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Aquestive Therapeutics (AQST)
NASDAQ:AQST
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Aquestive Therapeutics
(NASDAQ:AQST)
44Neutral
Positive Factors
Financial Position
Aquestive ended with approximately $93M in cash and cash equivalents, which management expects should provide financial runway into 2026.
Regulatory Progress
Aquestive expects to receive FDA acceptance of the Anaphylm NDA submission next quarter.
Negative Factors
Legal Challenges
The recent US District Court Ruling for Libervant brings uncertainty to the program’s future outlook on the US market, but Libervant is a small contributor to the overall AQST valuation.
Aquestive Therapeutics (AQST) vs. S&P 500 (SPY)
Market Cap
$261.02M
Dividend YieldN/A
Average Volume (3M)1.87M
Price to Earnings (P/E)―
Beta (1Y)1.22
Revenue Growth13.80%
EPS Growth-389.41%
CountryUS
Employees135
SectorHealthcare
Sector Strength78
IndustryPharmaceuticals
Share Statistics
EPS (TTM)-0.52
Shares Outstanding98,871,370
10 Day Avg. Volume1,281,855
30 Day Avg. Volume1,870,998
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)4.36
Price to Cash Flow (P/CF)-9.70
P/FCF Ratio0.00
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$9.68Price Target Upside266.67% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering7
Aquestive Therapeutics Business Overview & Revenue Model
Company DescriptionAquestive Therapeutics, Inc. is a specialty pharmaceutical company focused on identifying, developing, and commercializing differentiated products to address unmet medical needs. The company has a late-stage proprietary product pipeline focused on the treatment of Central nervous system (CNS) diseases, as well as orally-administered complex molecules that can be alternatives to invasively-administered standard of care therapies. Its product candidates include Libervant, Sympazan, and AQST-117 (Riluzole). Aquestive Therapeutics develops and delivers drugs via its PharmFilm® technology. The firm also collaborates with pharmaceutical partners to bring new molecules to market in differentiated and highly-marketable dosage forms. In addition to its proprietary product candidates, the company, with its partners, has a portfolio of development-stage products and commercialized products, such as Suboxone, a prescription medicine for the treatment of opioid dependence. The company was founded in January 2004 and is headquartered in Warren, NJ.
How the Company Makes MoneyAquestive 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.45
Neutral
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.30
Negative
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.40
Negative
| 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
Neutral
2.64
Price Trends
3.06
Negative
3.85
Negative
3.78
Negative
Market Momentum
-0.13
Negative
51.32
Neutral
53.43
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AQST, the sentiment is Neutral. The current price of 2.64 is below the 20-day moving average (MA) of 2.90, below the 50-day MA of 3.06, and below the 200-day MA of 3.78, indicating a neutral trend. The MACD of -0.13 indicates Negative momentum. The RSI at 51.32 is Neutral, neither overbought nor oversold. The STOCH value of 53.43 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral 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 (49)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
79 Outperform | $2.87B | 12.33 | 38.89% | ― | 31.85% | ― | |
68 Neutral | $10.69B | 33.14 | 14.16% | ― | 24.81% | 33.67% | |
64 Neutral | $1.79B | 24.29 | 7.55% | ― | 8.94% | 5171.26% | |
49 Neutral | $6.90B | 0.02 | -54.05% | 2.46% | 24.91% | -3.14% | |
48 Neutral | $30.37M | ― | 210.50% | ― | 1.63% | 6.97% | |
44 Neutral | $261.02M | ― | 77.48% | ― | 13.80% | -389.41% | |
42 Neutral | $241.55M | ― | -31.41% | ― | 389.82% | -22.66% |
* Healthcare Sector Average
Performance Comparison
AQST
Aquestive Therapeutics
2.94
-2.50
-45.96%
ACAD
ACADIA Pharmaceuticals
16.77
-2.79
-14.26%
NBIX
Neurocrine
109.07
-32.73
-23.08%
SUPN
Supernus Pharmaceuticals
31.38
-3.28
-9.46%
XOMA
Xoma
21.16
-4.45
-17.38%
MRNS
Marinus
0.55
-8.89
-94.17%
Aquestive Therapeutics Earnings Call Summary
Earnings Call Date: Mar 5, 2025 | % Change Since: -5.38% | Next Earnings Date: May 6, 2025
Earnings Call Sentiment Neutral
Aquestive Therapeutics demonstrated significant progress in advancing its lead asset Anaphylm towards FDA approval and preparing for international expansion. However, challenges include decreased quarterly revenue, increased net loss, and legal setbacks for Libervant. The sentiment is mixed with balanced highlights and lowlights.Highlights
FDA Filing for Anaphylm
Aquestive Therapeutics has begun the filing process with the FDA for approval of Anaphylm, an epinephrine sublingual film. The NDA acceptance is expected in June 2025, with a potential launch in Q1 2026.
