Aquestive Therapeutics

Advance patient care with PharmFilm® therapies by making injections obsolete for millions of patients worldwide.

Aquestive Therapeutics SWOT Analysis

Updated: October 4, 2025 • 2025-Q4 Analysis

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This analysis for Aquestive Therapeutics was created using Alignment.io™ methodology - a proven strategic planning system trusted in over 75,000 strategic planning projects. We've designed it as a helpful companion for your team's strategic process, leveraging leading AI models to analyze publicly available data.

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The Aquestive Therapeutics SWOT analysis reveals a company at a critical inflection point. Its entire near-term future hinges on the successful execution of its lead asset, Anaphylm. The company's core strength, the proprietary PharmFilm® platform, has created a massive opportunity to disrupt the multi-billion dollar epinephrine market. However, this is balanced by significant weaknesses in its cash position and commercial-stage experience, and the looming threats of regulatory risk and formidable competition. The strategic priorities are crystal clear: secure FDA approval for Anaphylm, fortify the balance sheet to fund the launch, and decisively win the market by highlighting clinical differentiation. This is a high-risk, high-reward scenario where flawless execution is not just a goal, but a necessity for survival and unlocking shareholder value. The path forward requires the relentless focus of Bezos and the bold vision of Musk to navigate these challenges successfully.

ARS Pharmaceuticals Viatris Kaleo Amphastar Pharmaceuticals Bausch Health

No past cycles

Mission & Vision SWOT Analysis OKR Plan Retrospective AI Strategy Data Acquisition

Advance patient care with PharmFilm® therapies by making injections obsolete for millions of patients worldwide.

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Strengths

PIPELINE: Positive FDA feedback on Anaphylm pivotal study for epinephrine
TECHNOLOGY: Proprietary PharmFilm® offers non-invasive delivery advantage
REVENUE: Growing royalty/manufacturing revenue from licensed products
MANUFACTURING: In-house cGMP facility provides control and cost efficiency
LEADERSHIP: Experienced team with drug development/approval track record

Weaknesses

CASHBURN: Significant cash burn rate from R&D and SG&A expenses
DEPENDENCE: Heavy reliance on the successful approval/launch of Anaphylm
COMMERCIAL: Limited commercial infrastructure for a major product launch
DEBT: Significant debt load could constrain future financing options
COMPETITION: Facing large, well-funded competitors like Viatris (EpiPen)

Opportunities

MARKET: Huge unmet need in >$2.5B US epinephrine market for a needle-free option
REGULATORY: Potential for Fast Track or Priority Review designation for Anaphylm
PARTNERING: Major ex-US licensing opportunities for Anaphylm post-NDA filing
EXPANSION: Leverage PharmFilm® for other rescue meds (e.g., glucagon, naloxone)
AWARENESS: Growing patient and physician preference for non-invasive treatments

Threats

APPROVAL: Risk of FDA Complete Response Letter (CRL) or delay for Anaphylm
COMPETITION: ARS Pharma's Neffy (nasal spray) potential first-to-market advantage
FINANCING: Need for additional capital raises, potentially diluting shareholders
REIMBURSEMENT: Payer pushback on pricing could limit market access and uptake
MACROECONOMIC: High interest rates making future debt financing more expensive

Key Priorities

EXECUTION: Secure Anaphylm FDA approval and prepare for a flawless launch
FINANCING: Secure non-dilutive funding or strategic capital for launch
DIFFERENTIATION: Clearly establish Anaphylm's clinical edge over Neffy
PARTNERING: Finalize an ex-US commercialization partner for Anaphylm

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Aquestive Therapeutics OKR

Updated: October 4, 2025 • 2025-Q4 Analysis

The Aquestive Therapeutics OKR plan is a masterclass in focus, directly translating strategic risks into actionable objectives. It correctly prioritizes the sequential, dependent nature of its goals: secure approval, fund the launch, win the market, and then expand. This isn't a generic growth plan; it's a high-stakes roadmap for a company transitioning from clinical to commercial stage. The Key Results are specific, measurable, and outcome-driven, addressing critical items from the SWOT and retrospective, such as securing non-dilutive funding and establishing clear market differentiation against competitors. This plan provides the clarity and alignment needed to navigate the company's most pivotal year, embodying the focused execution required to achieve its ambitious mission.

