Aquestive Therapeutics, Inc. (AQST)

Aquestive Therapeutics, Inc. (AQST) Healthcare & Pipeline Overview

Aquestive Therapeutics, Inc. focuses on developing and commercializing oral soluble film formulations for various conditions, including epilepsy and ADHD. With proprietary technologies and a pipeline of complex molecule products, Aquestive aims to improve drug delivery and patient outcomes in the specialty pharmaceutical market, competing with companies like ERAS: Erasca, Inc..

What Is the Investment Thesis for AQST?

Aquestive Therapeutics presents a compelling investment thesis centered on its innovative drug delivery technology and diversified product portfolio. The company's focus on oral soluble films addresses unmet needs in various therapeutic areas, offering improved patient compliance and bioavailability. Key value drivers include the continued commercial success of existing products like Sympazan and Suboxone, as well as the potential approval and launch of pipeline candidates such as Libervant for seizure treatment and AQST-109 for anaphylaxis. The company's gross margin of 58.3% indicates strong pricing power and efficient manufacturing processes. Upcoming catalysts include regulatory decisions on key pipeline products and potential partnerships to expand market reach. However, investors should be aware of the company's negative profit margin of -188.1%, indicating ongoing losses, and the potential risks associated with clinical trials and regulatory approvals.

Based on FMP financials and quantitative analysis

AQST Key Highlights

• Market Cap of $421.06M reflects the company's current valuation in the specialty pharmaceutical market.
• Gross Margin of 58.3% demonstrates efficient production and pricing strategies for its oral soluble film products.
• Profit Margin of -188.1% indicates ongoing losses, highlighting the need for revenue growth and cost management.
• Beta of 1.59 suggests higher volatility compared to the overall market, reflecting the risks associated with pharmaceutical development and regulatory approvals.
• Focus on oral soluble film technology provides a competitive advantage in drug delivery, potentially improving patient compliance and drug efficacy.

Who Are AQST's Competitors?

AQST is benchmarked below against 8 industry peers on price, market cap, and our AI MoonshotScore.

AI Score by Stock Expert AI · Price data: FMP / Yahoo Finance

What Are AQST's Key Strengths?

• Proprietary PharmFilm technology.
• Diverse product portfolio targeting multiple therapeutic areas.
• Established commercial infrastructure.
• Experienced management team.

What Are AQST's Weaknesses?

• Negative profit margin.
• Reliance on regulatory approvals for pipeline products.
• Competition from established pharmaceutical companies.
• Limited financial resources compared to larger competitors.

What Could Drive AQST Stock Higher?

• Potential FDA approval of Libervant for seizure treatment within the next 12-18 months.
• Continued expansion of Sympazan market through increased marketing and distribution efforts.
• Progress in clinical trials for AQST-109 for anaphylaxis, with potential commercialization in 2-3 years.
• Strategic partnerships and collaborations to expand product portfolio and market reach.
• Geographic expansion into new markets outside the United States.

What Are the Key Risks for AQST?

• Financial-distress signal — its Altman Z-Score of -3.12 sits in the distress zone (elevated bankruptcy risk).
• Weak fundamentals — a Piotroski F-Score of 2/9 flags soft profitability, leverage or efficiency.
• Regulatory setbacks or delays in the approval of pipeline products.
• Competition from established pharmaceutical companies and generic drugs.
• Product liability claims related to marketed drugs.
• Economic downturn affecting healthcare spending and demand for pharmaceutical products.
• Reliance on key partnerships for revenue generation and market access.

What Are the Growth Opportunities for AQST?

