt126.26M38.00M33.32M57.49M56.42M40.48M
Total Liabilities166.29M161.58M163.91M174.23M144.13M111.38M
Stockholders Equity-72.59M-60.16M-106.49M-118.55M-82.13M-48.50M
Cash Flow
Free Cash Flow-50.02M-35.92M-7.38M-12.31M-33.89M-45.98M
Operating Cash Flow-49.68M-35.76M-6.38M-9.79M-32.98M-45.46M
Investing Cash Flow-337.00K-159.00K-995.00K-2.52M-913.00K-517.00K
Financing Cash Flow20.69M83.59M3.97M11.56M30.11M28.46M

Aquestive Therapeutics Technical Analysis

Technical Analysis Sentiment
Positive
Last Price3.98
Price Trends
50DMA
3.81
Positive
100DMA
3.28
Positive
200DMA
3.42
Positive
Market Momentum
MACD
0.03
Positive
RSI
52.27
Neutral
STOCH
40.23
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 3.98 is above the 20-day moving average (MA) of 3.95, above the 50-day MA of 3.81, and above the 200-day MA of 3.42, indicating a bullish trend. The MACD of 0.03 indicates Positive momentum. The RSI at 52.27 is Neutral, neither overbought nor oversold. The STOCH value of 40.23 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 69 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 (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
67
Neutral
$490.30M3.7730.24%-22.74%
60
Neutral
$429.46M23.44%-3.48%36.57%
55
Neutral
$172.60M-57.22%-27.40%-475.41%
54
Neutral
$473.01M77.48%-24.38%-94.72%
54
Neutral
$36.15M-8.65%-6.79%61.56%
51
Neutral
$7.82B-0.16-39.78%2.19%21.38%-1.56%
49
Neutral
$271.21M-76.41%0.47%-430.88%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AQST
Aquestive Therapeutics
3.98
-0.48
-10.76%
EBS
Emergent Biosolutions
9.23
-0.30
-3.15%
LFCR
Lifecore Biomedical
7.60
1.60
26.67%
RMTI
Rockwell Med
1.14
-1.90
-62.50%
ESPR
Esperion
2.17
0.40
22.60%
DERM
Journey Medical Corp
7.47
2.64
54.66%

Aquestive Therapeutics Corporate Events

Private Placements and FinancingBusiness Operations and Strategy
Aquestive Therapeutics Announces $85M Stock Offering
Positive
Aug 15, 2025

On August 14, 2025, Aquestive Therapeutics announced an underwriting agreement for an offering of 21,250,000 shares of common stock at $4.00 per share, expected to raise $85 million. The proceeds will primarily fund the launch and commercialization of Anaphylm™, a sublingual film for severe allergic reactions, pending FDA approval, and support the company’s operations into 2027.

Product-Related AnnouncementsPrivate Placements and Financing
Aquestive Therapeutics Secures $75M Funding for Anaphylm
Positive
Aug 14, 2025

On August 13, 2025, Aquestive Therapeutics announced a $75 million strategic funding agreement with RTW Investments, contingent upon FDA approval of Anaphylm, a sublingual film for treating severe allergic reactions. This financing aims to support the potential commercialization of Anaphylm, strengthening the company’s financial position and offering a novel treatment option for patients. The agreement includes tiered revenue share payments to RTW based on Anaphylm’s net sales in the U.S., with payments ceasing upon reaching specified financial thresholds.

Product-Related AnnouncementsBusiness Operations and StrategyFinancial Disclosures
Aquestive Therapeutics Reports Q2 2025 Financial Results
Negative
Aug 11, 2025

Aquestive Therapeutics announced its second quarter 2025 financial results and business updates, highlighting the FDA’s acceptance of their New Drug Application for Anaphylm, a sublingual film epinephrine product. The company is preparing for a potential U.S. launch in 2026 and is also pursuing regulatory engagements in Canada and the EU. Aquestive aims to address unmet needs in emergency allergy treatment with Anaphylm, which offers advantages over existing epinephrine therapies. Financially, the company reported a net loss of $13.5 million for the second quarter of 2025, attributed to decreased revenues and increased expenses.

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.

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.

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.

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.Date of analysis: Aug 19, 2025