ARS Pharmaceuticals Viatris Kaleo Amphastar Pharmaceuticals Bausch Health

No past cycles

Mission & Vision SWOT Analysis OKR Plan Retrospective AI Strategy Data Acquisition

Advance patient care with PharmFilm® therapies by making injections obsolete for millions of patients worldwide.

LAUNCH ANAPHYLM

Achieve FDA approval and dominate the epinephrine market.

SUBMISSION: File Anaphylm New Drug Application with the FDA with zero refuse-to-file issues by Q1 2025.
APPROVAL: Secure full FDA approval for Anaphylm for allergic reactions (Type 1), including anaphylaxis.
READINESS: Build out commercial team and supply chain to support a full US launch within 60 days of approval.
AWARENESS: Achieve 75% aided brand awareness among the top 5,000 US allergists and ER physicians pre-launch.

SECURE CAPITAL

Fortify the balance sheet for a successful launch.

PARTNERING: Secure an ex-US partnership for Anaphylm with a minimum of $25M in upfront non-dilutive capital.
FINANCING: Raise sufficient capital to fully fund all operations through 12 months post-Anaphylm launch.
SPEND: Reduce quarterly non-essential operating expenses by 10% without impacting R&D or launch activities.
DEBT: Successfully restructure or refinance existing debt to extend maturity dates and improve covenants.

WIN THE MARKET

Establish Anaphylm as the superior needle-free option.

DATA: Publish pivotal Phase 3 study data in a top-tier, peer-reviewed medical journal before US launch.
ACCESS: Secure formulary access for Anaphylm covering 65% of US commercially insured lives within 6 months.
ADVOCACY: Partner with 3 major patient advocacy groups to drive awareness and preference for oral film delivery.
MESSAGING: Launch digital marketing campaign showing Anaphylm's usability vs. nasal sprays and auto-injectors.

EXPAND GLOBALLY

Establish a global footprint for our lead asset.

EUROPE: Sign a definitive commercialization partnership agreement for Anaphylm in the EU5 before end of 2025.
ASIA: Initiate partnership discussions for Anaphylm in Japan and China with at least two qualified candidates.
REGULATORY: Fully support our ex-US partner in preparing for EMA and other key regulatory body submissions.
PIPELINE: License one non-core, non-strategic pipeline asset for a specific region to generate upfront cash.

METRICS

Anaphylm NDA Submission & Acceptance
Anaphylm Net Revenue
Cash Runway (in months)

VALUES

Patient-Centric
Innovation
Integrity
Collaboration
Execution

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Aquestive Therapeutics Retrospective

AI-Powered Insights

Claude

Gemini

GPT

Aquestive Therapeutics Q3 2024 10-Q Filing
Aquestive Therapeutics Investor Presentations (Nov 2024)
Press Releases regarding Anaphylm FDA meetings and clinical data
Analysis of competitors ARS Pharma and Viatris public filings
Industry reports on the global anaphylaxis treatment market

ARS Pharmaceuticals Viatris Kaleo Amphastar Pharmaceuticals Bausch Health

No past cycles

Mission & Vision SWOT Analysis OKR Plan Retrospective AI Strategy Data Acquisition

Advance patient care with PharmFilm® therapies by making injections obsolete for millions of patients worldwide.

Toggle Theme

What Went Well

REGULATORY: Positive Type A meeting feedback from FDA on Anaphylm program
CLINICAL: Pivotal study data for Anaphylm met all primary and secondary endpoints
MANUFACTURING: Successful scale-up of cGMP manufacturing for Anaphylm launch
REVENUE: Met or exceeded revenue guidance on existing commercial products
PARTNERING: Continued progress in ex-US partnership discussions for Anaphylm

Not So Well

CASHBURN: Continued high quarterly cash burn rate due to R&D and launch prep
STOCK: Share price volatility despite positive clinical and regulatory news
COMPETITION: Competitor ARS Pharma received FDA approval for Neffy nasal spray
DEBT: Existing debt covenants remain a focus for investors and management
PIPELINE: Limited news flow on pipeline assets beyond the lead program