• Libervant Approval and Launch: Aquestive's Libervant, a buccal soluble film formulation of diazepam for seizure treatment, represents a significant growth opportunity. The market for rescue medications for epilepsy is substantial, with a growing need for convenient and rapidly acting formulations. If approved, Libervant could capture a significant share of this market, driven by its ease of administration and potential for improved patient outcomes. The timeline for potential FDA approval is within the next 12-18 months, making it a near-term catalyst for growth.
• AQST-109 for Anaphylaxis: The development of AQST-109, an orally delivered epinephrine product candidate for the emergency treatment of allergic reactions, including anaphylaxis, presents a major growth opportunity. The current standard of care, epinephrine auto-injectors, has limitations in terms of ease of use and patient acceptance. AQST-109's oral soluble film formulation could offer a more convenient and patient-friendly alternative, potentially capturing a significant portion of the epinephrine market. The timeline for potential commercialization is 2-3 years, pending clinical trial results and regulatory approval.
• Expansion of Sympazan Market: Sympazan, Aquestive's oral soluble film formulation of clobazam for Lennox-Gastaut syndrome, has the potential for further market penetration. By expanding its marketing and distribution efforts, Aquestive can reach a larger patient population and increase sales. The company can also explore new indications for Sympazan, further expanding its market potential. This growth opportunity is ongoing, with continuous efforts to increase awareness and adoption of Sympazan among healthcare providers and patients.
• Partnerships and Collaborations: Aquestive can pursue strategic partnerships and collaborations to expand its product portfolio and market reach. By partnering with other pharmaceutical companies, Aquestive can gain access to new technologies, therapeutic areas, and distribution channels. These partnerships can accelerate the development and commercialization of its pipeline products and enhance its overall growth prospects. The timeline for potential partnerships is ongoing, with continuous efforts to identify and evaluate potential collaboration opportunities.
• Geographic Expansion: Aquestive can expand its geographic presence by entering new markets outside the United States. The company can leverage its oral soluble film technology to address unmet medical needs in international markets, particularly in regions with a growing demand for convenient and patient-friendly drug formulations. This expansion can be achieved through direct sales, partnerships, or licensing agreements. The timeline for potential geographic expansion is 3-5 years, requiring careful market analysis and regulatory approvals.

What Opportunities Does AQST Have?

• Potential approval and launch of Libervant.
• Expansion of Sympazan market.
• Strategic partnerships and collaborations.
• Geographic expansion into new markets.

What Threats Does AQST Face?

• Regulatory setbacks or delays.
• Competition from generic drugs.
• Product liability claims.
• Economic downturn affecting healthcare spending.

What Are AQST's Competitive Advantages?

• Proprietary PharmFilm technology for oral soluble drug delivery.
• Patent protection for key products and formulations.
• Established relationships with pharmaceutical partners.
• Specialized expertise in developing and manufacturing oral soluble films.

What Does AQST Do?

Aquestive Therapeutics, Inc., founded in 2004 and headquartered in Warren, New Jersey, is a pharmaceutical company dedicated to addressing unmet medical needs through innovative drug delivery technologies. The company specializes in developing and commercializing oral soluble film products, offering a convenient and patient-friendly alternative to traditional tablets and capsules. Aquestive's product portfolio includes several marketed drugs, such as Sympazan, an oral soluble film formulation of clobazam for the treatment of Lennox-Gastaut syndrome, a severe form of epilepsy. They also market Suboxone, a sublingual film formulation of buprenorphine and naloxone for opioid dependence treatment. Zuplenz, another oral soluble film, addresses nausea and vomiting associated with chemotherapy and post-operative recovery. Azstarys, a once-daily treatment for attention deficit hyperactivity disorder (ADHD), is also part of their commercialized products. In addition to marketed products, Aquestive has a pipeline of proprietary product candidates, including Libervant, a buccal soluble film formulation of diazepam for seizure treatment, and Exservan, an oral soluble film formulation of riluzole for amyotrophic lateral sclerosis (ALS). The company is also developing complex molecule products like AQST-108, a sublingual epinephrine film for conditions other than anaphylaxis, AQST-305, a sublingual octreotide film for acromegaly, and AQST-109, an orally delivered epinephrine product for anaphylaxis. Aquestive also develops KYNMOBI, a sublingual film formulation of apomorphine for Parkinson's disease. Aquestive's focus on innovative drug delivery and specialized therapeutic areas positions it as a key player in the specialty pharmaceutical market.

