Submitted NDA for Anaphylm™ (epinephrine), the first and only oral sublingual film for patients with severe allergic reactions Advancing commercial readiness efforts with a planned Q1 2026 launch of Anaphylm, subject to FDA approvalCompany to host investor call on May 13, 2025, at 8:00am ET WARREN, N.J., May 12, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives t ...

Summary of the Conference Call for Aquestive Therapeutics (AQST) Company Overview - **Company**: Aquestive Therapeutics - **Focus**: Development of ANIFILM, an oral film epinephrine formulation for severe allergies [1][2] Key Points and Arguments Product Development and FDA Submission - **NDA Submission**: Recently submitted the New Drug Application (NDA) for ANIFILM, marking a significant milestone for the company [5] - **FDA Timeline**: Expecting acceptance letter from the FDA in June, with potential advisory committee meeting between mid-October and Thanksgiving, and PDUFA date anticipated in January or early February [7][8] - **Interactions with FDA**: Positive interactions noted, with the company feeling well-prepared for the submission process [8][12] Product Attributes and Clinical Data - **Key Product Attributes**: - Pharmacokinetics (PK) curve matches auto-injectors in the first 15 minutes, which is crucial for efficacy [12] - Storage conditions allow for portability, making it user-friendly [13] - **OASIS Study**: Demonstrated significant symptom relief within five minutes of administration, providing strong clinical evidence to support product claims [25][26] Market Dynamics and Competitive Landscape - **Market Size**: Current market estimated at 5 million doses per year, valued at approximately $1 billion, with expectations to double in the coming years [32][33] - **Growth Potential**: The market is projected to grow significantly, with estimates suggesting it could reach between $2 billion and $3 billion [33] - **Competitor Analysis**: Acknowledgment of a recent competitor's nasal spray product, with a focus on increasing awareness and acceptance among healthcare providers [27][28] Commercial Strategy - **Pre-Commercial Activities**: Emphasis on building awareness through community engagement, medical conferences, and presentations [15][16] - **Physician Engagement**: Targeting high decile allergists for initial product adoption, with plans to expand outreach post-launch [43][44] - **Payer Interactions**: Ongoing discussions with payers to ensure product access and equitable treatment in the marketplace [39][40] Financial Position and Launch Readiness - **Cash Position**: Company has a healthy financial position with multiple funding options available, ensuring readiness for product launch [41][42] - **Manufacturing Control**: The company controls its supply chain, allowing for flexibility and readiness as it approaches the final stages of FDA approval [49] Future Focus - **Primary Focus**: The company is fully committed to the successful launch of ANIFILM, prioritizing it above all other initiatives [50] Additional Important Insights - **Patient Demand**: There is a pent-up demand for alternative delivery methods for epinephrine, indicating a favorable market environment for ANIFILM [28][29] - **Clinical Experience Building**: Plans to create clinical use profiles to enhance physician comfort and familiarity with the product post-approval [30]

WARREN, N.J., May 05, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, announced today that the management team will participate in the upcoming Citizens Life Sciences Conference from May 7-8 in New York City. The Aquestive team will hold a fireside chat on May 8th at 10 am ET; management will also be hosting ...

Group 1 - The investment style described is termed "Fundamental Options," which combines fundamental analysis with options trading strategies [1] - The strategies pursued include income-oriented investments, particularly in Business Development Companies (BDCs) and Utilities, as well as growth investments in technology at reasonable prices [1] - The investment approach also encompasses deep value strategies based on Discounted Cash Flow and other industry-specific valuation methods, along with a focus on Dividend Aristocrats [1] Group 2 - The investor typically engages in long-term stock investments while also employing 20-25 options strategies for various purposes, including hedging, bullish substitutes, neutral trades, trading volatility, and earnings-related trades [1] - There is a passion for teaching and coaching in various life areas, including the authorship of a free local investing newsletter [1]

WARREN, N.J., May 01, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that it will report results for the first quarter ended March 31, 2025 and provide an update on recent developments in its business after market close on Monday, May 12, 2025. Management will host a conference call for inve ...

Core Insights - Aquestive Therapeutics, Inc. is participating in the Piper Sandler Spring Biopharma Symposium in Boston, with investor meetings scheduled for April 17, 2025 [1] Company Overview - Aquestive is a pharmaceutical company focused on advancing medicines through innovative science and delivery technologies, aiming to improve patients' lives [2] - The company is developing orally administered and topical gel products to deliver complex molecules, providing alternatives to standard therapies [2] - Currently, Aquestive has four commercialized products marketed by licensees in the U.S. and globally, and it is the exclusive manufacturer of these products [2] - The company collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies like PharmFilm® [2] - Aquestive is advancing a late-stage proprietary product candidate for treating severe allergic reactions, including anaphylaxis, and an early-stage epinephrine prodrug topical gel for dermatology conditions [2]

WARREN, N.J., April 01, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced positive topline results from its pediatric study for Anaphylm™ (epinephrine) sublingual film in patients aged seven to seventeen and weighing greater that thirty kilograms with a personal history of allergic reactions. Th ...