Learnings

MARKET: Regulatory de-risking is the single most important value driver
INVESTORS: Clear communication on cash runway and funding strategy is critical
COMPETITION: A competitor's approval validates the market but increases urgency
EXECUTION: Meeting stated timelines for regulatory submissions is paramount
FOCUS: Maintaining disciplined focus on the lead asset is the right strategy

Action Items

REGULATORY: Submit the Anaphylm NDA on the previously communicated timeline
FINANCE: Finalize a non-dilutive financing or strategic partnership
COMMERCIAL: Accelerate market access and payer engagement activities
MARKETING: Sharpen differentiation messaging against nasal spray competitors
INVESTORS: Increase investor outreach to explain Anaphylm's value proposition

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Organization	SWOT Analysis	OKR Plan	Top 6	Retrospective

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Aquestive Therapeutics Market

AI-Powered Insights

Claude

Gemini

GPT

Aquestive Therapeutics Q3 2024 10-Q Filing
Aquestive Therapeutics Investor Presentations (Nov 2024)
Press Releases regarding Anaphylm FDA meetings and clinical data
Analysis of competitors ARS Pharma and Viatris public filings
Industry reports on the global anaphylaxis treatment market

Founded: 2004 (as successor to Wolins Pharmaceutical)
Market Share: Niche player in existing markets; targeting significant share of epinephrine market.
Customer Base: Patients with epilepsy, opioid dependence, and severe allergies (anaphylaxis).
Category:
Pharmaceuticals
SIC Code: 2834
NAICS Code: 325412 Pharmaceutical Preparation Manufacturing
Location: Warren, New Jersey
Zip Code: 07059
Congressional District: NJ-7 WESTFIELD
Employees: 180

Competitors

ARS Pharmaceuticals View Analysis

Viatris View Analysis

Kaleo Request Analysis

Amphastar Pharmaceuticals View Analysis

Bausch Health Request Analysis

Products & Services

No products or services data available

Distribution Channels

Aquestive Therapeutics Business Model Analysis

AI-Powered Insights

Claude

Gemini

GPT

Aquestive Therapeutics Q3 2024 10-Q Filing
Aquestive Therapeutics Investor Presentations (Nov 2024)
Press Releases regarding Anaphylm FDA meetings and clinical data
Analysis of competitors ARS Pharma and Viatris public filings
Industry reports on the global anaphylaxis treatment market

Problem

Needle-phobia delays life-saving treatment
Difficulty swallowing pills in acute events
Complex administration of rescue medications
Portability and temperature stability issues

Solution

PharmFilm® oral dissolving film technology
Needle-free epinephrine delivery (Anaphylm)
Buccal film for seizure rescue (Libervant)
Easy-to-administer therapies for patients

Key Metrics

FDA approvals and regulatory milestones
Prescription volume (TRx) for key products
Quarterly revenue and net income/loss
Cash runway and burn rate

Unique

Proprietary, patent-protected film tech
Decades of formulation & manufacturing know-how
Focus on rescue drugs for acute conditions
Vertically integrated manufacturing control

Advantage

Extensive patent portfolio (IP moat)
In-house cGMP manufacturing expertise
Regulatory experience with film products
First-mover potential in oral epinephrine

Channels

Targeted specialty sales force
Digital marketing to physicians/patients
Partnerships with specialty pharmacies
Out-licensing to ex-US partners

Customer Segments

Patients at risk for anaphylaxis
Patients with epilepsy (LGS)
Caregivers (parents, school nurses)
Allergists, Neurologists, and ER physicians

Costs

Clinical trial and R&D expenses
Sales, general & administrative (SG&A)
Manufacturing and cost of goods sold (COGS)
Interest expense on outstanding debt

Aquestive Therapeutics Product Market Fit Analysis

Updated: October 4, 2025

Aquestive Therapeutics eliminates the fear and complexity of injections with its PharmFilm technology. By delivering proven medicines like epinephrine on a simple oral strip, it provides a faster, safer, and more reliable treatment for life-threatening conditions. This empowers patients and caregivers with the confidence to act decisively when it matters most, improving outcomes and saving lives.