Pediatric Study Progress for Anaphylm
The pediatric study for Anaphylm has progressed as expected, with data supporting the product label to mirror existing EpiPen auto injector parameters.
International Expansion Plans
Aquestive is preparing to submit applications for Anaphylm in the EU, UK, and Canada, exploring ex-U.S. partnerships for commercialization.
Development of AQST-108
Aquestive plans to open an IND for AQST-108, a topical gel formulation of epinephrine, with a Phase 2a trial expected in the next quarter.
Revenue Growth in 2024
Total revenues increased by 14% to $57.6 million for the full year 2024, driven by increases in license and royalty revenue.
Lowlights
Decreased Revenue in Q4 2024
Total revenue decreased by 10% to $11.9 million in Q4 2024, primarily due to decreases in license and royalty revenue.
Increased Net Loss
Aquestive's net loss for Q4 2024 was $17.1 million, more than doubling from $8.1 million in Q4 2023, driven by increased expenses and decreased revenues.
Court Ruling Against Libervant
A federal court ruling held that the FDA's rationale for granting Libervant approval and orphan drug exclusivity was not acceptable, prompting an appeal.
Decreased Suboxone and Sympazan Revenues
Manufacture and supply revenue decreased due to declines in Suboxone and Sympazan revenues, offset by increases in other product revenues.
Company Guidance
During the call, Aquestive Therapeutics provided several key metrics and guidance for the upcoming periods. The company announced that it expects FDA approval for its Anaphylm product in the first quarter of 2026, with the NDA acceptance anticipated in June 2025. They also plan to initiate the AQST-108 Phase 2a clinical trial in the next quarter. Financially, Aquestive reported total revenues of $57.6 million for 2024, up 14% from 2023, but anticipates revenues between $47 million and $56 million for 2025, factoring in potential erosion in Suboxone demand and including Libervant sales for ages 2 to 5. Non-GAAP adjusted EBITDA loss is projected to be $46 million to $53 million for 2025. As of December 31, 2024, the company had cash and cash equivalents of $71.5 million, with an additional $21.4 million raised in February 2025, bringing the pro forma total to approximately $93 million. Aquestive emphasized its commitment to continuing pre-commercial preparations for Anaphylm and the commercialization of Libervant, even amid ongoing legal challenges.Aquestive Therapeutics Corporate Events
Product-Related AnnouncementsBusiness Operations and Strategy
Aquestive Therapeutics Advances Product Pipeline and Market Access
Positive
Mar 10, 2025
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.
Product-Related AnnouncementsLegal ProceedingsBusiness Operations and StrategyFinancial DisclosuresRegulatory Filings and Compliance
Aquestive Therapeutics Initiates Anaphylm NDA Filing Process
Neutral
Mar 5, 2025
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.
Product-Related AnnouncementsBusiness Operations and Strategy
Aquestive Therapeutics Updates on Strategic Goals and Drug Progress
Positive
Jan 13, 2025
Aquestive Therapeutics has provided a business update, highlighting its progress and strategic goals for 2025. The company is preparing to submit a New Drug Application for Anaphylm™, an epinephrine sublingual film, in early 2025, aiming for approval and market launch by the first quarter of 2026. Aquestive is also advancing its AQST-108 topical gel for alopecia areata, with a Phase 2a clinical trial scheduled for mid-2025. The company has received FDA approval for Libervant®, a buccal film for seizure clusters in young pediatric patients, and is focusing on expanding its market reach for these innovative treatments, suggesting an optimistic outlook for capturing market share in these therapeutic areas.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.
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.