Aquestive Therapeutics, Inc. (AQST)
NASDAQ:AQST
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Aquestive Therapeutics
(NASDAQ:AQST)
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Rating:55Neutral
Price Target:
$5.00
▲(15.74% Upside)
Action:Reiterated
Date:05/15/26
The score is held back primarily by weak financial performance (large ongoing losses, negative equity, and continued cash burn). Offsetting this are positive earnings-call catalysts around regulatory progress and improved liquidity, along with supportive technical momentum. Valuation remains constrained due to losses and lack of dividend support.
Positive Factors
Regulatory progress — Anaphylm
Clear FDA engagement and alignment on study designs materially reduce regulatory execution risk. Having submitted the human factors protocol and secured Type A feedback supports a structured resubmission timeline (Type 2, ~6 months) and enables parallel international filings, improving the probability of eventual approval and predictable commercialization planning.
Negative Factors
Persistent cash burn & negative equity
Material ongoing operating and free cash-flow deficits alongside negative shareholders' equity signal structural balance-sheet weakness. Continued cash burn increases reliance on external financing, heightening dilution and covenant exposure risk if milestones slip, and limits the company’s ability to absorb cost overruns or extended regulatory timelines without additional capital.
Read all positive and negative factors
Positive Factors
Negative Factors
Regulatory progress — Anaphylm
Clear FDA engagement and alignment on study designs materially reduce regulatory execution risk. Having submitted the human factors protocol and secured Type A feedback supports a structured resubmission timeline (Type 2, ~6 months) and enables parallel international filings, improving the probability of eventual approval and predictable commercialization planning.
Read all positive factors
Aquestive Therapeutics (AQST) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$518.74M
Dividend YieldN/A
Average Volume (3M)1.53M
Price to Earnings (P/E)―
Beta (1Y)0.92
Revenue Growth-7.30%
EPS Growth-3.31%
CountryUS
Employees142
SectorHealthcare
Sector Strength45
IndustryDrug Manufacturers - Specialty & Generic
Share Statistics
EPS (TTM)-0.61
Shares Outstanding125,450,120
10 Day Avg. Volume2,304,451
30 Day Avg. Volume1,533,418
Financial Highlights & Ratios
PEG Ratio-0.19
Price to Book (P/B)-23.41
Price to Sales (P/S)17.69
P/FCF Ratio-14.87
Enterprise Value/Market Cap0.65
Enterprise Value/Revenue6.74
Enterprise Value/Gross Profit10.63
Enterprise Value/Ebitda-6.12
Forecast
1Y Price Target
$8.75Price Target Upside102.55% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering8
EPS Forecast (FY)-0.42
Revenue Forecast (FY)$50.52M
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...
How the Company Makes Money
Aquestive makes money primarily through (1) net product sales of its commercial medicines and (2) revenue from licensing/partnership and drug-delivery technology activities. Product revenue is generated by selling its branded therapies to the phar...
Aquestive Therapeutics Earnings Call Summary
Earnings Call Date:May 13, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:Aug 04, 2026
Earnings Call Sentiment Positive
The call contained multiple strong positives: substantive regulatory progress, a completed Phase I safety study with promising directional biomarkers for AQST-108, materially improved Q1 financials (revenues +66%, sharply reduced net loss and non-GAAP EBITDA loss), a strengthened liquidity position via a $150M Oaktree facility and RTW extension, and active commercial and medical affairs preparations (75-person sales force plan, conference/publication program). The primary negatives are the existing FDA CRL requirements (human factors and PK studies) that make resubmission timing dependent on FDA responses, expected challenges around payer coverage and physician-office friction at launch, the one-time nature of a portion of Q1 royalty revenue, and conditional access to some debt tranches. Overall, the positives (regulatory path clarity in progress, improved financials, strong liquidity, promising pipeline signal, and concrete launch planning) outweigh the risks and remaining obstacles, though execution on studies, FDA timelines, and market access remain critical.Positive Updates
Regulatory Progress Toward Anaphylm Resubmission
Completed a Type A face-to-face meeting with the FDA, completed a teleconference with the U.K. MHRA, submitted a pediatric investigational plan to the EMA, and submitted the human factors protocol to the FDA. Company guides to availability of human factors data and potentially PK data by the August earnings call and currently expects a Q3 2026 NDA resubmission (company expects a Type 2 submission with a 6-month review, while pursuing expedited review).
Negative Updates
Complete Response Letter (CRL) and Remaining FDA Requirements
Company received an FDA Complete Response Letter (Jan 30, 2026) that requires a human factors validation study and a PK study prior to approval. Resubmission timing and review length remain dependent on FDA responses and classification; while the company expects a 6-month Type 2 review, timing cannot be guaranteed and is contingent on FDA feedback and turnaround on human factors protocol review.
Read all updates
Q1-2026 Updates
Positive
Negative
Regulatory Progress Toward Anaphylm Resubmission
Completed a Type A face-to-face meeting with the FDA, completed a teleconference with the U.K. MHRA, submitted a pediatric investigational plan to the EMA, and submitted the human factors protocol to the FDA. Company guides to availability of human factors data and potentially PK data by the August earnings call and currently expects a Q3 2026 NDA resubmission (company expects a Type 2 submission with a 6-month review, while pursuing expedited review).