Needle-free rescue treatment for anaphylaxis

Ease of administration improves confidence

Proven delivery technology with faster onset

Before State

Fear of needles and auto-injectors
Difficulty swallowing pills during seizures
Complex, multi-step rescue medication use
Delayed treatment due to administration fear

After State

Simple, needle-free rescue treatment
Rapidly dissolving oral film medication
Confidence in administering life-saving dose
Discreet, portable, and easy-to-carry

Negative Impacts

Treatment hesitation leading to poor outcomes
Caregiver anxiety and administration errors
Reduced patient independence and confidence
Risk of injury from needles or aspiration

Positive Outcomes

Faster time to treatment administration
Improved patient and caregiver quality of life
Increased medication adherence and compliance
Potential for better clinical outcomes

Key Metrics

Customer Retention Rates - High for chronic meds like Sympazan

Net Promoter Score (NPS) - Estimated 50+ for ease of use

User Growth Rate - Dependent on new product launches

Customer Feedback/Reviews - Limited public reviews; focus on physician feedback

Repeat Purchase Rates) - Strong for chronic therapy patients

Requirements

FDA approval demonstrating safety/efficacy
Broad payer and formulary access
Physician and patient education on oral film
Seamless supply chain and distribution

Why Aquestive Therapeutics

Leverage PharmFilm® for proven molecules
Execute flawless clinical trials for FDA
Build targeted commercial sales force
Secure strategic ex-US partnerships

Aquestive Therapeutics Competitive Advantage

Decades of oral film formulation expertise
Proprietary manufacturing process control
Broad IP portfolio protecting technology
Focus on patient-centric drug delivery

Proof Points

FDA approvals for Sympazan and Libervant
Positive pivotal trial data for Anaphylm
Successful manufacturing for Suboxone film
Multiple global licensing partnerships

Aquestive Therapeutics Market Positioning

AI-Powered Insights

Claude

Gemini

GPT

Aquestive Therapeutics Q3 2024 10-Q Filing
Aquestive Therapeutics Investor Presentations (Nov 2024)
Press Releases regarding Anaphylm FDA meetings and clinical data
Analysis of competitors ARS Pharma and Viatris public filings
Industry reports on the global anaphylaxis treatment market

Strategic pillars derived from our vision-focused SWOT analysis

Flawless US commercial launch execution.

Secure one new IND-stage PharmFilm asset.

Establish a major ex-US partnership.

Achieve cash flow breakeven post-launch.

What You Do

Develops and commercializes oral film-based pharmaceuticals.

Target Market

Patients needing non-invasive, easy-to-administer medications.

Differentiation

Proprietary PharmFilm® technology
Needle-free administration for rescue therapies

Revenue Streams

Product Sales
Royalties & License Fees
Manufacturing & Supply Agreements

Aquestive Therapeutics Operations and Technology

AI-Powered Insights

Claude

Gemini

GPT

Aquestive Therapeutics Q3 2024 10-Q Filing
Aquestive Therapeutics Investor Presentations (Nov 2024)
Press Releases regarding Anaphylm FDA meetings and clinical data
Analysis of competitors ARS Pharma and Viatris public filings
Industry reports on the global anaphylaxis treatment market

Company Operations

Organizational Structure: Functional structure with focus on R&D, Clinical, and Commercial.
Supply Chain: Vertically integrated manufacturing at Indiana facility.
Tech Patents: Holds over 200 patents worldwide for its PharmFilm® technology.
Website: https://www.aquestive.com/

Top Clients

Board Members

Aquestive Therapeutics Competitive Forces

Threat of New Entry

Moderate. High barriers due to patent protection, clinical development costs, and regulatory hurdles. However, a novel tech could disrupt.

Supplier Power

Low. Aquestive controls its own manufacturing, and raw materials (APIs) are generally available from multiple sources.

Buyer Power

High. Pharmacy benefit managers (PBMs) and large insurance companies exert significant pressure on pricing and formulary access.

Threat of Substitution

High. Nasal sprays (Neffy) are a direct substitute. Auto-injectors are the entrenched standard of care. New delivery techs could emerge.

Competitive Rivalry

High. Intense competition from ARS Pharma's nasal spray (Neffy) and established auto-injectors like Viatris' EpiPen.

