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1. Company Snapshot

1.a. 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 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.

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1.b. Last Insights on AQST

Aquestive Therapeutics' recent performance was driven by the imminent FDA filing of its Anaphylm, a sublingual epinephrine film, which has blockbuster potential. The company's participation in the Piper Sandler Spring Biopharma Symposium, where it will host investor meetings, is also a positive development. Additionally, Aquestive's recent approval of Libervant, although mired in litigation, offers greater revenue opportunity. The company's focus on innovative science and delivery technologies is expected to bring meaningful improvement to patients' lives, further driving its growth.

1.c. Company Highlights

2. Aquestive Therapeutics: Anaphylm Approval and Launch Dynamics

Aquestive Therapeutics reported Q3 2025 total revenues of $12.8 million, a 4% year-over-year increase. However, excluding one-time deferred revenue recognition in 2024, total revenues decreased 8% year-over-year for the 9 months ended September 30, 2025. The net loss for Q3 2025 was $15.4 million, or $0.14 per share, compared to analyst estimates of -$0.11. Non-GAAP adjusted EBITDA loss was $8.6 million in Q3 2025. The company's full-year 2025 guidance is $44 million to $50 million in total revenue and a non-GAAP adjusted EBITDA loss of $47 million to $51 million.

Publication Date: Nov -30

📋 Highlights
  • FDA Approval Timeline:: Aquestive awaits FDA decision on Anaphylm by January 31, 2026, with a potential Q1 2026 launch.
  • Financing & Debt Refinancing:: Secured $85M equity and $75M commercial financing; pursuing debt refinancing amid robust capital markets.
  • Financial Performance:: Q3 2025 reported $12.8M revenue (4% YoY), but net loss of $15.4M ($0.14/share) and non-GAAP EBITDA loss of $8.6M.
  • Commercial Strategy:: Launching Anaphylm with a 50–60 rep sales force targeting 5,000 allergists; no direct-to-consumer ads planned in 2026.
  • Market Positioning:: Aiming for global partnerships post-US approval; addressing epinephrine market growth (8.8% Q3 YoQ) with patient-centric pricing.

Financial Performance and Guidance

The company's financial performance is largely driven by its existing products, while it prepares for the potential launch of Anaphylm, a sublingual film for severe allergic reactions. The FDA approval process is ongoing, with a PDUFA date of January 31, 2026. As CEO Dan Barber mentioned, "We are preparing for a potential launch in Q1 2026, with marketing materials ready and district managers being hired."

Anaphylm Launch Preparations

Aquestive is taking a disciplined approach to drive adoption of Anaphylm among productive prescribers, specifically allergists who prescribe over 200 epinephrine prescriptions annually. The company plans to launch with a sales force of 50-60 reps and managers to target this segment. The epinephrine market is growing, with an 8.8% growth in Q3 and 7.5% year-to-date.

Valuation and Growth Expectations

Analysts estimate next year's revenue growth at 46.9%. The current valuation metrics show a P/S Ratio of 13.93 and an EV/EBITDA of -15.21. These metrics indicate that the market is pricing in significant growth expectations, largely driven by the potential approval and launch of Anaphylm.

Manufacturing and Supply Chain

The company has a manufacturing site in Indiana and US-based component manufacturers, enabling it to supply the whole market upon approval. Aquestive expects to have supply in the channel in Q1 post-approval and can get the first prescription filled quickly.

Future Developments and Pipeline

Aquestive is also advancing its Adrenaverse platform, with Dr. Matthew Davis joining as Chief Development Officer. The company is working on AQST-108, a Phase II program for alopecia areata, with a small safety study planned, followed by a 24-week Phase IIa study.