Writing under the pseudonym "out of ignorance", I very much regard investing as a learning process. Investing failures are tuition paid. Investing successes enter the trove of lessons learned. In my Seeking Alpha articles I share my experience from decades of investing and from ~5 years of focused research on a variety of stocks, in recent years with a primary emphasis on healthcare stocks. I greatly appreciate those who take the time to share their reactions to articles, particularly those who share releva ...

Financial Data and Key Metrics Changes - Total revenue decreased to $11.9 million in Q4 2024 from $13.2 million in Q4 2023, a 10% decrease primarily due to declines in license and royalty revenue [31] - For the full year 2024, total revenues increased to $57.6 million from $50.6 million in 2023, a 14% increase driven by increases in license and royalty revenue [32] - Net loss for Q4 2024 was $17.1 million or $0.19 per share, compared to a net loss of $8.1 million or $0.12 per share in Q4 2023 [36] - Non-GAAP adjusted EBITDA loss was $11 million in Q4 2024 compared to $2.8 million in Q4 2023 [38] Business Line Data and Key Metrics Changes - Manufacture and supply revenue decreased to $10.7 million in Q4 2024 from $11 million in Q4 2023, primarily due to a decrease in Suboxone revenues [31] - License and royalty revenue decreased to $0.8 million in Q4 2024 from $1.9 million in Q4 2023, mainly due to prior year milestone royalty revenue [31] - Research and development expenses increased to $4.9 million in Q4 2024 from $2.9 million in Q4 2023, driven by clinical trial costs for Anaphylm [34] Market Data and Key Metrics Changes - The company plans to submit applications for Anaphylm in international markets including the EU, UK, and Canada [22] - The estimated market opportunity for JAK inhibitors, which are existing therapies for alopecia areata, is over $1 billion [24] Company Strategy and Development Direction - The company has begun the filing process with the FDA for Anaphylm and expects to launch in Q1 2026 if approved [9][10] - Plans to focus on international markets and partnerships for Anaphylm post-FDA submission [22] - The company is preparing for a potential advisory committee meeting for Anaphylm, expected in the second half of 2025 [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Anaphylm's profile and its potential to be preferred by patients due to its rapid absorption and ease of use [48] - The company anticipates total revenues of approximately $47 million to $56 million for 2025, including some erosion in Suboxone demand [41] - Management remains committed to ensuring access to Libervant for young patients despite recent legal challenges [26][66] Other Important Information - The company raised over $78 million in capital from institutional investors to support strategic priorities [30] - Cash and cash equivalents were $71.5 million as of December 31, 2024, with a pro forma adjustment to approximately $93 million after recent fundraising [39] Q&A Session Summary Question: Key topics for FDA advisory committee meeting - Management discussed confidence in Anaphylm's profile and the importance of rapid epinephrine uptake during allergic reactions [44][45] Question: Early adopters of Anaphylm - Management believes that anyone at risk of anaphylaxis will be an early adopter, with a focus on teenagers and young adults [49][50] Question: Commercialization strategy - The company is prepared to launch Anaphylm independently but is open to partnerships if beneficial [54][60] Question: Libervant's future - Management emphasized the importance of Libervant for patients and the ongoing efforts to ensure access despite legal challenges [66][102] Question: Market seasonality for epinephrine products - Management highlighted the seasonal nature of the epinephrine market, with a peak in demand during summer months [72][73] Question: Safety profile of Anaphylm - Management expressed confidence in the safety and efficacy data supporting Anaphylm, noting a robust clinical package submitted to the FDA [77][78]

Core Insights - Aquestive Therapeutics reported a revenue of $11.87 million for Q4 2024, reflecting a year-over-year decline of 10.2% and an EPS of -$0.19 compared to -$0.12 a year ago [1] - The revenue fell short of the Zacks Consensus Estimate of $13.5 million by 12.11%, while the EPS also missed the consensus estimate of -$0.14 by 35.71% [1] Revenue Breakdown - Manufacture and supply revenue was $10.66 million, below the average estimate of $11.38 million, representing a year-over-year decline of 3% [4] - License and royalty revenue was $0.83 million, significantly lower than the average estimate of $1.86 million, indicating a year-over-year decrease of 55.6% [4] - Co-development and research fees amounted to $0.27 million, compared to the average estimate of $0.43 million, reflecting an 18.2% year-over-year decline [4] - Proprietary product sales, net, were $0.10 million, below the average estimate of $0.20 million [4] Stock Performance - Shares of Aquestive Therapeutics have decreased by 11.1% over the past month, while the Zacks S&P 500 composite has declined by 4.1% [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]