Analysis of AI Strategy

Updated: October 4, 2025 • 2025-Q4 Analysis

The Aquestive Therapeutics AI SWOT analysis indicates that AI is not a product but a critical accelerator for its core business. The company's primary AI strength lies in its unique, proprietary dataset from years of PharmFilm® development, a classic moat for training specialized models. The most immediate opportunity is to apply AI to accelerate new product formulation and optimize manufacturing yields, directly impacting the bottom line and speed to market. However, a significant talent gap in AI expertise presents a major weakness. The strategic imperative is not to build a massive internal AI division, but to forge strategic partnerships with specialized AI firms. This allows Aquestive to leverage its data advantage without the heavy capital investment, focusing AI as a tool to make its core platform faster, cheaper, and more effective than competitors.

ARS Pharmaceuticals Viatris Kaleo Amphastar Pharmaceuticals Bausch Health

No past cycles

Mission & Vision SWOT Analysis OKR Plan Retrospective AI Strategy Data Acquisition

Advance patient care with PharmFilm® therapies by making injections obsolete for millions of patients worldwide.

Strengths

DATA: Decades of proprietary formulation and manufacturing data for AI models
PROCESS: Controlled in-house manufacturing process ideal for AI optimization
FOCUS: Niche technology platform allows for highly targeted AI application
IP: Potential to create new, AI-driven patents on formulation processes

Weaknesses

TALENT: Lack of in-house AI/ML expertise for drug formulation or discovery
SCALE: Insufficient data volume compared to large pharma for broad AI models
BUDGET: Limited financial resources to invest in a large-scale AI team/infra
INFRASTRUCTURE: Existing IT and data systems may not be AI-ready

Opportunities

FORMULATION: AI-driven discovery to speed development of new PharmFilm products
MANUFACTURING: AI for predictive maintenance and yield optimization in cGMP facility
CLINICAL: AI to optimize patient recruitment and site selection for future trials
COMMERCIAL: AI-powered targeting of high-prescribing physicians for Anaphylm

Threats

COMPETITORS: Large pharma using AI to develop rival delivery systems faster
PARTNERS: AI startups developing superior formulation platforms independently
OBSOLESCENCE: Risk of PharmFilm being leapfrogged by an AI-discovered tech
COST: High cost of implementing and maintaining effective AI systems

Key Priorities

FORMULATION: Partner with an AI firm to accelerate PharmFilm® formulation R&D
MANUFACTURING: Implement AI for predictive maintenance in the cGMP facility
CLINICAL: Use AI to optimize patient recruitment for future pipeline trials
COMMERCIAL: Leverage AI for targeting of high-value prescribers at launch

Create professional SWOT analyses in minutes with our AI template. Get insights that drive real results.

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Aquestive Therapeutics Financial Performance

AI-Powered Insights

Claude

Gemini

GPT

Aquestive Therapeutics Q3 2024 10-Q Filing
Aquestive Therapeutics Investor Presentations (Nov 2024)
Press Releases regarding Anaphylm FDA meetings and clinical data
Analysis of competitors ARS Pharma and Viatris public filings
Industry reports on the global anaphylaxis treatment market

Profit: Net Loss (FY 2023): -$54.9 million

Market Cap: Approximately $550 million (as of late 2024)

Stock Performance

Annual Report: Available on the company's investor relations website.

Debt: Approximately $50 million in long-term debt.

ROI Impact: Pre-profitability; ROI dependent on Anaphylm approval.

SWOT Index

Composite strategic assessment with 10-year outlook

/ 100

Category Challenger

ICM Index

STRATEGIC ADVISOR ASSESSMENT

Aquestive has a society-level ambition to replace needle-based care, but its achievability is tempered by significant regulatory and commercial hurdles. The SWOT is balanced on a knife's edge, with massive market upside offset by existential threats (cash burn, competition). The OKRs and Core Strategy are highly focused and effective, but the company's future is almost entirely dependent on a single binary event: Anaphylm's FDA approval and successful launch against a well-funded competitor.

SWOT Factors

Upside: 83.3 Risk: 86.7

OKR Impact

AI Leverage

Top 3 Strategic Levers

Secure Anaphylm FDA approval without delays or complications

Establish superior market access and reimbursement over Neffy

Raise non-dilutive capital via an ex-US partnership deal

AI Disclosure

This report was created using the Alignment Method—our proprietary process for guiding AI to reveal how it interprets your business and industry. These insights are for informational purposes only and do not constitute financial, legal, tax, or investment advice.

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