Read all positive updates
Company Guidance
Aquestive guided that, assuming timely FDA feedback on its human factors protocol (response expected in the next few weeks), it expects human factors data — and potentially pharmacokinetic (PK) data — to be available by the August earnings call and is targeting a third‑quarter 2026 resubmission of the Anaphylm NDA (anticipated to be classified as a Type 2, six‑month review, with a request for expedited review); financially, the company ended Q1 with approximately $110M cash, closed a $150M Oaktree debt facility (Tranche A $55M to refinance existing debt; Tranche B $20M available on FDA approval; Tranche C $25M on sales milestones; Tranche D $50M by mutual consent), which together with RTW funding positions the company to project >$150M in cash at launch (before ex‑U.S. or licensing deals) and to provide runway through launch, while 2026 guidance ranges remain total revenue $46–50M and non‑GAAP adjusted EBITDA loss ~$30–35M.Aquestive Therapeutics Financial Statement Overview
Summary
Income Statement
28
Negative
Balance Sheet
22
Negative
Cash Flow
18
Very Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 50.27M | 44.55M | 57.56M | 50.58M | 47.68M | 50.83M |
| Gross Profit | 31.90M | 25.99M | 39.69M | 29.75M | 28.29M | 35.84M |
| EBITDA | -55.36M | -70.49M | -26.62M | 1.18M | -39.58M | -45.11M |
| Net Income | -68.91M | -83.78M | -44.14M | -7.87M | -54.41M | -70.54M |
Balance Sheet | ||||||
| Total Assets | 141.13M | 160.43M | 101.42M | 57.42M | 57.07M | 61.99M |
| Cash, Cash Equivalents and Short-Term Investments | 110.73M | 121.17M | 71.55M | 23.87M | 27.27M | 28.02M |
| Total Debt | 133.58M | 131.44M | 38.00M | 33.32M | 57.49M | 56.42M |
| Total Liabilities | 175.18M | 194.09M | 161.58M | 163.91M | 175.62M | 144.13M |
| Stockholders Equity | -34.05M | -33.66M | -60.16M | -106.49M | -118.55M | -82.13M |
Cash Flow | ||||||
| Free Cash Flow | -44.32M | -52.99M | -35.92M | -7.38M | -12.31M | -33.89M |
| Operating Cash Flow | -43.84M | -52.43M | -35.76M | -6.38M | -9.79M | -32.98M |
| Investing Cash Flow | -479.00K | -562.00K | -159.00K | -995.00K | -2.52M | -913.00K |
| Financing Cash Flow | 86.39M | 102.62M | 83.59M | 3.97M | 11.56M | 30.11M |
Aquestive Therapeutics Technical Analysis
Negative
4.32
Price Trends
4.15
Negative
4.21
Negative
4.87
Negative
Market Momentum
0.02
Positive
46.54
Neutral
11.19
Positive
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 4.32 is above the 20-day moving average (MA) of 4.19, above the 50-day MA of 4.15, and below the 200-day MA of 4.87, indicating a bearish trend. The MACD of 0.02 indicates Positive momentum. The RSI at 46.54 is Neutral, neither overbought nor oversold. The STOCH value of 11.19 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative 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
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
61 Neutral | $419.48M | 15.84 | -1.59% | ― | -29.89% | 93.33% | |
56 Neutral | $306.26M | -27.74 | 10.62% | ― | -22.07% | -58.28% | |
56 Neutral | $805.76M | -6.83 | 1.99% | ― | 61.13% | 92.51% | |
56 Neutral | $432.67M | -6.28 | 174.92% | ― | 9.56% | 24.52% | |
55 Neutral | $518.74M | -15.79 | 190.87% | ― | -7.30% | -3.31% | |
53 Neutral | $319.11M | -1.35 | -0.07% | ― | 12.19% | 1.97% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% |
* Healthcare Sector Average
AQST
Aquestive Therapeutics
4.09
1.70
71.13%
EBS
Emergent Biosolutions
8.06
1.12
16.14%
SIGA
SIGA Technologies
4.37
-1.11
-20.31%
ESPR
Esperion
3.13
2.22
244.71%
ORGO
Organogenesis Holdings
2.43
-0.83
-25.46%
EOLS
Evolus
6.43
-3.53
-35.44%
Aquestive Therapeutics Corporate Events
Business Operations and StrategyFinancial DisclosuresPrivate Placements and Financing
Aquestive Secures New Oaktree Term Loan to Fund Anaphylm
Positive
May 13, 2026
On May 12, 2026, Aquestive Therapeutics entered into a new five‑year term loan facility of up to $150 million with funds managed by Oaktree, including a $55 million tranche funded at closing to refinance $45 million of existing debt without ...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Aquestive Advances Anaphylm NDA Resubmission After FDA Meeting
Positive
Mar 30, 2026
On March 30, 2026, Aquestive Therapeutics reported that it had received preliminary comments and successfully completed an in-person Type A meeting with the U.S. Food and Drug Administration regarding the planned resubmission of its New Drug Appli...
Business Operations and StrategyExecutive/Board Changes
Aquestive Therapeutics Announces Key Legal Leadership Transition
Positive
Mar 20, 2026
On March 16, 2026, Aquestive Therapeutics agreed that longtime Chief Legal Officer, Chief Compliance Officer and Corporate Secretary Lori J. Braender would step down from her legal and compliance posts and cease being an executive officer effectiv...
Business Operations and StrategyFinancial DisclosuresPrivate Placements and FinancingRegulatory Filings and Compliance
Aquestive Therapeutics Amends RTW Deal, Strengthens Financing Outlook
Positive
Mar 4, 2026
On March 3, 2026, Aquestive Therapeutics amended its existing revenue-sharing Purchase and Sale Agreement with RTW Investments to extend the marketing approval deadline for its lead product candidate Anaphylm to June 30, 2027, easing timing pressu...
Business Operations and StrategyRegulatory Filings and Compliance
Aquestive Highlights Strategy, Pipeline and Risk Disclosures
Neutral
Feb 26, 2026
On February 2026, Aquestive Therapeutics furnished an investor presentation for institutional investors, analysts and other stakeholders, outlining its corporate strategy and clinical pipeline. The materials, made available via the company’s...
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.