3. NewsRoom

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Jim Cramer: Joby Is 'Losing Too Much Money'

Nov -12

Source: benzinga.com

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Aquestive Therapeutics, Inc. (AQST) Discusses Anaphylm Regulatory Progress, Commercial Strategy, and Pipeline Development Transcript

Nov -07

Source: seekingalpha.com

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Aquestive Therapeutics, Inc. (AQST) Q3 2025 Earnings Call Transcript

Nov -06

Source: seekingalpha.com

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Here's What Key Metrics Tell Us About Aquestive Therapeutics (AQST) Q3 Earnings

Nov -06

Source: zacks.com

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Aquestive Therapeutics (AQST) Reports Q3 Loss, Lags Revenue Estimates

Nov -05

Source: zacks.com

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Aquestive Therapeutics (AQST) Projected to Post Quarterly Earnings on Wednesday

Nov -03

Source: defenseworld.net

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Aquestive Therapeutics to Report Third Quarter 2025 Financial Results and Recent Business Highlights on November 5 and Host Conference Call on November 6 at 8:00 a.m. ET

Oct -27

Source: globenewswire.com

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Are Medical Stocks Lagging Aquestive Therapeutics (AQST) This Year?

Oct -15

Source: zacks.com

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (8.50%)

6. Segments

Pharmaceutical

Expected Growth: 8.5%

Aquestive Therapeutics, Inc.'s 8.5% growth in pharmaceuticals is driven by increasing demand for its proprietary PharmFilm technology, expanding product pipeline, and strategic partnerships. Growing awareness of rare diseases and unmet medical needs also contribute to growth. Additionally, the company's focus on improving patient outcomes and adherence through innovative drug delivery systems fuels its expansion.

7. Detailed Products

Sympazan

Sympazan is a treatment for seizures associated with Lennox-Gastaut syndrome, a rare and severe form of epilepsy.

Libervia

Libervia is a buccally administered soluble film formulation of diazepam, a benzodiazepine, for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity in patients with epilepsy.

Exservan

Exservan is a treatment for oral mucositis, a common and debilitating side effect of cancer treatment.

8. Aquestive Therapeutics, Inc.'s Porter Forces

Forces Ranking

Threat Of Substitutes

Aquestive Therapeutics, Inc. has a moderate threat of substitutes due to the presence of alternative treatments and therapies for the conditions they are targeting.

Bargaining Power Of Customers

Aquestive Therapeutics, Inc. has a low bargaining power of customers due to the specialized nature of their products and the lack of alternative options for patients.

Bargaining Power Of Suppliers

Aquestive Therapeutics, Inc. has a moderate bargaining power of suppliers due to the presence of multiple suppliers for raw materials and the company's dependence on a few key suppliers.

Threat Of New Entrants

Aquestive Therapeutics, Inc. has a high threat of new entrants due to the growing demand for pharmaceutical products and the relatively low barriers to entry in the industry.

Intensity Of Rivalry

Aquestive Therapeutics, Inc. operates in a highly competitive industry with many established players, leading to a high intensity of rivalry.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight -715.12%
Debt Cost 7.32%
Equity Weight 815.12%
Equity Cost 18.65%
WACC 99.70%
Leverage -87.73%

11. Quality Control: Aquestive Therapeutics, Inc. passed 6 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

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Esperion Therapeutics

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Value: 9.0

Growth: 5.9

Quality: 6.1

Yield: 0.0

Momentum: 9.0

Volatility: 1.0

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ANI Pharmaceuticals

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Value: 4.3

Growth: 6.0

Quality: 4.4

Yield: 0.0

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Phibro Animal Health

A-Score: 4.9/10

Value: 2.7

Growth: 5.2

Quality: 4.2

Yield: 4.0

Momentum: 9.5

Volatility: 4.0

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OptiNose

A-Score: 4.4/10

Value: 7.4

Growth: 4.4

Quality: 5.1

Yield: 0.0

Momentum: 5.0

Volatility: 4.7

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Aquestive Therapeutics

A-Score: 4.4/10

Value: 8.0

Growth: 3.7

Quality: 5.8

Yield: 0.0

Momentum: 7.5

Volatility: 1.7

1-Year Total Return ->

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Evolus

A-Score: 4.1/10

Value: 9.2

Growth: 7.2

Quality: 6.2

Yield: 0.0

Momentum: 0.0

Volatility: 2.0

1-Year Total Return ->

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Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

1.11$

Current Price

6.39$

Potential

-82.66%

Expected Cash-Flows