What Products and Services Does AQST Offer?

• Develop and commercialize oral soluble film products for various therapeutic areas.
• Market Sympazan for the treatment of Lennox-Gastaut syndrome.
• Market Suboxone for the treatment of opioid dependence.
• Market Zuplenz for the treatment of nausea and vomiting.
• Develop Libervant for the treatment of seizures.
• Develop Exservan for the treatment of amyotrophic lateral sclerosis (ALS).
• Develop AQST-109 for the emergency treatment of allergic reactions, including anaphylaxis.
• Develop KYNMOBI for the treatment of episodic off-periods in Parkinson's disease.

How Does AQST Make Money?

• Develops proprietary oral soluble film formulations for various drugs.
• Outlicenses or co-promotes certain products with partners.
• Generates revenue through product sales and licensing agreements.
• Focuses on niche markets with unmet medical needs.

What Industry Does AQST Operate In?

Aquestive Therapeutics operates in the specialty pharmaceutical industry, which is characterized by high research and development costs, stringent regulatory requirements, and intense competition. The market for novel drug delivery systems, such as oral soluble films, is growing as pharmaceutical companies seek to improve drug efficacy and patient compliance. Aquestive competes with companies like ERAS: Erasca, Inc. and other specialty pharmaceutical firms. The industry is driven by factors such as an aging population, increasing prevalence of chronic diseases, and advancements in drug delivery technologies. Aquestive's focus on oral soluble films positions it to capitalize on the growing demand for patient-friendly drug formulations.

Who Are AQST's Key Customers?

• Patients suffering from Lennox-Gastaut syndrome (Sympazan).
• Patients with opioid dependence (Suboxone).
• Patients experiencing nausea and vomiting (Zuplenz).
• Patients with ADHD (Azstarys).
• Patients with seizures (potential Libervant customers).
• Patients with ALS (potential Exservan customers).
• Patients with Parkinson's disease (potential KYNMOBI customers).

Aquestive Therapeutics, Inc. (AQST) Valuation Context

Valued at $421.06M, AQST is classified as a small-cap stock. Relative to its peer group, AQST's quantitative score of 12/100 is below the peer average of 68/100.

AQST Revenue & Earnings Trend

In Q1 2026, AQST generated $14.4M in top-line revenue, marking a sequential increase of 11.0%. The company recorded a net loss of $8.1M, with diluted EPS of $-0.07. Revenue has increased across the last three reported quarters, suggesting sustained momentum for this small-cap Healthcare company. Across the four most recent quarters, AQST averaged $-0.15 in diluted EPS.

Company Profile

Aquestive Therapeutics, Inc. operates in the Drug Manufacturers - Specialty & Generic industry within the Healthcare sector. It is headquartered in Warren, US. The company is led by CEO Daniel Barber. AQST has traded publicly since 2018.

ROE 191%Key Financial Metrics

Return on equity for Aquestive Therapeutics, Inc. stands at 190.9%, a gauge of how efficiently it converts shareholder capital into profit. Return on assets is -48.8%, showing how much profit it generates from its asset base. Its free cash flow yield is -11.2%, a gauge of the cash the business throws off relative to its market value. A current ratio of 4.10 indicates the company holds enough short-term assets to cover its near-term obligations. Its earnings yield is -14.1%, the inverse of the P/E and a quick read on earnings relative to price.

F-Score 2/9Financial Health

Aquestive Therapeutics, Inc.'s Piotroski F-Score is 2/9, a 9-point checklist of profitability, leverage and efficiency — flagging fundamental weakness worth scrutiny. Its Altman Z-Score of -3.12 places it in the distress zone, a signal of elevated financial risk.

FY2026 estForward Outlook

Wall Street analysts project Aquestive Therapeutics, Inc. revenue of about $50.6M for fiscal 2026, with EPS near $-0.41. The estimate reflects 7 contributing analysts.

AQST Financials

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AQST Analyst Consensus

AQST MoonshotScore

Aquestive Therapeutics, Inc. Healthcare Stock: Key Questions Answered

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